Algolia Update English

Array ( [0] => Array ( [objectID] => 35113 [title] => Syngenta drops its appeal against the Faucheurs Volontaires [timestamp] => 1790812800 [date] => 01/10/2026 [annee] => 2026 [url] => https://infogm.org/en/syngenta-drops-its-appeal-against-the-faucheurs-volontaires/ [image] => https://infogm.org/wp-content/uploads/2026/10/21-O9-26-COUR-DAPPEL-WEB-768x459.jpg [extrait] => On Monday, September 21, 2026, at the Montpellier Court, the seat reserved for Syngenta’s lawyer was empty. And with good reason: the multinational – a subsidiary of the Chinese holding company Sinochem – had decided to withdraw its appeal against the civil-court acquittal won by the Faucheurs volontaires in the initial trial in Perpignan in […] [chapo] => On September 21, 2026, in Montpellier, Syngenta withdrew its appeal against the Faucheurs volontaires (volunteer crop destroyers) following the destruction of a sunflower plot in the Pyrénées-Orientales in 2016. In the initial proceedings, the Perpignan court had acquitted the activists, recognizing the defense of necessity. Consequently, Syngenta had appealed solely regarding the €760,000 in damages it was claiming. [texte] => On Monday, September 21, 2026, at the Montpellier Court, the seat reserved for Syngenta’s lawyer was empty. And with good reason: the multinational - a subsidiary of the Chinese holding company Sinochem - had decided to withdraw its appeal against the civil-court acquittal won by the Faucheurs volontaires in the initial trial in Perpignan in December 2020i. No appeal had been filed regarding the criminal aspect of the case by either the prosecution or Syngenta. A recap of the facts follows.Three hectares destroyed in 2016In 2016, 150 Faucheurs volontaires destroyed a three-hectare plot of sunflowers in Elne (Pyrénées-Orientales). They believed the plot was planted with herbicide-tolerant sunflowers (VrTH). A report by Ansesii (the French Agency for Food, Environmental and Occupational Health & Safety) had indicated that the sunflowers were produced via so-called "in vitro" mutagenesis. Despite Syngenta’s subsequent denials, the plants therefore constituted GMOs under European Directive 2001/18.During the initial trial, the judge officially affirmed that the VrTH sunflowers were GMOs - a claim denied by Syngenta, which had recently acquired Nidera, the company that owned the destroyed crops. In its ruling, the court found that "the civil party [i.e., Syngenta] is lying when it claims there were no GMOs in this field" and noted that "no authorization had been granted for this plot". The field was therefore being cultivated illegally. The court held that the burden of proof lies with industrial operators to demonstrate that their crops are not GMOs. A similar judgment had been handed down by the Dijon Criminal Court on January 17, 2019, in the case involving the destruction of Dijon Céréales’ rapeseed cropiii.Syngenta withdraws its appealRegarding the hearing scheduled for September 21, 2026, at the Montpellier Court of Appeal, the Faucheurs volontaires state in their press release: "This withdrawal is virtually unprecedented and stands out in the world of agrochemical multinationals, which typically engage in relentless litigation designed to wear down their opponents both morally and financially."ivIt is worth recalling that the public prosecutor did not appeal the acquittal secured in the initial trial in Perpignan; consequently, the recognition of the "state of necessity" defense went unchallenged. Syngenta had embarked on a solo legal campaign aimed at weakening the Faucheurs volontaires movement by demanding around €760,000 in damages. The outcome of the trial was therefore highly uncertain.The Faucheurs suggest several other possible reasons for this withdrawal. During the initial trial, Syngenta had partly justified its claim for damages by citing lost royalties on the destroyed seeds. However, "citing the protection of manufacturing processes, it had refused to disclose [the breeding method and variety name] of the destroyed plants. Yet, to substantiate its claims on appeal, would it have been forced to reveal confidential information regarding the techniques and varieties used - information that could prove detrimental to the company?", the Faucheurs ask.The fact remains that in 2016, at the time of the crop destruction, cultivating sunflowers derived from recent genetic modification techniques without official authorization was illegal. Furthermore, Nidera should have publicly disclosed the location of the plots where these crops were grown.A withdrawal linked to current protestsCould Syngenta’s withdrawal also be explained by a desire to "avoid bad publicity"? That is the question posed by the Faucheurs (crop-destroying activists). Indeed, the Perpignan Court had been receptive to arguments from the defense and its witnesses regarding the health and environmental risks associated with herbicides used on VrTH plants. It was for this reason - and due to the risks of GMO contamination - that the court recognized the "state of necessity" defense in 2020.With an international protest against Syngenta scheduled for Saturday, October 3 (taking place in the Eure department in France)v, Syngenta’s withdrawal takes on a new light: an attempt not to add fuel to the fire. It is also worth noting that Syngenta had been claiming tens of thousands of euros in damages for "reputational harm". Arguing this case at a time when Syngenta’s "black book" of controversies is only growing longer could have proven difficult. In the same statement, the Faucheurs write: "We can understand Syngenta’s caution; the company has no desire for a trial to expose the dark side of its operations and its involvement in numerous well-documented scandals."Inf’OGM has previously documented various actions and statements by Syngenta - such as a remark made in 2022 by its boss, Eric Eyrwald, who claimed: "Africans are starving because we are eating more and more organic products."vi A few years earlier, in 2018, the company was found jointly liable for the death of a Landless Movement farmer in Brazilvii.i Christophe Noisette, « OGM : relaxe pour les Faucheurs au nom de l’état de nécessité », Inf’OGM, 19 January 2021.ii Christophe Noisette, « L’Anses tergiverse sur les variétés tolérantes aux herbicides », Inf’OGM, 5 March 2020.iii Christophe Noisette, « OGM – Les Faucheurs volontaires relaxés définitivement à Dijon », Inf’OGM, 5 February 2019.iv Faucheurs volontaires d’OGM, « Contre un faucheur volontaire d’OGM, la multinationale Syngenta jette l’éponge ! », 21 September 2026.v Stop pesticides, international mobilization, « Pesticides, Syngenta, not here, not anywhere! ».vi Christophe Noisette, « Pour Syngenta, la bio pourrait aggraver la crise alimentaire actuelle », Inf’OGM, 9 May 2022.vii Christophe Noisette, « Brésil – Syngenta condamnée suite à la mort d’un paysan », Inf’OGM, 22 January 2019. Christophe NOISETTE noisette [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [1] => Array ( [objectID] => 34996 [title] => The Commission says it is acting as a matter of urgency to deregulate GMO micro-organisms… [timestamp] => 1790726400 [date] => 30/09/2026 [annee] => 2026 [url] => https://infogm.org/en/the-commission-says-it-is-acting-as-a-matter-of-urgency-to-deregulate-gmo-micro-organisms/ [image] => https://infogm.org/wp-content/uploads/2026/09/sanchez-sacristan-768x432.jpg [extrait] => The European Commission wants to deregulate genetically modified bacteria, yeasts and viruses in order to reduce the time it takes for them to be placed on the market, the risk assessments carried out on them, and the information provided to operators and the public… This is the package of measures proposed from December 2025! Under the guise of a so-called urgent need for action, the Commission has cut corners by failing to consult the public on this issue and by withholding certain documents, including a key "impact assessment". [chapo] => The European Commission wants to deregulate genetically modified bacteria, yeasts and viruses in order to reduce the time it takes for them to be placed on the market, the risk assessments carried out on them, and the information provided to operators and the public… This is the package of measures proposed from December 2025! Under the guise of a so-called urgent need for action, the Commission has cut corners by failing to consult the public on this issue and by withholding certain documents, including a key “impact assessment“. [texte] => In December 2025, as the end-of-year holidays approached, the European Union was in the midst of a legislative debate over whether plants genetically modified using new techniques of genetic modification (NGT) should be deregulated or not. It was during this same period that the European Commission chose to launch a similar legislative push on genetically modified micro-organisms (GMMs). This drive was initiated by Denmark, home to one of the leading multinational companies in the field of microorganisms, Novonesis, which was then holding the presidency of the Council of the European Union (EU).If the European Commission has shown, as we shall see, great haste in this matter, it is because it has taken considerable liberties with several procedural stages. However, according to the Commission, there is an "urgent" need to act in the interests of the EU’s competitiveness. Yet, to date, very few countries have deregulated GMOs produced using NGTs (GMO/NGT), as shown in an OECD report published in late 2025i.No public consultation and an accelerated timetableThe proposal was formally published on 16 December 2025ii. Like any legislative proposal put forward by the European Commission, the proposal to deregulate GMMs is the result of preparatory work by the Commission, which, in order to comply with "good practices", must take various steps. These typically include gathering external input and organising a public consultation to assess the expectations of citizens, businesses, trade unions, associations and so on.A distinctive feature of this proposal to deregulate GMMs is that no call for contributions or public consultation took place. The proposed text nevertheless refers to two such initiatives, with the Commission stating in the introductory remarks accompanying the proposal that "stakeholders’ views on GMMs expressed in the calls for evidence related to the Biotech Act 10 and the Food and Feed Safety Simplification Omnibus 11 stressing the recent innovations regarding GMMs and underlining the necessity to adapt the GMO framework to these developments have been taken into account". The Commission’s wording is accurate, since the consultations to which it refers did not concern the deregulation of GMMs that can be released into the environment. The first concerned the "Biotech Act", which deals primarily with biotechnology in general, but whose call for contributions made no mention of micro-organismsiii. The second focused on the safety of food and feed and refers to GMMs solely in the context of their cultivation in fermentersiv. Given that this proposal "is part of the Biotech Act"v, the Commission presumably considered that a dedicated consultation was unnecessary, disregarding citizens and placing them in the incongruous position of being unable to comment on a draft piece of legislation of which they had not been informed.In the absence of a call for contributions and prior public consultation, on what basis did the European Commission therefore base its decision? Still in its introductory remarks, the Commission refers to "an external study commissioned by the European Commission [...] ("Analysis of the Regulatory Framework for Biotechnology and Biomanufacturing in the EU")", which it states was "being carried out" and "in English only", as stated in the French version, at the time the proposal was formally tabled. The Commission also states that it gathered information "through 25 interviews (by November 2025)". Who did it interview? This information is not provided…A mandatory impact assessment… but one that does not existAmong the documents that the European Commission is required to provide when putting forward a legislative proposal is an "impact assessment". Carrying out such an assessment seems logical, as it involves evaluating the positive and negative impacts that the new measures proposed by the Commission would have. However, in the case of GMMs, the Commission does not know what the impacts of its proposal would be if it were to be adopted. Indeed, no impact assessment was attached on 16 December 2025, nor has one been provided even todayvi.“Because of the urgency to act on biotech, the Commission decided not to do an impact assessment before making the proposal but to present a staff working document substantiating the evidences collected, consultations, etc...”Irene Sacristán Sánchez, Director of the European Commission’s Biotech Unit, on 24 March 2026 before MEPsThe European Commission justified this lack of an impact assessment "considering the political urgent need to address the policy challenges identified in the European Biotech Act". It stated that an "an impact assessment could not have been delivered in the timeframe available before the proposal’s adoption". This position was confirmed by the Director of the European Commission’s Biotech Unit, Irene Sacristán Sánchez, on 24 March 2026vii. On that day, addressing MEPs sitting on the European Parliament’s ENVI–Public Health Joint Committee, she stated that "because of the urgency to act on biotech, the Commission decided not to do an impact assessment before making the proposal but to present a staff working document substantiating the evidences collected, consultations, etc...".This explanation is surprising, as work on this legislative proposal did not begin in autumn 2025. As early as 2022, the Commission commissioned the European Food Safety Authority (EFSA), which brings together European experts, to provide a report on the risk assessment of GMMs released into the environment. In 2023, it commissioned its other expert group, the European Network of GMO Laboratories (ENGL), to produce a report on the detection and identification of GMMs. And, in February 2024, whilst the Commission had begun to gather the necessary scientific documentation, the European Parliament asked it to review the available information on "micro-organisms, fungi and animals" with a view to deregulating GMMs derived from NGTs (GMM/NGT). The urgency to act claimed by the European Commission to justify not having had time to carry out an impact assessment of its proposal is therefore not justified, given that four years have passed since it began its work.However, on 16 December 2025, the Commission gave an assurance that "an analytical Staff Working Document (SWD) will be prepared. The analytical SWD will explain the proposal and will present the underlying evidence and impact analysis, including a cost–benefit assessment". At the time of publication of this article, almost a year later, these documents supporting the proposed directive on the release of GMMs have still not been published on the European Legislative Observatory’s website. Only the working documents supporting the Biotech Act have been made public.A proposal that over-interprets expert opinionsAmong the other measures taken by the Commission, it may be worth recalling the case of the two expert opinions mentioned above, which were compiled in 2022 and 2023.Regarding the detection and identification of GMMs and NGTs in the agrifood sector, the ENGL submitted its report in 2025. As Inf’OGM reported at the timeviii, this report concluded that "the vast majority of these micro-organisms are detectable and identifiable. However, “in some cases“, with the processes currently available, very small genetic modifications can be more complicated, or even impossible, to detect and differentiate from those that can occur without technical intervention on the genome". The European Commission’s interpretation of this report is along these lines, but the proposal it has chosen to put forward is not limited to "certain cases". Indeed, in its introductory remarks, it notes the existence of "certain challenges due to technical difficulties and to the fact that in some instances similar modifications to those obtained with NGTs may also occur naturally"ix. The proposed legislation therefore covers cases in which "it is not feasible to provide a method that detects, identifies and quantifies are also adapted in the proposal" the GMM. This generalisation is reflected in the proposed legislative measure, as it provides that "where this is duly justified by the notifier, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted". It is therefore up to businesses to declare whether their GMMs are traceable or not…As regards the issue of risk assessment for GMMs and NGTs, the Commission’s U-turn is more nuanced. In October 2025, EFSA published its reportx on the matter, which Inf’OGM will discuss in detail in a forthcoming article. The experts concluded, in particular, that "on a case-by-case basis for specific NGT-Ms, fewer requirements may be needed" to carry out a valid risk assessment. They specified that, given “possible hazards relate to genotypic and phenotypic changes introduced and not to the method used for the modification, it is recommended that any new guidance should take a consistent risk assessment approach for strains/products derived from or produced with microorganisms” genetically modified, regardless of the technique used.On this basis, the European Commission proposes that the current legislation on GMOs be amended to "establish specific requirements for GMMs with an inherently low risk profile to ensure that the risk assessment and procedures are proportionate to the risks the GMMs raise [and thus] lead to a reduction of time to market for low-risk GMMs".The very concept of "low-risk" GMMs does not exist in the EFSA opinion. Whilst it mentions risks that may be "less frequent" for certain GMMs, nowhere does it refer to the existence of "low-risk" GMMs. However, for the Commission, this change in terminology is sufficient to propose that it alone should be responsible for amending Directive 2001/18 so as to provide "procedural requirements for the risk assessment of low-risk GMMs adapted to their characteristics". This "low-risk GMM" status would be based on the notion that the GMM has a "Status of Qualified Presumption of Safety", which would be established by European experts via "the safety status assigned by the [EFSA] to selected groups of micro-organisms on the basis of an assessment showing no safety concerns" and on condition that the GMM does not contain "genes of concern which are not naturally present in the parental organism, in particular acquired antimicrobial resistance genes". It is therefore to be expected that, should the Council of the EU and the European Parliament grant it this power, the Commission will amend Directive 2001/18 so that no specific risk assessments are carried out for these GMMs…The Commission is using a single text to introduce two deregulationsProposed Directive 2025/0405, aimed at facilitating the commercial release of GMMs in Europe, contains another issue that has nothing to do with GMMs: that of organ production and transplantation in human medicine. A single piece of legislation to amend two directives dealing with different areas… a choice that raises questions. As noted by the French Senate in a report by its Committee on European Affairs dated 13 May 2026, this merging of the two subjects was carried out by the Commission “on the grounds that it introduces changes announced in the context of the new legislation on biotechnology [Editor’s note: the Biotech Act], which can only be implemented by means of a directive and therefore cannot be included in the proposed regulation [Editor’s note: the Biotech Act]”xi.However, this explanation does not account for why the European Commission did not put forward two proposals for directives, one to deal with GMMs and the other with organ transplantation. Once again, on 24 March 2026, during the meeting of the European Parliament’s Joint Committee on the Environment and Public Healthxii, Irene Sacristán Sánchez explained that the Biotech Act is like a puzzle and "the biotech act cuts across many sectors of legislations […] and these two elements are part of that". An explanation which, in fact, is not really an explanation at all… Moreover, concerning the proposal on organ transplantation, the French Senate ruled in May 2026 that "such a proposal for revision should have been separated from the revision of the GMO Directive".The urgency to act claimed by the European Commission enables it to initiate procedures to amend European legislation within very tight deadlines. Whilst discussions on the deregulation of GMO/NGT plants took three years, the Commission wishes to move more quickly on GMMs. The French Senate also notes that "in recent years, the European Commission has been putting forward an increasing number of legislative proposals aimed at simplification, notably in the form of “omnibus” bills, which are most often examined within very tight deadlines" and is alarmed that such a legislative proposal "is being examined within such a short time-frame, given that it concerns the regulation of genetically modified organisms, [a subject] that is particularly critical in view of the environmental, health and ethical issues" it raises. In addition to the numerous environmental and health impacts and infringements of farmers’ rights highlighted by a coalition of French organisationsxiii, the proposal is also set to be dealt with as a matter of urgency. Despite the seriousness of the issue, the European legislator is not resisting this pressure to act. The Council of the EU has, in fact, already adopted a favourable position six months after work beganxiv, whilst the Parliament could adopt its own position in less than a year’s time, next November…i Eric Meunier, « The OECD highlights disparities in regulations on GMOs obtained by NGTs », Inf'OGM, 24 September 2026.ii European Commission, « Document 52025PC1031 - Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs », 16 December 2025.iii European Commission, « Biotech Act ».iv European Commission, « Food and feed safety simplification omnibus ».v Remarks made by the European Commission at a meeting of the European Parliament’s Joint Committee Environment and Public Health on 24 March 2026. European Parliament, « Joint Committee Procedure ENVI-SANT CJ64 », 10:15:00, 24 March 2026.vi The documents to be attached by the Commission to its legislative proposal are available on the page dedicated to the proposal on the European Legislative Observatory website, under the heading "Documentation Portal/European Commission". The documentation portal still does not contain any European Commission documents other than the proposal made in December 2025.European Parliament, « Placing on the market of genetically modified micro-organisms and the processing of organs », visited on 28 September 2026vii European Parliament, « Joint Committee Procedure ENVI-SANT CJ64 », 10:15:00, 24 March 2026.viii Eric Meunier, « The majority of micro-organisms modified by NGTs are detectable », Inf'OGM, 23 December 2025.ix See point 3 of the Commission’s explanatory memorandum to its legislative proposal:European Commission, « Document 52025PC1031 - Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs », 16 December 2025x EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins, E. et al., « New developments in biotechnology applied to microorganisms », EFSA Journal, Vol. 22, Issue 7, e8895, 22 July 2024.xi French Republic, Senate, Commission of european affairs, « Political opinion on the Proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs », 13 May 2026.xii European Parliament, « Placing on the market of genetically modified micro-organisms and the processing of organs », visited on 28 September 2026.xiii Eric Meunier, « In France, a campaign against the deregulation of genetically modified micro-organisms », Inf'OGM, 9 September 2026.xiv Eric Meunier, « The Council of the EU wants to speed up the release of GMM into the environment », Inf'OGM, 6 July 2026. Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [2] => Array ( [objectID] => 34514 [title] => We’re on the same side: it’s time to support the independent press [timestamp] => 1790553600 [date] => 28/09/2026 [annee] => 2026 [url] => https://infogm.org/en/were-on-the-same-side-its-time-to-support-the-independent-press/ [image] => https://infogm.org/wp-content/uploads/2026/09/tribune-pluralisme-1024x682-1-768x512.jpg [extrait] => Whilst the algorithms of the GAFAM companies are seeking, day by day, to gain ever greater control over our internet searches and, ultimately, over our choice of news sources and our free will, some thirty figures from the french independent press are calling on readers to defend media pluralism. [chapo] => Whilst the algorithms of the GAFAM companies are seeking, day by day, to gain ever greater control over our internet searches and, ultimately, over our choice of news sources and our free will, some thirty figures from the french independent press are calling on readers to defend media pluralism. [texte] => As a member of the Syndicat de la Presse Pas Pareille, signatory to this open letter, Inf’OGM supports and echoes this call. We would, however, like to point out that the editorial team at Inf’OGM prefers the term "algorithm factories" to the somewhat misleading term "artificial intelligence". Indeed, as we have already highlighted in an article, "these computer factories require ever-larger servers, leading to increasingly problematic consumption of water and energy resources", and their operations are very much directed by humans… so there is nothing artificial about them at alli .Since this summer in France, our Google searches no longer link to sources. By processing millions of web pages, the search engine now provides us with an answer generated by "artificial intelligence" (AI). In doing so, Google disregards those who produce the information and appropriates the fruits of their labour. Whilst the biggest media players collude with the artificial intelligence giants, smaller players are ignored and find themselves rendered completely invisible. With AI, citizens are deprived of part of their free will. They no longer choose how they stay informed; "someone" chooses for them.Google is just one example of how big tech companies exploit information and steer public debate. Before Google, Facebook had deliberately excluded the media from the suggestions made to users, deeming them too unprofitable commercially.All this merely reinforces a phenomenon we know only too well: the monopolisation of news production by a select few, to the detriment of everyone else.« Only you, our readers, can ensure that we are not rendered permanently invisible ».Independent media outlets will never be led by a billionaire willing to lose tens of millions of euros a year simply to own a newspaper and the influence that comes with it. They rely solely on you. At a time when clarity in public debate and honesty in journalism must take precedence more than ever, when investigative journalism must prevail over deference, and when free media are needed to defend freedoms, we make this solemn and collective appeal to you.Only you, our readers, can ensure that we are not rendered permanently invisible. This is not about defending our own little fiefdoms, but about the pluralism of viewpoints – which, ultimately, means democracy, freedom and equality. We are on the same side. Join us, share this message, donate, subscribe! The time is now.The signatories:La Presse libre, Coop médias, Arrêt sur images, Basta, Blast, Cerise la coopérative, La Déferlante, Le Média, Le Poulpe, Le Syndicat de la presse pas pareille, Les Jours, Les utopiques, L’Iceberg, L’Observatoire des multinationales, Marsactu, Mediacités, Mediapart, Next, Politis, Qui vive, Reflets, Reporterre, Rue89 Bordeaux, Rue89 Lyon, Rue89 Strasbourg, Socialter, Splann!, Vert.ihttps://infogm.org/l-intelligence-artificielle-au-service-de-la-numerisation-des-genomes/ Collectif antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [3] => Array ( [objectID] => 34497 [title] => The OECD highlights disparities in regulations on GMOs obtained by NGTs [timestamp] => 1790208000 [date] => 24/09/2026 [annee] => 2026 [url] => https://infogm.org/en/the-oecd-highlights-disparities-in-regulations-on-gmos-obtained-by-ngts/ [image] => https://infogm.org/wp-content/uploads/2026/09/OCDE.jpg-768x453.webp [extrait] => The argument that the European Union must catch up with other countries by deregulating GMOs produced using new genetic modification techniques (GMOs/NGTs) is repeated ad nauseam by their proponents. However, at the end of 2025, an OECD report reviewed the legislation in force in some of the largest GMO-producing countries (Argentina, Brazil, Canada, the United States, etc.). And the least one can say is that the international legislative landscape is highly varied. [chapo] => The argument that the European Union must catch up with other countries by deregulating GMOs produced using new genetic modification techniques (GMOs/NGTs) is repeated ad nauseam by their proponents. However, at the end of 2025, an OECD report reviewed the legislation in force in some of the largest GMO-producing countries (Argentina, Brazil, Canada, the United States, etc.). And the least one can say is that the international legislative landscape is highly varied. [texte] => In 2025, the Organisation for Economic Co-operation and Development (OECD) sent a questionnaire to its members, accession candidates and key partners. This questionnaire concerned the regulation of GMOs produced using new techniques of genetic modification (GMOs/NGTs). In October 2025, it published the twenty responses received1. Of the respondents, eleven are members of the European Union (EU) and all referred to the response they had provided before the legislation deregulating these GMOs was adopted. Eight non-EU countries also responded: Argentina, Australia, Brazil, Canada, Japan, South Korea, South Africa and the United States. This therefore provides an opportunity to take stock of the existing legislation – or lack thereof – in these countries, even though the level of detail in the responses received varies from one country to another.A limited questionnaireIn its report, the OECD sets out several objectives for its questionnaire. It aimed to collect "public and official information on regulatory frameworks and approved/registered/reported/notified products of" new techniques of genetic modification. The OECD requested that products developed solely for research purposes, products currently undergoing the authorisation process, and regulatory frameworks currently under review (considered "confidential") be excluded. Genetic forcing technologies are also excluded, as they are "out of the scope because it is accompanied with insertion of transgenes", that remain in the organism. Finally, only plants are supposed to be the subject of the requested information, although "delegations are free to provide information related to other organisms".South America (Argentina and Brazil)ArgentinaFor Argentina, a candidate for OECD membership, a change in approach was implemented in 2021 following a legislative review process that began in 2020. The country has chosen to regulate GMOs/NGTs by focusing on the question of whether they should be classified as GMOs or non-GMOs. In its response to the OECD, Argentina explains that a procedure has been put in place to address this question. Based on the definition of a living modified organism as set out in the Cartagena Protocol and led by the National Advisory Commission on Agricultural Biotechnology (Conabia), this procedure is designed to determine whether the GMO/NGT is a "living organism that possesses a novel combination of genetic material obtained through the application of modern biotechnology". However, Argentina differs from the Protocol in that it also provides a definition of what it considers to be a novel combination of genetic material. For Argentina, such a combination is "change produced in the genome of the organism by the incorporation, in a stable and joint form, of one or more genes or nucleic acid sequences that form part of a defined genetic construct". In other words, GMO status is linked to the presence in the genome of a genetic sequence that has been stably inserted. Other modifications (deletions, substitutions, etc.) would not confer GMO status.BrazilIn 2018, Brazil, a key partner of the OECD, clarified its approach to GMOs and NGTs. As in Argentina, the National Technical Commission on Biosafety (CTNBio) assesses on a case-by-case basis whether GMOs produced using "innovative Precision Breeding Techniques" constitute GMOs under Brazilian law. These techniques are defined as "a set of new methodologies and approaches that differ from the genetic engineering strategy by transgenics, as they result in the absence of recombinant DNA/RNA in the final product". Five criteria have therefore been established to determine, on a case-by-case basis, whether a product is a GMO or not. If any one of the five criteria is met, the GMO in question will not be legally considered a GMO and will therefore not be subject to the requirements of Brazilian legislation on GMOs.Thus, the following will not be considered a GMO:« i) Product with proven absence of recombinant DNA/RNA, obtained by a technique that uses GMO as parental;ii) Product obtained by a technique that uses DNA/RNA that will not multiply in a living cell;iii) Product obtained by a technique that introduces site-directed mutations, generating gain or loss of gene function, with the proven absence of recombinant DNA/RNA in the product;iv) Product obtained by a technique where there is expression, temporarily or permanently, of recombinant DNA/RNA molecules, without the presence or introgression of these molecules in the product; andv) Product where techniques are used that employ DNA/RNA molecules that, whether absorbed or not in a systemic way, do not cause permanent modification of the genome ».North America (Canada and the United States)Canada and the United States, both members of the OECD, have historically taken a different approach to the rest of the world. For these countries, the issue is not whether a product is genetically modified or not.CanadaCanada focuses on "novel products", i.e. those with new characteristics or which are, in fact, new foods and therefore different from what is already available in Canada. Where a product is genuinely novel, Canada assesses, for example, the safety of plants with a view to their release into the environment, as well as their safety and efficacy as food for animals and humans. This assessment is based on a dossier submitted by the company wishing to market this novel food. As regards NGTs, they are considered by Canada to be GMOs2. However, this GMO status does not specifically alter the approach adopted, which is based on the final product and the question of its novelty. There is, nevertheless, one exception: where release into the environment is envisaged, "plants with DNA from genetic sources outside the plant species (foreign DNA) and plants with new herbicide tolerance traits are always considered to be novel"3.In the field of environmental release, novelty is assessed in Canada by first considering whether "the trait is new to cultivated populations of the species in Canada", and then whether "the plant has a potential to have a significant negative environmental effect"4. To put it another way, the assessment considers whether the new trait could give rise to "weediness", lead to gene flow to compatible plants, cause the plant to act as a parasite, or have an impact on non-target organisms or biodiversity.For food intended for human consumption derived from genetically modified plants, Canada has established that certain genetic modifications would not confer "novel" status, namely if the modification does not render a plant protein allergenic or toxic, does not increase the effects of known allergens or toxins, does not affect "key nutritional composition and/or metabolism", does not alter the plant’s use as food, or does not involve the presence of foreign DNA in the plant5.United States of AmericaThe United States takes a similar approach to Canada, although it is based on a different concept. With regard to release into the environment, the US considers whether the GMO is a pest, could become a pest, or contains DNA derived from a pest. If the answer is no, the organism is "not regulated", regardless of the genetic modification technique used.Between 2020 and 2 December 2024, however, exemptions were granted. These allowed certain GMOs to be exempt from the regulations in force. These exemptions applied to organisms with:“ a change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template;a targeted single base pair substitution;a gene known to occur in the plant’s gene pool, or a change in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool;an indel [an insertion/deletion] or contiguous deletion of any size, made at a targeted location, with or without insertion of DNA if generated without using a repair template, or without insertion of DNA if generated using a repair template”.This exemption also applied to plants with "up to twelve modifications, made simultaneously or sequentially, if each modification individually qualifies for exemption and occurs in a different gene" or "a plant-trait-mechanism of action combination that has been previously reviewed for risks to plant health and determined [...] not to be regulated".However, since a court ruling on 2 December 2024 by the US Federal Court in California6, these exemptions no longer apply and GMOs/NGTs are all regulated in the same way as any other GMO.Asia-Pacific (Japan, South Korea and Australia)JapanIn Japan, an OECD member, legislation was revised from 2019 onwards, and gradually thereafter, to address the issue of regulating GMOs produced using "genome editing technology". In its response to the OECD, Japan refers to the Cartagena Protocol to determine whether an organism is a GMO or not (the Protocol refers to "living modified organisms", or LMOs). However, the Japanese government’s interpretation of the Protocol appears to be a permissive one. The country has chosen to focus on the characteristics of the final product, regardless of the technique used, whereas the Protocol (just like the recently amended 2001 European regulation) defines LMOs not on the basis of their characteristics, but on the basis of how they have been genetically modified. Thus, for Japan, if an organism is genetically modified but no longer contains the genetic sequence(s).This non-GMO status may be granted subject to the provision of information demonstrating:the absence of inserted genetic sequences,the method of genetic modification used,the modified genetic sequence(s) and their functions,the new characteristics obtained, as well as any other new characteristics,the intended use of the organism,and information on "possible influences on biological diversity when the organism is used"7.Six ministries are involved, depending on the intended uses, whether in agriculture, forestry, veterinary or human medicines (and gene therapy), agri-food processing, research experiments or "the production of alcoholic beverages".South KoreaIn South Korea, a member of the OECD, a legislative proposal was tabled in September 2024 aimed at distinguishing between "conventional LMOs" and those produced "through genome editing". The aim of this proposal was to establish a differentiated regime between the two categories by exempting GMOs obtained through "genome editing" from the requirements of the GMO Act. However, to date, this proposal has not been successful, as discussions in Parliament have been suspended. As they are not exempt, GMOs/NGTs are therefore currently regulated as GMOs in South Korea.AustraliaIn Australia, an OECD member country, the deliberations and legislative process were spread out over time, with the final version of the Act adopted in February 2025. To date, several scenarios are taken into account when determining whether a product is classified as a GMO or not8.Basically, if an organism is modified by cutting its DNA without any "genetic" molecule being used to repair it, that organism is not legally a GMO. If, on the other hand, a DNA sequence is used as a guide or expression cassette – without being integrated into the genome – or for insertion, then the organism is legally a GMO. If "offspring" organisms are obtained from a GMO but the inserted or used genetic sequences are no longer present, they are not considered to be GMOs.Thus, among the techniques that result in GMOs legally defined as such in Australia are oligonucleotide-directed mutagenesis and any technique that utilises or inserts genetic sequences. In the case of RNA interference (where small RNA molecules are injected to bind to a "complementary" RNA sequence present in the cell and silence it), Australia has stipulated that this exemption should apply only to techniques using "short-lived RNAi"9. It therefore specifies that the exemption applies only if "the introduced RNA cannot lead to the production of infectious agents" and that "the organism’s genomic DNA sequence cannot be changed by the technique", whilst changes to DNA methylation are permitted.In Australia, food appears to have a rather distinctive status, as the definition of GMOs intended for human consumption was amended in September 202510. On this occasion, the approach was more radical, as the government chose to define GM foods by considering only the final product, rather than the technique used. Consequently, any "an organism or cells containing novel DNA" is considered to be a GMO.In view of the definition adopted for "novel DNA", Australia has therefore chosen, in relation to food for human consumption, to define a GMO as an organism containing DNA inserted by a technician into the organism or one of its cells; where such DNA originates from a species that is not sexually compatible, or contains a region of DNA that has been previously rearranged or recombined, or which "is not from an existing species".South AfricaIn South Africa, a key partner and the only country on the continent to have responded to the OECD questionnaire, a GMO is legally defined as "an organism the genes or genetic material of which has been modified in a way that does not occur naturally through mating or natural recombination or both". On the basis of this definition, South Africa replied to the OECD that its Executive Council had concluded that the risk assessment framework applicable to GMOs also applies to GMOs/NGTs. In other words, these are GMOs that must comply with the requirements laid down by legislation as decided by the government in 2021. As the African Centre for Biodiversity points out11, these legislative requirements therefore mandate the issuance of a marketing or trial authorisation, a risk assessment, labelling, and a method for detection and identification. It adds that, “sometimes [...] socio-economic and ethical considerations” are adressed.Disparate regulationsLooking at the eight non-EU responses, it is clear that the regulatory framework for GMOs/NGTs varies considerably. This contradicts what multinationals and the European Commission have suggested, namely that the EU should deregulate GMOs/NGTs to bring itself into line with other countries. On the contrary, it is possible that the EU’s decision will be the one to trigger legislative changes in other countries. Indeed, several have chosen to align themselves with European legislation, as the EU is the world’s largest import market.These differences could also give rise to significant problems in international trade, as well as heated debates within the Cartagena Protocol, of which most of the countries mentioned above are members. Indeed, a majority of the signatory countries to this protocol still regard GMOs/NGTs as GMOs subject to its provisions. Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [4] => Array ( [objectID] => 34522 [title] => NGT and patents: the EU has chosen to ignore the US precedent [timestamp] => 1790121600 [date] => 23/09/2026 [annee] => 2026 [url] => https://infogm.org/en/ngt-and-patents-the-eu-has-chosen-to-ignore-the-us-precedent/ [image] => https://infogm.org/wp-content/uploads/2026/09/52827453408_9a44d2db78_c-768x512.jpg [extrait] => New genetic modification techniques (NGTs) are presented by their proponents as a mean of promoting innovation in seed production and broadening farmers’ choices. However, the US experience shows that deregulating GMOs is not enough to make them accessible to users. According to a 2023 report by the US Department of Agriculture, the significant increase in patent fees on GMOs is hindering access to seeds in general. Europe, which has just adopted its regulation on GMOs produced using NGTs, arguing that it is necessary to boost variety innovation, was nevertheless aware of this report on the situation in the US. [chapo] => New genetic modification techniques (NGTs) are presented by their proponents as a mean of promoting innovation in seed production and broadening farmers’ choices. However, the US experience shows that deregulating GMOs is not enough to make them accessible to users. According to a 2023 report by the US Department of Agriculture, the significant increase in patent fees on GMOs is hindering access to seeds in general. Europe, which has just adopted its regulation on GMOs produced using NGTs, arguing that it is necessary to boost variety innovation, was nevertheless aware of this report on the situation in the US. [texte] => The debate on GMOs produced using NGTs was often reduced to the question of whether or not they should be subject to the rules applicable to GMOs. But behind this question – to which the Court of Justice of the European Union (CJEU) had answered "yes" in 2018 and 2023 – lay the issue of access to these techniques for companies that have the desire and the means to implement them. Above all, the impact of patents relating to these techniques and their products continues to raise questions regarding the potential appropriation of seeds and living organisms in general. Indeed, whilst NGTs are presented by their proponents as a driver of innovation and plant variety development, their deregulation does not bring the debate on patents to a close. This is a problem the United States has been facing since at least 2023, as its own Department of Agriculture (USDA) warned in a report on the effects of patents on competition and access to seeds1.In the United States, patents complicate access to seedsThe aim of this USDA report is to "promote fair competition and innovation in the field of seeds and other agricultural inputs". The document advocates striking a balance between intellectual property protection, innovation and maintaining sufficient competition. It therefore recommends strengthening public research and seed diversity to ensure a "more resilient" US agricultural sector. However, the report identifies intellectual property as one of the factors that can affect competition.A notable account provided by the USDA, highlighting anti-competitive practices, comes from the Independent Professional Seed Association (IPSA). This representative of US seed producers criticises the conditions imposed for obtaining a licence for patented traits and plants2 : "companies like ours must provide a multinational corporation with a list of all our customers, (complete with addresses), the amount of seed purchased by product for each customer, as well as our complete company financials. After giving them all our company information, we need to try to compete against their company and owned brands". In its report, the USDA thus demonstrates that there are situations where patent holders require the disclosure of sensitive commercial information in order to grant licensing rights, and that such practices create a relationship of dependency for small and medium-sized enterprises towards multinationals. Furthermore, whilst this report is limited to the plant sector, there is no reason to believe that its conclusions cannot also be applied to the animal sector.This issue of dependency is not limited to the cost of accessing patented technologies and products, which includes, in particular, royalties on sales made by licencees, and sometimes "entry fees" (a fixed sum dependent on several parameters, such as the technical field, the exclusivity of the rights, etc.), and milestone payments (upon reaching a regulatory or development milestone, or in the patent application process, etc.). Intellectual property in general, and patents in particular, confer real market power and increase the concentration of the seed sector in the hands of a few multinationals holding large patent portfolios3. This problem affects the US seed sector as a whole. What has been the situation since the NGTs introduced new intellectual property rights?Same causes and (likely) the same effects in the EUThe specific case of NGTs, which have recently been deregulated in the EU, is no exception to the general problem identified by the USDA in its report. In Europe, patents relating to NGTs began to be applied for and granted nearly fifteen years ago and now number in the tens of thousands. The vast number of patents granted for so-called "directed mutagenesis" techniques or tools such as CRISPR-Cas9, and their applications, bear witness to this. These techniques and tools have not led to a fundamental break with the existing patent system, as the examination of patent applications is carried out in a manner equivalent to that applied to GMOs produced up to that point4. Regulations on patents and GMOs (biosafety) are in fact distinct and, whilst they overlap to some extent, they do not cover exactly the same techniques and products. The deregulation of NGTs actually encourages breeders with the necessary resources to file a large number of patent applications in order to cover the associated developments as broadly as possible.In this regard, a note from the French Embassy in the United States, dated March 2026, sets out its observations regarding the commercialisation of GMOs/NGTs, and explains how the abundance of patents in the US plays a major role in this5. Despite more than 140 authorisations, only a handful of GMO/NGT plants are on the market, largely due to patent-related issues, according to the embassy. This discrepancy stems primarily from the proliferation of patents covering products whose development remains too uncertain and processes that have not yet been developed, which are intended to stifle competition. The note also rightly highlights that the majority of patents relating to CRISPR/Cas9, methods of use and the resulting characteristics are concentrated in the hands of a few major players. Licences can thus become a veritable "access toll" to NGTs, and small and medium-sized enterprises become legally and financially dependent on patent holders. This situation in the US contrasts with the promises made by multinationals and the European Commission regarding the deregulation of NGTs.What might therefore seem paradoxical – deregulating a product ultimately limits access to that product – is in reality not so. Whilst patents are often presented as a powerful driver of liberalisation in an economic sector, this liberalisation primarily benefits those best placed to take control of that sector, thereby making access particularly difficult for other players. Thus, the "liberalisation" of GMOs derived from NGTs in the EU makes them very difficult to access not only for interested players who do not hold the patents, but also – due to the effect of patents – for players in non-GMO sectors6. If these difficulties had already been documented in the United States, why has the EU not taken them fully into account and incorporated them into the development of the regulatory framework for NGTs?The new regulation does not depart from the US modelIn a communication dated 23 April 20267 following the adoption at first reading of the regulation on NGTs, the Commission reaffirmed that it was “fully committed to protecting the functioning of the internal market and the plant breeding sector, in particular small and medium-sized enterprises (SMEs)”. It reiterated some of its commitments regarding patents, notably that it “will oversee the drawing up of a code of conduct”, “will assess the functioning of licensing platforms and their use by the seed sector, to ensure transparency on patents and facilitated access to licences for SMEs under fair and reasonable conditions" and "will ensure that SMEs have access to support and guidance on patent matters relating to plants, in order to balance the relations between different players in the plant breeding market". These commitments by the Commission are accompanied by tools (such as a Code of Conduct) and procedures (such as the obligation – which will not be subject to any verification – to declare to the competent authorities patents relating to GMOs/NGT1 and the possibilities for obtaining licence agreements), which were adopted, amongst other measures, in December 2025 by the Council of the EU. However, these measures are in no way binding on patent holders and do not take into account the impacts on farmers and small and medium-sized breeders viii .Available prior to the adoption of the NGT Regulation in June 2026, the feedback provided by the USDA report and by the note to the French Embassy warning of patent-related difficulties could have prompted the European legislator to establish an appropriate legal framework for NGTs. Whilst the adopted regulation does contain a few "safeguards" (unverified transparency regarding relevant patents, information on "fair and reasonable" licences, future impact assessments and the creation of an expert group…), these provisions raise doubts as to whether their implementation, effectiveness and/or enforceability can be guaranteed, since they are neither mandatory nor binding. Thus, whilst acknowledging the problems associated with patents in the United States, the regulation on NGTs does not provide for clear, robust and mandatory tools and procedures to prevent them.Deregulation versus economic freedomEven if the Commission were to fulfil its various promises and commitments, questions remain unresolved on a number of points. For example, if an entity identifies one or more patents to which it can only gain access under licence, it must still be able to access the contractual terms of that licence. Furthermore, this unverified transparency vis-à-vis the competent authorities alone will not be sufficient to prevent relationships of dependency between multinationals and small and medium-sized breeders and farmers.The general problem posed by patents – which was the subject of numerous warnings from the European legislator before it chose to adopt the deregulation of GMOs and NGTs – is clearly illustrated by the US experience. The EU will not necessarily replicate the US model, but it will not be able to claim that "it did not know", as the facts were and are well documented. Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [5] => Array ( [objectID] => 33998 [title] => A new ethic in the face of biotechnology’s dangers [timestamp] => 1789689600 [date] => 18/09/2026 [annee] => 2026 [url] => https://infogm.org/en/a-new-ethic-in-the-face-of-biotechnologys-dangers/ [image] => https://infogm.org/wp-content/uploads/2026/09/The_gyri_of_the_thinkers_brain_as_a_maze_of_choices_in_biom_Wellcome_L0027293.jpg [extrait] => In an article published in Philosophies in July 2026, Grégori de Souza and Jelson Roberto de Oliveira argue that, from a philosophical standpoint, the genetic manipulation of plants raises new ethical questions. Biotechnology transforms living things into objects. In doing so, they assert, it alters the ontological foundations of life and calls for an ethic of responsibility that extends to the entire biosphere. [chapo] => In an article published in Philosophies in July 2026, Grégori de Souza and Jelson Roberto de Oliveira argue that, from a philosophical standpoint, the genetic manipulation of plants raises new ethical questions. Biotechnology transforms living things into objects. In doing so, they assert, it alters the ontological foundations of life and calls for an ethic of responsibility that extends to the entire biosphere. [texte] => The article by Grégori de Souza and Jelson Roberto de Oliveira, published in Philosophiesi in July 2026, offers a philosophical reflection on the power human beings arrogate to themselves to modify living organisms. The very notion of “humans” warrants scrutiny, as the article lumps all humans together. Yet, this power should be attributed specifically to “Western” culture - and, more precisely, to certain individuals working in public or private laboratories - even though those who remain silent or benefit from the results are, in a sense, implicated in the deployment of the technology. With that clarification made, let us return to the authors’ thesis.They aim to demonstrate that plant biotechnology cannot be evaluated solely on the basis of criteria such as disease resistance, loss reduction, and the like - or, to put it another way, through the lens of an apparently immediate human self-interest. Instead, they propose examining the impact these interventions have on the plants themselves and, by extension, on all life on Earth. Their reflections draw upon the thought of Hans Jonas, the philosopher who conceptualized the “responsibility principle” as applied to the living world. Jonas reformulates Kantian ethics in the following terms: “Act so that the effects of your action are compatible with the permanence of genuine human life on Earth”. Jonas proposes a principle that might be phrased as follows: before acting or employing a powerful technology, verify that its consequences do not risk destroying the conditions that allow future generations to live a truly human life on Earth.Biotechnology changes the nature of technologyThe authors distinguish biotechnology from older technologies. Until recently, technology primarily worked with inert materials: it shaped stone, metal, or other substances to create useful objects. The distinction was relatively clear: human beings were the transforming subjects, while nature - in this case, the mineral world -was the object of that transformation. One might raise the question of chemistry - which works with inert matter yet impacts living things - but that falls outside the scope of this article. With genetic modification techniques, this separation becomes far less distinct, as the entity being transformed is now a living organism - a being possessing its own activity, capacity for reproduction and evolution, and relationship with the world. The authors note that Hans Jonas lists eight aspects distinguishing biotechnology from traditional mechanical technology; we will examine some of these later in the article.The authors do not deny that humans intervened in the living world prior to the advent of biotechnology. They outline a brief history of plant domestication. This historical sequence allows the authors to trace a growing capacity for intervention: “domestication and artificial selection already constituted, in a sense, a pre-modern form of genetic intervention, albeit one practiced indirectly and empirically. In the modern era, molecular biology subsequently enabled direct intervention in genetic material”. Intervention shifted from farmers selecting observable traits in the fields to the direct modification of genetic material in the laboratory, working on isolated cells. Thus, they argue that each stage enhances the human capacity to shape the living world according to human needs or desires.For Hans Jonas - cited by the authors - this shift is fundamental: modifying a plant is not the same as manufacturing a machine. A machine is assembled from inert components and can be fully designed in advance; a plant, by contrast, is already a complex living system, embedded in a network of relationships involving the soil, water, climate, microorganisms, insects, other plants, animals, and agricultural practices. Genetic engineering, therefore, does not act upon neutral matter but upon a living entity that possesses its own dynamics. To borrow from Jonas, the intervention is not a matter of total construction, but rather of “determination through intervention alone”: one steers an existing system whose interactions cannot all be fully controlled.Among the other aspects distinguishing machine manufacturing from genetic intervention, Jonas cites uncertainty, irreversibility, and heredity. On one hand, the effects are less predictable than in mechanical engineering because “the number of unknowns in the design is immense”. On the other hand, when a genetic intervention produces unexpected effects, these can be difficult to reverse. Finally, genetic modifications can be inherited and thus affect future generations or populations; they may also be transferred to microorganisms through horizontal gene transfer, with possible effects on microbial communities as a whole. For Jonas and the authors, this notion of heredity “leads to another (the seventh aspect), concerning the power to influence the future: the power of living beings over those yet to be born, whether human or non-human”. Paradoxically, this critique can take on an almost Promethean quality. While human action can certainly threaten our own existence and that of many other species, can it destroy life on Earth altogether?The authors do not claim that every genetic modification would necessarily cause harm. Their point is to emphasize that the capacity of researchers and technicians - whether in multinationals or public research centers - to intervene in living systems is such that it must be accompanied by a responsibility commensurate with that capacity and its consequences. The more profound, enduring, and diffuse the technical power, the less justifiable it is to think in the short term or to rely solely on immediate benefits.Plants: technological platforms or living beings?According to the authors, biotechnology has focused primarily on plants. We might qualify this statement, however, as microorganisms were modified earlier and are widely used to serve our own ends.For the authors, plant life has often been viewed as an object, a raw material, or a biological “factory” intended to supply food, fiber, energy, industrial molecules, or pharmaceuticals - all while disregarding what matters to plants in their own right as living beings. Grégori de Souza and Jelson Roberto de Oliveira describe plants as the “great forgotten beings of the history of philosophy”. It is necessary, however, to nuance this perspective by focusing on the relationship with plants within recent Western culture. In other civilizations, plants are integral to the life of the community. The idea developed in this article stems from the worldview that emerged during the European Renaissance or the Enlightenment, a period that created a divide between nature and humanity. In other cultures, Jonas’s reminder would make little sense - though, notably, those cultures did not develop genetic modification technologies either.It is specifically the reduction of plants to their industrial utility that concerns the authors: “In many cases, the goal is also to increase nutritional value or modify specific food properties - such as color, texture, or ripening time. However, these criteria are invariably defined based on the needs of the agro-industrial system and the market, rather than from an ecological perspective or with regard to the flourishing of the plant itself as a living organism”. The authors challenge this industrial reductionism: while a plant is indeed a resource for humans, it is not merely a resource. In this regard, they extend the Kantian categorical imperative - “Act in such a way that you treat humanity, whether in your own person or in the person of any other, never merely as a means to an end, but always at the same time as an end”ii - to the terrestrial ecosystem.The “good” of plantsThe authors briefly point out that relying primarily on standardized or genetically uniform varieties contributes to the erosion of cultivated biodiversity, thereby making agricultural systems more vulnerable. They also address the issue of patents and the monopolistic concentration of seed companies, noting that this “leads to increased technological dependence among farmers and a reduction in the autonomy of local agricultural systems”. However, these ecological and political impacts are not the article’s central focus.While the authors are certainly aware of these issues, the article is structured around the concept of the “good” of plants. Here, too, the article draws on the work of Hans Jonas, who distinguishes between “good” and “value”. They write: “The good possesses an objective status; that is, it is characterized as a ‘good in itself’ - an intrinsic good belonging to the very being that possesses it by virtue of being alive - whereas value is something relational, established in connection with human beings”. In other words, value is assigned by someone: a variety has industrial value because it yields more, sells better, and so on. The “good”, by contrast, refers to what is good for the living being itself: the conditions of its persistence, development, and renewal, independently of the uses human beings may make of it. They conclude with this concise formulation by Hans Jonas: “being itself can justify duty”. We will return to this point later, but it is worth noting here that the expression “good in itself” has been criticized by philosophers such as Paul-Antoine Miquel. Miquel argues that this way of speaking about living beings risks essentializing them. Miquel’s approach differs: rather than speaking of “the good” as something established - something that in itself justifies the ethical imperative - he conceptualizes living things as open physical and chemical systems operating far from equilibrium, organized by constraints, cycles, and exchanges of energy and information. While this approach could complement the one proposed by Jonas, that is a topic for another article.Returning to the authors of the article: they do not claim that plants are conscious or sentient in the way animals are. They explicitly reject any such equivalence - a stance that, in our view, places them within “Western” culture, as previously noted. They argue only that a plant manifests an elementary form of interiority: “in plants, this interiority is expressed through their autonomous organization and their teleological orientation toward self-preservation, growth, reproduction, and ecological interaction, rather than through perception or consciousness in the phenomenological sense. This expression thus refers to plant life’s intrinsic relationship with itself and should not be understood as implying subjective consciousness”.Within this framework, the “good” of a plant does not imply that every individual plant must be respected in the same way one would respect a person. Instead, it refers to the conditions that allow plant life to sustain and renew itself: species integrity, genetic diversity, regenerative capacity, ecological relationships, and evolutionary continuity. The authors state this clearly: moral consideration for plants does not entail an absolute ban on cultivating or using them. As previously mentioned, the challenge lies in avoiding their reduction to mere technical objects and ensuring that the conditions for their existence are not permanently compromised.Towards a new form of responsibility and ethicsFor Jonas, modern humanity possesses such power that its actions can affect the very conditions of future life. Morality must therefore encompass generations yet unborn, as well as the living world upon which they will depend. The biosphere, “with all its wealth of species”, thus claims “its share of the respect due to anything that is an end in itself”.The authors apply this principle to biotechnology: the question should not merely be “can we modify a given plant?” but rather “do we have the right to make decisions whose consequences could permanently affect the living world and future possibilities for existence?”. Once again, the authors generalize this will to power to humanity as a whole; yet, while it tends to spread alongside the hegemonic expansion of Western culture, it remains the province of a specific category of individuals. In their defense, however, ethics seeks to formulate universalizable principles. They thus invoke Jonas’s “heuristic of fear”: when a serious and irreversible risk is plausible, it must be taken seriously, even if not all consequences have been scientifically established with certainty. This amounts to an “ethic of radical precaution” and calls for a “strengthening of solidarity among human beings”. At a time when certain organizations - such as the FNSEAiii and political figures such as Bruno Retailleauiv - seek to abolish the precautionary principle, the words of Hans Jonas take on profound significance.Citing Hans Jonas, the authors remind us that human responsibility must encompass the protection of the most vulnerable - specifically, in this instance, plants. “To the extent that [genetic engineering] represents an expansion of power to the point where it becomes demonstrably dangerous to the entire order of things [Editor’s note: the authors even use the term ‘crime’], it extends human responsibility to the future of life on Earth - life now left defenseless against the misuse of such power”. Restraint is therefore urgently needed. The authors write: “By speaking of ‘voluntary restraints’, Jonas appeals to the responsibility of biotechnology stakeholders themselves; they must resist the intoxication of utopias rooted in the illusion of progress, in favor of a mature freedom capable of stepping back to consider the gravity of the stakes involved”.In their conclusion, Grégori de Souza and Jelson Roberto de Oliveira note an impending acceleration in the power to design and modify living organisms through new genomic techniques (unfortunately described here as) “gene editing” and algorithms (unfortunaly labelled) “artificial intelligence”. They write: “The ability to design plants with unprecedented characteristics, reorganize metabolic systems, or introduce new genetic pathways means that human intervention could come to act directly upon the very biological architecture of ecosystems. In this context, ecological, evolutionary, and social risks become even more significant and harder to predict”.Ultimately, they argue that “plants can no longer be treated merely as technological platforms or simple productive resources. As life forms possessing intrinsic value and participating in the evolutionary continuity of the biosphere, they demand an ethical reflection that transcends instrumental logic”. And why limit this to plants? Could we not also extend this reflection to the living world as a whole, starting with microorganisms, which are widely used as technological platforms?i De Souza, G. et de Oliveira, J. R., « Genetic Manipulation of Plants: A More-than-Human Ethical Challenge », Philosophies, Vol. 11, Issue 4, 8 July 2026.ii Emmanuel Kant, « Groundwork of the Metaphysics of Morals », section II, 1785.iii Denis Meshaka, « Cornerstone of French and European law, the precautionary principle under attack by the FNSEA », Inf’OGM, 5 June 2026.iv Ulysse Legavre-Jérôme, « Présidentielle 2027 : Bruno Retailleau muscle ses propositions économiques », Les Echos, 19 February 2026. Christophe NOISETTE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [6] => Array ( [objectID] => 33613 [title] => Top 10 agribusiness giants: Corporate concentration in food & farming [timestamp] => 1789344000 [date] => 14/09/2026 [annee] => 2026 [url] => https://infogm.org/en/top-10-agribusiness-giants-corporate-concentration-in-food-farming/ [image] => https://infogm.org/wp-content/uploads/2026/09/portada_v2-768x450.jpg [extrait] => In times of war, market concentration allows companies to reap even greater profits, while farmers and consumers around the world suffer from rising fertilizer and food prices. This report provides a snapshot of the state of concentration in the agri-food sector. It follows up on the 2025 edition and assesses the state of market concentration in six key agricultural sectors: commercial seeds, pesticides, synthetic fertilizers, agricultural machinery, veterinary pharmaceuticals, and livestock genetics. [chapo] => In times of war, market concentration allows companies to reap even greater profits, while farmers and consumers around the world suffer from rising fertilizer and food prices. This report provides a snapshot of the state of concentration in the agri-food sector. It follows up on the 2025 edition and assesses the state of market concentration in six key agricultural sectors: commercial seeds, pesticides, synthetic fertilizers, agricultural machinery, veterinary pharmaceuticals, and livestock genetics. [texte] => Inf’OGM is publishing here the results of a study by GRAIN and the ETC Group on industrial concentration in six key sectors of the agri-food industry. This report unequivocally demonstrates the concentration of several markets in the agri-food sector in the hands of a few multinational corporations. The report reproduced below is an update to a previous version from 2025. It was posted online on July 29, 2026, on the ETC Group website and on July 30 on the GRAIN website. All 115 references provided by the organizations to support their report are available in their original versions on their websites.Why corporate concentration in the food system mattersJust five years ago, the COVID-19 pandemic and the Russian invasion of Ukraine disrupted food supply chains and drove up food prices. Today, another food crisis is looming. The Israeli-US war on Iran has already had devastating consequences for the local population and environment. Along with disruption to the oil markets and other geopolitical dynamics, it is also pushing up the prices of fertilisers and food.Taking advantage of the food system's dependence on nitrogen fertiliser, the world's largest nitrogen fertiliser companies systematically increased their margins during the natural gas supply shocks caused by both wars. For instance, by the third month of the war on Iran, CF Industries Holdings Inc., Nutrien Ltd and Yara were reporting quarterly sales increases of between 19% and 40%. This translated into even higher prices for farmers and eventually consumers around the world, particularly in the Global South. Less than three weeks after the war started, the UN was already warning that an additional 45 million people could be pushed into acute hunger.However, pandemics and wars are not the only causes of supply shocks across the food system. The climate crisis is increasing the frequency and effect of shocks, including the historic intensification of El Niño predicted for late 2026. The globalised food system, with its long supply chains and uniformity, is extremely vulnerable to such events. It is also vulnerable to corporations that exploit their monopoly power to extract more and more profit during times of volatility, at the expense of farmers, food workers, consumers and the planet.At a moment where we need to be reining in corporate power in the food system, developments in digitalisation and artificial intelligence (AI) threaten to make it even worse. All the big agricultural input firms are pushing farmers into using their digital farming platforms as a way to increase their sales and lock-in customers. These platforms, like Bayer’s Climate FieldView, Syngenta’s Cropwise and Corteva’s Granular, enable the input companies to collect data from participating farms and farmers, and then use this data to sell the farmers more of their products.Developments in digitalisation are also driving a convergence with powerful tech companies. Many of the largest seed, pesticide, fertiliser and machinery companies are partnering with tech giants like Microsoft, Google, Amazon and Meta. These big tech companies are rolling out digital agriculture programmes across the Global South through government programmes that farmers rely on for subsidies, inputs and other extension services. For example, the Indian government's new digital database, Agri Stack, gives Microsoft detailed information on 80 million Indian farmers, and is being used by the World Bank as a model for programmes in other countries as well.This report provides a snapshot on the state of agribusiness concentration. It updates our 2025 report to lay out the state of concentration in six key agricultural sectors: commercial seeds, pesticides, synthetic fertilisers, farm machinery, animal pharmaceuticals and livestock genetics. Another key sector – agricultural commodity traders – is covered in ETC Group’s 2026 report, Grain Traders, Greed and Oligopoly Power.As can be seen, concentration across all six sectors remains high. Five of them – seeds, pesticides, machinery, animal pharma and pig genetics – meet the definition of an oligopoly, in which four companies control more than 40% of a market. So too does the global market for phosphate fertilisers. While the world grapples with the climate and biodiversity crises, rising hunger levels, geopolitical conflict and another looming food crisis, a handful of large companies continue to hold enormous power over our food system.The situation is severe. We urgently need to find ways to dismantle corporate power and build food systems free from fossil fuels and corporate inputs, that provide diverse, nutritious and abundant food, dignified livelihoods and healthy ecosystems.Commercial SeedsThe commercial seed sector refers to crop seeds (primarily proprietary field crop and vegetable seeds, including those that are genetically modified) sold via the commercial market. Farmer-saved seed and seed supplied by governments and public institutions are not included.The top four companies that control the commercial seed sector remain the same as in 2023. Bayer, Corteva, Syngenta and BASF together account for half of the seed market, and Bayer alone accounts for 20%. These same four companies also account for 56% of the pesticides market. Overall, the commercial seed market has grown slightly in 2024 from the year before, but concentration in the sector remains similar, with the top four companies controlling 50% and the top 10 controlling 63% of the market (see Table 1).Big commercial seed companies continue to focus on genetically engineered crops, and are pursuing new varieties through gene editing. Bayer and Corteva each have multi-year partnerships with gene editing company Pairwise, for use of its CRISPR-based platform. Similarly, Syngenta entered a partnership in 2025 with gene editing company Tropic Biosciences to develop gene-edited vegetables.The big seed companies are also pursuing collaborations with tech companies to develop AI models for plant breeding and genetic engineering, often called “GenBio”. Bayer claims the use of AI will enable it to “write new genetic combinations” and to shorten the process of breeding new seeds from 5-6 years to just a few months. Corporate interest is driving a rush for data to train these AI models. The data is being pulled from public databases and other public information, and even from ecosystems (soils, plants and seeds), without any consultation, consent or compensation to the communities from whom this information is being stolen.Table 1. Top 10 corporations in the commercial seed sectorRankingCompany (Headquarters)Sales in 2024(US$ millions)% Global market share1Bayer (Germany)11,242202Corteva Agriscience (US)9,545173Syngenta (China/Switzerland)5,07494BASF (Germany)2,2924Total top 428,153505Groupe Limagrain (France)2,05846KWS (Germany)1,81537Yuan Longping (China)1,19128DLF Seeds (Denmark)79819Rjik Zwaan (Netherlands)740110Sakata Seeds (Japan)6001Total top 1035,35563Total world market56,000100PesticidesThe pesticides sector includes herbicides, insecticides and fungicides, which are different types of agrochemical products that target weeds, insects and fungi, respectively.The top four companies that control the commercial pesticide sector remain the same as in 2023. Syngenta, Bayer, BASF and Corteva together account for 56% of the pesticide market in 2024. These same four companies also account for half of the seed market. The top 10 pesticide companies control a whopping 78% of the total market (see Table 2).The pesticide sector’s legal woes continue. For the last decade, Monsanto (now owned by Bayer) has been fighting over 100,000 lawsuits brought by people who developed Non-Hodgkins Lymphoma that they blame on exposure to glyphosate-based herbicides like Roundup. Syngenta is facing lawsuits from people who allege they contracted Parkinson’s disease after exposure to the pesticide paraquat. In 2026, the company announced that it would stop global production of paraquat.The pesticide industry has responded to these legal battles by lobbying for legal immunity to future lawsuits. In February 2026, Bayer announced a class action settlement for US$7.25 billion to settle thousands of cases it was facing, but a judge later called the settlement “legally problematic”, describing it as a “filthy deal" that was filed in a secretive and hasty manner.Within two days, US president Donald Trump announced an executive order to protect the production of glyphosate-based herbicides and to seek immunity for companies producing glyphosate. In June 2026, the US Supreme Court ruled in favour of Monsanto in a decision that will block or limit thousands of current and future lawsuits against the company.These costly legal fights have forced companies to rethink their business models. Corteva is in the process of splitting itself into a seed company called Vylor and a pesticides company called New Corteva. This decision to “unbundle” its divisions helps Corteva insulate its seed business from the possible legal liabilities that it and other pesticide manufacturers increasingly face. In a 2025 presentation to investors, Bayer did not include glyphosate in its core pesticide business projections, as it will be managing glyphosate as a separate business from the rest of its core pesticide platforms.Table 2. Top 10 corporations in the pesticide sectorRankingCompany (Headquarters)Sales in 2024(US$ millions)% Global market share1Syngenta (China/Switzerland)[30]17,014222Bayer (Germany)11,101143BASF (Germany)8,308114Corteva Agriscience (US)7,3639Total top 443,786565UPL (India)4,54366FMC (US)4,25057Sumitomo (Japan)3,74258Nufarm (Australia)1,93829Shandong Weifang Rainbow Chemical (China)1,848210Sino-Agri Leading Biosciences Co (China)1,4522Total top 1061,56078Total world market78,000100Synthetic FertilisersChemical (or synthetic) fertilisers are a key and toxic component of industrial agriculture. The most widely applied are nitrogen-based fertilisers, accounting for up to 57% of global use, followed by phosphate fertilisers (23%) and potassium-based (potash) fertilisers (20%), according to the industry. Nitrogen fertilisers are highly dependent on fossil fuels, accounting for 7% of total emissions from the industrial food system and 60% of global anthropogenic nitrous oxide emissions.The global fertiliser market was estimated at over US$221 billion in 2024. The top 10 largest corporations had a combined revenue of US$68 billion (see Table 3). The amount would likely be higher if Eurochem was included, since it is a top fertiliser company that does not report its revenue. Sales for many of the top companies have declined from 2023, largely due to the fact that several fertiliser companies saw their profits soar during the first year of the war in Ukraine. Compared with 2023, revenues at seven of the top ten companies fell by between 4% (Sinofert) and 21% (OCI). The only companies that saw increased sales were Uralkali (1%), PhosAgro (7%) and OCP (11%). Overall, however, revenues of the 10 largest fertiliser companies remain 26% higher than in 2020, and reporting from the nitrogen fertiliser companies for the first three months of 2026 shows that they, at least, are now profiting handsomely from the US-Israel war on Iran.There is a significant level of corporate concentration in this sector. The top 10 companies control up to 31% of the market. But, depending on the type of fertiliser, this share can be even higher. Just four companies (Nutrien, Mosaic, OCP and ICL) control 25% of the global phosphate fertiliser market, and six firms (Nutrien, Mosaic, ICL, Uralkali, K+S and Eurochem) together account for 65% of the total volume of potash fertilisers sold.A notable trend on the African continent is the surge in investment from the Gulf region into the fertiliser industry. For example, Ma'aden, a Saudi Arabian company, is one of the leading suppliers of phosphate fertiliser to Africa, accounting for 40% of imports to Zambia and Zimbabwe in 2023. Emirati and Saudi companies have also increased their investments in fertiliser production. In Egypt, Saudi Arabia and Abu Dhabi's sovereign wealth funds together control over 40% of two of the country's largest nitrogen fertiliser producers. Fertiglobe (UAE) has facilities in Egypt, Algeria and South Africa and claims to be the largest nitrogen fertiliser producer in the Middle East and North Africa. SABIC (Saudi Arabia) owns a 49% stake in ETC Holdings, a subsidiary of the Mauritius-based Export Trading Group (ETG), a leading fertiliser trader in several African countries.Table 3: Top 10 corporations in the synthetic fertilisers sectorRankingCompany (Headquarters)Sales in 2024 (US$ millions)% Global market share1Nutrien (Canada)13,72562The Mosaic Company (US)10,58753Yara (Norway)10,30654OCP (Morocco)6,6063Total top 441,224195CF Industries Holdings, Inc. (US)5,93636ICL Group Ltd. (Israel)5,44327PhosAgro (Russia)5,31928Uralkali (Russia)3,54629OCI (Netherlands)3,318110Sinofert (China)2,9561Total top 1067,74231Total world market221,450100Farm MachineryThe farm machinery sector includes equipment used in agriculture, such as tractors, haying and harvesting machinery, and equipment used for planting, fertilising, ploughing, cultivating, irrigating and spraying. As farm equipment companies move towards digitalisation and automation, this sector can also include their proprietary digital platforms, drones, and robotic technologies.The top four companies in this sector remain the same as in 2023, and collectively account for 44% of the market. They continue to focus on integrating AI and digital platforms into their machinery. Together, the top 10 companies in the agricultural machinery sector control 53% of the market, and the largest – Deere & Company – alone accounts for 19% (see Table 4).Agricultural machinery companies are increasingly defining themselves as technology firms rather than just machinery manufacturers. They see their future profits coming less from selling equipment like tractors and combines, and more from controlling the digital platforms and infrastructure installed in them. These digital tools are built through partnerships with seed and pesticide companies, as well as telecom, cloud computing, data storage and other tech companies.The integration of digital technology in agricultural equipment has changed the ways in which farmers can operate, repair and prolong the lifespan of their machinery. For thousands of years, farmers have built and repaired their own tools and machines. Now, large agricultural machinery companies are designing their equipment so that it can only be repaired by specialised dealers using proprietary replacement parts. Farmers, especially in the Global North, who try to fix their machines themselves risk being locked out of their equipment or having their warranties voided.Farmers are resisting these measures and calling on governments to instate Right to Repair legislation that puts farmer autonomy before corporate profits, and ensures that “goods, owned or leased, are repairable at a reasonable price, within a reasonable time-frame by the owner or a repair service of the owner’s choice”.Table 4: Top 10 corporations in the farm machinery sectorRankingCompany (Headquarters)Sales in 2024(US$ millions)% Global market share1Deere & Company (US)31,803192Kubota (Japan)17,429103CNH Industrial (UK/Netherlands)14,00784AGCO (US)11,6627Total top 474,901445CLAAS (Germany)5,57436Mahindra and Mahindra (India)3,53227SDF Group (Italy)1,77218YTO Group (China)1,5230.99Kuhn Group (Switzerland)1,3170.810Iseki Group (Japan)1,1130.7Total top 1089,73253Total world market170.000100Animal pharmaceuticalsThe mass industrial production of cattle, chickens, pigs, shrimp and salmon makes these animals vulnerable to diseases. The sector therefore depends heavily on antibiotics, vaccines, vitamins, diagnostics, medical services, nutritional supplements (such as medicated feed) and other veterinary services.The global animal pharma market was valued at US$50 billion in 2024, including both livestock and pets. Corporate concentration is high, with the top 10 companies controlling almost 70% of the market. Zoetis alone controls one-fifth of the market (see Table 5).The share of products for livestock compared to those for pets varies between companies. It is particularly high at Phibro (75%), Ceva (72%), Merck & Co. (59%), Huvepharma (59%), and Elanco (51%). Within the livestock sector, the main customers are large-scale farms, particularly in the US, which accounts for half of the global sales of animal pharmaceuticals.The market share can be significant, depending on the animal. For example, Zoetis, Ceva, Boehringer, Elanco and Phibro together control 65% of the global poultry pharmaceuticals market.Animal health supply chains in the US and Europe – where all the top 10 companies are based – rely heavily on China for raw materials, such as vitamins, amino acids and active pharmaceutical ingredients. Zoetis, Boehringer, Virbac and Ceva all have manufacturing facilities in China, some in partnership with local companies. China has a large animal pharmaceuticals market as well, worth US$9.5 billion in 2024, along with large animal pharmaceutical companies, like China Animal Husbandry Industry Co., Ltd. (CAHIC), Tianjin Ringpu Bio-Technology Co., Ltd., and Shandong Sinder Technology Co., Ltd., that are also active in Africa and other parts of Asia.AI is used by animal pharmaceutical companies to accelerate laboratory research, enable real-time animal monitoring and provide predictive diagnostics and disease outbreak models. To train and feed its generative AI models, Zoetis is collecting masses of livestock genotype data through its testing programmes, including via access to Danone’s global dairy supply chain. Zoetis is also acquiring Neogen’s animal genomics business, which includes proprietary biological data assets from the US, Brazil, Australia, China and the UK.Table 5. Top 10 corporations in the animal pharmaceuticals sectorRankingCompany (Headquarters)Sales in 2024 (US$ millions)% Global market share1Zoetis (US)9,256192Merck & Co (US)5,877123Boehringer Ingelheim Animal Health (Germany)5,138104Elanco (US)4,4399Total top 424,710495Idexx Laboratories (US)3,69676Ceva Santé Animale (France)1,90447Virbac (France)1,51238Dechra (UK)1,00229Huvepharma EOOD (Bulgaria)900210Phibro Animal Health Corporation (France)7061Total top 1034,43069Total world market50,000100Livestock GeneticsFrom livestock farming to aquaculture, industrial animal production is rooted in corporate control over genetics through breeding material and reproductive technologies. In the previous edition of the “Top 10 Agribusiness Giants”, we highlighted the poultry genetics market, which is dominated by just three companies: Tyson Foods (US), EW Group (Germany) and Hendrix Genetics (Netherlands). Here, we will look at two other species that are particularly significant in terms of global consumption: pig and shrimp.In 2024, global pig production was 125.1 million tonnes, making it the second most produced meat after poultry. China, the EU, the US and Brazil together account for 77% of global production. The world pig genetics market was valued at US$2.2 billion, with just five European companies controlling half of it (see Table 6). With the exception of Genus plc, they are all privately held. According to Hendrix Genetics, 15% of the world’s pigs come from its breeding programmes, and some estimate that Genus plc’s pedigree herds sire a third of the world’s commercially farmed pigs.At a national level, Axiom Group claims to hold half of the French market, while Topigs Norsvin holds 34% of the Brazilian market. China counts on domestic genetics companies, and aims to be self-sufficient by 2035. Large Chinese pig producers such as Smithfield Foods (WH Group) use their own genetic lines. But Genus plc, Topigs Norsvin, DanBred and Genesus are important suppliers to the country, with nucleus farms and royalty-based contracts with large integrators. For example, in 2024, Topigs Norsvin and China's largest pig producer, Muyuan Foods, launched a joint venture nucleus farm.As with seeds and other animals, the gene editing of pigs has drawn strong criticism from the scientific community and civil society due to concerns about its impact on health and the environment. But companies are pushing to bring GM animals to market. Genus plc’s gene edited, disease-resistant pig has been approved in the US, Canada, Colombia, Brazil, the Dominican Republic and Argentina. The company expects similar authorisations in other Latin American countries and is seeking approval in China as well.Table 6. Top 5 corporations in the pig genetics sectorRankingCompany (Headquarters)Sales in 2024 (US$ millions)% Global market share1Genus plc (UK)444202Topigs Norsvin (Netherlands)325153DanBred (Denmark)15974Hendrix Genetics (Netherlands)13965Axiom Group (France)542Total top 51,12151Total world market2,187100Shrimp production and trade have grown exponentially over the past 50 years. This growth has almost entirely occurred through the development and expansion of industrial farming of a few species of large shrimp for export in Asia and Latin America, particularly China, Ecuador, India, Vietnam and Indonesia. Farmed production focuses on penaeid shrimps, with Pacific white or vannamei shrimp accounting for 80 to 85%, followed by the giant tiger prawn (9%).Shrimp farms are extremely vulnerable to diseases, and selection and breeding largely focuses on disease resistance. In Latin America, where shrimp farms are low-density and extensive, selection is done by exposing large populations to local pathogens and selecting survivors for grow-out. In Asia, where farms use a more intensive model based on smaller ponds and high stocking densities, selection is done in specialised, disease-free facilities and shipped as "Specific Pathogen Free" (SPF) broodstock to hatcheries for grow-out. In Latin America, selection tends to be carried out by the shrimp farming companies themselves and seed is much cheaper. In Asia, where SPF broodstock dominates, the market is increasingly controlled by a small number of multinational companies, most of them also involved in feed production and the livestock sector. The global shrimp SPF broodstock market was estimated at US$1.42 billion in 2024 (see Table 7).Table 7. Top companies in farmed shrimp geneticsCompany (Headquarters)Estimated market sharesCommentsShrimp Improvement Systems (SIS) (US)India (50%), Vietnam (40%), Indonesia (10-20%), China (5% of the imported broodstock market).SIS is owned by a British Virgin Islands company that is alleged to be ultimately owned by Charoen Pokphand Foods (CP Group) or its owners, the Chearavanont family. It claims to be the major broodstock supplier for the Indonesian CP Prima, a subsidiary of CP Group. The company has broodstock production facilities in Hawaii and Florida (US), and a hatchery in Andhra Pradesh (India).Hendrix Genetics (Kona Bay) (The Netherlands)Indonesia (70%), India (6%).The company operates nucleus breeding centres in Hawaii, broodstock multiplication centres in Indonesia, India and Thailand, and breeding facilities in Ecuador.CP Group (Thailand)Vietnam (15-20%), China (reported to be the main supplier of P. monodon hatcheries, but no figures available).Its breeding facilities in Thailand supply South and Southeast Asia. It is also expanding breeding operations in the US to supply Indonesia, India, South and Central America and the EU.SyAqua (Singapore)India (33%), Indonesia (5%).It is owned by Ocean 14 Capital. It has broodstock facilities in the US and Thailand.Groupe Grimaud (Blue Genetics)China (60% of the imported disease-tolerant and balanced lines).It has facilities in Mexico and the US.Guandong Haid GroupChina (15% of the national shrimp seed market).It is China’s largest aquafeed company, and has an aquaculture breeding and genetic programme. The company's breeding division is called Hisenor. It has eight shrimp breeding centres in China, and in 2025 it acquired Indonesia's only privately-owned SPF shrimp breeding facility, Global Gen. It also has hatcheries in Vietnam, Indonesia and Ecuador. Haid is also one of China's largest feed companies for pigs and poultry. Grain et ETC Group antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [7] => Array ( [objectID] => 33226 [title] => In France, a campaign against the deregulation of genetically modified micro-organisms [timestamp] => 1788912000 [date] => 09/09/2026 [annee] => 2026 [url] => https://infogm.org/en/in-france-a-campaign-against-the-deregulation-of-genetically-modified-micro-organisms/ [image] => https://infogm.org/wp-content/uploads/2026/09/France_in_XXI_Century._Microbes-768x439.jpg [extrait] => In an opinion piece published on 22 July 2026 on a French media’s website Mediapart, sixteen representatives of French organisations have expressed alarm at the potential deregulation of genetically modified micro-organisms. This deregulation, proposed by the European Commission in December 2025, has already received initial approval from the Council of the European Union, including that of the French government. In their opinion piece, the signatories specifically call on the French government “to make a genuine change in stance and to take a firm stand against this deregulation of GMOs”. [chapo] => In an opinion piece published on 22 July 2026 on a French media’s website Mediapart, sixteen representatives of French organisations have expressed alarm at the potential deregulation of genetically modified micro-organisms. This deregulation, proposed by the European Commission in December 2025, has already received initial approval from the Council of the European Union, including that of the French government. In their opinion piece, the signatories specifically call on the French government “to make a genuine change in stance and to take a firm stand against this deregulation of GMOs”. [texte] => The issue of GMOs has often been equated solely with plants. Following the introduction of the well-known Mon810 maize, Bt cotton and other transgenic rapeseed, the last three years have focused on plants genetically modified using new techniques. These plants were deregulated on 17 June 2026. However, as Inf’OGM has been detailing for several years, GM micro-organisms are also in the sights of certain multinationals. Consequently, on 16 December 2025, the European Commission proposed legislation aimed at deregulating the marketing of GM micro-organisms (GMMs). According to French organisations, this proposal could have alarming consequencesi.The position of French organisationsThese sixteen organisations – “environmental and biodiversity protection groups, and organisations representing farmers and processors in the organic, small-scale and GMO-free sectors” – argue in their joint open letter that the European Commission’s legislative proposal, endorsed on 16 June 2026 by the Council of the European Unionii, which aims to facilitate the marketing of GMOs intended for use as fertilisers, pesticides, medicines or in food processing, is incompatible with the precautionary principle. They emphasise that the world of microorganisms remains largely unknown and that the release of GMOs would have “profound and lasting” effects. Referring to the existence of an “incalculable number of microorganisms on Earth – numbering in the billions of billions”, 99.99 per cent of which “are unknown”, they point out that they “play an essential role in ecosystems and in human and animal health” and that they are “the source of all life”.For these organisations, the deliberate release of viruses, bacteria or other GMOs is not without consequences, particularly if it is not properly regulated. Pointing out that such organisms "replicate and interact with existing microbial communities", they list examples of the effects their release could have, such as the disruption of "essential functions performed by microbiota – nutrient cycles, soil fertility, regulation of pathogens" or impacts on "the resilience of ecosystems and their ability to cope with stresses, particularly climate-related ones". Above all, they emphasise that these GMOs, once released into the environment, “will be beyond any control and can no longer be removed from the environment”, in a biological context where microorganisms “multiply very rapidly, are constantly evolving, and exchange genetic material across species boundaries, whilst science currently lacks the means to track and understand all their developments and interactions, both amongst themselves and with other organisms”.In response to the European Commission’s proposal, the sixteen organisations are calling on the “French government to reject this proposal”. Although, on 16 June 2026, the French government was among those EU governments that expressed support for the European Council’s text, future stages of the legislative process could, in fact, allow the French government to reconsider its position. The organisations that have signed the open letter are calling for such a change in light of "the still limited understanding of microbial ecology, the serious potential risks – ranging from significant imbalances in microbial communities and horizontal gene transfer to disruptions to nitrogen and phosphorus cycles in soils – as well as the possible impacts on conventional and organic food production".What does the text under discussion provide for?The text, which received the EU Council’s approval on 16 June 2026, aims to facilitate the marketing and thus the release of GMOs, whether through transgenesis or any other genetic modification techniqueiii. Very similar to the European Commission’s proposal submitted to the Council of the EU and the European Parliament, this text could, if adopted, result in the deregulation of these GMOs.This deregulation – whether in the form of the European Commission’s proposaliv or the text from the Council of the EU – would be achieved through several measures, all of which involve amending Directive 2001/18, which currently governs the release of any GMO, be it a plant, animal or micro-organism.The first concerns the power granted to the European Commission to decide unilaterally on the content of the application dossiers to be submitted for the authorisation of GMOs and/or their products. Currently, this list is set out in an annex to Directive 2001/18, which could be amended by the Commission alone in the case of GMOs.The second proposed change concerns the duration of authorisations granted, which would be extended from the current ten years to an indefinite period. The immediate consequence would be that no reassessment of potential risks would take place, as is currently the case.The third lever, which was central to the proposal to deregulate plants and which is also found in the case of micro-organisms, is the possibility that a company would be allowed not to provide methods for the detection, identification and quantification of GMOs or their commercialised products, subject to the rather lenient condition that it justifies that it "is not possible to provide [such] methods". The EU and other economic operators (from farmers to consumers) would therefore be left in the dark regarding any contamination or illegal marketing. As patents held by private actors on GMOs, but also on non-modified micro-organisms, constitute a definitive barrier for all users, "wild" micro-organisms would, for their part, become even more powerful tools for the appropriation of micro-organisms.These three measures would apply to absolutely all GMOs. However, more comprehensive deregulation is being proposed for a sub-category that could potentially include several, if not many, of them.Which micro-organisms would be affected by complete deregulation?Unlike genetically modified plants, the micro-organisms affected by this potential almost complete deregulation would not be limited to those modified using new techniques. According to the European Commission’s proposal, this deregulation would apply to all GMOs, regardless of the technique used, that are classified as "low-risk". For the Council of the EU, this would apply to all GMMs that have been granted "qualified presumption of safety" status and do not contain "genes of concern"; such GMMs could then undergo a so-called "accelerated" procedure.In addition to the measures already mentioned, such GMOs would also undergo an "adapted" – in other words, streamlined – risk assessment procedure, as the European Food Safety Authority (EFSA) has considered that "fewer requirements may be necessary". Finally, the post-market environmental monitoring required under Directive 2001/18 might not be carried out if the company considers that such monitoring "is not needed". Without a method of analytical traceability, this monitoring would in any case be difficult to carry out…The proposal to deregulate these GMMs must now be put before the European Parliament. The Parliament could place it on its agenda as early as this autumn. Following this stage, discussions with the Council of the EU and the Commission are then expected to begin. The French government will therefore have plenty of opportunities to change its position.i Collective opinion, « Non à la dérégulation des Micro-organismes génétiquement modifiés », Médiapart, 22 July 2026.ii Eric Meunier, « The Council of the EU wants to speed up the release of GMM into the environment », Inf'OGM, 6 July 2026.iii Ibid.iv Eric Meunier, « The deregulation of GMO microorganisms is underway », Inf'OGM, 27 January 2026. Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [8] => Array ( [objectID] => 33699 [title] => Organic farming and biocontrol: two concepts that do not overlap [timestamp] => 1788825600 [date] => 08/09/2026 [annee] => 2026 [url] => https://infogm.org/en/organic-farming-and-biocontrol-two-concepts-that-do-not-overlap/ [image] => https://infogm.org/wp-content/uploads/2026/09/52203414392_2a31874692_c-768x623.jpg [extrait] => According to the European Commission, biocontrol products are intended to be a sustainable alternative to chemical pesticides. However, as we saw in a previous article, the Commission plans to group products that are genuinely low-risk together with products derived from biotechnologies - whose risks have not been assessed - under the single term "biocontrol". Yet, the term "biocontrol" creates confusion by fostering the illusion that it is a technique akin to organic farming. What is the reality? [chapo] => According to the European Commission, biocontrol products are intended to be a sustainable alternative to chemical pesticides. However, as we saw in a previous article, the Commission plans to group products that are genuinely low-risk together with products derived from biotechnologies – whose risks have not been assessed – under the single term “biocontrol“. Yet, the term “biocontrol” creates confusion by fostering the illusion that it is a technique akin to organic farming. What is the reality? [texte] => Inf’OGM decided to focus on biocontrol once it became clear that the definition currently under discussion at the European level could facilitate the marketing of products derived from biotechnologies. Furthermore, this definition could lead to semantic confusion with products used in organic farming - a confusion we believe it is important to highlight."Biocontrol" is a recent term that has gained prominence within the debate on alternatives to synthetic chemical pesticides. This term - which has already replaced "biological control" in French-language general and scientific literature - could also undermine organic farming, following the trend of so-called "agricultural greening" (integrated farming, high environmental quality standards, etc.). In this article, we will highlight a structural difference between biocontrol and organic farming, and then specify which products are authorized for biocontrol but not for organic farming, explaining the rationale behind this prohibition.Will the biocontrol of tomorrow be biotechnological?"Omnibus X" - a European Commission proposal to amend several regulatory texts related to food - introduces numerous products incompatible with organic farming, owing to its vague and very broad definition of biocontrol. The European Commission is opening the door to "biological macromolecules or molecules composed of elements thereof, as well as substances - including those of unknown or variable composition - derived from living organisms or resulting from biological processes" (such as plant extracts or metabolites produced by microorganisms). At the time, Inf’OGM wrote: "With such a definition, Omnibus X paves the way for market access for a new generation of so-called 'biological' molecules that can nonetheless be synthesized via 'genetic engineering' (e.g., interfering RNA, micro-peptides, macromolecules 'inspired' by living organisms)".Organic farming and biocontrol: different approachesBefore detailing the incompatibilities between biocontrol products and organic farming standards, the first point to note is that the two approaches are fundamentally different. Biocontrol is defined exclusively by its "products"; it operates on a logic of substitution. In theory, these new products replace synthetic chemical pesticides. Often, the same companies - such as Syngenta or BASF - sell both types. Indeed, they emphasize that chemical pesticides and biocontrol products work synergisticallyi.Organic farming, by contrast, is a holistic approach to agro-ecosystems based on obligations regarding methods rather than specific products. Its primary aim is to devise or reintroduce practices that reduce the reliance of crop and livestock farming on external inputs. In practical terms, crop protection in organic farming relies first on agronomic measures (crop rotation, stale seedbed techniques, sowing densities and dates, choice of varieties, etc.). Next come mechanical and physical interventions, supplemented where necessary by authorized inputs (organic fertilizers, certain biocontrol products, basic substances) - excluding synthetic chemicals and products derived from genetic engineering. Thus, whereas biocontrol involves a new range of products that are quite diverse and relatively ill-defined, organic farming emphasizes agronomic practices.Not all biocontrol products are authorized in organic farming.Let us now turn our attention to biocontrol products, starting with the proposal made by the European Commission in "Omnibus X", which aims to amend Regulation (EC) No 1107/2009 concerning pesticides. Omnibus X introduces - for the first time in European law - the categories of biocontrol "substances" and "products", defining them quite broadlyii and proposing a streamlined regulatory framework for themiii.France already has a definition for biocontrol products that - more or less - aligns with the proposed European definition. This French definition establishes a list of products recognized as "biocontrol" agents. For each product on the list, the Ministry of Agriculture specifies whether it is authorized for use in organic farming. By the end of 2025, 807 products in France were designated as biocontrol agents, and over three-quarters of them were authorized for organic farmingiv.Biocontrol products can serve various functions: "cidal" roles (herbicides, insecticides, fungicides, etc.), population regulation (such as pheromone trapping), or the regulation of plant growth and development.Biocontrol product categories prohibited in organic farmingThe primary distinction between biocontrol products and organic farming lies in the latter’s strict prohibition of herbicides and growth regulators. Organic farming standards (defined by Regulation 2018/848, Article 9 and Annex II) explicitly exclude all herbicides, even those that are entirely natural. For instance, pelargonic acid - originally discovered in geraniums - is not a product of synthetic chemistry; rather, it is an herbicide produced by extracting fatty acids from rapeseed or sunflower oil. Consequently, this product is not authorized for use in organic farming.As for growth regulators, they are prohibited under Article 5 of Regulation 2018/848, which stipulates that organic farming practices must respect natural systems and cycles. Gibberellic acid, for example, is a natural hormone that stimulates plant growth and development, controls stem elongation, triggers seed germination, and promotes both flowering and fruit enlargement. It is found in products such as Proliant or Perlan, which are authorized in France as biocontrol products but prohibited in organic farming.Herbicides and plant growth regulators are therefore strictly prohibited in organic farming; these are categorical bans. Other categories of substances - whether naturally derived or synthetic ones "recognized as identical" to the natural version and classified as biocontrol agents - include insecticides and fungicides. For these, specific products approved as biocontrol agents may or may not be authorized for use in organic farming. There are several reasons for these prohibitions. Biocontrol products can have systemic effects: they circulate within the plant's sap, trigger defense mechanisms, and leave measurable residues for extended periods (a classic example being phosphonates, despite their mineral nature). They can also have non-specific effects. For instance, rotenone kills a wide range of insects - including beneficial ones - and is highly toxic to aquatic organisms. This type of ecotoxicological profile is deemed incompatible with the biodiversity preservation goals inherent to organic farming, even though the active substance - formerly permitted in organic farming and now classified as a biocontrol product - is of plant origin.Omnibus X opens the door to new biocontrol productsOmnibus X paves the way for synthetic biocontrol substances that are "functionally identical and structurally similar" to natural substances. In organic farming, synthetic inputs that are "identical" to natural substances remain excluded in principle. Under European organic regulations, they may only be authorized on an exceptional basis: when no effective natural or agronomic alternative exists, and when using other available natural inputs would result in greater environmental impact (Articles 5g and 24 of Regulation 2018/848).It is based on the principle of excluding synthetic inputs - even those "identical" to natural substances - that organic farming prohibits, for example, potassium phosphonatesv, which are considered biocontrol products. This mineral fungicide exists in trace amounts in the soil; however, virtually all products sold are manufactured synthetically. Demeter adds that "the main metabolite of synthetic phosphonates is phosphonic acid, which is identical to the one derived from Fosetyl-Al, a product banned in organic farming. This renders any residue-based monitoring virtually ineffective, threatening the traceability and transparency of organic products"vi.Chemical mediators: a staple of biological controlWe just stated that synthetic versions "identical" to natural ones are, in principle, banned in organic farming. There is, however, an exception: chemical mediators (pheromones or kairomones). Although chemically synthesized, they are "identical" to natural pheromones; used for trapping or mating disruption and leaving no residues on fruit, they are permitted in organic farming. It should be noted, however, that some are not permitted because the dispenser or trap contains other substances banned under organic regulations (synthetic insecticides, problematic solvents, etc.). Furthermore, a synthetic chemical product is never entirely identical to the natural product it seeks to replicate.However, another type of chemical mediator is now entering the market. Already field-tested in Brazil, it consists of oil extracts from camelina plants genetically modified to produce precursors for the sex pheromones of lepidopteran pestsvii. This process was developed by ISCA (Innovative Solutions for Insect Control in Agriculture), a subsidiary of De Sangosse, a leader in the biocontrol market. Because it is derived from a GMO, this oil is effectively banned in organic farming. Restrictions on Microorganisms in Organic FarmingMicroorganisms are frequently used in organic farming, whether in powder form or in preparations based on plant fermentation. Indeed, nettle slurry and Bacillus thuringiensis (Bt) are two iconic examples of organic crop protection. Microorganisms also spearhead the field of biocontrol.Nettle slurry cannot be classified as a biocontrol product in the legal sense; instead, it is regulated as a "basic substance" (Regulation 1107/2009, Article 23), provided the specified production process is followed. Like any product resulting from fermentation, these slurries are preparations rich in microorganisms.As for Bt, any product containing it must meet specific criteria to be authorized for organic use. The Bt product must consist exclusively of co-formulants that are themselves authorized for organic farming. Similarly, formulations containing only isolated Cry toxins - without the Bt bacterium itself - are prohibited in organic farming, even though they might qualify as "biocontrol" products. Crucially, the Bacillus thuringiensis strain must not be genetically modified. Regulations governing organic farming are explicit: authorized microorganisms must "not be obtained from or derived from GMOs" (Regulation 2018/848). This criterion immediately rules out Bt GMO crops in organic farming, as the Cry toxins are produced by the genetically modified plant itself. In contrast, in the United States, transgenic Bt crops are recognized as "biocontrol products" because they utilize biological mechanisms. This country has also authorized the marketing of genetically modified microorganisms (GMMs) as "biocontrol products", such as Crymax, marketed by Certis Biologicalsviii, or Nogall, marketed by Bio-Careix.In Europe, under the definition proposed in the "Omnibus X" initiative, the European Commission refers to metabolites produced by microorganisms. It is important to note that these microorganisms can be genetically modified - such as those used to produce ledprona, the active substance (RNAi) in Calantha, an RNAi spray designed to combat Colorado potato beetles. These new genetic pesticides are incompatible with the standards and fundamental principles of organic farming. However, within the European Union, the Omnibus X proposal - when read alongside the Commission’s proposal to deregulate the commercial release of GMMsx - would allow authorized GMMs to be labeled as "biocontrol products" after having been approved as GMOs, doing so much more easily and without post-market oversight.What do organic sector stakeholders think of biocontrol and the Omnibus X proposal?To date, few stakeholders in the organic sector have criticized the European Commission’s proposal regarding biocontrol products (Omnibus X). Historically, they have often championed the first biocontrol products to reach the market, while remaining wary - as the FNAB was in 2014 - of potential co-optation by the agribusiness industry and the introduction of products with questionable ecotoxicological profiles. At the time, the FNAB president stated: "If biocontrol relies on products requiring marketing authorization or patents - and thus on private companies - it will be of far less benefit to farmers. Organic farmers value their autonomy; we do not want to trade one form of dependency for another". When asked by Inf’OGM, the FNAB clarified that "the proposals regarding biocontrol are also a cause for concern. It is primarily the definition that raises questions". They added: "The concept of 'similar' is vague and creates a grey area between 'natural' and 'synthetic' substances. Yet, this distinction is fundamental to organic farming. That said, organic regulations remain in place to ensure that synthetic substances are excluded from the organic label. So, while it creates an issue regarding clarity, it does not necessarily pose a direct threat to the organic sector".In 2025, prior to the publication of Omnibus X, IFOAM Organics Europe - the European federation for the organic sector - emphasized organic farming practices, stating that "in organic systems, biocontrol is just one of several tools used to manage pests, diseases, and weeds. In most cases, preventive and agronomic measures - such as crop rotation, variety selection, and the use of natural enemies - are sufficient. In fact, only 10% of organic farmland requires the use of natural substances in addition to preventive measures - with some crops, such as fruit and grapes, requiring them more than others”xi. According to IFOAM, biocontrol substances can be “natural substances or substances identical to them - such as extracts of natural origin (notably from plants or algae) or animal origin, substances produced by microorganisms or constituting biological organisms, and natural inorganic substances (of mineral origin)”. IFOAM Organics Europe sets two conditions. First, “organic farming requires substances for niche uses and with selective action, so as not to destabilize the ecosystem’s self-regulating balances and its naturally present beneficial organisms”. Second, “biocontrol agents used in organic farming must meet the requirement of being GMO-free”, covering both products derived from GMOs and products manufactured by GMOs.Thus, logically, in its response to the European consultation on the Omnibus X Regulationxii, IFOAM Organics Europe states: “While the definition of biocontrol products at the European level represents a positive step forward, the proposed definition is too broad. By including ‘substances of biological origin or produced via synthesis that are functionally identical and structurally similar to them’, it creates a grey area that fails to adequately distinguish natural substances from artificial synthetic ones. This wording allows certain new substances - such as RNAi or peptides - and future biotechnologies to fall under the biocontrol category […]. We therefore believe that a clear regulatory distinction must be maintained between natural substances (and those identical to substances found in nature) on the one hand, and artificial synthetic substances on the other”. The definition needs to be refocused on the concept of identity, with other substances continuing to follow standard regulatory procedures.Ultimately, IFOAM Organics Europe does not question the principle of biocontrol; indeed, it calls for a harmonized European definition and a rigorous assessment of these substances that takes their natural occurrence into account. The organization points out that "European assessment and authorization procedures were designed for synthetic substances and are ill-suited to natural substances, which struggle to gain approval despite offering crop protection alternatives that are less harmful than synthetic pesticides".Summary of products classified as "biocontrol" (or not) and products authorized for organic farming (or not)ProductBiocontrolOrganic farmingHerbicideYesNoGrowth regulatorYesNoSystemic insecticide or fungicideYesNoNon-selective insecticide or fungicideYesNoChemical mediatorYesYes, if and only if the trap or dispenser does not contain other prohibited substances.Non-GMO microorganismYesYes, subject to two conditions: – composed exclusively of co-formulants that are themselves authorized, – and the bacterium is "complete" (isolated toxin is prohibited).GMO plant or microorganism, or molecule produced from a GMOUnder discussionNoRNAi sprayUnder discussionNo i « Biocontrôle, le renouveau des pesticides ? », Inf’OGM, 28 novembre 2025.ii Christophe Noisette, « The European Commission is proposing legislation on biocontrol », Inf’OGM, 8 July 2026.iii Christophe Noisette, « Biocontrol: European Commission seeks lighter regulation », Inf'OGM, 2 July 2026.iv French Ministry of Agriculture, « Liste des produits phytopharmaceutiques de biocontrôle, au titre des articles L.253-5 et L.253-7 du code rural et de la pêche maritime », 24 July 2026.v “Pygmalion” by De Sangosse, “LBG-01F34” by De Sangosse, or “Boing” by HELM.vi Demeter France, « Phosphonates en agriculture Biologique : la position de Demeter France », 5 June 2025.vii https://hortimedia.ma/une-plante-genetiquement-modifiee-produit-des-pheromones-sexuelles-dinsectes-comme-alternative-aux-pesticides/viii CERTIS Biologicals, « Crymax ».ix « Bio-Care given permission to sell NoGall, and the world’s first genetically engineered microbe designed for outdoor use », LifeScienceHistory.com.x COM(2025) 1031.xi « Accelerating access to biocontrol in the EU: IFOAM Organics Europe issues recommendations », Bio Eco Actual, 20 May 2025.xii European Commission, « Feedback F33479098 from: IFOAM Organics Europe », 11 June 2026. Christophe NOISETTE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [9] => Array ( [objectID] => 32805 [title] => Update Algolia EN [timestamp] => 1788393600 [date] => 03/09/2026 [annee] => 2026 [url] => https://infogm.org/en/update-algolia-en/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => Inf'ogm [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [10] => Array ( [objectID] => 33593 [title] => For the FSC label, trees derived from NGTs are GMOs that cannot be certified as “sustainable” [timestamp] => 1788220800 [date] => 01/09/2026 [annee] => 2026 [url] => https://infogm.org/en/for-the-fsc-label-trees-derived-from-ngts-are-gmos-that-cannot-be-certified-as-sustainable/ [image] => https://infogm.org/wp-content/uploads/2026/08/Fsc-zertifizierung.jpg [extrait] => The Forest Stewardship Council (FSC), which certifies "sustainably" managed forests, held a public consultation on the interpretation of its definition of "genetically modified organism" (GMO)i - a definition adopted in 2000 and copied verbatim from the European definition in force since 1990. Currently, GMO tree plantations cannot obtain FSC certification. The consultation revealed conflicting views among the stakeholders (both members and non-members) who participated. However, among FSC members specifically, a narrow majority of respondents favored classifying trees derived from New Genomic Techniques (NGTs) as GMOs. Consequently, the FSC secretariat decided to keep trees genetically modified using NGTs within the GMO category, thereby maintaining the ban on their use in certified plantations. [chapo] => The Forest Stewardship Council (FSC), which certifies “sustainably” managed forests, held a public consultation on the interpretation of its definition of “genetically modified organism” (GMO)i – a definition adopted in 2000 and copied verbatim from the European definition in force since 1990. Currently, GMO tree plantations cannot obtain FSC certification. The consultation revealed conflicting views among the stakeholders (both members and non-members) who participated. However, among FSC members specifically, a narrow majority of respondents favored classifying trees derived from New Genomic Techniques (NGTs) as GMOs. Consequently, the FSC secretariat decided to keep trees genetically modified using NGTs within the GMO category, thereby maintaining the ban on their use in certified plantations. [texte] => In 2000, the Forest Stewardship Council (FSC) adopted a policy prohibiting GMOs in FSC-certified forests. The FSC defines a GMO based notably on European Directive 90/220: "an organism whose genetic material has been modified in a way that does not occur naturally by mating and/or natural recombination", subject to the same exemptions provided for by the European Union in 1990 and subsequently clarified by the CJEU. This prohibition and definition remain in effect.2021–2025: Attempts to modify the definition of a GMOIn 2021, the FSC launched a consultation on its Policy for Associationii. The Global Forest Coalition - which is not an FSC member - noted that this 2021 consultation focused in particular on the definition of a GMO and that pressure was being exerted to "relax" that definition in order to exclude certain new genetic modification techniques. Ultimately, the final text retained the original definition of a GMO. Pressure mounted when the FSC subsequently launched a "learning process on GMOs". As part of this initiative, the FSC attempted to distinguish between "genetic engineering" and "gene editing" (to use their terms): the former was presented as producing GMOs, while the latter was portrayed as a different process. Following an international campaign, the FSC office ultimately decided to close the process without making any changes to the existing definition.During the same period, the issue of New Genomic Techniques (NGTs) was gaining momentum internationally. In Europe, the European Commission proposed deregulating plants derived from these NGTs in 2023. Forestry companies holding FSC certification sought a separate regulatory framework from the FSC for NGT trees. Consequently, in 2025, the FSC organized a second consultation - running from July 30 to September 28 - to gather input from its members and other stakeholders on the following question: do trees with genomes modified via New Genomic Techniques fall under the FSC’s definition of a GMO? The FSC extended the consultation beyond its membership to identify the practical impact of a given interpretation on specific economic actors and NGOs, and to gauge the social, political, and economic acceptability of any potential position.A consultation dedicated to trees derived from NGTsThe consultation report was published on July 6, 2026. This consultation received 248 responses. 54% of the responses (148) disputed the view that new techniques would result in GMOs, compared to 37% (100 responses) that supported this position. 9% of respondents simply provided comments.Let us break down these responses. Among all respondents, 82 identified themselves as FSC members (approximately 33%), while a majority (around 65%) indicated they were not members.FSC members are divided into three chambers: economic (forestry companies, paper industries, certification bodiesiii), environmental (nature conservation associations and NGOs, environmental research institutesiv), and social (Indigenous peoples' organizations, trade unions, and forestry worker organizationsv). The specific list of members is not public. However, it is known that FSC International has over 1,160 members across 90 countries.The FSC report does not list by name the non-members who responded to the consultation. However, it specifies that they include academics, consultants, companies already certified by the FSC, NGOs (such as CBAN or the Global Justice Ecology Project), professional organizations (e.g., the New Zealand Forest Owners Association), and even private individuals.Focusing solely on FSC members, the group is relatively divided, with a very slight majority of responses favoring the classification of new techniques as producing GMOs under the FSC definition (see Table 1). Above all, there is a clear, marked divide within the group between the Southern economic chamber - which is strongly opposed to equating NGTs with GMOs - and the Northern economic and environmental chambers, which are generally in favor.It is therefore the non-members who tip the overall consultation result toward a majority "no" vote - meaning "no, new techniques do not yield GMOs under the FSC definition". Within this group, the "yes" vote is in the minority (21%), while the "no" vote prevails at 39%. These non-members, who lack voting rights at the General Assembly, use the consultation as a channel to influence the FSC’s position on trees derived from NGTs. Some of the support for equating NGTs with GMOs came from NGO networks mobilized against GM trees, whereas part of the opposition stemmed from certificate holders and economic actors already involved in FSC certification in Latin Americavi. Examples include large FSC-certified industrial pine or eucalyptus plantation companies in Chile or Brazil, as well as Latin American forestry cooperatives that use the label to export to Europe and North America.NGTs produce GMOsNGTs do not produce GMOsNo answer to the single multiple-choice question, but with commentsMembers :16 %15 %‍The Economic South Chamber2 %10 %‍The Economic North Chamber6 %3 %‍The Environmental South Chamber3 %2 %‍The Environmental North Chamber4 %0‍The Social North Chamber1 %‍Non members21 %39 %‍TOTAL37 % (100 answers)54 % (148 answers)9 %‍Table 1: Breakdown of responses by type of stakeholder (college and geographic origin) to the question, “Do new techniques result in GMOs as defined by the FSC?”Another aspect of this consultation warrants analysis: the difference in responses based on the respondents' geographical origin. "No" responses are far more prevalent in Latin American countries. Conversely, in Europe, "yes" responses predominate.NGTs produce GMOsNGTs do not produce GMOsNo answer to the single multiple-choice question, but with commentsLatine America7 %37 %‍North America5 %8 %‍Europe15 %3 %‍Rest of the world (Africa, Asia, Oceania, and international bodies)10 %6 %‍‍TOTAL37 %‍54 %‍9 %Table 2: Breakdown of responses by geographic origin of the respondents to the question, “Do new techniques result in GMOs as defined by the FSC?”The arguments put forwardThe FSC consultation then invites stakeholders to explain the arguments underlying their responses to the first question. Unsurprisingly, proponents of a distinct status for trees derived from NGTs employ arguments similar to those used by the European Commission and lobby groups to justify the EU legislation adopted on June 17, 2026, which deregulates plants produced via these new techniques. The FSC reports that those arguing against treating and regulating NGTs in the same way as transgenic GMOs claim that these techniques "produce precise, targeted modifications to the organism's genome without inserting foreign genetic material"; that the resulting genetic changes are "indistinguishable" from those occurring naturally or through "conventional" breeding methods; and that the process constitutes mutagenesis - a category excluded from the definition of GMO-producing techniques under current FSC policyvii. It should be noted that, following a 2018 clarification by the CJEU, the exemption for mutagenesis within the European Union applies exclusively to methods that have been "traditionally used for various applications and have a long safety record"viii.Finally, in their comments, these stakeholders put forward the same "economy of promise" argument: namely, that "maintaining an obsolete definition could restrict access to technologies that may prove essential for both research and commercial use, thereby limiting the development of more resilient, productive, and sustainable cultivars". They therefore call for a case-by-case approach based on an analysis of the final product rather than the technical process. They add that several countries have already deregulated products derived from these techniques - a misleading statement, given that only a few countries have "deregulated" GMOs obtained via NGTs. Inf’OGM has demonstrated in numerous articles that these arguments are fallacious.The consultation report highlights that "qualitative analysis of the responses revealed coordinated participation, with several contributions containing similar or even identical comments, indicating a collective effort to express shared viewpoints during the consultation process". It notes, in particular, "a clear clustering of responses from a group of certificate holders in Latin America opposing the proposed interpretation. There were also collective responses from academics, primarily from North America".In contrast to the position seeking to exclude NGT products from the FSC’s GMO classification, environmental groups and a large number of European respondents advocate for a strict interpretation of the FSC’s definition of a GMO. For them, any genetic modification meeting this definition warrants excluding such trees from the scope of "sustainable" certification. They also fear that by creating an exception for certain NGTs, the FSC could ultimately open a loophole leading to the gradual acceptance of all genetically modified trees in FSC-certified plantations, thereby posing risks to ecosystems and the label’s credibility. Finally, several comments highlight that, given the deregulation of NGT-derived products in certain jurisdictions - including the EU - the FSC’s stance carries significant symbolic and practical weight: keeping these products in the GMO category sends a strong signal against the normalization of such GMOs within the wood and paper supply chain.Choosing FSC: Beyond ConsultationUltimately, the report upholds a firm stance: trees derived from NGTs fall under the definition of a GMO as it has been in effect within the FSC since 2000. In doing so, the FSC respects the position held by the majority of its members. The decision proposed by the FSC secretariat in this report takes the existing GMO definition as its starting point and proposes interpreting it to explicitly include organisms developed using new genetic modification techniques.The FSC clarifies that the phrase "modified in a way that does not occur naturally" applies to both the final outcome and the process employed; this leads to the classification of any use of genetic modification techniques - whether transgenesis or NGTs - as falling within the GMO category. While the FSC, like the European Union, excludes certain techniques from the scope of GMOsix, trees with genomes modified using CRISPR or other new-technique tools remain subject to a ban on use, except within the relatively controlled context of research, as already provided for under the FSC’s current GMO policy.This consultation helps the FSC understand who opposes classifying "NGT" products as GMOs, as well as the locations and arguments involved. It enables the FSC to identify internal divisions based on geography and the nature of the stakeholders.However, the FSC’s position classifying "NGT" products as GMOs could be revisited if members wish to make it a subject of formal debate. In that event, the issue could be brought before a future FSC General Assembly, where the three chambers - economic, environmental, and social - each hold one-third of the votes, maintaining an internal balance between the North and the Southx.i Forest Stewardship Council, « Public Consultation on the Interpretation of Genetically Modified Organism (GMO) Definition (INT‑FSC‑STD‑01‑001_19) », rapport de consultation, 6 July 2026. Forest Stewardship Council, « New interpretation on the definition of GMOs published », 20 July 2026.ii In 2022, Inf’OGM requested the official consultation document from the FSC, but to no avail. Christophe Noisette, « FSC label: towards acceptance of GMO trees? », Inf’OGM, 27 September 2022.iii Example : Ikea, Rougier Gabon, Resolute Forest Products, l’Oréal.iv Example : WWF, FNE, Fundación FUNDECOR, Nature Conservancy of Canada.v Example : SNUPFEN Solidaires, Max Havelaar, Fundación ALTROPICO.vi Not all FSC certificate holders are members.vii The FSC policy on GMOs was adopted in 2000. It is based on Directive 90/220, without replicating it exactly. Indeed, the FSC does not adopt the distinction between techniques that produce GMOs but are excluded from the scope of the Directive and techniques that do not produce GMOs. The FSC therefore specifies: "The following techniques are not considered to result in genetic modification, provided that they do not involve the use of recombinant DNA molecules or GMOs as recipient or parental organisms:in vitro fertilization,conjugation, transduction, transformation, or any other natural process,polyploidy induction,mutagenesis,cell fusion (including protoplast fusion) of plant cells, where the resulting organisms can also be obtained through traditional breeding methods".Forest Stewardship Council, « FSC POLICY – FSC INTERPRETATION ON GMOS (GENETICALLY MODIFIED ORGANISMS) – FSC-POL-30-602 (2000) EN », 1st May 2000.viii EUCJ, « Case C‑528/16, point 51 », 25 July 2018.ix Christophe Noisette, « FSC label: towards acceptance of GMO trees? », Inf’OGM, 27 September 2022.x Each chamber holds 33.3% of the votes, and within each chamber, the votes are then weighted so that the "North" and the "South" each have 50% of the vote, thereby preventing members from the North from dominating decisions. Christophe NOISETTE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [11] => Array ( [objectID] => 32251 [title] => NGT Regulation: is Europe heading for a rise in seed prices? [timestamp] => 1787702400 [date] => 26/08/2026 [annee] => 2026 [url] => https://infogm.org/en/ngt-regulation-is-europe-heading-for-a-rise-in-seed-prices/ [image] => https://infogm.org/wp-content/uploads/2026/08/50175233497_f9308cc5ff_o-768x576.jpg [extrait] => In June, the European Parliament adopted a regulation on new genetic modification techniques (NGTs). Contrary to the demands of several civil society organisations – notably farmers’ groups, but also MEPs – the text does not ban patents on products derived from these NGTs. However, experience in the US shows that the strengthening of intellectual property rights over seeds has been accompanied by a general rise in their prices – particularly those of genetically modified seeds – and by increased concentration within the sector. This trend could also occur in Europe and, in the long term, have an impact on food prices. [chapo] => In June, the European Parliament adopted a regulation on new genetic modification techniques (NGTs). Contrary to the demands of several civil society organisations – notably farmers’ groups, but also MEPs – the text does not ban patents on products derived from these NGTs. However, experience in the US shows that the strengthening of intellectual property rights over seeds has been accompanied by a general rise in their prices – particularly those of genetically modified seeds – and by increased concentration within the sector. This trend could also occur in Europe and, in the long term, have an impact on food prices. [texte] => Intellectual property rights, particularly patents, are generally presented as a driver of plant innovation. They also serve to increase the market power of companies, such as multinational seed firms, and can contribute to a rise in seed prices1, as the US example demonstrates. This issue takes on a new dimension with the new European regulation on NGTs.Patents and the seed marketOn 18 June, the European Union (EU) adopted a new regulation on NGTs (new genetic modification techniques). A lengthy debate on the subject of patents – with proposals from several civil society actors and MEPs to either ban them or limit their scope to products resulting from the use of the patented invention – ultimately failed to lead to their abolition or restriction. The regulation does include transparency provisions2 but their implementation remains, to say the least, complex and/or ineffective given their non-binding nature.As a key participant in the debate, the European Coordination Via Campesina (ECVC) has advocated for such a restriction and has also called for a number of provisions to be introduced into the regulation to protect smallholder seed systems, as well as small and medium-sized seed producers. For example, the ECVC demanded that patent holders be obliged to provide methods for detecting and distinguishing patented Category 1 GMOs from any other plant obtained through essentially biological processes that are not patentable3. This provision was indeed the subject of an amendment proposed by Parliament, but it was not retained following the trilogue and the European Parliament’s final vote.Furthermore, a patent confers on its holder the right to prohibit third parties from carrying out any acts constituting the exploitation of the invention, in particular to exclude competitors from the relevant market, and to impose one or more patent licences on them. It also makes it possible to threaten farmers with infringement proceedings, even where they have not used the patented invention but their own seeds contain a patented feature, either naturally or as a result of accidental and unavoidable contamination. Patents therefore strengthen the market control exercised by their holders; ultimately, this applies not only to GMOs/NGTs but also to all other seeds threatened by these abusive extensions of the scope of patents. However, dominating or controlling a market goes hand in hand with, at the very least, influencing or even setting market prices, within the limits permitted by law. The economic effects of such rights are already evident in countries where they are widely used, for example in the United States.In the United States, patents are driving up the price of seedsThe United States has been a pioneer in the field of patents on living organisms, and biotechnology in particular4. GMOs are patentable there, including GMOs/NGTs. Plants and products derived from them are no exception to this, although a recent bill aims to limit the use of conventional utility patents on plants and plant genetic material5.As shown in a 2023 study6 by the USDA (US Department of Agriculture), the US agricultural seed sector is feeling the effects of the expansion of intellectual property rights, particularly patents held by multinationals. This phenomenon has contributed to the concentration of the seed market in the hands of these multinationals. For example, according to this report, between 2018 and 2020, the two seed companies Bayer and Corteva accounted for 72 per cent of the area sown with maize and 66 per cent of the area sown with soya in the United States, whether GM or non-GM. As the vast majority of maize and soybean acreage in the US is cultivated using genetically modified varieties (around 90–95 per cent for many years now7), these acreage figures therefore relate primarily to GMO production.The USDA report also shows that major US seed companies have, overall, increased their research and development expenditure and accelerated the development of new varieties. According to the US Department of Agriculture, this trend is driven by the prospect of being able to raise seed prices and generate higher revenues. According to the USDA, between 1990 and 2020, the prices paid by farmers for seeds in general rose by an average of 270 per cent, whilst the prices of seeds intended for crops with predominantly genetically modified traits soared by 463 per cent. By comparison, the prices received by farmers for their crop produce rose by 56 per cent. In other words, the cost of seeds has risen much faster than the value of the crops sold, which may be contributing to a squeeze on farmers’ margins.According to the USDA, the rise in the price of non-GM seeds can be attributed to a combination of several factors: i) the rising value of "improved" varieties and increased investment in research and development, ii) the growing concentration of the seed market, which has strengthened the market power of large companies, iii) the spillover of price dynamics from the GM segment to the seed market as a whole ("market effect").Indeed, large companies generally market ranges comprising both GM and non-GM varieties. The pricing strategies and margins developed for GM seeds can therefore influence the prices of other varieties offered in their catalogues.Is a similar trajectory possible in the EU?Several elements of the US system are also present in the European Union. The seed companies that dominate the market across the Atlantic are multinationals that are also present in Europe. The recent authorisation of GMOs/NGTs on the European market without traceability or labelling, following the adoption of the NGT Regulation, is another point of convergence with the US system – indeed, a more permissive regime8. Furthermore, as in the United States, European law permits, under certain conditions, the patenting of inventions relating to biological plant material, in particular plants or seeds exhibiting characteristics resulting from a technical intervention. The patentability of these companies’ GMOs/NGTs in Europe therefore contributes to an environment which, as in the United States, is conducive to an increase in the price of seeds.It cannot, however, be said that the US scenario will necessarily be replicated, insofar as the two regulatory frameworks are not entirely comparable. Differences may also exist in competition law. It is impossible to rule out the possibility that the same economic mechanisms leading to an increase in seed prices might be repeated in Europe. Several reports, including the Technopolis report of December 20259 commissioned by the European Commission, as well as those from NGOs and farmers’ organisations such as ECVC, highlight the issue of seed market concentration in the hands of a few firms, as well as the role played by patents.Consequences on several levelsThe rise in the price of seeds in Europe is, first and foremost, a factor weighing on the overall costs borne by all farmers, despite the "farmers’ privilege". Whilst European Union legislation allows farmers to reuse around thirty varieties of ‘farm-saved seed’ on their own farms, they are nevertheless required to pay "fair remuneration" to the seed company under the Plant Breeders’ Rights (PBR) scheme. Other seeds will have to be purchased by farmers, which will, in particular, increase their dependence on a few large seed companies and reduce their profit margins.Furthermore, as seeds are the first link in the food chain, an increase in their price could contribute to higher agricultural production costs and, ultimately, to higher food prices in Europe10. The potential rise in the cost of seeds linked to the strengthening of patent rights would, however, constitute a further factor driving up the cost of agricultural production. The extent to which a potential rise in seed prices is passed on to consumers depends on numerous factors, including yields, global prices, agricultural policies and bargaining power within the supply chains. It cannot therefore be stated that a rise in seed prices, linked to intellectual property rights, will automatically lead to higher food prices.Moreover, the USDA study does not measure this pass-through to the consumer. It does, however, clearly show that the extension of intellectual property rights, particularly patents, has strengthened the market power of seed companies and their ability to set higher prices. The USDA thus attributes the sharp rise in seed prices both to the value of new varieties and to the increased market power of companies. If this trend were to be replicated in Europe, a sustained rise in seed prices would constitute an additional factor driving up agricultural production costs, which, depending on the sector and market conditions, could be passed on in part to agricultural and food prices.The risks of patents on NGTsGiven the adopted NGT regulation, patents on plants derived from NGTs remain a sword of Damocles hanging over small and medium-sized players in the agricultural sector, such as breeders and farmers… These stakeholders will, in fact, be unable to prove that their traditional seeds and plants containing a trait covered by a patent utilising NGTs – whether "naturally" or as a result of accidental contamination – do not derive from the invention claimed by that patent. This legal risk could, consequently, place them in a position of infringement.Furthermore, the economic risk associated with rising production costs for conventional seeds may also stem from the need to navigate the "minefield" created by such patents and, for breeders, to eliminate any trait patented by others, including patents relating to native traits.Whilst not claiming that future European seeds – particularly GMOs and NGTs – will necessarily, by virtue of their technical nature, command a particularly high price, the USDA report does, however, show that in the United States, an increase in intellectual property rights – particularly patents – does indeed strengthen the market power of seed companies, leading to greater concentration within the sector and control over seed prices.Europe now possesses certain factors that could bring this scenario to fruition. Should the cost of seeds rise sustainably, the entire cost of European agricultural production – and potentially that of food – could be affected. In the event of a general rise in seed prices via the ‘market effect’, organic and non-GMO farmers could also suffer the consequences. Denis Meshaka antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [12] => Array ( [objectID] => 31070 [title] => Controversial ‘seeds’ regulation set for adoption [timestamp] => 1786320000 [date] => 10/08/2026 [annee] => 2026 [url] => https://infogm.org/en/controversial-seeds-regulation-set-for-adoption/ [image] => https://infogm.org/wp-content/uploads/2026/08/960px-Intsia_bijuga_and_Mucuna_gigantea_seeds_SF24205-01-768x576.jpeg [extrait] => The adoption of the future European regulation on plant reproductive material, known as the ‘seeds regulation’, has entered its final stages. The ‘provisional compromise’ is presented as a modernisation of the current legislation. Among other things, it extends the market for conservation varieties across the entire European Union and regulates the non-commercial exchange of seeds between farmers. However, this compromise has not achieved consensus. Whilst the peasant farmers’ organisation ECVC is calling for its rejection, organisations defending cultivated biodiversity welcome some of the progress made. The seed industry and the mainstream agricultural unions, for their part, welcome a framework that reinforces the current market organisation. [chapo] => The adoption of the future European regulation on plant reproductive material, known as the ‘seeds regulation’, has entered its final stages. The ‘provisional compromise’ is presented as a modernisation of the current legislation. Among other things, it extends the market for conservation varieties across the entire European Union and regulates the non-commercial exchange of seeds between farmers. However, this compromise has not achieved consensus. Whilst the peasant farmers’ organisation ECVC is calling for its rejection, organisations defending cultivated biodiversity welcome some of the progress made. The seed industry and the mainstream agricultural unions, for their part, welcome a framework that reinforces the current market organisation. [texte] => Proposed by the European Commission in July 2023, alongside the recently adopted new NGT Regulation, the draft ‘Seed Regulation’ has entered its final stages. It aims to replace ten directives that currently govern the production and marketing of plant reproductive material (PRM) in the European Union (EU) i . Beyond the widely shared objective of ‘modernising’ and simplifying a legal framework deemed complex, the negotiations have highlighted differences of opinion concerning conservation varieties, the exchange of seeds between farmers and, more broadly, the protection of cultivated biodiversity ii .A text on the verge of adoptionThree years after its presentation by the Commission, the PRM Regulation is nearing the end of its legislative process. A provisional compromise iii was reached on 17 June by the trilogue bringing together the European Commission, the Council and the European Parliament. On 29 June, the Parliament’s Committee on Agriculture and Rural Development (AGRI) approved this compromise in a single vote and without amendments. The compromise text was then also approved on 8 July by Coreper (the Committee of Permanent Representatives of the Member States), paving the way for its formal adoption by the Council of the European Union. The final vote in Parliament’s plenary session is expected after the summer recess, probably in September or October.Unlike the current directives, which allow Member States a certain degree of flexibility when transposing them into national law, this regulation will be directly binding on them, with no scope for adaptation. It is, however, due to come into force four years after its adoption, in order to allow the European Commission time to adopt numerous delegated acts (the European equivalent of decrees implementing a national law) and to give national authorities time to adapt their respective current regulations.Whilst the text aims to modernise and simplify the European system for the marketing of PRMs, it retains many of the principles that currently underpin the market. Variety registration, seed certification and the supervision of operators remain the main pillars of the regulation currently being adopted. Nevertheless, progress has been made by advocates of the free movement of seeds under increasingly digitised bureaucratic control.Legislative reforms and relaxations Among the changes provided for in the PRM Regulation, the regime for conservation varieties iv (Article 26), currently limited solely to vegetable varieties, is being extended to all plant species, with the aim of better preserving plant genetic resources threatened by ‘genetic erosion’. It also extends their marketing – currently restricted to their regions or countries of origin – to the entire European market. Article 26 also introduces a new category of locally adapted varieties that may be registered without undergoing official DUS (distinctness, uniformity, stability) testing. This development could facilitate the dissemination of varieties resulting from participatory breeding v or adapted to less intensive farming systems that promote agrobiodiversity. However, it offers no guarantee against a single company appropriating the designation of traditional ‘varieties’ developed by farmers – which are accessible to all without ever having been registered.Another development concerns the official recognition of conservation organisations and networks (Article 29), whose activities have hitherto fallen outside any European legal framework. The regulation will enable them to produce, exchange and market PRMs, including unregistered varieties, for conservation purposes. Numerous restrictions, such as certain reporting, traceability and volume control obligations, have been retained despite widespread protests from the stakeholders concerned.The compromise text also relaxes the rules concerning amateur gardeners (Article 28). They will be able to purchase, in small quantities, seeds of unregistered and uncertified varieties, provided they are accompanied by a producer’s label and a description accessible to the public.These new categories will not be required to demonstrate any history of use, which opens the door to the marketing of seeds of new varieties that may result from cross-breeding with NGT plants or be contaminated by such plants, and therefore lack any NGT labelling.Farmers will be able to take part in seed exchanges within recognised conservation networks, but the text does not extend the possibility of freely exchanging seeds outside these schemes. Indeed, and contrary to the current directives, the right to exchange seeds directly between farmers is regulated by the PRM Regulation (Article 30). Such exchanges are limited to small quantities, at a local level, without financial compensation, and are completely prohibited for certain species such as potatoes, vines, citrus fruits, hemp and poppies, as well as for varieties covered by a Plant Breeder’s Rights (PBR). They are also subject to various bureaucratic requirements and health checks.The production of the PRMs being exchanged is also subject to compliance with very strict health regulations designed for large-scale commercialisation rather than agricultural production. In most cases, these regulations prohibit any exchange of farmers’ seeds selected and produced under on-farm agricultural conditions. Adopting this regulation as it stands would therefore undermine the practices of most members of the French Farmers’ Seeds Network.Persistent shortcomings, according to civil society organisations For the Austrian seed conservation association Arche Noah, which has closely followed the negotiations, the text of the provisional agreement represents a mixed compromise vi . The organisation welcomes the European legal recognition of conservation networks, the expansion of the regime for conservation varieties, the creation of locally adapted varieties, the recognition of – albeit limited – seed exchanges between farmers, and the possibility of marketing seeds intended for amateur gardeners more easily. Arche Noah believes, however, that these advances are accompanied by increased administrative burdens. In particular, it criticises the significant traceability and record-keeping obligations that continue to weigh on professional operators, despite exemptions obtained for conservation networks. It also regrets the numerous restrictions governing such exchanges, such as the limitation to small quantities, the absence of financial compensation, and the exclusion of certain plant species. It should be noted that farmers’ fundamental rights to freely grow, use, exchange and market their own seeds in accordance with the UNDROP vii – rights regularly emphasised by the European Coordination of Via Campesina (ECVC), which has repeatedly expressed its opposition to this new regulation since 2003 – remain unaddressed by this provisional agreement.The Austrian association also criticises the fact that the assessment of the VSCU (Value for Sustainable Cultivation and Use) remains primarily based on yield criteria, without giving proper consideration to organic or low-input systems (recital 49).Finally, as the ECVC has repeatedly emphasised, it should be noted that the new European variety register does not provide any information on breeding methods, even though it will allow varieties to be registered on the basis of genetic characteristics that may result from the use of NGTs, replacing the current phenotypic traits. However, depending on growing conditions, a genetic trait may or may not ‘code’ for a phenotypic trait, which alone is of agronomic or commercial interest. Protected by professional secrecy, the link between such genetic markers and any intellectual property rights (patents, plant breeders’ rights, trade marks, etc.) will, on the other hand, greatly facilitate legal action against prohibited farm-saved seed, the collection of royalties due for ‘exempt’ species, and penalties for non-compliance with conditions of use for crops covered by trade marks…A broadly satisfied seed industry In a press release dated 26 June viii , SEMAE (the French inter-professional organisation for seeds and plants) endorses a ‘landmark agreement that maintains the key balances of the European system for the marketing of seeds and plants.’ It welcomes the fact that ‘the registration of varieties in an official catalogue remains the cornerstone of user information and protection, thereby guaranteeing transparency and traceability’, as well as that ‘the official control and certification procedures which ensure farmers have access to seeds meeting high-quality standards have been reinforced.’ Are we to believe that it is delighted that everything is changing so that nothing changes? At European level, Euroseeds (representing the European seed industry) and Copa-Cogeca (European agricultural trade unions and cooperatives) have issued a joint press release ix welcoming the agreement, which they regard as a balanced compromise reconciling the preservation of the foundations of the European seed system with the modernisation of the regulatory framework. Both organisations believe that this regulation’will provide greater legal clarity and consistency for both operators and public authorities, and will modernise the rules to enable breeders and producers to benefit from the latest innovations, technologies and digitalisation’.The likely future PRM regulation therefore remains essentially structured around the interests of the industrial seed sector. By prioritising DUS criteria and certification, the system continues to favour standardised varieties covered by plant breeders’ rights (PBRs) at the expense of diverse, evolving seeds adapted to local conditions. By introducing genetic markers, it will facilitate legal action against prohibited farm-saved seed or the non-payment of royalties due for exempt species, as well as against farmers’ seed that naturally contains, or is contaminated by, genetic elements associated with such markers and covered by patents.However, in the face of climate change and the erosion of cultivated biodiversity, farmers’ seeds are a valuable tool for resilience thanks to their adaptability and the genetic diversity they offer. For their advocates, they should therefore not be regarded as an exception to the system, but as a complementary pillar of European food security requiring a regulatory framework specifically tailored to farmers’ seed systems.i Meshaka, D. (2023), ‘EU – “Seeds”: the other proposal in the legislative package’, Inf’OGMii Meshaka, D. (2026), Agricultural biodiversity at risk with new seed regulation, Inf’OGM iii REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of the Council, and repealing Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC (Regulation on plant reproductive material) – Analysis of the final compromise text with a view to reaching an agreement on 8 July 2026 (in English iv A conservation variety means a variety which is of interest for the preservation of the genetic diversity of cultivated plants and which is maintained despite the fact that it does not necessarily meet the conventional criteria for commercial varieties. Article 3(29), which defines conservation varieties, specifies that they may be characterised by reduced uniformity due to a certain level of genetic or phenotypic diversity among the different reproductive units. v Citizen Science, Resoriv, ‘Participatory breeding in France: a collective project for local agriculture and food’, July 2013 (only in French) vi Let’s liberate diversity (Arche Noah), ‘Analysis of trilogue negotiations on plant reproductive material’, 10 June 2026 vii United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas. viii SEMAE, ‘European regulations on plant reproductive material (PRM): SEMAE welcomes a landmark agreement for the French seed and plant sector’, 26 June 2026 (only in French) ix Euroseeds, ‘Euroseeds welcomes trilogue result on new EU seed law’, 18 June 2026 Denis Meshaka denis.meshaka [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [13] => Array ( [objectID] => 30699 [title] => GMOs are not the answer to the climate crisis [timestamp] => 1785715200 [date] => 03/08/2026 [annee] => 2026 [url] => https://infogm.org/en/gmos-are-not-the-answer-to-the-climate-crisis/ [image] => https://infogm.org/wp-content/uploads/2026/07/264fb63_21317-1qptstn.ywit_-768x432.jpg [extrait] => Two economics researchers from Peking University, Kaixing Huang and Yaxuan You, have published a paper comparing greenhouse gas (GHG) emissions between countries that have grown genetically modified (GM) crops and those that have not. Their conclusion is unequivocal. They assert that genetically modified maize, soya, cotton and rapeseed increase greenhouse gas emissions from agriculture. However, this study has significant limitations: based on international statistics, it adopts an ‘accounting’ approach and does not challenge either globalised agriculture or genetically modified crops. Inf’OGM has nevertheless chosen to analyse it, as the subject is poorly documented and the study helps to shed light on its complexity. This article is intended as a contribution to the dossier on the impact of GMOs on the climate and, more specifically, on GHG emissions. [chapo] => Two economics researchers from Peking University, Kaixing Huang and Yaxuan You, have published a paper comparing greenhouse gas (GHG) emissions between countries that have grown genetically modified (GM) crops and those that have not. Their conclusion is unequivocal. They assert that genetically modified maize, soya, cotton and rapeseed increase greenhouse gas emissions from agriculture. However, this study has significant limitations: based on international statistics, it adopts an ‘accounting’ approach and does not challenge either globalised agriculture or genetically modified crops. Inf’OGM has nevertheless chosen to analyse it, as the subject is poorly documented and the study helps to shed light on its complexity. This article is intended as a contribution to the dossier on the impact of GMOs on the climate and, more specifically, on GHG emissions. [texte] => A recurring question regarding GMOs is that of their impact on climate change. GMOs are plants used in industrial agriculture, which is itself widely criticised for its negative impact on the climate1. Two researchers from Peking University, Kaixing Huang and Yaxuan You, therefore studied2 the impact of genetically modified crops on emissions of various greenhouse gases (GHGs) — methane, nitrous oxide and CO₂ — in agriculture across 145 countries between 1985 and 2018³3.What method was used?These researchers decided to ‘work’ at country level: they compared the GHG emission trajectories of countries that adopted GM crops (maize, soya, cotton, rapeseed) with those of countries that did not adopt them, or that adopted them later. In their ‘difference-in-differences’ (DID)4 econometric models, they include country-specific characteristics that remain constant (soil, agricultural structure), characteristics common to each year (global trends, world prices) and a set of climatic variables. In this way, they aim to avoid confusing the effect of GMOs with structural differences between countries or with general trends in the climate and the global economy.To put it another way, they do not directly compare ‘GM maize versus non-GM maize’ at plot level, but seek to determine how, overall, GHG emissions are changing in agricultural systems that do or do not incorporate these genetically modified crops.To measure this impact, they examine greenhouse gas emissions from two perspectives. On the one hand, they analyse GHG emissions linked to crops as a whole, which the FAO refers to as ‘agricultural soil emissions’: emissions from fields linked to synthetic nitrogen fertilisers, organic inputs (manure, crop residues), the conversion of organic soils (notably peatlands) to cropland, as well as CO₂ emissions from fuel used by agricultural machinery. The researchers do not take into account GHG emissions linked to the production5 of nitrogen fertilisers, nor do they mention the mineralisation caused by the intensive use of these fertilisers, or the soil degradation they entail6. This would further increase the negative impact of GMOs on the climate.On the other hand, they take into account emissions from the agricultural sector as a whole, which includes emissions from crops, livestock (enteric fermentation, manure management, grazing) and certain aspects of land-use change, notably the loss of tree cover and the conversion of previously forested or grassed land to cropland. In both cases, they use FAO inventories compiled in accordance with the IPCC’s standard methodology, converting methane, nitrous oxide and CO₂ into CO₂ equivalents – a conversion that is, by its very nature, imperfect7.GMOs increase carbon intensityFirstly, ‘carbon intensity’ refers to the quantity of GHGs emitted per hectare of cultivated land or per tonne produced: the higher this ratio, the more ‘carbon-intensive’ a unit of land area or agricultural production is, even if total production increases.Drawing in particular on the controversial study by Klümper & Qaim (2014)8, the researchers assume that the adoption of genetically modified varieties of maize, soya, cotton and rapeseed is associated, on average, with a rise in yields of around 13–14 per cent and an increase in the area under cultivation of around 15 per cent for these crops. This increase is far from universally accepted. Inf’OGM, citing a USDA report, stated that ‘the empirical evidence regarding [their] effects on yields is mixed’⁹9. In other words, it has not been established that GMOs systematically improve yields in all contexts. If, in at least some situations, yields do not increase, this means that the rise in GHG emissions estimated in this article is all the greater, which would reinforce the significance of their findings.This increase in yields (itself a matter of debate) and in the area under cultivation inevitably entails more inputs, more fertiliser and more mechanical labour. But the authors go further: they show that GHG emissions per hectare and per tonne are increasing. They question whether this rise is not simply a reflection of increased production: if GHG emissions are rising at the same rate as productivity, it could be argued that GMOs have no impact on GHG emissions per unit produced, even if the total emissions are increasing.On average, per hectare, countries that adopt GMOs do not simply ‘produce more with the same amount of inputs’: they use more fertiliser, irrigate more, increase the number of crop cycles and bring lower-quality land into production, the authors state. The authors also highlight a long-term negative effect on the quantities of pesticides used: the initial decline (particularly for Bt crops, which produce an insecticide) was fairly quickly offset by an increase linked to the emergence of resistant weeds or pests, or secondary pests that were not targeted by the Bt crops. It is this intensification of input use and the expansion into less favourable land that explains why GHG emissions per hectare are rising. Under these conditions, the increase in yield is not sufficient to offset the rise in inputs and the deterioration in soil quality: emissions per hectare are rising faster than yields. Consequently, emissions per tonne of maize or soya produced are also rising, which the authors quantify as an increase in the carbon intensity of these crops of between 9 and 11 per cent.GMOs are altering the agricultural landscape and may increase GHG emissionsIn practical terms, by cross-referencing FAO statistics on inputs and land area with GAEZ10 data on soil quality, the authors show that following the adoption of GMOs, nitrogen fertiliser use per hectare increased by an average of just over 20 per cent, energy consumption (fuel and irrigation) per hectare rose by around 8 per cent, the total agricultural area expands by around 3.5 per cent, the harvested area increases by nearly 6.8 per cent – a sign of more frequent multiple cropping (for example, in Brazil11) and reduced fallow land – and tree cover declines by an average of around 0.9 per cent in countries adopting GM crops. More specifically, they note that the expansion of GM maize and soya between 2000 and 2010 took place on land of lower agronomic quality, with an increase in the proportion of land classified as ‘low quality’ and a decline in ‘high-quality’ land, which requires more fertiliser and energy per tonne produced. The study does not take into account GHG emissions linked to land-use changes, for example when forests are converted into soya fields, as is the case in Brazil12.Indeed, they write, more profitable genetically modified crops (maize, soya, cotton, rapeseed) are gradually gaining ground at the expense of other non-GM crops, which is leading to a reorganisation of crop rotations. The authors show that, when GM crops are adopted, the areas devoted to non-GM crops of the same type (cereals, comparable oilseeds) decrease. However, they start from the assumption that, prior to the arrival of GM crops, each monoculture was located on the land best suited to it. The authors do not consider other types of agriculture: they simply observe what is happening. However, they could also have pointed out that high levels of efficiency in terms of overall yield per hectare and employment result from the complementarities between arable and livestock farming within the same area, from crop rotations, intercropping or even agroforestry. These practices are described in the literature13 as being far more efficient in terms of yield per hectare and less polluting and damaging to the land than monocultures.GMOs fuelling greenhouse gas-intensive intensive livestock farmingAnother important piece of the puzzle is the indirect effects on livestock farming. A significant proportion of GM maize and soya is consumed domestically – particularly as animal feed in intensive livestock farms that emit high levels of greenhouse gases – rather than being exported. The authors estimate that this has ‘boosted’ this type of livestock farming and that, as a result, emissions linked to livestock farming are increasing by an average of around 12 per cent.Initially, on average, countries that grow GM crops have a lower carbon intensity per tonne of crop than non-GM countries (they emit fewer GHGs per tonne produced). The study does not dispute this starting point; it focuses on what happens next: it shows that, following the adoption of GM crops, total emissions and carbon intensity per hectare and per tonne increase more rapidly than in countries that do not adopt GM crops.In this theoretical scenario, the authors consider emissions linked to agricultural production itself (the carbon intensity of crops). They assume that growing GM crops in countries with lower carbon intensity and then exporting them to countries with higher carbon intensity reduces the emissions associated with the production of these crops, even though this does not take into account CO₂ emissions from cargo ships and lorries. However, as a large proportion of GMO production is still used domestically to feed intensive livestock farming, this potential benefit is largely offset. And, once again, the authors are operating within the framework of globalised agriculture, which they do not question.Admittedly, it is likely that a few mixed-farming holdings still exist, but this is not the dominant model in countries that grow GM crops on a massive scale. Natural grasslands used for small-scale and extensive livestock farming are often regarded as the agrosystems that store the most carbon, by recycling animal manure into the soil and enriching microbial life. They can largely, and sometimes even entirely, offset methane emissions from ruminants, and pastoralism plays a crucial role in preventing forest fires. This is not the case with ‘off-land’ livestock farming, which relies on maize and soya monocultures, widely adopted through the use of GMOs.Ultimately, what the article documents is the establishment of an agricultural system that uses more land, more fertiliser and more energy, leads to more livestock farming and less tree cover. It is this combination that explains why total GHG emissions are rising in countries that adopt these GM crops.How can GM crops be made less harmful in terms of GHG emissions?The authors assume that GM crops are beneficial in terms of production and farmers’ incomes. This assumption is widely contested. Inf’OGM has often set this out in detail. They therefore propose two approaches to improve the use of GM crops. The first is to restrict GM crops to the most suitable land to prevent the conversion of marginal land, which drives up carbon intensity. The second is to encourage the export of crops produced in low-carbon-intensity countries (which use GMOs) to countries where carbon intensity is higher (such as those that do not use GMOs), rather than using almost all of the additional production for domestic livestock farming in intensive systems. This proposal is based purely on the accounting logic of GHG emissions, without taking into account the devastating effects of this approach on the food sovereignty of importing countries.To sum up, this article is an attempt to present GMOs in a more positive light, but at the same time – and this is the paradox – it also shows why this technology is not sustainable. This paradox is perfectly illustrated by the ‘solutions’ proposed, which are unrealistic given the history of the deployment of GMOs around the world over the past 25 years. Christophe Noisette noisette [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [14] => Array ( [objectID] => 29672 [title] => Plantibodies claims to be revolutionizing molecular culture [timestamp] => 1784851200 [date] => 24/07/2026 [annee] => 2026 [url] => https://infogm.org/en/plantibodies-claims-to-be-revolutionizing-molecular-culture/ [image] => https://infogm.org/wp-content/uploads/2026/07/26-3.jpg [extrait] => Molecular agriculture is an idea as old as transgenesis. Attempts to have tobacco, rice, or corn produce therapeutic molecules have been made many times, but the results have been few and inconclusive. A French startup, Plantibodies, is proposing a new approach: instead of extracting the target molecule from the plant, the idea is to grind the spinach leaves that contain it into a powder. [chapo] => Molecular agriculture is an idea as old as transgenesis. Attempts to have tobacco, rice, or corn produce therapeutic molecules have been made many times, but the results have been few and inconclusive. A French startup, Plantibodies, is proposing a new approach: instead of extracting the target molecule from the plant, the idea is to grind the spinach leaves that contain it into a powder. [texte] => Plantibodies is a young French biotechnology start-up founded in 2020 which plans to produce ‘therapeutic bioproteins’ in genetically modified plants. Its ambition is to be able to offer oral immunotherapies within the next ten years or so. Recombinant proteins – particularly antibodies – are intended for the treatment of inflammatory or autoimmune diseases of the gastrointestinal tract. According to the Presse Agence1 website, there are 300,000 people with inflammatory bowel disease (IBD) in France and 10 million worldwide.Beyond conventional molecular cultureThe idea of creating transgenic plants to produce proteins of therapeutic interest is not newii2. So-called ‘conventional’ molecular culture involves several stages: cultivation, extraction, purification and formulation of an injectable protein. To date, it has never been successfully implemented on a large commercial scale.Plantibodies’ approach is no longer to engage in ‘conventional plant-based protein production’ – which poses numerous technical problems and economic difficulties3 (see box below) – but to use the plant itself as an oral dosage form. By ‘oral dosage form’, we simply mean a capsule administered orally to patients. In practical terms, Plantibodies aims to grow plants in ‘controlled’ greenhouses that produce the therapeutic protein directly within the cells of edible plants. This means that, rather than extracting the protein from the plant, the plant’s leaves will be transformed into an oral medicine that releases the protein in the colon.Put another way, the patient will ingest the genetically modified plant directly, in the form of a powder or a standardised tablet. Plantibodies is thus bypassing part of the molecular culture production chain and hopes, through this approach, to accelerate the development and market launch of its medicine.The challenges of ‘conventional’ plant-based productionUsing plants or animals to produce therapeutic molecules is not a new idea. Plant-based production has long been presented as a low-cost alternative to bioreactors using microorganisms. In practice, however, this promise faces several major obstacles and, ultimately, few molecules are produced by plants in the field.First pitfall: growing pharmaceutical plants in open fields raises concerns about contamination of food supply chains, as well as contamination of related weeds. Once harvested, the issue of confusion between ‘pharmaceutical’ and ‘food’ batches is a well-documented reality.Second pitfall: proponents claim that the production cost for plants is 10 to 100 times lower than that for microorganisms grown in a contained environment. This fails to take into account the additional biosecurity costs (containment, strict separation of supply chains, enhanced analytical procedures), as well as the potential costs of contamination or a large-scale product recall.Third pitfall: this benefit has never actually been demonstrated. Furthermore, the purification stage is more complex with plants than with micro-organisms. “Purifying a low-abundance protein from a very rich protein mixture in a complex multicellular organism such as maize would have entailed high costs,” as we noted back in 2018.Finally, plant-based protein production has its own technical limitations: incomplete control over plant glycosylation to faithfully reproduce human profiles, and significant variability in yields depending on species and agronomic and climatic conditions, etc.The plants targeted by Plantibodies are edible species belonging in particular to the genera Brassica (cabbages), Lactuca (lettuces) and Spinacia (spinach), selected for their use as food and their ability to accumulate recombinant proteins in their leaves. The patent relating to this project is currently under examination4.Plantibodies raised nearly €290,000 in 2022 from various business angels (also known as ‘angel investors’) from the Grandes Écoles (BADGE), Bpifrance and Angels Santé, and subsequently raised a further €500,000 in 20265 from these same networks and the company Investessor. According to the company, this fundraising is primarily intended to finance a strategic co-development partnership signed in late 2025 with a Nasdaq-listed biotech company, the name of which has not been made public. This company specialises in rare gastrointestinal diseases, and the partnership centres on a preclinical programme including studies on biodistribution, toxicology and initial in vivo efficacy signals.These medicines are not due to be brought to market any time soonTo carry out this project, Plantibodies has joined forces with another start-up, Orius. Together, they responded to the call for proposals entitled ‘Innovations in Biotherapies and Bioproduction’ as part of the France 2030 initiative. Having been selected as winners, they have set up the PhytomAbs6 project. Orius is a Toulouse-based start-up specialising in ‘plant cultivation and optimisation’. It manages what it calls ‘biomecells’ – large cultivation chambers where technicians vary climatic conditions to identify the most optimal ones. In practical terms, Plantibodies modifies the plants so that they produce antibodies or therapeutic molecules. It then tranfers them over to Orius, which is responsible for optimising the cultivation conditions most favourable to these plants within its biomecells.Together, Plantibodies and Orius are currently at the pre-clinical research and development stage: a technology platform is being established, industrial partnerships are being formed, and in vivo and safety studies are underway, but no clinical trials have yet been announced. It is worth noting that clinical trials for this type of research can often take between eight and ten years.These genetically modified plants, intended for use as medicines, represent a new phase in the evolution of medicine. We have moved on from herbalists (whose practices are partly banned) to chemists, and for the past few decades we have been modifying plants in an attempt to produce molecules of pharmaceutical interest. This development is similar to that of plant breeding: from landrace seeds selected in farmers' fields to hybrid seeds, and then to GMOs in diffrent forms. At each stage, practitioners’ autonomy is eroded and living organisms become increasingly artificialised and privatised. Christophe NOISETTE noisette [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [15] => Array ( [objectID] => 29511 [title] => KWS: patents to control “native traits” [timestamp] => 1784678400 [date] => 22/07/2026 [annee] => 2026 [url] => https://infogm.org/en/kws-patents-to-control-native-traits/ [image] => https://infogm.org/wp-content/uploads/2026/07/Capture-decran-du-2026-07-21-14-27-52-e1784637718619.png [extrait] => Since 2022, the German seed company KWS has been developing a range of patent licences covering "native traits". Presented as a means of "promoting innovation in plant breeding", this strategy illustrates how patents can be used to control the use of these "native traits", even though they are already present in biodiversity. This approach by the German seed company, which is also known for its aggressive policy of defending its intellectual property, also highlights the current limitations of European patent law. [chapo] => Since 2022, the German seed company KWS has been developing a range of patent licences covering “native traits“. Presented as a means of “promoting innovation in plant breeding“, this strategy illustrates how patents can be used to control the use of these “native traits“, even though they are already present in biodiversity. This approach by the German seed company, which is also known for its aggressive policy of defending its intellectual property, also highlights the current limitations of European patent law. [texte] => This article serves as an illustration of the Inf’OGM article entitled "Patents and “native traits”: circumventing the limits of European law". It is therefore recommended that it be read in conjunction with that article, which provides the necessary theoretical framework and background information.The strategy developed since 2022 by the German seed company KWS is a clear illustration of the patent strategies relating to "native traits" (or "native characteristics") discussed in a previous Inf’OGM article1. By offering patent licences based on technical elements associated with these traits, the company demonstrates how patents enable private control over the use of characteristics already present in biodiversity, whilst remaining within the European legal framework.TraitWay: a showcase for a deliberate strategy In 2022, KWS launched its TraitWay catalogue online2, which offers patent licences covering "native traits" – that is, characteristics already present in plant biodiversity, such as disease resistance, cold tolerance or tolerance to various stresses. More specifically, the German seed company “offers its native trait related patent applications and patents for licensing to all interested parties via a standard commercial license agreement”. KWS therefore does not claim patent rights over the native traits themselves, which are not patentable.The company presents the TraitWay platform as a means of promoting plant variety innovation by giving breeders access to certain traits that it controls through intellectual property rights. According to KWS, this approach “is key to meet the challenges agriculture is facing across the globe” including climate change, food security and regulatory developments.Its communication regarding TraitWay is based on two aspects. On the one hand, it must take into account the fact that, in recent years, the European Union (EU) and the European Patent Office (EPO) have sought to clarify the rules allowing for the rejection of new patents on non-technical "inventions", notably by prohibiting the patentability of products obtained by essentially biological processes (Decision G3/19 of the EPO’s Enlarged Board of Appeal in May 2020)3. At the same time, KWS is promoting a portfolio of "native traits", available under licence, presented as a means of enabling "any interested party" to access "inventions" purported to solve climate and food security problems.A particular approach to patent lawThis dual stance – acknowledging the limits imposed by European law whilst commercially exploiting patents relating to "native traits" – strikes a delicate balance that KWS appears to embrace fully. And there is, in fact, nothing paradoxical about the opportunism of this position.Indeed, the seed company, which welcomed decision G3/19 of May 2020, emphasises the distinction between traits "developed or produced by technical means" (patentable) and those "incorporated into new varieties using essentially biological processes" (non-patentable)4, even when these traits are described as identical or equivalent5.The recent decision by the European legislator to deregulate GMOs obtained through new genetic modification techniques (NGTs) has reignited the debate, given the risk highlighted by many stakeholders that patents may be granted for traits already present in native biodiversity once they are introduced by technical means. KWS’s entire strategy is based on this distinction between the natural trait itself and the technical means used to highlight or introduce it.Technical claims to control "native traits"Certain families of patents in the KWS catalogue (see box below) were filed following amendments to the implementing regulations of the European Patent Convention (EPC) which came into force on July 1st, 2017. It should be noted that these provisions prohibit the patentability of products obtained by essentially biological processes (EPO Decision G3/19).KWS refrains from directly claiming these products – native plants or the traits they express. Instead, the German seed company bases its patents on claims covering technical elements related to the traits in question, such as molecular markers, nucleic acid sequences, methods of detection or identification, processes utilising these markers, or specific chromosomal regions6. Although marker-assisted selection is not patentable as such7, these claims enable indirect control to be maintained over, in particular, the identification of the traits in question and over the plants that express them.Patents have been granted on such specific molecular markers, which may be located on either side of a gene expressing a given trait, or cover large genomic regions. These patents may thus prevent third parties from using these markers, in particular by restricting certain breeders’ access to the genetic resources in question. As the sequences of such markers are highly conserved within the genome, it is difficult for these third parties to circumvent these patents by using other sequences or by employing other methods to identify the presence of these sequences.All patent applications filed by KWS after July 1st, 2017, most of which are still in force, relate to specific molecular markers and to the methods employing these markers. This enables KWS to claim control over plants expressing "native traits", without needing to rely specifically on patents relating to NGT1, provided that these plants contain sequences detected by the same molecular markers.A "breeder’s" licence programme restricting market accessWith regard to the exploitation of its patent rights, KWS offers licensing agreements. An analysis of its breeders licences8 sheds light on the seed company’s strategy. This "Standard Breeders’ Licence (Native Traits)"9 grants breeders a royalty-free, non-exclusive and "non-transferable" licence to use plant material containing the trait in question and the associated molecular markers in their breeding activities. The agreement permits cross-breeding, breeding work and the use of markers necessary for identifying the trait in question. The licence remains, however, highly restrictive and is limited solely to the explicitly defined use, excluding any genetic modification, broader use of biological material or commercial exploitation.Unsurprisingly, this standard licence prohibits any commercial activity. Furthermore, it defines this activity in particularly broad terms, since commercialisation begins as soon as an application is made for a plant breeders’ right (PBR), entry into the official catalogue or registration of a variety containing the trait in question. Thus, a breeder may spend several years developing a new variety incorporating the trait covered by the patent, but as soon as that variety becomes economically viable and needs to be registered or protected, the breeding licence is no longer sufficient. Another licence, this time subject to a fee, then becomes necessary, as highlighted by Laurent Guerreiro, president of the French breeding company RAGT, in February 202310. In short, after carrying out the breeding work leading to a marketable product, the licensee must still comply with the conditions set by KWS.This "Standard Breeders’ Licence" is therefore a tool used by KWS to control market access. Whilst it paves the way for the breeding of new varieties, KWS regains control once these varieties acquire commercial potential. However, breeders in the EU already benefit from an exemption allowing them to use patented material for breeding purposes (Article 27(c) of the Agreement on a Unified Patent Court). This exemption does not, however, allow them to commercialise the result of their breeding work when it contains the patented trait. For those familiar with it, the KWS licence is ultimately nothing more than a strict application of European law. Its main objective appears to be to organise the transition to the commercial phase through a contractual arrangement, allowing competing breeders to carry out their breeding work, and then requiring them to pay royalties when they develop a variety of commercial interest. Through this type of licence, KWS could also impose obligations on licensees that they would not have to fulfil if they did not take out a licence and relied solely on European law for their breeding activities.The example of KWS thus shows that the distinction between the non-appropriable "native trait" and the technical subject-matter eligible for patenting can, in practice, be circumvented through strategies of contractual protection and commercialisation. The new NGT regulation and its provisions on patents could reinforce these dynamics of appropriation.Traitway: a revealing patent portfolioAn examination of KWS’s patent portfolio relating to Traitway shows that, despite the diversity of the traits claimed (resistance to viruses, fungi and nematodes, cold tolerance, restoration of fertility or improved digestibility), the claims are based very largely on nucleic acid sequences, molecular markers, identification methods or associated technical processes. This uniformity illustrates the intellectual property strategy developed by KWS.Claimed "trait"Date of filing of the patent applicationStatusMain subject matter claimedVirus resistance – Beta vulgaris I17 June 2013Patent granted, upheld following opposition proceedingsNucleic acids (DNA, RNA) conferring resistance to a pathogen (the fungus Cercospora), molecular markers, identification methods, cells, seeds, etc.Resistance to fungi – Maize I4 September 2013Patentability examination in progressMarker-assisted plant, cells, seed, method for producing the plantCold tolerance – Maize27 November 2015Patent granted, subject to opposition proceedings (appeal)Maize plant with cold tolerance conferred by a specific chromosomal region, molecular markers, methods for selecting such a plant using markersCytoplasmic male sterility (CMS) restorer – Cereals21 December 2015Patentability examination in progressPlant with a chromosomal segment comprising various possible specific sequences encoding the restoration of pollen, organ or seed fertility; methods for detecting such a plant using various markersMale sterility – Beta vulgaris12 April 2016Patent granted, opposition period open (deadline mid-July 2026)Beetroot plant (Beta vulgaris) with mutation(s) to reduce or prevent the expression of a functional P450 oxidase; method for producing the plant; cell; DNA encoding various RNAs (including interfering RNAs); markers for identifying the plant and organs, tissues, seeds, etc. containing the mutation(s)Virus resistance – Beta vulgaris II10 August 2016Patent granted, no oppositionPlants resistant to BNYVV (beet necrotic yellow vein virus) with mutation(s) in the endogenous resistance gene Rz1; a method for identifying and producing these plants; nucleic acids expressing resistance; molecular markers; and cells and seeds modified by said nucleic acidsPost 1 July 2017‍Digestibility – Maize24 April 2018Patent granted, subject to opposition proceedingsMaize plant comprising a QTL (quantitative trait locus) allele associated with improved digestibility, method for producing such a plant, silage and feed produced thereby, method for identifying such a plant with preferential use of specific sequence markersNematode resistance – Beta vulgaris9 May 2018Patent granted, subject to opposition proceedingsNucleic acid molecules (DNA, RNA) encoding increased resistance to nematodes in Beta vulgaris (beetroot), a method for producing Beta vulgaris comprising these nucleic acids, seeds and cells comprising said nucleic acid molecules, and a method for producing Beta vulgaris using molecular markersFungal resistance – Beta vulgaris18 February 2019Patentability examination in progressNucleic acid molecules (DNA, RNA) encoding increased resistance to nematodes in Beta vulgaris (beetroot), a method for producing Beta vulgaris comprising these nucleic acids, seeds and cells comprising said nucleic acid molecules, a method for identifying said Beta vulgaris using molecular markers, oligonucleotides as molecular markersFungal resistance – Maize II20 December 2019Patentability examination in progressMethods for identifying a maize plant comprising screening for the presence of a QTL allele using various markers; a method for producing a maize plant comprising, in particular, the QTL alleleFungal resistance in plants17 August 2020Patentability examination in progressMethods for identifying a plant resistant or tolerant to Cercospora using various molecular markersFungal resistance – Brassica napus27 October 2020AbandonedCytoplasmic male sterility (CMS) restorer – Maize22 December 2020Patentability examination in progressMethod for identifying a sterility restoration locus with the possible use of molecular markers, molecular marker sequences Denis MESHAKA denis.meshaka [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [16] => Array ( [objectID] => 29171 [title] => Patents and “native traits”: circumventing the limits of European law [timestamp] => 1784160000 [date] => 16/07/2026 [annee] => 2026 [url] => https://infogm.org/en/patents-and-native-traits-circumventing-the-limits-of-european-law/ [image] => https://infogm.org/wp-content/uploads/2026/07/48628085088_7e96dfd9a3_c-768x432.jpg [extrait] => For over a decade, European institutions have sought to prevent the patenting of plants and traits obtained exclusively through essentially biological processes. However, patents relating to "native traits" continue to indirectly cover these traits through claims relating to associated technical features. The recent deregulation of GMOs/NGTs raises concerns about the risk of these patents extending to plants derived from traditional breeding and propagation – which are not patentable – and which therefore naturally contain such "native traits". [chapo] => For over a decade, European institutions have sought to prevent the patenting of plants and traits obtained exclusively through essentially biological processes. However, patents relating to “native traits” continue to indirectly cover these traits through claims relating to associated technical features. The recent deregulation of GMOs/NGTs raises concerns about the risk of these patents extending to plants derived from traditional breeding and propagation – which are not patentable – and which therefore naturally contain such “native traits“. [texte] => For several years now, European patent law has sought to exclude from patentability plants obtained exclusively by essentially biological processes (EBPs) and the characteristics or "native traits" that they express. Nevertheless, patent claims relating to the technical elements associated with such traits – such as molecular markers, genetic sequences or associated methods of detection and/or identification – remain a subject of debate. These elements may, in fact, form the basis of patents whose scope extends beyond the purely technical aspect to indirectly concern characteristics already present in biodiversity."Native traits" at the heart of a legal debateA "native trait" refers to an agronomic characteristic within a species that is associated with a gene or a set of genes: resistance to a disease, tolerance to climatic stress, improvement in a quality characteristic, and so on. According to "theory", the trait – also known as a "phenotypic characteristic" – is the observable expression of one or more "genes". In the absence of a legal definition, a "native gene" refers, in accepted terminology, to a genetic sequence already present within the diversity of a given plant species and those with which it can naturally cross-pollinate, whether cultivated or wild.For over a decade, the issue of patentability relating to such traits has fuelled a major European debate. Following the so-called "Broccoli" and "Tomato" decisions1 by the European Patent Office (EPO) in 2015, the European institutions have gradually affirmed their determination to prevent the patenting of plants and characteristics or traits obtained exclusively through plant breeding. In December 2015, in a resolution on patents and plant variety rights, the European Parliament stated that "products obtained through plant breeding, such as plants, seeds, characteristics and native genes, should not be patentable" (recital D)2.This stance led to an amendment to Article 28 of the Implementing Regulation to the European Patent Convention (EPC) in 2017, followed by Decision G3/19 of the Enlarged Board of Appeal of the EPO in May 2020. This decision confirmed that plants and animals obtained exclusively by means of PEBs are not patentable. However, this decision was not retroactive and did not apply to patents or patent applications filed before July 1, 2017. Patents covering such plants and animals therefore remain in force until July 20373.A ban with significant loopholesHowever, the debate is not over, since, for example, a report4 published in July 2025 by the Consultative Group on International Agricultural Research (CGIAR) shows that, in many countries, including in Europe, patents continue to cover genes or traits present in existing biodiversity. The report analyses the mapping of patents relating to inventions based on plant genetic resources for food and agriculture (PGRFA) under the ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) and associated digital sequencing information and/or genetic sequencing data (DSI or GSD). It examines how patents, particularly those claiming inventions related to native traits, may restrict further research, breeding and use of PGRFA. This report shows that the appropriation of natural characteristics remains a reality despite the restrictions introduced into European law, notably because the "disclaimer" – intended to prevent a patent on plants obtained by a technical process from extending to plants obtained by PEBs – is of very limited applicability, or even illusory5.The EPO’s prohibition, in principle, on claims relating directly to plants obtained exclusively by PEBs can, in fact, still be circumvented. Patents can actually still cover parts of plants, products that have undergone technical treatment, or genetic mutations obtained by technical means, in particular through new genetic modification techniques (NGTs), even when these mutations are strictly identical to characteristics found in nature. In practice, claims thus continue to confer exclusive rights over natural genetic resources, under the guise of technical formulations or methods for detecting and/or identifying a sequence or a plant.Indirect appropriation via molecular markersSince patents cannot directly cover a native trait as such, patent applicants have adopted new strategies for drafting claims. They are increasingly relying on claims relating to technical elements associated with such traits, such as molecular markers, methods of detection and/or identification, or other technical subject-matter distinct from the trait itself. In this way, they may seek to obtain protection that can have effects similar to a patent on the native trait itself.In practical terms, although molecular marker-assisted selection is not patentable6, processes utilising specific markers, as well as the sequences of which they are composed, may, however, be patentable before the EPO. Such claims therefore make it possible to retain indirect control over the identification of the traits in question and over the plants that express them.Patents have thus been granted on such markers, which may be located on either side of a gene expressing a given trait or cover large chromosomal regions. These patents can therefore prevent third parties from using these markers, and in particular restrict certain breeders’ access to the genetic resources in question. As the sequences of such markers are highly conserved within the genome, it is generally very difficult for these third parties to circumvent these patents by using other sequences or alternative identification methods.This development profoundly alters the practical scope of patents. Without directly claiming a trait naturally present in biodiversity, patent holders can exercise control over its identification and, indirectly, over the plants that carry it.An issue reignited by the new NGT regulationThe recent deregulation of GMOs produced using new genetic modification techniques (GMOs/NGTs) has reignited this debate. Many stakeholders, notably civil society organisations7, are concerned that patents may cover traits already present in biodiversity simply because they are introduced by technical means.The new regulation distinguishes between NGT1 plants – that is, plants with genetic modifications that "could also occur naturally or be obtained through conventional breeding" – and NGT2 plants, which remain subject to GMO regulations. This distinction is based in particular on the opinion issued by the European Food Safety Authority (EFSA)8, according to which the criteria applied to NGT1 plants allow them to be considered equivalent to plants obtained through conventional breeding, both in terms of genetic modifications and potential risks. EFSA considers that the genetic modifications defining NGT1 plants already exist in nature or may result from conventional breeding, and has not identified any additional risks associated with these plants compared with conventional plants.At the same time, the EPO continues to recognise the patentability of inventions relating to plants obtained by technical processes, including where these fall within the NGT1 category, provided that the general conditions for patentability are met. This results in a paradox: plants recognised as equivalent to those derived from conventional breeding may nevertheless be covered by a patent because they were obtained by a technical process.The absence of any obligation to provide methods for analytically distinguishing NGT1 plants from those derived from conventional breeding further reinforces these questions regarding the actual scope of the patents. If two plants are deemed equivalent and cannot be analytically distinguished, the question arises as to how far the rights conferred by a patent relating to an NGT1 plant may, in practice, extend to plants derived from conventional breeding that exhibit the same characteristic.The boundaries between the non-appropriable "native trait" and the patentable technical subject-matter therefore remain open to circumvention. The use of technical elements distinct from the native trait, such as molecular markers, now appears to be one of the main tools for indirectly extending the scope of certain patents to genetic resources present in biodiversity. This, however, appears to run counter to the direction taken for over a decade by European institutions, which have sought to prevent the appropriation of life forms through patents.The example of the German seed company KWS, which has been marketing a catalogue of licences covering "native traits" since 2022, provides a concrete illustration of this development. Its strategy, based on claims relating to technical elements that indirectly cover "native traits" and on the commercial exploitation of its patents, is the subject of a second article. Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [17] => Array ( [objectID] => 28380 [title] => The Council of the EU wants to speed up the release of GMM into the environment [timestamp] => 1783296000 [date] => 06/07/2026 [annee] => 2026 [url] => https://infogm.org/en/the-council-of-the-eu-wants-to-speed-up-the-release-of-gmm-into-the-environment/ [image] => https://infogm.org/wp-content/uploads/2026/06/413ce93a-b677-47e4-85ae-0e56b3116e4e-768x512.jpg [extrait] => On Tuesday 16 June 2026, the Council of the European Union achieved a qualified majority to enter into negotiations with the European Parliament on a draft directive that would allow the release of genetically modified micro-organisms into the environment under less stringent regulatory conditions. France has declared its support for this draft directive. This decision endorses the European Commission’s proposal of 16 December 2025 as part of the "Biotech Acts". These latter aim to simplify regulations for the benefit of businesses. [chapo] => On Tuesday 16 June 2026, the Council of the European Union achieved a qualified majority to enter into negotiations with the European Parliament on a draft directive that would allow the release of genetically modified micro-organisms into the environment under less stringent regulatory conditions. France has declared its support for this draft directive. This decision endorses the European Commission’s proposal of 16 December 2025 as part of the “Biotech Acts“. These latter aim to simplify regulations for the benefit of businesses. [texte] => When it comes to genetically modified micro-organisms, it is an understatement to say that the work of the Council of the European Union (EU) has been carried out at breakneck speed. Whilst it took the Member States nearly two years – between July 2023 and March 2025 – to agree on a negotiating mandate with the European Parliament on the issue of plants genetically modified using new techniques (GMOs/NGTs), it took them less than six months to vote on a similar mandate concerning genetically modified micro-organisms (GMMs) that may be released into the environmenti. Yet this concerns bacteria, yeasts or viruses that would be genetically modified and released into the environment via a "simplified" regulatory framework. At a time of regular epidemics, and even pandemics, the haste with which governments, including France’s, are simplifying the release of GM bacteria or viruses into the environment raises questions…As Inf’OGM reported in January 2026ii, the proposed directive put forward by the European Commission and subsequently worked on by the Council of the EU has an unstated but clear objective: to facilitate the marketing and release into the environment of GMMs by minimising any monitoring as far as possible. To this endiii, it is proposed to define GMMs as "any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids" and "in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination", with the exception of plant and animal cell cultures. Such a definition specific to micro-organisms enables the Council to add articles to Directive 2001/18 that would allow for the exemption of many GMMs…Exemptions for all GMOs, whether transgenic or notInitially, the text provides that the Commission alone shall decide on the content of the authorisation applications to be submitted within the EU in order to place GMMs on the market. It would be necessary to adapt the list of information required from a company to take account of "scientific and technical progress". The Commission could thus amend, by means of delegated acts, Annex 3 to Directive 2001/18, which lists the "specific information requirements in notifications". At present, the following are required: a description of the organism; the method(s) of genetic modification used; a description of the intended and unintended genetic modifications; an assessment of the risks to health and the environment; and post-release monitoring plans.The first authorisation granted would remain valid for a period of 10 years, as currently provided for in Directive 2001/18. However, the Council wishes that, at the end of these 10 years, its renewal should be for an unlimited period, as opposed to the current maximum duration of 10 years. Such an approach would mean that there would be no reassessment of potential risks not previously identified.A third "exemption" provided for in the EU Council text is the one allowing a company to be exempt from providing methods for the detection, identification and quantification of GMMs or their commercialised products if it can justify that "it is not feasible to provide an analytical method for identification and quantification of the GMM concerned". In such a case, the EU would be completely in the dark, as would other economic operators (from farmers to consumers), regarding any contamination or marketing within its territory. Such a situation would, as in the case of GMO/NGT plants and micro-algae, open the door even wider to the abusive extension of the scope of patents held by private actors - whether or not they relate to GMMs - thereby constituting a definitive obstacle for all actors using "wild" microorganisms.For GMMs presumed safe, almost total deregulationFor GMMs “in general without focus on specific techniques”, the EU Council’s text amends the European Commission’s proposal, namely the possibility that such GMMs might be classified as "low-risk". The Council refers to a "expedited procedure" which could apply, regardless of the genetic modifications carried out, to GMMs benefiting from a status of "Qualified Presumption of Safety" and containing no "genes of concern".In such cases, the text provides that the Commission may, on its own, supplement the eligibility criteria for this expedited procedure. It also provides that the content of authorisation applications and the authorisation procedure should be "adapted" for these GMMs in order to "streamline certain procedural elements and to expedite the timelines". Finally, as with the provision of a traceability method, the post-market environmental monitoring required by Directive 2001/18 may not be carried out if the company considers that such monitoring "is not needed".The European Parliament is at workNow that the Council of the EU has adopted a negotiating mandate with the European Parliament, the latter’s position is, in effect, awaited. For the time being, its work is being carried out within a joint Environment and Public Health Committee. MEPs sitting on this joint committee are discussing the matter and are expected to present a version of the European Commission’s proposal – whether amended or not – to all the MEPs in autumn 2026. If MEPs do not simply reject the text but decide instead to amend it, negotiations with the Council of the EU and the European Commission could then begin in a process known as a "trilogue". This process could then start in early 2027.i Council of the EU, « Council agrees mandate on measures to advance biotech innovation in the EU », 16 June 2026.ii Eric Meunier, « The deregulation of GMO microorganisms is underway », Inf'OGM, 27 January 2026.iii Council of the EU, « Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs - General approach », 8 June 2026 Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [18] => Array ( [objectID] => 33577 [title] => Biocontrol: European Commission seeks lighter regulation [timestamp] => 1782950400 [date] => 02/07/2026 [annee] => 2026 [url] => https://infogm.org/en/biocontrol-european-commission-seeks-lighter-regulation/ [image] => https://infogm.org/wp-content/uploads/2026/06/barskefranck-tractor-4217686-768x512.jpg [extrait] => Presented as an alternative to chemical pesticides, biocontrol operates on a logic of substitution that allows the pesticide industry to "green" its operations. Worse still, biocontrol products could overshadow beneficial approaches such as peasant agroecology or biological pest control. To facilitate the marketing of biocontrol substances, the European Commission proposed a definition and simplified regulations in the draft Omnibus X regulation in December 2025. [chapo] => Presented as an alternative to chemical pesticides, biocontrol operates on a logic of substitution that allows the pesticide industry to “green” its operations. Worse still, biocontrol products could overshadow beneficial approaches such as peasant agroecology or biological pest control. To facilitate the marketing of biocontrol substances, the European Commission proposed a definition and simplified regulations in the draft Omnibus X regulation in December 2025. [texte] => Inf’OGM decided to focus on biocontrol once it became clear that the definition currently under discussion at the European level could facilitate the marketing of products derived from biotechnologies. Furthermore, this definition could lead to semantic confusion with products used in organic farming – a confusion we believe it is important to highlight.According to the European Commission, biocontrol substances include microorganisms (bacteria, fungi, viruses), inorganic substances (potassium bicarbonate, clay), semiochemicals (pheromones, kairomones), and substances of natural origin or those "produced synthetically that are functionally identical and structurally similar to the former". As we noted in a previous articlei, this latter category could allow a new generation of synthetic pesticides - such as molecules produced via genetic engineering (e.g., interfering RNA or micropeptides) or synthetic macromolecules "inspired" by biological systems - to be classified as biocontrol products. Once authorized, a biocontrol substance would be designated as such on the list of authorized active substances maintained by the European Commissionii. The "biocontrol" label - which evokes "biological" and carries a more positive connotation than "pesticide" or "plant protection product" - would facilitate social acceptance.Biocontrol substances eligible for "low-risk" designationOmnibus Xiii aims to introduce major simplifications for these biocontrol substances without directly tackling the issue of the assessment process itself. To achieve this, the proposed text would allow many biocontrol substances to be classified as "low-risk" active substances. Work by the European Food Safety Authority (EFSA) and ongoing discussions regarding this text are already moving in this direction. A biocontrol substance would be subject to the active substance assessment criteria defined in Annex II of Regulation 1107/2009, unless it is also designated as "low-risk."Currently, Regulation 1107/2009 governs so-called "active" substances that serve a "plant protection" function; these can be either chemical or "biological" in nature. These active substances may also be classified as "low-risk" if they meet the criteria set out in Annex II of the regulation (see sidebar). In practical terms, Omnibus X paves the way for biocontrol substances to qualify as "low-risk" by establishing a definition of biocontrol substances that largely overlaps with products already designated as "low-risk" (such as certain microorganisms like Bacillus amyloliquefaciens - sold under the name Taegroiv - pheromones, certain mineral substances, plant extracts, etc.). The regulation leverages the established reputation of staples like Bt or pheromone traps - which have been authorized for organic farming for decades - to promote products derived from genetic or chemical synthesis, such as RNAi sprays or micropeptidesv.Omnibus simplifies regulations for "low-risk" substancesLow-risk substances are already subject to a less rigorous assessment process than other active substances. EFSA considers that an active substance (whether chemical, mineral, or biological - excluding microorganisms, which are treated and assessed differently) can qualify as a "low-risk substance" if it is not carcinogenic, mutagenic, or toxic to reproduction (CMR); is neither persistent nor bioaccumulative (PBT); is not an endocrine disruptor; and shows no neurotoxic or immunotoxic effects.Since 2022 - following the adoption of four implementing regulations amending Regulation (EC) No 1107/2009 - microorganisms have been assessed under a specific regime. A microbial strain can be approved as a low-risk active substance if it meets general safety criteria. These criteria include the absence of pathogenicity for humans and non-target organisms, the absence of toxins or hazardous metabolites, the absence of identified virulence factors, and the absence of a significant risk of gene transfer to other microorganisms. Furthermore, the EFSA assessment must demonstrate that the microorganism does not possess functional, transferable genes conferring resistance to antimicrobials used in human or veterinary medicine, nor characteristics of persistence or uncontrolled multiplication incompatible with "low-risk" status.Whether dealing with chemical molecules or microorganisms, the authorization process for low-risk substances is thus significantly streamlined.Omnibus X also proposes that "low-risk" status be applied retroactively to chemical or biocontrol active substances that have already been authorized.Finally, to determine whether a product is low-risk, Omnibus X proposes relying solely on the intrinsic properties of the active substance (hazard, theoretical exposure profile). Article 22 of Regulation 1107/2009, which defines the criteria for a low-risk active substance, is being revised under Omnibus X. Currently, for an active substance to qualify as low-risk, it must be shown that it is "foreseeable that plant protection products containing that substance will present only a low risk to human health, animal health and the environment, in accordance with Article 47(1)". Omnibus X proposes removing this condition, noting that its implementation "has proved difficult in practice, given that at the time of approval or renewal of approval of active substances, it is generally unknown whether or not the product-related criteria set out in Article 47 can be met". However, Article 47 itself is retained under Omnibus X: a low-risk product must be composed exclusively of low-risk molecules (including co-formulants such as safeners and synergists)."Priority" treatmentIn practical terms, what does Omnibus X propose to facilitate the marketing of biocontrol products as such? First, the European Commission calls for the assessment of biocontrol substances to be prioritized over that of other "plant protection substances". In its view, these substances support sustainable agriculture by potentially reducing the use of controversial chemical pesticides.Are Member States being sidelined in the risk assessment process?Under Regulation 1107/2009, a Member State acts as the rapporteur for the assessment of an active substance. Omnibus X introduces the possibility for EFSA to assume this role directly for biocontrol substances, on the grounds that their assessment "requires specific technical expertise" that some Member States might lack (an argument championed by multinationals and adopted by the European Commissionvi). To justify this proposal, the European Commission points to Member States with limited resources that would be unable to handle such dossiers. However, this move would primarily serve to bypass national agencies that are deemed overly critical - such as Anses (which is also facing attacks in France from the FNSEA) or the Federal Agency for Nature Conservation in Germany. In practice, this would shift the assessment process to the European level, where conflicts of interestvii have already been exposed and the relationship with the public is more distant. Omnibus X also proposes increasing EFSA’s budget if necessaryviii.Authorizations granted for 25 yearsA highly significant measure within Omnibus X concerns all plant protection products (whether chemical or "biological"). The European Commission proposes granting authorizations for an indefinite period, subject to certain conditions that could apply to a large number of substances. Re-evaluations would not be eliminated; however, they would be triggered solely at the Commission's initiative when it deems "new scientific knowledge" necessitates them, rather than occurring on the regular basis currently required by every authorization renewal application every 10 years. Omnibus X includes an exception for substances explicitly classified as being "of concern". In its opinion published in April 2026, the European Economic and Social Committee (EESC)ix stated that "the European Food Safety Authority (EFSA) should be empowered to flag the need for targeted re-evaluations of active substances approved for an indefinite period [...]. This matter should not fall solely within the remit of the Commission and the Member States"ix. Will the Commission take this opinion into account? And how will "new scientific knowledge" be assessed?Provisional authorizationsCurrently, Article 30 of Regulation 1107/2009 allows a Member State to issue a provisional market authorization - valid for a maximum of three years - for a plant protection product containing an active substance that has not yet been authorized. Omnibus X proposes restricting this procedure to biocontrol substances.The European Commission justifies this change, once again, by the need to make biocontrol substances "more quickly accessible and available to farmers". In practical terms, a provisional authorization - now valid for a maximum of five years - could be granted by a Member State that has, firstly, completed its assessment report and, secondly, concluded that all active substances in the plant protection product meet the criteria defining a "low-risk" substance or, failing that, can be considered "biocontrol active substances". Thus, a plant protection product containing biocontrol substances could be granted provisional authorization without waiting for a formal decision at the European Union level.This five-year period is presented as the time needed to finalize the comprehensive assessment and formal authorization of the active substance. Indeed, "to avoid unnecessary administrative procedures", the Commission proposes that "once the new biocontrol substance is authorized […], it should be possible to convert these provisional authorizations into regular authorizations without the need for a new assessment, unless the conditions established in the approval require a modification of the conditions set out in the provisional authorizations". Currently, once the active substance has been assessed by EFSA and approved by the Commission, the holder must submit a new, complete application for market authorization (MA) to the Member State. This will no longer be necessary. Once the active substance is authorized at the European level, the Member State can convert the provisional authorization for the final product into a definitive authorization (MA). In effect, this aligns the validation of the substance with the validation of the product, thereby greatly facilitating market access for biocontrol substances under the guise of administrative "simplification".Derogations for emergency situationsRegulation 1107/2009, in its current version, provides for the granting of derogations in cases of "emergency situations regarding plant protection". Article 4 allows a Member State to obtain a derogation for an active substance in the event of a "serious danger to plant health". The Omnibus X proposal seeks to add "a danger to plant production" (which need not be characterized as "serious") to the criteria for obtaining this emergency derogation. In a memo regarding Omnibus X, the organization Générations Futuresx explains that "this means the derogation could be invoked to approve highly hazardous substances when production levels (yields) for a specific crop are deemed to be under threat". The implementation details for this provision are particularly vague. There is legitimate concern that these derogations might be granted solely on the basis of strict yield comparisons focusing exclusively on immediate output, without regard for the broader context of long-term soil health, biodiversity, overall farm resilience, and food security. This derogation regime could pave the way for multiple exemptions, allowing the recurring use of substances normally prohibited under the regulation’s criteria.Another proposal involves ending the requirement for Member States - when granting such derogations - to draw up "a phase-out plan aimed at controlling the serious danger by other means, including non-chemical methods, and to submit this plan to the Commission without delay".Regulation 1107/2009 also allows Member States (under Article 53) to grant emergency derogations for a plant protection product (comprising an active substance, co-formulants, and synergists) "in special circumstances", for a maximum period of 120 days and for "limited and controlled" use. Such a derogation is permitted only if there is "no other reasonable means" of controlling the phytosanitary threat. This is how Calantha, an RNAi spray, received provisional authorization in Belgium to combat Colorado potato beetlesxi. The Omnibus Regulation does not alter Article 53. However, through the amendment to Article 4 discussed earlier, the European Commission is extending the scope of emergency derogations: they will now apply not only in cases of danger to "plant health" but also in cases of "threats to plant production".Authorizations valid everywhere?Omnibus X would radically overhaul the geography of authorizations. It proposes treating the Union as a single zone for products containing only biocontrol substances (amended Articles 3 and 33). If adopted, an authorization in one Member State would be de facto valid across the entire EU - unlike the current situation, where distinct "zones" may have different characteristics requiring tailored approaches. If a national authority fails to rule on a mutual recognition request within the prescribed timeframe, the authorization would be deemed granted (amended Article 67). Silence implies consent - a principle widely recognized as unfair.Finally, Omnibus X would eliminate a tool essential for post-market monitoring. The European Commission proposes exempting products containing only biocontrol substances from record-keeping obligations (Article 67) in the name of reducing the administrative burden on farmers.Multinationals are rejoicingOmnibus X therefore aims to facilitate the marketing of biocontrol products - or at least to introduce greater flexibility - notably by allowing them to be classified as "low-risk active substances". Consequently, industry associations advocating for industrial biocontrol (such as IBMA and Alliance Biocontrôle) welcome the prospect - should the Omnibus X proposal be adopted in its entirety - of a common definition, a single European zone, the possibility of provisional authorizations, 25-year authorizations, and so onxii. Conversely, for NGOs like Générations Futures or Pollinis, the assessment is more ambiguous: under the guise of "unleashing" biocontrol, Omnibus X establishes a streamlined regulatory regime that would benefit - far beyond ladybugs, pheromones, and Bacillus thuringiensis - microorganisms (whether genetically modified or not) as well as new synthetic products that are nonetheless "similar" to those produced by naturexiii.Ultimately, Omnibus X does not create a "green label" for biocontrol products - at least not yet - but it paves the way for such a concept. It does not formally alter the scientific principles of risk assessment already established by Regulation 1107/2009. Instead, it operates in other areas: timing (extended authorization periods, provisional authorizations), geography (single zone, tacit recognition), and traceability (simplified usage record-keeping).This proposal is currently under discussion within the Council of the EU. Since January 2026, the Cypriot presidency has put forward several compromise texts, with certain amendments addressing the "biocontrol" component. When asked by Inf’OGM, the Council of the EU’s press office indicated on May 27, 2026, that "the Council Presidency […] remains optimistic that an agreement among Member States on a common Council position (a 'negotiating mandate' with the European Parliament) can be reached in the coming weeks". However, an initial review of Member State positions on June 12, 2026, revealed that, as it stands, the Omnibus X text was not acceptable to a majority of states. Consequently, to date, the Council of the EU has not adopted a mandate to negotiate with the European Parliament. As for the European Parliament, the Agriculture and Environment Committees are spearheading the process through a joint committee. Amendments must be submitted to this committee by July 13, 2026, with a view to presenting and adopting a report in the autumn, before the full text is debated by MEPs in a plenary session.i Christophe Noisette, "The European Commission is proposing legislation on biocontrol", Inf’OGM, 8 July 2026.ii Article 7 of Omnibus X, amending Article 13(4) of Regulation (EC) No 1107/2009.iii European commission, « Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements », 16 December 2025.iv Corder asbl, « Des produits phytopharmaceutiques dits « à faible risque » existent en Belgique ».v Christophe Noisette, "The European Commission is proposing legislation on biocontrol", Inf’OGM, 8 July 2026.vi See the introductory remarks of the European Commission’s Omnibus X proposal, page 1.vii Martin Pigeon, « L’AESA : une indépendance sous influence », Inf’OGM, le journal, n°116, mai/juin 2012.Eric Meunier, « UE – OGM : l’AESA, objet d’une plainte pour conflit d’intérêts », Inf’OGM, 29 août 2012.« Efsa : la moitié des scientifiques seraient en situation de conflit d’intérêts », franceinfo et Brut, 20 June 2017.viii "The proposed initiative is expected to result in an increase of €15.073 million in the subsidy paid by the Commission to the Authority for the 2028–2034 period". This figure represents the total increase resulting from all the amendments introduced by Omnibus X. Source: 2025/0410 (COD), p. 19.European Commission, "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements", 16 December 2025.ix EESC, « Food and feed safety simplification omnibus », 29 April 2026.x Générations Futures, « OMNIBUS X – SECURITÉ ALIMENTAIRE ET ALIMENTATION ANIMALE – LE DÉMANTÈLEMENT SOUS COUVERT DE SIMPLIFICATION », 19 March 2026.xi Phytoweb, « CALANTHA ».xii IBMA, « IBMA welcomes the publication of the Proposal for the Simplification Package Omnibus », 17 December 2025. Alliance Biocontrôle, « Projet de règlement « omnibus sécurité alimentaire » : une avancée majeure pour libérer l’innovation en solutions de biocontrôle », 17 December 2025.xiii Pollinis, « Les pesticides génétiques ARNi, nouvelle arme de l’agrochimie contre le Vivant ».Générations Futures, « OMNIBUS X – SECURITÉ ALIMENTAIRE ET ALIMENTATION ANIMALE – LE DÉMANTÈLEMENT SOUS COUVERT DE SIMPLIFICATION », 19 March 2026. Christophe NOISETTE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [19] => Array ( [objectID] => 28539 [title] => Off-target effects of NGTs: CRISPR/Cas “fatigues chromatin” [timestamp] => 1782691200 [date] => 29/06/2026 [annee] => 2026 [url] => https://infogm.org/en/off-target-effects-of-ngts-crispr-cas-fatigues-chromatin/ [image] => https://infogm.org/wp-content/uploads/2026/06/science.adk6662-fa-768x315.jpg [extrait] => Touted as precise, simple and inexpensive, CRISPR/Cas is the flagship tool underpinning the promises made by GMOs derived from new genetic modification techniques (NGTs). Already at the centre of several controversies, CRISPR/Cas is once again making headlines. This time, it concerns the discovery of a new type of harmful effect. [chapo] => Touted as precise, simple and inexpensive, CRISPR/Cas is the flagship tool underpinning the promises made by GMOs derived from new genetic modification techniques (NGTs). Already at the centre of several controversies, CRISPR/Cas is once again making headlines. This time, it concerns the discovery of a new type of harmful effect. [texte] => The unforeseen effects of using CRISPR/Cas – its unintended effects on DNA, both off-target and on-target – have been documented for around a decadei. Yet they are overlooked in the legislative text adopted by the European Parliament on 17 June 2026ii, concerning NGTs. As for epigenetic and phenotypic effects, which often have a feedback effect on the genome, these are not mentioned either.Here we discuss a scientific publication from November 2025iii which specifically details the consequences of using CRISPR/Cas at the epigenetic level and, more precisely, at the chromatin level. What is chromatin? In what way might its modification be significant and call into question the use of the CRISPR/Cas tool?An overview of current knowledge on chromatinIdentified by Flemmingiv during the era of the optical microscope (around 1880) whilst observing eukaryotic cells, this substance, located within the cell nucleus, forms granules that stain when exposed to certain dyes. The scientist named it "chromatin" (from the Greek χρῶμα = chrôma = colour). Flemming also noted that chromatin transforms into filaments during cell division. These filaments would later be named chromosomes (coloured bodies).It was not until much later that it was discovered that the carrier of genetic information is a molecule called DNA, and that chromatin is a structure comprising DNA, proteins (called histones) and a few strands of RNA. This organisation forms a single unit and ensures the compaction of DNA within the nucleus (through successive coiling). Thus, the 2 metres of DNA in a human cell are confined in the form of chromatin within a compartment – the nucleus – measuring just a few micrometres (1 micrometre = 0.001 mm) whilst the cell is not dividing (interphase), and in the form of chromosomes when it is dividing. A chromosome represents the maximum compaction of a DNA molecule within the cell.Chromatin, which is highly decompacted compared to chromosomes, resembles a string of pearls, and its structure has been revealed by electron microscopy in very few locations within the nucleus of an interphase cell.Figure 1: Highly decompacted chromatin and the "string of pearls" interpretation.White arrows: "strand" = DNA moleculeBlack arrows: "beads" = nucleosome (8 histone protein molecules clustered together)It is during this decompaction phase that DNA can be active, i.e. transcribed into messenger RNA and replicated, but also repaired following a break. Outside this phase, the DNA is inaccessible, as it is highly condensed.This chromatin structure is not fixed. Indeed, "the protein components of the nucleosome, or histones, exist in the form of variants and can be modified; the nucleosome represents a variable module, providing an expanded repertoire of information in addition to that provided by the genetic code"v. This is sometimes referred to as the "histone code".These variants influence gene expression, which highlights the importance of maintaining chromatin integrityvi. Genotoxic stresses (on DNA) are among the factors influencing chromatin histones.CRISPR/Cas: a genotoxic stress that alters chromatin?It is worth recalling that the CRISPR/Cas9 complex is capable of cutting both strands of the DNA molecule, which disrupts DNA integrity (on-target and off-target effects), but also, and this is precisely what the study published in Sciencevii has just demonstrated: it affects the entire chromatin, that is, the structure that determines DNA expression in relation to histones. Using CRISPR/Cas9, the researchers introduced targeted double-strand breaks in the DNA (as biotechnologists do when producing GMOs), and then monitored changes in chromatin organisation and gene activity.The study was carried out on human cells as part of an experimental human gene therapy trial.The researchers found that, even after DNA repair (the rejoining of the two ends of each strand), the chromatin in the region targeted by CRISPR underwent substantial changes in its spatial organisation: the chromatin remained misfolded and showed reduced expression of several genes, a phenomenon known as transcriptional alterations. The authors, Susanne Bantele et al., refer to this phenomenon as "chromatin fatigue". They note that this is a previously unknown effect of cellular responses to DNA breakage and repair, with the potential to permanently alter the composition and function of cells genetically modified using the CRISPR/Cas9 tool. Double-strand breaks in DNA are particularly damaging to chromatinviii.This "chromatin fatigue" occurs whether CRISPR/Cas is used to silence a gene, to modify a gene via mutagenesis, or to carry out transgenesis."Chromatin fatigue", a long-lasting alterationThe authors of the study have shown that these chromatin alterations are long-lasting. These post-repair effects are inherited by daughter cells and alter gene expression across several cellular generations. The potential cellular and physiological consequences of these long-lasting modifications remain to be investigated, bearing in mind, amongst other things, that patients have already been treated with gene therapy using CRISPR/Casix.Furthermore, the organisation of DNA itself and within chromatin, together with histones and RNA, is a very ancient feature in the evolution of life and is shared by all eukaryotesx. We are gradually discovering that there is spatial and temporal variability in chromatin. However, even within this dynamic landscape, entire chromatin domains can be maintained in a stable manner, and the overall pattern remains the same across eukaryotesxi.The consequences of this chromatin fatigue, which alters gene expression in plants genetically modified using CRISPR/Cas, could include biochemical changes – such as the production of new toxins and allergens – or an altered nutritional valuexii.In animals genetically modified using CRISPR/Cas, including humans, disruptions to gene expression resulting from chromatin fatigue could trigger serious physiological consequences: "Chromatin architecture is a central determinant of genomic stability. Effective DNA repair requires dynamic chromatin remodeling to grant repair factors timely access to lesions and to orchestrate repair pathway choice. Disruption of chromatin-regulatory mechanisms or DNA damage response pathways undermines repair fidelity and contributes to a wide spectrum of human disorders, including developmental syndromes, premature aging, and multiple cancers”xiii.This new study paves the way for further researchxiv. For example, could "chromatin fatigue" affect the germ cells and offspring of organisms? In plants, studies into the phenotypic consequences of this chromatin fatigue should be carried out, at a time when the flagship tool of gene editing technologies, CRISPR/Cas, appears to be a significant cause of it."Chromatin fatigue" should be regarded as an epigenetic trace, a scar that could potentially pose a danger to the organism, but also as a marker of genome modification by CRISPR/Cas or other genetic modification processes, and therefore an obvious means of detecting and identifying these genetic modifications, whether intentional or not. However, in their drive to deregulate GMOs produced by NGT, the European Commission and the Council of the European Union have failed to take this into account.It is an irony of the story – and a curious fact to say the least – that some of the authors of the Science articlexv are employees of a company well known to biotech firms… or rather, a family of Danish companies: the Novo family! This group is, in fact, actively lobbying to deregulate genetically modified micro-organisms! Have the lobbyists at the Novo companies read the findings on chromatin produced by their own scientists? xvii A few examples:Annick Bossu, "Médecine : les technologies Crispr/Cas se cherchent encore", Inf’OGM, 20 February 2024.Annick Bossu, "OGM : quand la biologie met Crispr au pas", Inf’OGM, 10 November 2022.Eric Meunier, "OGM – Crispr/Cas peut « éclater » les génomes", Inf’OGM, 28 October 2021.ii Eric Meunier, "The deregulation of the GMO/NGT adopted in Strasbourg", Inf’OGM, 26 June 2026.iii S. Bantele et al., "Repair of DNA double-strand breaks leaves heritable impairment to genome function", Science, Vol. 390, Issue 6773, 6 November 2025.iv A pioneer in cytology (or cell biology), he described mitosis, chromatin…v Geneviève Almouzni, « La chromatine, un véhicule d’informations au-delà de la séquence d’ADN : sadynamique et sa stabilité », 25 November 2014.vi Ibid.vii S. Bantele et al., "Repair of DNA double-strand breaks leaves heritable impairment to genome function", Science, Vol. 390, Issue 6773, 6 November 2025.viii There are two main pathways for DNA repair, one of which is more faithful than the other. The less faithful pathway is thought to have a mutagenic effect, with a risk of causing malignant tumours. Numerous regulatory mechanisms influence the choice of one or the other of these pathways for the repair of double-strand breaks. One such mechanism relates specifically to the effects of chromatin.Joonyoung Her, Samuel F. Bunting, "How cells ensure correct repair of DNA double-strand breaks", Journal of Biological Chemistry, Volume 293, Issue 27, 6 July 2018.ix Annick Bossu, "Médecine : les technologies Crispr/Cas se cherchent encore", Inf’OGM, 20 February 2024.x Histones are not even unique to eukaryotic cells:Janet Iwasa, "Molecule of the Month: histones across the tree of life", 26 February 2026.xi Jannon Fuchs et al., “Chromosomal histone modification patterns – from conservation to diversity”, Trends in Plant Science, Vol. 11, May 2026.xii GMWatch, "Gene editing disrupts multiple gene functions through large-scale epigenetic changes in a way that persists through successive cell generations", 17 December 2025.xiii Joonyoung Her, Samuel F. Bunting, "How cells ensure correct repair of DNA double-strand breaks", Journal of Biological Chemistry, Volume 293, Issue 27, 6 July 2018.Adriana Chiaramida et al., "Chromatin Remodelling, DNA Double-Strand Break Repair, and Human Disease: How a Breakup Changes You", Biomolecules, 15 April 2026.xiv Lingjiang Chen, Zhiyong Mao, Yu Chen, "Chromatin fatigue: An epigenetic legacy of DNA repair", Ageing Cancer Res Treat, 2026.xv S. Bantele et al., "Repair of DNA double-strand breaks leaves heritable impairment to genome function", Science, Vol. 390, Issue 6773, 6 November 2025.xvi GMWatch, "Gene editing disrupts multiple gene functions through large-scale epigenetic changes in a way that persists through successive cell generations", 17 December 2025.Christophe Noisette, "Novonesis, a new Danish industrial giant promoting “biosolutions”?", Inf’OGM, 15 May 2024. Annick BOSSU antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [20] => Array ( [objectID] => 27569 [title] => The deregulation of the GMO/NGT adopted in Strasbourg [timestamp] => 1782432000 [date] => 26/06/2026 [annee] => 2026 [url] => https://infogm.org/en/the-deregulation-of-the-gmo-ngt-adopted-in-strasbourg/ [image] => https://infogm.org/wp-content/uploads/2026/06/polfjard-768x432.png [extrait] => On Wednesday 17 June 2026, MEPs adopted the compromise text deregulating GMOs produced using new genetic modification techniques (GMO/NGT). This text, which is identical to that adopted by the Council of the EU on 21 April 2026, means that GMO/NGT will be able to be placed on the market in the EU without authorisation, without risk assessment, without labelling (except on seed lots) and without the publication of methods for detecting and identifying them. It will come into force in 2028. [chapo] => On Wednesday 17 June 2026, MEPs adopted the compromise text deregulating GMOs produced using new genetic modification techniques (GMO/NGT). This text, which is identical to that adopted by the Council of the EU on 21 April 2026, means that GMO/NGT will be able to be placed on the market in the EU without authorisation, without risk assessment, without labelling (except on seed lots) and without the publication of methods for detecting and identifying them. It will come into force in 2028. [texte] => Meeting in plenary session in Strasbourg on Wednesday 17 June 2026, MEPs discussed the regulatory text that has been dominating the news on GMOs since December 2025. This text was the outcome of negotiations between representatives of the European Parliament, the Council of the EU and the European Commission. These negotiations were formally concluded by the Council of the EU on 21 April 2026i. MEPs, in turn, approved this compromise text without changing a single comma, despite fierce opposition from a wide range of stakeholdersii.A simplified regulatory framework or one that has been rendered meaningless?The adopted text will come into force in 2028, two years after its publication in the Official Journal of the European Union, which is expected shortly. Its general principle – the details of which Inf’OGM will examine in a forthcoming article – is, in practical terms, the deregulation of the vast majority of the announced "new GMOs", including plants and micro-algae.Although they still fall within the definition of GMOs – which has not been amended – these GMO/NGT will, under this Special Act adopted by Parliament, be eligible for "new genomic techniques 1" (NGT1) or "new genomic techniques 2" (NGT2) status. This is a somewhat puzzling designation, given that these GMOs are organisms rather than techniques. Nevertheless, this status will be granted simply upon declaration by the company wishing to market its GMO/NGT plant. NGT1 plants may have undergone multiple genetic modifications, the maximum number of which may vary from one species to another (40 in the case of soya, 80 in the case of maize, rapeseed and potatoes, 120 for wheat, etc.). The only condition is that no transgenes may be present in the final product. The NGT2 category will include plants modified by "directed mutagenesis" or "cisgenesis", but not classified as NGT1.Compared with current GMO regulations, the differences are significant. Thus, "NGT1" plants will be subject neither to a pre-authorisation risk assessment nor to formal marketing authorisation. Companies will not be required to provide a detection and identification method to track this GMO/NGT in imports, or following its release within the European Union. No post-market health and environmental monitoring will therefore be possible, and Member States will not be able to ban their cultivation on their territory.It should be noted that plants whose characteristics include tolerance to herbicides or the production of "known insecticidal substances" will not be eligible for NGT1 deregulated status and will therefore remain subject to current regulations.Patents? Measures that are neither mandatory nor bindingThe vast majority of these GMO/NTG plants that are granted deregulated status will remain subject to patents held by a handful of multinationals (Corteva, Bayer, BASF, Syngenta and Limagrain). In light of the documented risks to food sovereignty, corporate concentration, rising seed prices… and the political difficulties this issue has raised, non-binding measures have been included in the text adopted on Wednesday by Parliament. These measures apply only to seed companies, but pay no attention whatsoever to small-scale farmers, who may have their crops seized on the pretext of infringement in the event of contamination or the presence of native genes similar to those covered by patents relating to GMOs.According to the text, the European Commission will, for example, “oversee the drawing-up of a code of conduct at Union level to enhance the transparency of information relating to patents on plant biological material, to facilitate breeders’ access to such material and to enhance legal certainty for breeders and farmer”. The only requirement on the Commission is that it “shall simply ‘aim’ to ensure that the code of conduct contains certain key commitments, which will nevertheless remain voluntary”, as Inf’OGM has already reportediii.Another measure envisaged is the requirement for companies to declare, "to the best of their knowledge", any patents present in a particular deregulated plant, accompanied by the option to declare that they are unaware of any such rights. Patent holders will also be required to express their willingness to grant the corresponding licences on "fair and reasonable" conditions, although these terms are not defined.Finally, the European Commission will be assisted by an "expert group on the effect of the patenting of NGT plants" on plant variety innovation, breeders’ and farmers’ access to patented material (seeds and plants), the risks of litigation… with the possibility for the Commission to "submit legislative proposals" should it identify any problems – a power it already possesses, as the Commission is the sole body authorised to initiate legislative proposals within the European Union…Rejected amendmentsIn Strasbourg, the plenary session opened with amendments tabled by MEPs from various groups (the Greens, the S&D and the Left)iv. Apart from the first, which proposed rejecting the legislative proposal in its entirety, the other amendments were aimed, in particular, at restoring the European Parliament’s initial position as expressed in 2024. At that time, the European Parliament had demanded that methods for detecting and identifying commercialised GMO/NGT be provided, that these GMO/NGT be subject to health and environmental risk assessments and labelling, and that patents on such deregulated plants be prohibited or, at the very least, not be allowed to cover "native" genes and traits.But it did not take long for the 663 MEPs present in the chamber – who are no longer the same as those who amended this text in 2024 (the European elections having taken their toll) – to reject them. The vote was completed in barely 15 minutes, following brief statements from the leaders of the political groups. As no amendment received the absolute majority (a majority of the 720 MEPs in the Parliament) required for its adoption, the text was ultimately adopted without amendment. The bar was set high, but some amendments, for which the results were displayed live, were nevertheless rejected by a very narrow margin.Statements from the political groupsFor the European People’s Party, Jessica Polfjärd – a staunch advocate of deregulating these GMO/NGT and the Parliament’s negotiator during the trilogue – was the first to speak. Denouncing the amendments tabled as aimed solely at "blocking innovation", she unsurprisingly called for a vote choosing "science and innovation" and thus for the rejection of all the amendments put forward, so that "farmers [have] the tools to meet the challenges of the future" rather than "the tools of yesterday".Speaking on behalf of the Group of Socialists and Democrats, Christophe Clergeau called for “defending European farmers and seed producers, and free access to plant diversity” rather than “handing control of plants and agriculture over to a handful of agrochemical multinationals”. Recalling “that Parliament voted overwhelmingly against patents on NGTs […] across all groups” in 2024, he called for a vote to allow a few more months of discussions to improve the text presented to MEPs.The Patriots group, speaking through Silvia Sardone, explained that today’s vote did not concern GMOs, stating that they “remain opposed” to them. Through her, the MEPs from this group explained that today’s issue concerns NGTs, which are “entirely different”. According to them, “we must put an end to the campaign of manipulation being waged by the environmental Taliban”… read between the lines: vote against all the amendments.For the European Conservatives and Reformists Group, Pietro Fiocchi believes that “it is crucial to move forward with NGTs” to tackle the challenges of climate change. Believing that GMOs and NGTs are entirely different from GMOs, he presents these techniques as “a solution […] by reducing pesticide use […] and tackling water scarcity”.The Renew Group spoke through Pascal Canfin. He justified the call to vote against the amendments on the grounds that they represent “new tools for farmers”. The Renew Group “does not pit ecological solutions against technological solutions”. The group believes that the proposed text “will benefit farmers, their incomes, our crop yields and our food sovereignty”.On behalf of the Greens, Martin Haüsling called for a vote in favour of the amendments in order to allow time to discuss the issues at hand. He explained that the compromise text “runs completely counter to what Parliament wanted”. Explaining that it “puts European seed producers at risk”, he believes that this text “throws the door wide open to US and Chinese companies". Recalling the European Parliament’s 2024 call for "transparency, freedom of choice for consumers and labelling" – none of which are included in the text – he emphasised that it "throws the precautionary principle out of the window".The Left Group, through Anja Hazekamp, also defended the amendments. She explained that this text “deliberately undermines the very foundations of the European food system”. She also criticised the proposed text as being “the direct result of aggressive lobbying by major agri-biotech companies that are already making huge profits”, but which want to “expand their power over the food system”.The adoption by MEPs on Wednesday 17 June 2026 of the text, which had already been approved by the Council of the EU on 21 April 2026, brings to an end a legislative process that began in July 2023, following the confirmation by the Court of Justice of the European Union (CJEU), in February of the same year, of its previous 2018 ruling subjecting these "new GMOs" to the 2001/18 regulations. With this vote, the compromise text therefore becomes a European regulation. All that remains is the purely administrative formality of publication in the Official Journal of the European Union, a publication which will trigger the 20-day period at the end of which this regulatory text will enter into force, and the two-year period at the end of which it will be fully implemented, unless challenges are brought before the CJEU, which remains a possibility.i Council of the European Union, « Position of the Council at first reading with a view to the adoption of aREGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625 – Adopted by the Council on 21 April 2026 », 21 April 2026.ii Antoine Vépierre, « The deregulation of GMOs is drawing criticism from all corners of Europe », Inf'OGM, 15 June 2026.iii Denis Meshaka, « The Council of the EU wants to maintain the patentability of GMOs/NGTs », Inf'OGM, 21 January 2026.iv European Parliament, « Recommendation for a second reading on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625 », 17 June 2026. Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [21] => Array ( [objectID] => 28386 [title] => The European Commission is proposing legislation on biocontrol [timestamp] => 1782086400 [date] => 22/06/2026 [annee] => 2026 [url] => https://infogm.org/en/the-european-commission-is-proposing-legislation-on-biocontrol/ [image] => https://infogm.org/wp-content/uploads/2026/06/signal-2026-06-16-114259_002-768x576.jpeg [extrait] => In December 2025, the European Commission proposed a set of measures to amend the regulations governing food and animal consumption, compiled in a document entitled "Omnibus X". This document notably proposed the creation of a new legal category: "biocontrol substances", described as an alternative to chemical pesticides, whose development and marketing the European Commission aims to promote. However, on June 12, the Council of the EU noted the lack of a qualified majority for this text. [chapo] => In December 2025, the European Commission proposed a set of measures to amend the regulations governing food and animal consumption, compiled in a document entitled “Omnibus X“. This document notably proposed the creation of a new legal category: “biocontrol substances“, described as an alternative to chemical pesticides, whose development and marketing the European Commission aims to promote. However, on June 12, the Council of the EU noted the lack of a qualified majority for this text. [texte] => Inf’OGM decided to focus on biocontrol once it became clear that the definition currently under discussion at the European level could facilitate the marketing of products derived from biotechnologies. Furthermore, this definition could lead to semantic confusion with products used in organic farming – a confusion we believe it is important to highlight.Proposed in December 2025, Omnibus X1 introduces, for the first time in European law2, a definition not of biocontrol, but of biocontrol products. It also proposes a streamlined regulatory framework to facilitate their marketing. In its opening remarks, the Commission states that this will "reduce farmers' dependence on plant protection products containing chemical active substances" and "increase the accessibility and availability of sustainable plant protection products, including plant protection products containing biocontrol substances". Biocontrol thus becomes the showcase for a promise of transition, justifying, for the Commission, a structural easing of controls for a whole range of substances not classified as "of concern".As an introduction, it is important to note that the proposed definition formulated by the European Commission encompasses numerous products: from clay to RNAi sprays and pheromones. This allows for a wide range of interpretations, as biocontrol products can be substances of natural origin or synthetic if they are "similar" to the former. Here we find one of the foundational language elements of the deregulation of GMOs/NTGs. This deregulation is supposedly justified by an "equivalence" between these GMOs and what nature or conventional breeding does, an equivalence never scientifically explained.Biological control and biocontrol: a deliberate confusionThe European Commission, supported by the Council, proposes to amend Regulation (EC) No 1107/2009 on "plant protection products" (sic). They propose to create a new category of “plant protection products”: the so‑called “biocontrol substances”3. This choice of wording is problematic as it creates confusion. Indeed, it creates an equivalence between “biological control” and “biocontrol products”. Although the etymological relevance of the term “biocontrol” can be questioned in itself, Inf’OGM will use it here to clearly distinguish the two aforementioned approaches.The assimilation of the two is far from neutral. It places in a single legal category natural products used in a “systemic” approach – i.e. an approach that bases plant protection on the ecological balance of agronomic systems – and products with the exact same aim than their synthetic counterparts, which they are supposed to substitute – i.e. targeting a “pest” species identified as the cause of the unbalance of the agronomic system. The first type of product, identified legally in France as “low‑risk natural preparations” include ladybirds, nematodes, pheromone traps, Bacillus thuringiensis powders. In the perspective of a systemic approach, they are used to implement a strategy that combines farming practices aimed at slowing down the spread of pathogens and favouring beneficial organisms – such as crop rotations, population varieties and seeds, varietal and species mixtures, hedgerows… By contrast, industrial substitute products target undesirable species once they create issues in the field, and therefore remain firmly within the current paradigm of synthetic pesticides and biotechnologies.There is another major difference between these two sets of products: some biocontrol products are designed to be covered by patents, whereas natural products and practices used in the context of biological control are not.Challenging this misleading terminology is crucial. Indeed, as such, it may lead readers to believe that all biocontrol products are biological‑control products. Besides, the term “biocontrol” may suggest that these products are compatible with organic agriculture. Yet biocontrol products derived from synthetic chemistry or genetic engineering are not authorised in organic farming. We will further examine the opposition between biocontrol and organic agriculture in a forthcoming article.Omnibus X defines biocontrol productsThe first element of Omnibus X concerns the definition. Article 2 of Regulation 1107/2009 would be revised so that this regulation "applies to substances, including biocontrol substances [Editor's note: the current regulation states "including microorganisms"], which exert a general or specific action on harmful organisms or on plants".Omnibus X (Article 3.35) sets out what constitutes a biocontrol product for the European Commission. According to its proposal, it includes:microorganisms;inorganic substances "as found in nature," excluding heavy metals and their salts;"substances of biological origin" or produced synthetically, but "functionally identical and structurally similar" to the former. Here we find the same semantic and conceptual shift as in the transition from Directive 2001/18 (GMO products defined primarily by their method of production) to the new NGT Regulation (products defined by certain characteristics, regardless of their method of production).First observation: this proposed definition excludes macro-organisms (ladybugs, trichogramma wasps, etc.), which are the epitome of biological control. At the European level, there is no single harmonized authorization procedure for placing beneficial macro-organisms on the market or introducing them. Member States manage, and would therefore continue to manage, the introduction, production, and marketing of these organisms within their territories. France, for example, has included them among biocontrol products.Let's therefore examine these three categories of biocontrol products.MicroorganismsMicroorganisms (bacteria, fungi, viruses) are already regulated by Regulation 1107/2009 as "active substances" in plant protection products. With Omnibus X, they remain within the pesticide category, but this legislation proposes adding another status: that of "biocontrol products".Products consisting of or containing microorganisms have long been used in agriculture, such as powders rich in spores and crystals based on bacteria (Bacillus thuringiensis against certain insects, Bacillus subtilis against fungal diseases) or fungi (Trichoderma harzianum against Fusarium wilt). As of December 31, 2025, the European Food Safety Authority (EFSA) listed 138 microorganisms as "plant protection products".The inclusion of microorganisms in this definition raises the more specific question of genetically modified microorganisms (GMMs). To date, no genetically modified microorganism has been authorized as a pesticide in the European Union. However, several field trials have been conducted. For example, in the Netherlands, the bacterium Pseudomonas putida WCS358r, genetically modified to control pathogenic wheat fungi, was field-tested in the late 1990s by Utrecht University4.In contrast, several GMMs marketed as "biocontrol products" have been authorized in the United States. Let us mention two.As early as 1996, the bacterium Bacillus thuringiensis (Bt), genetically modified to produce several Bt toxins and thus broaden its insecticidal spectrum, was authorized. It is found in Crymax, a "biopesticide" (a term equivalent to "biocontrol product") marketed by the company Certis Biologicals5.Around the same time, the genetically modified bacterium Agrobacterium radiobacter K1026, also described as a "biopesticide", was used against crown gall. It was marketed by Bio-Care (Australia) under the trade name Nogall.Omnibus X does not address the issue of GM crops. With Omnibus X, the European Commission is making a major choice. Unlike Chili6, among others, it has decided not to exclude GM crops from biocontrol. However, as we have seen, microorganisms can be genetically modified for use, for example, as biocontrol substances (even though they are organisms and not substances) or to produce biocontrol substances (such as RNA intended to produce certain biological substances).Currently, Regulation 1107/2009 (Article 48) specifies that a plant protection product "containing a" GMO regulated under Directive 2001/18 "is subject to an examination concerning genetic modification, in accordance with that Directive" 2001/18. But the Commission has already proposed another text (Proposal 2025/0405)7, which amends Directive 2001/18 and explicitly aims to deregulate these GMOs. In genetically modified form, these microorganisms would thus be subject to significantly less stringent regulations for their formal authorization. Secondly, as biocontrol substances, they would be subject to amended Regulation 1107/2009, which aims to simplify their marketing. There would therefore be two regulatory frameworks for GM plants intended as biocontrol products.Inorganic substancesInorganic substances include simple mineral salts (potassium bicarbonate, calcium sulfate, certain silicates) used as fungicides or insecticides. They can also include clay, talc, lime, etc. Heavy metals - copper, for example - and their salts are specifically excluded from this definition8.Organic or synthetic substances and the problem of “similarity”The third category is conceived in extremely broad terms and defined in a particularly vague manner. It consists of substances “of natural origin” or “synthetically produced that are functionally identical and structurally similar to the former.” “Synthetic” is understood to mean “manufactured by humans in factories using chemical processes”9. These two conditions, “functionally identical” and “structurally similar,” are never defined, and there is no reference to OECD (Organisation for Economic Co-operation and Development) standards, protocols for analyzing molecular structures, or thresholds of similarity.This idea of equivalence between products derived from nature and those synthesized in the laboratory can only remind us of the political underpinnings of the deregulation of GMOs/NGTs. However, this equivalence is primarily postulated: it has never been systematically demonstrated, neither in the case of biocontrol nor in that of NGTs. This is primarily a political choice, lacking any scientific basis. But, more fundamentally, the idea that the synthetic version can be identical to the "natural" one, without providing any criteria to justify this, allows for the alignment of risk assessments between "natural" (based on millennia of human experience) and synthetic (recent, and therefore lacking any proven safety evidence), the latter not being inherently riskier10.In the recitals of the Omnibus X Regulation, this third category is further defined. It includes, on the one hand, substances emitted by living organisms into the environment that act as so-called "semiochemical" signals (pheromones between individuals of the same species or kairomones between different species).On the other hand, Omnibus X refers to “biological macromolecules or molecules composed of their components, as well as substances, including those of unknown and variable composition, originating from living organisms or resulting from biological processes” (extracts of plant products or metabolites produced by microorganisms, for example). With such a definition, Omnibus X is paving the way for a new generation of so-called “biological” molecules to enter the market, but which may be synthetic (interfering RNAs, micropeptides), or even synthetic macromolecules “inspired” by living organisms.When the text refers to metabolites produced by microorganisms, it is important to remember that these microorganisms may be genetically modified, like those used to produce ledprona11, the active substance (RNAi) in calantha. The question then arises as to whether these metabolites are subject only to Regulation 1107/2009 as pesticides or also to Regulation 1829/2003 as products intended for human and animal consumption produced from GMOs.This question resonates with the fact that, also in Omnibus X, the European Commission proposes amending Regulation 1829/2003 to enshrine in European legislation a practice in place since 2009, namely that metabolites produced by GMOs are not considered "produced from GMOs", and therefore subject to GMO legislation, but "produced using" GMOs, and thus not subject to this legislation (no labeling is required, in particular).Biocontrol products, a promising marketAccording to the company De Sangosse, microorganisms used in biocontrol constituted a $2.5 billion (€2 billion) market in 2021 globally (mainly in North and South America) and are expected to reach $7 billion (€6 billion) in 202912.Biocontrol “products” already on the marketWe have already mentioned calantha, an RNAi spray produced by GreenLight Bioscience to combat the Colorado potato beetle, which Belgium has provisionally authorized. The European Union has decided to evaluate calantha’s active ingredient, ledprona, according to Regulation 1107/2009, even though the existing protocols are poorly suited to this new type of genetic pesticide. We can also mention Micropep’s pesticides, based on small peptides derived from plant sequences. Others are in the development phase.Thus, by stretching the definition somewhat, could the project by researchers at Northeastern University12 (Boston, USA) to create a synthetic polymer that breaks down the protective layer that bacteria produce around themselves in order to make Pseudomonas aeruginosa bacteria more susceptible to conventional antibiotics not be considered a biocontrol substance? These molecules are not organisms: they therefore fall outside the scope of Directive 2001/18 on GMOs, even though they rely on biotechnology. Nor are they chemical pesticides. By broadening the definition of "substances of biological origin" to include compounds of "unknown and variable" composition, and by accepting synthetic equivalents declared "functionally identical" and "structurally similar" without specifying the criteria for this identity, Omnibus X could pave the way for these new biotechnologies.What about biostimulants?The Commission is taking advantage of Omnibus X to explicitly exclude "biostimulants" from the scope of the regulation. A new point in Article 3 defines these biostimulants as products that "stimulate plant nutrition processes" or improve tolerance to abiotic stress, without acting as a means of controlling harmful organisms. They fall under Regulation (EU) 2019/1009 on fertilizers, and not Regulation (EU) 1107/2009.The European Commission's proposed definition of biocontrol products is both very broad and very vague. It notably echoes the semantics used in the draft legislation on the deregulation of GMOs/NGTs, referring to synthetic products "similar" to those found in nature. However, this equivalence has never been scientifically demonstrated, and no rigorous protocol supports it. As with GMOs/NGTs, the Omnibus X proposal, once this definition is established, aims to propose regulatory relaxations. We will analyze these in a forthcoming article.The entire Omnibus X text is now in the hands of the EU Council, on the one hand, and the European Parliament, on the other. For the Council, the Cypriot Presidency has shown an impressive willingness to have an amended version of this text accepted by the Member States. Cyprus has thus repeatedly proposed a compromise text, including modifications to the definition of biocontrol products. The country had hoped that the Council, meeting on Friday, June 12, 2026, would express a qualified majority. However, this qualified majority was not reached. According to our information, this was due to opposition from Germany, Spain, and Italy, among others. Christophe NOISETTE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [22] => Array ( [objectID] => 27060 [title] => Patents on GMOs/NGTs raise issues that the EU may refuse to address [timestamp] => 1781568000 [date] => 16/06/2026 [annee] => 2026 [url] => https://infogm.org/en/patents-on-gmos-ngts-raise-issues-that-the-eu-may-refuse-to-address/ [image] => https://infogm.org/wp-content/uploads/2026/06/52963679101_c4fe84bd57_c-768x356.jpg [extrait] => In July 2023, alongside its proposal to deregulate new genetic modification techniques (NGTs), the European Commission promised an assessment of the impact of patents on plant breeding. The report, produced by Technopolis and published in December 2025, highlights several problems related to patents. These problems will not be resolved by the non-binding measures adopted by the Council of the European Union in April 2026. Do the European authorities really only listen to the voice of industry, even if it means ignoring the reports they commission? [chapo] => In July 2023, alongside its proposal to deregulate new genetic modification techniques (NGTs), the European Commission promised an assessment of the impact of patents on plant breeding. The report, produced by Technopolis and published in December 2025, highlights several problems related to patents. These problems will not be resolved by the non-binding measures adopted by the Council of the European Union in April 2026. Do the European authorities really only listen to the voice of industry, even if it means ignoring the reports they commission? [texte] => In a communication1 dated 5 July 2023, the European Commission undertook, by 2026, to assess "the impact that the patenting of plants and related licensing and transparency practices may have on innovation in plant breeding, on breeders’ access to genetic material and techniques and on availability of seeds to farmers as well as the overall competitiveness of the EU biotech industry". The report2, commissioned for this purpose by the Commission from the consultancy firm Technopolis, was published in early December 2025, just as the trilogue3 on the draft NGT Regulation between the Council, the Parliament and the European Commission concluded on 11 December. The Council has just adopted, on 21 April, its favourable position at first reading on the provisional compromise resulting from the trilogue4, whilst ignoring certain major issues highlighted by the aforementioned report.A report for form’s sakeTechnopolis is a consultancy firm regularly commissioned by the European Commission, as it is very supportive of the "new economy". Its report, entitled "Supporting innovation in the EU bioeconomy through intellectual property protection", can be described as "pro-patent" with regard to agricultural biotechnology. However, it presents a nuanced yet worrying assessment of the impact of such patents on certain stakeholders, particularly small and medium-sized seed companies and farmers.Technopolis highlights several difficulties posed by the patent system for these players in the plant sector, notably market concentration, patent stacking, the cost of freedom-to-operate studies (to verify whether a product or process can be used without infringing a patent), and tensions surrounding the concept of the breeder’s exemption5. These issues are indeed major challenges in the debate on patents relating to NGTs.Even though the Council had the Technopolis report at its disposal, its position at first reading, adopted in April, does not appear to have taken its lessons on board. The institution does acknowledge the difficulties highlighted by this document, but has not proposed any amendments to the text to offer effective solutions. In any case, the Council has not included any major measures clearly holding patent holders – predominantly multinationals in the case of Crispr-edited plants – accountable6. Worse still, it has ignored other problems highlighted by the report for which no response, or even the semblance of a response, is proposed by the Council of the European Union.Acknowledgement of the difficulties without any willingness to resolve themWas it this report that led the Council of the EU to acknowledge that patents restrict access to plant material and thus contribute to the concentration of the seed sector? Be that as it may, the text it adopted at first reading still refers to these risks. In practical terms, it encourages the use of so-called "fair and reasonable" licences and provides for the development of a "code of conduct". This non-binding code aims to enhance the transparency of information relating to patents on plant biological material, to facilitate breeders’ access to such material and to increase legal certainty for both breeders and farmers (hereinafter the "code of conduct")7.The adopted text also retains the creation of a database of information voluntarily provided by patent holders relating to "NGT plant biological material", including their potential willingness to grant licences (Article 9). The Technopolis report highlights, in fact, the lack of clarity regarding intellectual property rights and the difficulties faced by breeders in identifying such genetic material or traits that may be covered by a patent and in "facilitating their decision-making" in their breeding activities.Solutions to these initial problems therefore exist, and are even set out in the adopted text. However, the Council of the EU did not amend the wording to make these solutions binding, particularly on the main holders of patents on GMOs/NGTs. The Council, following the Commission’s lead, has thus chosen to reassure multinational seed companies rather than small and medium-sized seed producers and farmers, who are nevertheless the most vulnerable in the face of the "minefield" that such patents constitute.Deeper-rooted problems still being ignored…The Technopolis report highlights other equally significant problems that have nevertheless been ignored by the Council of the EU. The consultancy firm draws particular attention to certain imbalances between small and medium-sized breeders and multinationals. The latter, for example, have far greater financial and legal resources, enabling them to build up vast patent portfolios and defend them in disputes with such breeders.The report specifically mentions the situation of accidental infringement, which the Council of the EU does not address. This situation creates "legal uncertainty and threat of litigation [which] may also have a negative effect on the innovation of conventional breeders", the report states. Conversely, small and medium-sized breeders and other relevant SMEs "have fears about litigation, a limited knowledge about access to, costs, and benefits of the existing licensing platforms as well as the overall limited knowledge about the patent system and its potential", adds Technopolis.Furthermore, the Council of the EU fails to take into account the development of patent tangles cited in the report. These layers of rights covering genetic traits, processes or sequences make the legal environment particularly difficult to navigate and lead to a build-up of royalties. The Technopolis report notes that "the related complexity will likely render it impracticable for breeders to obtain all necessary licences to ensure freedom-to-operate. Options to mitigate this are (i) a more stringent interpretation of the scope of process claims, (ii) voluntary licencing platforms, as well as (iii) mandatory transparency”. While the Council of the EU has adopted the principle of these solutions – even those that are not strictly solutions, such as licensing platforms – it has not, however, made them mandatory.…or entrusted to othersThe report also highlights the growing tensions between patents and the plant breeders’ rights (PBR) system linked to the principle of the "breeder’s exemption". This exemption traditionally allows a variety covered by PBR to be used to create new ones. However, patents may limit this access to biological material and alter the current foundations of European plant breeding. The Council has retained a simple reference to Article 27(c) of the Agreement on a Unified Patent Court, as this provision is often cited as the legal basis for this exemption.Recital 62 of the text adopted by the Council of the EU leaves it to the Member States to implement this exemption: "Stakeholders raised concerns that patents relating to NGT plants might limit the access of breeders to those plants for the purpose of developing other plant varieties". The adopted text continues: "It is important that all Member States address those concerns and ensure legal certainty for plant breeders by taking appropriate steps to implement a corresponding limitation to patent rights in their national patent laws, to ensure its consistent application across the Union". Leaving this provision as it stands allows the Council of the EU to "pass the buck" to the Member States, so to speak.A procedural response in the absence of reformThe compromise text adopted by the Council of the EU does not alter the patent system. It does not call into question either the patentability of GMO/NGT plants or the European Directive 98/44 on biotechnological inventions. Furthermore, the mechanisms in this text concerning patents remain voluntary, providing incentives but being neither binding nor mandatory…The "code of conduct" (Article 30) is based on a general principle of voluntary commitment, without any obligation. For example, the calls for patent holders to grant licences on "fair and reasonable" terms do not create a legal obligation. As for the information provided in the database without any obligation or official verification (Article 9), it improves the visibility of patents but does not guarantee effective access to genetic material and therefore leaves its potential users in a state of legal and economic uncertainty.The EU Council’s reasoning is therefore incomplete if it wished to ensure that the patent issue did not arise. Its text acknowledges the difficulties created by patents, but does not address the far more contentious issue of extending the scope of patents to native traits "similar" to patented traits through the use of untraceable GMOs/NGTs. The institution confines itself to proposing measures to manage certain problems within the patent system rather than addressing their root causes. Failing to reject the proposal to deregulate GMOs/NGTs – even though such deregulation opens the door wide to patent-related problems – the text favours non-binding measures (transparency, licensing platforms, databases, etc.), which do not alter the existing legal framework, despite its inadequacy.The Council of the EU has therefore left several issues raised by the Technopolis report unresolved, in particular the concentration of the seed market, access for small and medium-sized breeders and other SMEs to certain "innovations", and their ability to operate in an increasingly complex intellectual property environment. This decision is all the more baffling given that a great many stakeholders have alerted – and continue to alert – MEPs to these issues. As for the French government, which voted in favour of the compromise text in April 2026, it is even more baffling given that it had in its possession a note from its embassy in the United States clearly stating that all these problems are very real in that country. Only MEPs meeting in plenary session on 17 June 2026 can still take action on this matter. Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [23] => Array ( [objectID] => 26985 [title] => The deregulation of GMOs is drawing criticism from all corners of Europe [timestamp] => 1781481600 [date] => 15/06/2026 [annee] => 2026 [url] => https://infogm.org/en/the-deregulation-of-gmos-is-drawing-criticism-from-all-corners-of-europe/ [image] => https://infogm.org/wp-content/uploads/2026/06/ogm-808x538-1-768x511.jpg [extrait] => On 17 June, between 12.30 and 1.30 pm, MEPs, meeting in plenary session, will vote, without debate, on the proposal to deregulate GMOs derived from new genetic modification techniques (GMOs/NGTs). Inf’OGM summarises here some of the positions, campaigns and other calls for action by civil society organisations, elected representatives, businesses and trade unions regarding the risks that its adoption would entail. [chapo] => On 17 June, between 12.30 and 1.30 pm, MEPs, meeting in plenary session, will vote, without debate, on the proposal to deregulate GMOs derived from new genetic modification techniques (GMOs/NGTs). Inf’OGM summarises here some of the positions, campaigns and other calls for action by civil society organisations, elected representatives, businesses and trade unions regarding the risks that its adoption would entail. [texte] => On the eve of the European Parliament vote1, it is an understatement to say that anger is mounting over the proposal to deregulate GMOs/NGTs. A demonstration is also planned for 16 June in Strasbourg2. Coming from a variety of stakeholders3 and from EU member states (and non-member states)4, criticism is mounting and calls to MEPs have multiplied in recent years. We offer you a non-exhaustive compilation of these, supplemented by three initiatives in Italy, Greece and France.An overview of European positions Having been involved since 2014 in legal proceedings before the Council of State and subsequently the Court of Justice of the European Union (CJEU), the French organisations involved5 in the appeal saw the European courts rule in their favour in 2018: GMOs obtained through genetic modification techniques developed mainly after 2001 cannot be exempted from regulation.As early as 2022, these French organisations were already warning of a potential loophole in the legislation, pointing out “the intention of the legislator [in 1990 and 2001], who never intended to exempt from GMO regulations plants obtained using new genetic modification techniques that emerged and were developed in the 1990s alongside transgenic plants, which are indisputably regulated GMOs”6. This 2018 court ruling, upheld on appeal in 2023 and binding on the European Commission, forms the basis of the deregulation proposal that has attracted considerable criticism. In November 2022, just as the European Commission had announced that it would present, in the second quarter of 2023, a legislative proposal “concerning new genomic techniques, such as targeted mutagenesis or cisgenesis”, the German Federation of Consumer Organisations (VZBV) spoke out in turn, quickly followed by some of its European counterparts7. Anticipating that the proposal could result in reduced regulation of GMOs/NGTs, it called on the European Commission to apply the precautionary principle. It was already calling for new GMOs/NGTs to be subject to a risk assessment and a pre-market authorisation procedure. It also demanded that they be labelled as such, so that consumers could decide whether they wished to buy and eat these products. In France, this was also the position taken by 16 consumer associations a year later8. In June 2023, again in France, it was the Federation of Trade and Distribution (FCD) which, using similar arguments, called for “the precautionary principle to be applied and for there to be complete transparency regarding the placing on the market of these products so that our customers can make an informed choice”9. However, the turning point in the scale of the mobilisation came following the publication of the text proposing the deregulation of GMOs/NGTs by the European Commission in July 2023. From then on, an agricultural union10, processors11 and organic producers12 asserted that GMOs/NGTs are incompatible with small-scale and even conventional farming, as well as the principles of organic farming, whilst the GMO-free sector called for their labelling13. For their part, small and medium-sized seed companies were beginning to realise the risks that patents would pose to their business and were alarmed by this14. Even recently, some of them have spoken out publicly to express their opposition to the text that could be voted on 17 June due to the risks associated with patents15. It is also worth noting the opposition expressed since then by certain researchers16, politicians17, chefs18 and, more recently, law professors19. Recent months have also seen a proliferation of joint open letters co-signed by coalitions of civil society organisations. These are notably aimed at calling on MEPs to protect the organic and GMO-free sectors, as well as small and medium-sized seed producers, and to ensure that citizens’ right to know what they are consuming is respected20. Finally, as part of public campaigns, in November 2022 Greenpeace raised awareness among consumers in 23 French cities about the issue of “new GMOs” and called on supermarket chains to demand that French and European authorities label all GMOs21. On 13 December 2023, around sixty members of the Confédération paysanne, the Faucheurs volontaires, Greenpeace, the Fédération Nationale de l’Agriculture Biologique (FNAB), Agir pour l’environnement and the European Coordination of La Via Campesina (ECVC) occupied Europa Expérience, a showcase venue for European institutions located in Paris22. There, they denounced the European Commission’s attempt to deregulate GMOs. On 5 May 2025, in Rennes, the local Alternatiba collective carried out “an act of civil disobedience by taking over billboards in the city centre to warn the general public about the possible forthcoming deregulation of GMO crops”23.In Italy, municipalities are declaring themselves GMO-freeSince 2024, ARI and Crocevia have been running a campaign encouraging municipalities and regions to declare themselves “municipalities free of old and new GMOs”24. Whilst the declaration signed by the municipalities stipulates a ban on growing plants or rearing animals produced using genetic modification techniques, whether for experimental or commercial purposes, it goes even further. Indeed, the resolution also requires school canteens to include a ban on foods containing GMOs in their specifications. Finally, this resolution requires the display of a sign stating “municipality free from old and new GMOs”.In 2024, we mentioned the town of Poppi, the first municipality to join this movement25. By 2026, 8 municipalities had joined the movement, including the municipality of Pesaro, which has over 100,000 inhabitants, bringing the number of signatory municipalities to 17 and now representing over 160,000 Italian citizens.In Greece, a symposium to denounce the deregulation of GMOs/NGTsOn 7 May, Greenpeace Greece and the seed and biodiversity networks Sito and AEGILOPS organised a public event in Athens26. Like France, Greece had historically opposed the deregulation of GMOs/NGTs, before changing its stance in 2025 and lending its support to the text proposed by the European Commission.During this event, and as the Panhellenic Federation of Agronomists’ Associations (POSG) also did in a press release27, the speakers reiterated the criticisms levelled at the deregulation text and at GMOs more generally:no analysis/detection protocols and a lack of labelling, rendering the traceability of these GMOs non-existent and leaving farmers, seed producers, processors and consumers in the dark;challenge to the argument of equivalence between mutations occurring naturally in fields and those induced by NGTs, which are not as precise as their deregulation advocates claim, as they produce off-target effects whose impacts are difficult to assess;the risks posed by patents to farmers, who will find themselves under threat for having selected plants whose genomes contain sequences on which multinational seed companies may have taken out patents.They are therefore asking to “Greek MEPs not to support the EU’s new proposal on genetically modified organisms, because it abolishes rights such as safety and transparency rules that were secured 25 years ago” and want “labelling requirements for GMOs to remain in place”.A demonstration on the eve of the European Parliament voteNumerous organisations have therefore stepped up their efforts to raise awareness and mobilise over the last three years to express their opposition to the deregulation of GMOs/NGTs. With the European Parliament vote fast approaching, they do not intend to stop there. A broad coalition of farmers, breeders, environmental organisations, beekeepers and citizens is therefore calling for a demonstration on 16 June in Strasbourg, on the eve of the vote, to “to stop the deregulation of GMOs and defend transparent, democratic, and precautionary GMO rules in Europe”28. It remains to be seen whether MEPs will listen to them and take care to defend the founding principles of Directive 2001/18. Antoine VEPIERRE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [24] => Array ( [objectID] => 27528 [title] => Illegal GMO flax in Jacquet brand wraps [timestamp] => 1781222400 [date] => 12/06/2026 [annee] => 2026 [url] => https://infogm.org/en/illegal-gmo-flax-in-jacquet-brand-wraps/ [image] => https://infogm.org/wp-content/uploads/2026/06/03029330802525_C1N1_s01-768x768.jpeg [extrait] => In April 2026, Jacquet, a subsidiary of Limagrain, withdrew wraps from the French market: they contained genetically modified flax not commercially authorized. While no genetically modified flax varieties are currently officially cultivated worldwide, Canada authorized the cultivation of one variety in 1996 before withdrawing the authorization in 2001. This country has also recently ended its mandatory flax export monitoring program. [chapo] => In April 2026, Jacquet, a subsidiary of Limagrain, withdrew wraps from the French market: they contained genetically modified flax not commercially authorized. While no genetically modified flax varieties are currently officially cultivated worldwide, Canada authorized the cultivation of one variety in 1996 before withdrawing the authorization in 2001. This country has also recently ended its mandatory flax export monitoring program. [texte] => GMOs are regulated by European and French legislation. Therefore, to be marketed, a GMO must have been authorized, and to obtain authorization, it must have undergone a health assessment. A method for detecting and identifying it in seeds, food products, or other materials must also have been validated. This last point is fundamental: without such a validated and standardized method, professionals and authorities cannot verify labeling compliance throughout the supply chain, nor monitor contamination, whether in food products (as in this case), seeds, or fields. Yet, illegal GMOs regularly arrive in our ports and on our plates.Recall of illegal wrapsOn April 16, 2026, the French consumer recall website Rappel Conso listed a product from the Jacquet brand, a subsidiary of Limagrain1. This product, "plain protein wraps", contained unauthorized genetically modified flax. Rappel Conso, created and implemented by the French government in April 2021, lists recalls of products intended for human and animal consumption, as well as non-food products, identified as posing a health or safety risk or being sold illegally. The presence of unauthorized or unlabeled GMOs are also reasons justifying a recall.According to Jacquet's consumer service, contacted by Inf'OGM, the recall was due to the presence of genetically modified flax "FP967/CDC Triffid" in the flour used, detected following tests conducted by the company itself. The company clarified: “The level of contamination is extremely low (trace amounts, barely above the LOD detection threshold of 0.01%), and based on the information currently available, we tend to conclude that this was an accidental contamination. Enhanced monitoring has been implemented”.The European Union’s Rapid Alert System for Food and Feed (RASFF)2, the European equivalent of French consumer recalls, indicates that the contamination originated in the Netherlands, one of the main entry points for numerous food products into the EU. Jacquet explained that “the product is indeed manufactured in the Netherlands, but the analysis was carried out in France”.Luxembourg also reported the presence of this flax in the same product, but did not indicate that it had "withdrawn" the product, unlike the measures taken in France3. It simply advised consumers to return the product to the store where they purchased it.A GMO flax with a mysterious originWhere does this genetically modified flax come from? Probably North America. While the United States authorized a herbicide-tolerant genetically modified flax, CDC Triffid FP967, developed by the University of Saskatchewan4, in 1999, there is no record of its commercial cultivation5. Canada, for its part, authorized the cultivation of this flax in 1996. Tested in fields in the 1990s in three states (Saskatchewan, Manitoba, and Alberta), it has never been cultivated on large areas.While some articles claim it has never been commercially cultivated6, RCAB7, a Canadian NGO, writes that in 2001, “about 40 seed producers were multiplying approximately 4,500 tonnes of seeds8 for future use, but all of this was wiped out when flax was withdrawn from the market that year”. Indeed, this authorization was revoked in 2001 at the request of the Flax Council of Canada and the Saskatchewan Flax Development Commission, to avoid “losing”9 the European market. Although Canada exports more than 60% of its flax production to the EU, the latter has never authorized the import of this genetically modified flax.Despite a strict and costly protocol, GM flax is still growingWhile in 2001, Canadian authorities emphasized that all the flax seeds produced had been destroyed (4,500 tons of seeds, theoretically enough to sow between 75,000 and 150,000 hectares, depending on the seeding rate), contamination by genetically modified flax was subsequently detected in Europe.In 2009, the presence of this flax, genetically modified to tolerate herbicides, was reported in 34 countries, according to the association France Nature Environnement10. This presence resulted in a significant drop in flax exports to Europe, which led the flax industry to finance large-scale testing on farms and in ports. According to a report by the NGO RCAB11, “in 2010, the Canadian government committed $1.9 million [€1.3 million] to develop methods for testing flax seeds for GMO contamination. In 2011, the subsidies enabled approved laboratories to offer farmers a 50% discount on the cost of these types of tests”. Every shipment was scrutinized. The industry also undertook significant work to rebuild stocks of GMO-free flax seeds. According to Marie-Hélène Bacon12, “in order to start from scratch, farmers were advised to dispose of any seeds they had saved from previous harvests, even if they no longer cultivated flax. In 2010, flax plants initially grown in greenhouses were sent to New Zealand, a country that had never cultivated flax in a hundred years, to multiply the seeds until 2012 in order to rebuild a healthy base of certified seeds”. Other drastic measures had been recommended by the Flax Council, such as not planting flax in a field that had been cultivated there in the previous five years.According to the same RCAB’s report, citing the Saskatchewan Flax Council13, the estimated cost of this incident was $29.1 million (€20.7 million) for the Canadian industry. Another consequence was the loss of autonomy for farmers. Indeed, farmers were strongly encouraged to purchase certified seeds, whereas “before 2009, approximately 75% of farmers who [grown] flax in Canada used their own on-farm saved seeds”14. All of these measures significantly reduced the presence of GM flax, but did not eliminate it entirely, as evidenced by the presence of Triffid flax in 2026 in Jacquet company wraps.Furthermore, in 2024, the presence of GM flax in animal feed was recorded in the RASFF register15: originating from Russia and Ukraine, this GM flax was found in several European countries16. The RASFF entry mentions, once again, that this is a self-regulation by a company, without specifying which one. It is important to note that Russia, Ukraine, and Kazakhstan are world leaders in oilseed flax production and export their output on a massive scale17. Russia and Ukraine have also cultivated GMOs illegally (soybeans, corn and rapeseed)18.End of monitoring of GMO flax by Canadian authoritiesThe irony is that Canada has just officially declared the end of the sampling and analysis protocol in place since 2009 for Canadian flaxseed exported to the European Union. This protocol was adopted to address the contamination of Canadian production by genetically modified flax not authorized in Europe. The announcement was made on April 24, 202619, one week after the public announcement of the market withdrawal of Jacquet wraps due to contamination by genetically modified flax, and the decision took effect on May 1. The Canadian government welcomes the work undertaken and explains on its website that "the removal of this non-tariff barrier demonstrates the safety, reliability, and quality of Canadian agricultural and agri-food exports". It adds that this decision "demonstrates the strength of the Canada-EU strategic partnership and our shared commitment to resolving persistent trade disputes through cooperation and dialogue".The issue is primarily economic. The government notes that this protocol would put Canadian exporters at a disadvantage compared to their competitors and welcomes the fact that the end of these monitoring programs “offers increased economic potential for Canadian flaxseed farmers and exporters”. When questioned by Inf’OGM about this surprising decision, given that Triffid flax has once again been found in Europe, the Canadian government responded: “The RASFF notification […] initially indicated Belgium, France, and the Netherlands as potentially involved. It appears that Kazakhstan and Canada were added later. This notification is part of an ongoing investigation. Therefore, Agriculture and Agri-Food Canada cannot provide further comment on this specific event”20.This response intrigues us because, when questioned by Inf’OGM, the European Commission stated that “the investigation into the origin of the flax seeds in the April 2026 notification is still ongoing”. Inf’OGM also asked the Jacquet company about the origin of this GM flax, and they replied that they did not know. Canada thus seems to be somewhat hastily absolving itself of any responsibility for this illegal presence of genetically modified flax in Europe…A long history of contamination in our importsThis story is reminiscent of the presence of illegal GM rice, papaya, soy, and corn in European imports for decades. Inf’OGM has extensively documented these cases of contamination. In 2006, the first case of GM rice was detected, and in 2024, 14 cases of illegal GM rice were still being reported to the RASFF.In 2026, European alerts concern, in addition to flax in these wraps, several cases of GMO soy from Argentina or Brazil in animal feed, GMO corn in polenta in Italy, and GMO rice in rice pasta from China21.Currently, customs and other food compliance control services have the ability to conduct inspections at points of import or in the European market because, as we wrote previously, they have approved and validated methods for detecting transgenic GMOs. European legislation requires any company applying for commercial authorization for a GMO in Europe to provide the analytical method for detecting and identifying it. In the proposal currently under discussion to deregulate GMOs produced using new genetic modification techniques (NGTs), this method would no longer be required for a very large number of them. By the summer, if the European Parliament votes for this text, already adopted by the Council of the EU on April 21, 2026, consumers will no longer be able to know what they consume nor will processors know what they work with22. Christophe NOISETTE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [25] => Array ( [objectID] => 26246 [title] => Cornerstone of French and European law, the precautionary principle under attack by the FNSEA [timestamp] => 1780617600 [date] => 05/06/2026 [annee] => 2026 [url] => https://infogm.org/en/cornerstone-of-french-and-european-law-the-precautionary-principle-under-attack-by-the-fnsea/ [image] => https://infogm.org/wp-content/uploads/2026/05/16063130992_341934c8d3_c-768x511.jpg [extrait] => The FNSEA (French National Federation of Farmers' Unions) recently called for the "precautionary principle" to be replaced by an "innovation principle". Behind this political and semantic offensive lies a challenge to the risk management framework enshrined in the French constitution. Whilst the European Commission says it intends to propose an “innovation regulation” before the end of the year, this demand from the FNSEA echoes the ongoing process of deregulating GMOs derived from new genetic modification techniques (NGTs). By seeking to abolish their assessment, traceability and mandatory labelling, Europe too is disregarding the precautionary principle, which it nevertheless enshrined in the Maastricht Treaty. [chapo] => The FNSEA (French National Federation of Farmers’ Unions) recently called for the “precautionary principle” to be replaced by an “innovation principle“. Behind this political and semantic offensive lies a challenge to the risk management framework enshrined in the French constitution. Whilst the European Commission says it intends to propose an “innovation regulation” before the end of the year, this demand from the FNSEA echoes the ongoing process of deregulating GMOs derived from new genetic modification techniques (NGTs). By seeking to abolish their assessment, traceability and mandatory labelling, Europe too is disregarding the precautionary principle, which it nevertheless enshrined in the Maastricht Treaty. [texte] => “At the FNSEA, we recognise the need to reopen the debate on the precautionary principle, to abolish it and replace it with a principle of innovation”. It was in these terms that Arnaud Rousseau, president of France’s leading farmers’ union, spoke on 2 April at the 80th congress of the FNSEA (National Federation of Farmers’ Unions). The union is thus no longer merely calling for a dismantling of regulations, but for a genuine change in doctrine. With the French presidential election approaching, the union is calling for “constitutional reform”, as the precautionary principle is enshrined in the Charter for the environment, which has been incorporated into the Constitution since 2005i.Rhetoric borrowed from the industrial lobbyIn 2019, the FNSEA and the JA (Young Farmers) were already calling for “better regulation of the precautionary principle”, which they described as a “principle of inaction”ii. Today, by promoting the “principle of innovation” at the expense of the “precautionary principle”, the FNSEA is echoing the rhetoric of certain European industrial lobbies, such as those representing the tobacco, oil and agrochemical industries (including Bayer and BASF)iii. To justify its call for accelerated agricultural innovation, the agrochemical industry repeatedly invokes arguments such as the "response to climate change" and "enhancing competitiveness". It also calls for a reduction in regulatory "constraints", in full alignment with the FNSEA’s demands.The principle of innovation is based on a logic that runs counter to that of the precautionary principle. The latter, enshrined in the French Constitution and the Maastricht Treaty, “aims to enable decision-makers to take protective measures when scientific evidence regarding a risk to the environment or human health is uncertain and the stakes are high”iv. Thus, European Directive 2001/18 on the deliberate release of GMOs into the environmentv is based on the precautionary principle and sets as its objective the “protection of human health and the environment”, notably through prior assessment, traceability and the labelling of GMOs within the European Union.The principle of innovation, promoted for several years by industry and recently highlighted by the European Commissionvi, argues, on the contrary, that regulations must not hinder the development of new technologies, such as NGTs or other biotechnologies. However, unlike the precautionary principle, it does not have the same legal status: it is enshrined neither in the European treaties nor in the French Constitution.Behind the opposition between the precautionary principle and the principle of innovation lies a political and industrial offensive, supported at European level by the Commission, aimed at prioritising technological development at the expense of risk prevention, despite the latter being enshrined in fundamental texts.Supporting GMOs in defiance of riskDirective 2001/18 states in its Recital 17 that it "should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record". However, new genetic modification techniques, such as CRISPR/Cas9, only emerged from 2012 onwards, i.e. well after the adoption of the European legislation in 2001. They therefore have no track record of use that would allow for the establishment of a “long safety record” within the meaning of the directive. Despite this lack of historical data, the European Commission is now proposing to remove GMOs/NGTs from the regulatory framework that has been in place since 2001. Their deregulation would therefore constitute a major contradiction with the very spirit of the directive and the European treaties.By seeking to abolish the precautionary principle, the FNSEA believes that there is no need to take into account the scientific uncertainties surrounding certain technologies. For the French union, the key is to champion innovation, including NGTs. This implies, via the text currently under discussion, that these techniques are exempt from the prior risk assessment, traceability and labelling requirements imposed on other GMOs by Directive 2001/18. The FNSEA is therefore among those who believe that genetically modified plants, derived from techniques too recent to have sufficient hindsight, can be grown in fields and end up on our plates without risk assessment, and without the possibility of identification for consumers, farmers, smallholders or GMO-free supply chains. This development, which advocates of deregulation justify in the name of innovation - a contemporary version of "Progress" - is viewed by its opponents as a disregard for the precautionary principle and a gradual dismantling of Directive 2001/18.A broader trendBehind the FNSEA’s request lies a broader strategy, which has been pursued for several years in Brussels and Strasbourg by the major European agricultural, industrial and seed lobbies. Like Copa-Cogeca, Euroseedsvii or CropLife Europeviii, these players advocate for the relaxation, or even the dismantling, of regulations governing biotechnology in the name of the “principle of innovation” and competitiveness. For several years, these organisations have been criticising a European regulatory framework that they consider too burdensome for their commercial activities, particularly in the fields of GMOs and pesticides… Their objective is clear: to shift European regulation towards an approach focused more on technological innovation and its economic opportunities than on the prevention of health or environmental risks.This Europe-wide offensive directly targets the precautionary principle, which they deem "irrelevant”. Proponents of NGTs argue that these “genome editing” techniques, “close to what occurs naturally”, should be treated as conventional breeding methods. Conversely, their opponents (notably citizens’, environmental and farmers’ organisations) point out that such exemptions do exist, but only for techniques that are “traditionally used” and whose safety has been “proven for a long time”, as justified by the precautionary principle.The European Commission has already decided to open this debate with a public consultation held in 2025 on "the Innovation Principle" with a view to a potential legislative text giving it substance. According to the Commission, “this European Innovation Act should improve the horizontal framework conditions in the EU to accelerate the commercialisation, uptake and diffusion of innovations”ix…By calling for the precautionary principle to be replaced by a principle of innovation, the FNSEA is undermining a constitutional pillar, downplaying the risks associated with GMOs and actively contributing to the drive for the deregulation of these technologies. One of the consequences will be the arrival on our plates of patented genetically modified plants without full assessment, traceability or labelling – and therefore invisible. This idea of substituting a principle that protects living organisms with uncontrolled innovations is, to say the least, deeply worrying. This gradual replacement, which is also reflected in the EU’s priorities, is evidence of intense industrial lobbying aimed at excluding all socio-ethical and environmental considerations from scientific assessment.i French Republic, "Constitutional Law No. 2005-205 of 1 March 2005 on the Charter for the environmenta", JORF, No. 0051, p. 3697, 2 March 2005.ii FNSEA and JA, « Décision du Tribunal Administratif de Lyon – JA+FNSEA appellent à un meilleur encadrement du principe de précaution », 21 January 2019.iii Corporate Europe Observatory, "The ‘innovation principle’ trap – Industries behind risky products push for backdoor to bypass EU safety rules”, 5 December 2018.iv European Parliament, European Parliament Research Service, Didier Bourguignon, “The precautionary principle – Definitions, applications and governance”, December 2015.v European Union, “DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC”, Official Journal of the European Union, No L 106, p. 1, 17 April 2001.vi Denis Meshaka, "Biotech Act : precaution sacrificed in the name of innovation?", Inf’OGM, 25 February 2026.vii Copa-Cogeca and Euroseeds, “Subject: Support for a science-based and innovation-friendly framework for New Genomic Techniques (NGTs) plants”, 10 December 2025.viii CropLife Europe, "CropLife Europe’s Position Paper on the use of New Genomic Techniques in plants", 30 August 2021.ix European Commission, "Public consultation, Research and Innovation", 21 November 2025 Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [26] => Array ( [objectID] => 26045 [title] => Deregulation of GMOs: 93 organisations call to “protect farmers’, breeders’ and citizens’rights” [timestamp] => 1780358400 [date] => 02/06/2026 [annee] => 2026 [url] => https://infogm.org/en/deregulation-of-gmos-93-organisations-call-to-protect-farmers-breeders-and-citizensrights/ [image] => https://infogm.org/wp-content/uploads/2026/06/S5_6690-768x512.jpg [extrait] => Following the European Council’s approval on 21 April of the text aimed at deregulating GMOs produced using new genetic modification techniques (GMOs/NGTs), it is now up to the European Parliament to vote on this text. Ahead of this vote, scheduled for mid-June, 93 European organisations have sent a joint letter to the members of the Parliament’s Environment Committee asking them to “protect farmers’, breeders’ and citizens’ rights”. [chapo] => Following the European Council’s approval on 21 April of the text aimed at deregulating GMOs produced using new genetic modification techniques (GMOs/NGTs), it is now up to the European Parliament to vote on this text. Ahead of this vote, scheduled for mid-June, 93 European organisations have sent a joint letter to the members of the Parliament’s Environment Committee asking them to “protect farmers’, breeders’ and citizens’ rights”. [texte] => On 29 April, 93 civil society organisations, farmers, livestock breeders and businesses from 18 European countries sent a letteri to MEPs sitting on the European Parliament’s Environment Committee. The aim of this letter is to raise awareness ahead of the committee’s vote on the proposal concerning new genomic techniques (NGTs), initially scheduled for 5 May (see box), but ultimately postponed until 17 June. Indeed, following the EU Council’s approval on 21 April of the compromise text resulting from the ‘trilogue’ negotiations, it is now up to the Parliament to give its opinion on this new versionii. The signatories of the letter condemn the proposed deregulation, focusing on two key points: patents, and the traceability and labelling of these GMOs, calling on MEPs to be particularly vigilant on these issues.“Safeguard traceability and labelling”As consumer organisations had already highlighted in October 2025iii, the authors of the letter point out that “freedom of choice is a fundamental principle enshrined in the Charter of Fundamental Rights of the European Union”. In this regard, farmers, breeders and food producers must be able to produce and/or use seeds and feed guaranteed to be GMO-free, whilst citizens must be able to know what they are eating.The organisations are therefore once again calling for the introduction of “full supply chain traceability measures and on-package labelling for all NGT products”, “followed by effective coexistence measures and the supply of detection methods”, as set out in the European Parliament’s initial proposal in February 2024iv. To lend weight to their demands, the authors also point out that such measures have already been requested on several occasions by agri-food companies, in September 2024v and May 2026vi.“Ensure protection from patents”As Inf'OGM reported on numerous occasionsvii, patents represent a major sticking point in the current version of the compromise text. The signatories note, as other stakeholders have done previouslyviii, that the patent system would “place a heavy burden on farmers and breeders by exposing them to infringement cases”. This would have the effect of hampering “the development of new varieties by hindering access to genetic resources, thus accelerating further biodiversity loss”. And, ultimately, they highlight the inconsistencies between this text and the EU’s stated ambitions, as patents would result in increasing “our dependency from the major US and Chinese patent holder companies at a time where the European food and agriculture sector is aiming for more autonomy”. This analysis was reinforced in late March 2026 by a note from the French Embassy in the United States addressed to the French government, but ignored by the latterix.On the subject of patents, the organisations are calling on MEPs to reinstate the restrictive provisions they had voted for at first reading in February 2024, “so that patent protection would not extend to genetic material that could also be obtained by conventional breeding”. According to them, this is the only effective way to ensure “the protection of European farmers and breeders”, with a recent study published by the European Commission itself showing that “patents have an important negative impact on small and medium-sized plant breeders”x.Will their message be heard by MEPs? We will find out on 17 June at the earliest.Is the European Commission failing to stand by its policy choices?The formal vote by the European Parliament’s ENVI Committee did not ultimately take place during the meeting on 4 and 5 May. Members of this committee were nevertheless able to hold an "exchange of views" with Oliver Várhelyi, European Commissioner for Animal Health and Welfarexi. During this exchange, the Commissioner stated that “additional traceability rules” had been added to the text on the deregulation of GMOs/NGTs negotiated in the trilogue, before contradicting himself by stating: “we have not changed any of the regulation to the traceability of GMOs and GMMs in food and feed”. Christophe Clergeau, one of the three authors of the 37 amendments tabledxii, was quick to point out these falsehoods, as no traceability is envisaged for GMOs obtained through Category 1 NGTs. He also questioned the fact that the European Commission is not taking responsibility for its policy choices, leading to “less transparency, less oversight, and fewer citizens’ rights to information”xiii.The European Parliament challenged by supporters of GMO/NGT deregulationOn 4 May, some thirty trade organisations describing themselves as "agri-food value chain partners" (including Copa-Cogeca, Euroseeds, EuropaBio and CropLife) also sent a letter to MEPs urging them "to support the adoption of the trilogue compromise text"xiv. Unsurprisingly, they reiterate the talking points they have used throughout their pro-deregulation lobbying in recent years: “to strengthen the competitiveness and resilience of the European agricultural and food supply systems” with a view to “of sustainability and climate change” and alignment “with the legislative developments and ongoing practice of the ever-increasing number of third countries [...] to assure the continued flow of agri-food products from and to the European Union”.The signatories believe that, in their view and as supported by the European Commission and the Council of the EU, “Category 1 NGT plants feature modifications that are indistinguishable from those bred with conventional method” and would therefore be subject to the same regulatory provisions as the latter regarding marketing authorisations. They also welcome the supposed traceability provided by seed labelling.On the issue of patents, the organisations use convoluted wording regarding an agreement "on provisions that balance the need for appropriate protection of intellectual property rights while safeguarding broadest possible access to such innovations for all, at fair, reasonable and non-discriminatory conditions”.Finally, satisfied with the agreement reached in the trilogue, the “European agri-food chain organisations [...] reject any amendments to this carefully-balanced compromise as this would halt the practical implementation and prevent Europe from finally catching-up and aligning with the rest of the world in his important area”.This final justification is consistent with the way in which the European Commission is urgently undertaking a number of legislative projects, without allowing time for analysis and reflection, let alone consultation.i Joint letter, « New Genomic Techniques – Upcoming ENVI Vote – Protect farmers’, breeders’ and citizens’ rights », 29 April 2026.ii Eric Meunier, « EU Council approves deregulation of GMOs/NTGs », Inf’OGM, 21 April 2026.iii Antoine Vépierre, « Consumer associations call for continued labelling and traceability of GMOs », Inf’OGM, 14 November 2025.iv Eric Meunier, « Les États membres bloquent la déréglementation des OGM », Inf’OGM, 8 February 2024.v Verband Lebensmittel ohne Gentechnik e.V. (VLOG), « Regulation of New Genetic Engineering: Food Industry for Freedom of Choice », 3 septembre 2024.vi Joint letter, « New Genomic Techniques – Upcoming ENVI Vote – Defend the European retail and foodindustry sector », 4 May 2026.vii Corporate Europe Observatory et GMWatch, « Biotech lobby groups are set to trap farmers and breeders in patent minefield », 12 April 2026.Denis Meshaka, « GMO/NGT Regulation: civil society organisations concerned about the outcome of the trilogue », Inf’OGM, 5 November 2025.Eric Meunier, « Patents and GMOs: different stakeholders, different solutions », Inf’OGM, 26 February 2025.Denis Meshaka, « GMO patents: is it possible to break the deadlock? », Inf’OGM, 10 February 2025.viii Joint statment, « JOINT STATEMENT ON THE DEREGULATION OF NEW GMOS – Protect the business of small and medium size breeders, farmers, and the organic and non GMO sectors in the EU », 11 February 2025.ix Eric Meunier, « GMO/NGT: A memo from the French Embassy in the United States ignored by the government », Inf’OGM, 1st June 2026.x European Commission, « Protection of biotechnological inventions ».xi European Commission, ENVI Committee, « Ordinary meeting 20260504-1500-COMMITTEE-ENVI », 4 May 2026.xii European Commission, ENVI Committee, « 2023/0226(COD) – AMENDMENTS 1 – 37 – Draft recommendation for second reading », 22 May 2026.xiii Christophe Clergeau, « Pourquoi le Commissaire Oliver Várhelyi n’assume-t-il pas ses choix politiques ? », May 2026.xiv Joint letter, « Re: EU Regulation for Plants derived from New Genomic Techniques », 4 May 2026. Antoine VEPIERRE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [27] => Array ( [objectID] => 26997 [title] => SLAPP: a transposition lacking ambition and parliamentary debate [timestamp] => 1780272000 [date] => 01/06/2026 [annee] => 2026 [url] => https://infogm.org/en/slapp-a-transposition-lacking-ambition-and-parliamentary-debate/ [image] => https://infogm.org/wp-content/uploads/2026/05/Screenshot-2026-05-28-at-18-03-30-Instagram.png [extrait] => ollowing the transposition into French law, at the end of April 2026, of the 2024 European Directive aimed at combating SLAPP (“strategic litigation against public participation”), Inf’OGM publishes here the press release dated 6 May 2026 issued by eleven organisations campaigning on this issue. Deploring “the lack of ambition in this text, drafted without consultation with civil society or parliamentary debate”, these eleven organisations had already published the opinion piece “SLAPP: just 35 days left to act” in the newspaper Le Monde on 31 March 2026, an opinion piece to which Inf’OGM and the Syndicat de la Presse pas pareille were signatories. [chapo] => ollowing the transposition into French law, at the end of April 2026, of the 2024 European Directive aimed at combating SLAPP (“strategic litigation against public participation”), Inf’OGM publishes here the press release dated 6 May 2026 issued by eleven organisations campaigning on this issue. Deploring “the lack of ambition in this text, drafted without consultation with civil society or parliamentary debate”, these eleven organisations had already published the opinion piece “SLAPP: just 35 days left to act” in the newspaper Le Monde on 31 March 2026, an opinion piece to which Inf’OGM and the Syndicat de la Presse pas pareille were signatories. [texte] => The French government had until 7 May to transpose a 2024 European directive aimed at combating gagging lawsuits. This has now been done with the decree of 30 April 2026, published on 5 May. The signatory organisations deplore the lack of ambition in this text, drafted without consultation with civil society or parliamentary debate, despite the major stakes involved in protecting freedom of expression.SLAPP are legal proceedings brought by companies, institutions or public figures against critical voices (generally the media, journalists, whistleblowers, NGOs, etc.) with the aim not of securing a legal victory but of achieving censorship. This constitutes a misuse of the judicial system that undermines public debate and thus poses a serious threat to democracy.To combat this phenomenon, on 11 April 2024 the European Union adopted a directive providing for several procedural tools. Like the other Member States, France was required to transpose it by 7 May 2026.Civil society had repeatedly urged the government and parliamentarians to approach the forthcoming transposition with ambition. The most recent example: last March, Le Monde published an open letter to this effect, signed by 138 organisations, media outlets and journalists’ associations.A missed opportunityDecree No. 2026-337 of 30 April 2026, published on 5 May, implements this transposition, but falls short of the challenges at stake.The directive establishes minimum protections, whilst allowing Member States to go further to protect freedom of expression. Rather than seizing this opportunity, France has opted for a minimalist transposition. Thus, the decree published on 5 May concerns only civil proceedings. Criminal defamation proceedings are not covered by the new protections, even though this is a classic means of silencing dissent. In other words, a very large proportion of gagging lawsuits remain beyond the scope of the new tools provided for in the text. Nor does this decree contain any strengthening of penalties, which is the only measure likely to deter those who bring such lawsuits.Yet other options were available. Our organisations went so far as to set out in concrete terms how this transposition could have been carried out to provide better protection against SLAPP.A lack of democratic debateFinally, this reform should have been implemented through a bill. A decree drafted behind closed doors by the Ministry of Justice does not address the issues raised by SLAPP. Freedom of expression, access to the courts and equality of arms before the law are all aspects that would have warranted a parliamentary debate. In this regard, our proposals remain available to parliamentarians who wish to make up for this missed opportunity to combat SLAPP effectively.At stake is the preservation of public debate, and thus the very foundations of our democracy. Sherpa, la Maison des Lanceurs d’Alerte, Greenpeace France, Anticor, Transparency International France, le Syndicat National des Journalistes (SNJ), le SNJ-CGT, la CFDT-Journalistes, Reporters Sans Frontières, le Fonds pour une Presse Libre, Un Bout des Médias. antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [28] => Array ( [objectID] => 25951 [title] => GMO/NGT: A memo from the French Embassy in the United States ignored by the government [timestamp] => 1780272000 [date] => 01/06/2026 [annee] => 2026 [url] => https://infogm.org/en/gmo-ngt-a-memo-from-the-french-embassy-in-the-united-states-ignored-by-the-government/ [image] => https://infogm.org/wp-content/uploads/2026/05/embassy_snow-768x432.jpg [extrait] => In late April 2026, the French government supported the deregulation of GMOs produced using new techniques of genetic modification (GMO/NGT). A month earlier, however, the French Embassy in the United States had sent the government a memo detailing the situation in that country. Despite more than 140 marketing authorisations, only a few GMO/NGT are actually on the market there… but with significant patent-related issues. The situation described bears no resemblance to the promises made by multinational corporations or the European Commission. [chapo] => In late April 2026, the French government supported the deregulation of GMOs produced using new techniques of genetic modification (GMO/NGT). A month earlier, however, the French Embassy in the United States had sent the government a memo detailing the situation in that country. Despite more than 140 marketing authorisations, only a few GMO/NGT are actually on the market there… but with significant patent-related issues. The situation described bears no resemblance to the promises made by multinational corporations or the European Commission. [texte] => On April 21, 2026, the Council of the European Union adopted a position in favour of deregulating the release and marketing of numerous GMO/NGT. This vote took place while numerous stakeholders were warning various governments about the risks of the appropriation of life associated with patents covering these techniques and/or the (plant) products obtained through themi. Agricultural unions, environmental protection groups, consumer associations (both Frenchii and foreigniii), citizen collectives that have long opposed GMOs, small and medium-sized seed producers, retailersiv, processors, restaurant owners… many have voiced their opposition to a European Union lacking regulatory oversight of these GMOs. By endorsing the compromise text negotiated in early December 2025 with the European Parliament and the European Commission, the French government chose to place its trust in measures - or promises of measures - that would reduce the risks of a few multinationals appropriating living organisms, while remaining fully aware that these measures are highly fragilev.This position of the French government becomes even more surprising in light of an internal memo it received from its embassy in the United States in late March 2026. This memo, intended for the French administration but which Inf’OGM was able to read, depicts a national situation very similar to what opponents of deregulation are predicting in Europe.20 years for “fewer than ten varieties”In the United States, NGTs “were incorporated into plant breeding programs in the 2010s”vi. That was nearly twenty years ago. This is a long enough period to expect that GMO plant products developed using these NGTs would be widely available on the market. Especially since the country has long had an approval system that the note describes as “fairly facilitative”. This system has led the U.S. administration to issue a favourable opinion for “nearly 140 varieties currently in development”. As noted, the United States applies a system similar to that proposed by the European Commission in the context of GMO/NGT deregulation. The U.S. system implies that “most NGT plant varieties, provided they do not incorporate exogenous genetic material (particularly from pests), are exempt from the cumbersome authorisation procedures required for GMOs ahead of marketing”.Despite these 140 approvals resulting from this very light regulatory framework, the French Embassy notes that “fewer than ten NGT varieties should beon the market in the United States”. A surprisingly low figure given the promises made by multinationals, which the embassy highlights: their ability, with these new genetic modification techniques, “to meet productivity requirements (hardier and healthier crops), adapt to climate change (drought resilience), but also ensure environmental sustainability (reduction in chemical inputs)”, in theory more quickly than with traditional breeding methods.“the patent and licensing ecosystem […] concentrated in the hands of a few major players”In addition to the fact that “scientists currently lack clarity on the true benefits of NGTs in terms of plant health (resistance to pests) or environmental resilience”, the note clearly identifies the key factor preventing the commercialisation of varieties modified by new techniques in a country that facilitates their market entry: patents.As the note points out, “patents are thus at the heart of these technological innovations, coupled with licensing agreements - whether exclusive or not - that ensure incentives for innovation through market regulation”. Thus, over the past twenty years, while fewer than ten varieties have been brought to market, the number of patents has skyrocketed: “by December 2024, more than 1,000 patents and patent applications had been granted or were pending approval [by the U.S. Patent and Trademark Office] for the use of CRISPR technology in agriculture. Sixty-nine had been granted in the field of field crops”.While, in the case of the CRISPR/Cas9 tool, the foundational patents are held not by multinationals but by research institutes (“the Broad Institute [...] on one side and UC Berkeley and the University of Vienna”), multinationals have got into the game by signing licensing agreements with them, and then in turn developing processes “to create new plant varieties, processes that will in turn be patented and commercialised through licensing”. Corteva has thus acquired several exclusive and non-exclusive licenses from various rights holders regarding the use of CRISPR/Cas9 for plant products, giving it a dominant position in controlling this technology and thereby requiring its competitors who wish to use this process to pay royalties.According to the embassy’s memo to the French government, “ultimately, the ecosystem of patents and licenses protecting i) the CRISPR-Cas9 technology, ii) the processes for creating new plant varieties incorporating CRISPR-Cas9, and iii) the characteristics of plant varieties resulting from these processes is, in fact, concentrated in the hands of a few major players”. This concentration is being criticised by several stakeholders in Europe at the attention of national and European lawmakers. However, according to the embassy, “in fact, abuse of a dominant position could be invoked”.What would the situation be in Europe if deregulation was adopted?The memo from the French Embassy explains that in the United States, the “platform” model - which aims to consolidate patents to serve as a one-stop shop for negotiations between holders of rights and licensees under “fair, reasonable, and non-discriminatory” terms - could be a solution. However, it notes that, despite the existence of such a platform for CRISPR/Cas9, “some American breeders prefer to turn to other CRISPR techniques, using alternative enzymes such as Cas12a, Cas13a, or Cas14a” to avoid a near-monopoly situation resulting from the use of patent rights.In short, “the absence of strict regulatory constraints governing the commercialisation of NGT plant varieties might suggest a form of ‘democratisation’ of gene-editing technology in the United States”. However, in reality, this is not the case, since the patent system “strongly protects both the research institutes that discovered the CRISPR technique and the multinationals that have filed numerous patents protecting their plant breeding processes”. Consequently, innovation in the field of plant variety creation by companies “ultimately remains the preserve of large firms. SMEs wishing to develop innovative varieties are thus forced to enter into licensing agreements with these multinationals, at high costs”.In conclusion, the embassy wrote to the French government in late March 2026 - one month before the European Council vote - that “as the intellectual property system is designed in the EU Regulation on NGTs, based on patents, nothing would seem to prevent the U.S. model from being replicated in the EU”. It adds, however, that it is “to be hoped that the ‘regulatory’ mechanisms provided for in the regulation (information platform, internal market surveillance, etc.) will fully fulfil their role and enable European SMEs to gain genuine access to innovation”. These mechanisms depend entirely on the goodwill of the patent holders, as the measures referred to by the French Embassy are not mandatory under the text adopted by the Council of the EU in April and which MEPs are expected to consider in June 2026.Upon reading the memo, one might therefore wonder why the French government chose not to take it into account on April 21, 2026, when it approved the proposal for a new regulation on GMO/NGT.i Antoine Vépierre, « A wide range of stakeholders opposed to the deregulation of GMOs/NGTs », Inf'OGM, 20 April 2026.ii Collective opt-out, « « Il faut des étiquettes sur les organismes génétiquement modifiés et les nouvelles techniques génomiques pour les consommateurs, mais aussi pour le commerce international » », Le Monde, 6 March 2025.iii Suzy Sumner, « Modified food, modified rights? Why genetically modify organisms labelling must stay », The Brussels Times, 14 October 2025.iv Collective opt-out, « « Avec cette nouvelle loi, les Français auront d’immenses difficultés à accéder à une alimentation sans OGM » », Le Monde, 6 December 2023.v Denis Meshaka, « The French Ministry of Agriculture concedes a compromise on patents in the GMO/NGT regulations », Inf'OGM, 23 April 2026.vi All the translations are from Inf’OGM. Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [29] => Array ( [objectID] => 25502 [title] => Europe set to approve a new mRNA vaccine for human use [timestamp] => 1779840000 [date] => 27/05/2026 [annee] => 2026 [url] => https://infogm.org/en/europe-set-to-approve-a-new-mrna-vaccine-for-human-use/ [image] => https://infogm.org/wp-content/uploads/2026/05/Twist_and.shout_785066466-768x576.jpg [extrait] => In late February, the European Medicines Agency (EMA) recommended granting marketing authorisation for a vaccine marketed under the name mCombriax. This is an mRNA "vaccine" against COVID-19 and seasonal flu, developed by Moderna, intended for people aged 50 and over. This opinion will be forwarded to the European Commission, which could adopt the marketing authorisation decision. Given that mRNA technology is still in its infancy and has not yet really proven itself in the medical field, this favourable opinion is somewhat surprising. [chapo] => In late February, the European Medicines Agency (EMA) recommended granting marketing authorisation for a vaccine marketed under the name mCombriax. This is an mRNA “vaccine” against COVID-19 and seasonal flu, developed by Moderna, intended for people aged 50 and over. This opinion will be forwarded to the European Commission, which could adopt the marketing authorisation decision. Given that mRNA technology is still in its infancy and has not yet really proven itself in the medical field, this favourable opinion is somewhat surprising. [texte] => The EMA’s recommendationi is indeed somewhat surprising, given that in the United States, following Moderna’s application for marketing authorisation for this vaccine, the Food and Drug Administration (FDA) had requested additional dataii.Moderna published the results of its initial trials for this vaccine in 2022. Then, in 2025, it stated that “mRNA-1083 had an acceptable tolerability and safety profile” and that “mRNA-1083 was demonstrated to be at least as immunogenic as recommended standard care vaccines against both seasonal influenza and COVID-19”iii.What is the situation regarding this vaccine and the clinical trial results that led the EMA to make this recommendation? Why is there such a marked disparity on either side of the Atlantic?mCombriax, a combination of two other Moderna vaccinesThe vaccine that Moderna tested in its clinical trials is described as "combined". It contains five different mRNA molecules grouped under the name "mRNA-1083"iv.To combat Covid, this vaccine contains mRNA derived from Moderna’s next-generation vaccine, a vaccine called mNEXSPIKE (against the latest known variant of the SARS-CoV-2 virus: Omicron XBB.1.5). mNEXSPIKE has been approved by the FDA and has recently been authorised, notably in Europev.To combat seasonal influenza, this vaccine contains, according to Moderna’s protocol, four messenger RNAs from a vaccine targeting seasonal influenza strains: AH1N1, AH3N2, B/Victoria and B/Yamagatavi. Prior to this combined vaccine, Moderna had already proposed an mRNA vaccine candidate against influenza under the name "mRNA-1010"vii. This vaccine was rejected in the United States in February 2026viii, as the study protocol was deemed insufficient, notably due to a lack of adequate comparison with a high-dose vaccine in people aged 65 and overix.The vaccine tested in clinical trials therefore contains a total of five different messenger RNAs derived from artificial genetic constructs. In mRNA vaccine technology, the mRNAs are predominantly encapsulated in artificial lipid nanoparticles, which is the case herex.In this combined vaccine, the mRNA designed to combat Covid is intended to trigger the production of the (modified) viral spike protein in cells, whilst the four mRNAs designed to combat seasonal influenza are intended to trigger the production of the corresponding four modified viral membrane proteins (haemagglutinins). Five modified antigenic proteins will thus be produced simultaneouslyxi.It should be noted that the version of mCombriax intended for marketing will contain only four mRNAs. The one targeting the B/Yagamata viral strain has been removed, as this strain is no longer recommended for use in vaccines by the WHOxii, the virus is no longer circulating, and the tested vaccine did not elicit a good immune response against this strain.In Europe, the EMA states that the composition of mCombriax should be updated regularly. This will involve changing the mRNAs corresponding to the viral strains circulating in the community and recommended by the WHO. A new authorisation will not be required.The EMA emphasises that the advantage of this combination is "single shot" vaccination and, according to Caducee’s website, "for healthcare professionals, the operational benefit is immediate: limiting the number of injections, reducing missed opportunities, and facilitating administration, particularly among patients who accept the flu vaccine but are still hesitant about the COVID-19 booster — or vice versa"xiii.Does this EMA proposal conceal a form of compulsory vaccination against Covid-19? Should we expect the flu-only vaccine to disappear? There is a precedent for this with certain vaccines that have been imposed on children.Unconvincing efficacy dataAccording to the EMA’s summary, which is based on the Phase 3 clinical trial of Moderna’s mRNA vaccine, the immune responses induced by mCombriax are considered "statistically non-inferior" to those obtained with the separately administered vaccines used as comparators. These comparators are Moderna’s COVID-19 vaccine (Spikevax) and traditional (inactivated virus) quadrivalent influenza vaccines from GSK (Fluarix) and Sanofi Pasteur (Fluzone).It should be noted that for Fluarix, the B/Victoria and B/Yamagata strains targeted are not those targeted by mRNA-1083. Moderna conducted its studies on approximately 8,000 people, with two cohorts: one aged 50 to 64 (the comparator was standard-dose Fluarix for influenza) and the other aged 65 and over (the comparator was high-dose Fluzone for influenza)xiv.However, relying solely on partial and purely biological immune responses (the presence and levels of antibodies in the blood) is scientifically insufficient, as other criteria come into play. As the Caduceexv website explains: "this choice of a non-inferiority criterion, which is standard in vaccinology when the aim is to integrate a new formulation into an existing standard, nevertheless calls for a cautious interpretation in medical communications: non-inferiority in terms of antibody titres does not automatically, on its own, translate into a measurable clinical benefit in terms of hospitalisations or mortality in the pivotal trial as publicly summarised. Tolerability data are reported as acceptable in EMA communications and the business press, but the level of detail (subgroups, rare events, the very elderly and those with comorbidities) will depend on the consolidated regulatory documentation".It is, however, on the basis of this fragile immunological standard that the EU risks authorising mCombriax. All the more so as no long-term efficacy studies have been conducted, which no longer seems to be a concern.Incomplete results regarding the vaccine’s safetySafety assessments of the mRNA-1083 vaccine included the monitoring of local and systemic adverse reactions for 7 days following vaccination, and of adverse reactions of varying severity for up to 28 days, and subsequently for up to 180 days following vaccination.In the EMA’s conclusions, only local side effects common to all vaccines are reported. In its press release of February 2026, Moderna states that “mRNA-1083 demonstrated an acceptable safety and tolerability profile”xvi.However, a closer examination of the phase 3 clinical trialxvii shows that, regardless of the vaccine - including the combined vaccine - people aged 65 and over experience more adverse effects of varying severity than those in the 50-64 age group. It also shows more serious adverse events among those vaccinated with the combined vaccine (71 out of 2,011) than among those vaccinated with two separate vaccines (52 out of 2,006) in the oldest age group.It should be noted that four deaths, which were not attributed to vaccination, occurred during the mRNA-1083 trial.As the uncertainties surrounding the messenger RNAs used in vaccines and their potential risks have already been documented by Inf’OGM, they will not be addressed herexviii. There are numerous risks, particularly those relating to the spike protein. The risks of contamination of these vaccines by residual DNA from their manufacture are also a cause for concern. These issues regarding genetic residues not properly removed during the purification phase have been raised for some time. With this type of multi-mRNA vaccine, which therefore requires multiple DNA templates, this problem should be analysed more seriously.The mRNA vaccine market and politicsAccording to Reuters, Moderna is under financial pressure to bring this vaccine to market, with the agency noting that the differing treatment of its mCombriax vaccine between Europe and the United States can be explained as follows: “Moderna is banking on the COVID-flu combination shot and also an mRNA-based flu shot to help it return to revenue growth as demand for COVID vaccines has collapsed in the years after the pandemic”xix.Reuters reports that the FDA, which had rejected Moderna’s mRNA flu vaccine in early February 2026, reversed its decision a week later after the company amended its application. The FDA is now due to announce its decision by 5 August. Reuters adds that this episode has fuelled “drugmaker and investor concerns over policy changes at the agency [the FDA]”xx.It is worth recalling that the US Department of Health and Human Services has cut funding for messenger RNA research. Members of the FDA have also resigned from their posts, a move that has not gone down well with the vaccine industry.In the United States, there is an “Advisory Committee on Immunization Practices” (ACIP) made up of independent experts. US states and insurance companies rely on its recommendations to reimburse vaccines. In 2025, the ACIP withdrew its recommendation for the mRNA vaccine against Covid, but in March 2026, a federal judge ruled that the ACIP was incompetent, following a complaint from professional associations, the majority of which are funded by the pharmaceutical industry. Consequently, the judge’s decision suspends the change to the vaccination schedule decided by the Department of Healthxxi, and mCombriax could be authorised in the United States next August.Are financial gains so important that health considerations are being sidelined? In any case, they are the primary concern of those who produce and market mRNA vaccines, whilst in-depth assessments of the risks and actual efficacy of such products are rarely, if ever, carried out properly. The fact that health agencies, such as the European Medicines Agency (EMA) in the case of mCombriax, do not require these assessments – or no longer do so – is extremely worrying.i EMA, « First combined COVID-19 and influenza vaccine for people 50 years and older », 27 February 2026.Moderna, « European Medicines Agency’s Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna’s mRNA Combination Vaccine Against Influenza and COVID-19 », 27 February 2026.ii Chris Dall, CIDRAP (University of Minnesota), « European regulators recommend approval of combined mRNA vaccine for flu and COVID », 27 February 2026.iii Amanda K. Rudman Spergel, Iris Wu, Weiping Deng et al., « Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years – A Randomized Clinical Trial », JAMA, 7 May 2025, Vol. 333, No. 22.iv Ibid.v Vidal, « Le nouveau vaccin à ARNm de Moderna, mNEXSPIKE, est Mayntenant autorisé en Europe », 24 February 2026.vi Amanda K. Rudman Spergel, Iris Wu, Weiping Deng et al., « Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years – A Randomized Clinical Trial », JAMA, 7 May 2025, Vol. 333, No. 22.vii Moderna, « Moderna Announces Interim Phase 3 Safety and Immunogenicity Results for mRNA-1010, a Seasonal Influenza Vaccine Candidate », 16 February 2023.viii « Fin de non-recevoir de la FDA à un projet de vaccin antigrippal à base d’ARN messager », AFP, 11 February 2026.ix « mCombriax : l’EMA recommande le premier vaccin combiné COVID-grippe dès 50 ans », Caducee.net, 1 March 2023.x Amanda K. Rudman Spergel, Iris Wu, Weiping Deng et al., « Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years – A Randomized Clinical Trial », JAMA, 7 May 2025, Vol. 333, No. 22.xi Pfizer also conducted trials of mRNA vaccine against seasonnal flu.Annick Bossu et Mireille Lambertin-Martinez, « Will the mRNA flu vaccine come into being? », Inf'OGM, 20 February 2026. xii Moderna, « European Medicines Agency’s Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna’s mRNA Combination Vaccine Against Influenza and COVID-19 », 27 February 2026.xiii « mCombriax : l’EMA recommande le premier vaccin combiné COVID-grippe dès 50 ans », Caducee.net, 1 March 2023.xiv Amanda K. Rudman Spergel, Iris Wu, Weiping Deng et al., « Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years – A Randomized Clinical Trial », JAMA, 7 May 2025, Vol. 333, No. 22.xv « mCombriax : l’EMA recommande le premier vaccin combiné COVID-grippe dès 50 ans », Caducee.net, 1 March 2023.xvi EMA, « First combined COVID-19 and influenza vaccine for people 50 years and older », 27 February 2026.Moderna, « European Medicines Agency’s Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna’s mRNA Combination Vaccine Against Influenza and COVID-19 », 27 February 2026.xvii ClinicalTrials.gov, « A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age ».xviii Annick Bossu, « Une deuxième vague de vaccins à ARNm arrive sur le marché », Inf’OGM, 5 November 2024.xix Bhanvi Satija, « EU regulator backs approval for Moderna’s combined COVID and flu vaccine », Reuters, 27 February 2026.xx Mariam E Sunny and Michael Erman, « US FDA reverses course, will review Moderna's flu vaccine application », Reuters, 18 February 2026.xxi Testimony of Pr. Charlotte Kuperwasser, molecular biologist in : Hélène Banoun, « Ils reconnaissent l’existence de ces sous-produits. Où sont les données ? », AIMSIB, 29 March 2026 Annick BOSSU antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [30] => Array ( [objectID] => 24889 [title] => German MEPs from the EPP raise concerns over patents [timestamp] => 1779148800 [date] => 19/05/2026 [annee] => 2026 [url] => https://infogm.org/en/german-meps-from-the-epp-raise-concerns-over-patents/ [image] => https://infogm.org/wp-content/uploads/2026/05/4529967335_460b789d1f_z.jpg [extrait] => As the European Parliament’s plenary vote on the deregulation of GMOs produced by new genetic modification techniques (GMOs/NGTs) approaches, the issue of patents remains a key point of contention. Against this backdrop, the German delegation of the European People’s Party (EPP) has called on the European Commission. It is asking the Commission to show willingness to review Directive 98/44 on "biotechnological inventions" to ensure free access to genetic resources and prevent them from being controlled by major seed companies. [chapo] => As the European Parliament’s plenary vote on the deregulation of GMOs produced by new genetic modification techniques (GMOs/NGTs) approaches, the issue of patents remains a key point of contention. Against this backdrop, the German delegation of the European People’s Party (EPP) has called on the European Commission. It is asking the Commission to show willingness to review Directive 98/44 on “biotechnological inventions” to ensure free access to genetic resources and prevent them from being controlled by major seed companies. [texte] => In a letteri addressed to Stéphane Séjourné, Vice-President of the European Commission and responsible for patent matters, members of the main national delegation of the European Parliament’s largest political group, the European People’s Party (EPP), which supports the deregulation of GMOs/NGTs, express serious concerns regarding patents, at odds with their group’s position. Could this influence the conservative party’s vote on the future NTG regulation in Parliament? Only time will tell.A (modest) show of pressure on the eve of the voteIn this official request, 11 German MEPs (from the CDU and CSUii) out of the 31 in the EPP are asking the European Commission to “provide a clear political signal ahead of the plenary vote that it is prepared to review and, where necessary, adapt Directive 98/44/ECiii in a timely manner in order to ensure that genetic traits which can also occur naturally or be obtained through conventional breeding are not subject to patent protection”.In this letter, these German conservative MEPs highlight, echoing the numerous positions taken on the subject, the consequences of patents on products derived from NGTs – GMOs/NGTs – on the “functioning of the European plant breeding sector”. In fact, small and medium-sized seed companies, as well as farmers and smallholders, are most severely affected. For these MEPs, the Commission must therefore, ahead of the plenary vote in Parliament next May, provide reassurances on these issues. Failing that, the MEPs would appear to be sending the message that a rejection of the compromise text, as adopted on 21 April by the Counciliv and by the European Commission on 25 April, could be justified.Protecting the conventional and small-scale breeding sector…A large part of the European plant breeding sector, particularly in Germany, uses plant breed breeders’ rights systems (PBR) rather than patents, which they consider unsuitable for this type of innovationv. A patent covers genetic modifications to a plant, not varieties. However, its scope extends to all plants and varieties exhibiting the patented genetic trait, even those that contain it naturally or through non-patentable natural selection. It prevents a breeder from selecting and marketing a new variety expressing this trait, unless the patent holder consents (granting of a licence).This is not the case for commercial varieties covered by a plant breeders’ right, which allows a breeder to select a new variety using a variety covered by a PBR. Patents on certain genetic traits also restrict farmers’ freedom to use, on their own farms, seeds from their own harvest, including when these traits are present in varieties not covered by a plant breeders’ right. Conversely, the PBR regime maintains, for some thirty agricultural species, a right to use farm-saved seed, even when such seed contains a patented trait.For the MEPs who authored the letter to Stéphane Séjourné, ensuring that the commercial exploitation of a plant containing a patented trait but obtained exclusively through conventional breeding is not prevented requires limiting the scope of patents to products obtained by a patentable technical process. They believe that an amendment to Directive 98/44 "on biotechnological inventions" proposed by the Parliament in February 2024 would grant this "immunity" to breeders and farmers from potential patents that could cover, in particular, farmers’ seeds and traditional varieties.…to the detriment of German multinationals?Agro-industrial multinationals (such as Bayer, BASF, KWS, Limagrain/Vilmorin…) defend the central role of patents, which they regard as essential to securing a return on their investment in research and development, including to appropriate "native traits" that are nevertheless present in naturevi.At the same time, a significant part of the German plant breeding sector relies primarily, if not exclusively, on the COV, which is considered more compatible with the circulation of genetic "material" and breeding activities. As stated in 2024 by the BDP (Bundesverband Deutscher Pflanzenzüchter), representing German seed producers, “free access to genetic resources is fundamental to the process of plant breeding. Biological material that also occurs or could occur in nature shall not be patentable, irrespective of the way in which it has been developed. Breeders are calling for this principle to become legally binding as soon as possible”. It should be noted that Bayer, BASF and KWS are all members of the BDPvii. This approach is also reflected in the positions of the Deutscher Bauernverband (DBV), Germany’s main agricultural union, representing seed users and breeders. It also warns against the effects of patents on access to genetic resources and on farmers’ ability to use their seedsviii.A likely futile interventionThis letter from German MEPs of the EPP once again highlights the problems caused by patents regarding access to genetic resources and freedom of selection. But at the same time, it advocates the idea of a European framework conducive to innovation, particularly the exploitation of NGTs. It does indeed highlight, albeit in a purely affirmative manner and without providing evidence, their “significant potential to contribute to more resilient agricultural systems, to strengthen innovation in plant breeding and to support farmers in addressing climate related challenges”.Although this request to the Commission comes late in the debate, it nevertheless highlights the diversity of views among MEPs within the political groups. With just a few days to go before the plenary vote in the European Parliament, this information is significant. Indeed, there are fears that MEPs may be forced to vote in line with their group’s position rather than their own convictions, or to be absent on the day of the vote, which would effectively amount to a vote in favour of the NGT regulation, without any amendments. For its part, the Commission might respond by agreeing to "look into the matter", or some other non-binding formula, but this might not be enough to reassure German MEPs from the EPP or other parliamentarians concerned about the issue of patents, nor even to postpone the vote.In 2024, the EPP had supported the European Parliament’s position on the proposed deregulation of GMOs/NGTs. Several MEPs from its German delegation had already expressed reservations about the impact of patents on breeders and access to genetic resources. The number of MEPs speaking out today via this letter is certainly a minority (11 out of the EPP’s 185 elected members), but their letter has the merit of publicly stating their position, whilst we wait to see whether it can influence the rest of the group and other MEPs sufficiently to make the vote in the European Parliament decisive…i Joint letter, "Patent framework for New Genomic Techniques and the need for a clear politicalsignal on Directive 98/44/EC", 8 April 2026.ii The CDU (Christian Democratic Union) is active throughout Germany, except in Bavaria. The CSU (Christian Social Union) is active only in Bavaria. In the European Parliament, CDU and CSU MEPs sit together within the EPP Group. There are 30 of them in total in the current parliamentary term.iii European Union, "DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998 on the legal protection of biotechnological inventions", Official Journal of the European Union, L 213/13, 30 July 1998.iv Germany abstained from this vote.v Following the example of the DBV, Germany’s main agricultural union:Denis Meshaka, "Patents and NGTs: the singular position of Germany’s main agricultural union", Inf’OGM, 6 February 2026.vi KWS, “KWS agricultural trait catalogue for licensing agreements”.vii Denis Meshaka, “The dilemma faced by certain seed companies in relation to intellectual property rights”, Inf’OGM, 6 December 2023.viii Denis Meshaka, "Patents and NGTs: the singular position of Germany’s main agricultural union", Inf’OGM, 6 February 2026. Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [31] => Array ( [objectID] => 24411 [title] => Multinational companies want the DSI and the money from DSI [timestamp] => 1778716800 [date] => 14/05/2026 [annee] => 2026 [url] => https://infogm.org/en/multinational-companies-want-the-dsi-and-the-money-from-dsi/ [image] => https://infogm.org/wp-content/uploads/2026/05/deja-chiffre-en-milliards-de-dollars-le-cout-lie-a-la-perte-de-nature-pourrait-etre-beaucoup-plus-eleve-pour-l-economie-mondiale-768x576.jpg [extrait] => This autumn, governments, businesses, Indigenous communities and other representatives of civil society are to meet in Yerevan (Armenia) to discuss the protection of terrestrial and marine biodiversity. As more and more genetic components of this biodiversity are being digitised, multinational corporations want to seize the opportunity to exploit the benefit-sharing fund for the use of DSI, known as the "Cali Fund". Their demands? To reduce the amount of the contributions and the ability of states to decide on national measures, and to widen the loopholes allowing them to bypass prior consent for the use of living organisms that make up biodiversity. [chapo] => This autumn, governments, businesses, Indigenous communities and other representatives of civil society are to meet in Yerevan (Armenia) to discuss the protection of terrestrial and marine biodiversity. As more and more genetic components of this biodiversity are being digitised, multinational corporations want to seize the opportunity to exploit the benefit-sharing fund for the use of DSI, known as the “Cali Fund“. Their demands? To reduce the amount of the contributions and the ability of states to decide on national measures, and to widen the loopholes allowing them to bypass prior consent for the use of living organisms that make up biodiversity. [texte] => The digitisation of our lifestyles through social media, smartphones, algorithms of “artificial intelligence”, and other brain implants is not the only digitisation underway. As already reported in our pagesi, the living organisms that make up terrestrial and marine biodiversity are facing a massive digitisation of the genetic information they contain. A program like the Earth Biogenome Project, which aims to digitise the genome of all known eukaryotes on Earth, is one example.But make no mistake, this digitisation of life, highly reductionist, is not solely intended to respond to a current trend of viewing and interacting with the world only through computers, connected glasses, or other smartwatches. For multinational seed and biotechnology companies, it is an essential step toward practices that some are already denouncing as biopiracy 2.0. And along this path, in a period of dismantling environmental law by the European Commission and of aggressive debates, illustrated internationally to the point of caricature by Donald Trump, the demands made by these multinationals, even if voiced by employees who "are writing in their personal capacities", are increasingly lacking in humility…A general strategy already decipheredThe genetic sequencing of living organisms feeds into both public and private databases. At the Convention on Biological Diversity (CBD), the term used is not "sequences", but "digital sequence information" (DSI). This term currently has no legal definition, neither in a treaty nor in any other document. This lack of a legal definition implies a certain ambiguity as to what it refers to.For companies with the financial, technical, and human resources, the databases containing these DSI become like gift packages from which they can select specific genetic sequences. Then, under the guise of biotechnological genetic modification processes, companies can claim patents on genetically modified sequences, referred to as "genetic information" when associated with a particular trait (or "function"). These patents grant them rights that, in most countries, they can extend retroactively to any organism containing these sequences and expressing their function, including organisms initially sequenced, provided the link between these sequences and their function is not already widely known. This extension of the scope of patents would indeed be possible if the products sold were no longer legally considered GMOs and therefore disseminated without any publication of detection and identification methods allowing them to be distinguished from any other organism. A case which is currently being debated in Europe with the still-under-discussion proposal to deregulate GMOs obtained through new techniques of genetic modification.For many years, to protect biodiversity from industrial biopiracy, companies wishing to use organisms that comprise this biodiversity have been required to:respect a procedure for obtaining prior, free, and informed consent from the countries and/or indigenous communities that have preserved these organisms;obtain a material transfer agreement that prohibits any intellectual property rights covering these organisms;and share with these countries or indigenous communities the financial benefits derived from these organisms.However, much like a hacker who would defend himself against the accusation of stealing someone's money because he seized the digital financial information from a bank account but not the physical cash from a wallet, these companies argue in various international forums that DSI are not genetic components of the living organisms where they were identified, but rather "products of research". This reasoning is baffling and would have the corollary of no longer being subject to these obligations intended to protect biodiversity from biopiracy. This bluff was so effective that the management of DSI appears to fall outside the scope of any already ratified international text, even though the CBD and the Nagoya Protocol, which govern prior consent and benefit-sharing, should indeed be applied.With corporate rhetoric amplified by governments of the "Global North", negotiations began on these DSI, culminating in 2025, as detailed in a previous articleii, with the establishment of a multilateral fund for sharing the benefits associated with these DSI, called the Cali Fund. Inf'OGM reported how, a year after its creation, the implementation of this fund is encountering resistance from companies to pay their contributions, given that they remain voluntary. An article published in September 2025 and co-signed by, among others, employees from Bayer (multinational seed and pharmaceutical company) and Novonesis (multinational microorganisms company), provides some explanationsiii.Extending the Cali Fund to physical resources?Considering that the Cali Fund is "still nascent and requires several years of technical negotiation for full implementation", these employees posit as a fundamental point that it would be impossible to "track and trace use of individual sequences". This assertion mirrors another, albeit still theoretical, claim concerning the multilateral fund itself, which is not "intended to require tracking and tracing of individual sequence records [since] payment is determined on the use of the global dataset". This fund is indeed intended to be financed by voluntary contributions from any actor in economic sectors likely to use DSI (biotech, seeds, pharmaceuticals, etc.). Explaining that this Cali fund still falls under "soft law", which could become legally binding once countries transpose it into their national law, these employees detail the three challenges they believe would arise in its implementation.One such challenge is the scope covered by the multilateral fund, which they consider too limited. While DSI can be recorded in public or private databases, the multilateral fund only covers public databases. The authors of the article are certainly not suggesting that DSI recorded in private databases should also be included. That approach is more insidious. According to them, research using DSI can mix DSI from public databases, DSI under embargo, or DSI from private databases generated following a material transfer agreement. It would therefore be complicated, according to the authors, to determine the portion to be paid into the Cali fund and the portion to be paid as benefit-sharing, "neither or both". This complexity is even greater when DSI are mixed to create new DSI. A final example given is research and development work combining DSI and physical genetic resources, which could lead to payments into the Cali fund, benefit-sharing under the Nagoya Protocol, and benefit-sharing under the ITPGRFA.The authors therefore propose that the Cali fund be adapted to include voluntary benefit-sharing related to the use of physical genetic resources if these resources are used to generate DSI. A proposal that surely hides the stripping away of the mandatory sharing of benefits linked to these physical genetic resources under the CBD, the Nagoya Protocol or the ITPGRFA, given that most public databases of DSI do not indicate in which physical genetic resources these DSIs have been identified.Reduce the amount of contributions and strengthen "legal certainty"?Currently, contributions to the Cali Fund are calculated quite simply. The companies concerned are encouraged to pay 1% of their profits or 0.1% of their revenue. An amount deemed manifestly too high by the authors of the article. Far from providing a specific figure, they merely denounce what they consider to be a calculation error. According to them, these amounts were adopted in the final hours of the meeting that led to the creation of the Cali Fund, solely to allow a consensus to emerge. Furthermore, studies on the amounts requested are still pending, implying that "parties knew that these rates would likely need further consideration".The main "error" raised in the article is that these two rates were allegedly calculated based on the revenue generated by companies "in sectors that typically use DSI and the overall economic output in their entirety". The authors of the article argue that the benefits specifically linked to the use of DSI stored in public databases were not taken into account, but rather “all [physical] genetic resources and all DSI regardless of whether they were publicly available or in scope of other ABS instruments”. Just as if DSI were not simply a representation of the genetic components of physical biological resources… meaning of living beings!The final challenge raised in the article concerns the “39” countries that have already incorporated the sharing of benefits related to DSI into their national law. While the authors believe this creates uncertainty that could even lead to double contributions (one from the Cali Fund and one from national law), they suggest that the policymakers should “articulate clearly that the DSI Multilateral Mechanismis intended as an alternative for national Access and Benefit sharing systems that extend to public DSI, not as an addition”, thus allowing them to replace potentially binding national law with non-binding international law. Their idea remaining that national law should be reduced, they propose that funding from the Cali fund be paid only to countries that have aligned their national law with the fund.DSI, DSI funds and their controlTo address what the authors of the article published in September 2025 consider to be significant obstacles to the operation of the Cali Fund, several proposals are put forward. Most aim to give multinationals greater freedom to exploit terrestrial and marine biodiversity without paying excessive amounts of money, or even to recover a portion of it. Other proposals seek to encourage voluntary contributions by directing the use of the limited funds allocated according to the needs of contributors seeking access to new resources and related knowledge. One proposal, for example, is that contributions to the Cali Fund be "distributed directly to project-based activities serving the CBD’s and Global Biodiversity Framework’s biodiversity protection objectives", particularly within the framework of the CBD. Bayer explained this position during a webinar in January 2026 as "supporting innovation".While the authors propose that multinationals be integrated into the Cali Fund's standing committee "as full members rather than observers", they do not neglect the legislative and financial aspects, the latter being the subject of the greatest number of proposals. These proposals clearly reflect the multinationals' intentions regarding what appear to be their minimum conditions for agreeing to contribute to the fund.On the legislative front, the proposals aim to compel states to prioritise the Cali Fund over national laws. Bayer and Novonesis would like countries to "recognise the DSI multilateral mechanismas an alternative to bilateral approaches", implying that national law should be set aside. This proposal is accompanied by another, a quite astonishing one, as the authors suggest that countries “commit to not enforce any national DSI claims from public DSI databases if a company has made a payment to the Cali Fund”.On the financial front, a highly opportunistic proposal aims to make contributions to the Cali Fund tax-deductible (requiring this international law to override the exclusive competences of national law). This is a way to reduce the actual contribution paid and participation in societal solidarity. The authors also suggest that other benefit-sharing instruments “could reciprocally recognize payments in other instruments as credited toward a Cali Fund contribution”. This recommendation directly targets the ITPGRFA Benefit-Sharing Fund, which is binding as soon as a patent is claimed on a plant genetic resource, its parts, or genetic components. It supports the obstructionist strategy of industry and developed countries, which aims to block negotiations on DSIs within this Treaty.Taking advantage of the situation, the discussions scheduled for autumn 2026 in Yerevan (Armenia) will clearly be seized as an opportunity for multinationals to turn a tool meant to protect biodiversity from biopiracy into one that facilitates it. These negotiations are therefore expected to be complicated and could, as employees from Bayer and Novonesis have written, take several years. Meanwhile, the sequencing of living organisms continues, and companies can continue to claim patents on DSI without prior consent, agreement, or other benefit-sharing arrangements.i Eric Meunier, « The genome of 1.8 million species is being sequenced », Inf'OGM, 11 December 2024.ii Denis Meshaka, « The Cali Fund: one year on, the promise is fading », Inf'OGM, 12 May 2026.iii Blom C. et al., « From frameworks to finance: how sharing benefits from the use of digital sequence information can evolve to contribute to biodiversity conservation », Nature Biotechnology, Volume 43, octobre 2025, pp.1599–1602. Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [32] => Array ( [objectID] => 24405 [title] => The Cali Fund: one year on, the promise is fading [timestamp] => 1778544000 [date] => 12/05/2026 [annee] => 2026 [url] => https://infogm.org/en/the-cali-fund-one-year-on-the-promise-is-fading/ [image] => https://infogm.org/wp-content/uploads/2026/04/Joe-Shlabotnik-768x515.jpg [extrait] => Adopted at the COP16 on biodiversity in November 2024, the Cali Fund was officially launched on 25 February 2025. Its aim is to collect a share of the revenue generated by the use of digital sequence information (DSI), which is predominantly exploited by industries in the Global North and identified in biological resources that very often originate from the Global South. The fund’s promise is to ensure the sharing of benefits arising from the use of this DSI, which in particular fuels numerous patent applications. But one year after its launch, the fund remains largely ignored by the main users of DSI. [chapo] => Adopted at the COP16 on biodiversity in November 2024, the Cali Fund was officially launched on 25 February 2025. Its aim is to collect a share of the revenue generated by the use of digital sequence information (DSI), which is predominantly exploited by industries in the Global North and identified in biological resources that very often originate from the Global South. The fund’s promise is to ensure the sharing of benefits arising from the use of this DSI, which in particular fuels numerous patent applications. But one year after its launch, the fund remains largely ignored by the main users of DSI. [texte] => Launched over a year ago, the Cali Fundi has still not garnered the support of the main contributors concerned. Companies using digital sequence information ("DSI"), also known as "digital sequencing data" or "genetic information", remain on the sidelines. They cite, among other things, a supposed lack of clarity regarding the rules and incentives for contributingii. To date, only one European company has made a contribution, of a symbolic amount, illustrating the gap between stated ambitions and the reality of the funding raised.What is the principle behind the Cali Fund?The Cali Fund is based on a simple observation. For the past fifteen years or so, vast quantities of DSI have been filling databases, particularly following the fall in the cost of sequencing the genomes of living organismsiii. Thus, biodiversity no longer circulates solely in the form of biological samples, but increasingly in the form of highly reductionist digital representations, namely DSI. A very large number of these DSIs are now freely accessible online in public databases, available free of charge to those with the resources and means to use them. They have become a strategic raw material for the pharmaceutical, cosmetics and agricultural sectors, as well as other users of biotechnology.Given the scale of these databases and their uses, the traditional tools for sharing the benefits arising from the use of genetic resources have been called into question and declared inadequate. Designed for plants under the ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) and for other genetic resources under the Nagoya Protocol, both of which implement the Convention on Biological Diversity (CBD), they are based on a bilateral system involving providers of physical genetic resources and their users. Such a model should, in theory, have been extended to DSIs, but its implementation has been hampered in particular by a lack of political will and foresight. So, how should access to these DSIs be negotiated? It was to answer this question that a multilateral mechanism, backed by the CBD, was devised, the principle of which was adopted by Decision 16/2 of COP16 in Cali (Colombia) in 2024. The "Cali Fund" is its financial instrument. It aims to capture a portion of the added value generated by the use of DSIs, primarily by industry in the Global North (“North”), in order to redistribute it to countries in the Global South (“South”) that are rich in biodiversity - and therefore in as yet unknown and unexploited DSIsiv - as well as to indigenous peoples and local communities.Still ineffective operationWhen the Cali Fund was launched, governance bodies were established and a “multi-stakeholder steering committee” began its work. Several studies initiated by the CBD Secretariat are currently underway to clarify the Fund’s operational procedures. We have repeatedly requested the study on the position of companies using DSI from the CBD Secretariat, which has not provided us with any response. Furthermore, during an online meeting co-organised in February 2026 by the Secretariat, the various invited speakers (DSI experts, development agencies, NGOs and companies) emphasised that, whilst political agreement on the Cali Fund had now been reached, the bulk of the work remained to be done. Some, including Bayer, thus reiterated the need to transform the Cali Fund into a mechanism that is both operational and credible.Behind the institutional implementation of the Cali Fund, some grey areas remain. The first, and most significant, is the very definition of DSIs, on which there is still no official international consensus. Furthermore, contributions to the Cali Fund remain voluntary, the terms of contribution for DSI users have yet to be determined, and the rules for redistributing any funds have yet to be clarified. At present, it is proposed that only entities in sectors likely to use DSIs and meeting at least two of the following three thresholds should be encouraged to contribute:$20 million (M) in total assets,$50 million in turnover,$5 million in profits calculated as an average over the previous three years.They would be required to contribute 0.1% of their turnover or 1% of their profits to the fundv. It should be noted that the public sector also uses DSI and grants the industrial sector patent licences for patent rights derived from this data. COP17, scheduled for October 2026 in Yerevan (Armenia), is expected to ratify these terms or reopen negotiations.To date, only one contribution to the Cali Fund has been recorded, that of the British start-up Tierre Vivavi. Amounting to barely $1,000 (approximately €850), it is more symbolic than a financial lever. This illustrates the stark disconnect between the ambitions set out by the CBD – to mobilise billions of dollars for biodiversity – and the reality of current funding flows. This observation comes as little surprise to critics of the Fund, particularly certain international NGOs, which, having initially welcomed its establishment, now doubt its effectiveness. The NGO Third World Networkvii points out, for example, that the contribution mechanism lacks clarity, particularly regarding how DSI users will actually finance the Cali Fund, as well as the monitoring of financial flows. This NGO also fears that the Fund’s implementation relies on non-harmonised national schemes, which may lead to disparate rules and reduce overall contributionsviii. The IPC (International Planning Committee for Food Sovereignty), on the other hand, calls on governments to reject this “tool of legalised biopiracy”ix.International governance under strainThe question of how multilateral mechanisms and national legislation interact remains unresolved. Some countries are considering introducing their own rules on the sharing of benefits arising from the use of DSI, whilst around twenty others have already adopted them. Furthermore, the Cali Fund, which operates under the CBD, is part of an increasingly complex international landscape, where several agreements now address DSIs, whether in the fields of health (WHO), agriculture (ITPGRFA) or marine biodiversity (BBNJ), not to mention the direct links with national, regional or international intellectual property offices.This proliferation of international legislative frameworks raises questions of consistency and coordination. It also appears to be at odds with the fact that the main users of DSI – industry in the Global North – wish to be entirely free of obligations, or at least to accept only the least restrictive ones. In fact, they want the Fund to be financed by voluntary contributions from states – that is, taxpayers – as is the case under the TRIPS Agreement. They are also pushing to turn the implementation of the Cali Fund to their advantage, as we shall see in a forthcoming article.COP17: a bold break with the past or yet another mirage?The issue of the fair and equitable sharing of benefits arising from the use of DSIs is a recurring theme that has been circulating for the past decade in various meetings, working groups, committees and conferences… without ever having been the subject of a resolution acceptable to all parties. It is worth recalling that this dispute stems from the observation that access to DSIs circumvents the obligations arising from access to physical genetic resources. More recently, certain states and industrial actors have contested that DSIs are genetic resources in the strict sense and therefore claim that the existing framework should not apply to themx. The question that arises is therefore: are DSIs genetic components of physical genetic resources or research products? In this context, COP17 and, above all, COP18 appear to be important meetings, but they could once again prove to be nothing more than mirages.At COP17 next October, the Parties must discuss several points, including the mandatory nature of contributions, the clarification of financial arrangements and the procedures for redistributing funds. Attaching binding conditions to these decisions will require courage and firmness on the part of negotiators from the South, who are often at a disadvantage compared to their counterparts from the North. The very credibility of the mechanism underpinning the Cali Fund is at stake. Just like the ITPGRFA Fund, which is still unable to recover the expected funds after 20 years of operation, its effectiveness cannot be judged solely on the basis of its principles, but also on its potential concrete results. The Cali Fund must demonstrate its ability to guarantee contributions, ensure their equitable distribution, and effectively support biodiversity conservation in DSI-supplying countries, particularly those in the Global South.The European Commission organised, from 10 to 12 March 2026, an "Informal Global Dialogue on DSI at the Cali Fund"xi. Representatives of governments, biotechnology companies, researchers and international experts gathered to explore concrete ways to strengthen the fund ahead of COP17. The meeting focused on the “the fund’s operationalisation, including how to mobilise contributions, how resources should be allocated, and how to ensure transparency, trust and effectiveness”. Discussions also “explored ways to encourage early engagement from companies relying on digital sequence information across sectors as biotechnology, pharmaceuticals, agriculture, food innovation and cosmetics”. To our knowledge, no summary report of this exchange has yet been published by the Commission. What did the participants in this meeting discuss? Did they propose concrete steps to ensure the Cali Fund fulfils its potential?An effective Cali Fund – one that imposes a truly binding mechanism – remains, for now, an unfulfilled promise. This promise does, however, reflect a genuine awareness of the challenges associated with the digitisation of the industrial representation of living organisms, but it has yet to be translated into action. Caught between "institutional innovation" and economic inertia, the Cali Fund is moving forward on promises that are still illusory and will be staking part of its future in the coming months.i CBD, UNEP and UNDP, "Cali Fund, for our Biodiverse Future", 2025.ii Bayer claims that COP 16 “fell short by introducing an additional layer of obligations and uncertainties”. According to the multinational, the multilateral system on which the Cali Fund is based demonstrates, in particular, “a mismatch between expectations regarding benefit-sharing and the commercial value derived from publicly available ABS, as well as a lack of legal certainty, which would explain why it has not yet attracted significant contributions from the private sector, reflecting a disconnect from the realities of the business world”.See also:Jesse Chase-Lubitz, "Industry groups say Cali Fund for biodiversity “not the right approach”, Devex, 3 March 2025.iii Denis Meshaka, “Digital sequencing information: Appropriating life without touching it?”, Inf’OGM, 16 April 2026.iv The concept of the Global North/Global South refers more to a historical and economic structuring of power relations than to a legal categorisation.Countries that can be considered part of the Global North with strong technological and scientific capabilities are: the United States, the European Union, Canada, Japan, Australia and New Zealand.Countries that can be considered part of the Global South and rich in biodiversity include: Kenya, Nigeria, South Africa, Brazil, Mexico, Peru, China, India, Indonesia and the Philippines.Some hybrid countries combine high biodiversity with technological and scientific power: China, India, Brazil, South Africa, but also the United States.v Orla Dwyer, "Revealed: “Cali Fund” for nature still empty as emails show industry hesitation", CarbonBrief, 6 August 2025.vi Aruna Chandrasekhar and Orla Dwyer, "‘Cali Fund’ aiming to raise billions for nature receives first donation – of just $1,000", CarbonBrief, 12 December 2025.vii Third World Network (TWN) is an international network of organisations and individuals committed to environmental, development and North-South relations issues, including the problem of Third World debt.viii TWN, “COP16: Cali Fund for DSI benefit sharing kicks off, but will money flow in?”, 20 November 2024.ix International Planning Committee for Food Sovereignty (IPC), “Governments at COP16 legalise digital biopiracy”, 20 November 2024.x Nagoya Protocol HuB, “Digital sequence information on genetic resources (DSI)”.xi European Commission, “One year on: EU helps drive momentum for Cali Fund for biodiversity ahead of COP17”, 16 March 2026. Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [33] => Array ( [objectID] => 24078 [title] => Global GMO acreage remains stagnant [timestamp] => 1778112000 [date] => 07/05/2026 [annee] => 2026 [url] => https://infogm.org/en/global-gmo-acreage-remains-stagnant/ [image] => https://infogm.org/wp-content/uploads/2026/04/green-plant-sprouting-from-bare-branch-with-skeletonized-leaf-in-misted-botanical-setting-768x768.webp [extrait] => In 2024, 209.8 million hectares of genetically modified crops were grown worldwide, representing 4.2% of global farmland. Beyond this relatively low percentage, it is also important to note that, for decades, genetically modified crops have been limited to just a few countries and four plant species. GMO proponents readily cite the Bt eggplant in Bangladesh, or African countries that have recently authorized transgenic cotton or cowpeas… But this optical illusion is a long-standing strategy designed to create the illusion of GMO success. [chapo] => In 2024, 209.8 million hectares of genetically modified crops were grown worldwide, representing 4.2% of global farmland. Beyond this relatively low percentage, it is also important to note that, for decades, genetically modified crops have been limited to just a few countries and four plant species. GMO proponents readily cite the Bt eggplant in Bangladesh, or African countries that have recently authorized transgenic cotton or cowpeas… But this optical illusion is a long-standing strategy designed to create the illusion of GMO success. [texte] => Nothing new under the sun when it comes to GMOs… The area under cultivation continues to grow, but slowly. According to GM Monitori, it is projected to reach 209.80 million hectares (Mha) by 2024. In 2018, the figure was 186.86 Mha, representing a 12% increase over six years (approximately 2% per year). This is not surprising. Indeed, very few new countries have authorized commercial cultivation, and the few new genetically modified crops that have been approved are not widely embraced by the markets.In other words, four countries - Brazil, the United States, Argentina and Canada - cultivate 85.2% (178.75 Mha) of the total area, and four crops - soybeans, corn, cotton, and canola - account for 99.2% of that. GM Monitor lists 28 countries growing GMOs, sometimes on a very marginal scale. Similarly, among more than a dozen other crops that have been authorized for commercial cultivation, some have never been grown to date. The other species - sugarbeet, alfalfa, eggplant, sugarcane, etc. - therefore account for less than 1% of global acreage. Yet they are often highlighted to give the impression that plant biotechnology is thriving.4.2% of agricultural land is used for GM cropsFew countries, few species, but above all, a small proportion of the world’s agricultural land. According to the FAO, agricultural land (arable land and permanent pasturesii) covers 4.9 billion hectares. Transgenic crops account for only 4.2% of this total. Thus, on a global scale, the increase in GMO acreage between 2018 and 2024 is quite marginal. To be exhaustive, it should be included certain forests and savannas that contribute to food production in various countriesiii. For example, in the Congo Basin, “bush meat” amounts to 4 to 5 million tons per year - equivalent to half of European beef production - accounting for 80% of the animal protein consumed in both rural and urban areas.YearGlobal GMO area (in Mha)Year-on-year change2018186,92019186,4-0,2%2020189,1+1,4%2021196,2+3,8%2022202,2+3,3%2023202,9+0,3%2024209,8+3,4%Annual change in the global area of land sown with GM crops (2018–2024).In Brazil, GM soybeans and corn continue to expandOver the 2018-2024 period, the increase in land area planted with transgenic GM crops is primarily driven by Brazil. In this country, the area planted increased by 20.92 million hectares between 2018 and 2024iv. Brazil is therefore responsible for 91.4% of the global increase over the past six years.By far the largest contributor, the area planted with soybeans increased by 13.3 Mha between 2018 and 2024, accounting for 56% of the increase. Brazilian soybeans are almost entirely genetically modified to tolerate herbicides, and 60% of this production is exported to China. The new acreage was mainly planted in the Cerrado regionv. In this region, soybean acreage rose from approximately 17.3 Mha in 2018vi to 23.8 Mha in 2023/24 (+6.5 Mha)vii, accounting for about 50% of the global increase.This expansion of cultivated land is linked to deforestation. According to Camila Santos of Fundação Solidaridad, “between 2019/20 and 2022/23, 42% of soybean expansion in MATOPIBA occurred over native vegetation, corresponding to 920 thousand hectares, showing a significant increase in deforestation for conversion into agricultural areas. In addition, the average annual expansion rate in the most recent period reached 1.457 million hectares, a growth much higher than the averages observed in previous periods”viii.The Matopiba region is the “new agricultural frontier”ix in the hands of agribusiness: the cultivation of these lands is accompanied by a major transformation of the landscape, villages turning into cities, road and rail infrastructure, etc.x The area under soybean cultivation is expected to continue increasing in these regions. However, this expansion is likely to be limited by a shortage of waterxi. Pro-GMO advocates will therefore be able to celebrate a growing increase in transgenic acreage, even though this crop is harmful to the environment, actively contributing to deforestation and feeding factory farms responsible for pandemics and other greenhouse gas emissions.The area planted with non-GMO soybeans remains marginal, at less than 2 million hectares, and is primarily destined for the European market.As for GMO corn, Brazil saw an increase of 7.13 million hectares between 2018 and 2024. This crop accounts for 30% of the overall increase. Brazilian corn is largely transgenic (over 95%). The increase in GMO corn acreage in Brazil is mainly due to the second harvest in the west-central regions (particularly in the state of Mato Grosso) and to the conversion of “degraded pastures” or the abandonment of sorghum cultivation in the Cerrado.This second harvest, known as Safrinha (or “small harvest”), is driven by several factors. First, the selection of earlier-maturing soybean varieties (particularly Intacta RR2 hybrids) has allowed soybean planting to be shifted from December/January (harvest in late April) to October/November (harvest in February), making it possible to grow corn on these lands. Thus, in Mato Grosso, the total corn acreage increased from 11.2 Mha in 2018/2019xii to 14 Mha in 2023/2024 (+2.8 Mha, or +20%), with 90–95% of this increase attributable to the corn Safrinha. Mato Grosso has thus become the world’s leading corn producer. Second, former areas used for extensive livestock farming, as well as sorghum and cotton cultivation, have been converted to corn. These conversions have mainly taken place in the Cerrado.The third crop that has driven the growth of GM crops in Brazil is cotton. Here too, there was strong growth between 2018 and 2024 (from 1.64 million hectares to 1.94 million hectares, or +20.6%), with a GM adoption rate remaining stable at 99%. In this case as well, the possibility of growing cotton after soybeans partly explains this increase. The second factor explaining the increase in cotton acreage is the development of irrigation, particularly in Mato Grosso, starting in 2020.Two other crops have been authorized for cultivation: eucalyptus (2015) and sugarcane (2017). For eucalyptus, no acreage has been recorded. As for transgenic sugarcane, the CTC 20 Bt variety (insect-resistant via the Bt Cry1Ab gene) was grown in 2018 on only 400 hectares (or 0.004% of the total sugarcane acreage). We have no data for subsequent years and can therefore infer that the areas remain limited. One reason is that the sugarcane borer Diatraea saccharalis exhibits strong resistance to the Cry1Ab toxin, and evolutionary changes are occurring more rapidly among insects in Brazil than in biotech companies… Furthermore, European markets remain reluctant to purchase sugar derived from genetically modified sugarcane. The importance of labeling should not be overlooked when it comes to the acceptance or rejection of a product derived from GMOs.GMO cropCultivated area in 2018 (in Mha)Cultivated area in 2024 (in Mha)Changes in cultivated land area 2018–2024Soybeans32,3445,69+29 %Corn13,0820,21+35,3 %Cotton1,641,94+20,6 %TOTAL46,9667,88+30,8 %Changes in the area under cultivation for GM soybeans, corn and cotton in Brazil between 2018 and 2024.Disappearance of GMO Crops in MexicoMexico has seen a drastic decline in the amount of land planted with GMOs. Genetically modified cotton was the only species authorized for cultivation there. However, according to the USDA, GMO cotton has virtually disappeared. The U.S. Department of Agriculture attributes this decline to the lack of recently authorized GMO varieties: “The only authorized genetically modified cotton seeds are obsolete varieties that are mostly unavailable on the global market. Producers report that only one genetically modified variety is currently available, and its limited adaptability to certain regions has led to lower yields for cotton growers”. The Mexican government is generally opposed to GMOs, as evidenced by the various decrees it has adopted. This explains why no new GM cotton varieties have been authorized since 2019.In other countries in the Americas, the situation has generally remained unchanged. There has been a slight decline in Canada and a slight increase in Bolivia.American countries that grow GMOsArea under GM crops in 2018(in Mha)Area under GM crops in 2024(in Mha)Changes in the area of land cultivated with GM crops (in Mha)USA74,7375,36+0,63Brazil46,9667,90+20,94Argentina23,6023,80+0,20Canada12,1511,66-0,49Paraguay3,804,38+0,58Bolivia1,361,80+0,44Uruguay1,211,51+0,30Colombia0,080,15+0,07Honduras0,030,07+0,04Chili0,010,010,00Mexico0,240,01-0,23TOTAL164,17186,6522,48Changes in the area of land cultivated with GMOs in the Americas between 2018 and 2024 (in Mha)In Africa, new countries have adopted GMOs, but the acreage remains limitedIn Africa, one country stands far ahead in terms of GM crop acreage: South Africa. Authorized as early as 1999, GMOs play a significant role there. Approximately 95% of the soybeans and cotton grown there are genetically modified. The situation has been generally stable since 2012, with significant fluctuations (notably a sharp decline in 2018, to just 2.52 million hectares). South Africa accounts for 94% of Africa’s GMO acreage (3.47 million hectares out of 3.7 million hectares).The second-largest African country in terms of GMO acreage is Sudan, where Bt cotton cultivation has stagnated for several years. This is explained by a fairly high adoption rate of GMO varieties (around 90%), according to the AgbioInvestor GM Monitor website (information that cannot be independently verified).The latest development comes from the authorization of GMO crops in six African countries:Bt cotton in Ethiopia (2020), Kenya (2020), Malawi (2020), and Eswatini (2024);TELA corn in Kenya (2024);BT cowpea in Ghana (2024) and Nigeria (2018). In Ghana, the authorization of BT cowpea has not led to any cultivation.Burkina Faso, for its part, abandoned Bt cotton in 2016.African countries growing GMOsArea under GM crops in 2018(in Mha)Area under GM crops in 2024(in Mha)Changes in the area of land cultivated with GM crops (in Mha)Afrique du Sud3,23,470,27Soudan0,170,20,03Éthiopie00,010,01Kenya00,010,01Nigeria00,0040,004Malawi00,002250,00225Total3,373,70,3Changes in the area of land cultivated with GMOs in African countries between 2018 and 2024 (in Mha)In Asia, Bt cotton dominates while Bt eggplant is becoming scarceIndia and China are the two Asian countries that have been growing Bt cotton for over a decade. Planting areas have remained generally stable. In India, there has been a slight decline in acreage over the 2018-2024 period (from 11.97 Mha to 11.21 Mha, or -6%), following a peak of 12.73 Mha in 2019. In China, Bt cotton acreage over the same period fell from 3.23 to 2.80 Mha. A new development in China is the introduction of GMO corn and soybean crops in 2023. By 2024, they account for 0.67 Mha and 0.04 Mha, respectively. These two new crops cause the total GMO acreage in China to increase between 2018 and 2024 (+0.28 Mha).In contrast, GM corn appears to be establishing itself permanently in Vietnam. Authorized in 2015, it will account for nearly 50% of the national corn acreage (0.43 Mha) by 2024.In Bangladesh, the Bt eggplant has lost its appeal. Approved in 2013, it was reportedly grown by 65,000 farmers (compared to 27,000 in 2018) on 6,400 hectares in 2021, according to Transparenz Gentechnikxiii, a website that tends to be pro-GMO. The site provides context: “They are grown on approximately 50,000 hectares by 150,000 small farmers for local markets”. However, by 2022, the area under cultivation had been reduced by more than half (to 2,800 ha) according to the USDA, representing 8.5% of the national croplandxiv. The USDA attributes this decline to a reduction in seed supply. The USDA notes that the Bangladeshi Ministry of Agriculture did not provide seeds in 2022–2023 due to a lack of funding. This area remained stable until 2024.In this country, as likely in others, the Ministry of Agriculture subsidized the cultivation of Bt eggplant. The USDA writes that “the Department of Agricultural Extension (DAE) encourages and helps farmers to cultivate Bt eggplant”. This includes, for example, free seeds and subsidized fertilizers. And USAID, in partnership with the seed company Mahyco, also provided financial and technical support to the government in establishing these crops.The Philippines was also a country highlighted by GMO proponents because it had approved a Bt eggplant, as well as Golden Rice, a genetically modified rice variety engineered to be richer in beta-carotene (a severe deficiency in beta-carotene can lead to blindness). However, in April 2024, the Philippine Supreme Court suspended these two authorizations and required new risk assessments. In this country, the cultivation of transgenic corn remains significant: 0.71 million hectares in 2024, representing 27.8% of the national cropland. It should be noted, however, that this area has remained stagnant since 2012 (0.69 million hectares).Asian countries growing GMOsArea under GM crops in 2018(in Mha)Area under GM crops in 2024(in Mha)Changes in the area of land cultivated with GM crops (in Mha)India11,9711,21-0,76China3,233,51+0,28Pakistan2,191,9-0,29Philippines0,560,71+0,15Vietnam0,040,43+0,39Myanmar0,180,19+0,01Indonesia00,02+0,02Bangladesh0,00290,0015-0,0014TOTAL18,172917,9715-0,2014Changes in the area of land cultivated with GMOs in Asian countries between 2018 and 2024 (in Mha)Australia lifts moratoriums, and GMO crops surgeFinally, in Oceania, the only country that grows GMOs is Australia. We are seeing a sharp increase in acreage, rising from 1 million hectares in 2018 to 1.41 million hectares in 2024. GM rapeseed accounts for approximately 46%xv of the total acreage, while GM cotton accounts for 99%. Australia also grows 0.08 million hectares of glyphosate-tolerant GM safflower, intended for the production of edible oil or biofuels. The country also authorized GM Indian mustard in October 2022 and GM bananas in February 2024, but no commercial cultivation has yet been reported.The key development is the gradual lifting of moratoriums. Tasmania is the only Australian state to have maintained a moratorium on genetically modified crops.The situation regarding genetically modified (GM) crops is therefore stable, with the exception of Brazil where soybean cultivation continues to expand, often at the expense of forests or by combining two crops (soybeans and corn or soybeans and cotton) on the same land. Soybeans are grown with heavy use of fertilizers and pesticides. It is a generally very polluting crop, which promotes the concentration of land ownership in the hands of capital. To celebrate an increase in GM acreage in newly established African countries, as some proponents of this technology sometimes do, is to deny reality. GM crops consist of four varieties cultivated in a few countries and intended for livestock feed and biofuels (corn, soybeans, rapeseed) or for textile production (cotton). They are not food crops and are not adopted by small farmers, with the exception of cotton in India and China, often due to the inability to obtain conventional cotton seeds. Genetically modified organisms (GMOs) produced using new genomic techniques (NGTs) are not cultivated on a large scale, and the few varieties actually grown are not those promoted by seed companies. According to the German NGO ENGA, of the three GMOs/NGTs cultivated worldwide, two are herbicide-tolerant (HTV) corn varieties that produce insecticides sold by Corteva. Furthermore, the first two GMOs/NGTs to be marketed - a GMO rapeseed from Cibus and a GMO soybean from Calyxt - were withdrawn from marketxvi.i AgbioInvestor, « Global GM Crop Area Review », April 2025.ii Most calculations of this ratio (GMOs/agricultural land) fail to take permanent grassland into account. However, GMOs are mainly used to feed livestock, just as permanent grassland does very effectively. If we compare GMOs to arable land (1.55 billion hectares), the ratio jumps to 13.5%.iii FAO, « FORESTS FOR IMPROVED NUTRITION AND FOOD SECURITY », 2011.iv AgbioInvestor, « AgbioInvestor GM Monitor », 2026.v These include, in particular, Matopiba, an acronym for the states of MAranhão, TOcantins, PIauí and BAhia.vi The Cerrado accounted for 48% of Brazil’s soya production as early as 2019 (Soterroni, 2019) and, with approximately 36 million hectares of soya in Brazil in 2018, this would amount to around 17.3 million hectares in the Cerrado.vii Serasa Experian S.A., « Agribusiness. Soy expansion dynamics in the Cerrado Biome from 2020/21 to 2023/24 », Florianópolis, Santa Catarina, Brazil, 2024.viii « 42% of the Soybean Expansion in Brazil’s Agricultural Frontier Was Over Native Vegetation From 2019/20 to 2022/23 », AgriBrasilis, 12 December 2024.ix The term "new agricultural frontier" refers to a new area of agricultural expansion.x Maria Heloisa Barbosa Borges, « Almost nobody notices, but this agricultural giant spreads across four states, transforms the cerrado into farmland, pushes cities upward, changes export routes, and silently helps Brazil discover a new economic center away from the spotlight », Click Petróleo e Gás, 23 March 2026.xi FAPESP, « Water overuse in Brazil’s MATOPIBA region could mean failure to meet up to 40% of local demand for crop irrigation », Phys.org, 5 November 2024.xii IMEA/CONABxiii Herausgeber Forum Bio und Gentechnologie e.V., « Bangladesch: Immer mehr Kleinbauern nutzen Gentechnik-Auberginen », 31 August 2022.xiv USDA, « Agricultural Biotechnology Annual – Bangladesh », 4 December 2023.xv USDA, « Agricultural Biotechnology Annual – Australia », 4 November 2023.xvi Eric Meunier, « Only three GMOs/NGTs are cultivated », Inf’OGM, 4 August 2025. Christophe NOISETTE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [34] => Array ( [objectID] => 23117 [title] => The French Ministry of Agriculture concedes a compromise on patents in the GMO/NGT regulations [timestamp] => 1776902400 [date] => 23/04/2026 [annee] => 2026 [url] => https://infogm.org/en/the-french-ministry-of-agriculture-concedes-a-compromise-on-patents-in-the-gmo-ngt-regulations/ [image] => https://infogm.org/wp-content/uploads/2026/04/2241703086_fa20cd541c_c-768x512.jpg [extrait] => At a "Seed Sector Meeting" in February 2026, the representative of the French Ministry of Agriculture defended the proposed deregulation of numerous GMOs. However, his remarks primarily revealed tensions, misunderstandings and disagreements within the French administration regarding the issue of patents… a subject that is nonetheless central to the future of plant breeding! [chapo] => At a “Seed Sector Meeting” in February 2026, the representative of the French Ministry of Agriculture defended the proposed deregulation of numerous GMOs. However, his remarks primarily revealed tensions, misunderstandings and disagreements within the French administration regarding the issue of patents… a subject that is nonetheless central to the future of plant breeding! [texte] => The "Seed Sector Meeting" held on 4 Februaryi took place against a specific political backdrop: the ongoing European discussions on a proposal to deregulate GMOs derived from new genetic modification techniques (GMOs/NGTs) have entered their final phase (votes scheduled for the Council of the European Union on 21 April and the European Parliament on 19 May). These discussions thus took place at a time when Member States still had the option to make decisions, as did MEPs. The Parliament can either definitively approve or reject the proposed text, or adopt one or more amendments that will open new negotiations with the Council and the Commission.A presentation by Laurent Jacquiau, from the DGAL (Directorate-General for Food) of the Ministry of Agriculture, who took part in the interministerial negotiations on the GMO/NGT Regulation, attracted particular attention. He highlighted the hesitations that existed within the French government itself when taking a stance on the issue of patents.Political support despite shortcomings on patentsDuring the meeting, Laurent Jacquiau conceded that the Ministry had had to make a political compromise during the negotiations on the GMO/NGT Regulation. The government did, in fact, choose to support a draft regulation lacking real and effective safeguards on the issue of patents (obligation to describe the process for identifying GMOs, transparency, exemption for breeders)ii. Laurent Jacquiau notably acknowledged that this had been debated internally: “At the time of the vote, we asked ourselves whether or not to vote for the text, despite the fact that we had secured nothing more binding on intellectual property. But we preferred to provide breeders with tools quickly to meet the challenges facing agriculture”.This statement by the DGAL representative summed up the tension generated by the issue of patents. The Ministry of Agriculture chose to press ahead with the deregulation of GMOs/NGTs in order to “provide breeders [Editor’s note: primarily industrial ones] with operational tools”, whilst leaving unresolved the issue of patents and their impact on the work of the most vulnerable among these same breeders. The political compromise chosen by France was therefore to prioritise the demands of the agro-industrial sector over the protection of small and medium-sized players in the agricultural sector (seed producers, breeders, farmers). The French government has thus refrained from reforming European patent law to adapt it to the specific issues relating to living organisms and agriculture.This choice is indeed not without consequences for these stakeholders. By facilitating market access for GMOs/NGTs plants, the text of the provisional compromise encourages the use of patent protection strategies for these plants. However, this dynamic is taking effect in an economic sector historically structured around the Plant Breeders’ Rights (PBR) alone, which prioritises the intellectual property of varieties whilst allowing their reuse, free of charge for the selection of other varieties, but restricted and subject to payment for farmers. The development of GMOs/NGTs will strengthen the role of patents to the detriment of this balance, a point that was also addressed during this "Seed Sector Meeting".The forced coexistence of patents and PBRsEchoing the comments of François Desprez, co-director of the seed company Florimond Desprez, Laurent Jacquiau pointed out that the tension between PBRs and patents existed long before NGTs and that this imbalance was already a major issue for the seed sector: “It is particularly pronounced in the vegetable sector. Improvements are therefore needed in the granting of patents, so that they genuinely cover innovations, and not simply native genes”. It should be noted that a patent granted on a genetic trait (such as resistance to a pathogen) can affect several varieties, making it a powerful tool for, where appropriate, prohibiting or demanding licence fees for the marketing of several plant varieties expressing that trait.This observation by the DGAL representative is also echoed by the UFS (French seed association for seed companies & plant breeders), represented at this meeting by its vice-president Régis Fournier (who is also a strategic advisor to the French firm Limagrin/Villemorin). The UFS has long defended the view that the PBR is a pillar of the European seed model, enabling the reconciliation of varietal innovation and the circulation of genetic resources. Régis Fournier nevertheless emphasises and acknowledges the divided stance of UFS members on the issue of patents: “We [the UFS] have stood in solidarity with the [French] administration, but we feel isolated in Europe. We must therefore organise the coexistence of plant variety rights and patents”.However, such coexistence remains difficult to envisage. Some operators do not believe this is possible. The main risk lies in the lack of transparency regarding patented plant traits, to the extent that many breeders describe the situation as “a minefield”. This lack of transparency is accompanied by an extension of the scope of patents to traits already present in plants other than those resulting from the original invention.Furthermore, the accumulation of patent rights on the traits of a single variety greatly complicates the work of breeders. It gives rise to both legal uncertainties, particularly regarding potential infringement, and economic constraints linked to the multiple royalties payable to patent holders.Internal disagreements and a lack of understanding of the issuesA particularly telling episode illustrating the public authorities’ predicament in this matter is when Laurent Jacquiau highlights the difficulties faced by the DGAL in gaining recognition for these issues, including within French and European institutions: “We ourselves are struggling to convince our colleagues at Bercy [French Ministry of the Economy], and, at the European Commission, they are struggling to convince the economic directorate in charge of patents that there are issues specific to plants. They didn’t even know that PBRs existed, nor that other protection systems existed. We will therefore really need your help [that of the seed producers present in the room] to convince them that there are real issues at stake, and that the world of plant variety innovation is not the same as that of industrial or pharmaceutical innovation”.This institutional ignorance reinforces the sense that there is a disconnect between the reality on the ground and the influence of certain lobbies on decision-making processes. This is also due to a more general confusion between different models of innovation, as patents may, according to the proposal to deregulate GMOs/NGTs – which removes the requirement to publish methods for detecting and identifying modified and patented traits – cover existing traits, and thus "discoveries" that are in principle not patentableiii. Plant variety innovation relies on long, cumulative processes based on cross-breeding and selection. Laurent Jacquiau emphasises that “cross-breeding plants has been practised since the dawn of agriculture: it is the foundation of the breeder’s profession. It is therefore essential that breeders are able to continue practising their profession”. In this context, the application of patent law originally designed for other technical sectors (mechanical engineering, chemistry, etc.) appears inappropriate and contributes to maintaining tensions over whether or not to protect plant innovations. This was one of the reasons for the creation of the sui generis right known as plant breeders’ rights.A compromise with fragile foundationsThe French Ministry of Agriculture’s support for the deregulation of GMOs/NGTs is based on a political compromise that leaves aside the issue of patents. The DGAL also acknowledges the existence of a problem of coexistence and imbalance between patents and plant breeders’ rights. Somewhat surprisingly, the DGAL further highlights internal disagreements, as well as certain limitations in understanding within the institutions, regarding these industrial property issues. All of this could explain the chaotic nature of the process of drafting and finalising the GMO/NGT regulation.Whilst the UFS, representing the seed sector, is currently attempting to maintain a balance between different intellectual property tools, it cannot, however, guarantee a fully stabilised and secure framework for the most vulnerable of its members. Amid political trade-offs, legal uncertainties and divergent analyses, the issue of intellectual property – patents and plant breeders’ rights – remains largely unresolved at a key juncture in the evolution of the European framework. The European Parliament’s decision – demanding, yet clear – to reject the patentability of GMOs/NGTs would have spared the EU legislator many difficulties.i This "2026 Seed Sector Meeting’" brought together Laurent Jacquiau (Head of the "Seeds and Alternative Solutions Office" at the DGAL), Régis Fournier (Vice-President of the French Seed Growers’ Union) and Denis Jamet (farmer and director of the AGPB, General Association of Wheat Producers).ii Denis Meshaka, “The Council of the EU wants to maintain the patentability of GMOs/NTGs”, Inf’OGM, 21 January 2026.iii Denis Meshaka, “Patents, living organisms and GMOs/NGTs”, Inf’OGM, 25 March 2026. Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [35] => Array ( [objectID] => 22869 [title] => EU Council approves deregulation of GMOs/NGTs [timestamp] => 1776729600 [date] => 21/04/2026 [annee] => 2026 [url] => https://infogm.org/en/eu-council-approves-deregulation-of-gmos-ntgs/ [image] => https://infogm.org/wp-content/uploads/2026/04/Screenshot-2026-04-21-at-12-05-54-Conseil-des-affaires-etrangeres-Public-session-2026-04-21-768x457.png [extrait] => On 21 April 2026, EU Member States voted in favour of deregulating GMOs/NGTs at the EU Foreign Affairs Council. The text is coming back now in the European Parliament’s court, with its Environment Committee due to meet on 5 May, ahead of a plenary session for discussions and votes by MEPs on 19 May 2026. [chapo] => On 21 April 2026, EU Member States voted in favour of deregulating GMOs/NGTs at the EU Foreign Affairs Council. The text is coming back now in the European Parliament’s court, with its Environment Committee due to meet on 5 May, ahead of a plenary session for discussions and votes by MEPs on 19 May 2026. [texte] => Since July 2023, the Council of the European Union (EU) had still not adopted a formal position on the European Commission’s proposal to deregulate numerous GMOs obtained through new genetic modification techniques (GMOs/NGTs). However, on Tuesday 21 April, the Council reached a qualified majority and formally adopted a favourable position at first reading. Much debated, this text had until now failed to secure agreement among Member States due to significant disagreements.A text that deregulates numerous GMOsThe text adopted by the Council of the EU, without any discussion during the meeting, was rejected by Croatia, Hungary, Austria, Romania, Slovenia and Slovakia. With Germany, Belgium and Bulgaria abstaining, this was not enough to block a qualified majority, as 18 out of 27 Member States, representing 66.59% of the European population, voted in favour ofi.The adopted textii therefore provides that GMOs/NGTs are to be classified into two categories.The first, known as "NTG 1", based on non-scientific criteria, would allow for potential marketing in Europe without risk assessment, without formal authorisation, but following "verification" of a declaration by the company, without any obligation to provide a method for detecting and identifying the deregulated GMO, without labelling (with the exception of seed lots), without the possibility for Member States to take national measures restricting or prohibiting such marketing, and without post-marketing environmental monitoring. There are, however, two exceptions: plants genetically modified using new techniques to resist herbicides or produce their own insecticide (provided it is "known") will not be eligible for this NTG1 status.The "NTG 2" category would cover other GMOs/NGTs and would be subject to a regime similar to that currently governing GMOs.One of the points of contention concerns the patents associated with these plants, which have been criticised by various stakeholders (NGOs, farmers’ unions, seed companies, etc.). For them, not being obliged to provide a method for detection and identification opens the door to an increase in patent applications on living organisms. This is precisely the issue that, since 2023, has been the subject of considerable disagreement among Member States and which remains unresolved by the text adopted by the Council on 21 April 2026.A real difficulty for the Council of the EU in taking a positionSince 2023, the lack of an official position from the Council of the EU had not prevented the opening of negotiations in 2025 between the Commission, Parliament and Council as part of the trilogue, which brings representatives from each of these European institutions together around the same table. Launched in the spring, these negotiations were expected to be complex given the differences of opinion expressed.On the one hand, as early as 2023, the European Commission proposed an almost complete deregulation of GMOs/NGTs, with no risk assessment (health, environmental, economic, social, etc.), no labelling (except for seed lots), no analytical traceability of these GMOs (no mandatory detection or identification methods to be provided), and no possibility for Member States to take national measures (principle of subsidiarity), whilst retaining the possibility of patenting plants derived from these NGTs…In 2024, the European Parliament contested this last point in particular, demanding that the granting of patents on these GMOs/NGTs should not be possible. This demand echoed – and continues to echo – the observation made by several stakeholders at the time and since, that the deregulation of these GMOs would open the door to increased appropriation of living organisms by multinationalsiii. Within the Council, the issue of patents – and others, such as labelling requirements for certain Member States – had been a source of fierce opposition, which was the root cause of its inability to reach a consensus on the proposed text.A compromise text offering false solutionsIn early December 2025, these negotiations resulted in a so-called "compromise" textiv that raises concerns. Indeed, this text does not mark any major change from the European Commission’s initial proposal. In addition to maintaining the absence of risk assessment, labelling or any obligation on companies to provide a method for detecting and identifying their GMOs (analytical traceability), the text proposes nothing binding to resolve the issue of patents.Only non-binding measures are set out, such as an assessment of the impacts that plant patenting, associated licences and transparency practices “have on innovation in plant breeding, on breeders’ access to plant biological material and techniques and on the availability of plant reproductive material to farmers, as well as on the overall competitiveness of the Union’s plant breeding industry, in particular small and medium-sized breeders, and the potential risks of market concentration”. All these impacts would magically disappear with the second proposed measure: the drafting of a "code of conduct" that multinationals would be expected to follow, but without any legal obligation. The same applies to "licensing platforms", which are supposed to ensure, without knowing what the terms actually mean, access to licences for SMEs under "fair and reasonable" conditions… A final example: an expected assessment by the European Commission of "the patenting of NGT plants, traits and techniques, as well as related licensing and transparency practices, have in the Union on […] the risk of litigation involving farmers or breeders in situations where patented plant biological material may appear in their crops or products due to accidental presence or similarity, without intentional use of the patented plant biological material”v . In the event that problems are identified – provided they are classified as such by the Commission – the latter may “submit legislative proposals to set up mandatory conditions or safeguards”…The Council of the EU approves the deregulation of GMOs/NGTsDespite the non-binding nature of the proposed measures, the disagreements between Member States that characterised 2024 and 2025, and the opposition from numerous stakeholdersvi, it is nevertheless this compromise text that has just been approved by the Council of the EU on 21 April 2026. As it had indicated on 19 December 2025 during an informal discussionvii, France has shifted its long-standing position and declared itself in favour of its formal adoption by the Council. Although, in December, the government boasted of having secured a commitment from the Commission to ensure the compromise’s content was upheldviii, this commitment did not introduce any binding provisions into the compromise text, as was recently confirmed by a representative of the French Ministry of Agricultureix.With this vote, the Council’s first-reading position on this text on the deregulation of GMOs/NGTs is therefore known for the first time since 2023. On the same day, the Council also adopted its position at first reading on a proposal made in 2023 by the European Commission regarding the production and marketing of forest reproductive materialx. This text specifically states that trees genetically modified using new techniques will indeed be subject to the text on the deregulation of GMOs, provided that the latter is ultimately adopted.The text adopted on 21 April 2026 on GMOs/NGTs will now return to the European Parliament to continue its legislative process. The next step will be a meeting of the Parliament’s Environment Committee on 5 May, before MEPs discuss and vote on their position at second reading on 19 May 2026.i A qualified majority is achieved if two conditions are met simultaneously:at least 55% of the Member States (i.e. 15 out of 27) have voted in favourthese Member States represent at least 65% of the total EU populationii The adopted text:Council of the EU, « Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625 », 8 April 2026.iii Antoine Vépierre, « A wide range of stakeholders opposed to the deregulation of GMOs/NGTs », Inf’OGM, 20 April 2026.iv Eric Meunier, « Qualified majority in the Council of the European Union to deregulate numerous GMOs », Inf'OGM, 24 December 2025.v The adopted text:Council of the EU, « Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625 », 8 April 2026.vi Antoine Vépierre, « A wide range of stakeholders opposed to the deregulation of GMOs/NGTs », Inf’OGM, 20 April 2026.vii Eric Meunier, « Qualified majority in the Council of the European Union to deregulate numerous GMOs », Inf'OGM, 24 December 2025.viii Eric Meunier, « French government in favour of deregulating many GMOs », Inf’OGM, 28 January 2026.ix Denis Meshaka, « Le ministère de l’Agriculture admet un compromis sur les brevets dans le règlement OGM/NTG », Inf’OGM, 14 avril 2026.x Council of the EU, « Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the production and marketing of forest reproductive material, amending Regulations (EU) 2016/2031 and (EU) 2017/625 of the European Parliament and of the Council and repealing Council Directive 1999/105/EC (FRM Regulation) », 10 April 2026. Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [36] => Array ( [objectID] => 22803 [title] => A wide range of stakeholders opposed to the deregulation of GMOs/NGTs [timestamp] => 1776643200 [date] => 20/04/2026 [annee] => 2026 [url] => https://infogm.org/en/a-wide-range-of-stakeholders-opposed-to-the-deregulation-of-gmos-ngts/ [image] => https://infogm.org/wp-content/uploads/2026/04/main-human-stop-avec-mains-couleurs-motif-vectoriel-dessin-d-illustration-2e50h4p-e1776691459226-768x930.jpg [extrait] => Whilst the process of deregulating GMOs/NGTs is continuing within the European institutions, opposition to it has been growing in recent weeks. These positions are being taken by a wide variety of stakeholders. Without claiming to be exhaustive, Inf’OGM offers an overview of the main statements published recently. [chapo] => Whilst the process of deregulating GMOs/NGTs is continuing within the European institutions, opposition to it has been growing in recent weeks. These positions are being taken by a wide variety of stakeholders. Without claiming to be exhaustive, Inf’OGM offers an overview of the main statements published recently. [texte] => As we have been documenting for nearly three years now, the European Commission is seeking to deregulate GMOs derived from new genetic modification techniques (GMOs/NGTs). Whilst organisations have long been campaigning on this issue, recent weeks have seen numerous statements emerging from a wide range of stakeholders. Although this surge in opposition is partly due to the timetable of the procedureii – which has accelerated since a compromise text was presented in December 2025 – the broad spectrum of stakeholders taking a stance on this new legislation highlights public concern and the dangers looming over many industries.Farmers and small seed producers on high alertA few weeks ago, we reportediii on the joint initiative by 18 French organisations sending an open letter to MEPs calling on them to “defend the founding values, principles and treaties of the European Union, as well as the position adopted by the European Parliament in February 2024”iv. This appeal aims to remind MEPs of the need to maintain detection, traceability and labelling for GMOs/NGTs, to reject the patent system and to ensure that the costs of coexistence measures are borne by GMO/NGT growers.This position is not shared by other stakeholders in the seed sector, such as members of the Syndicat des Trieurs A Façon de France (STAFF), who nevertheless reject the compromise textv. Indeed, whilst the union also rejects the patent system, it “fully recognises that varietal innovation and NGTs require significant investment in research”. Its concern regarding the proposed text centres in particular on the “lack of labelling and traceability”, leading to “increased risks of contamination during sorting and collection operations”, as well as the “forced acceptance of contamination in organic farming”. STAFF also bases its rejection of the text on the deregulation of GMOs/NGTs on one of the responses to concerns regarding patents: “the Commission will work with stakeholders to draw up a European code of conduct within a maximum of 18 months after the regulation comes into force”. The union believes that “implementing such a far-reaching reform without a prior framework is unacceptable”, summarising the procedure as: “deregulate today, reflect in 18 months”. It therefore calls on MEPs “to reject this agreement as it stands […] and on seed and agricultural professionals to mobilise to defend […] an intellectual property rights (IPR) model that guarantees a balance between breeders and farmers”.Organic farming in grave dangerAs we have seen in previous statements, the threats facing the organic sector are also highlighted. The FNAB (National Federation of Organic Agriculture) is under no illusion and has, in fact, long been a key player in any initiative aimed at denouncing the text on the deregulation of GMOs/NGTs. Its latest statement dates from 16 March, alongside 12 other organisationsvi. On this occasion, they published a 130-page document (which Inf’OGM will discuss in detail in a forthcoming article), submitted to the Commission on 21 February, which “highlights, in detail, the significant gaps and shortcomings in the way the Commission has prepared and drafted its legislative proposal, thereby undermining its legitimacy”vii. Drawing on a substantial scientific bibliography, they demonstrate “that the proposed regulation on NGTs is based entirely on flawed scientific paradigms, despite numerous studies and scientific warnings that the Commission could not have ignored, particularly regarding the risks” and highlight “shortcomings in the prior consultations and impact assessments, as well as problematic deficiencies in the organisation of institutional expertise, the results of which have been exploited”. Far more than a simple call for MEPs to vote against this text, the organisations are calling on the European Commission to withdraw its proposed regulation on GMOs/NGTs. They conclude by announcing that, should the Commission fail to take action within 60 days of receiving their letter, they intend to “exercise all available legal and administrative remedies, including [...] lodging an official complaint with the European Ombudsman”.Whilst the FNAB is taking a stand by calling for the withdrawal of the text, the position of its European federation, Ifoam Organics Europe, is aligned with this. In a press release dated 30 Marchviii, it points out that the compromise text negotiated in the trilogue has set aside the Parliament’s initial requirements regarding traceability, labelling and “the scope of patent rights on NGT crops”. As a means of action, Ifoam refers to two campaigns:"BLacked-out Ingredients", launched by some thirty European organisations calling on MEPs to mandate the labelling of GMOs/NGTsix .“No GMOs through the back door!”, also launched by a coalition of European organisations calling on MEPs for strict regulation of GMOs/NGTsx .New players are taking a standAgainst this backdrop, new players have more recently voiced their opposition to this text.On 3 February, Kokopelli, echoing the arguments put forward in January by the 18 French organisationsxi, launched an initiative open for signature by all citizens and organisations (over 15,000 to date)xii. The aim is to call on MEPs “to reject the regulation on plants derived from New Genomic Techniques (NGT) during the vote in the European Parliament’s plenary session”.On 9 February, Safe Food Advocacy Europe (SAFE), a European consumer organisation specialising in food policy, warned in a press release that the deregulation of GMOs and novel foods would mean “the end of organic food as we know it”xiii. At Biofach, Europe’s largest organic trade fair held annually in Germany, Luigi Tozzi, deputy director of SAFE, stated: “Organic food production is at serious risk under the new legislation, because the measures in place to separate organic food production from food derived from new genomic techniques will disappear soon. This means that in the future, products sold as organic may contain traces of NGT crops, restricting consumer choice and undermining the very concept of organic food production. This is a very serious threat for an important sector trusted by millions of European consumers”. SAFE believes that the European Union must guarantee consumers the traceability and labelling of GMOs/NGTs, as is the case under current regulations. To publicise its views, SAFE has also produced a short video as part of its campaign for full transparency on GMOs/NGTsxiv.On 25 March, the INRAE branch of the SUD Recherche trade union issued a press release calling for “a debate with strong involvement from INRAE, before it is too late for all the various stakeholders in the plant sector”xv. Indeed, beyond reiterating the criticisms of the biased scientific foundations of the proposal to deregulate GMOs/NGTs and recalling the false promises made and not kept regarding the first generations of GMOs, the union also warns of the risk of the French GMO-free seed sector disappearing if the patent system were to replace the COV system. According to the union, the deregulation of GMOs/NGTs and the shift from COV to patents would lead to the "concentration of the sector in the hands of a few companies, [the] closure of access (or even disappearance) to the diversity of genetic resources, [more] expensive seeds (licence fees), [the] impoverishment of biodiversity through the simplification of cropping systems, even as we are already witnessing a collapse in biodiversity that must be urgently addressed”.On 28 March, around forty chefs published an open letter in Le Monde denouncing the provisional agreement on the deregulation of GMOs/NGTs, which “threatens to break the bond of trust that binds [them] to [their] customers”xvi. Their main concern relates to the abandonment of GMO/NGT labelling, without which they “will no longer be able to identify whether an ingredient is genetically modified” and thus “guarantee [their] customers GMO-free cuisine”. Furthermore, they believe that “the arrival of these plants in Europe could exacerbate the genetic standardisation of crops in favour of a few standardised varieties”, leading to the loss of “local, heritage or forgotten varieties, [which] form the basis of our culinary reputation and define the identity of our small-scale producers”. Finally, they highlight the threat these plants pose to the organic sector, which, without strict traceability, will be unable to guarantee that open-field crops are not contaminated. They are therefore calling on MEPs to oppose the deregulation of GMOs/NGTs in order to preserve “the right to choose freely what we eat”.Slovakia lying in wait?In Slovakia, a country opposed to the text on the deregulation of GMOs/NGTs, a civil society coalition (Quid est veritas) has just issued an appeal to its government. It requests on “the Slovak Republic, in the interest of protecting the health of its citizens, biodiversity, transparency, and food sovereignty, maintain its dissenting position and file a petition with the Court of Justice of the European Union (CJEU) for a judicial review of the legality of the pending Regulation”. In their letter, the organisations begin by listing “the fundamental points of the proposal’s systemic failure” that they have identified:“Destruction of Market Transparency and Loss of Consumer Sovereignty” due to the removal of mandatory labelling;“Threat to Competition, Liquidation of Organic Farming, and Non-GMO Production” due to the loss of transparency and traceability;“Absence of Scientific Consensus and Violation of the Precautionary Principle”, as there is no relevant evidence demonstrating the safety of GMOs/NTGs nor any studies proving their equivalence to conventionally grown crops;“Uncontrolled Spread in the Environment and Threat to Biodiversity” through genetic contamination;“Disregard for the Will of Citizens”, with opinion polls confirming a societal demand for the maintenance of strict regulation and transparency.Should the regulation be adopted, the collective believes legal action is a possibility. Indeed, any EU Member State has two months to lodge such an appeal with the CJEU. Quid est veritas believes that Slovakia “ has an exceptionally high chance of success in upholding its promise to maintain current GMOregulations”. The group is therefore calling on its government to “reject the NGT deregulation and issue instructions [...] to file a petition with the CJEU for a review of the Regulation's compliance with EU law”.The imminent plenary vote in the European Parliament is therefore prompting many stakeholders to make public their arguments against all or part of the text on the deregulation of GMOs/NGTs negotiated in trilogue last December. Although the methods of action and grounds for rejection differ, the backlash is intensifying and seeing new players come forward, notably to engage with MEPs ahead of their vote. Whilst it is difficult to predict whether this will be enough to tip the balance towards a vote against the text, Slovakia appears to be opening up a new avenue for bringing down the Commission’s initiative. Will others follow suit?ii Eric Meunier, « What “discussion” procedures are imposed on European legislators? », Inf’OGM, 11 February 2026.Eric Meunier, « Le Conseil de l’UE prêt à voter la déréglementation des OGM/NTG ? », Inf’OGM, 16 April 2026.iii Antoine Vépierre, « French organisations call on MEPs to reject GMO deregulation », Inf’OGM, 9 March 2026.iv Joint open letter, "Nouveaux OGM : 18 organisations appellent les eurodéputés à rejeter l’accord", 9 January 2026.List of signatories: Agir pour l’environnement, Bio Consom’acteurs, Confédération paysanne, CSFV 49, FNAB, Foll’avoine, France Nature Environnement, Générations Futures, Groupe International d’Etudes Transdisciplinaires, Mouvement de l’Agriculture Biodynamique, Objectif Zéro OGM, OGM Dangers, POLLINIS, Synabio, UFC-Que Choisir, Vigilance OGM et Pesticides 16, Vigilance OGM 46, Vigilance OG2M.v STAFF, « Position du STAFF sur les Nouvelles Techniques Génomiques (NTG) », 10 December 2025.vi FNAB, « Déréglementation des OGM-NTG : 13 organisations dénoncent de graves défaillances scientifiques », 16 March 2026.Collective letter, « Lettre à la Commission européenne du 21 février 2026 – Proposition de règlement sur les nouvelles techniques génomiques (NTG) », 21 February 2026.List of signatories: Synabio, GIET, Foll’avoine, CNAFAL, FNAB, Pollinis, Vigilance OGM et Pesticides 16, OGM Dangers, Sciences citoyennes, FNE, RSP, Générations futures.vii Collective document, « Préoccupations, demandes d’information et revendications concernant laProposition de règlement de la Commission européenne sur les végétaux obtenus au moyende certaines nouvelles techniques génomiques et les denrées alimentaires et aliments pouranimaux qui en sont dérivées », 20 February 2026.Download the document in PDF format here.viii Ifoam Organics Europe, « “New Genomic Techniques”: Everything you need to know before the upcoming final vote on the legislative proposal », 30 March 2026.ix Blacked-out Ingredients Collective, « If you stay silent now, it stays dark later ».x Collective, « No GMOs through the back door! », 17 avril 2025.xi Antoine Vépierre, « French organisations call on MEPs to reject GMO deregulation », Inf’OGM, 9 March 2026.xii Kokopelli, "Les NGT, un danger pour notre autonomie agricole", 3 February 2026.Non-exhaustive list of signatory organisations and individuals: Sativa, Germinance and the Conservatoire des Mille Variétés Anciennes (seed producers); the FNAB (inter-professional body for organic farming); Pierre-Henri Gouyon, Isabelle Goldringer, Philippe Grandcolas (scientists); Philippe Piard, François Veillerette (environmental activists); Marie-Monique Robin, Yann Arthus-Bertrand (documentary filmmakers);...xiii SAFE, "Consumers about losing the battle for GMO-free organic food, SAFE warns", 9 February 2026.xiv SAFE, "The new legislation of NGTs will mean the end of organic food as we know it", 11 February 2026.xv Sud Recherce, "« NGT – nouveaux OGM » : 25 ans après le moratoire sur les OGM, pourquoi abandonner la souveraineté européenne dans le domaine végétal en basculant dans le régime industriel des brevets ?", 25 March 2026.xvi Collective, "« Pour nous, chefs, restaurateurs et cuisiniers, l’accord provisoire sur la déréglementation des nouveaux OGM marque un recul inacceptable »", Le Monde, 28 March 2026. Antoine VEPIERRE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [37] => Array ( [objectID] => 22550 [title] => Digital sequence information: Appropriating life without touching it? [timestamp] => 1776297600 [date] => 16/04/2026 [annee] => 2026 [url] => https://infogm.org/en/digital-sequence-information-appropriating-life-without-touching-it/ [image] => https://infogm.org/wp-content/uploads/2026/04/NCBI_Viridiplantae_Taxonomy_Tree_-_Force-Directed_-_4_Family-1-768x768.png [extrait] => Digital sequence information (DSI) has long been a source of tension between countries in the "Global North" and the "Global South". The latter provides the majority of the physical genetic resources containing this DSI, whilst the North, thanks to its bioinformatics capabilities, carries out most of the exploitation and financial capitalisation of this information. Thus, by linking biological functions to digitised genetic sequences, the North files numerous patent applications and captures the lion’s share of the profits, in violation of international conventions and treaties. In an attempt to legalise this new form of biopiracy, a pledge to share these benefits equitably – the Cali Fund – was formalised in 2024. It remains, however, ineffective, failing to address a major injustice. [chapo] => Digital sequence information (DSI) has long been a source of tension between countries in the “Global North” and the ”Global South“. The latter provides the majority of the physical genetic resources containing this DSI, whilst the North, thanks to its bioinformatics capabilities, carries out most of the exploitation and financial capitalisation of this information. Thus, by linking biological functions to digitised genetic sequences, the North files numerous patent applications and captures the lion’s share of the profits, in violation of international conventions and treaties. In an attempt to legalise this new form of biopiracy, a pledge to share these benefits equitably – the Cali Fund – was formalised in 2024. It remains, however, ineffective, failing to address a major injustice. [texte] => This article is part of a series devoted to intellectual property (patents, plant variety rights, trademarks, licences, etc.). It differs, however, in that it focuses on DSIs, not as a form of intellectual property, but as a legal concept that has become central today.Digital sequence information (or DSI) is not defined by any international legal textii. Nor has any agreement been reached on the name of this new virtual subject of international law, with the term GSD (Genetic Sequence Data) also being used in certain international meetings. This semantic issue is historically complexiii. For the sake of simplicity, we will refer to it here as "DSI". Most of these GSDsiv are freely accessible via public databasesv. These genetic components of physical biological resources, originating mainly from countries in the Global South (“South”), are now attracting significant scientific and economic interest, particularly from multinationals in the wealthy countries of the Global North (“North”)vi. These DSIs are fuelling an exponential surge in patent applications since the cost of genome sequencing fell dramatically in the 2010s. Such commercialisation of DSIs further contributes to the distortion of the concept of "invention", whose original meaning of "creation of the mind" is already undermined by its application to living organismsvii.From physical resource to digital resourceDSIs constitute an undefined set of digital data derived from the genetic sequencing of living organisms (plants, animals, microorganisms). Stored in computer databases, these DSIs are used as raw material for the development of certain products in the pharmaceutical and agro-industrial sectors (often combined within the same entity) as well as in the cosmetics industry. They are also used by the public research sector, increasingly often under contract with private companies. Thanks to these databases, there is no longer any need to access the physical biological resource in order to study its genetic characteristics and attempt to appropriate them.The appropriation of genetic resources is now taking place less and less via physical material, but primarily via DSIs. Thanks to highly sophisticated bioinformatics tools, the Northern industry cross-references databases with, in the case of the seed sector, other databases listing the characteristics of physical plant samples. It then files patent applications for organisms containing sequences presented as modified by patentable genetic modification techniques, whose functions are assumed and which express the said characteristics. If we take the well-known examples of stevia (production of ultra-sweet substances) or the neem tree (production of medicinal oil), whose current commercial exploitation relies on the patentability of the chemical synthesis of components from these plantsviii, this could now be achieved using the DSI contained in these plants and available in databases.In silico processes at the origin of "inventions"…The European Patent Office (EPO) is responsible for examining European patent applications for "inventions" involving DSI in accordance with the criteria applicable to all technical fieldsix: technical character, novelty, inventive step, industrial applicability and sufficiency of description. A simple genetic sequence characterised solely by its digital representation and lacking any function or "technical effect" is not patentable as such. However, if it is demonstrated that it is associated with disease resistance in a plant, or that it codes for a pathogenic virusx, it may be patentable.When assessing the novelty and inventive step of "inventions" based on DSIs, the EPO, which we consulted, states that it takes into account the entire "state of the art" available prior to the filing date of a patent application, including sequences from public databases. If the association of a sequence and its function is already disclosed in a database, a claim for an "invention" relating to that sequence may be rejected for lack of novelty, and obvious variants will generally fail to meet the requirement of inventive step. Regarding the criterion of sufficient description, an "invention" based on DSI may be considered sufficiently disclosed (without the deposit of biological material) if the genetic basis of the claimed feature is clearly described, enabling its reproduction using established techniques. In other words, if cross-referencing information from two or more databases allows a function to be attributed to a sequence, it is theoretically possible to obtain a patent on such an "invention", and even to claim any product containing that sequence – any organism – even if the latter has not been physically produced.… which encourage biopiracyThe EPO also states that it follows the recommendations of recital 27 of Directive 98/44, according to which, "whereas if an invention is based on biological material of plant or animal origin or if it uses such material, the patent application should, where appropriate, include information on the geographical origin of such material, if known". For a DSI to be subject to this requirement to provide information on geographical origin, the database from which it was sourced by the patent applicant must provide information linking it to some physical material and its place of collection. However, this remains highly unlikely given the current management of DSI by most databases worldwide. In any case, this would be of little use, since recital 27 specifies that “this is without prejudice to the processing of patent applications or the validity of rights arising from granted patents”.The ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture), which also seeks to establish rules on benefit-sharing for DSIsxi, nevertheless prohibits any intellectual property rights (IPR) over seeds or plants derived from the collections of its multilateral system. The Convention on Biological Diversity (CBD), for its part, requires free and informed prior consent before any access to a genetic resource, consent which may be conditional upon a ban on such IPRs. Only the absence of a strict obligation to indicate the origin of DSIs in any patent application currently allows these restrictions to be circumvented. The current formal recommendations, as they are not binding, are nothing more than wishful thinking.Furthermore, in May 2024, WIPO adopted a Treaty aimed at regulating the use of genetic resources through the mandatory disclosure of their geographical origin in patent applicationsxii. Whilst its objective is to ensure the equitable sharing of benefits, this Treaty nevertheless poses a threat of biopiracy by WIPO regarding DSIs. The Treaty does, in fact, contain an obligation to disclose the origin of "material of plant, animal, microbial or other origin containing functional units of heredity" where the invention is based on such material. This obligation could therefore only apply to inventions based on the physical forms of genetic material, and not on its genetic parts and components, as in the ITPGRFA. This is interpreted by Northern countries, for whom DSIs are not genetic components of biological materials but products of research, as a de facto exclusion from the definition of genetic resources under this WIPO Treaty. All patents relating to DSIs contained in genetic resources would thus contribute to a situation of biopiracyxiii. To date, no member of the European Patent Convention (which gave rise to the EPO for European Union member states) has ratified this Treaty, with Malawi currently being the only country in the world to have done so.Sharing the benefits of DSIs: a deadlock similar to that of IPRsThe widespread dissemination of DSIs via databases poses numerous problems. It is, for example, very difficult to prove that genetic information incorporated into a database was already known, contained in biological resources and/or associated with indigenous knowledge in its country of origin. This makes it almost impossible to challenge certain patents on the grounds of lack of novelty when an "invention" is based on such "information"xiv. Furthermore, this lack of traceability prevents the sharing of benefits with the provider – who is therefore unknown – of this information.The Nagoya Protocol does indeed provide for the sharing of benefits arising from the use of genetic resources. However, as this sharing is bilateral between the provider of the physical material and its user, it is not suited to DSIs. Indeed, the considerable number of DSIs, their digital nature and consequently their irreversible circulation on an international scale across thousands of open-access databases for millions of users, makes such an adaptation impossible. This is why COP15 proposed a multilateral systemxv to be implemented through the Cali Fundxvi decided at COP16, which is intended to be funded on a voluntary basis – which is the main problem – by the primarily industrial users of DSI. The financial mechanism, which could involve the payment of 0.1% of turnover or 1% of the user’s profit, is expected to be decided at COP17 in Yerevan (Armenia) in October 2026. However, industry in the Global North remains broadly opposed to such a benefit-sharing system, as it considers that the use of DSIs does not constitute a direct use of physical resources and should therefore not be subject to these obligationsxvii. Patent applications filed by this industry on the basis of these DSIs therefore currently benefit only the industry itself.Other international instruments seek to establish benefit-sharing rules for DSIs. This is notably the case with the BBNJ Agreement on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdictionxviii as well as the WHO (World Health Organisation). They could opt for the system to be decided by the CBD or develop their own mechanism, or even a combination of the two, at the discretion of the industry players called upon to contribute.Intellectual property rights in a vacuumThere are currently several points of contention surrounding the issue of DSIs, reflecting the application of intellectual property rights to innovations that are far removed from practical use. On the one hand, the decisions of patent offices apply only in the countries that adhere to them, as is the case with the EPO, which remains focused on patentability criteria and the existence of a demonstrated effect (function) of a sequence, whether or not identified in a database. On the other hand, there is an international law that claims to seek to protect biodiversity, as well as its custodians and providers, by promoting the equitable sharing – despite the ineffectiveness of the Cali Fund – of the benefits derived from DSIs with the countries providing genetic resources.The various industrial players in the North who file numerous patent applications based on DSIs will use these rights in the traditional manner (as bargaining chips, in infringement actions, in litigation, for licensing, etc.). But their patent portfolios, which are set to become vast, will also, for many of them, cover industrialists, indigenous peoples and farmers in the Global South, from where the majority of the biological material underlying these DSIs originates. It is therefore conceivable that an Indonesian farmer might have to pay royalties to a multinational that has exploited a DSI derived from his own traditional varieties, or might no longer have any right to use them, or that a Kenyan community might have to do the same for a therapy based on an anti-malarial plant originating from its territory, where it is already used for this purpose.Unless an urgent response is provided to the industry’s use of DSIs – which is intense, daily and legally effective – the situation will persist. This would notably entail making restrictions on the patentability of genetic resources, including their genetic components, mandatory, as well as a contribution to the Cali Fund. Otherwise, the issues of biopiracy and the sharing of benefits derived from these DSIs risk remaining the primary sources of contemporary injustice in the field of intellectual property.ii Denis Meshaka, "Despite negotiations in 2024, disagreements over DSIs persist", Inf’OGM, 7 March 2025.iii Convention on Biological Diversity, “Submission from the secretariat of the Commission on Genetic Resources for Food and Agriculture: exploratory fact-finding scoping study on ‘digital sequence information’ on genetic resources for food and agriculture”, 17–29 November 2018.iv Secretariat of the Convention on Biological Diversity, “Combined Study on Digital Sequence Information in Public and Private Databases and Traceability”, 29 January 2020.v Three major databases are considered the key players: the EMBL-EBI (European Molecular Biology Laboratory – European Bioinformatics Institute), the DNA DataBank of Japan (DDBJ) and GenBank, hosted by the National Center for Biotechnology Information (NCBI) in the United States. Together, these databases form the International Nucleotide Sequence Database Collaboration (INSDC).vi The concept of the Global North/Global South refers more to a historical and economic structuring of power relations than to a legal or geographical categorisation.Countries that can be considered part of the Global North, with strong technological and scientific capabilities: the United States, the European Union, Canada, Japan, Australia and New Zealand.Countries that can be considered part of the Global South, rich in biodiversity: Kenya, Nigeria, South Africa, Brazil, Mexico, Peru, China, India, Indonesia, the Philippines.Certain hybrid countries combine high biodiversity with technological and scientific power: China, India, Brazil, South Africa, but also the United States.vii Denis Meshaka, "Patents on life: extension through language and law", Inf’OGM, 27 March 2026.viii Convention on Biological Diversity, “Study to identify specific cases of genetic resources and traditional knowledge associated with genetic resources that are in transboundary situations or for which it is not possible to grant or obtain prior informed consent”, 9–14 November 2020.Eric Meunier, "Des vitamines et additifs produits par des OGM", Inf’OGM, le journal, no. 174, January/March 2024.ix Denis Meshaka, "Patents, living organisms and GMOs/NGTs", Inf’OGM, 25 March 2026.x Researchers have developed a monoclonal antibody against the Ebola virus using the virus’s genetic sequence from GenBank, thereby eliminating the need for physical samples from the country of origin (PCT patent application WO2016123019).xi Denis Meshaka, "Deadlock over Digital sequence information within the ITPGRFA Agreement", Inf’OGM, 29 September 2025.xii WIPO, “Diplomatic Conference for the Conclusion of an International Legal Instrument on Intellectual Property Related to Genetic Resources and Traditional Knowledge Associated with Genetic Resources”, 13–24 May 2024.xiii K.M. Gopakumar, “WIPO opens more widely the door to biopiracy”, Inf’OGM, 6 November 2024.xiv Denis Meshaka, “Patents on life: extension through words and law”, Inf’OGM, 27 March 2026.xv Denis Meshaka, "COP15 : accord a minima sur les ressources génétiquescord a minima sur les ressources génétiques", Inf’OGM, 22 December 2022.xvi Convention on Biological Diversity, COP16 in Cali, “Decision 16/2, Digital Sequence Information on Genetic Resources”, 1st November 2024.xvii IFPMA, “Opening statement at COP 16: Multilateral mechanism (MLM) for digital sequence information (DSI)”, 21 October 2024.xviii United Nations, “Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas beyond National Jurisdiction”, 2024. Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [38] => Array ( [objectID] => 22273 [title] => A robot to pollinate genetically modified tomatoes [timestamp] => 1776038400 [date] => 13/04/2026 [annee] => 2026 [url] => https://infogm.org/en/a-robot-to-pollinate-genetically-modified-tomatoes/ [image] => https://infogm.org/wp-content/uploads/2026/04/d979175a-031a-459c-8432-7345364c762e-768x553.jpg [extrait] => Agritech is the convergence of genetics, robotics and digital technology. The tomato we’re about to discuss could serve as a symbol of this: it has been genetically modified to be more easily pollinated by a robot, which is itself controlled by a network of connected computers, commonly referred to as “artificial intelligence” (“AI”). This “innovation” is, above all, an illustration of the current headlong rush toward technology. [chapo] => Agritech is the convergence of genetics, robotics and digital technology. The tomato we’re about to discuss could serve as a symbol of this: it has been genetically modified to be more easily pollinated by a robot, which is itself controlled by a network of connected computers, commonly referred to as “artificial intelligence” (“AI”). This “innovation” is, above all, an illustration of the current headlong rush toward technology. [texte] => In China, researchers from several public research centers, including the Institute of Genetics and Developmental Biology of the Chinese Academy of Sciences, have genetically modified a tomato to produce “male-sterile lines bearing flowers with exserted stigmas”i. Let’s break this down. In tomatoes, the stigmas (the part of the flower that receives pollen) are enclosed or hidden inside the stamen tube formed by the five fused stamens. The tomato is primarily self-pollinating: it self-fertilizes. In the open air, the wind or insects, through the air movement created by their wing beats, allow pollen to fall onto the stigmas and fertilize them. Self-pollination is a natural barrier to the production of F1 hybrid lines (the controlled crossbreeding of two different plants). To produce these F1 hybrids, tomatoes must therefore be manually castrated (removal of the anthers that produce pollen, i.e., the male gamete) so that they can be fertilized by pollen from another tomato line. This operation alone accounts for 70% of the production cost of F1 hybrids, according to the previously cited article published in Cell.A Tomato with Two GMO ParentsThe research team selected two types of genetically modified tomato parental lines. The first is described as “male-sterile” because it will not produce pollen. Consequently, it will receive pollen from the other line. It is based on the Ailsa Craig variety. Using the CRISPR complex, the researchers induced a genetic modification in the GLO2ii gene (which belongs to the MADS-box gene family, which plays a key role in floral development). The result is a tomato with an exserted stigma and male-sterility.The second line, which could be qualified as “male”, is based on a wild tomato (Solanum pimpinellifolium) used by researchers for its resistance to certain diseases, its taste, etc. But it has two drawbacks for breeders: its size and its photoperiod – the reaction of living organisms to variations in the length of day and night – which are unsuitable for greenhouse conditions. The researchers again used CRISPR to genetically modify the sequences responsible for flowering (SP and SP5G). The result: a more compact cherry tomato that can flower continuously under artificial lighting.Next comes the robot. Equipped with two connected cameras, it is designed to analyze images of flowers from the two parental lines in real time. To do this, the algorithm first had to be “trained” using thousands of photos of tomato flowers. According to the robot’s developers, the algorithm improves with each attempt. But this requires a team of people sitting behind screens to “label” this data, as reported in an article by Basta!. All this information is stored in enormous data centers that consume vast amounts of energy and water. In practice, the robot vibrates the pollen-donor line, causing the pollen to fall into a box. It collects the pollen and deposits it on the tip of the pistil of the male-sterile line, which receives the pollen.In summary, the researchers created a male-sterile tomato by genetically modifying it and then used a robot to fertilize it with pollen collected from another line, which was also genetically modified. This enables the continuous greenhouse production of F1 hybrid tomatoes, 24/7. According to the researchers, this strategy has also been implemented for soybeans. Soybeans, due to their tightly closed flowers, are in fact one of the most self-pollinating plants and are among the most resistant to industrial F1 hybrid productioniii.Hybrids: A Booming MarketThe production of F1 hybrids is nothing new. For a century, it has been the first step in the process of plant privatization. Indeed, a farmer who uses F1 hybrids cannot use his harvest to produce his own seeds without risking the degeneration of his future crops. This control over “reproduction”, through technological and legal barriers, is justified in the name of “hybrid vigor” (heterosis) – a yield increase that varies greatly depending on the species and which, moreover, is accompanied by a significant decline in the nutritional quality of the crops.According to Global Market Insights, the global market for F1 hybrid seeds was valued at 56 billion U.S. dollars in 2023 and could reach 110 billion dollars by 2032iv. Another consulting firm estimates the market at $33 billion in 2025 and projects that it will reach $85 billion by 2034v.In China, hybrids accounted for 77.6% of the seed market in 2022, while open-pollinated varieties accounted for 22.4%vi. The Chinese market for F1 hybrid tomato seeds is particularly significant: it is valued at 8.5 billion yuan (approximately 1.1 billion euros) in 2024 and could exceed 15 billion yuan by 2030 (approximately 1.90 billion euros)vii.Thus, a company that adopts the technology package described in this article could see its revenue skyrocket. For now, this is not a commercial product but a scientific project. However, the authors state that they have filed patents, without providing further details on the claims of these patents. Nevertheless, for commercial use, any company wishing to bring this tomato to market will need to obtain licenses for certain technologies used, such as CRISPR/Cas9.China: from “rustic” tomatoes to smart greenhousesChina is the world’s leading tomato producer, with 68 million tons projected for 2025, and could reach 108 million tons by 2030viii, the vast majority of which is destined solely for the Chinese market. Currently, tomatoes are primarily produced by small-scale farmers, often under contract with large companies. But greenhouse tomato production is skyrocketing, and significant investments are being made in this sector. These are often “high-tech” greenhouses.Runtai Agricultural Technology Development Co., Ltd. has established an agricultural complex covering nearly 17 hectares in the city of Kokdala, in the Xinjiang Uyghur Autonomous Region (northwest China), dedicated to the intensive production of tomatoes. According to the Chinese media outlet People Dailyix, in these greenhouses, tomatoes are grown year-round, without soil, surrounded by numerous sensors to “optimize” production, just like in the Netherlands… In this article, the company’s executive director, Tang Yue, emphasizes that “compared to traditional open-field planting, the park-based planting method offers significant advantages, increasing annual yield by a factor of 5 to 6 and using only 1/20th of the amount of water required for traditional irrigation, making the crop more environmentally friendly”. However, this equation overlooks the energy and water costs associated with digital technology, which is used extensively in this park. And beyond the environmental issue, what about small-scale farmers? They will never be able to withstand such competition and will therefore have to abandon their land.Another example is Beiing Hongfu Agriculture, one of China’s largest tomato greenhouses, spanning 50,000 square meters. The company has invested 320 million yuan to develop a semi-automated, controlled system. The facility incorporates numerous sensors to “monitor, control, and optimize the environment”, as described in an article promoting these greenhousesx. The sensors collect data on air temperature and humidity, light, CO2 concentration, and soil moisture, among many other parameters. This data is then analyzed and compared to desired optimal standards, before commands are automatically sent to a network of equipment to control the greenhouse. “Hongfu” tomatoes can be found in supermarkets across China, including Carrefour stores in Beijing and Metro stores in Shanghai. The article, which reads more like an advert than a real article, notes, however, that “amid the bevy of technological tools in use at the facility, pollination is still done in the most traditional way possible – with the help of bumblebees”. This detail is intriguing.Robots and GMOs for pollinationIndeed, given these significant investments in tomato greenhouses, can’t we imagine another use for this GMO tomato and its pollinating robot? Couldn’t this combo also be sold to address the decline of bumblebees? Pollinating insects are indeed in decline worldwidexi, primarily due to the inputs used in industrial agriculturexii.As we have seen, tomatoes are primarily self-pollinating. Naturally, they do not need pollinating insects to reproduce. However, in greenhouses, without “natural” wind, self-pollination is less effective: pollen can get stuck in the anthers. This is where bumblebees come in. By landing on the flowers and vibrating them with their thoracic muscles (or flight muscles), they allow the pollen to detach and fall onto the stigma. This is known as sonication pollination. Their presence is often associated with yield increases of between 20 and 30%. Their decline forces growers to import costly colonies, which are often sensitive to stress, transport and heatxiii. Will pollinator robots one day be competitive with these farmed bumblebees? Will they enable better pollination than bumblebees?This technological project is nothing more than a headlong rush: we are attempting to repair the damage caused by overdeveloped industrial agriculture and its technologies with even more technology, thereby creating new damage and new dependencies, even though it is not an effective long-term solution. On the contrary, it amounts to digging ourselves deeper into a system that has been criticized by numerous studies. This is the analysis offered by Frédéric Jacquemart in an article published by Inf’OGM: “The field of GMOs is no exception to this brilliant strategy. Notably, decision-makers, having observed that genetically homogeneous crops inevitably lead to the emergence of pathogens requiring even more pesticides, are implementing programs aimed at restoring cultivated biodiversity. How? By generating this biodiversity using the tools of what they call ‘genome editing,’ which, in current practice, means CRISPR/Cas”. Frédéric Jacquemart and his co-signatories state that it is “urgent to establish a comprehensive (systemic) assessment that takes into account the organization of the complex natural systems on which we depend in order to guide public decision-making”… And it is sometimes wise to accept that traditional farming and agroecological practices are more effective for feeding the world while preserving health and the environment.i Yue Xie, Tinghao Zhang, Minghao Yang, Hongchang Lyu, Yupan Zou, Yangchang Sun, Jun Xiao, Wenzhao Lian, Jianhua Tao, Hua Han, Cao Xu, « Engineering crop flower morphology facilitates robotization of cross-pollination and speed breeding », Cell, Volume 188, Issue 21, pp. 5809-5830, 16 October 2025.ii The genetic mutation is known as "glo2-inver" and consists of an inversion of 2,795 nucleotide pairs and a translocation of 420 nucleotide pairs.iii Jean-Pierre Berlan, La Planète des clones, Editions la Lenteur, 14 June 2019, 240 p.iv Global Market Insights, « Hybrid Seeds Market Size & Share 2024 - 2032 », August 2024.v Fortune Business Insights, « Hybrid Seeds Market Size, Share And Analysis by Crop Type(Cereals (Rice, Corn, Barley, and Sorghum), Oilseeds (Canola, Soybean, Cotton, and Sunflower), Fruits & Vegetables (Tomato, Cabbage, Chilli & Bell pepper, Okra, Cucumber, and Melons)), And Regional Forecast, 2026-2034 », 16 March 2026.vi Mordor Intelligence, « China Seed Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031) ».vii Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, « Crop Matchmakers: AI-powered Robotic Breeder GEAIR Takes Over Hybrid Crop Breeding », 11 August 2025.viii Fortune Business Insights, « Asia Tomato Market Size, Share & Industry Analysis, By Product Type (Fresh and Processed), By Nature (Conventional and Organic), By Form (Whole/Fresh, Canned, Diced, Frozen, Pulp, Paste, Puree, and Powder), By End-Use (Household/Retail [Supermarkets/Hypermarkets, Convenience Stores, and Others], Foodservice, and Industrial [Sauces & Condiments, Ready Meals, Snacks, Beverages, and Others]), and By Country, Forecast Period 2026–2034 », 16 March 2026.ix « Xinjiang : à Kokdala, la technologie permet de récolter plus de tomates avec moins d’eau », Le Quotidien du Peuple en ligne, 21 June 2024.x Wang Yulian, « Explore one of China’s largest intelligent tomato greenhouses », CGTN, 26 June 2020.xi Fred Lewsey, « Pollinators – The first global risk index for species declines and effects on humanity ».xii Muséum national d’Histoire naturelle, « Le déclin des insectes met en péril le vivant », 9 May 2023.xiii Xavier Van achter, « Variation de la taille des bourdons en conditions contrôlées et naturelles », Mémoire en Biologie des Organismes et Écologie, Université de Mons, 2019. Christophe NOISETTE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [39] => Array ( [objectID] => 21998 [title] => In 2020, France believed it was possible to distinguish GMOs/NGTs [timestamp] => 1775606400 [date] => 08/04/2026 [annee] => 2026 [url] => https://infogm.org/en/in-2020-france-believed-it-was-possible-to-distinguish-gmos-ngts/ [image] => https://infogm.org/wp-content/uploads/2026/03/Analyzing_Immune_Activation_33597341278-768x778.jpg [extrait] => If the European Commission manages to convince the European Council and Parliament to accept its legislative proposal, many GMOs could be deregulated in Europe. Since the 2010s, it has been argued that these GMOs produced using new techniques (GMOs/NGTs) cannot be distinguished from organisms that have arisen naturally or through conventional breeding. Yet, in 2020, France explained in detail how to make this differentiation technically possible. A fact that the French government seems to have forgotten since… [chapo] => If the European Commission manages to convince the European Council and Parliament to accept its legislative proposal, many GMOs could be deregulated in Europe. Since the 2010s, it has been argued that these GMOs produced using new techniques (GMOs/NGTs) cannot be distinguished from organisms that have arisen naturally or through conventional breeding. Yet, in 2020, France explained in detail how to make this differentiation technically possible. A fact that the French government seems to have forgotten since… [texte] => It was 2020 when the French government responded to a questionnaire from the European Commission on GMOs/NGTsi . The Commission was then consulting EU Member States on their practices and views to prepare what would become, in 2023, its proposal to deregulate these GMOs. However, in the introductory remarks of this text, the Commission states that "in some cases, products containing or consisting of plants with genetic modifications introduced by NGTs cannot be differentiated from products containing or consisting of plants bred with conventional breeding methods by analytical methods"ii . This point is all the more significant given that these “some cases” will be extended to all GMOs/NGTs and will therefore form the basis for the proposal to deregulate virtually all of them. Whilst Inf’OGM has on several occasions highlighted the feasibility of identifying and distinguishing these GMOs, the French government had already reached the same conclusion as early as 2020.Are GMOs/NGTs really untraceable?As the French government noted in 2020, the initial observation is very basic, but deserves to be explained. As things stand, current European legislation on GMOs requires authorisations to be issued before any GMOs are released onto the European market. These authorisations are conditional upon applicants providing analytical methods to detect and identify their GMOs. France states that “NGT products authorised at European level in future should logically comply with this obligation, thus providing the competent authorities with the analytical tools needed to perform checks”. With such methods at its disposal, France explains that it has identified “no particular difficulties [...] to implementing NGT product traceability, as it will be possible to verify the documentary traceability information given by analytical testing".However, quite logically, it is subsequently clarified that in the case of unauthorised NGT products, the difficulty arises as to whether they would be detectable and identifiable in the event of their illegal presence in Europe. At this stage, France identifies two cases in which the question of the ability or inability to detect and identify these GMOs arises.The first concerns organisms modified by the insertion of genetic sequences “that do not contain the sequences routinely screened for and for which no prior information is available on the sequences introduced”. In response to these cases, which do not appear to be the most difficult to resolve, as demonstrated by the work of the Co-Extra network in Europe on unknown transgenic GMOsiii, France states that “exploratory research is being conducted by ANSES” (detection of exogenous sequences using high-throughput sequencing methods and statistical analysis, for example). Taking a cautious approach, France stated that “it would be premature at this stage to comment on the possibility of using this method for the detection of plant products derived from NGTs containing DNA insertions”.The second difficult case that could arise concerns “NGT products which have mutations without DNA having been inserted”. In this regard, the government states that “the detection of mutations is theoretically possible when information is available on the modified sequences or their precise location”, with, once again, work by ANSES enabling such mutation detection at a rate of “single-nucleotide mutations”. It adds elsewhere in its response that, for these cases, “a multidisciplinary approach involving laboratories carrying out basic research into genome plasticity, GMO-detection laboratories and IT specialists could be explored. This would enable the information available concerning the modifications which may be made to genomes to be collected and processed so as to translate it into molecular tools for detecting those modifications”. Whilst the government considers that this approach would not make it possible to determine whether the modifications occurred naturally or were obtained by NGT, it nevertheless states that by “mounting a profile on a set of genome positions, it would be possible to assess the likelihood of a given profile occurring naturally”. It is worth noting here, in addition, that reviewing patents can also provide information on the genetic modification processes used.At national level, France explains that ANSES “wishes bring together research teams for this approach, but such research requires substantial funding – obtained, for example, through a call for expressions of interest”. The European Commission could also play a role since, “to supplement the information available on NGT products placed on the market or developed around the world, the Commission could initiate discussions with non-EU countries in order to identify more specifically the conditions in which the data needed to detect such products could be transmitted to the European authorities. Indeed, some non-EU countries have set up a procedure whereby before they determine the legal status of products obtained from new techniques, those products are subject to examination on the basis of a file. This means that data is available from the authorities of these countries even for products not covered by the regulations”.However, the government maintains the view that “for products that are not declared or for which no information is provided on the genetic modification, no solution has been identified to enable their detection and therefore the implementation of controls”. The information available on GMOs/NGTs that are likely to be placed on the market “is very incomplete”. Above all, “in the event that a mutation were detected, no method would allow a distinction to be made between a natural mutation, a mutation resulting from random mutagenesis or a mutation resulting from a NGT, in the absence of a specific trace in the genome”. But solutions do exist, and the French government lists some of them for the European Commission.France highlights solutions, some of which are already in place!One of the solutions highlighted by France was analytical traceability (which relies on laboratory analyses). This is essential as a complement to documentary traceability to avoid “distortions in competition between, for the one part, European producers using NGTs for which it would be possible to check the proper implementation of documentary traceability and, for the other part, non-EU countryproducers using NGTs for which the inspection authorities would be forced to accept import certificateswithout any means of checking their validity”.To overcome the difficulties involved in carrying out such analyses in cases of GMOs for which no detection or differentiation methods exist, France proposed several avenues to the European Commission. It stated that the establishment of a major European research programme “could enable progress to be made on the issue of the traceability of NGTs”. This programme could focus on avenues such as “research on the characteristics of techniques that can provide information on genetic modifications to products”, or on the fact that “changes obtained by genome-editing techniques may have different characteristics to those generated by mutagens or occurring naturally in nature. They may affect areas of the genome not normally subject to mutations, or occur on all or part of the copies of the gene”.In addition to this European research programme – which will ultimately not be implemented by the Commission – France highlights ongoing initiatives which it suggests are useful. This includes the Europol programme combating counterfeiting through its "OPSON on seeds, plants and intellectual property rights" operation. France points out that this programme “organises the collection and exchange of information between national anti-fraud agencies. 1 500 institutions in networks are able to react to the slightest alert, including the units of DG SANTE responsible for seeds”. On 6 March 2020, representatives of this programme were questioned about the identification of counterfeit products “derived from NGTs, which are often presented as indistinguishable from non-counterfeit products derived from traditional breeding processes”. According to the French government, their response was that Europol has “never needed to carry out a DNA analysis. The documentation, along with surveillance of the internet and the dark web, had up to now always been sufficient. According to Europol, it is not impossible to identify and distinguish new GMOs which have not been declared or identified as such”. For Europol, the need to carry out DNA analyses is a possibility that should not be ruled out.Another possibility suggested concerns the implementation of a so-called matrix approach. This would involve combining “documentary approaches providing convergent bodies of indirect knowledge, presumptions and evidence with analytical approaches. Databases and decision-making support tools could assist the analyst in routine work formalised in advance by research”.Finally, in 2020, the French government did not rule out the possibility of a regulatory framework for GMOs/NGTs, since the issues related to their detection and differentiation could be overcome by combining existing research programmes at the time, surveillance operations already in place such as Europol, or by setting up new research programmes. Although, according to the government, this approach would be costly, it is nonetheless not impossible. Paradoxically, whilst, at the end of 2025, France’s representative in Brussels argued in favour of deregulating these numerous GMOs, the government wrote in 2020 that it considered that "in general, while it is true that detection methods are currently not available for all NGTs, the French authorities consider that this should not prevent the implementation of regulations to govern these new techniques"... i French Government, "Questionnaire on new genomic techniques to contribute to the study requested by the Council and endorsed by the Joint Working Group of GMO competent authorities on new genomic techniques on 15 January 2020", 3 July 2020. ii European Commission, "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625", 5 July 2023. iii Eric Meunier, “Nouveaux OGM : leur traçabilité confirmée”, Inf’OGM, 12 August 2021. Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [40] => Array ( [objectID] => 21527 [title] => MEXICO – Stacked GM corn: what are the risks? [timestamp] => 1775174400 [date] => 03/04/2026 [annee] => 2026 [url] => https://infogm.org/en/mexico-stacked-gm-corn-what-are-the-risks/ [image] => https://infogm.org/wp-content/uploads/2026/03/sin-maiz.png [extrait] => Although it went largely unnoticed by the media, a victory was secured in Mexico on 17 March 2025 by indigenous peoples and certain scientists: a ban on the cultivation of GM maize was enshrined in the national Constitution. More recently, on 21 January 2026, another milestone victory was achieved by those campaigning against the risks posed by GM maize imported from the United States. But what is this maize, and what risks does it pose? [chapo] => Although it went largely unnoticed by the media, a victory was secured in Mexico on 17 March 2025 by indigenous peoples and certain scientists: a ban on the cultivation of GM maize was enshrined in the national Constitution. More recently, on 21 January 2026, another milestone victory was achieved by those campaigning against the risks posed by GM maize imported from the United States. But what is this maize, and what risks does it pose? [texte] => Even before the constitutional reform of March 2025, it had become illegal to grow genetically modified maize in Mexico. However, according to experts, this still occurs, particularly for scientific purposesi. For this country, the major problem is that cross-pollination with native maize varieties has been taking place since the introduction of GM maize in the early 1990s. Contamination had in fact been observed by scientists as early as 1998ii! Nowadays, transgenic maize in Mexico, mainly imported from the United States, is used to feed livestock. Nevertheless, contamination is still being detectediii.Due to their genetic modifications, these imported maize varieties are tolerant to herbicides and capable of producing Bt insecticidal proteins.However, in response to insect resistance to Bt toxins produced by genetically modified plants and weed resistance to herbicides, the biotechnology and seed industry has stacked transgenes within a single plant. Maize is the prime example of this accumulation of modified genes.A recent publication by Mickaël Antoniou, a researcher at King’s College London (United Kingdom), commissioned by the Mexican authorities, examines the risks of stacked genes and the consequences of this stackingiv.The greatest danger: cross-pollinationIt is estimated that the history of maize began around 9,000 years ago in Mexico, where a local plant, teosinte, was cultivated by the earliest Native American civilisations at an altitude of 1,500 metres. Teosinte is a plant adapted to the tropical climate and humid summers; it bears numerous ears, each containing only a few grains. It is believed that the evolution of teosinte, the ancestor of maize, occurred both naturally through spontaneous genetic mutations and, above all, through farmer-led selection. This selection process led to the development of a vast number of maize varieties adapted to different climates and altitudes, providing a food source with a yield far superior to that of teosinte.Following cross-pollination between North American GM maize and indigenous maize, contamination is jeopardising the integrity of these numerous indigenous maize populations, as it reduces the genetic diversity of maize - a diversity also threatened by patents. The adaptive capacities of indigenous maize are thus reduced, thereby limiting the possibilities for a varied diet across different regions. The nutritional quality of the maize is also significantly affectedv.Thus, contamination poses the greatest danger from these GM crops, which harm all small farmers and the entire Mexican population, particularly as maize, in all its diversity, represents a strong cultural value linked to Mexican identity. This encroachment on indigenous maize by industrial GM maize has become a driving force behind a remarkable citizens’ strugglevi. It is against this backdrop that, in 2026, the "Colectividad en Defensa del maíz" has just won a final legal victory in Mexico, with the court ruling that "the country’s Ministry of Economy had violated the constitutional right to petition"vii. Indeed, the Ministry had failed to respond to a petition from the collective calling for a counter-action against the United States for depriving them of the benefits of the Mexico-US treaty “in the field of agricultural biotechnology”. Since 2013, when the moratorium on GMO maize sowing came into force, this struggle by local collectives has been successful, despite all the legal challenges brought by multinational companies such as Monsanto, Syngenta and Dow-Dupont (now Corteva).Gene stacking in maize and the assessment of its risksGene stacking, the industry’s mechanistic response to the emergence of resistance, is not a recent phenomenon.As early as 2012, Inf’OGM noted the presence, in a single maize variety - maize 3122 (imported into Europe) - of four genetic modifications involving the insertion of transgenes designed to express the Cry1Ab, mCry3A, Cry34/35Ab1 and Cry1F to kill the European corn borer and the corn rootworm, and two genetic modifications to tolerate two herbicides, one based on glyphosate and the other on glufosinate, making a total of six stacked transgenesviii. Sub-combinations are possible, either in the laboratory or following the sexual reproduction of the maize in question. However, no risk assessment has been carried out on these.As for the risk assessment of maize with all stacked transgenes, Mickaël Antoniou, in his report for the Mexican governmentix, emphasises that “a direct assessment of the toxicity of these stacked varieties of GM maize has simply not been carried out”. In the September 2025 press articlex, he adds: “What’s happened over the years is that, as insects have become resistant to the early Bt toxins that were engineered into the corn, companies have added more variants of Bt toxins into the crop – up to six now, in some varieties. In addition, you’ve got not just glyphosate-tolerant genes, but up to three different herbicide-tolerant genes added on top of that”. He goes on to add: “What regulators have done – no doubt, what industry has convinced them to do – is that if a GMO crop was passed as safe with one or two Bt toxins in it, it was assumed that when you combine more traits into one crop, there is no additional risk”. Similarly, he challenges the principle of substantial equivalencexi and criticises the limited use of proteomics (the science of all proteins in a cell, an organism, etc.) and other so-called ‘omics’ techniquesxii to assess the toxicity of stacked-gene GMOsxiii.In Europe, gaps in the risk assessment of the first transgenic maize varieties had already been highlighted by Inf’OGM. This assessment is based either on erroneous assumptions (such as the claim that the Bt insecticidal proteins produced by these maize varieties are identical to those produced by the original bacterium), or on invalid tests, as in the case of maize Mon810xiv.Health risks associated with gene stackingMickaël Antoniou explains that the health risks of GM maize and its associated pesticides stem from three main sources: the Bt insecticidal proteins produced by genetically modified plants, DNA damage caused by the genetic modification processes themselves, and the associated herbicides used on genetically modified crops.The issue is of particular significance in Mexico, where maize, a symbol of national identity, forms the basis of the population’s diet.Regarding Bt toxins, he points out that they “have never been an integral part of the human diet, especially in the special form they have been engineered into the crop” and, further, “evidence suggests Bt toxins may survive digestion, enter the bloodstream”.He concludes that there is therefore a risk of toxic or allergic reactionsxv.Regarding what we call unintended effects on DNA, he states that “the GM transformation process – the process by which a GMO is generated in the laboratory – is highly mutagenic. What do I mean by that? Inadvertently, you create unintended damage to the DNA of the crop. Much of this DNA damage remains in the final marketed product. What is the danger from this? DNA damage can change the function of multiple genes – not just one, but many genes. And by changing the pattern of gene function in the organism, you will change its biochemistry and its composition, including the unexpected production of new toxins and allergens”. The risks associated with herbicides are already well documented in the scientific literaturexvi. For his part, Mickaël Antoniou explains: “we conducted a rat feeding study exposing animals to a mixture of glyphosate, 2,4-D and dicamba”xvii. The studies showed that “exposure to glyphosate resulted in glomerular and tubular dysfunction, and increased thyroid hormone levels in a dose-dependent manner in dams. The additive effects were evident from treatment with the glyphosate, dicamba, 2,4-D mixture on kidney and thyroid function of dams”.The researcher concludes that “regulators are failing to consider combinatorial toxicity”, that is to say, the combined deleterious effects – genetic, molecular and cellular disruptions – resulting from gene stacking. These effects are, however, revealed by proteomics as well as by metabolic studiesxviii.Mexico is indeed facing a major health problem for its inhabitants due to contamination, but also for farm animals fed with this maize containing stacked genetic modifications. The report written by Mickaël Antoniou highlights the numerous health risks associated with such maize, to which must be added the environmental risks posed by the pesticides used on it. This reinforces the country’s arguments for exercising caution regarding these GMOs. The fight to preserve indigenous maize is therefore more than justified, a fact understood by the current Mexican Presidentxix.i Kate Linthicum, ‘Don’t mess with Mexico’s maíz: Constitutional amendment to ban GMO corn seeds’, Los Angeles Times, 13 March 2025.Marie-Pierre Smets, member of the Board of Directors of FIAN Belgium, “Le maïs mexicain, au cœur des luttes paysannes”, 28 October 2022.ii Lilian and Bernard Eddé, “Contamination du maïs mexicain : la controverse scientifique”, Inf’OGM,1st November 2003.iii The latest in 2023.United Mexican States, "Mexico – Measures Concerning Genetically Engineered Corn (MEX-USA-2023-31-01)", p. 39, 15 January 2024.iv Stacy Malkan, "Are GMOs safe? A molecular geneticist speaks out", U.S. Right to Know, 10 September 2025.Professor Michael Antoniou, King’s College London, UK, "EXPERT REPORT ON THE TOXICITY OF AGENTS CONTAINED IN GENETICALLY ENGINEERED CORN AND THE HEALTH RISKS ASSOCIATEDTO ITS CONSUMPTION”, 28 May 2024.Dr Michael Antoniou is a professor of molecular genetics in the Department of Medical and Molecular Genetics at King’s College London (United Kingdom).v Government of Mexico, “Mexico – Measures Concerning Genetically Engineered Corn (MEX-USA-2023-31-01)”, p.39, 15 January 2024.vi Led primarily by the coalition “La Colectividad en Defensa del maíz”.vii Demanda Colectiva Maíz, “Demanda Colectiva Maíz gana sentencia a Economía por desatender petición de contrademandar a EEUU”, 21 January 2026.viii Eric Meunier, “ETATS-UNIS – Deux « super maïs » OGM tuant six ravageurs et résistant à deux herbicides”, Inf’OGM, 29 May 2012.ix Government of Mexico, “Mexico – Measures Concerning Genetically Engineered Corn (MEX-USA-2023-31-01)”, p.39, 15 January 2024.x Stacy Malkan, “Are GMOs safe? A molecular geneticist speaks out”, U.S. Right to Know, 10 September 2025.xi The principle of substantial equivalence essentially involves comparing the components of a transgenic plant (proteins, nutrients, minerals, etc.) with those of conventional plants. If the differences observed correspond to known differences between varieties of the same species, the transgenic plant is considered to be substantially equivalent.xii These are various disciplines of biology whose names end with the suffix "-omics", such as genomics, proteomics, transcriptomics, metabolomics (metabolic studies)…xiii Stacy Malkan, "New scientific methods challenge claims that GMOs and glyphosate are safe", U.S. Right to Know, 16 September 2025.xiv Eric Meunier, "Risques OGM dans l’UE : de moins en moins bien évalués", Inf’OGM, le journal, no. 168, July/September 2022.Frédéric Jacquemart, “Expertise des OGM : l'évaluation tourne le dos à la science”, Inf’OGM, 2012.xv Stacy Malkan, “Are GMOs safe? A molecular geneticist speaks out”, U.S. Right to Know, 10 September 2025.xvi For example:Mesnage, Robin et al., "Major pesticides are more toxic to human cells than their declared active ingredients", BioMed Research International, vol. 2014, 2014.Defarge N, Takács E, Lozano VL, Mesnage R, Spiroux de Vendômois J, Séralini GE, Székács A., "Co-Formulants in Glyphosate-Based Herbicides Disrupt Aromatase Activity in Human Cells below Toxic Levels", Int J Environ Res Public Health, 26 February 2016.xvii Anca Oana Docea, Andrei Eugen Cirstea, Liliana Cercelaru et al., “Effect of perinatal exposure to glyphosate and its mixture with 2,4-D and dicamba on rat dam kidney and thyroid function and offspring’s health”, Environmental Research, vol. 237, part 1, 15 November 2023.xviii United Mexican States, "Mexico – Measures Concerning Genetically Engineered Corn (MEX-USA-2023-31-01)", p. 39, 15 January 2024.Mesnage, R., Teixeira, M., Mandrioli, D. et al., "Multi-omics phenotyping of the gut-liver axis reveals metabolic perturbations from a low-dose pesticide mixture in rats", Commun Biol 4, 471, 14 April 2021.xix Government of Mexico, « Plan Nacional de Maíz Nativo beneficiará 1.5 millones de campesinos: presidenta Sheinbaum", 13 November 2025. Annick BOSSU antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [41] => Array ( [objectID] => 21522 [title] => Since 2018, the EU has been able to regulate GMOs/NGTs [timestamp] => 1775001600 [date] => 01/04/2026 [annee] => 2026 [url] => https://infogm.org/en/since-2018-the-eu-has-been-able-to-regulate-gmos-ngts/ [image] => https://infogm.org/wp-content/uploads/2026/03/gdpr-security-data-information-europe-privacy-1450661-pxhere.com1_-768x514.jpg [extrait] => Prior to 2018, some Member States had decided not to submit certain applications for trials authorisation of GMOs obtained through new techniques (GMOs/NGTs) to the GMO legislation. However, in 2018, a ruling by the Court of Justice of the European Union (CJEU) clarified that these GMOs must indeed be treated as regulated GMOs. According to a 2021 report by the European Commission, these cases of wrongfully deregulated GMOs have been rectified, and the trials in question have been cancelled or brought into compliance with regulations. These cases suggest that regulating such GMOs is indeed feasible. [chapo] => Prior to 2018, some Member States had decided not to submit certain applications for trials authorisation of GMOs obtained through new techniques (GMOs/NGTs) to the GMO legislation. However, in 2018, a ruling by the Court of Justice of the European Union (CJEU) clarified that these GMOs must indeed be treated as regulated GMOs. According to a 2021 report by the European Commission, these cases of wrongfully deregulated GMOs have been rectified, and the trials in question have been cancelled or brought into compliance with regulations. These cases suggest that regulating such GMOs is indeed feasible. [texte] => In January 2025, a report issued by the Dutch government raised the question of whether the definition of GMOs as established by European Directive 2001/18 was interpreted in the same way by all Member Statesi. The responses received indicate that, prior to 2018, some had already dealt with GMOs/NGTs. In their transparent responses, certain Member States explained that they had then considered these GMOs to fall outside of the scope of Directive 2001/18, classifying them as exempted GMOs. It is a report published by the European Commission in 2021, four years before the Dutch report, that shed some light on these cases of national deregulation decisions. Following the 2018 CJEU’s ruling, which reminded everyone that these are regulated GMOs, these national decisions had to be reviewed.The public declarationsAccording to the 2025 Dutch report, certain Member States were asked prior to 2018 about the legal status of GMOs obtained through “directed mutagenesis”. At that time, the CJEU had not yet confirmed the response that these were regulated GMOs. Those Member States had therefore chosen to respond that such GMOs “were exempted from the application of the GMO legislation”. The same report specifies that in these cases, “evidence had been asked, e.g. by whole genome sequencing, that only the point mutations were present in the material”. Further clarification is provided for cases where “any other sequence, e.g. relating to the transforming plasmid used in the mutation technique, was present, the material was handled as GMO”. After 2018, the “position [regarding the deregulation of these GMOs] was adjusted following the [CJEU] judgement. This adaptation also required rapid alignment with compliance measures”. Which GMO cases are we talking about, and, more importantly, which Member States are involved?Adjustment to GMO status in certain statesWhile preparing its proposal to deregulate numerous GMOs - which it would present two years later - the European Commission published a study on these GMOs/NGTsii in 2021. In the responses of the 27 Member States, two questions are of particular interest.One question asked whether the Member States had registered “plant varieties obtained by NGTs” in their national catalogues. According to the responses receivediii, no varieties genetically modified using new techniques were listed in a national catalogue of plant varieties in 2020. Since such registration is mandatory for marketing seeds of plant varieties, it therefore appears that, officially, for the pre-2020 period, no varieties genetically modified using new techniques were marketed.Another question concerned “experience […] on the application of the GMO legislation, including experimental releases (such as field trials and clinical trials), concerning NGT-products”. The responses provide information on trials that may have been planned or conducted prior to 2018 and the regulatory framework that applied to them.BelgiumBelgium reports that it has processed three applications for field trials. One trial in 2011 involved cisgenic potatoes, and two others, in 2018 and 2019, involved genetically modified corn created using the CRISPR/Cas tool. Belgium specifies that an application for GMO corn (without clarifying whether it refers to one of the two previously mentioned applications) was initially submitted in 2016 and processed as exempt from GMO legislation. Belgium considered at the time that “the genetic modifications achieved in the plants are similar in type and extent to those that can be obtained via natural or induced (using chemical or physical agents) mutagenesis” and that they raised no “additional safety concerns as compared to products developed through conventional mutagenesis techniques”. However, in 2020, the response provided to the European Commission stated that the application had been resubmitted under GMO legislation and was being processed as such.DenmarkFor its part, while Denmark reports that it has not received any applications for the release of GMO/NGT plants, it has received applications for microorganisms in contained environments. It notes that, in the industrial sector, the Ministry “faces an increase in applications for production activities due to the fact that the gene-editing techniques (CRISPR) make it easier and faster to create new production strains”. Here, the country is referring to genetically modified microorganisms (GMMs) used in fermenters; this is hardly surprising, given that Denmark is home to the world leader in microorganisms, Novonesis.ItalyItaly also reports having received requests for authorisations or information. One example involved the contained use of genetically modified mosquitoes created through gene drive technology. In 2020, the year the response was provided, Italy stated that this contained use was “underway at the Innovation Hub of Genomics Genetics and Biology” as part of the “Target Malaria” project. However, the country does not specify how the request was handled, whether within the GMO regulatory framework or not. The University of Milan also inquired in 2017 about potential field trials of various “varieties of rice with mutations obtained through [...] genome editing techniques”. Without specifying the initial response, Italy explains that since 2018, an application must be submitted in accordance with Directive 2001/18.FinlandIn Finland, the Natural Resources Institute Finland (LUKE) conducted genetic modification research in 2020 using new techniques (which Finland refers to as “genome editing”) on barley, “with plans to expand into other crop species”. While Finland notes that managing this research as GMO-related implied “an increased administrative burden which slows the research”, it does not report any inability to comply with European GMO legislation. The same organisation was also conducting “GE [genome editing] on animal cell lines, currently only as a research tool with no applications to be released as animals or products”. In full transparency, Finland then explains that, following the 2018 CJEU ruling, “an interim decision that in the absence of legal certainty, the [CJEU] ruling is not extended to contained use [of GMOs/NGTs] before a binding legal analysis of it is received from the Commission Legal Service”. In February 2020, Finland also decided, contrary to the CJEU’s ruling, not to reverse its previous decisions, which stated that “deletion mutants obtained with new mutagenesis techniques are not in the scope of Gene Technology Act, if no foreign genetic material remains in the final organism”.GermanyIn Germany, the response indicates that, prior to the CJEU ruling in 2018, the country was already advising petitioners to comply with the requirements of Directive 2001/18. It notes that “projects involving NGTs have so far been carried out exclusively in closed systems”. However, three requests for clarification on the procedures for managing field trial projects involving GMO/NGT plants were submitted prior to 2018. Although it does not provide details on these projects, the German government states that “in one case, sequencing data that was subsequently requested showed that recombinant DNA from an integration event of the corresponding vector design was present. This shows the importance of the comprehensive sequencing of NGT organisms”. Germany concludes this point by noting that, following the CJEU ruling in 2018, the field trial projects were ultimately not conducted in Germany.NetherlandsIn the Netherlands, “since the 1990s many field trials with GM plants took place in the Netherlands, including trials with plants obtained by cisgenesis and intragenesis”. In a 2020 response to the Commission, the country also noted that a trial was planned for 2021 involving potatoes genetically modified using CRISPR. However, the 2018 CJEU ruling does not appear to have been a problem, as the Netherlands explained that “specific measures were not deemed necessary. The Netherlands generally considered products of NGTs/new mutagenesis techniques as GMOs before the [CJEU] ruling”.RomaniaFor its part, Romania reports an application for authorisation for the contained use of microorganisms modified by “the classical mutagenesis and CRISPR/Cas 9 technique”. This application, authorised in 2018, was processed in accordance with Directive 2009/41. This directive governs the contained use of GMOs. Since the CJEU ruling concerned Directive 2001/18, it therefore had no implications in that country.SwedenIn Sweden, the government informed the European Commission that “one application for introduction of a variety produced with an NGT in the national variety catalogue was withdrawn following the [CJEU] ruling”. It explains that this withdrawal was carried out because the applicant did not want its variety to be considered genetically modified and “will therefore not commercialisetheproduct in the European Union”. No details regarding the variety in question are provided in the questionnaire returned by Sweden.Spain’s response is difficult to interpret The response received from the Spanish government is ambiguous, to say the least, regarding whether the government has actually applied the CJEU’s decision to applications received before 2018. While it states that “the case-by-case principle and GMO legislation are applied to the notifications which could arise for contained use or voluntary release of products obtained by NGT”, it refers to tables listing these applications, which it claims are “notifications for products obtained by NGT presented or, where appropriate, authorised in Spain in line with applicable GMO legislation”. However, the tables provided are not very informative due to truncated rows and a layout split across multiple pages.Above all, the government states that, for products “obtained by genetic modification which are excluded from the legislation (e.g. ‘classic’ mutagenesis)” no specific information is required to certify that they are not GMOs, except in certain cases (organic products or those subject to specific national monitoring). The meaning of the term “classical” mutagenesis is not specified, making the response ambiguous. It appears that as early as 2020, Spain was already surreptitiously classifying new genetic modification techniques as “classical” mutagenesis. Regarding the additional information requested for products obtained through new techniques, the Spanish government responds in the future tense, as if the information were not available at the time, two years after the CJEU’s decision. It states that “it will be useful to provide documentary identification only in certain cases where the products obtained by NGT may have been considered either intentionally or unintentionally as standard products”.No requests in other statesThe other European countries, namely, in alphabetical order, Austria, Bulgaria, Croatia, Cyprus, the Czech Republic, Estonia, France, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Poland, Portugal and Slovenia, responded that they had never received a request for GMO/NGT trials.Surprisingly, France joins this list of countries with a more convoluted response, stating that “we do not have any information suggesting that plants obtained from new mutagenesis techniques have been subject to field trials in France”, and specifying that “we have not received any applications to conduct any such trials”. This response thus overlooks commercial crops of Clearfield rapeseed, which ANSES itself reported in 2019 were obtained through mutagenesis applied to isolated and in vitro-multiplied cell cultures - a method that produces GMOs subject to regulation based on the 2018 CJEU decisioniv.The French government does, however, point out that trials of genetically modified Camelina Sativa plants developed using the CRISPR tool have been conducted in the United Kingdom. As France notes, this clarification stems from the fact that these plants “were developed in France by the National Institute for Agricultural Research (INRA, now INRAE)”, adding that on January 18, 2019, it sent a note to the European Commission detailing “the information available to them on the products which might be marketed in non-EU countries and the patents on those products”.Despite claims by certain Member States or the European Commission regarding the impossibility of implementing the requirements of the legislation on GMOs/NGTs, it is clear that Member States did indeed succeed in doing so after 2018. Especially since, as Inf’OGM will report in a forthcoming article, France also outlined in its response the procedures to be followed to ensure that these GMOs/NGTs are detectable and distinguishable. This reality of compliance with current legislation contrasts with the European Commission’s argument that this same legislation is not applicable…i Danish government, « Interpretation of the GMO definition in EU Member States », 20 January 2025.ii European Commission, « Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16 », 29 April 2021.iii European Commission, EC study on new genomic techniques, « Stakeholders’ consultation ».iv Christophe Noisette, « L’Anses tergiverse sur les variétés tolérantes aux herbicides », Inf’OGM, 5 March 2020. Eric MEUNIER antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [42] => Array ( [objectID] => 21042 [title] => Patents on life: extension through language and law [timestamp] => 1774569600 [date] => 27/03/2026 [annee] => 2026 [url] => https://infogm.org/en/patents-on-life-extension-through-language-and-law/ [image] => https://infogm.org/wp-content/uploads/2026/03/54139429174_8c170dae46_c-768x513.jpg [extrait] => In the field of life sciences, the scope of a patent depends not only on the invention described, but also on the way it is claimed and the legal framework governing its protection. Drafting strategy, functional claims, homology percentages… these are all tools that can considerably broaden the scope of the initial "invention". In the context of genetic sequences and digital data associated with living organisms, these mechanisms are now of particular importance. [chapo] => In the field of life sciences, the scope of a patent depends not only on the invention described, but also on the way it is claimed and the legal framework governing its protection. Drafting strategy, functional claims, homology percentages… these are all tools that can considerably broaden the scope of the initial “invention“. In the context of genetic sequences and digital data associated with living organisms, these mechanisms are now of particular importance. [texte] => In the previous article1, we outlined how patent law has gradually been applied to living organisms and genetic information. But the actual scope of a patent also depends on how it is drafted and interpreted. In the field of living organisms and biotechnology, certain drafting strategies and legal provisions do indeed allow for a substantial broadening of the protection claimed. It is this dynamic of extension that we examine here.A scope extending beyond the initial "invention"The "life sciences" industry employs various drafting strategies to obtain very broad patents, describing in particular genetic sequences and their function - sometimes presumed - often at the risk of legal fragility. Since the first patent on a biological subject matter (a recombinant human growth hormone) was granted in 19822, applicants have sought to cover not only a precisely identified sequence, but also all its possible variants. To do so, they use speculative claims based on percentages of "identity", "similarity" or "homology" between the claimed sequence, originally identified, and a whole set of sequences that the patent intends to cover via this system of percentages. These formulations, which are flexible to say the least, thus make it possible to encompass a very large number of sequences not explicitly described in the text of the patent, and whose functionality is not demonstrated. This raises the question of compliance with patentability criteria, in particular the industrial application required by the European Patent Office (EPO). The EPO does not set a specific threshold for these percentages, examines patent applications on a case-by-case basis, and case law varies. For example, in decision T 2437/13 (Coronavirus/Amsterdam Institute), the EPO Board of Appeal held that a sequence claimed as having "at least 95% homology" must be understood as having 95% nucleotide identity in an alignment3. In decision T 2101/09, concerning sequence identity, the Board stated that the required level of identity depends on the circumstances of the specific case and the requirements of the European Patent Convention (EPC) (inventive step, sufficiency of description, etc.)According to another approach, an invention can be defined by the function of a biological material rather than by a specific sequence4. This broadens the scope of patents, but also increases their vulnerability in the event of litigation. This is the case, for example, with antibodies, regarding which several European and US decisions have emphasised that a vague or hypothetical function is not sufficient to satisfy the requirements of industrial applicability (or its US equivalent: the utility criterion). Whilst a few antibody sequences may be given as examples in a patent application, this is generally insufficient to justify a claim which, because it is drafted in functional terms ("antibody A capable of binding to receptor R"), could cover tens of thousands of discovered antibodies or inventions.European law also provides for the "scope of protection" conferred by a patent, notably in Articles 8 et seq. of Directive 98/44. According to these provisions, "the protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics". Furthermore, "the protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product in incorporated and in which the genetic information is contained and performs its function". It is therefore not necessary for the product to be derived from the patented invention or its reproduction, as is the case with a patent relating to biological material.When a sequence or genetic information is patented, this extension therefore implies that the rights attached to the patent apply to any product in which that sequence is incorporated and performs its function (a plant is a biological material). Thus, the drafting strategy aimed at broadening the claims upstream is combined with a legal mechanism for extending protection downstream, which further increases the potential scope of the rights conferred. Moreover, this exacerbates legal tensions surrounding their validity and effects, particularly in the fields of plant science, biodiversity and agriculture. This aspect of patents acting as a barrier can stifle innovation, but also prohibit the use of biological materials containing patented genetic information that does not originate from the patented invention. This is what is referred to as "patents on native genes".A shift from the tangible to the virtualIn the early 1980s, patents mainly covered cells, microorganisms, proteins, genes, reagents…5. Although defined directly or indirectly in patents by sequences, these tangible elements could be found in fermenters, laboratory refrigerators or freezers… However, in recent years, the description of a growing proportion of such "inventions" has become intangible. We have moved from the era of biological material isolated from living matter to the era of virtual material, with putative functions, defined by information derived from genetic sequencing – "genetic information" in European law or "digital sequence information" (DSI) in international law – stored in digital databases.As confirmed to Inf’OGM by the EPO, patent applications based on DSI are treated as if they were inventions embodied in living matter. Yet the issue at stake is the patenting of digital information to which industry attributes a biological function via bioinformatics processes. As we shall see in a subsequent article, the EPO consistently considers that the concept of DSI, which is still not legally defined, does not constitute a specific category under European patent law. Indeed, it appears neither in the EPC nor in the EPO guidelines. As such, the EPO considers that it does not therefore constitute "an independent basis for assessing patentability", which does not prevent the granting of patents relating to "genetic information".Inf’OGM has already extensively documented the impact of patents on living organisms. Today, this impact has taken on a concrete form and potential scale, particularly through patents on genetic resources, which are plunging a whole sector of the agricultural and food economy – as well as other uses of living organisms – into legal uncertainty. In particular, this affects the most vulnerable players – though they are the most fundamental – such as farmers, small and medium-sized seed producers, and other users and processors of organic products. Let us imagine that a person identifies a genetic sequence present in a plant and converts it into a digital sequence of the DSI type in a database. They then file a patent application claiming it as genetic information associated with a function. Although the patent formally covers digital data, its scope may extend to any organism containing this sequence and expressing the function described in the patent. Thus, any use of wild plants, local varieties or micro-organisms in which the DSI-type sequence exists naturally could be affected. A farmer re-sowing a traditional variety containing this sequence could then face opposition on the grounds of the patent, not because he has reproduced or copied the patented invention, but because he is using an organism in which the sequence covered by the patent is present.Under the law, a patent on living organisms thus does not confer a right to exploit them, but a right to prohibit their use by third parties. This is harmful in many respects, particularly when the living organisms in question are cultivated or wild biodiversity, or the seeds of farmers. Shouldn’t knowledge about living organisms, on the contrary, benefit society as a whole, rather than being reserved for certain actors – notably industrialists and research institutes – in return for payment? Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [43] => Array ( [objectID] => 21036 [title] => Patents, living organisms and GMOs/NGTs [timestamp] => 1774396800 [date] => 25/03/2026 [annee] => 2026 [url] => https://infogm.org/en/patents-living-organisms-and-gmos-ngts/ [image] => https://infogm.org/wp-content/uploads/2026/03/Brevet-US_Hormone-croissance--768x483.png [extrait] => A patent confers the right to prevent third parties from exploiting an invention. Whilst historically it applied to specific technical objects and/or the processes for obtaining them, its extension to living organisms – and subsequently to genetic information – has transformed its scope. Between the broadening of claims, mechanisms for extending protection and growing legal uncertainties, patents now represent a threat from the biotechnology industry to fundamental economic and societal issues, particularly food sovereignty. [chapo] => A patent confers the right to prevent third parties from exploiting an invention. Whilst historically it applied to specific technical objects and/or the processes for obtaining them, its extension to living organisms – and subsequently to genetic information – has transformed its scope. Between the broadening of claims, mechanisms for extending protection and growing legal uncertainties, patents now represent a threat from the biotechnology industry to fundamental economic and societal issues, particularly food sovereignty. [texte] => Against a backdrop marked by debates surrounding GMOs produced using new genetic techniques (GMOs/NGTs) and, more broadly, by growing questions regarding the appropriation of living organisms, the issue of patents lies at the heart of major economic, legal and ethical challenges. Initially covering mechanical objects, chemical substances, etc., patenting expanded in the 1980s to include material biological products1. More recently, they have come to cover intangible, legally undefined objects based on genetic information identified in organisms or biological products: "digital sequence information" or "genetic sequence data" (DSI/GSD)2. In the context of the ongoing European legislative debate on the possible deregulation of numerous GMOs, many of which could result from the use of DSI by "artificial intelligence" (AI) systems, and in light of the tensions arising from these developments, it seems necessary to return to the fundamentals of patent law. This involves recalling its principles, conditions and limitations.The patent: a legal instrumentA patent is an industrial property title issued by an official institution, the INPI (Institut National de la Propriété Industrielle)3 for France and the European Patent Office (EPO)4 for countries5 bound by the European Patent Convention (EPC)6. A patent granted by the INPI applies only within French territory. When issued by the EPO, a patent may subsequently be validated in some or all of the signatory countries to the EPC, such as France. Opposition proceedings against a granted patent may also be brought by third parties before the EPO or, in the case of a French patent, before the INPI.The EPO and the INPI merely grant patents; they are in no way responsible for what happens thereafter, particularly matters of infringement, which are dealt with by the respective national courts. Nevertheless, since June 2023, a European court may be seised of actions for infringement and invalidity of the "European patent with unitary effect" obtained following a patentability examination conducted by the EPO. This is the Unified Patent Court (UPC), which currently covers 17 EU countries7 and whose list evolves as the Agreement on a Unified Patent Court is ratified8.A granted patent confers on its holder a monopoly on the commercial, and in some jurisdictions also non-commercial, exploitation of an invention, as well as the right to prevent a third party from exploiting it without their consent9. Infringement is exploitation without authorisation. It is assessed at national level, meaning that each European country has its own legislative system (except in the case of a European unitary patent – see above) to enable a patent holder to defend their rights. However, the patent holder may himself require a licence to exploit the invention if it constitutes an improvement on a broader invention that has already been patented. For example, one might have patented a process improving the accuracy of Crispr/Cas9, but require a licence from the holders of the fundamental rights to this technique in order to commercially exploit this improvement.To obtain a patent, one must first apply for it. This is known as a "patent application". This patent application is a document, filed for example with the INPI or the EPO, which describes the invention in detail in a section called the "description" and, in a section called the "claims", defines the essential features of the claimed invention. Taking the example of a hammer, one would need to define the handle and the striking head. For a genetic sequence, or a protein – for example, an antibody or a hormone – its sequence and function must be defined. Genetic sequences are patentable because, in France and at the EPO, their isolation, description and associated function(s) are considered to constitute "an invention". The scope of such a patent is not limited to the use of the isolated sequence alone. It extends to the use of any organism containing that sequence, which is therefore no longer isolated and expresses its function. The processes of isolating these sequences and determining their function are now increasingly carried out virtually using "AI" algorithms.A patent application also contains administrative information, such as the name of the applicant, the inventors, an abstract of the invention… and, where applicable, a list of genetic sequences. The description must – according to the EPC and the French Intellectual Property Code (CPI) – set out the invention "in a sufficiently clear and complete manner so that a person skilled in the art [Editor’s note: a toolmaker or a biotechnology engineer]can carry it out" without having to exert an inventive effort beyond their ordinary skills. This "reproducibility" of the invention can be understood as the ability to obtain identical results in the same way, ensuring that the invention produces sufficiently stable and predictable effects. However, it poses particular problems in the biotechnology sector, where one is dealing precisely with living organisms, their complexity and often their inability to be reproduced identically10. Other legal and administrative factors not mentioned here contribute to the granting, maintenance and defence of patents.The hammer, the natural gene and NGTsNeither the CPI nor the EPC provides a positive definition of an invention, but it is conventionally agreed that it is "a technical solution to a technical problem". If one seeks to drive a nail into a piece of wood more easily – the technical problem – the hammer certainly constitutes a technical solution. However, the term "invention" takes on a particular meaning when it comes to living organisms.To be considered patentable, an invention must meet certain legal requirements11. It must be new (according to the law, "not form part of the state of the art", i.e. what is already known) and involve an inventive step (according to the law, "not obvious from the state of the art"). "Obviousness" to a person skilled in the art is a relatively subjective concept, which is often at the heart of the debate in disputes over the validity of a patent. An invention must also be capable of industrial application; that is to say, according to the law, its subject matter can be made or used in any kind of industry, including agriculture.What these same conditions make clear is that a discovery is not patentable. Indeed, a discovery is not an invention in the sense of a "creation of the mind" capable of being protected by intellectual property law. But what, then, of inventions based on living matter? In what way are a protein, or a gene encoding a protein, new when they do indeed exist in nature? In what way are they an invention and not a discovery under patent law?The answer provided by European legislation (transposed into French law) is set out in Directive 98/4412: "Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature". The EPO, which has incorporated this provision into its legislation, clarifies this point with regard, for example, to the patentability of plants: “obtained by technical processes, it may be considered patentable if the trait in question (e.g. colour, resistance to pests, yield, vigour etc.) was previously found in nature”. The aim, according to the EPO, is “to encourage and recognise the discovery of incorporating the characteristic in a plant using a technical method and making the associated technical invention available to the general public, the development of which is usually faster and more systematic than a natural process and thus offers numerous benefits for plant breeding”. It is worth noting that the EPO does not specify in what way, or to what extent, the technical process is faster or more targeted, or indeed whether it goes beyond what a natural process does or can do, and appears here to be echoing arguments put forward by industry.The key point seems clear: if a human intervenes technically on natural biological material – "isolates" it, as the law puts it – the biological material or genetic information thus isolated becomes new and potentially patentable. The United States has taken a stricter stance, with the 2013 Myriad Genetics ruling by the Supreme Court, which decided that the isolation step is not sufficient, as the isolated DNA remains, after all, DNA found in nature. Since then, only complementary DNA (or cDNA)13, an artificially synthesised copy of the DNA of a gene existing in nature, can be patented in the United States.Another fundamental concept in our subject area is the EPO’s definition of the various technical processes of mutagenesis. In its guidelines for the examination of patent applications, the EPO defines "targeted" mutagenesis and "random" mutagenesis as techniques, and the resulting plants as patentable provided that the general conditions for patentability are met14. A so-called "random" mutagenesis process is therefore patentable provided it is reproducible by a person skilled in the art, meaning it is no longer random within the meaning of patent law. New genetic modification techniques (NGTs) and the products derived from them are also patentable. Furthermore, the issue of essentially biological processes (EBPs) – which are not patentable – has fuelled the debate on patentability for years. Products derived from such processes were in fact patentable until July 2017. Media coverage of failed legal challenges to such patents and several decisions by the European Parliament were necessary to put an end to this situation15.In its application to living organisms, the patent has gradually moved away from its original purpose. The isolation of biological materials, the identification of genes and, more recently, the use of DSI have contributed to shifting the patent from the material realm to that of information. But the extension of the scope of patents is not solely due to these technical developments. It also stems from the way in which patent applications are drafted and from certain legal mechanisms that extend protection beyond the original subject matter of the"invention". It is this extension through language and the law that needs to be examined, which will be the subject of the next article in Inf’OGM. Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [44] => Array ( [objectID] => 19104 [title] => 71 MPs urge the French government to reject the deregulation of GMOs derived from new genomic techniques [timestamp] => 1773792000 [date] => 18/03/2026 [annee] => 2026 [url] => https://infogm.org/en/71-meps-urge-the-french-government-to-reject-the-deregulation-of-gmos-derived-from-new-genomic-techniques/ [image] => https://infogm.org/wp-content/uploads/2026/03/Screenshot-2026-03-09-at-12-21-00-l17b2359_proposition-resolution-europeenne.pdf.png [extrait] => Following the approval by European Union member states, including France, of the draft text on the deregulation of GMOs derived from new genomic techniques (GMOs/NGTs), French MPs tabled a motion for a resolution on 21 January 2026. This motion for a resolution calls on the government to oppose the European text. [chapo] => Following the approval by European Union member states, including France, of the draft text on the deregulation of GMOs derived from new genomic techniques (GMOs/NGTs), French MPs tabled a motion for a resolution on 21 January 2026. This motion for a resolution calls on the government to oppose the European text. [texte] => On 19 December 2025, contrary to its initial position, the French government representative came out in favour of the deregulation of GMOs/NGTs. This French U-turn, mirroring those of Poland and Greece, enabled a qualified majority of Member States to be reached on this text1. It was following this new stance, motivated by non-binding commitments from the European Commission, that 71 MPs (12% of the Assembly) from La France insoumise decided to table a European motion for a resolution “aimed at opposing the deregulation of plants derived from new genomic techniques and defending a strict European framework for health, environmental and democratic protection”2.A resolution based on legal groundsIn this resolution, the MPs outline chronologically the various stages leading up to this compromise text. Starting with the origins of the European Commission’s proposal for deregulation, they recall that the public consultation conducted in 2022 had clearly demonstrated European citizens’ commitment “to upholding the precautionary principle, maintaining mandatory labelling, ensuring full traceability, and the need for an in-depth democratic debate prior to any amendment of the existing regulatory framework”. Ignoring these results, however, the Commission had pursued its objective of proposing the deregulation of GMOs/NGTs plants, culminating in a compromise text between representatives of the European Parliament, the Council of the EU and the European Commission on 4 December last year3. MPs then denounced its “contradiction with the European legal framework as interpreted by the Court of Justice of the European Union” (2018)4, which had been confirmed by the French Council of State in 20205.The initiators of this resolution then warn of the risks that the deregulation of GMOs/NGTs would entail, pointing in particular to a “serious infringement of citizens’ right to information, guaranteed by Directive 2001/18/EC, by consumer law, and by the case law of the CJEU”, failure to respect the precautionary principle and a “practical inability to ensure the compliance of their production” for the organic sector, Protected Designation of Origin (PDO), Protected Geographical Indication (PGI), as well as smallholder farming and GMO-free sectors. Like many stakeholders, whether opposed to this text or not, they also raise the issue of patents, which would reinforce “the concentration of intellectual property in the hands of a few multinational seed companies, through the extension of patentability to living organisms”.Finally, the MPs who signed this resolution condemn the techno-solutionism and scientific reductionism embodied by GMOs/NGTs, arguing that they are promoted on the basis of false promises (resistance to climate hazards and pathogens). In their view, these genetically modified plants would merely “encourage the continuation of intensive agricultural models that are heavy users of inputs, homogenising landscapes and exacerbating the erosion of cultivated biodiversity”.Resolutions already rejected in early 2024This initiative by French parliamentarians echoes two resolutions tabled in early 20246, whilst the European Parliament was deliberating on the position to adopt regarding the proposal to deregulate GMOs.On 8 January 2024, Lisa Belucco, Sébastien Peytavie, Nicolas Thierry and Marie Pochon, all four MPs from the Ecologist – Nupes group, tabled a draft resolution opposing the deregulation of GMOs/NGTs7. On 24 January, 51 MPs from seven different parliamentary groups did the same8. However, these two texts were merged by their authors on 20 February, enabling the tabling of a single "Proposal for a European resolution to prevent the deregulation of new genetically modified organisms", this time backed by 82 MPs9. However, on 27 February, the National Assembly’s Committee on European Affairs decided to reject the proposal, followed by the Committee on Sustainable Development and Spatial Planning on 29 March 2024.In April 2026, the French government will have to formally vote on a text proposing the deregulation of GMOs/NGTs resulting from the trilogue negotiations at the end of 2025 (between representatives of the Parliament, the Commission and the Council of the European Union). Although it has arrived late in the process, this motion for a resolution against the deregulation of GMOs/NGTs could nevertheless, if dealt with in time, lead to a strong stance from the National Assembly towards the government ahead of the vote next April. The government might then find it more difficult to secure France’s support for the proposed text.What procedure does a motion for a resolution follow? A European motion for a resolution forms part of the "political dialogue" procedure between the European Commission and national parliaments. As such, the Commission is required to forward all its draft texts to the parliaments of the Member States. National assemblies may then adopt European resolutions addressed to their government and the Commission. However, in France, European resolutions must first be examined by the National Assembly’s Committee on European Affairs, comprising 48 MPs, which may adopt, reject or amend them. A committee responsible for the substance of the resolution will then give its opinion (in the case of GMOs/NGTs, the Committee on Sustainable Development and Spatial Planning). If the resolution is adopted in committee, it is then put to a vote in the Assembly’s plenary session. If it is also adopted there, it is then forwarded to the Government and the European Commission, which is required to respond within three months. Although they have no legal implications, these resolutions nevertheless carry political weight, as they represent the majority of MPs. The Government also regularly reports on how it has taken these resolutions into account in European negotiations. Antoine VEPIERRE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [45] => Array ( [objectID] => 18735 [title] => Crispr/Cas9 : from patent disputes to the widespread use of GMOs [timestamp] => 1773619200 [date] => 16/03/2026 [annee] => 2026 [url] => https://infogm.org/en/crispr-cas9-from-patent-disputes-to-the-widespread-use-of-gmos/ [image] => https://infogm.org/wp-content/uploads/2026/03/CRISPR_logo-768x654.png [extrait] => A dispute over patent rights to Crispr/Cas9 has been ongoing for several years between its main discoverers, universities and research institutes. To date, the outcome of this dispute and its impact on the Crispr/Cas9 economy remain unpredictable. Added to this is an ongoing dispute over Crispr applications between the parties to the main dispute and companies. Despite this, the widespread use of this tool for modifying living organisms, and the associated health, environmental and socio-economic consequences, seem inevitable. [chapo] => A dispute over patent rights to Crispr/Cas9 has been ongoing for several years between its main discoverers, universities and research institutes. To date, the outcome of this dispute and its impact on the Crispr/Cas9 economy remain unpredictable. Added to this is an ongoing dispute over Crispr applications between the parties to the main dispute and companies. Despite this, the widespread use of this tool for modifying living organisms, and the associated health, environmental and socio-economic consequences, seem inevitable. [texte] => For the past dozen years or so, patents relating to Crispr/Cas9 have been the subject of litigation between the main "inventors" of this genetic modification tool, which is widely used in public and private research. Crispr/Cas9 is the subject of several patent rights and is logically at the heart of a dispute with an uncertain outcome, both for the holders of these rights and for the licence holders. This article provides an overview of the litigation in the jurisdictions where it is most active: Europe and the United States. It is unlikely that all of these patent rights, some of which affect farmers and small/medium-sized seed producers, will disappear at the end of the proceedings. At a time of debate on the deregulation of GMOs in Europe and disagreement on the issue of patents, this example of litigation shows that, when it comes to patents, the biotech industry is opportunistically juggling a legal landscape that is still in flux.The origins of the Crispr/Cas9 disputeIn 2012, five main players filed patent applications covering different aspects of Crispr/Cas 9 within a very short period of time: California-Vienna-Charpentier (University of California, University of Vienna and Emmanuelle Charpentier – CVC), the Broad Institute (MIT-Harvard, with certain rights held by Rockefeller University), the University of Vilnius, the South Korean company ToolGen and the multinational Sigma-Aldrich (Merck) (see table).This proximity of patent applications is a major cause of Crispr/Cas9 litigation, particularly due to the complexity of assessing the conditions of patentability, namely novelty and inventive step. Some patent applications were filed before the results of "competing" laboratories' work were published and thus became enforceable against the patentability of these applications. While the granting of patents is relatively clear in Europe – it is the date of filing that counts – it is more complicated in the United States, which in 2012 still applied a system giving priority to the first inventor rather than the first applicant. This legal peculiarity is at the root of the so-called "interference" dispute between CVC and the Broad Institute in the United States.The current situation in Europe and the United StatesCVC and the Broad Institute are now considered to hold the fundamental patents on the Crispr/Cas9 tool. We will therefore focus on these two entities in particular.In EuropeCVCSince 2012, CVC has filed various patent applications with the European Patent Office (EPO) relating to Crispr/Cas91. However, in September 2024, it unexpectedly withdrew two of its main patents on Crispr/Cas92, following a preliminary unfavourable opinion from the EPO Board of Appeal. In this preliminary opinion, the Board highlighted the insufficient disclosure of the invention concerning the PAM sequence3 and questioned the "right of priority" conferred by the corresponding US patent applications4. This strategic withdrawal from the European proceedings allowed CVC to avoid a negative final decision by the Board of Appeal, which could have affected the US proceedings. CVC thus appears to have chosen to prioritise the US market over the European market.Another application by CVC was successful in January 2025, when the EPO granted it a patent with broad claims relating to guide RNAs, modified RNAs used to guide the Cas protein to the targeted DNA sequence. However, this patent is currently the subject of a major opposition procedure5. In an attempt to have it revoked, the opponents have submitted hundreds of "prior art" documents, i.e. documents published before CVC filed its patent application. All this points to a lengthy procedure, adding to the uncertainty surrounding the ownership and therefore the effect in Europe of this key patent on the use of Crispr/Cas9. In November 2025, CVC saw another of its major patents, relating to the use of RNA to guide Cas9 to a target DNA, revoked in a similarly extensive opposition procedure6 . CVC has appealed this decision.Broad InstituteIn March 2024, the EPO Board of Appeal ruled that the Broad Institute was indeed entitled to claim, for its European patents, the priority of its fundamental US patent rights on the Crispr/Cas9 tool for eukaryotes, i.e. animals, including humans, plants and fungi (even though Crispr/Cas9 had been discovered in prokaryotes). This strengthened the Broad Institute's prospects of obtaining significant patent rights for Crispr/Cas9 in Europe. This dispute is still pending before the EPO at the opposition stage (first instance or appeal).To date, only the Broad Institute has definitively granted patents (having passed the opposition stage or not having been opposed) at the EPO7. However, their scope is limited to methods of genetic modification of prokaryotic cells by introducing one or more mutations. They cover applications that are currently of less commercial significance than, for example, the genetic modification of eukaryotes.In the United States The United States is the scene of a particular dispute concerning the inventorship of the Crispr/Cas9 invention8. In March 2022, the CVC was confirmed by the United States Patent and Trademark Office (USPTO) as the first to have "invented" the Crispr/Cas9 system. However, this decision also affirmed that the Broad Institute ultimately holds the rights to the application of Crispr/Cas9 in eukaryotic cells. However, in May 2025, following a complaint by CVC, the Federal Court of Appeal overturned and challenged9 this decision by the USPTO, which had granted priority for the use of Crispr/Cas9 in eukaryotic cells to the Broad Institute. The Court found that the USPTO had confused the legal standards for the conception of the invention with its implementation and had not properly evaluated the evidence in the record. The Court reaffirmed that conception does not require certainty of success and asked the USPTO to re-examine the issue of conception in a manner consistent with the Court of Appeal's opinion. This decision also has repercussions as it further delays other parallel interference proceedings to determine the first inventor: on the one hand between CVC and, individually, ToolGen and Sigma-Aldrich; on the other hand between the Broad Institute and, individually, ToolGen and Sigma-Aldrich.Impact of litigation on licencesThis May 2025 decision by the US Federal Court of Appeal has prolonged the dispute between CVC and the Broad Institute over the use of Crispr/Cas9 in eukaryotic cells, which is believed to be the main source of financial revenue. The final decision of the USPTO will have significant repercussions on the licences granted by CVC and/or the Broad Institute.While licence agreements have already been signed, entities holding such licences may have to review the contractual provisions, which may already be included in the contracts. Similarly, entities seeking a licence or wishing to invest in structures using Crispr/Cas9 will also need to anticipate the various possible outcomes of the dispute and negotiate appropriate licence terms with the structures they hope will ultimately be recognised as the rights holders. Finally, once the dispute has been definitively resolved, which may still take several years, users of Crispr/Cas9 who do not yet have licences from the winning party in the dispute will have to obtain a licence for the latter's patent rights.It is currently very difficult to determine the impact of the dispute on licences, not only because it is still ongoing, but also because of the complexity of the patent landscape. However, licences already granted by the current holders of the fundamental rights to Crispr/Cas9 remain in place. This is the case, for example, with the exclusive licence agreement for agricultural uses between CVC and Corteva, which in turn grants sub-licences, and the exclusive agreement between the Broad Institute and Editas Medicine10 in the therapeutic sector. In practice, entities wishing to exploit Crispr/Cas9 generally need to obtain several licences – licences on ToolGen and Sigma-Aldrich (Merck) application patents may also be necessary – in order to ensure global coverage and limit the risk of litigation. If a user of Crispr/Cas9 does not obtain all the necessary licences, they only have insufficient exploitation rights, which is not, in fact, total freedom of exploitation.The holders of the main patents could choose to agree to create a patent pool to reduce transaction costs, avoid cumulative royalties and provide security for licensees. However, the establishment of such a mechanism could encounter obstacles, particularly in terms of setting the amount of royalties11 and their distribution. In the absence of a widely adopted pool, companies wishing to exploit Crispr/Cas9 must continue to deal with a variety of bilateral agreements, cross-licences12 and an uncertain legal environment.HoldersClaimed scope (overview)CommentsFundamental rights/discovery of Crispr/Cas9CVCDiscovery of Crispr/Cas9, targeted DNA modifications, sgRNA, general applicationsHolder of founding patents, in litigation (interference) with the Broad Institute for eukaryotic applicationsBroad InstituteCrispr/Cas9 in eukaryotic cells, general applicationsHolders of founding patents, major player in the European and US portfolio; success reinforced by EPO decisions on priorityVilnius UniversityPAM site, Cas nickaseFirst to file patent applications on the use of Crispr/Cas9 but without describing or claiming the guide RNA subsequently discovered by CVCApplication patents / specific techniquesToolGenRibonucleoprotein (RNP) technology, PAM siteSignificant portfolio for industrial and therapeutic applications, strategic licencesSigma-Aldrich (Merck)Optimised Cas9, reduction of off-target effectsExtensive portfolio for industrial and therapeutic applications, strategic licencesTable: Historical holders of Crispr/Cas9 patent rightsBehind the legal debate, a trivialisation of GMOsGMOs are a major health, environmental and socio-economic concern for many civil society organisations. Faced with the power of multinationals, which also want to impose their patents, civil society's capacity for action is limited.The current legal conflict surrounding new genomic techniques should not obscure a fundamental reality: the modifications obtained by Crispr/Cas9 do indeed produce GMOs. They cause changes to the genome whose health and environmental effects are neither insignificant nor fully understood. Presenting these techniques as simple "improvement" tools – as multinationals in particular do – amounts to trivialising their use, a trivialisation that only increases the potential risks.From a legal standpoint, the complexity of the issue makes the practical use of genetic modification techniques such as Crispr/Cas9 particularly uncertain. The holders of the fundamental patents have not yet been clearly established, and each party is seeking to defend its interests, at the risk of nullifying the effect of certain major patents relating to Crispr/Cas9.It is in this climate of legal uncertainty that the current evolution of the European regulatory framework on GMOs is taking place. The draft regulation aimed at deregulating GMOs derived from new genetic modification techniques (NGTs), including Crispr/Cas9, confirms a worrying step backwards. By removing the traceability and labelling requirements that curb patent abuse, it strengthens the control of large multinationals over living organisms, increases the legal uncertainty of small seed producers and farmers in relation to patents and, potentially, puts upward pressure on seed prices. Ultimately, it is seed, agricultural and then food sovereignty that could be called into question. Denis MESHAKA antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [46] => Array ( [objectID] => 18086 [title] => Search [timestamp] => 1773360000 [date] => 13/03/2026 [annee] => 2026 [url] => https://infogm.org/en/search/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => Inf'ogm [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [47] => Array ( [objectID] => 6973 [title] => [timestamp] => 1773014400 [date] => 09/03/2026 [annee] => 2026 [url] => https://infogm.org/en/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Shopping basket [chapo] => [texte] => Shopping basket [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [48] => Array ( [objectID] => 15213 [title] => French organisations call on MEPs to reject GMO deregulation [timestamp] => 1773014400 [date] => 09/03/2026 [annee] => 2026 [url] => https://infogm.org/en/french-organisations-call-on-meps-to-reject-gmo-deregulation/ [image] => https://infogm.org/wp-content/uploads/2026/03/logo-18-orgas-Site-Web-768x432.png [extrait] => On 19 December 2025, EU Member States declared themselves in favour of deregulating GMOs derived from new genomic techniques (GMOs/NGTs). After a brief passage through the European Parliament's Environment Committee, this text must now be formally adopted by the Council of the European Union. If this is the case, it will be up to the European Parliament to vote on the text. 18 French organisations are taking this opportunity to send an open letter to MEPs calling on them to "defend the founding values, principles and treaties of the European Union, as well as the position adopted by the European Parliament in February 2024". Other European organisations are encouraging European citizens to contact MEPs directly. [chapo] => On 19 December 2025, EU Member States declared themselves in favour of deregulating GMOs derived from new genomic techniques (GMOs/NGTs). After a brief passage through the European Parliament’s Environment Committee, this text must now be formally adopted by the Council of the European Union. If this is the case, it will be up to the European Parliament to vote on the text. 18 French organisations are taking this opportunity to send an open letter to MEPs calling on them to “defend the founding values, principles and treaties of the European Union, as well as the position adopted by the European Parliament in February 2024“. Other European organisations are encouraging European citizens to contact MEPs directly. [texte] => In December 2025, negotiators from the European Parliament, the Council of the European Union and the Member States agreed on the text aimed at deregulating GMOs/NGTs1. According to the legislative procedure to be followed2, the text still has to be formally adopted by the Council of the EU. If necessary, the European Parliament will vote on this text in plenary session, which could take place in May 2026. In view of this vote, on 9 January 2026, 18 French organisations published an open letter3 to remind MEPs of the commitments made by the previous European Parliament in April 20244. Other associations and organisations have also mobilised to denounce this deregulation, such as Kokopelli5. The Demeter Biodynamic Federation and Save our Seeds offer a tool on their websites to call on MEPs to take action6.A reminder to MEPs of their initial positions...The main reason why the organisations are writing this open letter to MEPs is because the agreement reached in the trilogue "directly contravenes the positions taken by the European Parliament". In fact, the position adopted by MEPs in April 2024 called for "plants derived from NTGs to be subject to mandatory labelling" and for "a ban on the patentability of plants derived from NGTs that are indistinguishable from plants derived from traditional non-patentable breeding,as well as restrictions on the extension of the scope of patents". These provisions were not included in the draft text negotiated in trilogue.The signatories point to "a glaring paradox, since on the one hand plants derived from category 1 NGTs are presented as being similar to plants derived from conventional breeding, and on the other hand they are already covered by multiple patents whose scope, under current European law, extends to similar plants derived from conventional breeding, which are not patentable. However, under European law, plants derived from essentially biological processes (including conventional breeding) are not patentable"....and the risks posed by abandoning themIn their letter, the organisations focus on the risks that this deregulation would pose to farmers, seed producers, consumers and certain sectors.Legal uncertainty would weigh on farmers due to patents, combined with "the removal of the obligation to publish detection and identification methods". As a result, they would face "potential risks of abusive patent infringement lawsuits in the event of accidental contamination or if traditionally bred plants had the same traits and sequences as those patented".As for seed producers, the danger would also come from patents. The signatories explain that these could cause them to lose customers, force them to be bought out or negotiate licensing agreements with multinationals, or even cease trading. Like farmers, they could "also be prosecuted for infringement".As for consumers, "the right to information and freedom to choose one's food would no longer be respected, as there would be no traceability and no labelling". Another consequence of this removal would be that it would be impossible to discriminate against imported products, "particularly those from Brazil and Argentina [under the recently signed Mercosur agreement], where GMOs account for a high percentage of crops".Finally, the signatories point to the threats to the organic and GMO-free sectors, particularly due to possible contamination. While certain measures can limit this contamination, they warn of the additional costs that this could entail. They believe that "the costs of coexistence measures and the impacts in the event of environmental or health problems should not be borne by sectors that oppose the use of new GMOs". In other words, those who grow GMOs/NGTs should bear the consequences.One might think that this open letter is just another in a long list of appeals to European decision-makers by civil society organisations7. In reality, it is much more significant than that. At this advanced stage of negotiations on the text deregulating GMOs/NTGs, MEPs are the last representatives of European citizens who can still put a stop to this process. In view of the aforementioned changes to agriculture, social life and the environment, it is important to alert MEPs and make them face up to their responsibility.Other letters to sign or send A few weeks later, Kokopelli took the same approach with an open letter to MEPs5. In it, the seed producer sets out the same arguments against the deregulation of GMOs/TTGs. The association is even calling on citizens to co-sign the letter. Furthermore, it is seeking "public figures" to give "more weight to [its] arguments" thanks to their "notoriety". The letter already has more than 5,000 signatories and aims to reach 100,000.Both the Demeter Biodynamic Federation and the Save our Seeds organisation have posted a tool online that allows citizens to contact the MEPs of their choice6. The aim of these open letters is to demand that MEPs defend the right of European citizens "to choose and protect GMO-free farming" by guaranteeing traceability and "labelling on traceability" from the seed producer to the end consumer and by being aware of the problem posed by patents. Antoine VEPIERRE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [49] => Array ( [objectID] => 15244 [title] => Nanoparticles galore in pesticides [timestamp] => 1772409600 [date] => 02/03/2026 [annee] => 2026 [url] => https://infogm.org/en/nanoparticles-galore-in-pesticides/ [image] => https://infogm.org/wp-content/uploads/2026/02/hpgruesen-agriculture-1359862-scaled-riuf9hh6bsnbm0uageiubqkepn1wb3ebvaet9m1268-768x512.jpg [extrait] => A report by ANSES, published last April, proposes to increase vigilance regarding the use of nanopesticides. These nanometric molecules are highly volatile, which considerably increases their potential for dissemination and contamination, as well as their potential toxic effects on the body. The problem is that not only is their sale unregulated in Europe, but the regulations do not provide for their detection. [chapo] => A report by ANSES, published last April, proposes to increase vigilance regarding the use of nanopesticides. These nanometric molecules are highly volatile, which considerably increases their potential for dissemination and contamination, as well as their potential toxic effects on the body. The problem is that not only is their sale unregulated in Europe, but the regulations do not provide for their detection. [texte] => Inf’OGM has co-published with Sciences Critiques an article by Blandine Flipo shedding light on the issue of nanopesticides, pesticide products containing nanoparticles used in agriculture. This article illustrates how the issues of information, monitoring and risk assessment are shared with the field of GMOs, at a time when many of them are facing potential deregulation.On 1st April 2025, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) published a report entitled, which went surprisingly unnoticedi. This exploratory study, conducted with the Laboratoire national de métrologie et d’essais (National Metrology and Testing Laboratory, LNE Group), the French group responsible for carrying out measurements, set out to test for the presence of particles smaller than 100 nanometres in some of the most commonly used plant protection products.The results are revealing: with the exception of one biocide, the researchers detected the presence of these nanoparticles in all of the products tested, both solid and liquid, in highly variable proportions."There are currently no regulations on nanopesticides"Ludwig Blanc is a farmer in Chabrillan, in the Drôme region of France. He grows fresh basil and white garlic, which is sold in the local Super U supermarket. As a conventional farmer, he regularly handles plant protection products. Does he know that these products probably contain nanopesticides? "I'm not a chemist or an analyst", he tells Sciences Critiques. "I don't know exactly what's in them, but I know it's not mineral water! But whether they're small, very small, or even tiny, I'm not surprised".Ludwig Blanc explains that he takes training courses with Certiphyto (individual certificate for plant protection products) representatives from the Drôme Chamber of Agriculture: "We are informed about everything related to equipment, masks, goggles and suitable gloves. We are extremely well trained". However, he admits that he has not received any information about nanomaterials: "I am not qualified to say whether the masks and regulations are up to date, or whether they are sufficient to manage the risks of nanomaterials".And for good reason: to date, there are no regulations on nanopesticides, as Mathilde Detcheverry of the Association for Civic Monitoring and Information on Nanoscience and Nanotechnology Issues (AVICENN) explains: "While in Asia and the United States, some manufacturers disclose the use of nanos in pesticides, this is not the case in the European Union. This does not mean that they do not use them, simply that they apply a precautionary principle... at least in terms of marketing and communication! In fact, they are not legally obliged to indicate the presence of nanos on the packaging of their products, unlike cosmetics and food brands, which are required to do so. At European level, neither Regulation No. 1107/2009 on plant protection products nor Regulation No. 2019/1009 on fertilising products takes into account the size of the particles used in pesticides and fertilisers (whether for active substances or co-formulants)".In France, things are different: since 2013, manufacturers have been required to register any product containing 100 grams or more of nanoparticles in the R-Nano registerii, managed by ANSES. However, in 2016, researchers interested in this register managed by ANSES made a strange discovery. Eric Houdeau, a researcher at the French National Research Institute for Agriculture, Food and the Environment (INRAE) and former ANSES expert in the "Nano and Food" working group, explains: "Looking at the R-Nano register, we realised that the agricultural sector has the highest number of registrants". However, none of these products are officially sold as nanopesticides. How is this possible?Nanos everywhereFirst, we need to know what we're talking about! Bruno Lamas, a researcher at INRAE, explains: "Nanopesticides can contain particles ranging from 1 to 1,000 nanometres, whereas the official definition of nanoparticles is normally 1 to 100 nanometres". There are nanoparticles of copper, silver and titanium dioxide, but also preparations in the form of micelles, a kind of nanometric capsule containing active substances (which can also be imagined in nanometric form), as well as hybrid forms (a combination of the two).In short, there are many types of nanopesticides, which vary according to their composition. In addition, European regulations specify that nanoparticles must account for more than 50% of the total number of particles in a given substance for it to be considered a nanomaterial. This is not necessarily the case with conventional plant protection products...Julien Durand-Réville is health manager at Phytéis (formerly the Union des industries des protections des plantes), a professional association of 18 companies that produce plant protection products for agricultural use. He confirms: "To our knowledge, there are currently no synthetic active substances with nano characteristics intentionally placed on the market in Europe for this purpose. However, there are certain co-formulants (powders, capsules, etc.) in which some of the distribution size contains nanoparticles"."When grinding techniques are used, we know that nanoparticles are inevitably produced".Eric Houdeau, InraeHe explains this unintentional presence of nanomaterials by an industrial process: "When you grind powder or a mineral, there are large, medium, small and very small particles. And some of the smallest ones fall below the threshold for being considered nano. Thus, in a bag of powdered product, part of the weight is made up of these very small particles, and the product as a whole must therefore be declared in the R-Nano database. Even if, in terms of distribution, these small particles are tiny in relation to the total weight of the bag. Our products weigh artificially "dozens of kilograms" where, in other sectors of activity, intentional nanoparticles are sold directly to users in the production chain (i.e. a few grams)". He adds that these particles are only found in "co-formulants", not in active substances, and have not been intentionally added for any potential "nano-specific" properties.However, according to European regulations, all chemicals must be assessed by the European Chemicals Agency (ECHA), which manages the REACH regulationiii. ANSES (or the European Food Safety Authority - EFSA - at European level) carries out a risk assessment when these chemicals are present in food or the environment. Eric Houdeau, an expert at ANSES, continues: "When grinding techniques are used, we know that nanoparticles are inevitably produced, which have the particularity of passing through biological barriers, with potential effects on health. Even if their volume share remains low in the final product, they are present in the billions. However,we do not know what specific impacts these nanoparticles have". He regrets: "We are putting products on the market for which we are unable to assess the risk. Yet it is the very essence of REACH and the health authorities to carry out risk assessments!".Effects on the microbiotaLast October, four researchers from the INRAE Research Centre in food toxicology in Toulouse (including Bruno Lamas and Eric Houdeau) published a scientific review of studies on the impact of copper-based nanoparticles on the intestine in the journal The Science of the Total Environmentiv.Researcher Bruno Lamas, co-author of the review, summarises: "What we found is that, at equal concentrations, copper nanoparticles are more cytotoxic than micrometric particles. In animals, their ingestion also causes more marked alterations in the microbiota and intestinal barrier. This intestinal microbiota, composed of bacteria and fungi, produces molecules that are beneficial to the host through the digestion of certain dietary fibres. However, in the presence of copper nanoparticles, the production of these molecules is significantly reduced. These observations suggest that copper nanoparticles have more harmful effects on the intestine".Why? It is not a question of the volume of material, but of the quantity of particles, explains Eric Houdeau: "Even if you apply less active ingredient with nanomaterials than with conventional pesticides on cultivated land, you still end up with many more ultra-fine products on the same surface area." With just 100 grams, millions of nanoparticles are spread on agricultural land at once, "which accumulate in crops and end up being consumed by humans at the end of the food chain"."The amount of nanoparticles present in products must be reduced as much as possible".AnsesIn light of the various existing studies, Anses concludes in its report: "Given the current state of knowledge on possible changes in particle shape, for example after dilution of the product and depending on the method of application used, there is considerable uncertainty about the levels of exposure of humans and environmental organisms". It recommends that, in the absence of clear regulations and risk assessment methods, "nanoparticles in the product should be reduced as much as possible".Finally, with regard to particle size characterisation, it calls for "the methods recommended in the regulations in force on chemical substances (REACH regulation) to be incorporated into the testing requirements under the regulations on plant protection substances and products".Mathilde Detcheverry of AVICENN supports all of these measures. She confirms the urgent need to change the regulations so that a robust and systematic assessment of the risks associated with nanomaterials is finally made mandatory before they can be used in pesticides or fertilisers. She adds that "regular checks must be carried out by the authorities to ensure that non-compliant nanopesticides are not illegally sprayed on our fields". Until that day comes, farmers like Ludwig Blanc and so many others will remain unaware that they are handling particles so tiny that they can pass through anywhere... with effects that we are only just beginning to measure.i ANSES, « AVIS révisé de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à « Analyse des résultats d’une étude exploratoire visant à mesurer la présence de nanoparticules dans des produits phytopharmaceutiques et des produits biocides et à proposer, le cas échéant, des mesures de gestion afin de protéger les populations et l’environnement potentiellement exposés » », 2025.ii Ministère de la Transition écologique and ANSES, « R-Nano.fr – Declaration of nanomaterials ».iii ECHA, "Understanding REACH".iv Eva Casale, Lauris Evariste, Eric Houdeau, Bruno Lamas, "Copper nanoparticles in agriculture: from expected benefits of reduced copper use to toxicity on gut health", Science of the Total Environment, volume 1004, 15 November 2025. Blandine FLIPO, journaliste à Sciences Critiques [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [50] => Array ( [objectID] => 21601 [title] => Deregulation of GMOs/NGTs: the ENVI Committee drives the point home [timestamp] => 1772064000 [date] => 26/02/2026 [annee] => 2026 [url] => https://infogm.org/en/deregulation-of-gmos-ngts-the-envi-committee-drives-the-point-home/ [image] => https://infogm.org/wp-content/uploads/2026/02/Toenailing_example_with_hammer_and_nail-768x566.jpg [extrait] => On 28 January 2026, the European Parliament’s Environment Committee confirmed, by a large majority, its support for the deregulation of almost all GMOs obtained through new techniques (GMOs/NGTs). This vote follows the informal approval by Member State representatives of the compromise text resulting from the trilogue on 19 December 2025. [chapo] => On 28 January 2026, the European Parliament’s Environment Committee confirmed, by a large majority, its support for the deregulation of almost all GMOs obtained through new techniques (GMOs/NGTs). This vote follows the informal approval by Member State representatives of the compromise text resulting from the trilogue on 19 December 2025. [texte] => A further step was taken on Wednesday 28 January 2026 in the long legislative process aimed at deregulating almost all plants derived from new genetic modification techniques – GMOs whose name is being obscured by referring to them as NGTsi. A trilogue between representatives of the European Commission, the European Parliament and the Council of the EU (the Member States) resulted in a provisional text during the winter of 2025ii. This text was approved by the permanent representatives of the EU Member States on 19 December 2025iii. The next stage in the legislative process was a confirmatory vote by the Parliament’s ENVI Committee. On 28 January, by a large majority (59 votes in favour, 24 against and 2 abstentions)iv, this committee also approved the compromise text.What does the compromise text adopted by the ENVI Committee propose?Before analysing the votes in the ENVI Committee, let us briefly summarise the main points of this compromise text:Creation of two categories of GMOs: NGT1 and NGT2. Category 1 plants would be those declared "equivalent" to plants that can be obtained conventionally, based on criteria with uncertain scientific foundations. Plants genetically modified to tolerate a herbicide or produce an insecticide could not, as discussions currently stand, be declared NGT1.No authorisation procedure for NGT1, but a simple declaration, unverifiable by public authorities.Elimination of risk assessment, labelling (except for seed lots) and documentary traceability, and post-market monitoring for so-called NGT1 plants (surely the majority of GMOs).End of the obligation to provide an analytical method for identification and quantification of NGT1s.No compensation fund for contaminated organic or "GMO-free" crops, as, according to recital 23b of the proposal, such crops, if contaminated "accidentally or technically unavoidably" (sic), will not be downgraded.The possibility of patenting the genetic information of GM plants classified as NGT1 remains; a vague "voluntary" (or non-binding) code of conduct, which is difficult to enforce, has been proposed alongside other equally non-binding measures.Who voted for this text in the ENVI Committee?As a reminder, the distribution of MEPs across committees strictly reflects the political composition of the Parliament in plenary. Given that the largest group is the European People’s Party (EPP), it de facto has the largest number of MEPs on this committee. However, each group is free to decide which MEPs (full members or substitutes) will sit on the committee. This is not insignificant in the case of GMOs, where national political leanings and dissent within parliamentary groups are pronounced, as we shall see later.FORAGAINSTABSTENTIONThe Left1 (20%)4 (80%)0Greens05 (100%)0S&D7 (44%)9 (56%)0Renew8 (89%)1 (11%)0PPE24 (100%)00ERC7 (70%)1 (10%)2 (20%)ID / PfE11 (100%)00ESN03 (100%)0NI1 (50%)1 (50%)0TOTAL59 (69.4%)24 (28.2%)2 (2.4%)Table 1: Results (and percentages) of votes by political group in the ENVI CommitteeAs we have seen, this confirmation vote was therefore passed by a majority of the 90 MEPs sitting on this committee, with 59 votes in favour, 24 against and 2 abstentions.The few absentees (5 out of 90) were mainly from parties generally opposed to the deregulation proposal: the European Left (1 out of 6), the Greens (2 out of 7), the Socialists (1 out of 17) and the Renew/Renaissance group (1 out of 10).It is worth noting that the Chair of the ENVI Committee, the Spanish Socialist Antonio Decaro, did not take part in the vote. Nor did Pascal Canfin, shadow rapporteur and French MEP from the Renew group, who nevertheless did not shy away from making a pro-deregulation statement. On LinkedInv, he writes: “Unlike GMOs, which introduce genetic material from other species into a plant, NGTs are carried out solely within the same genetic pool: in other words, they accelerate what nature does, they do not modify it. This is a fundamental distinction that justifies a specific legislative framework”. He thus echoes the European Commission’s falsehood regarding the definition of a GMO, as well as the seed industry’s false promises: “These new seeds will enable us to move faster in building drought resistance, adapting to higher temperatures, reducing fertiliser requirements…”Unsurprisingly, all the environmentalists present voted against the bill. The "European United Left" group (GUE/NGL) followed suit, with 80% voting against. Members of the Socialism & Democracy group were divided, with 7 in favour and 9 against. A far-right group, Europe of Sovereign Nations, voted 100% against the text, stating that this is primarily a matter of opposition to the EU and that they wish to be able to decide sovereignly at national level whether or not to deregulate GMOs/NGTs.Two groups voted unanimously in favour of the text: the European People’s Party and Patriots for Europe.In the Parliament, currently, the Renew Group (77), the EPP (188) and Patriots for Europe (84) hold 349 seats, or 48.5%. If we add another far-right group (ECR), which voted unanimously in favour of deregulation within the ENVI Committee, this rises to 59.3% of all MEPs.If we analyse the votes in the April 2024 plenary session, we can see that votes within the groups are often fairly unanimous, though not entirely uniform. Thus, Renew voted 84% in favour of deregulation, the EPP 76% and the Patriots 92%. MEPs from the GUE and Greens groups, meanwhile, either voted against the text (97% and 82% respectively) or abstained.If we apply these 2024 proportions to the current MEPs, we would get between 386 and 391 votes in favour (the majority stands at 359). We have not taken into account the votes of ESN MEPs (who were absent during the previous parliamentary term but voted against in the ENVI Committee), nor those of the non-attached MEPs, whose vote is by definition impossible to predict. This is therefore merely a projection, but it nevertheless puts the ENVI Committee’s vote into perspective. Indeed, on 28 January, all EPP MEPs voted in favour of deregulation… Yet, in plenary, the group was not united in 2024. The question therefore remains as to how MEPs will vote during the upcoming plenary session, as, last January, in the case of the motion of censure against the European Commission regarding the Mercosur treaty, the newspaper Le Point reported that "the [EPP] leadership has decided to crack down hard: any EPP MEP voting in favour of the censure would face six months of disciplinary sanctions"vi. Will such a threat be used during the plenary vote on the text concerning the deregulation of GMOs/NGTs?Number of MEPs in 2025Number of MEPs FOR(based on the 2024 ratio)The Left460Greens/EFA530S&D13658Renew7767PPE188143ERC7842ID / PfE8477ESN25NI324TOTAL719392Table 2: Projected percentage of votes in the ENVI Committee (2025) for the European Parliament’s plenary sessionThe ENVI Committee has become more supportive of deregulationIn January 2024, the ENVI Committee had voted on an earlier version of the deregulation text, the initial version proposed by the European Commission in July 2023. A number of amendments were adopted at that time (which were subsequently put to a vote in plenary). However, the spirit of the European Commission’s proposal remained in the text voted on that day by the MEPs on the committee. Inf’OGM has compared the voting results within this committee (this table does not take into account MEPs who did not take part in the votes).FORAGAINSTABSTENTION202420252024202520242025The Left0.016.7100.066.70.00S&D25.041.268.871.46.30Green0.00.0100.052.90.00Renew75.080.016.710.08.30PPE100.0100.00.00.00.00ERC100.0100.00.00.00.02.4ID71.470.00.010.028.60ESN0.0100.0100.00.00NI0.050.0100.050.00.00TOTAL57.369.437.828.24.92.4Table 3: Votes by political group in the ENVI Committee in 2024 and 2025 (in %)It appears that the ENVI Committee was less supportive of the deregulation of GMOs/NGTs in 2024 than in 2025 (57.3% in favour in 2024 compared with 69.4% in 2025). What has changed most is the position of MEPs from the GUE and S&D groups, which shifted from 0% in favour to 16.7% and from 25% in favour to 41.2% respectively. The EPP and the Greens remain consistent in their voting: 100% in favour for the EPP and 100% against for the Greens.It should be noted that an election took place between the two votes. The number of MEPs appointed to the ENVI committee rose from 78 (in 2024) to 83 (in 2025). As a result of the election, the groups most opposed to deregulation lost six MEPs (GUE and the Greens), whilst the EPP and far-right groups gained a total of 12 MEPs.Thus, if we analyse both sets of data, it becomes clear that the shift to the right in the European Parliament following the 2024 elections worked in favour of the deregulation of GMOs/NGTs within the ENVI Committee. Will the same be true in plenary?Nationality has a marginal influence on votingAs for the political groups that voted inconsistently, the nationality of MEPs may partly explain the voting pattern. Thus, the members of the Socialist and Left groups who voted for deregulation are Spanish, Croatian, Lithuanian, Maltese or Swedish. This is not insignificant. These countries have very often, if not always, been very supportive of GMOs. Seventy per cent of the ECR group voted in favour of the text, but the MEPs who voted against or abstained are Greek or Polish, two countries traditionally opposed to GMOs.An MEP’s nationality can sometimes shed light on their vote, particularly for those in the S&D and GUE groups. For parties with a clear stance, such as the EPP, EPP-ED or the Greens, no national influence could be identified.Following this confirmation vote by the members of the European Parliament’s ENVI Committee, the text has been referred back to the Council of the EU, where Member States must still formally adopt it at first reading. This vote could take place in the spring, possibly in April. If the vote is in favour, the compromise text would be sent back to the ENVI committee. The committee would then have to make a voting recommendation to MEPs meeting in plenary, possibly in April or later.Breakdown of votes by MEPs from the countries most heavily represented on the ENVI CommitteeThe countries with the most MEPs on the ENVI Committee who voted on this text are: Germany (17), Italy (11), the Czech Republic (7), Sweden (6), France (6) and Spain (6). Together, these six countries account for 62% of the votes cast by the ENVI Committee on this text.FORAGAINSTTOTALGermany6917‍Italy9211Czech Republic617Sweden‍516France‍426Spain‍606i Eric Meunier, "La Commission européenne veut en finir avec les OGM", Inf’OGM, 24 July 2023.ii Council of the EU, “Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement”, 11 December 2025.iii Eric Meunier, ‘Qualified majority in the Council of the European Union to deregulate numerous GMOs’, Inf’OGM, 19 December 2025.ivEuropean Parliament, Committee on the Environment, Public Health and Food Safety, “Result of roll-call votes – 28 January 2026”, 28 January 2026.vPascal Canfin, “Agreement on new genomic techniques: solutions for agricultural transition and climate change resilience”, 4 December 2025.viEmmanuel Berretta, “Motion of no confidence against Ursula von der Leyen: François-Xavier Bellamy faces sanctions”, Le Point, 21 January 2026. Christophe NOISETTE antoine.vepierre [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [51] => Array ( [objectID] => 15194 [title] => Biotech Act : precaution sacrificed in the name of innovation? [timestamp] => 1771977600 [date] => 25/02/2026 [annee] => 2026 [url] => https://infogm.org/en/biotech-act-precaution-sacrificed-in-the-name-of-innovation/ [image] => https://infogm.org/wp-content/uploads/2026/02/51820297248_145378502c_c-768x512.jpg [extrait] => In a recent proposal for regulations claiming to "strengthen the biotechnology and biomanufacturing sectors", the European Commission wants to see these sectors governed by a policy that "balance innovation with safety, equity and environmental protection". However, the text mainly aims to promote industrial competitiveness and attractiveness to investors. It provides for faster authorisation procedures for "biotechnology products", a lighter regulatory framework and prioritisation of so-called "strategic" projects in order to reduce time to market. [chapo] => In a recent proposal for regulations claiming to “strengthen the biotechnology and biomanufacturing sectors“, the European Commission wants to see these sectors governed by a policy that “balance innovation with safety, equity and environmental protection“. However, the text mainly aims to promote industrial competitiveness and attractiveness to investors. It provides for faster authorisation procedures for “biotechnology products“, a lighter regulatory framework and prioritisation of so-called “strategic” projects in order to reduce time to market. [texte] => On 2 July 2025, the European Commission announced its strategy for life sciences1. This includes several initiatives2, among which is a proposal for a regulation to "strengthen the biotechnology3 and biomanufacturing4 sectors", the text of which was presented on 16 December 20255. This proposal is one of a series of new legislative initiatives relating to living organisms6 and is part of an increasingly complex process of challenging the current regulatory framework7. The European Commission's approach is based primarily on its objectives of simplification and reduction of regulatory constraints, but it calls into question measures to protect health, the environment and certain citizens' rights. This proposed biotech regulation thus seeks to redefine priorities in order to continue to make living organisms a commodity at the service of multinationals and start-ups.Which sectors are affected?Officially focused on health biotechnologies, the proposed biotech regulation actually covers a broader scope, also affecting agriculture, food and industry. It is part of the Commission's European strategy for life sciences, which includes a strategy to promote start-ups and the bioeconomy.On the health side, the proposed regulation concerns, among other things, “innovative” therapy medicinal products (Regulation 1394/2007), including gene (medical GMOs), cell and tissue therapies. It also covers industrial “biomanufacturing”, fermentation processes, research and production infrastructure, access to biological and health data, and the use of digital tools and artificial intelligence throughout the development chain for these products.The European Commission also wants to link this proposed biotech regulation with the one currently being negotiated on plants modified by NGTs (new genetic modification techniques). It states that this proposal is "consistent with the vision for agriculture and food" (General Food Law), a Commission communication8 dated February 2025 in which it proposes to build “a sustainable agri-food system... for current and future generations". This communication considers NGTs to be "keyfor accelerating the development of climate-change resilient, resource-saving, nutritious and high-yielding varieties, thereby contributing to the EU's food security and food sovereignty...". According to the Commission, they "can also yield microorganisms with positive impact on agricultural production, for example by reducing the need for synthetic fertilisers".This extension of the scope of the biotech regulation will not necessarily result in environmental and health risk assessments that are commensurate with the challenges at stake, at the risk of ignoring the precautionary principle.Simplifying to optimise the industrial processThe text of the proposal describes biotechnology and biomanufacturing as "essential to the competitiveness, strategic autonomy and economic security” of the European Unionand a “pillar of the Union's societal well-being in key areas such as health and food". This observation stems from the text's central diagnosis that "the EU lags behind other global regions when it comes to translating its world-class science and innovation into commercially viable products". The Commission points out that this situation, described in particular by the Draghi report, which is very popular and forms the basis of the trend towards legislative "simplification"9, too often leads companies to leave European territory to invest, develop, employ, create value and market their products elsewhere.Risk assessment in the biotechnology and biomanufacturing sectors is not presented as an issue to be reinforced, but is implicitly seen as a factor slowing down progress. Thus, the biotech regulation introduces the concepts of "strategic projects" and "high-impact strategic health biotechnology projects”, which benefit from priority treatment and enhanced administrative support. Any company developing an innovative project may ask a competent authority in a Member State to designate its project as a "strategic project".This objective of accelerating market access is being achieved in particular through experimental frameworks (regulatory sandboxes) that allow innovative products to be tested under adapted, i.e. reduced, regulatory conditions. Although these tests are to be supervised, the very principle of the system is based on a temporary derogation from the normal regulatory framework, which postpones risk assessment to a later stage after marketing. The simplification process also extends to the experimental procedures.The Commission therefore does not see its proposed biotech regulation as a means of protecting citizens and the environment from the impacts of biotechnology, but rather as a tool for optimising the industrial process.When innovation takes precedence over precautionThis priority given to innovation is particularly evident in the provisions relating to GMOs. Directive 2001/18/EC is explicitly mentioned, not to recall its protection objectives, but to suggest that its requirements and their implementation in Member States would slow down the conduct of clinical trials involving GMOs in the medical and veterinary fields. This proposed biotech regulation does not formally amend Directive 2001/18, but gradually circumvents its scope by stacking specific and derogatory regimes for veterinary medicinal products. This process had already begun with Regulation 2020/1043, which introduced derogations from the directive for clinical trials of medicinal products containing or consisting of GMOs and intended to treat or prevent coronavirus disease (COVID)10.The text continues this logic by amending Regulation 1394/2007 on advanced therapy medicinal products. It introduces the possibility of creating a category of "advanced therapy medicinal products [or ATMPs] containing or consisting of genetically modified organisms presenting no or negligible risks". They use techniques based on viral vectors, somatic cells or genetically modified material using NGTs. The Commission reserves the right to specify these categories by means of delegated acts in order to perpetuate the legislative framework for ATMPs. In concrete terms, it wants to be able to adopt such acts to amend Regulation 1394/2007 "by clarifying the definition, without extending its scope, of what constitutes a tissue engineered product, in light of technical and scientific advancements in the field of ATMPs”. This mechanism would enable the Commission to amend the regulatory framework quickly, without in-depth legislative debate, while reducing the scope of the independent and prior risk assessment that is nevertheless essential in this still poorly understood field of life sciences.Overall, the proposed biotech regulation places great emphasis on "innovation" (mentioned more than 200 times), while making no reference to the "precautionary principle", a cornerstone of European environmental law. Despite this, the European Commission continues to draw a clear political line, subordinating precaution to innovation and competitiveness.What is the current status of the European procedure?The proposed biotech regulation has now been submitted to the European Parliament and the Council as part of the ordinary legislative procedure. Amendments may be proposed, but the text is already part of a broader drive towards regulatory simplification, strongly promoted by the Commission and supported by a clear European industrial strategy.The upcoming institutional debate on biotechnologies applied to living organisms will have to address a fundamental trade-off: how far is the European Union prepared to go in reducing risk assessments and circumventing the precautionary principle, to the detriment of developing and maintaining a legislative framework that protects European citizens? Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [52] => Array ( [objectID] => 14964 [title] => Will the mRNA flu vaccine come into being? [timestamp] => 1771545600 [date] => 20/02/2026 [annee] => 2026 [url] => https://infogm.org/en/will-the-mrna-flu-vaccine-come-into-being/ [image] => https://infogm.org/wp-content/uploads/2026/02/mRNA-vaccine-story_2col.jpg [extrait] => At the end of November 2025, the New England Journal of Medicine published an article on a clinical trial of a messenger RNA vaccine against seasonal influenza. The article was written by researchers working for Pfizer, the company that developed the vaccine. Pfizer is keen to show that its vaccine is more effective than conventional vaccines. However, independent experts have pointed out major omissions and inconsistencies in the publication, which minimise or even call into question the trial's conclusions. [chapo] => At the end of November 2025, the New England Journal of Medicine published an article on a clinical trial of a messenger RNA vaccine against seasonal influenza. The article was written by researchers working for Pfizer, the company that developed the vaccine. Pfizer is keen to show that its vaccine is more effective than conventional vaccines. However, independent experts have pointed out major omissions and inconsistencies in the publication, which minimise or even call into question the trial’s conclusions. [texte] => As early as 1990, the first work on messenger RNA (mRNA) vaccines focused on combating seasonal flu, but encountered technical difficulties inherent in the mRNA molecule when introduced into an organism1. Biotechnological innovations and nanotechnologies subsequently made it possible to overcome certain implementation difficulties and develop mRNA injections against Covid-192.Pfizer has been working since September 2021 on the development of an mRNA vaccine against influenza3. The advantage of such a vaccine, as stated by the company, would be that it could be produced quickly to cope with the rapid mutations that affect influenza viruses. The article4 published in the New England Journal of Medicine (NEJM) concerns the phase 3 clinical trial, the last stage before a possible marketing authorisation application5.After presenting the "vaccine" that Pfizer is working on, we will look at the flaws in this phase 3 trial and the data discarded by Pfizer in the dedicated article. We will therefore question the validity of this trial. A critical eye is needed, as mRNA is a new industrial biotechnology production platform that is regularly cited as an example to be promoted in agriculture and medicine. In the latter field, the European Commission's proposal for a "Biotech Regulation" seeks precisely to open the doors wider to biotechnology in medicine6. However, the results we will discuss show that with this type of vaccine, we are moving closer to a form of medicine that generates additional risks rather than benefits.A quadrivalent messenger RNA vaccineFor the development of seasonal influenza vaccines, regardless of how they are manufactured (messenger RNA or otherwise), the World Health Organisation (WHO) issues annual recommendations on the circulating strains to be taken into account for vaccine production7. The vaccine can be, for example, trivalent or quadrivalent, depending on the number of recommended virus strains. The mRNA vaccine in the Pfizer trial is quadrivalent, meaning that it is designed to combat four virus strains: two A strains (A/H3N2 and A/H1N1) and two B strains (B/Yamagata and B/Victoria)8.The mRNA in the Pfizer vaccine is a mixture of the four genetically modified viral mRNAs. Each of these injected mRNAs should enable the synthesis of a modified viral haemagglutinin (viral protein chosen as an antigen) specific to each of the four selected virus strains. The genetic modifications made to the mRNA molecules are similar to those made to the anti-Covid mRNA vaccine to optimise its action: stabilising it to evade the immune system. These mRNAs are encapsulated in lipid nanoparticles, as in the anti-Covid vaccine. However, this vaccine with four genetic mRNA constructs is, in fact, much more complex than the mRNA vaccine against Covid.Omission or minimisation of dataThe published article gives the results deemed positive by Pfizer concerning the action of its vaccine in 18-64 year olds, but does not include the results for people aged 65 and over, an age group that is nevertheless heavily affected by seasonal flu. However, this age group represented 60% of the participants in the overall Phase 3 trial involving all adults aged 18 and over, as shown on the ClinicalTrials.gov website9.Based on the complete data on ClinicalTrials.gov, some independent experts (epidemiologists, microbiologists, physicians, pharmacologists) have calculated that, compared to the conventional inactivated influenza vaccine10, seniors experienced an 8% increase in serious adverse events, an 80% increase in non-serious adverse events, +129% acute renal injury, unspecified (16 vs. 7), +184% acute respiratory failure (17 vs. 6), and low but slightly higher all-cause mortality11. The complete data show a comprehensive picture of results, particularly for adverse effects in people aged 65 and over, which the NEJM article does not mention.In France, this shortcoming is cautiously mentioned in the journal Fréquence Médicale12, which notes in its article that "the focus on healthy 18-64 year olds limits the scope of direct extension to children, people aged 65 and over, pregnant women and immunocompromised individuals". It goes on to state that the prospects for this vaccine must include, among other things, "dedicated trials in seniors".It should also be noted that, although the results for 18-64 year olds show greater vaccine efficacy compared to the conventional vaccine13 in terms of immunogenicity (blood tests for antibodies and lymphocytes), these results should be put into perspective, as the Pfizer vaccine is only superior for influenza A strains, but not for influenza B strains. The reasons for this are not explained in the NEJM article.In this article, which only considers the 18-64 age group with regard to the adverse effects of this mRNA vaccine, it is stated that "the adverse event profiles [editor's note: related to mRNA or conventional vaccines] were similar in both groups". However, the same article goes on to note that "adverse events considered by the investigator to be related to the vaccine were reported in 3.3% of mod RNA recipients and 1.4% of control recipients", which does not appear to be "similar".Furthermore, although Pfizer does state in the NEJM publication that a total dose of 30 micrograms of vaccine mRNA was injected in people aged 18-64, there is no detail on the distribution of doses by strain.In the same article, Pfizer notes that the mRNA flu vaccine was "associated with more reactogenicity events"14 than the non-mRNA flu vaccine, but that most were "mild to moderate". However, the complete data show much higher figures for the mRNA vaccine than for the conventional vaccine in the table of reactogenicity at 7 days, across all age groups.The Fréquence Médicale article also emphasises the reactogenicity of the vaccine, but calls for it to be reduced with a view to improving the mRNA vaccine for production. This is proof that it should not be overlooked in the current state of the vaccine.A global trial marked by negligenceA very significant bias in this phase 3 trial is the choice of the control group. Some researchers point out that the results of Pfizer's study are "invalid" because the vaccine was not tested against an unvaccinated control group, but only against a conventional inactivated vaccine (also quadrivalent). "There is no placebo group, which means that the entire efficacy claim is based on its relative efficacy compared to the influenza vaccine available at the time," said Karl Jablonowski, PhD in biomedical informatics15. The independent experts also point out that "by comparing it to a vaccine that is already in use [editor's note: the conventional vaccine], the actual rate of adverse effects is underestimated".The aforementioned article in Fréquence Médicale also deplores the "comparison with an approved vaccine rather than a placebo".There are also shortcomings in terms of the doses of mRNA injected. In the phase 3 trial in people over 65, there is no data on the total dose of vaccine mRNA injected, nor on the distribution of doses by strain. The phase 1/2 trial proves that numerous dosages and combinations were tested, but the figures are hidden in the data. In any case, this demonstrates the difficulty designers had in finding a tolerable and effective dose for each strain.On the other hand, the trial highlights that participants in the 18-64 age group had antibodies against three of the four influenza strains tested prior to vaccination, which means that these individuals had been in contact with the virus in previous years. It would have been more rigorous to seek only individuals who were free of these antibodies, or to create two subgroups, those with antibodies and those without.Finally, on the fundamental issue of vaccine safety, the possibility of a risk of recombination between genetically modified vaccine mRNAs and circulating wild-type influenza viruses is not addressed. This is particularly important given that there are four strains of vaccine RNA in this vaccine and that the EMA (European Medicines Agency) recognises this risk between the RNA of live vaccines (authorised but not marketed in France) and the RNA of wild viruses16.The precautionary principle not respectedHow can we explain the publication of a study that only reports the estimated positive results for a segment of the population that is not particularly affected by flu complications? Meanwhile, for elderly people affected by this disease, the results indicating side effects have been excluded from this publication. Without knowing whether a link exists, it should be remembered that the annual flu vaccination market is worth several billion dollars each year.This omission is a serious breach of the precautionary principle, as are other oversights in the trial, such as the possible recombination of viral RNA, which compromises the safety of mRNA injections.This failure to take the precautionary principle into account is precisely what the new team at the Food and Drug Administration (FDA) in the United States is questioning. Given Pfizer's lack of rigour and concealment of data, the FDA will not approve the trial without additional data on the safety of this vaccine17.It should be noted here that Moderna and GlaxoSmithKline (GSK) are also conducting clinical trials of an mRNA vaccine against influenza. These companies are also encountering setbacks with the same FDA18.Furthermore, the concealment of data could lead to criminal liability for Pfizer, a company that is no stranger to the courts, "if it can be shown that there was intentional deception, material harm or foreseeable risk, and collaboration with Pfizer to conceal the data"19.mRNA vaccine technology still leaves questions unanswered, particularly regarding its medium-term efficacy and long-term safety. It should also be noted that mRNA vaccines are the only vaccines for which the quantity and quality of the antigen produced cannot be controlled, as each organism reacts differently.With regard to the mRNA vaccine against influenza, due to its great complexity (several different mRNA genetic constructs that must produce different antigenic proteins), we are still a long way from scientifically conclusive results and the essential safety requirements. As things stand, this proposed mRNA vaccine technology against influenza presents more risks than benefits.Proposing such a vaccine seems more like a race between competitors and shows a lack of responsibility on the part of companies... which should curb politicians' enthusiasm for this RNA technology in medicine and agriculture. Annick BOSSU et Mireille LAMBERTIN-MARTINEZ [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [53] => Array ( [objectID] => 14956 [title] => Palmer amaranth, an extremely invasive weed, arrives in France [timestamp] => 1771459200 [date] => 19/02/2026 [annee] => 2026 [url] => https://infogm.org/en/palmer-amaranth-an-extremely-invasive-weed-arrives-in-france/ [image] => https://infogm.org/wp-content/uploads/2026/02/Amaranthus_palmeri.jpeg [extrait] => As soon as farmers began using herbicides on a large scale, weeds tolerant to these substances appeared. This is a simple biological phenomenon: living organisms are constantly adapting. The cultivation of genetically modified plants has accelerated this development of tolerance, which has significant agricultural and economic consequences. In France, a highly invasive weed known as Palmer amaranth, which is resistant to several types of herbicides, could soon take hold. This is the fear expressed by ANSES in a report published in December 2025. [chapo] => As soon as farmers began using herbicides on a large scale, weeds tolerant to these substances appeared. This is a simple biological phenomenon: living organisms are constantly adapting. The cultivation of genetically modified plants has accelerated this development of tolerance, which has significant agricultural and economic consequences. In France, a highly invasive weed known as Palmer amaranth, which is resistant to several types of herbicides, could soon take hold. This is the fear expressed by ANSES in a report published in December 2025. [texte] => Genetically modified plants, whether through transgenesis or mutagenesis, are almost all tolerant to one or more herbicides. Initially sold as a tool to reduce herbicide spraying or to replace certain herbicides with others, they have ultimately contributed to their increase1. This is mainly due to the emergence of weeds that have developed resistance to these herbicides.The most emblematic case is Palmer amaranth, which has become resistant to several active ingredients in herbicides, including glyphosate (the active ingredient in Roundup) and ALS inhibitors. It is present in 28 states in the United States, covering several hundred thousand hectares. The first herbicide-resistant amaranth were discovered in 1989 in Texas. In 2013, researchers reported that amaranths resistant to five modes of herbicide action had been identified2, and then, in 2020, to eight modes of herbicide action3. The cultivation of corn, soybeans, and cotton genetically modified to resist herbicides has accelerated the spread of this “super weed”. The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) notes in a recent report that “since the 2000s, A. palmeri has become the main weed in GMO corn and soybean crops in the United States"4. These weeds have therefore become difficult to destroy. To get rid of them, it is necessary to either increase the spray doses or use other, sometimes more harmful, herbicides. In the United States, yield losses of up to 91% in corn, 79% in soybeans, and 77% in cotton have been documented5.Palmer amaranth soon to be present in FranceThis plant is considered invasive, mainly because it adapts very well. "Since the early 20th century, A. palmeri has demonstrated a strong ability to adapt to new climatic conditions during its spectacular expansion beyond its native range across North America (Briscoe Runquist et al., 2019). It cannot therefore be ruled out that this species may adapt to climates that we consider unfavorable to its establishment in light of this work or for which our analyses reveal a high level of uncertainty", according to the ANSES report published in December 2025.ANSES took up this issue on its own initiative because “the probability of A. palmeri establishing itself in mainland France is considered high with low uncertainty”. There are several reasons for this: “the difference in agricultural practices in mainland France (no GMOs and few direct seeding) compared to the United States and Brazil (heavy use of GMO varieties combined with no-till farming and non-selective herbicides that favor resistant populations)”. In the United States, there are sometimes rotations between two crops, such as soybeans and corn, that are tolerant to the same herbicide for several years in a row. This increases selective pressure.The second reason for this self-referral is the presence of this plant in neighboring countries. The report specifies, for example, that Spain “is currently facing a severe infestation of A. palmeri populations that are resistant to various herbicides and are having a significant impact on summer crops and certain perennial crops such as orchards, vineyards, and alfalfa”. The report also mentions the presence of amaranths resistant to glyphosate or ALS inhibitors in Piedmont and Emilia-Romagna (Italy). It is also present in other European countries, such as Belgium and Germany, but on a more occasional basis. ANSES therefore concludes that the probability of A. palmeri entering the country is “considered very high with moderate uncertainty”.However, according to ANSES, “commercial exchange (animal feed) and agricultural equipment between Spain and France exist”. This would be the primary entry point for this weed. Imports, particularly of soybeans and corn, from the United States or Brazil are another entry point. ANSES specifies in its report that “imported products such as soybeans and corn for the manufacture of livestock feed are not subject to any specific regulations or controls, and are the proven and regular source of introductions of A. palmeri”.As a result, ANSES believes it is highly likely that Palmer's amaranth will soon arrive in France. This plant could then cause “significant” economic damage. The report states that “based on all available data, [ANSES] considers that the impact of A. palmeri in its current distribution area is very high in agricultural environments on summer crops, with low uncertainty. On the other hand, the impact of A. palmeri on natural environments is low, with low uncertainty”.In Europe, no herbicide-tolerant transgenic varieties are authorized for cultivation. However, other types of GMOs tolerant to ALS inhibitor herbicides, such as Clearfield or Conviso varieties, are grown, particularly in France and Spain. Known as Herbicide Tolerant Varieties (HTVs), these include rapeseed, sunflower, and beet. The use of these herbicides on these crops will have two consequences: they will be ineffective in “combating” resistant amaranth, and there will be a potential increase in the number of weeds that have become resistant to these herbicides. As a result, farmers will be tempted to use other, more toxic herbicides, or even to request that banned herbicides be authorized. This is what happened in the United States.ANSES overlooks Clearfield and other HTVs crops in EuropeThe report does not mention Clearfield or Conviso varieties grown in Europe, the HTVs crops we have just mentioned. This omission raises questions. Before 2010, NGOs and the Confédération Paysanne farmers' union denounced the cultivation of HTVs rapeseed and sunflowers. In 2015, these organizations filed an initial appeal. This long battle culminated in the July 2018 ruling by the Court of Justice of the European Union (CJEU), which reiterated that these varieties were GMOs. In another report, ANSES also recognized that Clearfield rapeseed and sunflowers were GMOs. In 2020, a draft decree by the Ministry of Agriculture prohibiting the marketing of Clearfield rapeseed varieties was drafted, but it was never published in the Official Journal.Finally, it is also worth remembering that Clearfield varieties were promoted in France by highlighting the fight against ragweed, another invasive weed that is highly allergenic. However, as Inf'OGM pointed out in 2022, "in addition to the proven ineffectiveness of HTVs, repeated use of the same herbicide leads to a known phenomenon of herbicide resistance in the target plant. As a result, in just a few years (HTVs have only been listed in the French catalog since 2010 for sunflowers and 2012 for rapeseed), ragweed has become resistant to ALS inhibitors, frequently in the Rhône-Alpes region and to a lesser extent in Aquitaine and Occitanie"6.Recommendation: classify amaranth as a harmful organismIn its December 2025 report, ANSES recommends classifying Palmer amaranth as a harmful organism. This would involve a number of measures: inspection of imported soybean and corn shipments, territorial surveillance, particularly in regions favorable to its establishment, early detection, and implementation of an eradication program in the event of confirmed observation.The case of Palmer amaranth is not an isolated one. Teosinte, a wild plant closely related to corn, is another example. Researchers at INRAE, IRD, and CNRS have found that DUO corn, which is resistant to herbicides, has, through genetic exchange, enabled “teosinte to acquire [...] resistance to herbicides”7. The problem of herbicide-tolerant weeds - which are therefore difficult to eradicate - is directly linked to the use of herbicides. The European Union is currently discussing the possible deregulation of plants derived from new genomic techniques (NGT1). The text under discussion would, in theory, exclude herbicide-resistant GMOs from this deregulation. This confirms what environmental associations and certain farmers' unions have been saying for more than 20 years: HTVs are harmful to agriculture and contribute to an increase in the doses of herbicides sprayed. Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [54] => Array ( [objectID] => 14809 [title] => What “discussion” procedures are imposed on European legislators? [timestamp] => 1770768000 [date] => 11/02/2026 [annee] => 2026 [url] => https://infogm.org/en/what-discussion-procedures-are-imposed-on-european-legislators/ [image] => https://infogm.org/wp-content/uploads/2026/02/Entrepreneur-Faces-Path-of-Confusion-Vector-Image-768x573.png [extrait] => Since July 2023, EU institutions have been engaged in discussions on the proposal to deregulate many GMOs. These discussions follow an established procedure of negotiations between the Council of the European Union, the European Parliament and the European Commission. Complex but logical, this procedure can sometimes confuse those who follow it. Inf’OGM helps you see things more clearly. [chapo] => Since July 2023, EU institutions have been engaged in discussions on the proposal to deregulate many GMOs. These discussions follow an established procedure of negotiations between the Council of the European Union, the European Parliament and the European Commission. Complex but logical, this procedure can sometimes confuse those who follow it. Inf’OGM helps you see things more clearly. [texte] => There are numerous legislative projects that have been initiated by the European Commission over the past two years, as well as those that have already been announced. In areas related to biotechnology, these projects tackle existing legislation aimed at protecting the environment, health and citizens' rights, as Inf'OGM recently pointed out in an opinion piecei. It is essential to understand how European legislators discuss, exchange views and put forward their own points of view, or at least those of their voters.Focusing on the work currently underway on the possible deregulation of many GMOs (with key dates already set for the stages that have been completed), Inf'OGM has outlined below the step-by-step procedure for the adoption or rejection of European legislation. The work of the European Commission (in yellow), the Council of the European Union (in blue), the European Parliament (in salmon pink) and the trilogue or conciliation meetings (in green) are shown in chronological order.i « GMOs, seeds, pesticides, transparency… European law under attack! », Inf'OGM, 22 January 2026. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [55] => Array ( [objectID] => 14732 [title] => Patents and NGTs: the singular position of Germany’s main agricultural union [timestamp] => 1770336000 [date] => 06/02/2026 [annee] => 2026 [url] => https://infogm.org/en/patents-and-ngts-the-singular-position-of-germanys-main-agricultural-union/ [image] => https://infogm.org/wp-content/uploads/2026/01/csm_dbv_logo_rgb_181005_weisser_rahmen_neu_c86ec27e87-768x269.jpg [extrait] => While the deregulation of GMOs obtained through new genetic modification techniques (GMOs/NGTs) is currently under review, the issue of patents continues to provoke contrasting positions within European agricultural organisations. In this context, the position of the Deutscher Bauernverband (DBV), Germany's main agricultural union, is particularly noteworthy. While in favour of the use of these NGTs, it nevertheless warns of the risks associated with patents. This is an original position among European agricultural organisations. [chapo] => While the deregulation of GMOs obtained through new genetic modification techniques (GMOs/NGTs) is currently under review, the issue of patents continues to provoke contrasting positions within European agricultural organisations. In this context, the position of the Deutscher Bauernverband (DBV), Germany’s main agricultural union, is particularly noteworthy. While in favour of the use of these NGTs, it nevertheless warns of the risks associated with patents. This is an original position among European agricultural organisations. [texte] => The DBV is a union representing more than 90% of Germany's 300,000 farms1. On 1st December 2025, in a communication on NGT, which it supports2, the DBV explicitly criticised patents applied to plants. It considers them a major risk to varietal innovation, competition between breeders and farmers' autonomy. This dissociation between innovation and appropriation of living organisms is a singular position within the mainstream European agricultural union movement, which is characterised by less assertive positions, but is generally favourable to patents.An atypical majority union among Copa-Cogeca membersIn her statement, DBV Secretary General Stefanie Sabet welcomes the principle currently under discussion of deregulating GMOs derived from NGTs. However, unlike the majority of agricultural organisations that have taken a favourable position on NGTs, the union considers that the issue of patents crosses a clear red line: "Patents must not block progress in breeding. If the essential characteristics of plants are monopolised by certain companies, our farmers and small and medium-sized breeders will lose access to important genetic material". The DBV points to several risks: damage to competition between breeders, increased seed prices and reduced varietal diversity. It is also concerned, in the longer term, about a "concentration on a few main high-yield crops, while plant species that are important at regional level will disappear from the market".The DBV's position is rather atypical among the majority of European agricultural unions affiliated to Copa-Cogeca (an organisation representing professional agricultural organisations and agri-food cooperatives), which certainly express their commitment to plant variety rights, but demand access to GMOs derived from NGT without opposing their patentability. This is all the more remarkable given that it comes from an agricultural union representing the majority of German farms. Another German union, the Arbeitsgemeinschaft bäuerliche Landwirtschaft (ABL), shares this opposition to patents, but takes a more explicitly small-scale farming approach, in line with the positions defended by the European Coordination Via Campesina (ECVC).This stance breaks with the industrial sector's position...The uniqueness of the DBV's position also lies in the nature of its argument. The German union bases its argument on a different premise from that of the dominant seed industries, which often hold patents: "innovation and progress have been possible until now even without patents". This argument is not shared by the large seed companies, which, with their considerable financial resources, believe that patents are essential for a return on their investment in research and development.The DBV therefore differs from this approach, arguing that patents not only stimulate innovation, but can also stifle it, for example when they relate to new or pre-existing genetic traits in nature. Without denying the link between biotechnological innovation and patents, the German union emphasises that other mechanisms, such as plant variety rights (PVRs), also make it possible to reward innovation. It therefore focuses the debate not on innovation itself, but on the methods used to ensure its recognition and remuneration.It should be noted that the link between biotechnological innovation and patents is felt by some medium-sized seed companies, such as the French companies RAGT and Florimond Desprez. These companies only have access to new genetic modification techniques by negotiating very expensive licences with the few large multinationals that hold the main "lock" patents on NGTs3. They have therefore tended to express their opposition to patents on products derived from NGTs, favouring PVR instead....and aligning themselves with NGOsAt the institutional level, on 19 December 2025, the permanent representatives of the EU Member States voted in favour of a provisional compromise that does not in any way call into question patent rights, including for NGTs and their products4. The reasons for the silence of Germany, which is home to a number of major biotech companies (Bayer, BASF, etc.), remain officially unknown.The DBV's position is more transparent, as it has already made it clear in the past by explicitly criticising patents covering native traits or those resulting from conventional breeding. The German union has co-signed joint positions with European civil society organisations (No Patents on Seeds) and organic farming organisations (Bioland), calling for significant restrictions on plant patents, or even the total exclusion of plants from the scope of patentability when their characteristics exist in nature5. This type of alliance is rare for a majority agricultural union and highlights the cross-cutting nature of the DBV's position.No European consensus among agricultural unionsOther Copa-Cogeca member unions are also critical of patents on GMOs derived from NGT. The LTO (Netherlands) recognises the virtues of NGT, but warns of the risk that plant characteristics could be patented, which could slow down varietal innovation, and argues that GMOs/NGT should remain patent-free6. Similarly, COAG (Spain), a member of ECVC and Copa-Cogeca, informed us that they are opposed to GMO and patents on all GMOs, old and new. In Poland, the main agricultural unions, also members of Copa-Cogeca, criticise patents, which they consider responsible for farmers' dependence on multinationals and an infringement of their sovereignty over seeds.The FNSEA, the majority union in France, a member of Copa-Cogeca and equivalent to the German DBV, has adopted a position clearly in favour of deregulating GMOs. It has not commented on the threat posed by patents on biological material and genetic information, particularly plants, or on their use by farmers. As signatories to an open letter dated 27 November in the context of the trilogue on the NGT Regulation7, the FNSEA and 27 other national organisations are focusing on supporting deregulation at European level, without making patent restrictions a major critical issue, unlike the DBV.Several European trade unions share a position similar to that of the FNSEA, favouring a positive or ambiguous approach to patents. This is precisely the case with Copa-Cogeca, which also includes cooperatives that own companies producing patented seeds, such as Limagrain/Vilmorin. As a member of these organisations, the DBV acknowledges the existence of the debate on patents, but recommends separating it from the debate on the deregulation of GMOs/NGTs, so as not to hinder the adoption of new rules8.Coordination Rurale, France's second largest trade union, has opposed the patentability of seeds since 2016 without opposing GMOs/NGTs9. The Confédération paysanne, France's third largest trade union and a member of ECVC, opposes patents on plants10, believing that they privatise living organisms and threaten farmers' right to select, conserve, use and exchange their seeds.Weak signs of a coming divide?The differences between unions on the issues of NGT regulation and patents raise several questions. While a significant number of unions highlight the problems associated with patents, a majority seem satisfied with the current trend towards deregulation of GMOs obtained through new techniques11. However, it is questionable whether they have fully assessed all the consequences of maintaining patents on farmers' activities, particularly the economic impact. Unless the limited exemption granted to farmers12 authorising the controlled use of a specific list of seeds is really enough to reassure the unions...The DBV is the main union in a major agricultural country in the European Union13. Germany is also a historical pillar of the European patent system, particularly in the chemical and biotechnology sectors. However, it did not express any position at the meeting of EU Member State representatives in December 2025. Does this reflect a weak signal of awareness of the potential problems that patents can pose for agriculture, but also for small and medium-sized breeders? In any case, these relatively unusual positions raise questions about the overall perception of the agricultural stakeholders concerned and their understanding of the issues at stake at European level. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [56] => Array ( [objectID] => 14689 [title] => Limagrain has established a presence in the United Arab Emirates [timestamp] => 1770163200 [date] => 04/02/2026 [annee] => 2026 [url] => https://infogm.org/en/limagrain-establishes-presence-in-the-united-arab-emirates/ [image] => https://infogm.org/wp-content/uploads/2026/01/Silal-x-Limagrain-768x512.jpg [extrait] => In June 2025, Limagrain, a French multinational seed company, signed a partnership agreement with Abu Dhabi Developmental Holding Company (ADQ), an Emirati sovereign wealth fund. In early October, this partnership resulted in the creation of a joint venture including a research unit focused on "genetic editing". [chapo] => In June 2025, Limagrain, a French multinational seed company, signed a partnership agreement with Abu Dhabi Developmental Holding Company (ADQ), an Emirati sovereign wealth fund. In early October, this partnership resulted in the creation of a joint venture including a research unit focused on “genetic editing“. [texte] => On 25 June 2025, Limagrain announced in a press release that it had "entered into exclusive discussions to build a strategic and financial partnership with ADQ"i. Under this agreement signed with Vilmorin & Cie, a subsidiary of Limagrain, ADQ will acquire a 35% stake in Limagrain's vegetable seed business. In early October, this agreement was formalised with the creation of a joint venture in line with the respective strategies of Limagrain and the United Arab Emirates (UAE). For the French seed producer, the aim is to accelerate "its development and, more specifically, to strengthen its leadership in the global vegetable seed market". For ADQ, the challenge is to leverage "modern technologies" (robotics, digital, genetics) to increase local production and ensure its sovereignty in terms of food security.Limagrain's "Ambition 2030"On 27 June, two days after its agreement with ADQ, Vilmorin & Cie announced the sale of AgReliant, "focused on the research, production, and sale of seeds, primarily corn and soybean" for the North American market, which it co-owned with KWSii. According to the company, "this transaction marks an important milestone for Vilmorin & Cie, enabling to further focus on its strategic priorities and to reinforce its other territories as it continues advancing on its Ambition 2030". However, the proposed partnership with ADQ is also "fully in line with Vilmorin & Cie and its shareholder Limagrain's strategic roadmap, “Ambition 2030”. It would further accelerate Vilmorin & Cie’s growth – particularly in its Vegetable Seeds business line – and support the Group in achieving its 2030 strategic objectives"iii.So what are the ambitions of this strategy? With a view to achieving a turnover of €400 million, it is based in particular on the internationalisation of Limagrain, which states that it wants to help farmers "adapt to the effects of climate change (more frequent and intense periods of drought, irregular rainfall, increased pest pressure, etc.)" by providing "diversified genetic resources and appropriate technological tools to create new, more efficient seed varieties – and therefore plants".As we mentioned in a previous articleiv, Limagrain had already, in February 2023, publicly called on France to support the deregulation of GMOs obtained through new genetic modification techniques (NGT), considering them "essential to support the transition towards a resilient economy and a sustainable food system". In March 2025, during an interview organised by the Afja (association of agricultural journalists)v, Sébastien Chauffaut, CEO of Limagrain, even stated: "We will market the first varieties derived from new genomic techniques in 2029".He also asserted that "a country's ability to produce and promote its seeds is a diplomatic asset that allows it to negotiate from a position of strength", thus making seeds "a diplomatic weapon in the service of competitiveness". This vision echoes the UAE's "National Food Security Strategy 2051"...ADQ, a sovereign wealth fund serving a strategyCreated in 2018, ADQ is a major global investor, ranking among the top 10 sovereign wealth funds in terms of investment volume in 2023. As such, since 2020 it has been managing the operating surpluses of numerous national companies, which it can invest abroad in order to achieve its objectives: "investing in critical infrastructure, which underpins economic growth, and integrating into global supply chains to enhance self-sufficiency and resilience" in order to "improve the lives of people and communities"vi. While energy, health, transport and industry are key areas of investment for ADQ, agriculture and food supply are also highly strategic for the UAE. The country is 90% dependent on imports, mainly due to its desert climate. To date, ADQ's major investment in this area has been the acquisition of 45% of the Louis-Dreyfus Group, a multinational agricultural commodities trading company based in Amsterdam (Netherlands), which is part of the "ABCD Group"vii.With a view to breaking free from this heavy dependence on imports, in 2018 the UAE developed the "National Food Security Strategy 2051"viii. According to Grain, "its aim was to see the UAE in the top ten of the global food security index by 2021 (in reality, it was number 35) and number one by 2051. The plan not only involves more overseas farms but also a ramp up in domestic food production to cut the UAE's reliance on food imports from the current 90% [...] to 50%"ix. This strategy explicitly plans to rely on innovative technologies and international partnerships to achieve these objectives. To this end, the emirate has already entered into a partnership with Bayer in 2023. As reported by Revista Cultivarx, this partnership aims to conduct trials of vegetable seeds in order to adapt them to the growing conditions of the Emirati desert climate. It is therefore no surprise that the UAE is now entering into an agreement with Limagrain, a competitor of Bayer, which is likely hoping to benefit from the enormous investment capacity of Emirati sovereign wealth funds.A partnership taking shapeIn early October 2025, this agreement took shape with the creation of a joint venture between Limagrain Vegetable Seeds and Silal, an Emirati agritech specialistxi. The result of this alliance is the Centre of Excellence for Abiotic Resilience and Crop Genomics (ARC-GEN) in the Al Ain region. The press release announcing this inauguration clearly states that this research centre aims to develop genetically modified vegetable plants that are able "to stand with extreme conditions such as heat, drought, and salinity". To this end, scientists will draw on "advances in crop genomics, the study of plant DNA, to develop new vegetable varieties". More specifically, "The GeneEditing Research Unit will apply advanced scientific techniques to refine plant genes and create stronger varieties with improved traits".Citing the promise of agriculture adapting to the challenges of climate change through the development of GMOs, Sébastien Vidal, President of Limagrain, welcomes this partnership between the UAE's cutting-edge infrastructure and his company's expertise in the field of seeds, believing that it will provide appropriate solutions "for the future of agriculture and food sovereignty, hand in hand, with respect for people, cultures, and shared values".This alliance between Limagrain and the UAE is in fact only a small part of the UAE's overall strategy, which, by choosing agritech (vertical farming, hydroponics, controlled environment agriculture, robotics, etc.), aims to bring about a "disruption of food systems to be able to grow anything anywhere regardless of climate and environment"xii. Modifying living organisms to overcome soil and climate limitations, all in order to remain a "leader" in technological innovation and on international markets, is the reason given for the United Arab Emirates' investments today. For its part, Limagrain makes no secret of its ambitions. Already present in 53 countries, the multinational company has positioned itself as a guarantor of food sovereignty, "disregarding all politics and bias"xiii. But the race for innovation and international partnerships could also be driven by a desire to gain market share at any cost, so as not to remain the fifth wheel in the global seed industry rankingsxiv...i Limagrain, "Limagrain, via its subsidiary Vilmorin & Cie, has entered into exclusive discussions to build a strategic and financial partnership with ADQ on Vegetable Seeds", 25 June 2025.ADQ, "ADQ to acquire a strategic stake in Limagrain Vegetable Seeds and launch joint R&D partnership in UAE focused on the development of desert-adapted seeds", 25 June 2025.ii Vilmorin & Cie, "Vilmorin & Cie and KWS to sell North American Joint Venture AgReliant Genetics to GDM", 27 June 2025.iii Vilmorin & Cie, "Vilmorin & Cie has entered into exclusive discussions to build a strategic and financial partnership with ADQ on Vegetable Seeds", 25 June 2025.iv Denis Meshaka, « Limagrain, a “cooperative” that has always bet on GMOs », Inf'OGM, 12 May 2025.v Mouhamed Ben Diene, « « Les semences … de véritables armes diplomatiques » », JA Mag, 19 March 2025.vi ADQ, "01 ― What we stand for - Driving economic resilience".vii The "ABCD Group" refers to the four multinationals that share 70% of the global grain market (Archer Daniels Midland, Bunge, Cargill, Louis Dreyfus).Laurie Debove, « Les ABCD, les 4 géants céréaliers, tirent des superprofits records de la crise alimentaire », La Relève et La Peste, 18 November 2022.viii UAE, "National Food Security Strategy 2051", updated on 30 December 2024.ix Grain, "From land to logistics: UAE's growing power in the global food system", 3 July 2024.x Rajaa Kantaoui, "Silal and Bayer announce partnership to drive innovation in agriculture",Revista Cultivar, 5 December 2023.xi Silal, "Silal partners with Limagrain Vegetable Seeds to launch Centre of Excellence for Abiotic Resilience and Crop Genomics", 1st October 2025.xii UAE Ministry of Climate Change and Environment, "A Guide to Food Security in the UAE", 2023.xiii Gaëlle Chazal, « Dans un monde qui se fracture, Limagrain "doit se rappeler que son métier est d’abord de nourrir les populations" », La Montagne, 21 June 2025.xiv ETC Group & Grain, "Top 10 agribusiness giants: corporate concentration in food & farming in 2025", 10 June 2025. [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [57] => Array ( [objectID] => 14729 [title] => MEPs approached by industry to deregulate GMOs/NGTs [timestamp] => 1769990400 [date] => 02/02/2026 [annee] => 2026 [url] => https://infogm.org/en/meps-approached-by-industry-to-deregulate-gmos-ngts/ [image] => https://infogm.org/wp-content/uploads/2026/01/Behind_the_scenes_during_the_European_Parliament_hearings_with_Commissioners-designate_2024_-_55555560696-768x512.jpg [extrait] => Since the European Commission submitted its proposal to deregulate almost all GMOs in 2023, multinational seed companies and lobbyists have been busy lobbying European institutions to support this proposal. Companies and civil society organizations can request meetings with MEPs. These meetings are listed, at least in part, on the Parliament's website. In this article, Inf'OGM shows that supporters of GMO deregulation had 59 meetings, compared to 23 for opponents. [chapo] => Since the European Commission submitted its proposal to deregulate almost all GMOs in 2023, multinational seed companies and lobbyists have been busy lobbying European institutions to support this proposal. Companies and civil society organizations can request meetings with MEPs. These meetings are listed, at least in part, on the Parliament’s website. In this article, Inf’OGM shows that supporters of GMO deregulation had 59 meetings, compared to 23 for opponents. [texte] => In 2024, Inf’OGM had already published an article on meetings between MEPs and stakeholders dedicated to the deregulation of GMOs modified by new genetic modification techniques (NGT)1. This artice was compiled during the 9th legislative term, between May 2023 and the end of June 2024. The conclusion was unambiguous: of the 135 meetings reported, 57.6% were with supporters of deregulation (80) and 33.1% with opponents (46). We wrote at the time that “the balance is therefore one meeting for the ‘opponents’ for every two meetings for the promoters”.2024-2026 review of meetings between MEPs and lobbyistsInf'OGM replicated this monitoring work and analyzed MEPs' meetings between July 2024 and 6 January 2025 on GMOs covered by the deregulation project. The conclusion is the same as between May 2023 and June 2024. Of 82 meetings with non-institutional actors, 59 were with actors in favor of deregulation (68.6%), compared to 23 with actors opposed to it (26.7%). The ratio for this period was therefore 2.6 (1.7 for the previous period). The gap has widened.Let us first return to the concept of “favorable” and “unfavorable” actors. We based our analysis on statements made by the entities we found. On the one hand, we find international seed companies, lobbying organizations, agricultural unions that are members of COPA-COGECA, and agricultural organizations involved in international trade. For example, the Deutscher Raiffeisenverband e.V. (DRV) is the association that represents German cooperative companies in the agricultural and agri-food sectors. This organisation has taken a position in favor of deregulation as early as 20232. On the other side of the spectrum, we find organizations that defend small-scale or organic farming, as well as environmental NGOs. In our count, we have removed four meetings with national delegations (Denmark, Spain, and the Netherlands). We have chosen not to count them among the actors with private interests, but it should be noted that these countries have positions favorable to deregulation. In addition, two meetings are difficult to verify.We emphasize the same precautions as usual: these are meetings listed in the European Parliament's “transparency” tool. We conducted our search using keywords (NGT, GMO, and their derivatives). It is entirely possible that a meeting labeled “fish”, for example, could also be an opportunity to discuss the proposed deregulation of GMOs.In the end, we drew up a list of 86 meetings for this period, involving 35 MEPs. The vast majority of MEPs (26, or 74.2%) are members of the ENVI committee, which is the committee responsible for this text for the European Parliament, and eight MEPs are members of the AGRI committee. Only one MEP is not a member of either of these committees, Valérie Hayer, whom we will discuss later in this article.In the previous article, we wrote that “the first lesson is that few MEPs were approached: 41 out of 705 MEPs”. This is even more true for the 10th legislature, where only 35 out of 720 MEPs (4.8%) were approached for a meeting on this issue.Tota number of MEPsNumber of sollicitred MEPsTota number of nationalitiesNumber of sollicited nationalities2023-202470541 (5,8%)271432024-202572035 (4,8%)2711Unlike in the previous parliamentary session, the most sought-after members of parliament are not the “rapporteurs”. The rapporteur and shadow rapporteurs4 together accounted for 21 of the meetings (24.4%) listed in this database.Committee ENVIName of the rapporteur5"Favorable" appointments“Unfavorable” appointmentsPersonnal opinionPOLFJÄRD Jessica (PPE)91favorableShadow rapporteurs :CLERGEAU Christophe (S&D)01unfavorableSARDONE Silvia (PfE)12favorableFIOCCHI Pietro (ECR)11favorableCANFIN Pascal (Renew)00favorableHÄUSLING Martin (Greens/EFA)23unfavorableHAZEKAMP Anja (The Left)0Meeting with Netherlands’s governmentdéfavorableTotal1384 favorables /3 unfavorablesA decline in the number of meetingsBefore detailing these meetings, it should be noted that between May 2023 and the end of June 2024, 135 meetings were reported, compared to 86 meetings, or nearly a third fewer between July 2024 and 6 January 2026: a sharp decline. This can be explained by the fact that the European Parliament adopted its position in plenary in April 2024.However, there was an increase in these meetings at the end of 2025, when the Council of the EU, under the Danish Presidency, was under pressure to adopt a position that would mean the text would be returned to the European Parliament at the end of 2025.More meetings for pro-deregulation advocatesBetween July 2024 and 6 January 2026, the vast majority of MEPs' meetings were with stakeholders in favor of GMO deregulation (59, or 68.6%). These stakeholders included multinational companies (Bayer (3), Corteva (13), Limagrain (4), Syngenta (3)), umbrella organizations (Crop Life (2), Euroseed (5), Phyteis (2), Union française des semenciers (3)), research institutes, and unions affiliated with COPA-COGECA.On the side of those opposed to deregulation, 23 meetings were recorded (26.7%). These included NGOs (Friends of the Earth, Greenpeace, Testbiotch) and unions defending small-scale farming (ECVC) or organic farming (Ifoam, Fnab, Bio Austria, Synabio). Many meetings brought together several of these stakeholders at the same time6.Finally, the German farmers' union Deutscher Bauernverband is a somewhat special case: it advocates deregulation of GMOs/NGTs, but is clearly opposed to patents on plants derived from NGTs. This union requested meetings with two MEPs: Norbert Lins (CDU, member of the European People's Party group, Germany) and Christine Singer (FPÖ/ID, Austria).The right and far right in favor of deregulating GMOs/NTGsWe also studied the number of meetings according to the political groups of MEPs.The result is clear: only the Greens and the parties of the European United Left were approached as a priority by those opposed to deregulation. All other groups met with more supporters, even those from the Socialism & Democracy group.FavorableUnfavorableInstitutional actorsTOTAL‍Number of meeting% of total appointmentsNumber of meeting% of total appointmentsGUE / NGL114,3571,41 (Netherands’s gouvernment)7S&D5503302 (Danish ans Spanish government)10Green222,2777,89Renew1292,300,01 (Danish government)13PPE1881,8418,222ECR685,7114,37ID1583,3316,618TOTAL5968,62326,7486The group that was most sollicited was the EPP, the European right wing: 22 meetings, or 27% of all meetings recorded. Most of these meetings were requested by pro-deregulation actors, who were clearly keen to talk to the group with the largest number of MEPs in the European Parliament.However, it was the Renew group that was the most unbalanced in its meetings. It did not meet with any actors opposed to the GMO deregulation project. This was due to one French MEP in particular: Valérie Hayer. She had a total of 12 meetings: 11 with actors deliberately in favor of deregulation and one with the permanent delegation of the Danish government. She was the MEP that multinationals most wanted to meet. She had more meetings than the rapporteur for the text, Jessica Polfjärd. However, Valérie Hayer is not a member of the ENVI or AGRI committees, but she sits on the Conference of Presidents. This “committee” plays a key role in the organization of the European Parliament. It is responsible for organizing parliamentary work, setting the agenda for plenary sessions, assigning responsibilities to committees and delegations, and managing relations with other institutions.Conversely, none of the multinationals met with Pascal Canfin, also from the Renew group, but shadow rapporteur.One political group was particularly sollicited by pro-GMO/NTG companies and stakeholders: the far right, which made a sensational entry into the European Parliament in the last elections. For France, Rassemblement Nantional (RN) MEPs Valérie Deloge and Anne-Sophie Frigout had seven meetings with favorable stakeholders (Corteva, Limagrain, Phyteis (formerly Union de l'Industrie de la Protection des Plantes) and the French Seed Union), but none with unfavorable organizations.It should also be noted that Christophe Clergeau (PS, France), who had been in high demand during the previous legislative term (10 meetings), has been little involved since July 2024 (only one meeting). However, he is still the shadow rapporteur on this text. His public statements against the deregulation project are clear, and stakeholders have undoubtedly decided that he will not change his mind.It is currently essential to clarify who is meeting whom in the European Parliament. Since the representatives of the Council of the EU reached a majority in favor of deregulating almost all GMOs, the ball is now in the European Parliament's court. The ENVI Committee will give its opinion in the coming days, and the Parliament could vote on the issue in plenary session by spring. MEPs will therefore all have their say, unless group voting instructions take precedence over individual positions. Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [58] => Array ( [objectID] => 14666 [title] => The European Commission as absolute ruler over GMO and pesticide legislation? [timestamp] => 1769731200 [date] => 30/01/2026 [annee] => 2026 [url] => https://infogm.org/en/the-european-commission-as-absolute-ruler-over-gmo-and-pesticide-legislation/ [image] => https://infogm.org/wp-content/uploads/2026/01/delegate-768x512.webp [extrait] => The legislative texts concerning GMOs proposed by the European Commission aim to almost entirely remove the regulatory framework for GM plants and microorganisms. In addition to this deregulation, two new measures have been discreetly slipped in. The first, which is common to the pesticides dossier, would consist of authorising these products without any time limit. The second would give the European Commission full powers over future legislative changes. [chapo] => The legislative texts concerning GMOs proposed by the European Commission aim to almost entirely remove the regulatory framework for GM plants and microorganisms. In addition to this deregulation, two new measures have been discreetly slipped in. The first, which is common to the pesticides dossier, would consist of authorising these products without any time limit. The second would give the European Commission full powers over future legislative changes. [texte] => December 2025 marked an important turning point in the GMO debate in Europe. The Council of the European Union approved the provisional agreement reached in the trilogue concerning the deregulation of GMO plants obtained through new techniques of genetic modification (NGT). This provisional agreement may now be submitted to the European Parliament. In the same month, the European Commission presented to the European legislators some proposals to deregulate the release of genetically modified micro-organisms (GMMs), to tolerate their presence in food products and to encourage the development of biotechnologies in Europe. Among this jungle of texts, certain proposed changes stand out and deserve closer attention.Unlimited authorisationsThe first new feature would be to issue marketing authorisations for GMOs, GMMs and pesticides that are unlimited in time. Currently, these authorisations are limited in duration and need to be renewed. This requires companies to submit a renewal application, which involves a new risk assessment. The Commission, like the Council of the EU, is proposing to get rid of these time limits.For GMO plants obtained through NGTs, this change is to be understood between the lines. Directive 2001/18 and Regulation 1928/2003 currently stipulate that marketing authorisation for a GMO is granted for a period of ten years. A renewal must be requested at least one year before the end of the ten-year period and, if granted, will in turn be valid for ten years. The compromise text agreed by the Council of the EU on 19 December 2025 proposes to remove this very concept of authorisation. For plants genetically modified by NGTs classified in category 1 (with complete deregulation), a procedure to verify NTG1 status would be provided for, resulting in a declaration of status NGT1i. Based on a declaration by a company that its plant is NGT1, the final decision of the European authorities would therefore be "only declarative"ii. As these decisions are not authorisations in the strict sense of the term, this explains the absence of any reference to a time limit or the need to renew this decision. It should also be noted that, as the provisional text does not provide for detection and identification methods, the procedure for verifying the declaration would not be carried out without analysis, but would rely entirely on the declaring company.For plants genetically modified by NGTs classified in category 2, authorisation would be required, valid for a maximum period of ten years. However, unlike the current practice, the renewal of this authorisation would be valid for an unlimited period, "unless the decision [...] provides that the renewal is for a limited period, on justified grounds based on the findings of the risk assessment [...] and on experience with the use, including results ofmonitoring"iii.In the case of GMMs, whether transgenic or not, the proposal made by the European Commission on 16 December 2025 is clear on the issue of the duration of authorisation. The Commission proposes that "consentgranted under Part C [Editor's note: which deals with marketing] shall be valid for an unlimited period oftime"iv. It even proposes to specify, just in case, that the article of Directive 2001/18 dealing with the renewal of authorisations should logically not be applied.This approach by the Commission is not limited to GMOs, as it can also be seen in the case of pesticides. Following a proposal for a directive made on 16 December 2025, the so-called "Omnibus" directive on food safety, the association Générations Futures communicated specifically on this point of the duration of authorisations. It stated that "it is official: the Commission is proposing to grant unlimited authorisations for a large number of pesticides in Europe"v. While it specifies that this concept of unlimited authorisation should not apply in all cases, the cases that are exempt would be subject to very vague wording, opening the way to "a significant risk of arbitrary interpretation". Above all, it points out that the proposal would effectively mean that "for all substances already authorised and not undergoing renewal, the authorisation period would become unlimited", citing glyphosate as an example, which "would see its authorisation period become unlimited". At national level, authorisations granted for products containing active substances authorised at European level would, of course, be for a "maximum authorisation period of 15 years". However, the resulting risk reassessment could only take into account "data on substances available at the time of their last assessment at Community level". It is therefore impossible, as Générations Futures explains, to incorporate the "latest knowledge available to Member States" unless the Commission agrees to re-examine the substance.The Council of the EU puts the Commission in sole controlThe second new development concerns the powers that would be conferred on the European Commission if the provisionnal compromise text on the deregulation of GMO plants was adopted.In the case of GMO plants, several articles in the compromise text would allow the European Commission to change the implementation of the legislation on its own. To understand the extent of these powers, we must first remember how the deregulation of GMO plants obtained through NGTs would work. The first step would be to verify a company's declaration that a GMO plant is NGT1 or NGT2. To this end, the legislation would establish "equivalence" criteria, which would opan access to NGT1 status and pave the way for deregulation. In a second step, once NGT1 status has been verified, the GMO would no longer be subject to risk assessment and could be marketed in Europe without labelling (except for seed lots), traceability methods or environmental monitoring.The first delegation of power proposed in the compromise text would allow the Commission, through delegated acts, to modify the criteria for equivalence between a plant known as "NGT" and a conventional plantvi. This is in order to "adapt them to scientific and technological progress". The Commission could thus modify the type and extent of genetic modifications accepted as "equivalent" to those that could occur naturally or through conventional breeding. The only constraint on the Commission would be that it would have to publish a report justifying its decision.The second is also of great importancevii. The Compromise text proposes that the Commission alone should be able to decide on the technical information required from companies to demonstrate that a plant is an "NGT" plant and to be provided in the declaration dossier to be submitted in Europe prior to any release. It could also decide alone on the content of formal applications submitted.In the same vein, the European Commission could decide alone on the information required concerning the declaration of existing patents, the content to be transmitted in the event of a licence declaration, or what should be put in writing as a final declaration of NGT status. This is a major point, to say the least, as the issue of patents has been – and still is – a significant point of disagreement between Member States, parliamentarians and within European companies.The final delegation of power would concern NGT2 plants, which would be regulated, unlike NGT1 plants. For these NGT2 plants, companies seeking to market them would benefit from advantages if their GM plants have new characteristics considered "sustainable" by the European legislator, characteristics listed in the legislative text. The Council proposes that the European Commission alone should be able to amend the list of characteristics considered "sustainable"viii and entitling companies to these advantages. These benefits would consist of reduced deadlines (four months) for the European Network of GMO Laboratories (ENGL) to process authorisation applications and exemptions from financial contributions to the ENGL for small and medium seed companies providing a detection and identification method for a GMO they wish to market.For GMO plant, these delegations of power would be granted to the European Commission for a period of five years after the legislation enters into force, renewable tacitly unless the Parliament or the Council interveneix. These bodies could, within two months, oppose a delegated act in preparation or decide to revoke these delegations of power. Paradoxically, their revocations would not affect the validity of delegated acts already adopted.The legislative proposal made on 16 December 2025 on GMMs contains roughly the same delegations of power. The European Commission could thus modify the list of information required prior to the release of these microorganisms into the environmentx. Above all, the European Commission could, on its own, add criteria defining an GMM as "low risk", a status paving the way for even greater deregulationxi. It could also amend the list of information required prior to the release of these "low risk" GMMs and modify the requirements for assessing the risks associated with themxii.If adopted, these various legislative texts on GMO plants and GMMs would therefore create a rather unprecedented situation. Member States and MEPs would thus entrust the keys to the GMO dossier to the Commission alone, thereby depriving themselves of any real capacity to intervene in these matters at a later date. This situation could be a cause for concern for some, given the European Commission's current position, which is very much in favour of reduced regulation and considerable freedom of action for multinationals and their patents. This freedom is increasingly being eroded, or even completely removed, when it comes to other economic actors and citizens to be able to produce and consume without GMOs.i Council of the EU, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement », articles 6.10 and 7.6, 11 December 2025. ii Council of the EU, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement », whereas 20, 11 December 2025. iii Council of the EU, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement », articles 17, 11 December 2025. iv European Commission, « Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs », article 24c, 16 December 2025. v Générations Futures, « Omnibus sécurité des aliments : C’est officiel, la Commission propose d’accorder des autorisations illimitées pour un grand nombre de pesticides en Europe », 16 December 2025. vi Council of the EU, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement », article 5, 11 December 2025. vii Council of the EU, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement », article 25(a), 11 December 2025. viii Council of the EU, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement », article 22, 11 December 2025. ix Council of the EU, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement », article 26, 11 December 2025. x European Commission, « Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs », article 24(b), 16 December 2025, xi Eric Meunier, « The deregulation of GMO microorganisms is underway », Inf'OGM, 27 January 2026.xii European Commission, « Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs », article 24(e), 16 December 2025, Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [59] => Array ( [objectID] => 14673 [title] => French government in favour of deregulating many GMOs [timestamp] => 1769558400 [date] => 28/01/2026 [annee] => 2026 [url] => https://infogm.org/en/french-government-in-favour-of-deregulating-many-gmos/ [image] => https://infogm.org/wp-content/uploads/2026/01/Linolschnitt_-_Daumen_hoch-768x1074.jpg [extrait] => On 19 December 2025, the French government came out in favour of deregulating GMOs obtained using new techniques of genetic modification (NGT). Having previously abstained, it has, according to our information, changed its position following a commitment made by the European Commission. This commitment, which has not yet been made public but which Inf'OGM has been able to read, does not, however, add anything to the provisional text proposed to deregulate GMOs. France's position has enabled a qualified majority of Member States to be reached on a text that, furthermore, does not provide for any risk assessment of GMOs obtained using new techniques and classified in category 1, any labelling or traceability of these GMOs, or any environmental monitoring. [chapo] => On 19 December 2025, the French government came out in favour of deregulating GMOs obtained using new techniques of genetic modification (NGT). Having previously abstained, it has, according to our information, changed its position following a commitment made by the European Commission. This commitment, which has not yet been made public but which Inf’OGM has been able to read, does not, however, add anything to the provisional text proposed to deregulate GMOs. France’s position has enabled a qualified majority of Member States to be reached on this text. [texte] => On 19 December 2025, during a meeting of their permanent representatives in Brussels, a qualified majority of European Union Member States reached an agreement on a compromise text aimed at deregulating GMOs obtained through new techniques of genetic modification (NGT). However, negotiations are not yet over, as this text still has to be formally approved, rejected or amended by the European Council and Parliament.While Germany, Austria, Belgium, Bulgaria, Croatia, Hungary, Romania, Slovakia and Slovenia did not support the text on 19 December, France, Poland and Greece changed their initial position and approved the text as presented. These changes in position enabled the Council of the European Union to reach a qualified majority, with 55% of Member States voting in favour, representing at least 65% of the total population of the EU.A debate blocked, then unblocked by FranceSince July 2023 and the European Commission's proposal to deregulate GMOs obtained through new techniques of genetic modification, discussions between Member States within the Council of the EU have stalled over the issue of patents and the risks they pose to farmers and seed producers. As deregulation would mean a complete lack of traceability and labelling for GMOs obtained using new techniques and classified as category 1 (i.e. the likely majority of GMOs), companies holding patents would find themselves in a position of strength to enforce them on any plant in which they believe there is genetic information or material covered by these patents. Farmers and seed producers would find themselves under the constant threat of a "minefield" of often inaccessible licensing rights, with living organisms becoming the property of the companies holding the patents.After two years of discussions within the Council of the EU and a failure to find common ground, a compromise text, resulting from inter-institutional negotiations, was put on the Council's table in early December 2025 with false solutions to try to resolve the issues related to patentsi. On 19 December, thanks to a change of position by three countries, including France, the text was provisionally adopted. As far as France's position is concerned, according to our information, the government decided to support the text because the European Commission has made commitments to protect the European seed sector. However, this commitment made by the Commission is not binding and, above all, does not add anything new to the compromise text on which France claimed to be hesitating.A non-binding commitment that adds nothing newIn its statement, which Inf'OGM has read, the Commission states that it is committed to protecting the European seed sector, particularly small and medium-sized enterprises (SMEs). In addition to publishing reports every five years on the impact of patents on the seed sector, the Commission undertakes to monitor the impact of the proposed regulation on GMOs obtained by new techniques on the European seed sector. The idea is to assess whether the deregulated commercial development of GMO plants obtained by these new techniques, and in particular their patentability, leads to negative impacts such as the exclusion of SMEs.This commitment is already in line with the provision in the text stating that the Commission "should conduct an assessment on the impact that the patenting of plants and related licensing and transparency practices may have on innovation in plant breeding, on breeders’ access to plant biological material and techniques and on the availability of plant reproductive material to farmers as well as the overall competitiveness of the EU plant breeding industry, in particular small and medium sized breeders, and the potential risks of market concentration"ii.In concrete terms, the Commission is thus taking a committment that the code of conduct proposed in the compromise text, which it should oversee the drafting of in cooperation with the Member States.iii, would be drafted at least six months before the entry onto force of the potential future regulation. While the text provides for a code of conduct to be ready no later than 18 months after the regulation enters into force, it should be noted that there is a real difference here, as the Commission has committed to reducing this period by two years...With regard to “licensing platforms”, the Commission undertakes to assess their functioning and use in terms of transparency on patents and access to licences for SMEs, which must be on fair and reasonable terms. This commitment also echoes what the compromise text proposes, namely to make "patents on category 1 NGT plants available to breeders on fair and reasonable conditions"iv.With regard to SMEs specifically, the Commission is committed to ensuring that they have access to patent support and advice to compensate for their lack of resources in this area. The nature of the support and advice is not specified. However, this idea is already included in the text, which calls for "Breeders [to] benefit from guidance [Editor’s note : to be produced by the European Commission] to help them navigate the plant intellectual property landscape"v.Another commitment made by the European Commission directly concerns European Directive 98/44 "on the legal protection of biotechnological inventions" by patents. Here, the Commission undertakes, only if it deems it relevant, to update or supplement a notevi it drafted in 2016 providing its interpretation of the articles concerning the criteria for patentability of inventions relating to plant genetic information, the concept of essentially biological processes and the conditions for the mandatory granting of reciprocal licences. It also undertakes to consider establishing mandatory conditions or safeguards relating to access to patented biological material if it was observed that the system is not functioning properly.Once again, the compromise text already specifies that "the Commission shall regularly conduct an assessment on the impact that the patenting of NGT plants, traits and techniques as well as related licensing and transparency practices, have in the Union on [...] potential litigation involving farmers or breeders in situations where patented biological material may appear in their crops or products due to accidental presence or similarity, without intentional use of the patented material"vii. And to provide that if this assessment reveals "significant barriers to access to patented plant biological material, undue restrictions on experimentation, negative effects on breeders and farmers, increased market concentration, reduced diversity in seed supply, insufficient transparency, or other evidence that the system is not functioning smoothly", the Commission shall "where appropriate, submit legislative proposals to set up mandatory conditions or safeguards".The French government is satisfiedThis "commitment" made by the European Commission has not yet been made public. It will presumably be included in the minutes of the meeting of 19 December 2025. In terms of content, wording and form, this commitment adds nothing new to the compromise text and is only a moral commitment on the part of the European Commission made within the framework of a tacit agreement of good cooperation between the European institutions. However, these promises were considered sufficient by the French government to give its approval to this provisional text on the deregulation of numerous GMOs. Thanks in particular to this change in France's position, the permanent representatives of Member States have achieved a qualified majority. The text is now temporarily in the hands of the European Parliament's Environment Committee before returning to the Council for a more formal adoption, known as the "first reading".i Denis Meshaka, « The Council of the EU wants to maintain the patentability of GMOs/NGTs », Inf'OGM, 21 January 2026.ii UE Council, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement », Whereas 46a, 11 décembre 2025.iii Ibid., Article 29a.iv Ibid., whereas 17b.v Ibid., whereas 46d.vi « Note 2016/C 411/03 », Official Journal of the European Union, Volume 59, 8 November 2016.vii Conseil de l’UE, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Analysis of the final compromise text with a view to agreement », article 30(a), 11 décembre 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [60] => Array ( [objectID] => 14659 [title] => The deregulation of GMO microorganisms is underway [timestamp] => 1769472000 [date] => 27/01/2026 [annee] => 2026 [url] => https://infogm.org/en/the-deregulation-of-gmo-microorganisms-is-underway/ [image] => https://infogm.org/wp-content/uploads/2026/01/4_Gentechnisch-veraenderte-Mikroorganismen-und-Viren.jpg [extrait] => A proposal for a directive made by the European Commission on 16 December 2025 calls on Member States and the European Parliament to deregulate the marketing of genetically modified bacteria, yeasts, viruses and other micro-organisms, including transgenics. According to the Commission, the aim would be to allow companies to market these GMO microorganisms (GMMs) under lighter or even no rules. This would involve an “adapted” health and environmental risk assessment, an end to traceability, an end to environmental monitoring... Following the plants, the deregulation of GMOs is therefore continuing, this time with microorganisms, with perhaps the animals next in line in 2026. [chapo] => A proposal for a directive made by the European Commission on 16 December 2025 calls on Member States and the European Parliament to deregulate the marketing of genetically modified bacteria, yeasts, viruses and other micro-organisms, including transgenics. According to the Commission, the aim would be to allow companies to market these GMO microorganisms (GMMs) under lighter or even no rules. This would involve an “adapted” health and environmental risk assessment, an end to traceability, an end to environmental monitoring… Following the plants, the deregulation of GMOs is therefore continuing, this time with microorganisms, with perhaps the animals next in line in 2026. [texte] => In 2023, the European Commission openly proposed deregulating plants and microalgae genetically modified using new techniques of genetic modification (NGT). While discussions between European authorities on this issue are still ongoing in early 2026i, the Commission seems to have decided that following the same path for microorganisms would be too risky. Thus, rather than putting a proposal for a new regulation on the table for legislators, on 16 December 2025 the Commission chose to propose an amendment to an existing directive, 2001/18. Arguing that there was an "urgency" to table this proposal for a directiveii, the Commission used arguments that are sometimes misleading, just as it failed to provide all the documents supporting its proposal, even though this was mandatory. Inf'OGM will return to this situation at a later date, after describing the content of the proposal in this article.Reducing the regulation of all GMMs, including transgenic organismsThe amendments to Directive 2001/18 contained in the Commission's proposal are few in number but effective in achieving the deregulation of GMMs. The Commission proposes, as a first step, to define GMMs as "any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids" and "in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination", with the exception of plant and animal cell cultures. Although Directive 2001/18 already defines organisms, including therefore micro-organisms, introducing this definition allows the Commission to propose the inclusion in Directive 2001/18 of articles devoted entirely to micro-organisms.The Commission therefore proposes adding a complete chapter dedicated to GMMs to Part C, which deals with the placing on the market of GMOs or their products (Part B deals with experimental releases into the environment). The proposed chapter contains three proposals for the addition of articles on the risk assessment of GMMs, their traceability and the duration of authorisations issued. Mechanically, it is essential to note here that these proposals concern all GMMs, i.e. both transgenic microorganisms and genetically modified microorganisms that supposedly do not contain transgenes in the final product."Adapted" risk assessment, unlimited authorisation period, etc.Contrary to the provisions of Directive 2001/18, the Commission is initially proposing to the Council and the European Parliament that it alone should decide on the content of authorisation applications to be submitted in the EU in order to market GMMs or products thereof. It justifies this proposal by the need to adapt the list of information required from a company to "scientific and technical progress". This information should be provided in each authorisation application file (known as a “notification”). The Commission wishes to be able to amend Annex 3 to Directive 2001/18, which lists the “information requiredin the notification”, on its own, by means of delegated acts. Currently, this annex requires information to be provided on the description of the organism, the genetic modification method(s) used, the description of the desired and undesired genetic modifications, the assessment of risks to health and the environment, and plans for environmental monitoring after commercial release. Having been committed for several years to simplifying the management of GMOsiii, or even deregulating them, it is reasonable to assume that the European Commission intends to reduce the amount of information required rather than maintain it.The second proposal is summarised in a few lines. This time, it involves amending Directive 2001/18 so that authorisations for the marketing of GMMs are issued for an unlimited period. Currently, the directive sets a maximum period of ten years, after which a renewal application must be obtained in order to continue marketing a GMO. The main consequence of such a measure is that there would be no reassessment of potential risks, as is currently the case. If a risk were to be discovered after an authorisation had been granted, it would therefore not be taken into account, by definition.No traceability method requiredA third proposal is to allow companies to be exempt from providing methods for detecting, identifying and quantifying GMMs or their commercialised products if they duly justify that it is "not possible to provide amethods". This last measure would therefore blind the EU and other economic operators (from farmers to consumers) to any contamination or illegal commercialisation on its territory. Above all, as is the case with plants and microalgae, this would open the door even wider to patents held by private actors on GMMs, but also on non-modified micro-organisms, constituting a definitive obstacle for all actors using "wild" microorganisms.At this stage, the European Commission is therefore proposing that the marketing of bacteria, yeasts, viruses or any other GMMs, whether transgenic or not, be authorised for an unlimited period. This authorisation would be based on dossiers (including risk assessments) whose content could only be decided by the European Commission, without the company having to provide a method for detecting and tracing GMMs and their products.Total deregulation of GMMs obtained by NGTThe fourth proposed measure appears to be the one containing, as for plants modified by NGT, an even more complete deregulation of GMMs. This time, the aim is to distinguish GMMs from other GMMs which would be described as "low risk". While the former would be subject to the requirements of Directive 2001/18, which would have been greatly reduced, if not eliminated, as we have just seen, the latter would be virtually deregulated.Based on a July 2024 opinion from the EFSA stating, with regard to the assessment of risks associated with micro-organisms, that "on a case-by-case basis for specific [micro-organisms modified by “new genomic techniques”] fewer requirements may be needed’iv, the Commission proposes that GMMs could be declared "low risk". This declaration would be made if they are "taxonomically and molecularly well characterised", if they belong to a group of micro-organisms whose supposed safety has already been established and, crucially, if they do "not contain genes of concern which are not naturally present in the parental organism, in particular acquired antimicrobial resistance genes". Put more simply, "low-risk" GMOs would be all GMOs that do not contain transgenes.In addition to proposing that it alone should be able to supplement these "low-risk" classification criteria by means of delegated acts, the Commission also proposes that the risk assessment provided for in Directive 2001/18 should be "adapted" for these GMMs. Similarly, the post-marketing environmental monitoring provided for in Directive 2001/18 could be waived if the company considers that such monitoring is "not needed’.Submitted to the European authorities on 16 December 2025, the European Commission's proposal will now go through the same procedure as that followed for plants in 2023. The Member States, meeting within the Council of the EU, will examine it and, if they reach an agreement, will issue their version of the text. For its part, the European Parliament will do the same as part of a process that is expected to begin in 2026.i Eric Meunier, « Qualified majority in the Council of the European Union to deregulate numerous GMOs », Inf'OGM, 24 December 2025.ii It is a proposal for a new Directive modifying existing Directive 2001/18, a proposal made under procedure reference 2025/0405, « Placing on the market of genetically modified micro-organisms and the processing of organs ». iii Eric Meunier, « OGM dans l’UE : une directive progressivement allégée », Inf’OGM, le journal, n°165, October/December 2021. iv EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins, E., Bresson, J.-L., Dewhurst, I. C. et al., « New developments in biotechnology applied to microorganisms », EFSA Journal, 22(7), e8895, 22 July 2024. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [61] => Array ( [objectID] => 14614 [title] => GMOs, seeds, pesticides, transparency… European law under attack! [timestamp] => 1769040000 [date] => 22/01/2026 [annee] => 2026 [url] => https://infogm.org/en/gmos-seeds-pesticides-transparency-european-law-under-attack/ [image] => https://infogm.org/wp-content/uploads/2026/01/INFOGM_logo-768x409.jpeg [extrait] => In less than two weeks, between 10 and 19 December, 2025 ended with a rather unprecedented offensive by the European Union authorities against several European texts protecting the environment, health and citizens' rights. GMOs, pesticides, seeds, corporate responsibility... everything is being called into question in order to "simplify" life for businesses in Europe. Faced with this frenetic pace, Inf'OGM continues its watchdog work, which is essential for public debate, the proper functioning of democracy and the protection of life, by providing accurate, rigorous and reliable information. [chapo] => In less than two weeks, between 10 and 19 December, 2025 ended with a rather unprecedented offensive by the European Union authorities against several European texts protecting the environment, health and citizens’ rights. GMOs, pesticides, seeds, corporate responsibility… everything is being called into question in order to “simplify” life for businesses in Europe. Faced with this frenetic pace, Inf’OGM continues its watchdog work, which is essential for public debate, the proper functioning of democracy and the protection of life, by providing accurate, rigorous and reliable information. [texte] => At a time when the search for and extraction of raw materials are taking precedence over all other considerations, greenhouse gas emissions are set to increase. Most of the "solutions" proposed are high-tech, energy-intensive and capital-intensive. In agriculture and the living world, these solutions are being sought in biotechnology, in line with the desire to artificialise and appropriate living organisms so that patents held by companies ultimately apply to all terrestrial and marine biodiversity.The end of 2025 was particularly trying for all those who are mobilising, either from a journalistic point of view or through their commitment to issues related to the environment, health, corporate responsibility, food sovereignty, transparency and the rights of farmers and consumers, or even the transparency of European decisions. Between 10 and 19 December 2025, the European legislator continued or began the revision of no less than seven legislative texts aimed at reducing the regulation of GM plants, GM microorganisms and pesticides, reducing the rights of farmers and further reducing corporate responsibility. An eighth text on "innovation" has already been announced for 2026.In response to this, Inf'OGM provides as much information as possible on the objectives pursued by the European Commission and those who whisper in its ear: to be able to market GMOs, pesticides and medicines without hindrance, with as little risk assessment, information for citizens and accountability as possible, and with no time limit on the authorisations issued.Chronology of an "urgent" end-of-year timetable"Seeds" fileOn 10 December, the Council of the European Union entered into trilogue with the European Commission and the European Parliament to discuss a possible future "seeds" regulation which, if adopted, would strip farmers of their rights to select and produce their own seeds and accelerate the erosion of cultivated biodiversity1."Pharma" fileOn 11 December, representatives of the Commission, Parliament and Council agreed on a proposal for a directive, known as the "Pharma" directive, claiming to "improve the competitiveness" of the EU sector by reducing and simplifying the regulatory framework for new medicines, including gene therapies, which modify the genome of certain human somatic cells2.Corporate "responsibility" fileOn 16 December, MEPs adopted the Omnibus 1 Directive, proposed by the Commission in February 2025. This directive drastically reduces the obligations on companies to be vigilant and responsible for the environmental, health and social impacts of their activities and those of their subcontractors. Similarly, the obligation to produce reports demonstrating the sustainability of their activities and their "ecological transition" is consequently reduced3."Biotechnology" and "Innovation" files On 16 December, the European Commission proposed the "Biotech Act" regulation4, which aims to simplify European rules governing research, production and use of biotechnology in order to free multinationals from rules deemed too restrictive. An additional legislative proposal, known as "Innovation", has already been announced by the Commission for 2026, which will be developed on the same basis of "simplification"5.Pesticides fileAlso on 16 December, the European Commission proposed the "Omnibus X" directive on food. This aims to make marketing authorisations for a large number of pesticides unlimited in time. It also stipulates that in the event of a future ban on an active substance, the period during which a company may continue to market it shall be 18 months... extendable to 36 months if it is considered that no other reasonable means of control are available to replace products containing the banned substance6.GMO micro-organisms fileThe same "Omnibus X" directive also aims to legalise the marketing of food products that still contain traces of genetically modified micro-organism DNA, or even complete micro-organisms (declared non-viable)7.On the same day, 16 December, the Commission proposed a directive to ease restrictions on the release into the environment of genetically modified yeasts, bacteria and even viruses, with the rules for such releases to be decided by the European Commission alone8.GMO plantsOn 19 December, the Council of the European Union reached a qualified majority to deregulate a large number of GMOs so that they can be marketed without assessment of the risks to health, the environment and agricultural systems, without labelling, without traceability and without environmental monitoring9. The European Parliament is now due to vote on this text in early 2026.A "poorly managed" processThe European Commission's haste meant that most of the texts concerned were not translated into national languages. In addition, the European Union Ombudsman denounced cases of administrative mismanagement due to this haste. At the end of November 2025, she highlighted procedural shortcomings, such as the lack of comprehensive justification for the urgency of making legislative proposals to citizens "and documenting the reasons why it deviated from its internal rules on law-making". Other problems were highlighted, such as the publication of documents supporting a proposed directive or regulation "after" its adoption, or the lack of clear internal records of an assessment of consistency with climate action.Trilogues: legislative discussions that are impossible to followAll the legislative proposals mentioned above go before the Council of the European Union and the Parliament. These two bodies provide, at different levels, a certain degree of transparency about their work.The Parliament provides access to texts, amendments tabled, votes by individual MEPs, the agendas of dedicated committees, the minutes of many of its meetings, etc.The Council of the European Union, for its part, publishes the texts that have been worked on or even adopted, the agendas of meetings, and the discussions and positions defended by Member States can be followed when ministers meet. However, when it comes to meetings involving the permanent representatives of Member States or members of the administration, the positions defended and any votes are less accessible.This changes completely when the discussion phase between the institutions begins. This three-way discussion phase, known as a trilogue, has no set procedure and there is a complete lack of transparency. While the representatives of each institution attending the meeting may be known, the dates of the meetings, agendas, content of the positions defended and negotiated, and minutes of the meetings are simply not made public. Only the texts finally adopted by the negotiators end up being made public due to the transparency of the Parliament or, to a lesser extent, the Council.The role of citizen watchdog of critical informationFor citizens and stakeholders who want to follow developments, make their voices heard and/or take action, accurate, rigorous and reliable information is one of the keys to entering the debate. Inf'OGM, a citizen watchdog group for critical information on GMOs since 1999, was created for this purpose.Today, we find ourselves in the middle of a minefield where only the Commission and certain insiders wish to hold the map and the language to read it. Working for transparency and establishing information that is as factual and rigorous as possible has therefore never seemed so relevant and important from a democratic point of view. It is becoming almost an act of resistance in the face of a public authority that is struggling not to give in to the demands of multinationals. This role has already become increasingly difficult to fulfil in recent years, since the debate has been deliberately complicated by the use of erroneous, if not misleading, semantics10. Today, we must also contend with the frenetic pace set by the European Commission, which, while reflecting a certain nervousness on the part of those in charge, nevertheless requires us to keep up with this pace in our journalistic work. At the start of 2026, Inf'OGM is strengthened in its determination and conviction that transparency and rigour in information are and will remain the basis for public debate, which is more necessary than ever. [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [62] => Array ( [objectID] => 14609 [title] => The Council of the EU wants to maintain the patentability of GMOs/NGTs [timestamp] => 1768953600 [date] => 21/01/2026 [annee] => 2026 [url] => https://infogm.org/en/the-council-of-the-eu-wants-to-maintain-the-patentability-of-gmos-ngts/ [image] => https://infogm.org/wp-content/uploads/2026/01/3206341781_afa96704ca_c-768x480.jpg [extrait] => On 19 December 2025, in a still provisional text, the Council of the European Union maintained the patentability of GMOs derived from new genetic techniques (NGT). To this end, it relied on existing law and called for voluntary, but non-binding, commitments, without taking into account the impact on farmers and small seed producers. This text still needs to be validated, amended or rejected by the European Parliament, which had voted against these patents in 2024 and will have to take a position in 2026 without being able to propose new amendments. [chapo] => On 19 December 2025, in a still provisional text, the Council of the European Union maintained the patentability of GMOs derived from new genetic techniques (NGT). To this end, it relied on existing law and called for voluntary, but non-binding, commitments, without taking into account the impact on farmers and small seed producers. This text still needs to be validated, amended or rejected by the European Parliament, which had voted against these patents in 2024 and will have to take a position in 2026 without being able to propose new amendments. [texte] => Since the European Commission proposed deregulating GMOs obtained through new genetic modification techniques (NGT) in July 2023, the problem posed by associated patents has been slowing down the adoption of a new regulation. On 19 December 2025, the Council of the European Union (EU) reached a qualified majority for the first time on a text1 that claims to resolve this issue2. While it does not include the ban on patents on deregulated GMOs requested by the European Parliament in April 2024, it is useful to understand why the measures proposed by the Council would not change anything. The Parliament is due to review this provisional text again in 2026.A simple reminder of the law In its position, based on the proposal resulting from the trilogue, the Council of the EU recalls that, in accordance with Directive 98/44 and Article 53(b) of the European Patent Convention, plants obtained exclusively by essentially biological processes (EBPs) are not patentable. Reference is also made to the practice of the European Patent Office (EPO) of imposing disclaimers, whose theoretical function – the reality is more complex3 – is to encourage those claiming a patent on a product obtained by a patentable technical process to indicate which "plants [notoriously known]obtained by essentially biological processes" are not covered by this patent. Provided that those claiming are aware of the existence of such plants. The Council could have maintained the obligation to provide methods for detecting and distinguishing patented GMOs/NGTs from plants obtained via EPPs. However, this provision, which had been introduced by the Parliament at the instigation of, among others, the European Coordination Via Campesina (ECVC)4, has been removed from the provisional text. This provision would have provided explicit protection for farmers and small and medium-sized seed producers sued for infringement of a patent covering an invention based on NGTs, as they would be unable to prove that their traditional seeds and plants did not originate from the claimed invention.A voluntary "code of conduct"... and therefore ineffectiveThe main proposal in the provisional text is the creation of a "code of conduct" for holders of patents relating to plant biological material (recital 46g and Article 29a). If this text is ultimately adopted, the European Commission, in cooperation with the Member States, will "oversee the drawing up of a Union-level code to support transparency on patents on plant biological material [in particular for plants derived from NGTs], breeder’s access to such material and legal certainty for breeders and farmers". The development of and compliance with this code would be based on voluntary participation, in particular by patent holders and various private licensing platforms (such as the ACLP5 or the ILP) as well as "other civil society organisations and interested parties". In Article 29a of the Council text, the Commission will simply have to "aim" that the code of conduct includes certain key commitments, which will nevertheless remain voluntary . These would include the provision of clear public information on patents, the granting of licences on "fair and reasonable" conditions, and the amicable settlement of disputes involving SMEs (small and medium-sized enterprises) or farmers in cases of unintentional presence of patented material, i.e. in cases of contamination and not in cases of abusive extension of the scope of patents as mentioned above. Similarly, for licensing platforms, the Commission should only encourage moderate fees, standard contracts and fair dispute resolution mechanisms. There is therefore no obligation for the Commission to achieve specific results in these requests.In this approach, which can be described as "soft law", flexible or non-binding, the "commitments by patent owners" are formulated as objectives to be achieved and not as legal obligations. Although the Commission is asked to set measurable objectives (annual reporting, regular monitoring, five-yearly evaluation that may lead to legislative proposals, etc.), the effectiveness of the system would depend on the goodwill of patent owners and platforms, but also on the Commission itself, which reserves the right to supplement this system if necessary. This would be done without any express guarantee that the commitments proposed by the Council would actually be incorporated or respected. According to the Council's text, the code should be finalised within 18 months of the entry into force of the NGT Regulation.A draft fraught with other uncertainties The Council's text includes other specific provisions that raise questions about their clarity, the guarantee of their implementation and/or their applicability. One thing is certain, however: none of the proposals made by the Council are in the form of obligations. All would be implemented within a non-binding, optional framework. Another major point to note is that all the proposals made concern only European seed companies. Farmers are deliberately "forgotten" by the Council of the EU, which, in doing so, maintains its desire to make these actors dependent on industry patents, as also shown by the ongoing revision of the PRM (plant reproductive material) Directive, known as the "Seeds Directive"6.Transparency and licencesThe text appears to demonstrate a desire for transparency without really providing the means to achieve it. In particular, it does not guarantee that all relevant information relating to patents covering deregulated and commercialised GM plants would actually be accessible to small and medium-sized breeders and farmers. In particular, the creation of a mandatory public register of patents covering GMOs/NGTs is not guaranteed. Such a register could only be maintained on the basis of information voluntarily provided by patent holders. However, for example, the current list of plants covered by patents on the Pinto basis, managed by the European seed association Euroseeds, depends solely on the goodwill of patent holders and cannot therefore be exhaustive, nor does it claim to be. It is not certain that the industry can be relied upon to comply scrupulously with this voluntary information procedure.During the procedures for verifying the status of plants genetically modified by NGT, a company requesting such status for one of its products would be asked to submit information on published patents or patent applications including one or more claims on the biological material of the plant. It may declare that it has no knowledge of such rights. As this submission is made "to the best of its [the NGT1 status applicant] knowledge", questions arise as to the guarantees of completeness, transparency and legal certainty offered by such a provision in the draft agreement. Similarly, the so-called "fair and reasonable" licences " (Articles 6 and 7) are not precisely defined7 and would not be accompanied by any control mechanism to verify that the patent holder is actually willing to grant such a licence, or even entitled to grant it if their invention is also covered by other patents that they do not hold themselves. The patent holder could, of course, attach a written statement expressing their willingness to grant licences on "fair and reasonable" terms, but this would remain optional and would have no binding legal effect. It would therefore be more of a tool for declarative transparency than a genuine means of regulation. Furthermore, the Council's text does not address the issue of patent stacking or the cumulative royalties that may be charged for licences, even though this phenomenon has been identified as a major obstacle to access to genetic material and innovation in plant breeding.Impact assessments and expert groupThe Council proposes the creation of an "NGT plant patent expert goup and the assessment of the impact of NGT plant patenting" (Article 30a). This panel would assist the Commission in "patent enforcement practices on farmer’s access to modified genetic resources [GMOs/NGTs], transparency of the patent landscape and innovation in the field of NGT plants". The text further proposes that this group collaborate with the Commission on "surveying the patent licensing practices for thebreeding and marketing of NGT plants protected by a patent, ongoing patent application procedures on NGT plants and patent enforcement practices vis-à-vis farmers and, if available, case-examples thereof". This provision therefore recognises the existence of certain structural risks created by patents on GMOs/NGTs. However, it ignores the risks of creating dependency among operators downstream in the food chain (processors, distributors) and of undermining the diversity of food supply and consumer choice. It does, however, provide for an assessment of these risks just one year after the implementation of this new regulation, even though they will not yet be truly visible. Measures would then only be taken in the event of negative findings in the future, after several years of implementation. But how can the neutrality of the experts be guaranteed? Other European institutions have had no qualms about calling on industry experts or representatives, raising questions of conflicts of interest8.Breeder exemption The text agreed by the Council does not include a breeder's exemption. Nor does it explicitly refer to Article 27(c) of the Agreement on a Unified Patent Court (UPC)9, which is often cited as the basis for a 'breeder's exemption'. This exemption allows the breeder to develop a new variety based on a plant covered by a PVR (plant variety right). However, this new variety cannot be marketed without the consent of the holder of a patent covering an element or information contained therein. However, the UPC only applies to countries that are signatories to it10, and not to all EU countries. Only national provisions would allow breeders to benefit from such an exemption, which would, however, only be applicable in the national jurisdiction concerned. Furthermore, they do not prohibit the claiming of "classic" patents not subject to the AUPC (Agreement on a Unified Patent Court), patents that will be chosen by all seed producers who do not want to be forced to grant licence rights for their patents.It should be noted that the Council has therefore focused solely on seed companies. Farmers have been completely overlooked by the Member States, which voted by a qualified majority on 19 December. This political oversight is in line with the ongoing work on the revision of the legislation on PRM, or the "seeds" regulation. If adopted, this revision could facilitate the dissemination of GMOs/NGTs1 without any information on the patents covering them.Industry interests before the public interestUltimately, the "patents" section of the text resulting from the trilogue, on which the Council of the EU reached a qualified majority, is based mainly on reminders of existing law, promises of voluntary commitments and future assessments. It provides no legal guarantees against the risks that patents pose to small and medium-sized breeders, farmers and non-GMO producers. On the contrary, it encourages the privatisation of rights within "clubs" reserved exclusively for patent holders, where the largest companies, with the most extensive portfolios and the most important patents, will impose their rules on the entire sector. The main causes of imbalance in the current patent system remain virtually untouched.Once again, it is primarily the interests of the seed industry that seem to have been favoured, to the detriment of essential issues: the preservation of cultivated biodiversity, the survival of small and medium-sized breeders and farmers, and, ultimately, consumer information and freedom of choice regarding their food. Do the proposed "transparency" measures, which lack any real obligations or control mechanisms, not amount to a form of invisibility, a subtle form of opacity? These issues seem to have been relegated to the background in order to facilitate the commercialisation of GMOs and secure industrial investment. But what about the public interest? Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [63] => Array ( [objectID] => 14539 [title] => Agricultural biodiversity at risk with new seed regulation [timestamp] => 1768435200 [date] => 15/01/2026 [annee] => 2026 [url] => https://infogm.org/en/agricultural-biodiversity-at-risk-with-new-seed-regulation/ [image] => https://infogm.org/wp-content/uploads/2026/01/5075826879_d728c4d44c_c-768x512-1.jpg [extrait] => On 10 December 2025, the Council of the European Union approved a mandate to begin negotiations with the European Parliament on a new seed regulation. Many civil society organisations have criticised the draft regulation for failing to protect small and medium-sized breeders, seed producers and farmers. They are calling for a diverse seed market, the implementation of farmers' rights to seeds and guaranteed access to varieties suited to their farming systems. [chapo] => On 10 December 2025, the Council of the European Union approved a mandate to begin negotiations with the European Parliament on a new seed regulation. Many civil society organisations have criticised the draft regulation for failing to protect small and medium-sized breeders, seed producers and farmers. They are calling for a diverse seed market, the implementation of farmers’ rights to seeds and guaranteed access to varieties suited to their farming systems. [texte] => In response to the European Commission's proposal to revise the seed regulation in July 2023, more than 240 European NGOs, farmers' organisations and breeders' organisations sent an urgent alert on 25 November 2025 to the Council of the European Union, where the EU Member States sit1. Their aim was to convince them to amend the text to strengthen agricultural biodiversity in order to improve the resilience of food production rather than weaken it, as the signatories of the letter argue. Their efforts were in vain, as on 10 December 2025, the Council approved a mandate to open trilogue negotiations with the Parliament and the Commission in early 2026 on the basis of a text that weakens agricultural biodiversity2.Why does the European Commission want a new regulation?On 5 July 2023, the European Commission presented a proposal to revise the legislation on seeds, officially known as "plant reproductive material" (PRM)3. The term "plant" refers to "living plants and living parts of the plants " including seeds, seedlings, tubers, stolons, grafts, but also cell cultures and other micropropagation materials 4. This reform, which aims to merge several legislative acts, has the stated objective of "simplifying and harmonising the rules for the production and marketing of seeds at European Union level"5. It should be noted that a regulation is a legislative act that is immediately applicable in Member States, unlike a directive, which must first be transposed into national law. In April 2024, the European Parliament voted in favour of this new PRM regulation. The Council has now adopted its version of the text and mandated the Council Presidency to enter into negotiations with the Commission and Parliament (the trilogue).The position of the Council of the EUBehind this revision, the draft presented by the European Commission claims to aim to facilitate the marketing of new varieties, while the Council emphasises the objective of encouraging more resilient agriculture through PRMs that is " of high and reliable quality, adapted to the environmental and climate challenges Europe faces". According to the Council, this step is a move towards "a modern, coherent and future-proof framework for plant reproductive material" that is supposed to respond to European agricultural challenges.In broad terms, the text to be discussed in trilogue highlights the introduction of "simpler and clearer rules". It promises to align these rules with European phytosanitary controls by "integrating PRMs more closely into the EU's horizontal control framework and strengthening traceability". The text also promotes "the use of digital tools, biomolecular techniques and modern breeding techniques" and provides for a mandatory assessment of the value for sustainable cultivation and use (VSCU) for key agricultural species (with the exception of vegetables, fruit trees and turf), potatoes and vines. The Council also says it wants to support agrobiodiversity and "niche and locally adapted varieties, and [...] provide greater flexibility for different purposes of use for breeders, other professional operators and non-professional operators". The Council assures that these adjustments will reconcile innovation, competitiveness and sustainable management of genetic resources. But what is the reality?Agricultural biodiversity in dangerThe main criticism levelled by the 240 organisations in their letter to the Council on 25 November remains valid: failing to protect agrobiodiversity by defending a very strict variety authorisation system that promotes standardisation. The organisations point out that the Food and Agriculture Organisation of the United Nations (FAO) announced in 2010 that 75% of agricultural crop diversity had already been lost between 1900 and 2000, while 75% of the world's food comes from only 12 plants and 5 animal species. As the organisations point out, "this trend has been driven by a focus on uniformity and the concentration of the seed market in the hands of a few large companies". They add that "agrobiodiversity relies on the non-commercial exchange of PRMs practiced by gardeners and farmers for on-farm breeding and dynamic management, as well as on small, local seed producers, many of which offer a greater range of crop diversity than some of the largest players in the market ". In this context, Magdalena Prieler of the Austrian association Arche Noah, co-signatory of the letter, warns: "If ministers hand this market over exclusively to the seed industry, seed producers, farmers and local consumers will all find themselves in the same boat. Some will be banned from working, others will lack varieties adapted to climate change, and still others will have to give up regional specialities in the future. This would be a totally unacceptable capitulation to the companies that dominate the market"6.With a view to the 2026 trilogue, Arche Noah points to persistent shortcomings in the Council's position. The Austrian association therefore demands "that the transfer of plant reproductive material for the purpose of preserving agrobiodiversity remain exempt from seed legislation, as is currently the case in several Member States, including Austria. Farmers' freedom to exchange seeds among themselves must be guaranteed, and the administrative burden for very small farms must remain proportionate"7.This issue was highlighted by Guy Kastler in the columns of Inf'OGM in February 20248. The analysis presented explained that the PRM proposal "would also regulate all exchanges of seeds and seedlings, including between farmers, biodiversity conservation associations and amateur gardeners, unlike the current directives which apply only to exchanges 'with a view for commercial exploitation' and not with a view for selection and conservation on the farm and in the garden ." If adopted, this proposal "would prohibit exchanges of seedlings between farmers and limit exchanges of seeds to restricted quantities not yet defined. It would subject them to the same health constraints as the global seed trade, which would be far more restrictive than those for agricultural cultivation".Agrobiodiversity under attack on two regulatory fronts In 2025, mobilisation against the deregulation of GMOs obtained through new genome editing techniques (NGT) intensified to denounce the removal of labelling, traceability and the rights of small and medium-sized breeders and farmers, in favour of increased concentration of seed power. The trilogue between negotiators from the Commission, the Council and the European Parliament on the deregulation of these GMOs has just been the subject of a consensus proposal to the European institutions (Parliament and Council). While the Council of the EU announced on 19 December 2025 that it had approved this proposal by a qualified majority9, the Parliament will examine it in January 2026.In their letter, the signatory organisations warn that not one but two major pieces of legislation – the seed and GMO/NGT regulations – could profoundly redefine the European seed and agricultural framework, to the detriment of agrobiodiversity and the resilience of agricultural systems. These two reforms are not simply technical choices, but directly affect cultivated biodiversity, food sovereignty, farmers' ability to select and exchange their seeds, access to plant genetic resources, and transparency towards consumers. They are also closely linked, because by changing the rules on seed marketing, the EU would facilitate the spread of GMOs/NGTs, whose marketing is based on patented and uniform varieties. Thus, the reform of seed regulations contributes, in practice, to the liberalisation of GMOs/NGTs, which profoundly transforms the legal and economic framework for seeds in Europe10.In such a context, maintaining a public, pluralistic and informed debate seems essential. But is this still possible when certain key parliamentary voices, which have long warned of the harmful impacts of such reforms, seem to be giving up? Citizens and organisations will have to closely monitor upcoming European decisions and continue to mobilise if they do not want current policy directions to hinder the future of agricultural and non-GMO biodiversity in Europe.Measures proposed by the 240 organisations to ensure effective protection of agricultural biodiversity: Exclude activities carried out for the purposes of conservation and dynamic management of genetic diversity from the scope of the regulationExchanges of PRM for selection or conservation should not be treated as commercialisation. They are essential to agrobiodiversity and should not be subject to market rules. The conservation objective should therefore be excluded from the scope of the draft regulation via Article 2.4. Guarantee farmers the right to conserve, use and exchange their own seeds, including in exchange for financial compensationThese practices have generated a high level of crop diversity and enabled farmers to ITPGRFA adapt seeds to their needs and exchange them, particularly in times of crisis. Since the EU recognises these rights, which do not fall within the scope of commercialisation (UNDROP, CBD)0, it should also exclude them from the scope of the PRM regulation. PRM exchanges between farmers for selection or conservation purposes should not be treated as professional operators or be subject to commercial rules, but only to those of agricultural production.Facilitate the registration and use of old and new conservation varieties for all crops and without geographical limitationsConservation varieties are essential for organic and agroecological agriculture. They should not be limited to certain species or their region of origin, except to the detriment of their users' activities. These restrictions must be removed and their registration must be simple, free and accessible to all. These varieties must be non-hybrid, non-GMO or GMO/NGT and free of intellectual property rights. All varieties developed for specific growing conditions or commonly known fruit varieties should be registered as conservation varieties, without additional administrative burdens, in order to guarantee continued access.Conduct value for cultivation and use (VCU) assessments under organic or low-input conditionsSustainability cannot be reduced to a single trait or gene: it must be assessed systemically. VCU (value for cultivation and use) assessments must be carried out under organic or low-input conditions and, for varieties intended for organic farming, must be carried out under organic conditions for all species and in all Member States.Reducing the administrative burden on 'nano-enterprises' (one to three employees, less than €100,000 in turnover)11in order to enable a diversified seed market and avoid increased concentration in the hands of a few major playersThe Commission promised to reduce the burden on SMEs. However, the new obligations would significantly increase the workload for small seed producers, to the point of forcing some of them out of business. Nano-enterprises, which are essential for providing a wide variety of local varieties, should be exempted from the new notification, administration and traceability requirements in order to preserve this diversity.Ensuring transparency of selection methods and availability of information on intellectual property rights (IPR)Transparency, through labelling and public databases on selection methods and IPR, is essential to ensure fair access and informed choices. It provides breeders and farmers with the information they need to select new, diverse and resilient varieties. Selection techniques and associated rights must therefore be made public in national and European registers. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [64] => Array ( [objectID] => 14526 [title] => Inf’OGM pays tribute to Arnaud Apoteker [timestamp] => 1768348800 [date] => 14/01/2026 [annee] => 2026 [url] => https://infogm.org/en/infogm-pays-tribute-to-arnaud-apoteker/ [image] => https://infogm.org/wp-content/uploads/2026/01/ArnaudApoteker_byNoisette-768x512.jpg [extrait] => It is with deep sadness that we learned of the passing of Arnaud Apoteker on Friday, 9 January 2026. Arnaud was a very important figure in the history of Inf'OGM. Founding member, he remained on the Board until 2025. [chapo] => It is with deep sadness that we learned of the passing of Arnaud Apoteker on Friday, 9 January 2026. [texte] => Arnaud was a very important figure in the history of Inf'OGM. Founding member, he remained on the Board until 2025. He contributed his knowledge and skills to the organisation. In the early years, he patiently supported the editors, systematically proofreading articles to ensure they were accurate and precise, both in terms of content and form. His insightful contributions during meetings, his ability to synthesise information and his humour were invaluable to the association. His cheerful and uncomplicated nature accompanied us throughout all these years.Beyond our association, Arnaud was one of the first people in France to question GMOs. As a pesticide campaigner for Greenpeace since 1991, he was one of the iconic faces of the campaigns against GMOs in France and Europe. In particular, he worked to raise awareness, inform the public and create guides to products with and without GMOs, enabling consumers to make informed choices. In 1999, he published a book with the now iconic title Du poisson dans les fraises (Fish in Strawberries), an educational, informative book with a concise and powerful style, a high-quality tool for raising awareness. He based his campaign on sound scientific knowledge. He always refused to allow science to be exploited, distorted or disparaged. He was able to forge strategic alliances with a wide range of people.After leaving Greenpeace in 2011, he continued his fight for healthy food and agriculture, free from GMOs and pesticides, as a parliamentary assistant to Green Party MEPs, General Delegate of the Justice Pesticides association, and by participating in the creation of the International Tribunal against Monsanto, which was symbolically held in The Hague in 2016. More recently, he was actively involved in the Justice pour le Vivant coalition, which succeeded in getting the government to reform its protocols for evaluating and authorising pesticides, which were deemed inadequate, in order to bring them into line with current scientific knowledge.Beyond this fight, Arnaud was a gentle and cheerful person. He argued calmly and knew how to put the people he worked or collaborated with at ease. Despite his career, his skills and his international renown, he always remained humble, even discreet.On Friday, we lost a friend.Our thoughts are with Josiane, her children, her grandchildren and all her friends.Our hearts are heavy.We will continue, Arnaud, to carry on your sense of justice, sincerity and reliable, critical information at Inf'OGM.The entire Inf'OGM team, employees and volunteers, past and present. [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [65] => Array ( [objectID] => 14498 [title] => New GMOs to produce medicines tested in Spain [timestamp] => 1768176000 [date] => 12/01/2026 [annee] => 2026 [url] => https://infogm.org/en/new-gmos-to-produce-medicines-tested-in-spain/ [image] => https://infogm.org/wp-content/uploads/2026/01/tobacco-nicotiana-tabacum-leaves-nature-landscapes-ea3691.jpg [extrait] => Near Valencia (Spain), in Polinyà del Xúquer, a trial of genetically modified tobacco to produce a molecule of therapeutic interest has been authorised. This tobacco has been modified using genetic modification techniques presented as new (NGT). The two partners in charge of the trial, the company MadeInPlant and the agricultural union AVA, declared the trial in December 2024, in accordance with Directive 2001/18 governing GMOs, even though they claim that this tobacco is not a GMO but an NTG plant. [chapo] => Near Valencia (Spain), in Polinyà del Xúquer, a trial of genetically modified tobacco to produce a molecule of therapeutic interest has been authorised. This tobacco has been modified using genetic modification techniques presented as new (NGT). The two partners in charge of the trial, the company MadeInPlant and the agricultural union AVA, declared the trial in December 2024, in accordance with Directive 2001/18 governing GMOs, even though they claim that this tobacco is not a GMO but an NTG plant. [texte] => The Spanish company MadeInPlant and the agricultural union AVA have obtained authorisation to conduct field trials on genetically modified tobacco that they planted in 20251. In this trial, nicotine is supposed to have been largely replaced by another molecule, anatabine, an alkaloid with anti-inflammatory and neuroprotective properties. Anatabine occurs naturally in the leaves of plants in the Solanaceae family, such as tobacco. It helps the plant defend itself against insects. The increase in the amount of this molecule sought by technicians should serve as a medicine for Alzheimer's disease, multiple sclerosis and intestinal inflammation. At least, that is what the company involved in this trial claims. However, the effectiveness of anatabine against Alzheimer's disease has not yet been proven in humans. The available data is limited to preclinical studies2 on animal models showing a reduction in brain inflammation and amyloid markers.A "NGT" plant with transgenic originsSurprisingly, the public information document (Summary Notification Information Format, SNIF)3 for this trial is only available in Spanish on the website of the Spanish Ministry for Ecological Transition, but has not been posted on the European Commission's website listing GMO field trials in Europe.Technically, according to this SNIF, "the tobacco plants involved in this trial have mutations (deletions and insertions) in the endogenous MPO genes. The mutations were generated using the CRISPR/Cas9 system". More specifically, "the modified plants have mutations in the MPO1 (N-methylputrescine oxidase 1) genes of tobacco, an enzyme that catalyses the second step in the biosynthesis pathway of alkaloids in tobacco. The mutations introduced consist of insertions or deletions in the gene sequence that result in the production of truncated proteins and potentially their loss of function. Under greenhouse conditions, these lines show reduced nicotine levels and increased anatabine levels". It is specified that "these plants do not contain any exogenous DNA fragments".The trial is regulated under Part B of Directive 2001/18. However, the stipulation that no fragments of exogenous DNA are present in the final plant means that, if the deregulation bill currently under discussion is adopted, this trial would enable the company to apply for deregulated GMO status. However, this plant was obtained from transgenic tobacco. Indeed, it is also specified that the first stage of the production protocol for this genetically modified tobacco involves transgenes introduced using Agrobacterium (transgenes expressing the CRISPR/Cas complex and selection markers). It is then specified that one of the steps consists of selecting plants that no longer contain these transgenes. According to the dossier, the absence of these transgenes has been confirmed by sequencing (PCR).What are AVA and MadeInPlant?According to SNIF, the aim of this trial is to "determine the optimal growing conditions in the field for the modified strain for use as an anatabine “biofactory” plant". The trial, planned for an area of 2,500 m², is being conducted jointly by the Valencian Farmers' Association (AVA) and the Valencian company MadeInPlant.The AVA is a member of the Spanish union ASAJA, itself a member of COPA-COGECA at European level. Its treasurer, Miguel Minguet, is currently vice-president of the European organisation in the field of ‘plant health’ (sic). ASAJA welcomed the agreement reached during the trilogue on Wednesday 3 December4 and stated: "It is essential that the agreement confirms that NTG 1 plants, because they are indistinguishable from conventionally bred plants, will be regulated in the same way as the latter". The union provided one of its farms for the trial.MadeInPlant is a Spanish biotechnology company, a spin-off of the Spanish National Research Council (CSIC) and the Polytechnic University of Valencia (UPV), specialising in the production of ‘biomolecules’ using plants as ‘biofactories’5. It uses genetically modified plants to produce antibodies, human growth factors, metabolites and enzymes for the pharmaceutical, cosmetics, agri-food and research sectors. This company is also active in the field of synthetic biology6.MadeInPlant also works on other projects, sometimes through other companies, such as CTAEX. The two entities cooperate on initiatives such as the AGROFACTORY project, funded by the European Union (EAFRD), which aims to develop ‘biofactory’ crops based on Nicotiana tabacum tobacco to produce thaumatin. They also share partnerships with NOMAD Bioscience (or NAMBAWAN) for greenhouse and field trials on protein-producing plants (thaumatin, antibacterial/antiviral proteins), including regulatory and technical aspects7. CTAEX has also filed applications for similar GMO tobacco field trials in Spain8. Thaumatin is not a molecule of therapeutic interest. It was originally extracted from the fruit of the katemfe tree, native to tropical Africa, for its intense sweetening power (approximately 2,000 to 3,000 times greater than sucrose). This molecule is therefore mainly used as a low-calorie sweetener with no impact on blood sugar levels9. It is found in sugar-reduced products such as drinks, chewing gum, desserts and confectionery. It is authorised in the European Union as an additive under the name E957.The AVA invents its own definition of GMOArticles referring to this trial, such as those published in Agronews Comunitat Valenciana10, Bolsamania, Valencia News and Democrata.es, repeat the agricultural union's statement almost word for word. In a press release11 published on 25 July 2025, it states that "the genomic techniques used in the study belong to the group of new gene editing techniques (NGT), which allow precise modifications to be made to the plant's genome without incorporating DNA from other species. This clearly distinguishes them from genetically modified organisms, traditionally known as GMOs, and makes them a key tool for the development of safer and more widely accepted agricultural biotechnology".This statement is neither scientifically nor legally justified. To date, GMOs are defined by Directive 2001/18, which makes no reference to transgenesis or the addition of genes from other species. An GMO, let us reiterate, is "an organism, with the exception of human beings, whose genetic material has been modified in a way that does not occur naturally through multiplication and/or natural recombination". The genetic modification made to this tobacco corresponds in every respect to this definition. Despite the distinction they wish to make between plants obtained by ‘new genomic techniques’ and GMOs, this tobacco is indeed a GMO. They themselves recognise this de facto: they have submitted an application for authorisation in accordance with current European GMO legislation, namely Directive 2001/18.Tobacco to boost the local economy?The company MadeInPlant emphasises on its website that this therapeutic tobacco project will also have a positive impact on the local economy: "The declining competitiveness of traditional herbaceous crops has jeopardized the viability of many agricultural enterprises, contributing to rural depopulation in various regions of Spain. A prime example is traditional tobacco cultivation, which not only faces profitability challenges common to other crops but also increasing stigmatization due to its conventional uses. This situation calls for viable and sustainable alternatives".This statement is partly misleading. In fact, the decline of tobacco cultivation in Spain is mainly due to the end of European subsidies12, the end of Tabacalera's monopoly, which guaranteed attractive prices for producers13, and the decline in global demand, not to an intrinsic "decline in competitiveness" or decisive stigmatisation. It is unlikely that ‘therapeutic tobacco’ could actually revive such agricultural activity. In 2007, a French start-up, Librophyt, also conducted field trials of GMOs to produce therapeutic molecules14. This company ceased operations around 2010 due to a lack of commercial viability. In practical terms, extracting biomolecules from plants is not profitable on a large scale15. On average, less than 1% of the total weight of the plant is obtained, with fairly high purification costs. Has MadeInPlant found a solution to these technical and economic difficulties? Nothing in their communication allows us to say so.Health as a pretext for deregulating GMOs/NGTsThis new trial highlights how health is being exploited to accelerate the deregulation of genetically modified plants using new techniques. However, the AVA agricultural union concludes its press release as follows: "This approach opens the door to applications in commercially important crops such as citrus fruits, rice and tomatoes, with the aim of improving nutritional properties, increasing resistance to pests and diseases, and reducing the use of plant protection products". The promise of transgenic plants capable of producing any therapeutic molecule at low cost has not been fulfilled, despite numerous trials and public funding. Promoters of GMOs/NGTs reiterate this promise, claiming that the tools they have developed, notably Crispr, can solve the technical difficulties of transgenesis. So far, this has not yet been demonstrated factually. Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [66] => Array ( [objectID] => 14454 [title] => Despite pitfalls and dangers, gene drive is still on the table [timestamp] => 1766620800 [date] => 25/12/2025 [annee] => 2025 [url] => https://infogm.org/en/despite-pitfalls-and-dangers-gene-drive-is-still-on-the-table/ [image] => https://infogm.org/wp-content/uploads/2025/12/Mosquitos_messed_up_1888750788.png [extrait] => In September 2025, the French Academy of Sciences published a summary of the risks it identified as being associated with gene drive. This technique, which emerged around ten years ago, presents a variety of potential dangers and is uncontrollable. As a result, it has not yet been deployed in the wild. However, the current context is very conducive to its development and the precautionary principle is under threat. [chapo] => In September 2025, the French Academy of Sciences published a summary of the risks it identified as being associated with gene drive. This technique, which emerged around ten years ago, presents a variety of potential dangers and is uncontrollable. As a result, it has not yet been deployed in the wild. However, the current context is very conducive to its development and the precautionary principle is under threat. [texte] => Inf'OGM devoted a comprehensive report to gene drive in 2020i. Five years on, a report by the French Academy of Sciencesii provides an opportunity to take stock of new emerging issues and lay the foundations for ethical and philosophical reflection.Furthermore, in August of the same year, 2025, the project to genetically engineer malaria-carrying mosquitoes was halted in Burkina Faso. What were the reasons for this?A hegemonic project based on transgenesisIt should be remembered that the technology of gene drive is based on transgenesis in sexual species. The DNA fragments (or transgenic cassette) used encode the CRISPR/Cas complex, a tool that will cut the DNA and copy the transgenic cassette identically into the cell resulting from fertilisation. This cassette can contain one or more genes of interest, if necessaryiii.The aim is for all descendants to carry the trait desired by the technicians. These traits will be forced by the technique. This will occur in each generation and therefore, step by step, in theory, all descendants would be genetically modified with the forcing cassette. This transmission is hegemonic and will be all the more effective as the species concerned has a short lifespan.However, the implementation of gene drive is very difficult and presents many risks. As the report of the Academy of Sciences states, "undertaking a benefit-risk assessment of CRISPR homing gene driveiv is inherently difficult. It is impossible to fully anticipate all possible impacts. Furthermore, there is no standard method to weigh up the various pros and cons in a way that would satisfy everyone, according to their various perspectives". This explains why, despite the many promises made by biotechnicians and industry, gene drive has not yet been deployed in nature.The promises of gene driveThe promises of gene drive relate to public health, agriculture and species conservation.In medicine, gene drive is being considered in the hope of controlling or eliminating vector-borne diseases by targeting disease-carrying organisms, particularly mosquitoes, for example against malaria (see box).In agriculture, the promise lies in combating insects considered pests (fruit flies, locusts, etc.) that damage crops or affect livestock. Gene drive is being studied to reintroduce sensitivity genes into weeds that have become tolerant to herbicides so that they become sensitive to these herbicides once again !Finally, in the field of species conservation, the promise of gene drive lies in protecting endangered species by controlling invasive plant or animal species or by introducing beneficial traits into populations at risk of extinction.Two approaches are being considered for gene drive: modification and suppression.In the first case, the objective is to obtain a population in which 100% of the members carry the transgenic gene drive element. In the second, the objective is to reduce or eliminate a target population, for example by introducing genetic modifications that cause sex-specific sterility or reduce reproductive success, leading to the collapse of the population.Complicated implementationThere are two types of implementation difficulties. On the one hand, there are biological limitations that would make gene drive technology ineffective or only marginally effective, and on the other hand, there are cases where gene drive technology could not be stopped.Risks of ineffectivenessIn the laboratory, gene drive systems have been developed in yeasts and various sexually reproducing animals, including flies, mosquitoes and mice. In the case of plants, the application of gene drive is difficult for several reasons. Many plants reproduce vegetatively, which limits the spread of a forced transgenev. They have long life cycles, and many species are polyploidvi, making the technique much more difficult to apply. Finally, chromosome repair following breaks generated by CRISPR/Cas is less effective than in animals.In insects, there are closely related species that are capable of reproducing with each other but do not do so for biological or ecological reasons, leading to reproductive isolation. These are called cryptic species. In the case of campaigns to eliminate mosquitoes that carry pathogens, the successful elimination of a target population by a forced transgene could leave an ecological niche that could be filled by cryptic mosquito species. This could lead to the expansion of these cryptic species, which are also carriers of the pathogen. In such a scenario, the initial forced transgene would fail.Another potential reason for failure is the resistance of certain target populations to gene drive, either through already present resistance alleles or through new mutations. Strategies are currently being studied in the laboratory to counter this resistance, but it is impossible to predict how they will perform under natural ecological conditions.The risks of not being able to stop gene driveIn the event of undesirable effects following the implementation of a forced transgene, one might want to stop it. However, stopping a forced transgene is not simple since transmission is hegemonic. A forced transgene could continue to spread within the target population, even if its implementation has been stopped.Therefore, in laboratories, some researchers are attempting to implement complex strategies, still based on transgenesis, to inactivate the genes encoding the CRISPR/Cas system. However, these theoretical models depend on many factors, and some forced transgenes are proving unstoppable. One strategy being considered by technicians would be to have forced organisms synthesise anti-CRISPR proteins discovered in bacteriophagesvii. However, applying this technique in nature would require the continuous, uninterrupted release of forced, anti-CRISPR individuals!Despite these limitations, the French Academy of Sciences does not rule out the implementation of gene drive. Its report states: "Further experimental validation and mathematical modeling, particularly in spatially heterogeneous environments, will be necessary to assess the range of conditions allowing this anti-drive strategy to successfully mitigate gene drive propagation". However, the author of the report adds that "close monitoring of the target population and ecosystem" will be necessary, which implies that "if an initial gene drive release proves problematic, local communities are condemned to pursue remediation actions with the research team"... Local populations and local researchers do not all agree with the release of modified insects (see box).The dangers of forced transgenes in natureGene drive belongs to a particular category of techniques with a high ecological impact, alongside with nuclear energy and virus manipulationviii.Genetically forced organisms are designed to act in natural ecosystems, where multiple species have been interacting with each other and their physical environment for millions of years, building a dynamic balance, a form of stabilityix.What a forced transgene will do in an ecosystem where it is entirely foreign, unknown and, moreover, artificial is unpredictable. Many types of mutations can occur in the genetic forcing element and transform an original forcing into a new one (see box), with new potential adverse effects on the phenotype of the organisms carrying the forcing and on ecosystems (e.g. insecticide resistance). In addition, mutations in the transgene sequence of one of the elements of the CRISPR/Cas complex (the guide RNA) can alter the target site of cleavage in the DNA, and the cassette may insert itself elsewhere in the genome.These ecological impacts are highlighted in the report by the Academy of Sciences, which states that "the goal of eliminating an invasive species might be to return to an ancestral equilibrium similar to the one prior to the invasion. But local eradication of an invasive species leaves an empty ecological niche that can trigger diverse cascading trophic effects on the distribution and abundance of multiple other species in direct and indirect interaction with the eliminated species". The ancestral balance cannot be restored, the evolution of life does not know how to reverse course, but constantly creates something new in response to contingencies. This is precisely why the implementation of gene drive is so difficult and needs to be re-examined.Another major concern is that transgenes of gene drive designed to target a specific population may contaminate other populations of the same species or another species. The longer these transgenes are present in nature, the greater the risk. This can occur through sexual reproduction between closely related populations or species, or through horizontal transfer, mainly via viruses and micro-organisms capable of transporting DNA fragments. This is very worrying, as distant species can thus be affected by gene drive. This risk has been taken into account by the Academy of Sciences, which considers that "the risk of transmitting the gene drive to another species exists".The Academy of Sciences is asking ecosystem scientists "to thoroughly assess the ecological role of the target species within its ecosystem". This is a daunting task, and perhaps impossible given the known history of life on Earth. Indeed, the ecological "roles" of species are intertwined, there is not just one per species, and they change over time: an ecosystem is complex and evolving... and our understanding of ecosystems is also evolving!Other risks of gene editingSociological risks are addressed in the Academy of Sciences report. They get our attention : "These risks stem from public perception and governance issues. As previously seen with COVID-19 vaccines during the pandemic, negative public perception can rapidly spread via social media. One of the greatest risks is an unauthorized release of gene drive organisms into the wild, whether accidental or deliberate, because this could severely damage public trust in scientists, institutions or regulators". The Academy of Sciences therefore fears that the consequences of gene drive in nature could damage the reputation of other biotechnologies, which it tells us are very useful. We would argue that, given the major risks to the environment posed by gene drive, this "sociological" risk is minimal.As for the human populations that would be affected by gene drive, "scientists and policymakers must prioritize transparency, inclusivity, and active engagement with local populations". This is wishful thinking when we know that it is large multinational companies from rich countries that want to introduce genetically modified mosquitoes to combat malaria in countries in the "South" and that meetings with local populations mainly consist of persuading them to accept this technology (see box).The accidental release of genetically modified individuals into the wild during trials is mentioned in the report, and the author reassures us that biologists have put in place a series of very strict safety rules and protocols. However, she adds that "international discussions around gene drive research have not yet converged on a set of rules and guidelines to be respected worldwide".The malicious use of gene drive is also addressed by the Academy of Sciencesx. Gene drive could be used to build two types of biological weapons: "suppression drives that would target insect species necessary for agriculture (e.g. pollination) and modification drives that would render pest or disease-carrying insects resistant to insecticides or able to deliver toxins to humans". However, the report concludes that an effective preventive measure would be to "exclude from scientific papers the methodological details for applying gene drive to non-model species". This seems rather weak in view of the widespread surveillance on the Internet. Wouldn't this be yet another reason to stop research into gene drive?The gene drive project has not been abandoned despite the major risks of destroying ecological balances. Extremely sophisticated methods are still being used to implement it in laboratories and adjust it to make it more effective, even though there is a risk that it will be impossible to stop.What right do researchers and industrialists have to persist, when ecological solutions exist to address the problems that genetic engineering seeks to solve? When society in all countries has not been consulted? When we know that living organisms are unpredictable and that it is impossible to control artificial elements introduced into nature?The answer is undoubtedly that the industry's criteria in the risk-benefit balance are not the same as those of the general public.Genetic engineering project halted in Burkina Faso In August 2025, the government of Burkina Faso ended the Target Malaria project, which aimed to eradicate malaria by using gene drive technology to eliminate Anopheles gambiae mosquitoes, the vectors of the diseasexi.This project was designed in a laboratory at Imperial College London. The project's experimental protocol consisted of three phases, each focusing on a particular strain of genetically modified mosquitoes. Only the third phase involved the use of gene drive. All strains produced by Imperial College were sent to the local Target Malaria team in Burkina Faso for field trials, and each phase was normally to be concluded with a release of mosquitoes. This gene drive project was the most advanced in the world, thanks to huge funding, mainly from the Bill and Melinda Gates Foundation, but also from DARPA (US Agency for Advanced Defence Research Projects).In July 2019, during the first phase of the project in the village of Bana, Target Malaria researchers released 6,400 male mosquitoes that had been genetically modified to be sterile (but not forced!) to see how they would adaptxii. Notable irregularities concerning the information provided to the population of Bana had been notedxiii.It is at the second phase, which began in March 2022, that the project has just been halted. A release of 16,000 genetically modified male mosquitoes had been carried out on 11 August 2025. The mosquitoes released were of a different genetically modified strain. In fact, the strains of GM mosquitoes sent to Burkina Faso, although tested in the London laboratory, caused numerous problems. Andrea Crisanti, who heads the London laboratory, explained that the proposed strain had significant flaws that could have "multiple implications for disease transmission and ecological adaptation". In preparation for the release, repeated crossbreeding of the genetically modified strain with local mosquitoes, which was necessary to ensure its adaptation, apparently did not work properly. Andrea Crisanti identifies the cause as the omission of complex genetic phenomena, such as chromosomal inversions, and a lack of knowledge about genes linked to malaria transmission or those linked to adaptation to humidity or drought. Another problem stems from the fact that mosquito breeding conditions were not controlled in the field, particularly with regard to humidity levels. The researchers and civil society organisations that identified these flaws thus enabled the project to be withdrawnxiv. They advocate other methods of combating malaria.Other researchers at Imperial College disagree: "Several independent assessments, including a review by Burkina Faso’s biosafety regulatory authority and a separate environmental study, concluded the risks of the release were “negligible""xv.The third phase of the project, gene drive, currently being prepared in London, has also been criticised. The WHO expert report (2022) identified problems: the transgenic cassette has become unstable due to a mutation and the project fails to clearly identify all the mosquito species to be targetedxvi.i "Forçage génétique : vers une désorganisation du vivant ?", Inf'OGM, le journal, no. 160, July/September 2020."Mini-guide | Forçage génétique : vers un contrôle du vivant ?", Inf'OGM, December 2022."Gene drive: the new technique that could eradicate entire species", Inf'OGM, 18 October 2021.ii Courtier-Orgogozo V., "Risks associated with CRISPR homing gene drive", C R Biol., volume 348, pp. 211-227, 8 September 2025.iii Eric Meunier, "Forçage génétique : une transmission hégémonique de transgène", Inf'OGM, le journal, no. 160, July/September 2020..iv This is the new name given by biotechnicians to the transgenic cassette containing the CRISPR/Cas complex.v The use of this expression is of semantic convenience: it actually refers to the genes in the transgenic cassette.vi A cell or organism is polyploid when it has more than one copy of the same chromosome (e.g. soft wheat has 7 different chromosomes with 6 copies each, i.e. 42 chromosomes)vii Annick Bossu, "Médecine : les technologies Crispr/Cas se cherchent encore", Inf'OGM, 20 February 2024.viii This is the new name given by biotechnicians to the transgenic cassette containing the CRISPR/Cas complex.ix Frédéric Jacquemart, "Biodiversity and stability of natural systems: what are the impacts of GMOs?", Inf'OGM, 18 November 2025.x "Forçage génétique : vers une désorganisation du vivant ?", Inf'OGM, le journal, no. 160, July/September 2020.xi Abdou Razak OUEDRAOGO, "Santé : Fin des moustiques génétiquement modifiés au Burkina Faso", aconews.net, 22 August 2025.xii Christophe Noisette, "BURKINA FASO – Les moustiques transgéniques disséminés", Inf'OGM, 3 July 2019.xiii Irina Vekcha, « Burkina Faso – Le projet Target Malaria continue malgré les irrégularités », Inf’OGM, 1st February 2022.xiv Irina Vekcha, « Expérimentation du forçage génétique, au Burkina Faso : « Lâcher des moustiques génétiquement modifiés au Burkina Faso est dangereux » estime Mme Irina Vekcha Professeur de génétique à l’ENSA (Université d’Agriculture du Sénégal) », Agropasteur, 4 août 2025.xv Kai Kupferschmidt, "After 'humiliating' raid, Burkina Faso halts 'gene drive' project to fight malaria", Science, 3 September 2025.xvi Irina Vekcha, « Expérimentation du forçage génétique, au Burkina Faso : « Lâcher des moustiques génétiquement modifiés au Burkina Faso est dangereux » estime Mme Irina Vekcha Professeur de génétique à l’ENSA (Université d’Agriculture du Sénégal) », Agropasteur, 4 août 2025. Annick BOSSU [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [67] => Array ( [objectID] => 14451 [title] => Qualified majority in the Council of the European Union to deregulate numerous GMOs [timestamp] => 1766534400 [date] => 24/12/2025 [annee] => 2025 [url] => https://infogm.org/en/qualified-majority-in-the-council-of-the-european-union-to-deregulate-numerous-gmos/ [image] => https://infogm.org/wp-content/uploads/2025/12/coreper-conseil-ue.jpg.webp [extrait] => On Friday 19 December, the Member States meeting within the Council of the European Union reached a qualified majority agreement on a text to deregulate many GMOs. This text, negotiated two weeks earlier between representatives of the European Commission, the European Parliament and the Council, proposing broad deregulation of GMOs obtained through new techniques of genetic modification, has finally convinced a sufficient majority of States. The European Parliament is now due to consider it in January 2026. [chapo] => On Friday 19 December, the Member States meeting within the Council of the European Union reached a qualified majority agreement on a text to deregulate many GMOs. This text, negotiated two weeks earlier between representatives of the European Commission, the European Parliament and the Council, proposing broad deregulation of GMOs obtained through new techniques of genetic modification, has finally convinced a sufficient majority of States. The European Parliament is now due to consider it in January 2026. [texte] => Before working on numerous legislative proposals made in the recent days by the European Commission (unregulated release of genetically modified micro-organisms into the environment, omnibus law on pesticides, biotech law, forthcoming innovation law, etc.), the Council of the European Union focused on friday 19 December 2025, on the proposal made by the European representatives two weeks earlier to deregulate many GMOs obtained through new techniques of genetic modification (so-called "new genomic techniques" / NGT).Based on the European Commission's proposal made in July 2023i, the European Parliament's position voted on in April 2024ii and the European Council's mandate given to Denmark in March 2025iii, this agreement between negotiators caused quite a stir among key players such as farmers and associationsiv. The negotiators had indeed chosen to present a text containing measures aiming at deregulating GMOs obtained through NGTs and did not address the concerns repeatedly expressed by certain Member States, the European Parliament and many stakeholders involved in the debate (farmers, seed producers, the organic and GMO-free sectors, associations, etc.).At a meeting of the permanent representatives of each Member State (Coreper 1) on Friday 19 December, the Council of the European Union reached a consensusv on this proposal. Pending the European Parliament's vote in 2026, the text is still provisional. But if it were to be endorsed by Parliament, what does it provide for?No labelling, no traceability, no risk assessment, no...The deregulation text agreed by the Council of the European Union takes the approach of declaring that GMO plants obtained by "targeted mutagenesis or cisgenesis" would be declared as NGT plants. They could be classified into two categories (NGT1 and NGT2) according to the nature of the genetic modifications made. In short, category 1 plants would be those defined as "equivalent" to plants that can be obtained conventionally, based on criteria of uncertain scientific basis. NGT2 plants would be those not classified in category 1. As already analysed, the vast majority of genetically modified plants should logically be presented as NGT1 by their manufacturers, as this status offers the most extensive deregulation and operates on the basis of a simple verification of a declaration made by a company.For NGT1s, the proposed authorisation system would be based on a fairly lax approach. Marketing authorisation or authorisation for field trials would no longer be formally required. Only recognition of a plant's NGT status would need to be requested on the basis of a simple declaration. This could be done in a Member State upon simple request to conduct a field trial or with a view to marketing. The final decision would be made by the European Commission. But, with no method of detection and identification required from the companies as we’ll see, the European Union would have no choice but to trust the statements made by companies in the files submitted to confer NGT1 or 2 status.Once this NGT status has been obtained, GM plants obtained using new techniques, and in particular NGT1, would no longer be subject to GMO legislation (no authorisation required, no risk assessment for NGT1, no traceability or labelling except for seeds, no monitoring of environmental impacts, etc.).In addition to removing many GMOs from current GMO legislation, the text, which will be examined by the European Parliament in 2026, maintains an approach that would render the European Union virtually blind to GMOs obtained by NGT present on its territory. The negotiators had decided not to accept the European Parliament's requests regarding the labelling of these category 1 GMOs when they are imported, produced and/or marketed in Europe. Only seed buyers would have access to such labelling. In addition to this deliberate choice to no longer inform European citizens about what they are consuming, negotiators also chose to make it impossible for the European Union to verify companies' claims and carry out checks on European territory (such as the labelling of seed batches). Indeed, the requirements to provide a method for detecting, identifying and quantifying GMOs obtained by new techniques proposed by the European Parliament have not been retained.Finally, it should be noted that plants that have obtained NGT1 status would not be subject to assessments of risks on health, environment and agrarian systems. European legislators argue that NGT1 plants pose no greater risk than plants obtained by conventional methods. Will these plants modified by NGTs be toxic, allergenic or have reduced nutritional value? No one will know, as this would no longer be required. Only NGT2 plants would be subject to an environmental risk assessment, which again should be rare.Insecticidal plants that cannot be deregulated?A rather unexpected novelty is to be noted in the version of the text agreed by the Council on Friday 19 December. The European Parliament and the Council of the European Union had already proposed that plants genetically modified by NGT to tolerate herbicides should not be declared category 1, even if they meet the requirements of that category. MEPs highlighted the specific growing conditions required by these plants. The negotiators, and now the Council, have taken up this proposal to exclude from NGT1 status the plant tolerating herbicides, adding to it the plants obtained by new techniques which characteristic would be to resist insecticide. However, the wording is uncertain, to say the least, with negotiators proposing to exclude NGT plants that have the characteristic of producing "a known insecticidal substance" from NGT1 status. Known to whom, how and where are all questions that arise and make the scope of such an exclusion unclear.GMO-free organic farming, until further notice...In the specific case of agriculture and production meeting the "organic" label, it is proposed to note that this label prohibits the use of GMOs obtained by NGT, since it excludes GMOs. While it is noted that organic and conventional production chains are already sufficiently separate, the sector's requests to establish analytical traceability, coexistence measures, labelling for consumers and the establishment of compensation funds, have not been accepted. The only measure proposed by the negotiators and the Council is a tolerance for the presence of GMOs obtained by NGT in organic production in cases of "adventitious or technically unavoidable presence". This intention may be laudable, but it would nevertheless open the way for the adventitious presence of GMOs obtained by NGT in organic production. However, these notions of "adventitious or technically unavoidable presence" would not be defined and, once again, the EU would not have methods for detecting and identifying these GMOs obtained by NGT provided by their manufacturers, as this is not a mandatory requirement.Above all, the future of European organic regulations seems to be in question. The text voted on this morning by the Council states that a more in-depth examination of the compatibility of NGT1 plants with the principles of organic farming would be necessary because "it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. Currently, the compatibility of the use of new genomic techniques with the principles of organic production requires further consideration. The use of category 1 NGT plants should therefore be prohibited in organic production, until such further consideration takes place".Fears over patents remain unresolvedOne of the stumbling blocks between the institutions concerns patents. While the European Parliament called for a ban on patents on GMOs obtained by NGT and classified as category 1, the Council of the EU was unable to reach a consensus due to significant differences between Member States. On 4 December, negotiators proposed measures to try to reassure everyone. However, most of these measures are optional, as they are "voluntary" or non-binding, as explained by the European Coordination Via Campesina (ECVC) in its press release of 11 December. Inf'OGM will write about these proposed measures in more detail, but we now know that a qualified majority of the Council of the European Union seems satisfied with this optional nature.At this stage, the details of the positions expressed by the Member States are not known, as Coreper 1 meetings are not broadcasted live. However, the qualified majority reached within the Council on 19 December shows that some states have given ground. This Council vote now sends the text to the European Parliament for MEPs to give their opinion on it in 2026. The MEPs who are the members of the Parliament's Environment Committee will be the first to take action, possibly in January 2026.i European Commission, "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625", 5 July 2023.ii European Parliament, "Plants obtained by certain new genomic techniques and their food and feed - European Parliament legislative resolution of 24 April 2024 on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (COM(2023)0411 – C9-0238/2023 – 2023/0226(COD))", 24 April 2024.iii Council of the European Union, "Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625", 7 March 2025.iv Eric Meunier, “Déréglementation des OGM : la balle est dans le camp du Parlement européen”, Inf’OGM, 5 December 2025.v See preparatory documents of Coreper meeting on 19 December:Council of the EU, Coreper I, 19 December 2025, "Related documents". Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [68] => Array ( [objectID] => 14425 [title] => The majority of micro-organisms modified by NGTs are detectable [timestamp] => 1766448000 [date] => 23/12/2025 [annee] => 2025 [url] => https://infogm.org/en/the-majority-of-micro-organisms-modified-by-ngts-are-detectable/ [image] => https://infogm.org/wp-content/uploads/2025/12/1359712483qyB-768x432.jpg [extrait] => In 2025, the European network of GMO laboratories (ENGL) published a report written by several of its experts on the detection and identification of genetically modified microorganisms using new techniques in the food and feed industry. According to this report, the vast majority of these micro-organisms are detectable and identifiable. However, "in somecases", with the processes currently available, very small genetic modifications can be more complicated, or even impossible, to detect and differentiate from those that can occur without technical intervention on the genome. [chapo] => In 2025, the European network of GMO laboratories (ENGL) published a report written by several of its experts on the detection and identification of genetically modified microorganisms using new techniques in the food and feed industry. According to this report, the vast majority of these micro-organisms are detectable and identifiable. However, “in somecases“, with the processes currently available, very small genetic modifications can be more complicated, or even impossible, to detect and differentiate from those that can occur without technical intervention on the genome. [texte] => 23 december 2025 - Since the original publication of this article in French on 16 December 2025, the legal proposal has been released by the European Commission and Inf’OGM will write an article about it by the beginning of next yearReleasing genetically modified viruses, bacteria or yeasts into the environment or industrial sectors (including agri-food) without control and without knowing the risks they may pose? This seems to be the objective pursued by the European Commission, which appears to be preparing a legislative initiative to deregulate these genetically modified micro-organisms (GMMs). At a time when multinationals are working to artificialise and gain property over living organisms, micro-organisms are clearly part of the picture. To this end, European experts are being mobilised to provide the European Commission with all the reports necessary to justify a possible proposal for deregulation. In 2025, experts from the European Network of GMO Laboratories (ENGL) delivered their report on the detection and analytical identification of GMMsi. This report only concerns the use of GMOs in food and feed, not their release into the environment (in the soil, on plants) or their use in other sectors, such as the production of agrofuels.Which products are we talking about?Prior to considering the detection and identification capabilities of GMOs obtained through new techniques of genetic modification (so-called "new genomic techniques", NGT), it is important to remember the different uses of these GMMs. The issue of GMMs in food and feed chains concerns both the GMMs themselves and the batches of products obtained from them, in the event of contamination by the producing GMM. These different situations have been summarised by the ENGL in the introduction to their report with four scenarios:Molecules produced by GMMs, purified and with no remaining trace of the GMM or its DNA (amino acids, vitamins, hormones, etc.);"Complex products" in which no trace of the GMM or its DNA is found (cell extracts, enzyme preparations, etc.);Products obtained from GMMs in which the GMM is no longer capable of multiplying, but where its DNA is still present (inactivated culture starters, "biomasses single-cell protein preparations"ii and cell extracts, etc.);Products consisting of or containing GMMs capable of multiplying or transferring DNA (live cultures for fermented foods, etc.).It is important to bear these four situations in mind from a theoretical point of view. The 3rd and 4th cases involve the presence of GMMs or their DNA. The first two cases involve their presence only in the event of contamination, due to insufficient purification of the molecules, for example, which does not rule out other possible signs of their use that are currently unidentified. In the event of commercial authorisation of molecules or GMMs themselves, the European Union will need to establish the necessary protocols for their detection and identification.Detection and differentiation are already possible in a (very) large number of casesWhen asked whether GMMs obtained through NGTs are detectable and identifiable, experts respond quite simply, stating that "the genetic modifications found in NGT-Ms are similar to those in plants obtained by targeted mutagenesis and cisgenesis, and the analytical challenges, therefore, will also be similar as well". For the ENGL, these challenges will arise "in somecases" due to detection and identification methods that "may not always meet the requirements". This rhetoric has already been adopted for the detection and identification of plants genetically modified by NGTs, which has led the European Commission to generalise "certain cases" to "all plants" modified in this wayiii.These few specific cases would be those of genetic modifications involving the change of a single nucleotide (a single building block of DNA) or "short mutations of a few nucleotides". In these cases, experts consider that the most commonly used method, PCR, which is quite old and basic, may not meet regulatory requirements, which stipulate that a method must be sufficiently sensitive and specific to a given genetic modification. They emphasise that such a PCR method would be insufficient to establish that a particular modification detected was produced by a new technique of genetic modification.For the ENGL, combining PCR with other analytical methods represents an "attractive option". For example, it explains the possibility of "whole genome sequencing (WGS) and simultaneous detection of several key targets composing a unique genetic fingerprint associated to the specific" GMM. Such an analytical approach can be used for bacteria and viruses, allowing "specific identification" of a particular strain. The same applies to analysis protocols combining complete genome sequencing and bioinformatic analysis. However, once again, experts highlight certain cases in which such analysis protocols would provide uncertain results. This is the case for "the analysis of mixed samples containing several microorganisms [which] is still very complex". Another special case is that of GMMs that have not been authorised, described as unknown, for which the ENGL considers that quantification would be very complex. However, the ENGL points out that this quantification step is not mandatory in legal procedures for regulatory measures to be taken, making this complexity of quantification an invalid argument for deregulating GMMs.Finally, the experts consider that PCR or sequencing-based methods are functionning for GMMs obtained by new techniques that are known or declared. The challenge, in their view, concerns unknown GMMs, especially those in which the genetic modification involves only a few nucleotides. A similar situation for unknown GMMs arose for transgenic plants in the early 2000s, in response to which the European Union nevertheless enacted mandatory labelling, detection and identification requirements. It had also set up a research and management programme, the Co-Extra programme, which had worked to establish protocols for identifying unknown GMMs. Such a programme could be set up and funded by the European Union for unknown GMMs.A proposal to deregulate GMMs in the pipelineThis opinion from ENGL experts is part of a wider drive by the European Commission, which appears to be gathering the reports it needs to formulate a proposal to deregulate GMOs.In August 2022, it asked the European Food Safety Authority (EFSA) to provide it with an "overview" of GMMs already on the market. This report was provided in December 2023iv. In 2022, the Commission had already mandated EFSA on the subject of the risks associated with GMMs obtained by NGTs, a mandate to which EFSA responded in June 2024v, after opening a consultation two months earliervi. The documents required by the European Commission to produce a proposal for deregulation were therefore missing an opinion from experts in GMO detection and identification.Also in 2024, the European Parliament confirmed the European Commission's position on this issue. It responded to the proposal to deregulate numerous GMO plant (including certain micro-organisms) presented in 2023 by including a request that was anything but insignificant. MEPs wrote that the "available knowledge on other organisms, such as microorganisms, fungi and animals should be reviewed with a view to future legislative initiatives on them"vii. They therefore asked the European Commission to present "a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions evaluating the specificities of and needs for other sectors not covered in this legislation, such as microorganisms, including a proposal for further policy actions"viii.i Sowa, S., Broothaerts, W., Burns, M., De Loose, M., Debode, F. et al., "Detection of microorganisms, obtained by new genomic techniques, in food and feed products", Publications Office of the European Union, Luxembourg, 2025.ii This would be, for example, the production of protein preparations obtained from the cultivation of bacteria or yeasts (unicellular organisms).iii Eric Meunier, "GMO/non-GMO equivalence: the Commission turns “certain cases” into a general rule", Inf'OGM, 17 décembre 2025.iv Eric Meunier, "Few micro-organisms modified by Crispr are already on the market", Inf'OGM, 30 janvier 2024.v EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins, E., Bresson, J.-L., Dewhurst, I. C. et al., "New developments in biotechnology applied to microorganisms", EFSA Journal, vol. 22, issue 7, e8895, 22 July 2024.vi (in French) Eric Meunier, « An ongoing public consultation on GM micro-organisms », Inf’OGM, 2 April 2024.vii European Parliament, « Plants obtained by certain new genomic techniques and their food and feed - European Parliament legislative resolution of 24 April 2024 on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (COM(2023)0411 – C9-0238/2023 – 2023/0226(COD))», see whereas 9, 24 April 2024.viii Ibid., see article 30, point 5b.Sowa, S., Broothaerts, W., Burns, M., De Loose, M., Debode, F. et al., "Detection of microorganisms, obtained by new genomic techniques, in food and feed products", Publications Office of the European Union, Luxembourg, 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [69] => Array ( [objectID] => 14369 [title] => GMO/non-GMO equivalence: the Commission turns “certain cases” into a general rule [timestamp] => 1765929600 [date] => 17/12/2025 [annee] => 2025 [url] => https://infogm.org/en/gmo-non-gmo-equivalence-the-commission-turns-certain-cases-into-a-general-rule/ [image] => https://infogm.org/wp-content/uploads/2025/12/Equivalence_of_knots.svg_.png [extrait] => The proposal to deregulate some of the GMO plants made by the European Commission in July 2023 is based in particular on the assumption that new techniques of genetic modification can produce organisms with modifications that could also be obtained using so-called "conventional" methods. To make this claim, the European Commission uses a subtle but decisive semantic abuse in its proposal… [chapo] => The proposal to deregulate some of the GMO plants made by the European Commission in July 2023 is based in particular on the assumption that new techniques of genetic modification can produce organisms with modifications that could also be obtained using so-called “conventional” methods. To make this claim, the European Commission uses a subtle but decisive semantic abuse in its proposal… [texte] => Since July 2023, the European Union has been discussing the possible deregulation of numerous GMOs. The arguments put forward by proponents of this deregulation are striking for their numerous abuses and semantic distortions. Sowing confusion and ambiguity around established concepts, these semantic abuses are used deliberately to serve a political objective aimed at deregulating a number of GMOs. After noting that the very concepts of "genetic resources", microorganisms, and even the definition of a GMO are twisted at willi, having deciphered the confusion between tools (e.g. Crispr), techniques (e.g. mutagenesis) and methods (e.g. technical protocols for genetic modification)ii, and having examined the terms precision, targeting and control of genetic modification techniquesiii, Inf'OGM addresses one of the European Commission's two central assumptions, namely the "equivalence" between GM plants and conventional (non-GM) plants."Certain cases" or all cases?In its introductory remarks explaining the reasons behind its proposal to deregulate numerous GMOs obtained using new techniques of genetic modification (referred to by the Commission as “new genomic techniques”/NGT), the Commission argues that "In certain cases, substantially equivalent plants can be obtained with conventional breeding methods and with targeted mutagenesis and cisgenesis". This argument is subtly transformed in the rest of the text, moving from "certain cases" to NGT in general. The Commission writes in recital 2 of the proposed legislation that "NGTs […] can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods or in organisms with more complex modifications".In addition to this generalisation, the use of the term "can" is also intriguing. It theoretically implies that this equivalence is not certain, or even almost improbable. There are several examples of plants that would be considered deregulated because they meet the criteria for the NGT1 category and yet could not be obtained by selection, except by waiting billions of yearsiv.Another subtle shift is the change from "substantially equivalent" to "equivalent". This wording is repeated in recital 14, which adds plants that occur "naturally" to conventional methods: "NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques ("category 1 NGT plants") should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation".Equivalence, according to the European CommissionBeyond these abuses or semantic transformations from the conditional to the affirmative, from "certain cases" to "all cases", or from "substantially equivalent" to simply "equivalent", the European Commission therefore focuses its reasoning on the concept of equivalence.Given the implications of the proposed deregulation, it is important to read the proposed definitions of equivalence carefully. For the European Commission, "a NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications"v. In simpler terms, it is different, but equivalent. It is also worth noting that what is referred to here as a "genetic modification" is a set of genetic modifications of different types. A genetic modification as stated in the definition of equivalence we have just seen can be a "substitution or insertion of no more than 20 nucleotides", a "deletion of any number of nucleotides" or insertions, substitutions or inversions of certain genetic sequences.To understand the absurdity of the reasoning proposed by the European Commission, let us consider the genetic modification of the "deletion of any number of nucleotides" type. An organism from which half of the genome has been removed in the laboratory – provided it is still viable – would therefore be "equivalent" to an organism with a complete genome, according to the European Commission…The Council of the European Union takes the same lineFor the Council of the European Union, the definition adopted in the negotiating mandate given to the country holding the Council Presidency is similar to that of the European Commission, but worsevi. For the Council, "a NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications per monoploid genome". This clarification "per monoploid genome" means that, in the case of wheat for example, the number of genetic modifications included in the equivalence is no longer 20 but 120 (wheat has six copies of the genome or, in other words, six haploid genomes).The European Parliament takes a hard lineFor its part, the European Parliament has taken the argument to a rather unimaginable level. It states that "a NGT plant is considered equivalent to conventional plants if [...]The number of the following genetic modifications, which can be combined with each other, does not exceed 3 per any protein-coding sequence"vii. What are referred to as "coding sequences" can be equated – for purely mathematical purposes – with the number of genes. In the case of maize, which contains 32,000 identified genes, the European Parliament therefore considers that a plant containing up to 96,000 genetic modifications would be equivalent to maize without genetic modification. If a genetic modification can be a substitution of 20 nucleotides, corn undergoing 96,000*20, or 1,920,000 nucleotide substitutions, will be declared "equivalent" to corn without genetic modification... Wheat, on the other hand, contains more than 100,000 genes, so 300,000 genetic modifications would be tolerated in deregulated GMO/NGT1 wheat, equivalent to 6,000,000 nucleotide substitutions to claim equivalence with non-genetically modified wheat...This calculation can be roughly made today, but will potentially be even higher tomorrow, as the number of known coding sequences evolves with research, following the example of micro coding sequences that were still little known, if not unknown, ten years ago.Deregulating a GMO wheat on the principle that it is, or may be, "equivalent" to conventional or natural wheat is, semantically speaking, a tour de force: declaring two fundamentally different plants to be equivalent. And even then, only in terms of genetic sequences, since legislators do not seem to be interested in epigenetic modifications, for example!It is also interesting to note an additional paradox of pro-deregulation European legislators. All GMOs that are declared deregulated will have to be reported to the authorities. However, the authorities will have no way of verifying the claims made by multinational companies, as the Commission's proposal does not make it mandatory to provide methods for detecting and identifying the genetic modifications that have been made. It considers that "in certain cases, genetic modifications introduced by these techniques are indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques"viii. The European Union would therefore choose to blindly trust multinationals to decide whether to deregulate a GMO…i Eric Meunier, "More words, always words…", Inf'OGM, 7 November 2025.ii Eric Meunier, "When lexical confusion serves political purposes", Inf'OGM, 12 November 2025.iii Eric Meunier, "Directed, targeted, precise mutagenesis… Are these adjectives misleading?", Inf'OGM, 17 November 2025.iv Frédéric Jacquemart, President of the International Group of transdisciplinary studies (Groupement International d’Études Transdisciplinaires (GIET)), « Note pour le ministère de l’Agriculture », February 2025.v European Commission, « ANNEXES to the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 », 5 July 2023.vi Council of the European Union, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 », 7 March 2025.vii European Parliament, « Plants obtained by certain new genomic techniques and their food and feed European Parliament legislative resolution of 24 April 2024 on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) », 24 April 2024.viii Whereas 7, European Commission’s proposal of July 2023 :European Comission, « Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 », 5 July 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [70] => Array ( [objectID] => 14352 [title] => Pairwise shapes the food of the future with NGT [timestamp] => 1765756800 [date] => 15/12/2025 [annee] => 2025 [url] => https://infogm.org/en/pairwise-shapes-the-food-of-the-future-with-ngt/ [image] => https://infogm.org/wp-content/uploads/2025/12/w30-gene-edited-greens-768x512.png [extrait] => While the European Commission is attempting to deregulate new genome modification techniques (NGT), the US company Pairwise is multiplying its "partnerships" combining the Crispr/Cas tool and its Fulcrum platform. Concluded with both private and public players, these agreements anticipate the landscape following the potential deregulation of NGT. They will also influence the conditions for the dissemination of NGT and the arrival of "Pairwise-type" products on our plates. [chapo] => While the European Commission is attempting to deregulate new genome modification techniques (NGT), the US company Pairwise is multiplying its “partnerships” combining the Crispr/Cas tool and its Fulcrum platform. Concluded with both private and public players, these agreements anticipate the landscape following the potential deregulation of NGT. They will also influence the conditions for the dissemination of NGT and the arrival of “Pairwise-type” products on our plates. [texte] => In November 2025, Pairwise signed a licensing agreement with the International Rice Research Institute (IRRI) to allow the institute to use its patented CRISPR/Cas tool. This agreement is one of many1 concerning the Crispr tool, for which Pairwise itself holds an exclusive licence from Massachusetts General Hospital (MGH) for the development of agricultural applications2. Through its Fulcrum platform, using its own Crispr SHARC enzyme, Pairwise claims to be "developing new traits quickly without creating GMOs". These promises are misleading from a European legal standpoint (these are GMOs), reinforced by an aggressive marketing strategy and rhetoric promoting the desire to "build a better food system".Marketing focus, denatured products and partnerships galorePairwise was co-founded in March 2017 by Tom Adams, a former Monsanto executive, Feng Zengh of the Broad Institute, one of the first researchers to work on Crispr, and other scientists (from Harvard Medical School, MGH, etc.) with the aim of developing the use of Crispr in agriculture. But with hindsight, "product marketing" seems to have taken precedence over any desire to improve the food system.Since its initial collaboration with Bayer in November 2019 to create new varieties, Pairwise has been developing genetically modified plants using new genomic techniques protected by its patents. The company's goal is to market foods presented as "innovative", such as Norfolk Plant Sciences' purple tomato3. These foods have unnatural characteristics "for consumers seeking variety in produce", says Pairwise. In April 2020, Pairwise established its first partnership with Plant Sciences to create various GMO berries, including black raspberries, "which naturally have five times more antioxidants than blueberries... and, when genetically modified, expand growing seasons and enable year-round production".In May 2023, the company launched its Fulcrum platform, which it describes as "using Pairwise developed genetic editing tools, artificial intelligence and a library of traits and expertise". Through this platform, Pairwise licenses Crispr patent rights, which it owns or controls, to multinationals such as Corteva and Bayer. In August 2023, Pairwise established a collaboration with Bayer, which will result in a first product in May 2024: a blend of salad mustard varieties that will reduce the wasabi taste of raw leaves. "Pairwise created a new product for consumers who prefer a less-pungent taste but still want the nutrition of fresh mustard greens", says the Durham, North Carolina-based company, confirming once again its strategic choices.Pairwise is continuing this approach, announcing in June 2024 that it has developed the first seedless blackberry via its Fulcrum platform. While the natural antioxidant medicinal properties of blackberries are highlighted, Pairwise's main selling point is their pleasant taste: "Blackberries are a snackable fruit with significant health benefits; however, data indicates that more than 30% of berry buyers do not like the seeds, and many more do not even buy the fruit because of the seeds." In September 2025, Pairwise confirmed this by announcing a "strategic partnership with Sun World International to develop the Holy Grail of fruits and vegetables: the pitless cherry." In mid-November 2025, it granted a new licence for its Fulcrum platform to the Dutch company Enza Zaden for the development of "novel crop varieties and sustainable farming practices".Resolutely strategic institutional links Perhaps with a view to "building a better food system", Pairwise has for some time been establishing agreements with other types of actors, notably public research centres that are members of CGIAR (Consultative Group on International Agricultural Research), an intergovernmental organisation for joint (public and private) research4. Another agreement concerning yams was concluded in Africa with the International Institute of Tropical Agriculture (IITA) in October 2024, with the assistance of the Gates Foundation5. In June 2025, the International Maize and Wheat Improvement Centre (CIMMYT), based in Mexico City6, obtained a licence for the Fulcrum platform "for the development of improved crop varieties for smallholder farmers" accross 20 countries where CIMMYT implements food security programmes. The crops concerned include maize, wheat, sorghum and important regional staple foods such as pearl millet, finger millet, cowpea and groundnut.The most recent agreement was signed in November 2025. Pairwise signed it on rice with the IRRI, a core member of CGIAR. This consortium of 15 public research centres is one of the historical pillars of global agronomy. It was built on the principle of open access to biological resources and agronomic innovations. The introduction of Crispr and Pairwise's Fulcrum platform – both patented – into its operations therefore marks a significant and worrying shift. However, the use of patented technologies runs counter to the spirit of openness and free access that has historically guided the CGIAR.Through IITA, IRRI and CIMMYT, the entire CGIAR network is exposed to new patent-licensed genetic modification techniques. This could also indirectly affect another CGIAR member, CIRAD, a French public organisation focused on agriculture in the Global South. This development raises questions about the policy pursued by this network, which has historically been built around knowledge sharing, germplasm circulation7 and free innovation rather than industrial property rights.Pairwise is looking ahead to the Europe of NGTs...The subject of patents occupies a major place in the ongoing trilogue on the deregulation of GMOs/NGT between the European Commission, the Parliament and the Council of the EU: the patentability of GMO products obtained via NGT, the impact of patents on small and medium-sized seed producers and farmers, and the risk of concentration of patent rights among a few multinationals. Pairwise is at the crossroads of these issues. It holds a significant patent position on CRISPR, grants licences to private and public partners, and is thus positioning itself as a technology platform that may become difficult to circumvent.The simultaneity of the acceleration of the above-mentioned agreements and the European debates gives particular meaning to Pairwise's initiatives. Even without an explicit causal link, the US company is strengthening its presence, particularly in Europe (Corteva, Bayer), at a time when the rules of the game for GMOs/NGT are being revised. This dynamic corresponds to well-known mechanisms in regulatory economics. In periods of transition, actors establish alliances, build systems and create contractual relationships that subsequently become difficult to undo.... and is positioning itself as a future leader in the sectorToday, questions remain. With regard to the agreements relating to the Fulcrum platform, particularly those binding CGIAR members, questions arise concerning the ownership of the results of research on different crops and their industrial exploitation. Pairwise could, through specific contractual clauses, strengthen its intellectual property rights over several plant traits.Furthermore, if the Fulcrum platform were to become more widespread, would it eventually become the "standard" in the development of GMO products derived from NGT, thus positioning Pairwise as a major player in the sector? Finally, by developing fruits without seeds or pits, which are therefore unable to reproduce naturally, Pairwise is challenging the very concept of natural plant reproduction by using genetic modifications via technical protocols that are still far from being fully mastered. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [71] => Array ( [objectID] => 14334 [title] => Will satellites save agriculture? [timestamp] => 1765411200 [date] => 11/12/2025 [annee] => 2025 [url] => https://infogm.org/en/will-satellites-save-agriculture/ [image] => https://infogm.org/wp-content/uploads/2025/12/North_Caucasus_Agriculture_Russia_by_Planet_Labs-768x576.jpg [extrait] => "How can we feed 10 billion people in 2050 with limited natural resources? To address this challenge, agritech start-ups are capitalising on the latest research findings to offer disruptive innovations and provide more efficient and environmentally friendly solutions" . This is how agritech is presented by BPI France, the French public investment bank. Once again, we see the famous promise to feed the world. To achieve this goal, we need to innovate, invest, digitise, robotise... [chapo] => “How can we feed 10 billion people in 2050 with limited natural resources? To address this challenge, agritech start-ups are capitalising on the latest research findings to offer disruptive innovations and provide more efficient and environmentally friendly solutions” . This is how agritech is presented by BPI France, the French public investment bank. Once again, we see the famous promise to feed the world. To achieve this goal, we need to innovate, invest, digitise, robotise… [texte] => Behind agritech lies an alliance between companies specialising in seeds, agricultural machinery, geospatial technology (GPS), weather forecasting, nanosensors, satellites, digital data storage (data center) and algorithms, all of which are essential for analysing billions of pieces of data in record time. These links take many forms, ranging from partnerships to mergers and acquisitions. But the general idea is to collaborate to build the agriculture of tomorrow, agritech, which dreams of doing away with farmers altogether. In this article, we will describe examples that illustrate this alliance.Robots to make agriculture greener, really?The robotisation of agriculture is one of the European Union's objectives. It has decided to inject €2.3 million into the AgRoboConnect project. The latter's ‘objective is to support farmers in adopting robotic weeding systems for more efficient and sustainable agricultural practices’. The rhetoric of precision as a guarantee of sustainability is at the heart of this vision, which aims to transform global agriculture. This programme is just one example among many. The sums committed at various levels are considerable.In this technophile project, the best-known example is the use of geolocation tools embedded in agricultural equipment (tractors, combine harvesters, etc.). Indeed, in the "utopia" of multinational agricultural companies, machines are supposed to become autonomous and, to do so, they need to "know" the exact contours of the fields, and even more importantly, the spacing between rows, etc. John Deere is a pioneer in this field. It was one of the first to offer tractors and combine harvesters equipped with sensors.It continues to invest in this field, as evidenced by a "strategic partnership" with the Swiss company Leica Geosystems1, a subsidiary of the Swedish group Hexagon AB2, signed in 2024 to remain at the cutting edge of technology and hopefully distance itself from its competitors. Leica Geosystems is a company that designs, manufactures and markets GPS devices, total stations3 and 3D scanners45. John Deere also needs to analyse its data, which is not its core business. It has therefore partnered with Trimble6. But John Deere also needs to store its data in order to use it. To do this, it has partnered with Amazon through its subsidiary Amazon Web Services (AWS)7. In the field of robotics, KWS, an international seed company, is collaborating with the start-up EarthSense, which markets TerraSentia, an autonomous robot equipped with cameras and guided by GPS to analyse plants in the field and, according to them, "improve varietal selection through AI".In France, similar alliances also exist. RAGT, a seed company, has, for example, launched the KAFE Challenge project, in conjunction with Agreenculture8. This project focuses on demonstrating the feasibility of strip cropping. Marketed as an agroecological practice, it involves cultivating a 40-hectare plot by alternating different crops in strips, such as barley, maize, field beans and soya. The seeds are, of course, supplied by RAGT. To achieve this, the project combines a number of technologies. It is developing robots for use in agriculture. These robots are described as ‘intelligent’ and the company claims that they can be controlled remotely (up to 600 km away) and can analyse data collected in the field in real time (phenotyping, disease detection, yield estimation) using image recognition algorithms, among other technologies. For this company, it is a revolutionary and environmentally friendly solution thanks to ‘ultra-precision in field operations and optimised use of inputs’.Firstly, it should be noted that this company has not yet provided any precise figures on the reduction of inputs on a plot of land in France. However, assuming that all these techniques make it possible to reduce the amount of herbicide sprayed, the question that needs to be asked is: how much energy and greenhouse gases have been saved compared to the amount needed to produce these machines and process the digital data? In 2025, data centres accounted for around 2% of global electricity consumption, or around 415 terawatt hours (TWh) per year, and generated nearly 171 million tonnes of CO2 per year worldwide, equivalent to the annual emissions of a country such as the Netherlands. Even more worrying is the fact that the electricity consumption of data centres is increasing by around 12% per year and could therefore double by 2030. Not to mention their considerable water consumption: by 2025, data centres are expected to use between 300 and 400 million cubic metres of water worldwide, which is equivalent to the annual drinking water consumption of a city with a population of 10 to 15 million9. So, are AI-controlled robots environmentally friendly?Satellites and AI to monitor cropsAWS is omnipresent in today's digital landscape. The company has formed partnerships with Bayer and many other companies in the agricultural sector. For Bayer, AWS supports its ability to use artificial intelligence (AI): "Bayer Crop Science sees generative AI as a catalyst enabling thousands of its scientists and data engineers to build innovative agricultural solutions for farmers around the world". To realise its ambitions, the agricultural division of the multinational life sciences company Bayer, which accounts for around a third of the German group's turnover (€5 billion), is developing a new data science platform based on Amazon SageMaker Studio (AWS), explains Will McQueen, Head of Data Assets for Crop Science at Bayer. Equipped with the AI capabilities of Amazon Bedrock and Amazon Q, the platform has been designed to facilitate and accelerate the creation of "unprecedented" agricultural products, according to the manager10. In 2015, Bayer had already acquired the Zoner geo-information system from Canada's Calgary IntelMax, which is designed to provide farmers with recommendations based on analyses of data from their plots.Let's continue to examine the Bayer case. Still in the field of artificial intelligence, the multinational also has a strategic partnership with the start-up Iktos. The latter specialises in AI-assisted molecule design11. Bayer has also acquired proPlant, a software company specialising in health diagnosis and crop pest alert applications12. This company has since been renamed Bayer Digital Farming GmbH.We can also cite a few alliances and partnerships formed by Syngenta in the field of agritech, to show that this is a general trend among multinational seed companies. In 2025, it renewed and expanded its partnership with Planet Labs, a provider of daily satellite images which, according to the company's advertising, are accurate to within three metres. These images are integrated into Syngenta's Cropwise digital platform. The aim is to enable farmers to monitor the condition of their fields remotely and, in theory, detect infestations or diseases at an early stage. Syngenta is also collaborating with xFarm Technologies on the same type of application. Finally, there is Heritable Agriculture, a spin-off of Google X (Alphabet) specialising in the use of AI in agriculture. In 2025, Syngenta signed a partnership with this company to apply "artificial intelligence" to vegetable variety selection. The idea is to collect large amounts of data, store it and analyse it. This data comes from field trials, weather and environmental data. When signing this alliance, Syngenta emphasised that it would enable it to ‘predict’ the performance of vegetable varieties based on geographical and climatic conditions. Nothing less. Syngenta has created a venture capital fund, Syngenta Group Venture, which allows it to invest in numerous start-ups in the agritech constellation.This non-exhaustive list of interconnected companies paints a picture of soil-less agriculture that is part of a rapid artificialisation of living things. Listening to living things, feeling them, sensing them cannot be done through data and computer screens. These tools and this digitisation distance farmers from reality and gradually transform them into mere tools themselves. They are merely the arm that operates a joystick, waiting for algorithms to dictate the treatments to be carried out. This dynamic is part of a larger movement of uprooting, enlargement of farms and the gradual disappearance of farmers. Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [72] => Array ( [objectID] => 14308 [title] => In the face of technological development, should we take the time to reflect on the bigger picture? [timestamp] => 1765411200 [date] => 11/12/2025 [annee] => 2025 [url] => https://infogm.org/en/in-the-face-of-technological-development-should-we-take-the-time-to-reflect-on-the-bigger-picture/ [image] => https://infogm.org/wp-content/uploads/2025/12/No_Chaos_-_acrylic_painting_on_paper_-_abstract_art_made_in_2007_by_Dutch_painter_Fons_Heijnsbroek.tif.jpg [extrait] => The development of GMOs, of the digitisation of living organisms and of the "biocontrol" are indicators of multinationals' growing ambitions to appropriate living organisms, but not only. It is also, if not above all, a technological development which, once adopted, has a major impact on the global system that constitutes our societies and their environment. The changes are so significant that Frédéric Jacquemart refers to them as "systemic disruptions". These disruptions should motivate our societies to adopt a global approach in order to better prepare and accept the necessary emergence of other "viable structures", to use his wording. [chapo] => The development of GMOs, of the digitisation of living organisms and of the “biocontrol” are indicators of multinationals’ growing ambitions to appropriate living organisms, but not only. It is also, if not above all, a technological development which, once adopted, has a major impact on the global system that constitutes our societies and their environment. The changes are so significant that Frédéric Jacquemart refers to them as “systemic disruptions“. These disruptions should motivate our societies to adopt a global approach in order to better prepare and accept the necessary emergence of other “viable structures”, to use his wording. [texte] => Technologies generate increasingly powerful means of action on the systems in which we live. However, the assessment of the effects of these technologies is limited to the direct consequences of their products (e.g. a GMO on a particular group deemed relevant, such as a laboratory rat clone, the Eisenia fetida worm, etc.).Complex systems, such as ecosystems and societies, are maintained through their organisations, which have been built up step by step over the course of evolution. Artificially modifying these organisations creates a major risk, which can even threaten the very survival of these systems, of which we are a part. However, this issue, which surpasses all others in importance, is simply not taken into account in the current assessment of technological risks!For forty years, Frédéric Jacquemart has been desperately arguing that technology should no longer be developed blindly with regard to what constitutes our common destiny.A first example of this global, systemic approach was given in the opinion piece "Biodiversity and stability of natural systems: what are the impacts of GMOs?"i. Today, Inf'OGM is publishing a second opinion piece, introducing another aspect, this time societal, of this blind technological production. It is not intuitive that GMOs could contribute to a surge in systemic violence, and yet...Introductory note on the global (systemic) approach to disruptive and reactive violenceAuthor's note: this note is extremely short and therefore inevitably appears simplistic and dogmatic. Its purpose is not to demonstrate, but merely to draw attention to this global, systemic approach, which can be developed and justified at length.We live in complex adaptive systems (ecosystems, societies, etc.) on which we are totally dependent. These systems can be represented by networks of interactions between elements. This is an approximation, but it is already very useful.These systems, which arise from the interactions between elements, have their own dynamics, organisation and evolution. These dynamics, organisations and evolutions are not the sum of individual interactions, but are a (strong) emergence from these interactions, which cannot be reduced to them.In return (recursively), the organisations of the systems act on the elements and their connections, thus enabling the system to continue.Primate groups are limited in number. Groups of "native" humans are limited to an average of 150 individualsii. Beyond that, there is division. However, we live in societies of tens of millions of individuals. Therefore, to ensure the cohesion of such societies, many things must be shared: language, symbols, customs, beliefs, stories, ethics, values, institutions, education, etc., at all levels (fractal organisation) and in a consistent manner.These systemic constraints on individual behaviour are extremely strong, but this does not detract from free will, which, on the contrary, is made possible by these restrictions, without which humanity would not exist. Even groups smaller than the "Dunbar number" have collective constraints. Moreover, on our scale, the space for freedom within these constraints is enormous. We are not slaves to the system. In the same way, gravity is a constraint imposed on all bodies, but it is permissive of life and allows immense freedom. Having to breathe is also a constraint, and so oniii.Very importantly, as we shall see, the vast majority of this coherence is necessarily achieved through the unconscious.The framework for this discussion is based on the evolution of Western culture or civilisation (globalised, which is important). In order to represent it quantitatively on a graph, discrete parameters are requirediv. We can use very significant and structuring technological developments, such as the power of microprocessors (Fig. 1) or artificial intelligence (AI) (Fig. 2), or the evolution of a global result of technological development such as demographics (Fig. 3). Broadly speaking, and this will come as no surprise to anyone, this evolution is roughly exponential. This means that after a very long period of very little change (on a global scale), there is a phase of very rapid growth, which tends towards infinity. We are at the point on the curve where the rate of growth is enormous and where even a tiny advance in time leads us to infinity, which is clearly unreachable. This fact has been highlighted by many people, but has not been taken into account by decision-makers (nor by most NGOs, for that matter...). Yet it clearly means that the cultural engine of this civilisation (once again, globalised) is inevitably crumbling. It can be shown that this process of crumbling is already underway.Whether one values the principles and other elements that have sustained it (work, family, homeland, patriarchy, etc.) or rejoices in seeing them crumble, in any case, it is not a choice: Western civilisation is coming to an end and there is no way to save it. The question is therefore not one of choice, but rather of preserving the possibility of allowing one or more other civilisations to emerge, and this possibility depends on preventing the reactionary violence generated by the systemic disruptions resulting from these profound changes.Without going into detail, let us take the example of the unprecedented increase in the speed of change of society. Faced with such changes, not everyone reacts at the same speed or in the same way. And this is true in different contexts: some people will be very comfortable and will even demand faster computers or AI, but will be uncomfortable with changing social mores, for example. The speed of evolution of a complex system is not a descriptive parameter, but a component of the organisation of the system itself. Significantly accelerating or slowing down such a system disrupts its organisation, to the point of possibly destroying it. Here, this leads to the breakdown of the bonds that generate the organisation of society and the formation of new ones, with the creation of islands that are increasingly separated from each other, generating their own ethics, language, myths, etc. The alteration of sociological coherence processes means that, even though we are only at the beginning of this process, many countries have already become ungovernable and new forms of violence are taking hold: clan violence caused by systemic disruption and violence with no other motive than a visceral reaction to a loss of being meaning.Let us not forget that the dynamics of social systems are expressed through the unconscious of individualsv. The erosion of the system unconsciously pushes individuals towards violence, which in turn increases the erosion. Positive feedback loops quickly become uncontrollable: this is a matter of major urgency.Even though the unconscious accounts for the vast majority of intellectual activity and often prepares and makes decisions, the conscious mind interacts closely with it (again, recursion). Without going into this area, which is very important to our subject, let us say that the conscious mind has the ability to become aware of the unconscious's output and can oppose it, at least in some cases. If we understand, even roughly, how society functions as a complex system and that its evolution normally generates violent impulses, we can recognise and reject these impulses when they arise. This will not hinder the process of erosion of the current dominant culture, but it will allow us to move on to other viable structures. What's more, it will enable us to enjoy what will undoubtedly be a complicated but exciting phase of cultural metamorphosis.NB: we have called this exciting adventure "the great epic" and introduced it in a video. You can contact the author at grandeepopee@orange.fr.Figure 1: Evolution of microprocessor power.Figure 2: Evolution of AI based on three parameters.Figure 3: evolution of global demography since the Neolithici Frédéric Jacquemart, "Biodiversity and stability of natural systems: what are the impacts of GMOs?", Inf'OGM, 26 November 2025.ii Dunbar, R.I.M., "Neocortex size as a constraint on group size in primates", Journal of Human Evolution 22(6), pp. 469–493, 1992. There is a wealth of literature on this subject following this article.iii For further reading (and improvement), see the important concept of "enablement" by Giuseppe Longo and Maël Montévil:Giuseppe Longo, Maël Montévil, "Extended criticality, phase spaces and enablement in biology", Chaos, Solitons & Fractals, Emergent Critical Brain Dynamics, 55, pp.64-79, 2013.iv Parameters in the common sense of the term, not mathematical.v This refers to the unconscious in neuroscience, which differs from that in psychology and psychoanalysis. Frédéric Jacquemart, Groupe International d'Études Transdisciplinaires (GIET) [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [73] => Array ( [objectID] => 14282 [title] => Mon810 maize and teosinte: hybridisation still unmonitored [timestamp] => 1764892800 [date] => 05/12/2025 [annee] => 2025 [url] => https://infogm.org/en/mon810-maize-and-teosinte-hybridisation-still-unmonitored/ [image] => https://infogm.org/wp-content/uploads/2025/11/GMO_maize_test_11-768x512.jpg [extrait] => For several years, EFSA and ANSES have been asking Bayer to monitor the emergence of teosinte, the wild ancestor of maize, in fields cultivated with Mon810 maize in Portugal and Spain. In 2023, the company was still not doing so. However, the presence of teosinte in Europe has been confirmed. A scientific study has even shown experimentally that the Mon810 transgene can be transmitted from maize to teosinte plants collected in Spanish fields. The production of transgenic insecticidal protein is therefore not under control. [chapo] => For several years, EFSA and ANSES have been asking Bayer to monitor the emergence of teosinte, the wild ancestor of maize, in fields cultivated with Mon810 maize in Portugal and Spain. In 2023, the company was still not doing so. However, the presence of teosinte in Europe has been confirmed. A scientific study has even shown experimentally that the Mon810 transgene can be transmitted from maize to teosinte plants collected in Spanish fields. The production of transgenic insecticidal protein is therefore not under control. [texte] => In 2023, Mon810 genetically modified maize, modified to express the Cry1Ab insecticide protein, was grown on 46,327 hectares in Spain and 1,898 hectares in Portugal. The cultivation of this maize was authorised in the European Union in 1998 for a period of ten years. Since then, it has remained legal due to a request for renewal of authorisation submitted by Bayer in 2007, to which the European Commission has not responded, a lack of response effectively amounting to an extension of the authorisation. Crops in Spain and Portugal are subject to annual environmental monitoring reports, which are reviewed each year by European and French expert committees. These reports reflect the experts' concerns, repeated year after yeari, about the lack of adequate monitoring of this teosinte in Mon810 maize fields.In Europe, teosinte can acquire the Mon810 maize transgeneThe experts' concerns were reinforced in 2024 by the publication of a Spanish scientific articleii. This article is in line with studies on the occurrence of crossbreeding between transgenic and non-transgenic maize initiated by Quist and Chapela in 2001, when they detected the presence of Bt transgenes in local Mexican maize varietiesiii.In the 2024 article, as reported by ANSES in its opinion published in early 2025iv, Spanish scientists demonstrate "the production of the Cry1Ab protein and resistance to target insects in hybrid plants resulting from spontaneous crosses between MON810 maize and teosinte collected in Spain". Indeed, after collecting teosinte plants in Spain and crossing them experimentally with MON810 maize over a three-year period, these scientists claim to have obtained crosses within a year that are capable of killing insects by producing Cry1Ab protein.For the European Food Safety Authority (EFSA)v, these results "suggest that the potential for hybridisation between maize MON 810 and teosinte may be higher than previously assumed under experimental conditions". They add that these teosinte/Mon810 maize hybrids can produce viable seeds and have a selective advantage over teosinte plants. However, they believe that further studies are needed ‘under real-life conditions’ to establish whether "the acquisition and expression of the cry1Ab gene in teosinte/maize hybrids could enhance their persistence or invasiveness". As for whether this introduces an additional risk to target and non-target organisms of the transgenic Cry1Ab protein, the answer will depend on the results of a study to be conducted, if it is conducted…It is indeed conceivable that if plants in nature start producing insecticide, the total amount of insecticidal protein will no longer be controlled (if it is controlled in GMO fields). Some areas would see insects exposed to quantities greater than the lethal dose to kill 50% of the exposed population (LD50), while other areas would see this quantity fall below the LD50. Such a situation could lead to the emergence of insects that have developed resistance to the insecticidal protein. In other words, insects resistant to Bt maize would be selected, which would deprive farmers of the use of natural Bt bacteria, authorised in organic farming, and encourage the proliferation of Bt teosinte in maize crops, at the risk of banning all “non-GMO” or organic maize cultivation. Breeders would be deprived of the use of teosinte to incorporate its hardiness traits into new non-GM varieties. Such contamination could also irreversibly disrupt the balance of biodiversity.Experts remain critical of Bayer's practicesThe problem is that the concerns raised over several years about the presence of teosinte in Spain and, since this scientific article was published in 2024, the proven ability of these teosintes to acquire the Mon810 transgene, do not seem to have been heard by Bayer, which, in turn, is doing nothing about it.ANSES points out, for example, that the company no longer surveys Portuguese farmers growing Mon810 maize, but only Spanish farmers. This is a practice that ANSES, like AESA, does not approve of, as it states that it would like the questionnaire developed by Bayer for farmers "to also be submitted to Portuguese farmers, since growing conditions, and therefore effects, may differ between Portugal and Spain". As for the questions asked to Spanish farmers, these same experts explain that farmers "must indicate whether the five most abundant weeds in their MON810 maize fields are different from those identified in conventional maize crops". This is an inadequate question, since it does not allow for the identification of teosinte if it is not one of the five most abundant weeds in Mon810 maize fields. ANSES and EFSA are therefore once again calling for "the presence of teosinte to be the subject of a specific and explicit question in the questionnaires sent to farmers".However, this information, which has not been collected by Bayer, forms the basis of the more specific monitoring work recommended by the experts. As the EFSA points out, "this lack of new data limits the ability to test specific risk hypotheses within the established pathways to harm, and to confirm or refute previously established assumptions in the ERA and risk management of maize MON 810". For French and European experts, the presence of teosinte should be specifically taken into account in cases of MON810 maize cultivation because it can crossbreed with maize. This should translate into:monitoring for possible dispersion of the Cry1Ab transgene, a possible cross between maize and teosinte which, according to ANSES, could ultimately lead to "a flow of the transgene into conventional maize varieties",- and monitoring for the appearance of "hybrid plants in refuge areas, which could compromise the effectiveness of a strategy to prevent the development of resistance to the Cry1Ab protein in insects".In summary, ANSES requests that "the presence of teosinte, and where applicable the surface area of these populations, as well as the presence of the cry1Ab transgene within these populations, be taken into account by the authorisation holder in its monitoring plan for MON810 maize".For its part, Bayer, as reported by ANSES and EFSA, considers that the appearance of teosinte is a general agronomic problem affecting all types of maize cultivation. Reading the ANSES, the company therefore concludes that "a report on the emergence or occurrence of teosinte in the context of the safety assessment of MON810 maize is not justified".Risks ahead?The experts' concerns relate to potential risks that are fairly easy to imagine in the event of transfer of the Mon810 transgene to teosinte present in Mon801 maize fields, especially if teosinte populations were to grow in these fields in the coming years.One of the problems is that such a transfer could give teosinte plants insecticidal properties, as shown in a Spanish scientific article published in 2024. This situation would be all the more worrying given that these insecticide-producing teosinte plants could in turn spread and transmit the transgene to other non-transgenic maize plants. Ultimately, the production of transgenic protein would be amplified, as would, logically, the quantities of insecticidal protein present in the environment. In some places, it could be found in quantities greater than those anticipated when commercial cultivation was authorised in 1998. Non-target insects could then be impacted and killed by this protein. In other places, it could be found in insufficient quantities. In this case, target insects could have the opportunity to adapt and develop resistance.The company's reaction – or lack thereof – is surprising. While the European Union is seeing its teosinte population increase and researchers have shown that it is possible to transfer a transgene from GMO maize to these teosintes, the company has chosen to do nothing. This lack of response could allow a larger-scale agronomic problem to develop, providing an opportunity to promote new genetically modified plants as a solution…i Eric Meunier, « Problems ahead due to cultivation of GMO maize in Europe? », Inf'OGM, 6 February 2024.ii Arias-Martín M, Bonet MCE and Beldarraín IL, « Teosinte introduced into Spain and Bt maize: hybridisation rate, phenology and cry1ab toxin quantification in the hybrids », Revista de Ciências Agrárias, n°47, pp. 297-301, 2024.iii David A. Cleveland et al., « Detecting (trans)gene flow to landraces in centers of crop origin: lessons from the case of maize in Mexico », Environ. Biosafety Res., n°4, pp.197–208, 2005.iv Anses, « Note d’appui scientifique et technique (AST) de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (Anses) relative à la demande de commentaires sur le rapport annuel (2023) de surveillance environnementale de la culture du maïs génétiquement modifié MON810 en Espagne et au Portugal », 8 January 2025. v EFSA (European Food Safety Authority), Messéan, A., Álvarez, F., Devos, Y., Sánchez-Brunete, E., & Camargo, A. M., « Assessment of the 2023 post-market environmental monitoring report on the cultivation of genetically modified maize MON810 in the EU », EFSA Journal, 23(8), e9613, August 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [74] => Array ( [objectID] => 14278 [title] => NGT regulations: trilogue of the deaf under pressure from Denmark [timestamp] => 1764633600 [date] => 02/12/2025 [annee] => 2025 [url] => https://infogm.org/en/ngt-regulations-trilogue-of-the-deaf-under-pressure-from-denmark/ [image] => https://infogm.org/wp-content/uploads/2025/11/3982526653_2eb5b8b400_c-768x432.jpg [extrait] => Negotiations on the future European regulation on new genetic modification techniques have been focusing on two sensitive issues for several months: patentability and sustainability. Keen to conclude the dossier before the end of the year, the Danish Presidency is stepping up efforts to find a compromise, at the risk of neglecting issues that are of particular concern to small and medium-sized breeders and farmers. Denmark will seek an agreement this week, having already threatened to freeze discussions and refer the text back to the European Parliament for a second reading. [chapo] => Negotiations on the future European regulation on new genetic modification techniques have been focusing on two sensitive issues for several months: patentability and sustainability. Keen to conclude the dossier before the end of the year, the Danish Presidency is stepping up efforts to find a compromise, at the risk of neglecting issues that are of particular concern to small and medium-sized breeders and farmers. Denmark will seek an agreement this week, having already threatened to freeze discussions and refer the text back to the European Parliament for a second reading. [texte] => In July 2023, the European Commission proposed deregulating many GMOs derived from new genetic modification techniques (NGT). Since then, the Commission, the European Parliament and the Council of the European Union have been engaged in negotiations known as "trilogue". These negotiations are currently stalled on two points where there is still no consensus – patentability and sustainability – as revealed in an informal document ("non-paper") from the Danish Presidency of the Council, dated 24 October and obtained by Inf'OGM. The positions of the Parliament on the one hand, and the Council and the Commission on the other, remain far apart despite concessions made by MEPs. However, Denmark wants an agreement on these two points to be reached before the end of the year. To this end, it is threatening to halt the trilogue and send the text directly back to Parliament for a second reading if MEPs do not give in on patents, labelling and traceability. Denmark believes that a majority, with the support of the far right, would then back the Council's positioni .The positions of the players on 'sustainability'Initially, the negotiations were to focus on the two key points voted on by Parliament: traceability and a ban on patents on NGT1. In addition to criteria related to the genetic nature of the modifications themselves, the Renew group in Parliament wants deregulated status (NGT1) to be granted only if the “sustainability” of GM plants that can be deregulated is demonstrated using measurable criteria, which are still very broad at this stageii . This introduces a third front which, if the Council accepts a compromise on this point, risks forcing the Renew group to vote in favour and thus abandon the issues related to labelling and patents. A company would therefore have to officially declare that its plant meets these criteria, provide data to prove it, and agree to random checks by the authorities to verify that these declarations are accurate. The Danish Presidency and the Council are asking that the NGT1 deregulated status not include this "sustainability" criterion but be based solely on the presumed equivalence of the GMO/NGT1 plant with a plant obtained through conventional breeding, as they fear that additional checks would complicate the procedure.Three approaches remain under consideration for these sustainability criteria:a list of positive traits (NGT1 status granted if at least one trait is sustainable),a list of negative traits (NGT1 status granted to the exclusion of certain traits, such as herbicide resistance),or an incentive-based system (NGT1 status not conditional on sustainability, but positive traits would give rise to incentives).We can assume that "incentives" refers to a system in which sustainability is not a mandatory condition for NGT1 status, but where advantages (faster procedures, reduced costs or easier market access, etc.) would be granted to actors who develop plants with characteristics deemed sustainable.In short, Parliament wants to make NGT1 status conditional on measurable sustainability criteria, verified by data and controls. The Commission prefers an incentive system where sustainability is not mandatory but "rewarded", while the Council wants to base NGT1 status on equivalence with conventional breeding.For its part, the European Coordination Via Campesina (ECVC) points out that "Sustainability can never be reduced to a single genetic trait : on the contrary, it is always polygenic and, of course, depends on the agricultural model and the territories in which the plant is cultivated”. It sets out its position in a note in which it establishes a list of non-sustainable traits that prevent plants containing them from accessing the NGT1 category (see box)iii .The position of stakeholders on patentabilityIntroduced into the debate in February 2024 during the parliamentary vote on the exclusion of NGT-derived material from patentabilityiv, the issue of patents remains the main sticking point in the trilogue. According to the non-paper, the Parliament, which initially proposed banning patents on NGT1 plants, is now willing to compromise, provided that "safeguard mechanisms" are included in the regulation to ensure fair access to plant material – including patented material – for breeders.The proposed safeguard mechanisms would include:a clear definition of the characteristics that can be protected,the exclusion of natural or conventionally bred traits from patentability,guarantees to prevent market concentration and preserve access for SMEs,the right for farmers to save their seeds,fair, reasonable and non-discriminatory (FRAND) licences,a research exception for breeders.This proposal is surprising in that it plans to exclude natural or conventionally bred traits, even though the Commission bases its entire approach on the alleged impossibility of distinguishing NGT1 from conventional plants.Even if, under pressure from Denmark, the Parliament's position could change, no clear and protective consensus seems to be emerging at this stage for small and medium-sized seed producers and farmers. Indeed, even if the patent guarantees newly demanded by the Parliament can be seen as safeguards, they are not enough to reassure seed producers and farmers. Two examples among the proposed safeguards illustrate this: "fair” licences and the exclusion of native traits.Fair licencesThe issue of fair licences – allowing a third party to use a plant or NGT1 product covered by a patent with the patent holder's authorisation – illustrates the uncertainty that still reigns in Europe on the subject of patents. The FRAND licence, for example, proposed by the Parliament, is usually used for inventions that are essential to a particular technical standard, such as Wi-Fiv. Its purpose is to ensure that these patents are not misused to restrict competition. However, it is not clear that genomic technologies can accommodate technical standards, at least not in the short term. Furthermore, the concept of "fair licensing" is not precisely defined by European law, even though Article 12 ("Compulsory cross-licensing") of Directive 98/44 on biotechnological inventions refers to "reasonable terms" vi. In practice, reference is made to national law on the subject, in this case Article L 613-15-1 CPI for France vii. A clarification by the Council adds to the uncertainty: the patent holder is not required to indicate whether they would agree to grant a licence, which does nothing to promote transparency.The Danish Presidency states that "tools already exist to address some of these concerns [Editor's note: the use by a third party of a plant or NGT1 product covered by a patent] and proposes to strengthen transparency, including monitoring of licensing platforms, through a code-of-conduct like mechanism". However, these platforms are not accessible to everyoneviii, and it seems difficult to reconcile such divergent interests as those of industry and "small players" within a code of conduct. This is particularly true given that the pro-NGT European Commission will play a central role in drafting the code.Exclusion of natural traitsPatents covering native traits have already been granted in Europe, and the deregulation of plants derived from NGTs would amplify this phenomenon. However, the exclusion of native traits from the scope of a patent – the disclaimer according to the EPO (European Patent Office) – proposed by the Parliament remains a false solution for protecting small and medium-sized seed producers and farmers. The EPO explains that in order to prevent a patent on plants obtained by a technical process from extending to plants obtained by biological processes, a disclaimer explicitly excluding the latter must be included in the patent claims. This applies to applications filed since 1 July 2017, without retroactive effect.In its decision G 1/03ix, the EPO's Enlarged Board of Appeal specifies that a disclaimer must exclude only what is necessary, while remaining clear and concise. However, excluding specific biological elements, such as plant material, is very complex, if not impossible. This is particularly true if the European Commission asserts that all GMO/NGT1 are equivalent to natural plants. Thus, writing in a claim that "the patent does not cover plants obtained by biological processes" may be concise, but not necessarily clear, as it is not easily applicable. And even with such a disclaimer, the alleged infringer would still have to prove that their product is obtained by a non-patented process, according to the principle of reversal of the burden of proofx.ECVC considers that this exclusion obligation is "illusory because it can unfortunately only concern products known to the breeder claiming a patent. No breeder can know all the biological material and genetic information contained in all the plants cultivated globally". ECVC adds that an exclusion “only apply to plant and seeds are “notoriously well known”, registered in the common catalogue of varieties, deposited in official public collections or which are the subject of official scientific publications describing in detail their characteristics and the biological materials or genetic information they contain. It does not concern most peasant seeds and many traditional varieties, which will therefore always be threatened with appropriation by patents covering the ‘native’ characteristics they contain”.Furthermore, even without mentioning the disclaimer, the "non-retroactivity" rule allows many patents on products obtained by essentially biological processes (EBP) to remain valid until 2037. To protect small and medium-sized seed producers and farmers, the EPO would have to decide to apply retroactivity to these patents, which seems unlikely, if not impossible. Alternatively, national courts must invalidate European patent claims filed before July 2017 relating to such products. However, it should be noted that the Commission bases its entire approach on the alleged impossibility of distinguishing NGT1 from conventional plants.Protection still insufficientEven if all the guarantees demanded by Parliament – including the "total breeder's exemption"xi – were clear, the fact that it has dropped its demand for a total ban on patents on plant material derived from NGTs would open the door to abuses. The power of industrial groups, which hold numerous patents, leaves little room for small and medium-sized seed producers, for whom patent law remains a foreign and complex discipline that could be used as a tool to buy them out.A total ban on plant material derived from NGTs, as originally proposed by Parliament, would therefore be the most effective solution. However, it would not provide complete protection given the maintenance of process patents and the associated legal consequencesxii. It would also require an amendment to Directive 98/44 on biotechnological inventions in patents, which both Member States and the Commission are totally opposed to.The Danish Presidency pushes aheadDenmark is leading a political offensive to deregulate GMOs/NGTs during its presidency of the Council of the EU. It wants to move quickly, as the countries that will subsequently hold the EU presidency (Cyprus, Ireland, Lithuania and Greece) are not seen as active Member States on this issue. The Danish Presidency is also under strong pressure from its own population, 82% of whom oppose the deregulation of GMOs/NGTs, according to a YouGov pollxiii. The same poll also shows that 84% of Danes are unaware that their government supports the deregulation proposed by the European Commission.The European institutions are entering into final negotiations to decide whether GMOs/NGTs will be exempt from labelling and traceability requirements, and to develop real solutions for patents. To justify the Danish position, Food Minister Jacob Jensen, who believes that NGTs do not produce GMOs, argues that deregulating GMOs/NGTs would accelerate the ecological transition, provide sustainable solutions for food production and make it possible to ban certain PFAS pesticides (per- and polyfluoroalkyl substances). However, these arguments merely repeat the misleading narratives developed over many years by industry and scientists in favour of GMOs/NGTs, and ignore the consequences of patent rights on small and medium-sized seed producers and farmers.Proven characteristics of unsustainability according to the European Coordination Via Campesina (ECVC): • Herbicide tolerance traits, which lead in the long term to increased use of herbicides, soil depletion, the creation of resistant weeds, and are linked to health problems among farmers;• Insecticide production traits, which pose a high risk of harmful interaction with the environment, including pollinators;• Traits linked to production of antifungal substances, which pose a high risk of harmful interaction with the environment, in particular with fungi essential for plant survival, productivity and/or seed fertility.i Bartosz Brzeziński, "Far right to the rescue on Europe’s gene-editing revolution", Politico, 20 November 2025.ii European Commission, “ANNEXES to the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625", 7 July 2023.iii ECVC, "Trilogue on the draft regulation on new genomic techniques (NGTs): ECVC’s proposals on patents and sustainability", November 2025.iv Eric Meunier and Denis Meshaka, "Is 2024 the year when patents on life are politically challenged?", Inf'OGM, le journal, No. 176, July/September 2024.v World Intellectual Property Organisation, "Standard essential patents". vi European Parliament and Council of the European Union, "DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998 on the legal protection of biotechnological inventions", Official Journal of the European Union, L213/13, 30 July 1998.vii République française, Code de la Propriété Intellectuelle, Article L613-15-1, JORF, 9 December 2004.viii Denis Meshaka, "Brevets et COV : des semenciers au milieu du gué ?", Inf'OGM, 23 January 2024.ix European Patent Office, "G 0001/03 (Disclaimer/PPG) 08-04-2004".x Denis Meshaka, "Excluding GMOs/NGTs from patentability would be an illusion", Inf'OGM, 4 March 2024.xi Denis Meshaka, “GMO/NGT Regulation: civil society organisations concerned about the outcome of the trilogue", Inf’OGM, 5 November 2025.xii Denis Meshaka, "GMO patents: is it possible to break the deadlock?", Inf'OGM, 10 February 2025.xiii "Poll: 82% of Danes oppose GMO deregulation, at odds with government position", GMWatch, 5 November 2025. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [75] => Array ( [objectID] => 14223 [title] => Biodiversity and stability of natural systems: what are the impacts of GMOs? [timestamp] => 1764115200 [date] => 26/11/2025 [annee] => 2025 [url] => https://infogm.org/en/biodiversity-and-stability-of-natural-systems-what-are-the-impacts-of-gmos/ [image] => https://infogm.org/wp-content/uploads/2025/11/500px-Dobzhansky_Evolution_Notre_Dame.jpg [extrait] => There is no shortage of observations of a living world in the process of destruction, with examples such as collapsing biodiversity and climate change. However, the solutions proposed and adopted by decision-makers in technophile countries are fueling this destruction, as in the case of GMOs. In the opinion piece published here by Inf'OGM, Frédéric Jacquemart calls for the implementation of a “global (systemic) assessment” that would “take into account the organization of the natural complex systems on which we depend in order to guide public decision-making”. [chapo] => There is no shortage of observations of a living world in the process of destruction, with examples such as collapsing biodiversity and climate change. However, the solutions proposed and adopted by decision-makers in technophile countries are fueling this destruction, as in the case of GMOs. In the opinion piece published here by Inf’OGM, Frédéric Jacquemart calls for the implementation of a “global (systemic) assessment” that would “take into account the organization of the natural complex systems on which we depend in order to guide public decision-making”. [texte] => Western (globalized) civilization has developed and continues to develop increasingly diverse and powerful technologies. One of the observed results of this accelerated growth is the destruction of the living world... of which we are a part. The major challenges that arise from this (collapse of biodiversity, climate change, critical instability of societies) are a cause for concern among many scientists, policymakers, and the public. We would therefore expect questions to be asked about why and how such brilliant technoscience has led to the threat of mass species extinction and widespread violencei. However, quite the contrary, recognizing the problems and their extreme seriousness, solutions are being put in place to resolve them, constructed in the same terms as those that generated them. Something's wrong? Let's go harder and faster in the same direction. Obviously.The field of GMOs is no exception to this brilliant strategy. In particular, think tanks have observed that genetically homogeneous crops inevitably lead to the emergence of pathogens that require even more pesticides, and are therefore implementing programs aimed at restoring cultivated biodiversity. How? By generating this biodiversity using tools known as “genome editing”, which in current practice means CRISPR/Cas. For example, there is a French program called Sélection Végétale Avancée (Advanced Plant Selection) with a budget of several million euros aimed at “ensuring the agroecological transition” by producing artificially diversified plants. As such a program was presented at one of the french ANSES’ committees, the following opinion was produced to fuel the debate. To give it credibility, it was submitted to a number of renowned scientists for co-signing. These signatures do not commit their authors to anything other than the scientific validity of the note and, in particular, not to the use made of it. Inf'OGM has decided to publish this opinion.Note on biodiversity and the stability of natural systemsIn the 1970s, following the work of Ilya Prigogine, among others, the theme of complex systems emerged, followed by adaptive systems. This raised questions about the stability, resilience, and adaptability of natural complex systems, which clearly maintain themselves despite their size and the disturbances they undergo.At the time, there was much debate about whether the stability of systems depended on the diversity of their components, even though the term “biodiversity” was not introduced into ecology until the 1980s.It is clear, for example, that the emergence of a pathogen in an ecosystem will cause less damage if it aims a diverse and redundant functional group than if it attacks a genetically homogeneous group, as is the case with current plantations in industrial agriculture and forestry.However, with the pioneering work in this field by Gardner and Ashbyii, followed by Mayiii, it appears that, beyond a certain threshold, increasing the connectivity or variety of components reduces the stability of systems and ultimately even destroys them. The stability of ecosystems is therefore not directly linked to biodiversity understood as the diversity of species and genomes and, in the case of this work, non-historical.As Theodosius Dobzhansky wrote: “Nothing in biology makes sense except in the light of evolution”. The conclusions of Gadner, Ashby, May, and many others since then concerned a random rather than historical evolution of diversity and connectivity.What makes the coherence of a natural complex system so immensely improbable is that any element that emerges during evolution is immediately confronted with the other elements of the system (general coevolution), in different ways depending on the scales and modules involved. In doing so, it produces at least local changes and persists if it proves to be compatible with the organization of the system, which is thus built step by step, historically. This historicity means that every change, every bifurcation occurring over time could have not happened or could have been different: events in a natural complex system are essentially contingent. On the other hand, although randomness is present at all stages and on all scales, these changes are not arbitrary, in the sense that randomness operates under restrictions and that any emergence is confronted with the totality of the system. This biodiversity (as observed) could have been different from what it is at a given moment, but it cannot be arbitrary, as in the case of the aforementioned models where, in fact, an increase in biodiversity via elements not derived from this autonomous evolutionary process alters or even destroys the stability of the systems.In fact, tropical forest ecosystems, which have very high biodiversity, are stable and resilient, but so are temperate forest ecosystems with average biodiversity, and even very poor desert ecosystems are stable and resilient.What makes a natural complex system stable and resilient is its organization, which, for ecosystems, translates into a certain level of biodiversity: this biodiversity has been historically shaped by the evolution of ecosystems. It is the biodiversity that we observe today and that must obviously be preserved in order to preserve their adaptability.Due to the sheer number of possible connections, it is completely impossible for an external entity to intentionally generate a being that is consistent with a natural complex system. Introducing artificial beings into these systems would amount to randomly increasing diversity and therefore presents a high risk of destabilizing the system.GMOs are precisely artificial living beings, random in relation to the organization of the ecosystems and societies into which they are introduced. Programs to introduce non-native plants (especially trees) that are supposedly drought-resistant are just as ecologically destructive, for the same reasons. In general, the transfer of living organisms from one geographical area to another cannot be done blindly, as is too often the case today, including for biological control purposes.There is an urgent need to establish a global (systemic) assessment that takes into account the organization of the natural complex systems on which we depend in order to guide public decision-making.Co-signatories (for the moment):– Luc Abbadie, professor emeritus of ecology at Sorbonne University, former director of the Institute of Ecology and Environmental Sciences in Paris;– Gilles Benest, doctor of ethology and ecology, honorary attaché at the National Museum of Natural History, honorary lecturer at Paris Diderot University;– Bertheau Yves, Honorary Director of Research at INRA, National Museum of Natural History;– Blandin Patrick, former professor of general ecology at the National Museum of Natural History, Honorary President of the French Committee of the IUCN;– Blouin Manuel, professor of ecology at Agrosup Dijon;– David Chavalarias, Director of the Paris-Ile de France Institute for Complex Systems;– Myriam Ermonval, former Research Fellow in Virology at the Pasteur Institute;– Pierre-Henri Gouyon, Professor Emeritus at the National Museum of Natural History and Agro Paris-Tech;– Lecointre Guillaume, Director of the Systematics and Evolution Department at the National Museum of Natural History;– Longo Giuseppe, Emeritus CNRS Research Director at the Cavaillès Interdisciplinary Center at the École Normale Supérieure (ENS) in Paris;– Miquel Paul-Antoine, philosopher of biology, professor of contemporary philosophy at the University of Toulouse Jean Jaurès;– Montévil Maël, research fellow at the CNRS, République des savoirs, USR 3608, École Normale Supérieure (ENS) Paris;– Morand Serge, Director of Research at the CNRS (Institute of Evolutionary Sciences, Montpellier) and Associate Researcher at CIRAD (ASTRE);– Petit Caroline, Centre Cavaillès, République des savoirs (UAR 3608) École Normale Supérieure;– Sélosse Marc-André, Professor at the National Museum of Natural History;– Soto Ana, Professor, Department of Immunology, Tufts University School of Medicine, Boston;– Testart Jacques, Honorary Director of Research in Reproductive Biology at Inserm.i This does not mean rejecting science or technology. These issues can be explored further if readers request it.ii Gardner, M.R. and Ashby, W.R., “Connectance of large dynamic (cybernetic) systems: critical values for stability” Nature 238: 784, 1970.iii May, R.M., “Will a large complex system be stable?”, Nature 238: 413-414, 1974. Frédéric Jacquemart, Groupe International d’Études Transdisciplinaires (GIET) [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [76] => Array ( [objectID] => 14146 [title] => Seed Treaty’s MLS enhancement package risks legitimizing biopiracy and inequity [timestamp] => 1763596800 [date] => 20/11/2025 [annee] => 2025 [url] => https://infogm.org/en/seed-treatys-mls-enhancement-package-risks-legitimizing-biopiracy-and-inequity/ [image] => https://infogm.org/wp-content/uploads/2025/11/mls_landingpage-768x329.png [extrait] => For some times now, the International Treaty on Plant Genetic Resources for Food and Agriculture is discussing an expansion of its scope to all plant genetic resources for food and agriculture. Many stakeholders and observers are fearing this would end up in legitimizing biopiracy. As the next meeting will occur in Lima (Peru) starting in November, the 24th, Inf’OGM publishes the analysis of Nithin Ramakrishnan, from Third World Network, one of the stakeholders of this meeting. [chapo] => For some times now, the International Treaty on Plant Genetic Resources for Food and Agriculture is discussing an expansion of its scope to all plant genetic resources for food and agriculture. Many stakeholders and observers are fearing this would end up in legitimizing biopiracy. As the next meeting will occur in Lima (Peru) starting in November, the 24th, Inf’OGM publishes the analysis of Nithin Ramakrishnan, from Third World Network, one of the stakeholders of this meeting. [texte] => As the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA, or Seed Treaty) prepares to meet in Lima (Peru), from du 24th to 29th Novemberi, countries face a critical decision that could risk legitimizing biopiracy and inequity.It could reshape how the world shares and governs its crop diversity. The Ad Hoc Open-Ended Working Group to Enhance the Functioning of the Multilateral System (MLS) of Access and Benefit Sharing has submitted a Draft Package of Measuresii that, if adopted, would expand the scope of the MLS from 64 food crops to all Plant Genetic Resources for Food and Agriculture (PGRFA).The draft is presented as a long-awaited “enhancement” of the MLS. After all, who would oppose “enhancing” a mechanism supposedly meant to share seeds and the benefits that arise from them? But there is an underlying troubling reality: the proposed reforms threatens to widen the gap between access and fair and equitable benefit sharing, weaken governance, undermine accountability and transparency, and further undermine the already fragile rights of farmers over the genetic resources they have cultivated for centuries, as well as national sovereignty over those resources.This draft package set for consideration at the Seed Treaty’s 11th Session of its Governing Body (GB11) meeting in Lima deserves a detailed scrutiny. Given the several agenda items to be covered in GB11, it is doubtful whether Contracting Parties can sufficiently focus on this agenda item – which changes the very fundamentals of the Seed Treaty.This essay takes a brief look at core issues. A brief look which has, as a starting point, the observation that developed countries are currently seeking free access to DSI contained in the PGRFA of the multilateral system, meaning with no requirement of standard material transfer agreement regulating generation of DSI from such PGRFA, their use and benefit sharing. They also oppose proposals to forbid patenting of such DSI, violating Articles 12.3 (d) and undermining the protection granted to farmers’ rights under Article 12.3 (e) of the Treaty. Having those two points unresolved will constitute a major breach to the protection of biodiversity.About the draft package itself, this essay first explains the MLS and current state of play, then addresses the issues such as expansion of access to PGRFA, elusive benefit sharing, digital biopiracy, lack of transparency and accountability, unilateral withdrawals from standard material transfer agreements, weakening of farmers rights and sovereign rights.Failed promise of the Multilateral System for access and benefit sharingAdopted in 2001, the Seed Treaty was designed to protect and promote the conservation and sustainable use of plant genetic resources for food and agriculture (PGRFA) – the seeds, tubers, and other plant material that underpin our food systems. Its Multilateral System (MLS) was a remarkable idea: instead of negotiating with countries and provider communities for accessing seeds, countries would create a common regime that covers certain crop varieties – 64 in total – accessible via a Standard Material Transfer Agreement (SMTA). In return, users such as seed companies, research institutions, and gene banks would be supposed to share the benefits in a fair and equitable manner, both monetary and non-monetary, flowing from their use. The recipients also accept to not claim any intellectual property on the provided phytogenetic resources, its parts and/or its genetic components.The principle was elegant: access and benefit sharing (ABS) were to be “mutually reinforcing”. Access to seeds would promote innovation, and the resulting benefits, i.e. knowledge, technology, improved varieties, and profit sharing from commercialization, would return to those who had conserved and provided the resources. The Seed Treaty’s architects imagined a virtuous circle between farmers’ fields and research laboratories, rooted in fairness and transparency. The 64 crops were chosen for their central importance to food security and the shared dependence of countries on their genetic diversity.Two decades later, this balance is faltering. While the MLS has facilitated access to millions of seed samples, benefit sharing has remained negligible. Of the more than 7 million transfers of plant materials reported since the Treaty’s inception to over 28,000 users, only six usersiii have made monetary contributions to its benefit-sharing fund. The promised reciprocity has largely failed to materialize. Currently more than 97% of the Benefit Sharing fund comes from voluntary contributions. Around 90% of the Fund is contributed by the States.However, the Treaty has an inbuilt justification or counter argument to cover-up its failure to generate benefits from the use of shared resources: “declaring access to PGRFA itself as a major benefit”. Article 13 declares so, although the provision is very clear that the benefits “arising therefrom” such access should also be shared fairly and equitably.Package to expand access, not to share benefitsDespite failure in benefit sharing, the Treaty is now considering a draft package of measures that prioritizes access while sidelining benefit sharing, directly contradicting the Treaty’s Article 10.2 requirement that both be mutually reinforcing.The most dramatic proposal is to expand the MLS to cover all plant genetic resources for food and agriculture. This essentially means every seed and other planting material with potential value for food and agriculture. Until now, only a negotiated list of 64 crops is included, chosen for their importance to food security and interdependence among nations. The proposed draft abandons this careful selection.It proposes a one-time, full expansion of the MLS to cover all plant genetic resources for food/feed and agriculture of “actual or potential value for food and agriculture”, through an amendment of the Treaty. Once a plant’s “potential value” is claimed, its genetic material would fall automatically within the MLS, forcing countries to share it under the SMTA. In practical terms, this would require all Contracting Parties to make virtually their entire national/governmental seed collections available through the MLS, with no legal guarantee that their part of the corresponding benefits will flow back to them or to the farming communities who originally contributed those seeds.Similarly, the MLS would pave the way for international gene banks to easily collect the seeds from developing country authorities, and distribute them widely, with almost no measure in place to prevent or reduce the menace of biopiracy. While developing countries are being pressed to share more, there is no corresponding obligation on the international gene banks to report back or inform the countries of origin, whom they are sharing the seeds for what purpose.The implications are sweeping. Private users could take, experiment, and commercialize seeds from international gene banks, monopolize outcomes of their research, without notifying the countries of origin or farming communities who originally contributed these seeds. Thus the expansion would compel Parties, especially developing countries, to open all their public collections and national gene banks to global access, even though the system still lacks basic accountability and safeguards. Prior informed consent requirements and benefit sharing obligations under the complementary Convention on Biological Diversity (CBD) and its Nagoya Protocol on access and benefit sharing (ABS) would be sidelined too.Elusive BenefitsWith respect to monetary benefits, the draft package touts new payment options for users who “sell seeds” incorporating PGRFA received from the MLS – the “subscription” and “single access” models. But these are merely old mechanisms dressed in new jargon, with very little improvement.Most glaringly, these options fail to address the fundamental imbalance between the purpose clause of the Treaty, reproduced verbatim in the SMTA, and the benefit sharing provisions.For example, a company brewing beer from barley accessed through the MLS or developing food products from MLS-derived crops need not share monetary benefits because such uses fall outside “seed (PGRFA) sales”. Similarly, firms that use the Digital Sequence Information (DSI) from MLS materials to develop genetic traits or synthetic food ingredients have no duty to contribute financially to the Benefit-Sharing Fund.Under the "subscription" option, companies pay an annual fee – based on their total “seed” sales – in exchange for unlimited access to all MLS materials. However, they can exclude up to two of their most profitable crops from benefit-sharing payments. This “partial subscription” would allow major seed companies to avoid contributing on the very crops from which they earn the most revenue.The "single access" option allows users to pay only when they commercialize products developed using MLS materials. Despite its name, it does not limit how much material that can be accessed, creating a loophole that lets frequent users avoid subscription obligations altogether.In addition, the package now gives users new privileges to withdraw unilaterally from benefit-sharing agreements with no clear oversight by the FAO, which acts as the third party beneficiary and/or guardian of the MLS. The proposals lack clarity about how the MLS deals with commercialization of products developed using MLS materials, once the recipients withdraw from the SMTA.When it comes to non-monetary benefits, the package literally makes no improvement. Non-monetary benefits, such as technology transfer, collaborative research, or acknowledgment of farming communities’ contributions, remain voluntary and largely unenforced. The SMTA only obligates users to share the information that results from their research through a Global Information System established under the Treaty. However, users could still avoid disclosing “confidential information” – a term with no qualification or definition in the SMTA. There is no time prescribed for such sharing of information as well. It must be noted that sharing of information resulting from research does not mean the research results are publicly accessible. Such research results, even if information, could very well remain behind paywalls or protected by intellectual property rights.It is strange that while the SMTA maintains exemptions or discounts to the monetary benefit sharing contributions from the sale of seeds that are "available without restrictions" for research and breeding, it does not institute mechanisms such that those seeds are made available through the MLS. This is despite the treaty’s proclaimed position that access to PGRFA under MLS itself is the major benefit.Anonymous use of DSI and digital biopiracyPerhaps the most complex – and dangerous – issue lies in how the draft treats digital sequence information (DSI), the genetic code derived from seeds, also called “genetic sequence data” (GSD).In the genomic era, physical genetic materials are no longer the only means of accessing seeds. Once a seed’s genome is sequenced, its genetic information can be stored in online databases, analyzed, and used to create new varieties or even synthetic organisms without further interaction with the original material. Unfortunately, currently this information is being shared online, where anonymous users can access data and monopolize research outcomes as well as commercialize the same without informing the country of origin or farmer communities who developed the seed from which DSI is extracted.Adding to this concern, the collect by researchers or not-for-profit entities of the peasants' knowledge associated to this or this plant variety often facilitates free and unaccounted access to such a knowledge with respect to characteristics of PGRFA (traits of interests), further helping in identifying genetic sequences associated with such traits and commercializing the same. Such collection of traditional knowledge also alienates value from farmer communities.Developing countries have consistently argued, in line with the Convention on Biological Diversity (CBD) and its Nagoya Protocol on ABS, that benefits arising from the use of DSI must also be shared. The 2024 CBD COP Decision 16/2 explicitly recognized countries’ sovereign rights to regulate DSI and stipulate benefit-sharing conditions. The 2025 WHO Pandemic Agreement followed similar principles for genetic data.Yet, the Seed Treaty’s draft package moves in the opposite direction. Paragraphs 53 and 55 of the draft resolution reduce benefit sharing from DSI to a mere “expectation,” and then declare that any such expectation is already met through payments under the subscription model.Developed countries oppose explicit mention of DSI/GSD both in the Treaty and the SMTA. This means there is nothing binding about generation, storage, use or benefit sharing from the use of DSI in the package of measures. It is astonishing that although the Treaty is being amended to alter the scope of the MLS, there is no proposal to ensure benefit sharing from the use of DSI is also binding. Similarly under the SMTA, there are only two paragraphs dealing with DSI, which are proposed by the developing countries. Again, these paragraphs merely deal with the obligation of recipients of seeds from the MLS with respect to DSI.As seen at the beginning of the article, developed countries, however, seek free access to DSI contained in the PGRFA of the multilateral system, meaning with no requirement of standard material transfer agreement regulating generation of DSI from such PGRFA, their use and benefit sharing. They also oppose proposals to forbid patenting of such DSI, violating articles 12.3 (d) and undermining the protection granted to farmers’ rights under Article 12.3 (e) of the treaty. Furthermore any attempt to define DSI as an integral component of the PGRFA is vehemently opposed by the developed countries. Some of them are of the view that the voluntary mechanism of Cali Fund may address the benefit sharing emanating from the use of DSI.Thus the package effectively eliminates all obligations to share benefits from the use of digital data generated directly from MLS materials, or accessed from online databases. Recipients can extract, analyze, and commercialize genetic sequences from MLS seeds, via developing profitable bio-informatics services or patenting traits, without returning a cent to provider countries or farmers. Even CGIAR centres like the International Rice Research Centre are set to sell (plans to introduce subscription databases) data developed using this DSI.The package also fails to establish rules for database accountability. It does not require DSI to be stored in databases answerable to the Treaty’s Governing Body or the FAO. It does not call for “user registration” in these databases and the need for “data access agreements” which obligate users to share benefits. Neither does it contain proposals for persistent unique identifiers that identify sequences with the country of origin or contributing farmers. Instead, it even allows users to mention the MLS itself as the source of the seeds.This proposal, if adopted, would erase the link between genetic information and the communities or countries from which it originates, legitimizing digital biopiracy under the Seed Treaty. It must be noted that a substantial part of DSI/GSD is already existing in databases unaccountable to the Treaty Governing Body, and this proposal instead of controlling this menace, is going to legitimize such practices, in turn accelerating digital biopiracy in future.Undermining transparency and accountabilityTransparency is central to the credibility of any multilateral ABS system, if it is to be consistent with the objectives of the CBD and its Nagoya Protocol that require access to genetic resources to be appropriate, taking into account all rights over such resources.The Treaty’s Article 10.2 promised a mechanism that is “efficient, effective, and transparent”. Yet the new draft legitimizes opacity in the name of “confidential business information”.Previously, providers of seeds were obliged to report every SMTA signed by them on seeds to the Governing Body for ensuring traceability. Over time, this practice eroded. The Governing Body now receives only aggregate numbers, not details of who received what. This leaves the information on the origin of seeds lost, and the links between access to PGRFA and marketing of new seeds cut off. The new draft legitimizes this practice promoting opacity over transparency, by introducing explicit confidentiality clauses. Under the proposed amendments to Article 5(e) of the SMTA, information on material transfers will be treated as "confidential business information", and will be used only for aggregated reporting.This change would formalize the current practice where only general statistics on the number of SMTAs signed or accessions shared are reported to the Governing Body. The identity of users, the materials accessed, and the nature of resulting products are withheld from Contracting Parties and the public.Thus, neither national governments nor farmers can track where their genetic resources go, who uses them, or what products emerge. Such secrecy undermines accountability, invites misuse, and limits the ability of farmers or researchers to challenge potential misuse or spurious patent claims on their seeds.Unilateral withdrawals, eroding oversightAnother concerning innovation in the proposal for revised SMTA is the introduction of unilateral withdrawal rights for recipients after ten years of signing the SMTA. Companies can simply notify the Governing Body and withdraw. There are many nuances relating to the commercialization of benefits developed using the MLS post-withdrawal; they remains either unaddressed or ambiguously touched upon.Such clauses risk creating an escape route for companies to terminate their obligations just as they begin to reap commercial benefits.The FAO, acting as the third-party beneficiary on behalf of all Contracting Parties, would have no authority to review or condition such withdrawals. Thus in effect the third-party benefits are revoked without their consent, as parties can unilaterally withdraw from the SMTA. This undermines the FAO’s role and contradicts the UNIDROIT Principles on International Commercial Contracts, which stipulate that rights benefiting third parties cannot be revoked without their consent.Hollow acknowledgment of Farmers’ RightsThe Seed Treaty’s Article 9 recognizes Farmers’ Rights: to save, use, exchange, and sell seeds, and to share in the benefits derived from their resources. Yet in both the current system and the proposed draft, these rights remain largely ornamental.The draft resolution’s sole reference to farmers reads like a disclaimer: the revised agreement “is not intended to limit” farmers’ rights. This token acknowledgment sidesteps the substantive issue of how the MLS impacts farmers both as providers and as recipients of benefits. It must be noted that there is no obligation in the SMTA on the recipients of seeds to acknowledge farmers’ contributions in their research results and/or in their intellectual property claims, even when farmer variety seeds are used or when their traditional knowledge is involved.Moreover, the definition of “Plant Genetic Resources for Food and Agriculture under Development (PGRFA-D)” in the SMTA would continue to weaken the protection farmers’ seeds enjoy in the Treaty. By defining PGRFA-D as materials derived only from seeds accessed through the MLS, the text excludes farmers’ seeds that are continuously under development in their fields from this protection. This would allow international gene banks or companies to access farmers’ seed varieties, available with national gene banks or government institutions (even though they continue to be used in fields), without their consent. This contradicts the Treaty’s spirit and its explicit provision, Article 12.3(e), which asserts that farmers retain discretion over their materials as a developer.Without consent and transparency (as discussed above), farmers could see their seeds transformed into patented varieties that they would then have to buy back. There is also no guarantee that the benefits from the commercialization of MLS resources would directly reach the farmer communities.Sovereignty constrained in the name of “enhancement”The proposed amendment to Annex 1 to expand the scope of the MLS to all PGRFA also limits the ability of countries to exercise their sovereign rights over genetic resources. It allows them to exclude only a “certain and limited number” of species from the MLS and only once, at the time of ratification or accession as the case may be.They must also “state clear reasons” for any exclusion, restricted to legal or cultural grounds. Furthermore, the draft resolution proposes to deny benefit-sharing funds for projects on the crops excluded from the MLS, an implicit threat to those who assert their rights.This conditional sovereignty is a direct threat to international law on genetic resources. Nations have the inherent right to determine access to their genetic resources. Forcing them to justify exclusions and limiting the exceptions undermines that principle. Such pressure tactics echo a broader trend in global biodiversity governance: the steady erosion of developing countries’ control over their biological wealth in the name of “open access”.These measures contradict the principle of "permanent sovereignty over natural resources" enshrined in international law and reaffirmed in the CBD and its Nagoya Protocol.Therefore, as the Governing Body convenes in Lima, Contracting Parties – especially from developing countries – must carefully weigh whether this is truly an “enhancement” or an erosion of the principles that gave birth to the CBD and the Seed Treaty. The world’s food security deserves an outcome that strengthens equity, transparency, and sovereignty, not one that compromises them.i https://www.fao.org/plant-treaty/eleventh-governing-body/enii FAO, ITPGRFA, FOURTEENTH MEETING OF THE AD HOC OPEN-ENDED WORKING GROUP TO ENHANCE THE FUNCTIONING OF THE MULTILATERAL SYSTEM, « Package of measures to enhance the functioning of the Multilateral System: draft negotiating text contained in the Report of the thirteenth meeting », June 2025.iii Canadian seed company (3187 USD), Nunhems Netherlands BV (732301 USD), Bejo Zaden BV (88135 USD); Uniquest Pty Ltd (218 USD); Zollinger Bio (355 USD); NuCicer (484 USD). Nithin Ramakrishnan - Representing the Third World Network (TWN) in GB11 of ITPGRFA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [77] => Array ( [objectID] => 14160 [title] => GMOs on the agenda at COP 30 [timestamp] => 1763510400 [date] => 19/11/2025 [annee] => 2025 [url] => https://infogm.org/en/gmos-on-the-agenda-at-cop-30/ [image] => https://infogm.org/wp-content/uploads/2026/03/COP30-1-768x432.jpeg [extrait] => At a time when countries are meeting in Belém, Brazil, to discuss the tools needed to combat climate change, Inf’OGM wishes to shed light on the role of biotechnology in these negotiations. Biotechnology companies are making several promises: GMOs will help combat world hunger and climate change. [chapo] => At a time when countries are meeting in Belém, Brazil, to discuss the tools needed to combat climate change, Inf’OGM wishes to shed light on the role of biotechnology in these negotiations. Biotechnology companies are making several promises: GMOs will help combat world hunger and climate change. [texte] => On several occasions at the COP (Conference of the Parties) climate conference, the biotechnology industry has attempted to promote its innovations as relevant tools in the fight against climate change.Biotech industries in force at COP30At COP 30, the Brazilian presidency is actively promoting agrofuels, which are said to emit less greenhouse gases than fossil fuels. It wants to convince 19 other countries (including India, Italy and Japan) to join its "Belém Commitment for Sustainable Fuels" (or Belém 4X)1, which aims to quadruple production and use by 2035. However, biofuels are problematic in more ways than one. In Brazil, as we mention in our podcast2, agrofuels are often produced from sugar cane. Among the companies involved in this industry in Brazil is the French company Tereos3, which owns the Beghin-Say sugar brand. Brazil has authorised several genetically modified yeasts to officially convert bagasse into ethanol. Bagasse is the fibrous residue of sugar cane once it has been pressed to extract the sugar. Bagasse is considered waste. So, in theory, there is no competition with food crops.However, a study by the Getulio Vargas Foundation, conducted in 2024, challenges this idyllic image. Marcello Santana, a researcher at the Brazilian School of Economics and Finance, which is part of this foundation, explains that there are two ways to increase sugar cane production: replanting more often or expanding cultivation to new areas. Let us quote directly from the conclusion of this study: "Our study revealed that when ethanol production increases in Brazil, only 8% of the new ethanol comes from sugar cane that has been planted more intensively. The remaining 92% comes from new areas." It goes on to say: "In this research, we identified that 20% of these new areas were originally forests, which implies deforestation to produce the plants needed to produce this biofuel. 70% of the new areas were either pasture or used to grow other crops, such as wheat and maize."In other words, fuels produced from sugar cane and genetically modified yeast have contributed to deforestation in Brazil. This advertising of a biofuel produced solely by fermenting waste therefore does not hold water.Agribusiness companies decided to get heavily involved in COP 30. Bayer paid €161,000 to become a "diamond" sponsor of COP 30 and secure a place in Agrizone, the conference's "sustainable agriculture" pavilion. It also restored a historic building in Belém to create the "Casa Bayer", a meeting place for political, economic and civil actors during the COP. Bayer is promoting its seeds there, which it describes as climate-resilient4.Many other conferences and workshops organised by multinationals promote the "agritech" package (digital, genetic, robotic) as a means of making agriculture more resilient to climate change and reducing our greenhouse gas (GHG) emissions5. Syngenta is hosting a discussion for experts entitled "Farming for the Future: Boosting Agricultural Productivity While Protecting the Planet"6. Speakers include Teresa Cristina Vendramini, former president of the Brazilian Rural Society (Sociedade Rural Brasileira, SRB), who has always supported the cultivation of genetically modified soybeans to tolerate herbicides (particularly RoundUp). However, these crops have contributed to deforestation in the Amazon and Cerrado7 and, as such, are significant emitters of greenhouse gases.For its part, CropLife8 is organising several events for delegations, aimed at promoting the benefits of "innovative agricultural solutions", particularly in biotechnology9. The general argument is that more productive agriculture using modern technologies emits less GHG per calorie produced.GMOs promoted since the first COPThe idea that GMOs are allies for the climate is not new. Let's take a brief look back at history.We have already mentioned two GMOs eligible for carbon credits in our podcast10. In 2003, in Milan (Italy), during COP 9, it was agreed that companies and governments in "Northern countries" could plant fast-growing transgenic trees in "Southern countries" as part of the "Clean Development Mechanisms" defined by the Kyoto Protocol. The simplistic argument was that the faster trees grow, the better they can act as carbon sinks. In addition to the criticisms levelled at these carbon sinks (the need to protect the trees so that they do not die, the prohibition on the use of wood by local populations, etc.), the use of genetically modified trees has been denounced as worsening an already poor solution due to the risks they entail.However, projects involving trees to store more carbon continue to develop, as evidenced by the company Living Carbon. In April 2025, Microsoft committed to purchasing 1.4 million tonnes of carbon credits from Living Carbon for a reforestation project covering just over 10,000 hectares of mining land in the Appalachian region. These carbon credits are certified by Isometric11. We estimate that between 15 and 20 million trees will need to be planted on this area. What type of tree is it? It is impossible to know. In any case, Isometric has not explicitly excluded GMO trees from its methodology. The information is all the more difficult to obtain as US agencies have deemed that these transgenic poplars can be planted without authorisation. And there is no requirement to keep a public register.The other "innovation" is NUE technology, which stands for Nitrogen Use Efficiency. Developed by Arcadia BioScience, this process is supposed to create transgenic plants that would require less nitrogen fertiliser. However, industrial fertilisers emit nitrous oxide, a powerful greenhouse gas. Arcadia BioScience has signed licensing agreements with major seed companies such as Monsanto (now Bayer), Dupont and Vilmorin. In 2012, NUE technology became eligible for carbon credits12. Is this technology effective? It is impossible to know: no objective data has been published. Verra, the carbon credit certifier that had validated this technology, abandoned it in 2023. When questioned by Inf'OGM, Verra stated that this was due to "lack of use".A second, broader methodology has been accredited: it includes NUE seeds, but also fertiliser management practices. It has been used in 35 projects, but it is impossible to know whether or not these projects involve the use of NUE seeds. In concrete terms, NUE transgenic plants are F1 hybrid varieties selected to be grown according to the principles of industrial agriculture. Therefore, even if these seeds do indeed allow for better absorption of nitrogen fertilisers, which again has never been demonstrated in the field, this will not offset the greenhouse gas emissions inherent in this type of agriculture.At COP 25 in Madrid, Spain, in 2019, European Commission President Ursula von der Leyen presented the Green Deal. In a provisional version obtained by Inf'OGM13, the Commission announced that innovation, and in particular "new genomic techniques", are necessary to "adapt to climate change and improve the sustainability of food systems". The barely disguised reference to GMOs behind this new expression disappeared from the final version. But in 2021, at COP 26 in Glasgow, Scotland, the idea was back on the negotiating table. It was at COP 26 that the US-Emirati initiative "AIM [Agricultural Innovation Mission] for Climate" was officially launched14. Once again, the aim was to promote GMOs and less restrictive regulations to facilitate their dissemination. Among the companies involved is Pivot Bio, which genetically modifies microbes to produce nitrogen. Karsten Temme, CEO and co-founder of the company, explains that, as part of its partnership with "AIM for Climate", his company "will bring together the best minds and ideas to accelerate the pace of our product development and increase farmers' access to a reliable and sustainable source of nitrogen". When questioned by Inf'OGM, a representative of the European Commission revealed that, as part of its partnership with AIM for Climate, the Commission has announced €750 million in investment in research and innovation "for climate-smart agriculture for 2021 and 2022 combined". This amount corresponds to the funding available under the Horizon Europe work programme calls for proposals for 2021 and 2022, in particular the topics of Horizon Europe cluster 6 ("Food, bioeconomy, natural resources, agriculture and environment") and the "A Soil Deal for Europe" mission.2 “Agrocarburants, pire que le pétrole ?”, Inf’OGM, 1 October 20253Christophe Noisette, "Brésil – Le sucre de canne transgénique arrive", Inf'OGM, 9 March 2018.4 Channel World Seed by ISF, "#WorldSeed2025: 'Climate Resilience Starts with Seeds: Our roadmap to Brazil COP30'," 19 May 2025.5 "Agritech: a new dependence for farmers", Inf'OGM.6 Syngenta Group, “COP30 in Brazil: Five Innovative Solutions for Sustainable Agriculture and Global Food Security,” 13 October 2025.7 Christophe Noisette, “Soja : le Cese condamne la déforestation importée”, Inf’OGM, 25 June 2020.Christophe Noisette, "Le soja en Amérique latine : chance ou cauchemar ?", Inf'OGM, le journal, no. 157, November/December 2019.8 Denis Meshaka, "Pro-GMO multinationals indirectly manage the Svalbard seed bank", Inf'OGM, 28 November 2024.9 CropLife Brasil, "CropLife Brasil will be at COP30 in Belém, bringing the voice of tropical agriculture to the centre of the climate debate," 8 November 2025.10 "L’arbre qui cache les biotech", Inf'OGM, 15 October 2025.11 Isometric, "Reforestation."12 Arcadia Biosciences, “U.N. Clean Development Mechanism Approves Arcadia Biosciences Methodology, Links Carbon Credits to Crop Genetic Improvements for First Time,” 19 December 2012.13 Christophe Noisette, "Changement climatique : « ne changeons rien » !", Inf'OGM, le journal, no. 158, January/March 2020.14 Charlotte Krinke, "Le changement climatique : une opportunité pour les OGM ?", Inf'OGM, 15 December 2022. Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [78] => Array ( [objectID] => 14136 [title] => Directed, targeted, precise mutagenesis… Are these adjectives misleading? [timestamp] => 1763337600 [date] => 17/11/2025 [annee] => 2025 [url] => https://infogm.org/en/directed-targeted-precise-mutagenesis-are-these-adjectives-misleading/ [image] => https://infogm.org/wp-content/uploads/2026/03/LT_accuracy-768x652.png [extrait] => Being precise, targeting and achieving one's goal, directing a mutagenesis... these are adjectives that convey a sense of control and precision. However, on closer inspection, these adjectives mean nothing in a legal text. Because, in the European Commission's proposal to deregulate a number of GMOs, they are not accompanied by their corollaries: targeted where? Precise to what degree? Directed by what or by whom? [chapo] => Being precise, targeting and achieving one’s goal, directing a mutagenesis… these are adjectives that convey a sense of control and precision. However, on closer inspection, these adjectives mean nothing in a legal text. Because, in the European Commission’s proposal to deregulate a number of GMOs, they are not accompanied by their corollaries: targeted where? Precise to what degree? Directed by what or by whom? [texte] => In both 1990 and 2001, European legislators established that genetic modification techniques used to modify the genetic material of an organism in a way that does not occur naturally through multiplication and/or natural recombination resulted in GMOs. This definition includes both the method used to achieve genetic modification and the modification itself. But the legislator went further in its thinking.Mutagenesis, in 1990 and then in 2001The same legislator drew up a non-exhaustive list of techniques that produce GMOs subject to the requirements of the legislation. It cited, for example, techniques of ‘recombinant nucleic acid techniques’ consisting of inserting nucleic acid molecules into an organism in which they do not occur naturally.Another technique was cited as producing GMOs: mutagenesis. In Directive 2001/18, this ‘mutagenesis’ produces GMOs that are not subject to the requirements of the legislation, but only in cases where it is used traditionally and with proven safety on the one hand, and on condition that it does not involve the use of recombinant nucleic acid molecules or GMOs on the other. This terminology was clarified in 2018 by the Court of Justice of the European Union (CJEU) as not applying to mutagenesis techniques developed mainly after 2001, thus confirming that more recently developed mutagenesis techniques (since 2001 but also during a period priori to 2001) do not result in exempt GMOs eitheri. In 1990, as in 2001, the legislator therefore made a clear distinction between techniques involving the insertion of DNA sequences and what it then called ‘mutagenesis’.Mutagenesis in 2025, according to the European CommissionIn its proposal to deregulate many plant GMOs (and certain micro-organisms) in 2023ii, the European Commission discreetly introduced a broader legislative view of what mutagenesis is. It proposed to define ‘targeted mutagenesis’ as ‘mutagenesis techniques resulting in modification(s) of the DNA sequence at precise locations in the genome of an organism’.Reading Annex 1, which the European Commission attached to the proposed regulation in 2023, it is clear that, this time, mutagenesis can involve the substitutions of nucleotides by other nucleotides, insertions (additions) of genetic sequences ‘of up to 20 nucleotides’ or deletions (losses) of sequences. Through a rather subtle rhetorical manoeuvre, the Commission also proposes that these modifications be cumulative. Substitutions or insertions of sequences can be added to each other without limit. This is a far cry from the 2001 version of ‘mutagenesis’, which did not cover sequence insertions...‘Targeted’, ‘precise’ mutagenesis…In addition, the European Commission adds the term ‘targeted’ to the term mutagenesis. It justifies this qualifier by explaining that ‘one or more modifications’ would be caused ‘at precise locations in the genome of an organism’. By referring to ‘one or more modifications’, the Commission is opening the door for multinationals to present plants as being genetically modified in a controlled manner, even though they have been obtained by trial and error, as shown by certain files submitted in the United States of Americaiii.For its part, in 2024, the European Parliament did propose to replace the term ‘precise’ with ‘targeted’iv. The intention behind these words is to reassure: if the modification is 'targeted', it means that it is controlled, even safe. But ultimately, without further clarification, what constraints would the term ‘targeted’ impose on a company? In principle, any application for authorisation of GMOs obtained by ‘targeted mutagenesis’ could be subject to this new regulation. A company could easily claim to have ‘targeted’ a particular sequence in an organism's genome and could just as easily conceal the fact that it had to try 809 times before succeeding.The added consideration that these modifications take place ‘at precise locations in the genome’ is also noteworthy. Although the term ‘precise’ suggests precision in the technique and/or technicians, this is not the case, as the term is not binding. By definition, a genetic modification obtained anywhere in a genome, whether in the initially desired location or elsewhere, will often be found in a location in the genome that is precisely identified a posteriori, i.e. after the first application of the claimed process. Like a car stopping at random anywhere between Marseille and Paris, once stopped, it will be in a precise location on the road, which will be described as precise since any car wishing to reproduce that exact route will also stop there.A specific political aim too?Given the vagueness of terms such as ‘targeted’ or ‘precise’ when used in conjunction with mutagenesis, the question of legislative issues arises. As we have already seen, a company will have no difficulty in claiming that a particular GMO has been obtained by ‘targeted mutagenesis’ with mutations occurring at a precise location in the genome. One example that springs to mind is the company Cibus and its description of its canola 5715. In 2013, this genetically modified plant was described as having been obtained by ‘directed mutagenesis’, with the company even using a term that is no longer part of the debate today, namely ‘oligonucleotide-directed mutagenesis’v. However, in 2018, the CJEU reminded everyone that this mutagenesis technique produces GMOs that are subject to the requirements of European legislation on GMOs. In 2020, Cibus changed its description and explained that its canola had in fact been obtained by a mutagenesis method called ‘somaclonal variation’, hoping to escape European GMO regulationsvi.As this rapeseed has disappeared from the marketvii, the final outcome of a legal procedure in Europe will not be known, but it reveals how easy it is for a company to change the description of the same GMO. By using imprecise terms, European legislators are likely to make it even easier for companies to circumvent GMO legislation…i Court of Justice of the European Union, « Case C‑528/16 », 25 July 2018.ii European Parliament, Legislative Observatory, « 2023/0226(COD) Plants obtained by certain new genomic techniques and their food and feed », 5 July 2023.iii Annick Bossu and Eric Meunier, « Les mots à la base de la stratégie des multinationales », Inf’OGM, le journal, n°173, October/December 2023.iv See the proposed modification of article 3 : European Parliament, « Plants obtained by certain new genomic techniques and their food and feed », 24 April 2024.v Eric Meunier, « Colza Cibus : une mutation aux origines mystérieuses », Inf’OGM, 29 September 2020.vi Eric Meunier, « Canola OGM : le gouvernement canadien au secours de Cibus », Inf’OGM, 10 November 2020.vii Claire Robinson and Jonathan Matthews, « GMO company Cibus investigated for deceiving investors », GMWatch, 8 July 2024. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [79] => Array ( [objectID] => 14118 [title] => Consumer associations call for continued labelling and traceability of GMOs [timestamp] => 1763078400 [date] => 14/11/2025 [annee] => 2025 [url] => https://infogm.org/en/consumer-associations-call-for-continued-labelling-and-traceability-of-gmos/ [image] => https://infogm.org/wp-content/uploads/2025/11/tara-clark-Gk8LG7dsHWA-unsplash-768x768.jpg [extrait] => On 14 October 2025, eight consumer associations from various EU Member States published an opinion calling on European institutions to maintain GMO labelling to enable European consumers to make informed choices about their food. [chapo] => On 14 October 2025, eight consumer associations from various EU Member States published an opinion calling on European institutions to maintain GMO labelling to enable European consumers to make informed choices about their food. [texte] => As trilogue negotiations on the regulation of GMOs derived from new genetic modification techniques (known as "new genomic techniques" or NGTs) continue to progress within the European institutions1, European consumer associations published a joint opinion piece2 in The Brussels Times calling for the maintenance of GMO labelling and traceability, which the European Commission is proposing to abolish. According to them, this is in the "the general interest and the right of consumers to know what they eat and their freedom of choice". Among the signatories are two French organisations: UFC-Que Choisir and POLLINIS."A GMO, whatever its name, remains a GMO"After recalling the historical context of the emergence of GMOs in the late 1990s and mentioning the citizen mobilisations that led to their regulation by European legislation, the signatories of the opinion assert that the new legislative proposal, made by the European Commission in July 2023, "would undermine consumers' right to information". As we have pointed out several times in our articles3, this proposal envisages the removal of risk assessment, labelling and traceability requirements for GMOs obtained through NGTs. To justify this deregulation, the European Commission claims that NGTs do "the same thing as nature, or as conventional breeding". However, this argument is widely rejected by the signatory organisations, which claim that "a GMO, whatever its name, remains a GMO".To justify their position, they cite the 25 July 2018 ruling by the Court of Justice of the European Union (CJEU) stating that NGTs produce GMOs and must be regulated as such4. Furthermore, to support their request to maintain GMO labelling, the signatories cite publications by the European Food Safety Authority (EFSA), ANSES5 , the German Federal Agency for Nature Conservation6 and the Austrian Environment Agency7, which "have never supported exempting these plants from risk assessment".The organisations then raise the issue of patents related to these GM plants derived from NGT, not this time to warn of the threat they pose to small and medium-sized breeders, farmers and the organic and GMO-free sectors, as was the case in a previous opinion piece8, but to point out that "agrochemical companies patent these plants and are able to distinguish them from their competitors’ products" and that "therefore it is possible to differentiate them". At this point, they urge MEPs not to renege on their 2024 vote in favour of GMO/NGT labelling and, consequently, "to ensure that labelling and traceability are upheld during the trilogue discussions".A call for compliance with general food legislationThe signatories continue their argument by referring to general food legislation, Regulation 178/20029, a fundamental text for these consumer protection organisations. In particular, they invoke:Article 18, which requires the traceability of foodstuffs throughout the supply chain, and thus consider that "exempting GMO-NGTs from traceability would violate this law".Article 8, which establishes a "right to know" for consumers, in particular through labelling, which should enable them "to make informed choices about the food they purchase".Reference is also made to the Treaty on the Functioning of the European Union and the European Charter of Fundamental Rights, which stipulate the need for a "high level of protection" for consumers.This new opinio therefore shows that, beyond the regulatory texts governing GMOs themselves, the proposal to deregulate GMOs derived from GTN involves other fundamental texts. If this proposal were to be adopted, it is highly likely that civil society organisations would mobilise against the breaches of European consumer and citizen rights that it would entail.1Eric Meunier, "The European Commission’s legal initiatives on the Living", Inf'OGM, 7 November 2024.2 Collective opinion, "Modified food, modified rights? Why genetically modified organisms labelling must stay", The Brussels Times, 14 October 2025.List of signatory organisations: AK, ASUFIN, CECU, Eurocoop, Foodwatch, POLLINIS, UFC-Que Choisir, ZPS.3 Eric Meunier, "The European Commission’s legal initiatives on the Living", Inf'OGM, 7 November 2024.4 Charlotte Krinke, "Europe – Les nouveaux OGM sont des OGM comme les autres" Inf'OGM, 25 July 2018.5 Anses, "Risques et enjeux socio-économiques liés aux plantes NTG", 22 January 2024.6 Bundesamt für Naturschutz, "For a science-based regulation of plants from new genetic techniques", 2024.7 Michael Eckerstorfer, Andreas Heissenberger, "NEW GENETIC ENGINEERING – POSSIBLE UNINTENDED EFFECTS", November 2023.8 Collective, "Joint statement on the deregulation of new GMOs. Protect the business of small and medium size breeders, farmers, and the organic and non GMO sectors in the EU", 11 February 2025.9 European Commission, "Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety", Official Journal, No. L 031, p. 0001–0024, 1st February 2002. Antoine VEPIERRE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [80] => Array ( [objectID] => 14108 [title] => When lexical confusion serves political purposes [timestamp] => 1762905600 [date] => 12/11/2025 [annee] => 2025 [url] => https://infogm.org/en/when-lexical-confusion-serves-political-purposes/ [image] => https://infogm.org/wp-content/uploads/2026/03/Noun_disorientation_Nithinan_2452297.svg_.png [extrait] => Plants and fungi genetically modified using CRISPR or other “targeted mutagenesis” techniques, genetically modified organisms (GMOs) designated by the acronym "NGT" for “new genomic techniques”... These various expressions are used in speech and writing by many legislators and scientists, even though they are inappropriate. But they are used for an explicit purpose: to obtain the deregulation of a very large number of GMOs by systematically removing the words “genetically modified”, which cause public mistrust. [chapo] => Plants and fungi genetically modified using CRISPR or other “targeted mutagenesis” techniques, genetically modified organisms (GMOs) designated by the acronym “NGT” for “new genomic techniques”… These various expressions are used in speech and writing by many legislators and scientists, even though they are inappropriate. But they are used for an explicit purpose: to obtain the deregulation of a very large number of GMOs by systematically removing the words “genetically modified”, which cause public mistrust. [texte] => Directive 2001/18 is currently the European legal text defining GMOs and regulating their release into the environment. According to this directive, a GMO is “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”. With this definition, the legislator has taken into account both the method used to genetically modify an organism and the genetically modified organism itself. In other words, the legislator defines these organisms by reference to the method used to genetically modify them. The terms used are deliberately those of everyday language, as this is a legal text and not a scientific publication opened to controversy like any scientific publication thereby enabling science to progress. Above all, this definition is much broader than that of “transgenesis”, a term that, it is to be noted, never appears in this directive. However, in order to further its plans to deregulate plant GMOs, the Commission has used, if not abused, biased semantics, as we shall see.“Tools” give their names to complex protocolsSince the debate on the new techniques of genetic modification of plants began, the vocabulary used has been ambiguous, even misleading. Initially, the term “New Breeding Techniques” was commonly used in communications by proponents of GMO deregulation.... The term “breeding techniques” is more marketable than “techniques of genetic modification” as it is now understood by the public. But this expression was eventually replaced by “new genomic techniques”. This latter is confusing on several levels. The first is the acronym NGT itself, used to refer to “NGT plants” instead of “GM plants”, which is what these organisms actually are. The second confusion is the expression “NGT plants” which means nothing. In fact, once the acronym has been developed, talking about NGT plants as the Commission does means talking about “new genomic techniques plants”. This is like naming an organism after a technique, as if a child were named natural birth or cesarean section. It is clear that placing organisms and techniques on the same level is a deliberate manipulation of the meaning of words. Some are more rigorous and refer to “plants derived from NGT”.Another semantic abuse is to talk about “organisms modified by Crispr”. In this case, the complex technical and experimental protocol is reduced to the mere designation of one of the many tools used in such a protocol. The consequence? Many members of the European Commission, Parliament, or Council of the European Union ignore, forget, neglect, or fail to mention that modifying an organism, for example using the CRISPR tool, involves other tools and methods depending on the protocols chosen. For example, it is common to use isolated plant cells grown on artificial media loaded with chemicals, most of which are mutagenic, and to use transgenes so that the cells can synthesize the “Cas” molecules that are essential for any use of Crispr/Cas techniques, artificial genetic sequences to bring about the desired genetic modification in the nucleus of the target cells, hormones to generate a plant from isolated cells while inducing new “unintended” genetic or epigenetic modifications that are known but never sought afteri...Names of methods designed to create confusionThe regulatory debate currently underway is based on a proposal made by the European Commission in July 2023ii. This proposal, which requires an amendment to Regulation (EU) 2017/625 (which applies only to products intended for human and animal consumption), changes the very definition of a GMO to which it applies. It thus excludes from the definition GMOs obtained by mutagenesis and cell fusion techniques developed mainly before 2001 and whose safety has therefore been proven for a long timeiii. Under current legislation, these GMOs are exempt from the application of this directive, but they are still GMOs according to Directive 2001/18 concerning - like the proposed new regulation - the release into the environment. This exclusion therefore nullifies an objective and verifiable time criterion (the date of 2001). It also justifies the deregulation of “new GMOs”, declared "equivalent" to the old exempted GMOs, to which are discreetly added those derived from “advanced techniques such as embryo rescue, induced polyploidy, and bridge crosses”... Especially since “such as” means that there may be others that will inevitably appear in the regulations themselves, as both technology and social acceptance of those new genetic manipuations evolve.While terms such as CRISPR, NGT, cisgenesis, “targeted mutagenesis” and “directed mutagenesis” are regularly mentioned, it seems beneficial to return to the text itself. In its proposal, the European Commission focuses on “plants obtained through certain new genomic techniques” and their commercialization (in food, in the environment, etc.). Not all new techniques, but certain ones! It specifies that one of the two “new genomic techniques” in question is “targeted mutagenesis”, defined as “mutagenesis techniques resulting in modification(s) of the DNA sequence at precise locations in the genome of an organism”. However, many so-called “random” mutagenesis techniques are targeted when they can be reproduced by a skilled person who wants to obtain the desired mutation and the associated patented trait.If we add the proposed definition of “cisgenesis”, which would be a technique “of genetic modification resulting in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool”, the reader is left with legal definitions proposed by the European Commission in language that is intended to be “scientific” but is surprisingly imprecise, even false, since cisgenesis is traditionally (in most cases) a specific technique of transgenesis, but rarely a NGT. This imprecision also allows the European Commission's annex to ultimately propose nucleotide substitutions as well as deletions and insertions of sequences without size limits. The full range of possible modifications, with the exception of the definitive insertion of transgenes…The vagueness and confusion surrounding the terms used have been the basis for arguments in favor of deregulating GMOs. As a result, the vocabulary used by the European Commission in its proposal is not free from ambiguity. This is a paradoxical situation, since the simplicity of the definition provided by Directive 2001/18, the legislation governing GMOs since 2001, makes it all the clearer: a GMO is “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”.i See the example of waxy maize of Dupont/Pioneer (now Corteva), in :Annick Bossu and Eric Meunier, « Les mots à la base de la stratégie des multinationales », Inf’OGM, le journal, n°173, October/December 2023.ii European Commission, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 », 5 July 2023.iii See note 2, article 3. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [81] => Array ( [objectID] => 14086 [title] => More words, always words… [timestamp] => 1762473600 [date] => 07/11/2025 [annee] => 2025 [url] => https://infogm.org/en/more-words-always-words/ [image] => https://infogm.org/wp-content/uploads/2026/03/Il_faut_se_mefier_des_mots_15831849596-768x1152.jpg [extrait] => For several years, Inf’OGM has been working to monitor and decipher the words used by multinationals and legislators in discussions about GMOs, industrial property or the digitisation of living organisms. The choice of words is by no means insignificant, and naming a subject, a tool or elements of nature contributes to a good understanding of the issues at stake... or to maintaining confusion! [chapo] => For several years, Inf’OGM has been working to monitor and decipher the words used by multinationals and legislators in discussions about GMOs, industrial property or the digitisation of living organisms. The choice of words is by no means insignificant, and naming a subject, a tool or elements of nature contributes to a good understanding of the issues at stake… or to maintaining confusion! [texte] => In this new series of articles, Inf'OGM addresses the case of several terms deliberately used by manufacturers, the European Commission and certain legislators for strategic purposes. For example, we will look at the confusion between tools (e.g. Crispr), techniques (e.g. mutagenesis) and methods (e.g. technical protocols for genetic modification), the issue of precision, targeting and control of genetic modification techniques, and the equivalence of plants. These articles complement the cases already discussed in the past, which we summarise in this first article.The artificialisation of nature in order to appropriate itIn early 2021, as debate began to emerge over the legal status of digital sequence information (genome or proteome sequences stored on computers), Inf’OGM addressed the semantic issue of “genetic resources”i.This expression, used originally in 1967 at the International Conference on Crop Plant Exploration and Conservation, organised by the FAO, was taken up at the Earth Summit in Rio in 1992 by the Convention on Biological Diversity (CBD). This international convention establishes that a ‘genetic resource’ is ‘genetic material of actual or potential value’, also linking it to non-physical intangible components such as traditional knowledge. In 2014, the Nagoya Protocol differed slightly from this definition by referring to ‘the genetic and/or biochemical composition of genetic resources’. But the term ‘resources’ itself is at the heart of a utilitarian view of nature. As Annick Bossu and Christophe Noisette explained in their article published by Inf'OGM, this term places ‘living organisms in an extractivist industrial vision [...] as a material goods’. When the adjective ‘genetic’ is added, it encompasses all living things, plants, animals and micro-organisms, reducing them to genetic sequences alone. Similarly, the patent directive refers to ‘biological material’.Due to the improvements in the storage conditions for physical resources and the ability to sequence genetic sequences quickly and cheaply, then store them in computers, the doors to the appropriation of living organisms (via patents) are opening a little wider. Indeed, dematerialising organisms by recording certain sequences of their genome, certain proteins, etc. in computer databases makes these sequences accessible to companies, which aim to make a market out of them. Even if they do not find what they are looking for, algorithm factories will find ways to respond to the expectations of manufacturers. As a symbol of the importance of words, for these companies, ‘genetic resources’ recorded in a computer cannot be described as ‘physical’. According to European and North American industries and governments, they have no connection with biological samples. They should therefore not be subject to the protection of biological diversity, established in particular by the CBD, even though the patents that these companies apply for on the basis of digitised sequences apply to the living organisms that make up that biological diversity...‘Microorganism’, a term used to enable patents on organismsIn July 2023, the European Commission announced that it would propose a regulation concerning GMO plants obtained using new techniques of genetic modification. In this wording, the term ‘plants’ was then interpreted unambiguously, with the clarification that this text would not apply to micro-organisms and animals. In September 2025, however, Inf'OGM reported that some micro-organisms were indeed covered by this proposal, explaining that the legal concept of the term ‘micro-organism’ varies from one text to another, to the extent that it can even refer to complete organisms that are not ‘micro’ at allii.As a starting point for semantic monitoring, in 1990 the European legislator defined a microorganism as ‘any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material’. This definition was adopted as part of the directive regulating the use of genetically modified microorganisms. In another context, that of patents, it was in 1995 that the European Patent Office (EPO) decided that this term also applied to isolated plant and animal cells, even though they are incapable of reproducing and transferring genetic material on their own, without the array of chemicals used in laboratories. However, for the EPO, ‘the term ‘micro-organism’ includes bacteria and other generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory, including plasmids and viruses and unicellular fungi (including yeasts), algae, protozoa and, moreover, human, animal and plant cells’. This list of examples of micro-organisms according to the EPO, which is broader than the one found in European legislation, allows multinationals to extend the scope of patents to any complete organism that has been obtained from plant or animal cells isolated in the first stage.However, it is an international text from 1977 that offers the broadest, if not absurd, definition of what a microorganism is. The Budapest Treaty, signed by 91 states, regulates the deposit of microorganisms as samples within international depositary authorities. In its annex listing the ‘microorganisms’ that can be deposited as samples, this treaty lists bacteria, viruses, protozoa... but also DNA, RNA, plasmids (i.e. molecules that by definition are not alive), embryos, nematodes (worms), and even seeds.Paradoxically, multinationals may defend the opposite position when their interests require it. For example, within the Cartagena Protocol, which regulates the transboundary movement of GMOs, some companies argue that they want "to exclude from the scope [of the Cartagena Protocol] certain products derived from modern biotechnologies, such as RNAi pesticides, vaccines, viruses… because they are not themselves living organisms, even though they are disseminated with the aim of modifying the genome or epi-genome of living organisms", according to Guy Kastler in an analysis published by Inf'OGMiii. Legally considering certain products to be micro-organisms in order to obtain patents, while at the same time claiming that they are not organisms in order to avoid the obligations of GMO regulation... A real art in itself…The legal definition of a GMO at the heart of political negotiationsSince December 2024, European Union Member States have been debating the semantics of the very definition of a GMO, which has been legally established since 1990iv. This work clearly reflects that the interpretation of words, taken together or separately, is of great importance when it comes to legal texts, as they define what the law applies to.On the initiative of the Netherlands, a discussion has therefore begun on several words in the definition of a GMO provided by Directives 2001/18 (GMOs) and 2009/41 (GM microorganisms), namely ‘an organism [or microorganism], with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination’. Which words are Member States raising questions about in terms of interpretation? According to the Netherlands, several words need to be discussed in order to align the approaches taken when implementing the definition of a GMO.Thus, the expression ‘has been modified’ could be interpreted in two different ways. For some Member States, all descendants of a GMO would also be GMOs, while for others, the descendants could be considered non-GMOs. The expression ‘in a way that does not occur naturally’ is also debated. Some States interpret it as referring to the technique, while others consider that it refers only to the genetic modification obtained. In the latter case, this would be a significant reversal in the application of European legislation on GMOs, which has always been implemented taking into account both the genetic modifications obtained and the way in which they have been obtained.One final expression deserves attention, namely ‘with the exception of human beings’. According to the Netherlands, some Member States consider that human cells and tissues can be regarded as GMOs if genetically modified, because these human cells, like human tissues, are not ‘human beings’ in the strict sense of the term! Such an interpretation would open the door to genetic modifications, initially on human tissues. And then...The examples of semantics we have just seen already illustrate that the interpretation of words is still of great importance in the strategy aimed at appropriating living organisms while avoiding as many regulatory frameworks as possible, even if it means arguing everything and its opposite depending on the forum for discussion. In future articles, we will see how semantics continues to be a tool for circumventing existing frameworks and, in the case of GMOs, even deregulating them.i Annick Bossu and Christophe Noisette, « « Ressource génétique » : une mauvaise expression », Inf’OGM, le journal, n°162, January/March 2021.ii Denis Meshaka and Eric Meunier, « “Microorganism”: uncertainty in wording as a legislative strategy? », Inf'OGM, 10 October 2025.iii Ibid.iv Eric Meunier, « The European Union discusses its definition of a GMO », Inf'OGM, 16 April 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [82] => Array ( [objectID] => 14098 [title] => GMO/NGT Regulation: civil society organisations concerned about the outcome of the trilogue [timestamp] => 1762300800 [date] => 05/11/2025 [annee] => 2025 [url] => https://infogm.org/en/gmo-ngt-regulation-civil-society-organisations-concerned-about-the-outcome-of-the-trilogue/ [image] => https://infogm.org/wp-content/uploads/2026/03/Edvard_Munch_-_Anxiety_-_Google_Art_Project-768x990.jpg [extrait] => As the trilogue on the regulation of new genomic techniques (NGT) continues, civil society organisations are expressing their concerns about the outcome of the discussions, particularly on the issue of patents. This is evidenced by two recent position statements: those of the European Coordination Via Campesina (ECVC) and Arche Noah, which illustrate their mobilisation around this crucial debate at a key moment when European decisions are being made. [chapo] => As the trilogue on the regulation of new genomic techniques (NGT) continues, civil society organisations are expressing their concerns about the outcome of the discussions, particularly on the issue of patents. This is evidenced by two recent position statements: those of the European Coordination Via Campesina (ECVC) and Arche Noah, which illustrate their mobilisation around this crucial debate at a key moment when European decisions are being made. [texte] => The outcome of the ongoing trilogue (negotiations between representatives of the Parliament, the Council and the European Commission) on the NGT regulation remains uncertain, particularly with regard to patents covering GMOs obtained through these techniques. ECVC and Arche Noahi have analysed the positions of the European Parliament and Council. Each organisation presents its opinion in its own briefing note ii,iii. These briefs come at a strategic moment in the trilogue, when decisions are being made and the impact studies on patents requested by the European Commission in July 2023iv could either reduce or reinforce their concerns. We highlight two aspects of these briefs that are important in the debate: the "breeder's exemption" and the traceability of products derived from NGTs.Extending the "breeder's exemption"The ongoing discussions concern a fundamental issue relating to patents, which has recently become more prominent: the "breeder's exception"v. In plant variety rights law, this exception allows breeders to freely use varieties covered by a plant variety right (PVR) to select new varieties, without seeking authorisation from the rights holder or paying licence fees. This principle guarantees open access to plant material and, at first glance, encourages diversity in the commercial supply of new seeds. However, in European patent law, this exception is currently limited to experimentation and research. However, this remains insufficient to preserve freedom of selection in the face of the expansion of patents on genetic sequences or information present in plants derived from peasant or traditional selection. Thus, the idea of creating a "total exemption for breeders", leaving breeders free to use patented biological material to select and market new varieties, is gaining ground. This mechanism is described as follows by German lawyers Metzger, Hertz and Kockvi : "While the use of a patented process for making of a NGT plant still requires a license, the use of the NGT plants by breeders, who create and commercialise new plant varieties, would not be covered by the patent. The limitation will apply to all existing patents and patent applications".Arche Noah supports this proposal for a total exemption for breeders. The association criticises the current European patent system for ignoring the breeder's exemption by preventing the use of patented material (containing, for example, a gene associated with pest resistance) to develop and market new varieties. Arche Noah believes that this restriction hinders innovation and limits crop diversity. In its briefing note, the NGO clarifies its position on total exemption: "Breeders would no longer be require authorisation from the patent holder or need to pay license fees if they develop (or have developed) a variety with the same characteristics, provided they have not used the patented process and they use essentially biological processes such as crossing or selection (but not exclusively)". Arche Noah extends its position to the situation of farmers: "In the same spirit, farmers who multiply or propagate a variety with the same characteristics as the patent claim but obtained without using the patented process, may also do so without authorisation of the patent owner".It is on this last point that ECVC, as a farmers' organisation, places particular emphasis. It considers that patents on seeds threaten not only the work of breeders, but also the fundamental rights of farmers to save, exchange and reuse their seeds. For ECVC, the concentration of power in the hands of a few multinational seed companies increases farmers' dependence and undermines food sovereignty. The organisation, which has always opposed the International Union for the Protection of New Varieties of Plants (UPOV) since its 1991 reform, cites, without endorsing it, the existence of this request for total exemption for breeders made by many seed companies and taken up by Arche Noah. It refers to the fact of "aligning patent law with the European Unitary patent and UPOV provisions that allow a breeder to freely reuse a variety covered by a PVR to select a new one. The variety may then only be marketed after removal of the patented biological material or genetic information". ECVC points out that this solution, "while this solution does have merits for the seed sector, it does not in any way resolve the major risks that farmers will face if NGTs are deregulated: being banned from using and reusing their own seeds, an obligation to pay royalties for certain species, biopiracy, risk of infringement proceedings and seizure of their harvest, etc".Limiting the scope of patents via this "total exception" can be considered without having to amend the European Patent Convention. Such a revision is, in any case, unrealistic in the short termvii. This would involve introducing articles specifying a new rule for the application of patent law that takes into account recent developments in genetic modification techniques, directly into European Directive 98/44 (supplementing Articles 8 and 11) and/or into the national patent laws of EU Member States. Such a change would affect all patents already granted as well as pending patent applications.Traceability and infringementAnother aspect of the subject of "patents and NGTs" appears unsurprisingly – because it is fundamental – in the ECVC technical note: the obligation of "analytical traceability" for plants derived from NGTs. As the organisation points out, the removal of the obligation to publish the methods for detecting and identifying GMOs – as currently required by European Directive 2001/18 and which the proposed new NGT regulation aims to remove – would allow "abusive extension of the scope of patents to peasants’ or conventional seeds that have been accidentally contaminated, or that present a trait similar to the patented trait without having used the patented invention". Such a measure would effectively place farmers, small seed producers and the GMO-free sector in a situation of serious legal uncertainty: they would not know whether they were growing or marketing patented plants or seeds and, moreover, they could see their traditional seeds confiscated by new patents covering their "native traits". This would have a fundamental impact on their work and their income. This abuse of patents would place most of them in an impossible situation: having to prove that they have not used a patented process to obtain their seeds. This is known as "reversing the burden of proof".Arche Noah refers to infringement on several occasions, also highlighting the burden of proof of non-infringement that threatens small and medium-sized breeders. However, the NGO does not explicitly link this to the issue of traceability: "Limiting the scope of patents granted on NGTs/GMOs and applying fair proportionate rules on the burden of proof would also provide plant breeders, farmers and food processors who do not work with NGTs or regulated 'old' GMOs the freedom to operate and innovate without concerns of patent infringement." Seed producers who registered and marketed their varieties before a competitor claimed a new patent can easily prove that they did not use the patented invention. But this is not the case for farmers, who have no way of proving the genetic composition of seeds from their own selections that they have never sequenced or registered.The requirement for traceability, not only in terms of documentation but also in terms of the publication of detection and identification processes, is therefore the cornerstone of the protection of farmers' rights against the risks of patent infringement, not to mention the risks resulting from accidental contamination. This requirement, introduced in Directive 2001/18, filled a gap in the "biotech inventions" Directive 98/44/EC. Why should it no longer be maintained today, at least in patent law, if it is unfortunately removed from GMO/NGT law?The European debate on NGTs is at a decisive moment, with farmers and consumers potentially being led to cultivate or consume GMOs without their knowledge. While the Commission supports the position of a seed industry that wants to make these new GMOs "invisible" in fields and supply chains, civil society organisations are advocating for limited or total transparency requirements. Another form of invisibility affects small seed producers and farmers faced with the complexity and opacity of patents covering plant materialviii: the persistence, until 2037, of old patents on products derived from essentially biological processes, with only new patents being - theoretically - impossible to obtain since july 2017ix.An outcome that is cause for concernWhile Arche Noah calls for a complete overhaul of European legislation on patents on life forms, ECVC supports their total ban and, in the short term, a structural but pragmatic transformation, fuelled by the defence of farmers' rights. It should also be noted that a significant legal divergence remains between the two organisations regarding random mutagenesis. Arche Noah considers that it should be expressly excluded from patentability, as it is considered a conventional method, while ECVC warns against its impossibility without illusory short-term modification of the European Patent Convention and cautions against industry propaganda presenting this solution as the only strategic escape routex.As the European trilogue enters its decisive phase, ECVC and Arche Noah each hope to influence what could be the last opportunity for the European legislator to regulate the crucial issue of patents on GMOs derived from NGT or on NGT itself. The coming months will be decisive in determining whether the final text of the regulation will take into account the concerns raised by these two organisations and, more broadly, by other civil society actors. If not, it could perpetuate a system that allows for patents that are as opaque as they are powerful, effectively ignoring the breeder's exception to plant variety rights and depriving small farmers of their seed freedom.At the last trilogue session, discussions focused mainly on the definition of NGT1 (amendments to Annex 1xi) and traceability. The Parliament also appears to have softened its "anti-patent" stance on NGT, indicating that it could "deviate from the total ban"xii. Amendments were also proposed to remove the labelling requirement, which was intended to provide simple, factual information on the presence or absence of GMOs in cultivated seeds and commercialised products covered by patent rights.i Arche Noah, an Austrian association for the conservation and development of crop diversity, defines itself as an NGO (non-governmental organisation) European Union, Accredited organisation, "ARCHE NOAH GESELLSCHAFT FUR DIE ERHALTUNG DER KULTURPFLANZENVIELFALT UND IHRE ENTWICKLUNG VEREIN".ii Arche Noah, "Briefing on Patents on NGT plants and processes", September 2025.iii ECVC, "Patents on GMOs-NGTs: State of play and solutions to protect farmers, smallbreeders, and the GMO-free sector", October 2025.iv European Commission, "Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions", 5 July 2023.v Eric Meunier, "Patents and the evolution of Plant Breeder ‘s Right (PBRs)" Inf'OGM, le journal, No. 176, July/September 2024.vi Axel Metzger et al., "Mitigating impact of patents on plants obtained from New Genomic Technique (NGT)", 27 January 2025.vii This type of change affecting the basic principles of the EPO (European Patent Office) patent system would require consensus among the member states of the European Patent Convention (EPC), which also includes countries that are not members of the European Union. This generally requires a diplomatic conference.viii Denis Meshaka, "De Bolster: another Dutch SME under patent threat," Inf'OGM, 22 July 2024.ix Zoé Jacquinot, "Produits issus de procédés biologiques : finalement non brevetables", Inf'OGM, 4 June 2020.x Denis Meshaka, "'Essentially biological process', a definition shaken up", Inf'OGM, 22 April 2024.xi Trilogue on GMOs/NGTs, "ANNEX I - Criteria of equivalence of NGT plants to conventional plants," October 2025.xii Maria Simon Arboleas and Sofia Sanchez Manzanaro, "Gene-editing talks inch forward as MEPs soften on patent ban," Euractiv, 14 October 2025. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [83] => Array ( [objectID] => 14070 [title] => The European Commission is more attentive to biotech companies than to citizens [timestamp] => 1761868800 [date] => 31/10/2025 [annee] => 2025 [url] => https://infogm.org/en/the-european-commission-is-more-attentive-to-biotech-companies-than-to-citizens/ [image] => https://infogm.org/wp-content/uploads/2026/03/eu-biotech-alliance-930x515-1-768x425.png [extrait] => In early August, the European Commission launched a multilingual online public consultation on its forthcoming "Biotechnology Regulation". Presented as an exercise in transparency and citizen participation, the questionnaire is in fact primarily designed to gather the industry's position. In particular, it does not address the ethical and civic dimensions raised by new genome editing techniques (NGTs), such as health risks, the appropriation of living organisms by industry, or the management of health data. This regulation could offer the Commission and multinationals a way out if current or past negotiations on other legislative acts fail to achieve their objectives. [chapo] => In early August, the European Commission launched a multilingual online public consultation on its forthcoming “Biotechnology Regulation“. Presented as an exercise in transparency and citizen participation, the questionnaire is in fact primarily designed to gather the industry’s position. In particular, it does not address the ethical and civic dimensions raised by new genome editing techniques (NGTs), such as health risks, the appropriation of living organisms by industry, or the management of health data. This regulation could offer the Commission and multinationals a way out if current or past negotiations on other legislative acts fail to achieve their objectives. [texte] => The public consultation on the "Biotechnology Regulation"i launched in August by the European Commission (EC) is part of the European Union's (EU) 2024-2029 "Competitiveness Strategy", which aims to "to create an enabling environment to accelerate the transition of biotech products from laboratory to factory to the market "ii. Unsurprisingly, the key words that dominate this 47-page document are: competitiveness, economic growth, innovation, investment... On the other hand, biotech issues that are close to citizens' hearts, such as the assessment of health and environmental risks, the artificialisation and appropriation of living organisms, and the potential impacts on biodiversity, are ignored. Furthermore, certain questions appear to have been formulated or chosen in such a way that answers can only be found within the industrial sector or among a seasoned audience, as evidenced by the titles of sections 1 to 7 of the document (see box). Is this to provide biotech companies with legislative tools that they would not have obtained elsewhere?Questions that are not very accessibleThe online consultation on the Biotechnology Regulations is intended for a very broad audience: "citizens, innovators, entrepreneurs, industry, financial institutions, investors/venture capitalists, researchers/research organisations, civil society (including consumer, patient and environmental organisations), other users of biotechnology (e.g. farmers and foresters), trade unions, national and regional authorities and any other stakeholders". The aim of this consultation is to ensure that "all stakeholders have the opportunity to express their views and share insights on the main challenges faced by the [biotechnology] sector". However, the majority of the questions asked remain fairly general and/or require significant prior knowledgeiii.Not all of these questions are clearly accessible to the general public, particularly civil society and non-specialist citizens, even though they are the ones most directly affected. Even NGOs and small businesses may find it difficult to provide relevant answers. Take, for example, the first three questions in Section 1, which illustrate the very broad and sometimes abstract scope of the questions: "Biotechnology and biomanufacturing products can positively impact the EU economy (Question 1), the EU society (Question 2) and the environment (Question 3)". The expected responses (as for the entire questionnaire) are formulated on a Likert scale – from "strongly disagree" to "strongly agree" – which requires an overall assessment capacity that not all audiences necessarily have.Another illustrative example concerns question Q1 in Section 2: "Taking into account recent initiatives and legislation adopted or under discussion at EU level, to what extent do you agree with the following statement : EU rules lead to regulatory barriers for biotechnology and biomanufacturing products to reach the market in the following phases...". Several technical development phases (pre-clinical, pre commercial trials, clinical trials, etc.) for such products are then proposed, with the same Likert scale response options. The complexity of the exercise, or even the impossibility of completing it, is obvious for several profiles of the public surveyed.These questions from the Commission also convey positive assumptions ("positively impact the EU economy"), as talking about a "negative impact" would be less in line with its initial objective of competitiveness. As we shall see, these choices of words, reflecting the stance of biotech companies, influence the responses.Closed and leading questionsThe questionnaire uses closed-ended questions that guide the responses. Question 3 (Section 1) above on the "positive impact" of bioproduction on the environment illustrates this logic. This is also the case for the following question (Question 4), which asks about the statement: "Biotechnology and biomanufacturing products that reach the EU market are safe and secure." The public surveyed must take a position on such very general statements. No questions address the conditions necessary to guarantee such safety, nor the scientific uncertainties or post-marketing monitoring mechanisms. Furthermore, a response of "not applicable" or "I don't know" to this type of question can be interpreted as a lack of opposition, a classic statistical bias in this type of survey.Through these very broad and binary formulations, the questionnaire does not seek to shed light on the conditions under which these "positive effects" of biomanufacturing products are possible, nor on health risks, monitoring mechanisms, traceability or the management of scientific controversies. The phrase "products are safe and secure" (Section 1) is based on the assumption that safety has already been established. It is formulated as a statement to be approved or rejected, with a positive framing that may suggest that the statement is true. However, the issue of safety is precisely the subject of regulatory debate. Instead of asking whether the products are actually safe, the Commission is in fact asking whether we agree with its statement, which is not neutral. Above all, if the answer is yes, would the EC consider completely dispensing with risk assessment, since the assumption would be that there is no risk?Furthermore, by referring to “perceived regulatory barriers” (Section 2), the Commission suggests that these rules are inherently problematic. The question is biased, as it invites respondents to consider existing regulations on "market entry for biotechnology products and products derived from biomanufacturing" as an obstacle, rather than neutrally assessing their role in protecting health and the environment, for example.Missing or incomplete questionsBeyond the various complex, closed or biased questions, this questionnaire is also problematic due to its omissions and the fact that it ignores several important topics. This is particularly the case with the deregulation of GMOs obtained through certain new genome editing techniques, which is a crucial issue. Although the European Union has been debating this issue since July 2023, no specific questions are asked about labelling, traceability, let alone the possible effects of these technologies on agriculture, food and the environment. The same is true for the subject of biocontroliv, which is not mentioned at all. By diluting these topics into broad categories ("agriculture" and "environment"), the Commission is giving itself the leeway it needs to aggregate the responses and draw its own political conclusions.Furthermore, although this is a genuine democratic issue, the section on health data is addressed in a partial manner and from a single perspective: its value for “research and innovation”. Section 7 of the questionnaire, devoted to the European Health Data Space (EHDS)v, which came into force in March 2025, effectively highlights the usefulness of such data for biotechnology, without any specific questions on the overall democratic governance of this sensitive data, in particular the consent of the patients concerned or the protection of such data...Among other illustrations of such gaps or omissions, we can also mention the subject of intellectual property in the biotechnology sector, which is presented as a "factor driving investment", an "insufficient skills" and therefore one to be strengthened within this sector... Nothing is said about confiscatory patents on living organisms, the challenges of equitable access to plant genetic resources, and the concerns this raises among citizens, farmers, seed producers, and others.Excluding citizens from essential debatesPresented as an exercise in transparency, this consultation on the future "Biotechnology Regulation" resembles a survey designed to allow the results to be interpreted as reflecting European support. By favouring closed questions, avoiding certain sensitive topics and framing the debate from an essentially economic perspective, this consultation effectively excludes a significant portion of the public, namely those who are directly affected: citizens. Yet the topics covered are of general interest: food security (and even sovereignty), public health, the appropriation of living organisms, the small-scale farming model, etc.The consultation is open until 10 November 2025. It remains to be seen whether citizens, NGOs and other critical organisations will be able to make their voices heard in a framework that, for the moment, seems designed to reduce their influence rather than recognise it.Summary of the "Public questionnaire to gather data for the development of European legislation on biotechnology"Section 1 — General views on biotechnologySection 1* — Presence of business in the EU marketSection 2 — The regulatory environment in the EUThe following questions seek to collect views on the regulatory environment in the EU, in particular the perceived regulatory barriers.Section 3 — Access to capitalThe following questions seek to collect views on access to public and private capital and related barriers.Section 4 — Biotechnology clusters and/or cluster organisationsThe following questions seek to collect views on biotechnology clusters and/or cluster organisations in the EU.Section 5 — Biotechnology manufacturingThe following questions seek to collect views on biotechnology manufacturing in the EU.Section 6 — Availability, upskilling and reskilling the biotechnology workforceThe following questions seek to collect views on the needs of the workforce in biotechnology in the EU.Section 7 — Data and Artificial IntelligenceThe following questions seek to collect views on the challenges related to access to data and on the development, deployment and use of Artificial Intelligence (AI) in biotechnology.i European Commission, Public Consultation on the "Biotechnology Act", 4 August 2025 - 10 November 2025.ii Denis Meshaka, "The European Commission wants its 'biotech revolution'", Inf'OGM, 11 February 2025.iii European Commission, "Public questionnaire to gather data for the development of European legislation on biotechnology".iv The use of GMOs to combat organisms considered harmful, but also RNA, for example.Christophe Noisette, "Le biocontrôle : un terme récent et problématique", Inf'OGM, le journal, no. 177, October/December 2024.v Denis Meshaka, "The European Commission postpones its 'biotech law' once again", Inf'OGM, 3 June 2025. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [84] => Array ( [objectID] => 14040 [title] => The Asilomar 2025 conference, a pipe dream [timestamp] => 1761091200 [date] => 22/10/2025 [annee] => 2025 [url] => https://infogm.org/en/the-asilomar-2025-conference-a-pipe-dream/ [image] => https://infogm.org/wp-content/uploads/2026/03/collection-miroir-a-alouettes-768x576.jpg [extrait] => The Asilomar Conference (California, United States) on ‘recombinant DNA’ was organised in 1975 by molecular biology researchers. Its aim was to define the safety conditions necessary for handling genetically modified bacteria shortly after the first attempts at transgenesis.Today, despite their medical, agricultural and environmental promises, biotechnological advances, combined with other technologies such as ‘artificial intelligence’, are above all a sword of Damocles hanging over all living things. In 2025, a new Asilomar conference failed to produce a joint statement by the participants. [chapo] => The Asilomar Conference (California, United States) on ‘recombinant DNA’ was organised in 1975 by molecular biology researchers. Its aim was to define the safety conditions necessary for handling genetically modified bacteria shortly after the first attempts at transgenesis.Today, despite their medical, agricultural and environmental promises, biotechnological advances, combined with other technologies such as ‘artificial intelligence’, are above all a sword of Damocles hanging over all living things. In 2025, a new Asilomar conference failed to produce a joint statement by the participants. [texte] => The 50th anniversary of the Asilomar Conference provides an opportunity to recontextualise the conditions under which it was held and to recall the fears of the time. Other conferences followed in the wake of the first, and the one in February 2025, entitled "The Spirit of Asilomar", is an opportunity for Inf'OGM to take stock of some of its aspects, particularly societal and ethical ones.The early 1970s: the beginnings of transgenesisIn 1971, following the discovery of restriction enzymes, "tools" that, like the current Crispr/Cas, can split DNA, biochemist Paul Berg1 and his colleagues at Stanford University (United States) planned to insert a fragment of DNA from the SV40 virus, a simian virus2, into the genome of the bacterium Escherichia coli. In fact, an intermediate step was necessary, involving a virus that attacks bacteria, the bacteriophage lambda3. This was one of the first known attempts at transgenesis, then known as gene "cloning" or recombinant DNA techniques. However, the final step, which consisted of placing the recombinant DNA into Escherichia coli, could not be completed in the original experiment. Why?These technical achievements raised concerns. A colleague of Berg's4 drew his attention to the fact that SV40 was known to cause cancerous tumours in mice; wasn't there a risk that these manipulations could create carcinogenic bacteria that could escape from the laboratories? Later, in 2008, Paul Berg wrote: "We therefore decided to postpone our experiments until we were certain that this risk did not exist. Most researchers, like myself, recognised that this new technology opened up extraordinary prospects for genetics and could ultimately lead to exceptional opportunities in the fields of medicine, agriculture and industry. But we acknowledged that the unbridled pursuit of these goals could have unforeseen and harmful consequences for human health and terrestrial ecosystems"5. This concern about risks led to a moratorium on genetic manipulation under a newly established "precautionary principle": "If we had any courage at all, we would tell people not to conduct these experiments until we know where they are leading us," suggested biologist Norton Zinder in 19746. Their fears were mainly motivated by the risk that their research could lead to the development of biological weapons, with the shadow of the Manhattan Project7 still looming large.The 1975 Asilomar ConferenceHeld in the United States in February 1975, the Asilomar Conference resulted in the lifting of the moratorium and the establishment of "safety rules". The era of "genetic engineering" and then biotechnology could begin. How can this change of direction be explained?This international conference, attended by around 150 people, mostly biochemists or molecular biologists, including some of the project's initiators such as Paul Berg, was held behind closed doors. Lawyers, journalists, a few politicians and doctors were also present. However, no social scientists or philosophers were there.Thus, by choosing to hold the conference behind closed doors and selecting the participants, the organisers "deliberately limited the discussions to technical risks, sidestepping broader societal and ethical challenges to make the issue more manageable for self-regulation"8. It was a closed circle.However, according to Paul Berg, the conference was heated, with some wanting to maintain the moratorium. But a turning point in the discussions took place: "What turned the debate around was the suggestion to assign a risk assessment to the different types of experiments being considered and to apply safety guidelines differently depending on the degree of risk"9.The main focus was on implementing containment measures, educating laboratory staff, and establishing biological barriers between genetically modified microorganisms and humans. In short, the aim was to manage risks and trust scientists in the field, who were supposed to be in control of their manipulations – a leitmotif that is still relevant today.Furthermore, this conference never considered the ecological and socio-economic impacts, particularly on agriculture, and did not anticipate the appropriation of living organisms through the patenting of genes and organisms. As for health risks, they did not take into account epigenetic phenomena, which were little considered in the 1970s, the era of "all genetics". In the same year as the conference, Robert Sinsheimer, a molecular biologist, stated: "At Asilomar, no explicit consideration was given to the broader social or ethical implications that the launch of this line of research might have, or to its role as a possible prelude to longer-term and larger-scale genetic engineering of the planet's flora and fauna, including, ultimately, humans"10.Today, the explosion of biotechnology, nanotechnology and digital technology is reshuffling the deck. This is all the more true as the private sector is becoming omnipresent in these fields, with many financial demands, which was not or only rarely the case in 1975.The "spirit of Asilomar" of 2025The summit "The Spirit of Asilomar and the Future of Biotechnology" was held in Asilomar from 23 to 26 February this year, 2025, on the occasion of the 50th anniversary of the 1975 international meeting11.The presentation of this spirit of Asilomar 2025 is appealing because it addresses current ethical concerns, linking them to quotes from the researchers who prepared the 1975 conference.Reading through the topics covered, the task ahead seemed daunting: "research on pathogens and biological weapons, artificial intelligence and biotechnology, synthetic cells, biotechnologies beyond conventional containment, defining the future of biotechnologies"12. However, a short summary published by the scientific journal Cell13 indicates that corporate interests were taken into account...The 2025 meeting, like the 1975 meeting, was a closed-door event with 300 selected participants, including representatives from the social sciences, the arts, journalism and NGOs, but above all many researchers in new biotechnologies, synthetic biology and "artificial intelligence" (AI), which would now be "beneficial". A conference organised in Asilomar by the Future of Life Institute in 2017 had also established principles for regulating "ethical" AI, to which Elon Musk is a signatory14.In the spirit of the 1975 conference, which was based on fears of potential risks to human health, the 2025 conference highlights the balance of benefits and risks of new technologies for human society. This effectively validates these technologies: there is no question of challenging them, no suggestion of a moratorium as in the early 1970s... This can be seen as an ideological step backwards. However, the transhumanist potential of synthetic biology and algorithms would require reflection prior to implementation. For example, we are now imagining bringing back extinct species through genetic manipulation, synthetic biology, or the use of stem cells (known as IPS)15. We are even considering "resurrecting the dead" through AI: a trained algorithm would be able to find digital traces of the deceased on the Internet, allowing their loved ones to communicate with them16! In an equally reductionist perspective, there is talk of creating digital twins of living beings to solve medical problems17, even though not all components of living beings can be digitised and many of them are unknown.Were these considerations taken into account at this year's Asilomar conference? No statement summarising the conference's conclusions has been published. However, a few requests for commitment or petitions have been presented18.For pathogenic microorganisms, for example, we see recommendations being considered for benefit/risk assessment, control and transparency of experiments, scenarios in the event of laboratory escapes, etc. The use of bioengineering in species conservation is encouraged, provided it is interdisciplinary. With regard to the release of GMOs into the environment, the aim is to mitigate risks while maximising benefits! The request concerning AI is clear: "Advances in AI promise to significantly accelerate beneficial biological discoveries and innovations and will undoubtedly be one of AI's most important contributions to humanity and society. However, AI methods can also increase the risk of accidents and enable malicious activities targeting deliberately harmful applications, such as the development of biological weapons." This is followed by a number of non-binding recommendations governing this technology.However, one request catches our attention. It "recognises that there are experiments and experimental objectives that should not be undertaken or pursued because the risks, as understood, far outweigh the potential benefits. These experiments and objectives should be defined by 'red lines' that science practitioners will not cross." The use of the conditional tense is significant here.In short, technologies are accepted without being questioned about their existence. Wishes and safeguards are simply proposed. Total control and unfailing reductionism can be read between the lines.Finally, the request regarding genetic modifications in the human species is empty: it calls for an international debate. We would like to point out that a declaration against the legalisation of human genetic modification called the International Coalition to Stop Designer Babies has been written and submitted for signature19.According to the testimony of a person present at the conference20, the main topic throughout the discussions was not safety or ethics, but how to remedy the public's lack of confidence in biotechnology. Various proposals were put forward: using public relations, encouraging "ethical innovation" and "community-based technology", etc. According to this participant, when the suspension of funding for some of these technologies by DARPA (the US military research agency) was mentioned, someone replied: "Then we would have no more projects." As for the risks, those that had been identified came mainly from "bad actors".This 2025 conference therefore falls short of the moral, ethical and intellectual standards one might expect. Could the lack of a joint statement be an admission of failure? On the contrary, it fits perfectly into a transhumanist rush forward dominated by economic interests. What if all this were just a cleverly crafted mirage?1 Nobel Prize in Chemistry in 1980.2 Vacuolating Simian Virus, a DNA virus discovered in rhesus macaques and found in polio vaccines."Simian Virus 40 - Definition," Techno-Science.net.3 The following year, another researcher perfected this technique by using a vector, a small circular DNA molecule, a plasmid capable of reproducing on its own within the bacterium.4 Robert Elliot Pollack, biologist and philosopher.5 Berg, P., "Asilomar 1975: DNA modification secured", Nature No. 455, pp. 290–291, 2008.6 The Spirit of Asilomar and the Future of Biotechnology7 Development of the A-bomb in the United States during the Second World War.8 Pat Thomas, "Frankenfoods – Chewing Over a Polarised Debate", A bigger conversation, 18 December 2024.9 Berg, P., "Asilomar 1975: DNA modification secured," Nature No. 455, pp. 290–291, 2008.10 The Spirit of Asilomar and the Future of Biotechnology11 "Summit | 'The Spirit of Asilomar and the Future of Biotechnology'," Inf'OGM.12 The Spirit of Asilomar and the Future of Biotechnology, "Programme".13 Molla, Kutubuddin A. et al., "The Spirit of Asilomar: lessons for the next era of biotechnology governance", Trends in Biotechnology, Volume 43, Issue 8, pp. 1809–1812, August 2025.14 Alexis Orsini, "The '23 Asilomar Principles' aim to regulate the development of artificial intelligence," Numerama, 1 February 2017.15 "Un mammouth 2.0 pour sauver le climat ?", Inf'OGM, 17 September 2025.Zoé Jacquinot and Olivier Leduc, "Bioéthique : qu’est-ce qui se cache derrière les cellules iPS ?", Inf'OGM, 10 February 2020.16 Valérie Mils, "Du rite funéraire au deadbot, notre lien aux morts réinventé", Toulouse Museum, 16 January 2025.17 Annick Bossu, Hervé Le Meur and Eric Meunier, "Vivant numérisé et technologisé : ayez confiance ou taisez-vous !", Inf'OGM, 11 March 2021.18 Rice Research Repository, "2025 'The Spirit of Asilomar and the Future of Biotechnology'," 2025.19 International Coalition Stop Designer Babies, "International Declaration Against Legalisation of Human Genetic Modification", 2025.20 Save Our Seeds, "The new 'Spirit of Asilomar': Move fast, don't ask questions," GMWatch, 15 May 2025. Annick BOSSU [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [85] => Array ( [objectID] => 13978 [title] => Soon genetically modified cocoa? [timestamp] => 1760659200 [date] => 17/10/2025 [annee] => 2025 [url] => https://infogm.org/en/soon-genetically-modified-cocoa/ [image] => https://infogm.org/wp-content/uploads/2026/03/Pepiniere_de_cacao-768x512.jpg [extrait] => On August 6, 2025, the agri-food group Mars acquired a license to use CRISPR tools from the biotech company Pairwise with the aim of developing genetically modified cocoa trees. If this partnership between the biotech and agri-food worlds is worth looking into, it is because it concerns the world leader in chocolate products, which has been interested in the issue for several years now. [chapo] => On August 6, 2025, the agri-food group Mars acquired a license to use CRISPR tools from the biotech company Pairwise with the aim of developing genetically modified cocoa trees. If this partnership between the biotech and agri-food worlds is worth looking into, it is because it concerns the world leader in chocolate products, which has been interested in the issue for several years now. [texte] => On August 6th, Mars and Pairwise announced having signed a partnership. This allows the agrifood giant Mars to obtain a license for the use of CRISPR tools from the biotech company Pairwise "in order to conduct research and development activities on cocoa". More specifically, Mars "aims to develop this advanced plant breeding technology in order to improve cocoa production". Carl Jones, director of plant science at Mars, aims to "help crops better adapt to climate challenges, disease pressures and resource constraints"1.Mars, a world leader in chocolateBeyond the chocolate bar of the same name, the Mars group also holds the brands M&M’s, Snickers, Twix, Balisto, Bounty, Milky Way, Skittles, Snickers,... which makes it the world leader in chocolate (more than 50 billion dollars in turnover in 2023)2. However, as mentioned by Claire Sergent on France Info, "cocoa comes mainly from Côte d'Ivoire and Ghana, but in recent years, production has dropped sharply. [...] The price of cocoa beans has quadrupled in three years'3. Mars thus suffers from these hazards. This partnership is therefore important for the company, which wishes to secure its supply through the development of GM cocoa trees.A project that datesThis investment by the company Mars had been announced for a long time. In 2010, the company, in partnership with the US Department of Agriculture (USDA) and the IT group IBM, already indicated having participated in the sequencing of the genome of the cocoa tree Matina 1-64. Then, in 2018, Inf'OGMreported the company’s promise to "invest one billion dollars to modify the cocoa tree genome with Crispr/Cas9, to allow these plants to survive modified climatic conditions"5.However, if in 2015 some scientists were promising to "ultimately contribute to the production of disease-resistant and high-yield cocoa trees", others stressed that "creating an ideal GMO chocolate will not be easy"6. Indeed, "finding the right blend of flavours, while ensuring disease resistance, rapid growth and high productivity" seems to be complex. And, in fact, 10 after these declarations of intentions and promises, there has still been no mention of GMO cocoa trees for commercial crops.We can see that, beyond the multinational seed companies, new genetic modification techniques are also of interest to the giants of the agri-food industry. With their investment and lobbying capabilities, these companies can quickly evolve research and legislation. If the proposal for the deregulation of GMOs derived from new techniques initiated by the European Commission were to be adopted, consumers could therefore find themselves eating GMO chocolate without their knowledge in the coming years.March already confronted with GMOs recentlyMars has also already had to deal with GMOs, but this time involuntarily. In 2021, for example, a contamination by GMO rice from India was reported in Europe. This rice had been used as an ingredient in processed products, such as sweets sold by Mars (M&M’s Crispy).0. Antoine VEPIERRE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [86] => Array ( [objectID] => 13962 [title] => “Microorganism”: uncertainty in wording as a legislative strategy? [timestamp] => 1760054400 [date] => 10/10/2025 [annee] => 2025 [url] => https://infogm.org/en/microorganism-uncertainty-in-wording-as-a-legislative-strategy/ [image] => https://infogm.org/wp-content/uploads/2025/09/24488127330_fe0569a494_c-768x512.jpg [extrait] => When reading legislation, one sometimes finds oneself thinking that it is a good thing that legislators are not responsible for editing the dictionaries in our libraries. The specific case of the term "microorganism" provides a striking example. Behind this term lie biological entities whose contours vary according to the regulatory texts. Bacteria, yeasts, algae, nematodes, even DNA or seeds: these are just some of the examples given by various regulatory texts, which show that the legislative definition of "microorganisms" has constantly varied according to economic interests. What do these texts have in common? They all can blur the traceability requirements imposed by GMO legislation. [chapo] => When reading legislation, one sometimes finds oneself thinking that it is a good thing that legislators are not responsible for editing the dictionaries in our libraries. The specific case of the term “microorganism” provides a striking example. Behind this term lie biological entities whose contours vary according to the regulatory texts. Bacteria, yeasts, algae, nematodes, even DNA or seeds: these are just some of the examples given by various regulatory texts, which show that the legislative definition of “microorganisms” has constantly varied according to economic interests. What do these texts have in common? They all can blur the traceability requirements imposed by GMO legislation. [texte] => While many communications claimed – and still claim – that the proposal to deregulate "new GMOs" only concerns plants, in March 2025 Inf’OGM showed that it also targets certain micro-organisms (unicellular algae)i. The reason is semantic. Regarding the scope of its deregulation proposal, the European Commission refers to two taxonomic groups that are widely considered to cover plants, but which in fact also cover single-cell algae, marine or aquatic plants, which are also considered microorganisms. Reading a law, a proposed law or even an international treaty therefore requires a prerequisite that is often overlooked, namely understanding the meaning of the words used and the definitions applied. Problems arise when several legislative texts provide varying legal definitions. An example of this is the different legislative definitions of the term 'micro-organism'."Organism", a basic termFocusing on the term "organism" is not a challenge here, as it determines the definition of the term "microorganism". According to European Directive 90/220, adopted in 1990, which regulated the use of GMOs, an organism is "any biological entity capable of replication or of transferring genetic material"ii. European Directive 2001/18, which replaces 90/220, uses the same definitioniii.The Cartagena Protocol, an international protocol adopted under the 1992 Rio Convention to prevent biotechnological risks, considers organisms in more detail. It defines living organisms as "any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids"iv. It should be noted here that the list of examples given is not exhaustive, as the term "including" is not restrictive.Legally, therefore, "organisms" in Europe and internationally are biological entities capable of replicating/reproducing or transferring genetic material. This is an approach focused on the entity itself, which does not take into account the environment in which it can exist and evolve."Microorganism", a term used to pave the way for patents"Micro-organisms" should therefore, logically, be defined on the basis of these definitions of organisms. This is the case with European Directive 90/219, which regulated the use of genetically modified micro-organisms (GMMs). This text defined them as "any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material"v .Legislation governing GMOs and GMMs is not the only legislation to address microorganisms. In the field of patents, it was in 1995 that the Board of Appeal of the European Patent Office (EPO) provided, in its decision T 356/93vi, a clarification that it considered necessary internally. It ruled that the interpretation of the term micro-organism "takes clearly into account the developments of modern industrial microbiology" and concluded from this interpretation that "processes carried out on vegetable cells may be defined as 'microbiological processes', and their products, namely genetically modified vegetable cells and their products [...] may be defined as "the products thereof"". For the EPO, isolated plant cells are therefore micro-organisms. The Board thus clarified that processes using them, like the products obtained, were and still are patentable! Since this clarification, the EPO has noted in its Guidelines indicating the practices and procedures to be followed during the examination of (applications for) patents that "the term 'micro-organism' includes bacteria and other generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory (see T 356/93), including plasmids and viruses and unicellular fungi (including yeasts), algae, protozoa and, moreover, human, animal and plant cells"vii. If the list of examples given here is broader than existing European legislation, then the aim is clearly to extend patentability to a larger number of micro-organisms, even if the entities cited are not micro-organisms in the common sense of the term.Twenty years earlier, an international treaty with a very broad visionThe Budapest Treaty was adopted in 1977. As an international treaty signed by 91 countries around the worldviii, it regulates the deposit of microorganisms as samples within international depositary authorities (IDAs) in order to fulfil the requirement of sufficient description of an invention using these microorganisms. As a microorganism cannot be fully disclosed in writing in a patent text, such a sample deposit constitutes a description required for the granting of a patent.While reading it, the Treaty provides a surprisingly broad viewix of what micro-organisms can be, while specifying on its website that it does not have a definition of this termx. Nevertheless, it provides an annex listing examples of "micro-organisms" that can be deposited with the IDAs, the content of which is surprising to say the leastxi. While the list includes microorganisms as they are generally understood (bacteria, viruses, protozoa, etc.), there are other examples that are unexpected to say the least: DNA, RNA, embryos, nematods (worms), plasmids and even seeds are included in the table entitled "List of kinds of microorganisms accepted by IDAs."Variable approaches depending on regulatory issuesThe inclusion of isolated plant cells in the definition of "micro-organisms" in the EPO texts in 1995 paved the way for the inclusion of animal cells in other texts. Thus, in 2009, a European directive (2009/41) aimed at regulating the contained use of micro-organisms defined micro-organisms as "any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture"xii.Broadening the definition of a "microorganism"From 2009 onwards, other pieces of legislation will in turn broaden the examples of "microorganisms" given. This was the case in 2012 with the adoption in Europe of Regulation 528/2012 on the use of biocidal products. This time, a micro-organism is defined as "any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths"xiii. The presence of algae in this list is particularly noteworthy, since some algae are among the taxonomic groups of living organisms that the European Commission proposes to deregulate when genetically modified, as we saw in March 2025xiv.When European legislators talk about micro-organisms, as in the case of the European Parliament asking the Commission for a proposal to deregulate them when they are GMOs, what are they talking about? According to non-binding texts, such as the European Commission's glossary, these may be organisms invisible to the naked eyexv. However, as we have just seen, European legislation and international treaties take a very broad view of what constitutes a micro-organism, which obviously serves the interests of businesses. For example, companies have patent rights applying to a number of isolated molecules or cells and, with the proposed deregulation of GMOs, could have a large number of non-plant organisms deregulated because they are considered "micro-organisms".These companies are not afraid of paradoxes, because within the Cartagena Protocol, some want "to exclude from the scope (of the Cartagena Protocol) certain products derived from modern biotechnologies, such as RNAi pesticides, vaccines, viruses… because they are not themselves living organisms, even though they are disseminated with the aim of modifying the genome or epi-genome of living organisms," as reported by Guy Kastler in an analysis published by Inf'OGMxvi. Here, their position makes strategic sense, since the Cartagena Protocol regulates the transboundary movement of GMOs. In such a text, arguing that these molecules or organisms – although considered microorganisms under European patent law or certain European Union legislation – do not constitute organisms would allow them to be excluded from the obligations imposed by the Protocol. Molecules and organisms that would remain patentable under EPO directives!i Eric Meunier, "The European Commission's proposal to deregulate GMOs does cover GMO microorganisms" Inf'OGM, 11 March 2025.ii "Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms," Official Journal No. L 117, pp. 0015–0027, 8 May 1990.iii "Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission statement", Article 2, Official Journal No. L 106, pp. 0001–0039, 17 April 2001.iv Secretariat of the Convention on Biological Diversity, "Cartagena Protocol on Biosafety to the Convention on Biological Diversity: text and annexes", Article 3, 2000.v « Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms », article 2, Official Journal n° L 117, p. 0001 – 0014, 8 may 1990.vi EPO, "Decision of the Technical Board of Appeal 3.3.4, dated 21 February 1995 - T 356/93 - 3.3.4", EPO OJ, pp. 545-585, 31 August 1995. vii EPO Guidelines, Part G, Chapter II, 5.5.1.viii WIPO, "Budapest Treaty".ix WIPO, "Summary of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure", 1977.x WIPO, "Budapest System FAQs".xi WIPO, "Lists of Types of Microorganisms Accepted for Deposit by ADIs".xii "DIRECTIVE 2009/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 on the contained use of genetically modified micro-organisms", Official Journal of the European Union, L 125/75, 21 May 2009. xiii "Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance", Article 3, OJ L 167, pp. 1–123, 22 May 2012.xiv Eric Meunier, "The European Commission's proposal to deregulate GMOs does cover GMO microorganisms" Inf'OGM, 11 March 2025. xv Scientific Committees, "Micro-organism". xvi Guy Kastler, "Interconnections between new biotechnologies and DSI or GSD", Inf'OGM, 11 July 2024. Denis MESHAKA et Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [87] => Array ( [objectID] => 13956 [title] => In Europe, legislative developments concerning living organisms are progressing slowly [timestamp] => 1759881600 [date] => 08/10/2025 [annee] => 2025 [url] => https://infogm.org/en/in-europe-legislative-developments-concerning-living-organisms-are-progressing-slowly/ [image] => https://infogm.org/wp-content/uploads/2026/03/Panneau_Chantier_Route_Druillets_St_Cyr_Menthon_2.jpg [extrait] => Since 3 May 2022, the European Commission has launched numerous legislative initiatives relating to living organisms. The deregulation of plants and certain GMO micro-organisms, the digitisation of living organisms and patents are all topics being discussed by Member States and the European Parliament. If adopted, these projects would make it easier for companies with the means to appropriate living organisms. What is the current status of these projects? Inf'OGM takes stock. [chapo] => Since 3 May 2022, the European Commission has launched numerous legislative initiatives relating to living organisms. The deregulation of plants and certain GMO micro-organisms, the digitisation of living organisms and patents are all topics being discussed by Member States and the European Parliament. If adopted, these projects would make it easier for companies with the means to appropriate living organisms. What is the current status of these projects? Inf’OGM takes stock. [texte] => Since the publication of our November 2024 article1, there has been little overall progress on the European legislative projects currently under discussion. Most of the issues remain under discussion within the Council or Parliament (or even at earlier stages), with no decisive progress. Technical debates on micro-organisms, traces of genetically modified micro-organism (GMM) DNA and supplementary protection certificates for plant protection products (pesticides) have not led to any final decisions. Sensitive issues, such as genetically modified animals, remain blocked due to a lack of political consensus. There is therefore a relative inertia on the part of the European Union (EU) institutions, including the Commission, which one would imagine would want to see certain issues resolved.The main developments concern two issues in particular. On the one hand, in March 2025, the Council of the EU adopted a negotiating mandate on the regulation governing GM plants obtained through new genetic modification techniques (procedure 2023/0226), paving the way for discussions with the European Parliament and the Commission in the context of the trilogue2. Furthermore, the EU has continued its international engagement with the BBNJ Agreement on the conservation and sustainable use of marine biological diversity in areas beyond national jurisdiction. To this end, it has published an official communication on the signing and ratification of this agreement. These two developments mark important but limited steps forward in a legislative landscape that is still largely awaiting concrete decisions.In addition, two public consultations on initiatives published by the European Commission are currently underway. The first, which concerns food safety for humans and animals, aims to simplify the administrative burdens associated with marketing authorisations, particularly for products derived from GMOs. The second, which is part of the Commission's "Life Sciences" strategy, concerns a comprehensive regulation on biotechnology3.The table below (which Inf'OGM will update regularly) summarises the various procedures currently underway.Summary of the European Commission’s legislative initiatives relating to LivingGMO DEREGULATIONPlants obtained by “NGT“GMM obtained by “NGT“GMM DNA in lots of additivesPharmaceutical GMMAnimals obtained by “NGT“Food safetyPurposeDeregulation of numerous GM plantsDeregulation of numerous GMMRegulatory status of products containing GMM DNA tracesHarmonization of the authorisation procedure for medicinal productsDeregulation of numerous GM animalsStimulate innovation by optimizing research and innovation and facilitating rapid market access for biotechnological innovationsProcedure reference2023/0226Request from EP on the 07/02/242023/0132Request from EP on the 07/02/24Proposal from ECText of the proposal (05/07/2023)To follow the discussions (Last meeting to date : 20/09/2021)Text of the proposal (26/04/2023)Consultation (End : 14/10/2025)EP’s CommissionText of the report (24/01/2024)Text of the report (21/03/2024)EP’s voteDecison adopted (07/02/2024)Decison adopted (10/04/2024)2nd EP’s voteText adopted (24/04/24)EU Council voteFinal textCommencement“LIFE SCIENCES”DSIPATENTSSEEDSBiotech Regulation (Biotech Act)UNCLOSEuropean Health Data SpacePhytopharmaceutical productsMedicinal productsSeed regulationPurposeSimplification of administrative burdens related to marketing authorizations, including products derived from GMOs (omnibus package)Signature of the BBNJ agreement (GR and DSI in international waters)Access to genetic, genomic and proteomic human dataUnitary supplementary protection certificate for plant protection productsUnitary supplementary certificate for medicinal productsProduction and marketing of plant reproductive material in the UnionProcedure reference2023/03532022/01402023/01262023/01272023/0227Proposalfrom ECConsultation (End : 10/11/2025)Text of the proposal (12/10/2023)Text of the proposal (03/05/22)Text of the proposal (27/04/23)Text of the proposal (27/04/23)Text of the proposal (05/07/23)EP’s CommissionText of the report (19/04/24)Text of the report (05/12/23)Text of the report (24/01/2024)Text of the report (31/01/2024)Text of the report (22/03/24)EP’s voteDecision adopted (24/04/24)Decision adopted (13/12/23)Decison adopted (26 février 2024)Decison adopted (28/02/24)Decison adopted (24/04/24)Interinstitutional negociationsAgreement adopted (22/03/24)2nd EP’s voteText adopted (24/04/24)EU Council voteFinal textText adopted (19/07/2024)Commencement Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [88] => Array ( [objectID] => 13915 [title] => A biotech “Alliance”: when lobbying becomes institutionalised [timestamp] => 1759190400 [date] => 30/09/2025 [annee] => 2025 [url] => https://infogm.org/en/a-biotech-alliance-when-lobbying-becomes-institutionalised/ [image] => https://infogm.org/wp-content/uploads/2026/03/eu-biotech-alliance-930x515-1-768x425.png [extrait] => At the end of July 2025, the EU Biotech and Life Sciences Alliance was quietly launched in the European Parliament. Supported by the lobby group Europabio, its aim is to bring together MEPs to "ensure that the [European] Union takes bold and coordinated action" to strengthen its biotechnology sector. While this initiative reflects a desire to maintain Europe's competitiveness, it raises a major political question: where does democratic representation end and institutionalised lobbying begin? [chapo] => At the end of July 2025, the EU Biotech and Life Sciences Alliance was quietly launched in the European Parliamenti. Supported by the lobby group Europabio, its aim is to bring together MEPs to “ensure that the [European] Union takes bold and coordinated action” to strengthen its biotechnology sector. While this initiative reflects a desire to maintain Europe’s competitiveness, it raises a major political question: where does democratic representation end and institutionalised lobbying begin? [texte] => In Brussels, lobbying is nothing unusual, with thousands of "interest groups" with different interests (NGOs, industries, trade unions, etc.) seeking to make their voices heard and influence European decisions. With the creation of the EU Biotech and Life Sciences Alliance, the biotech sector is seeking to strengthen its position in the European Parliament: in addition to the usual meetings in the offices and corridors of the European institutions, there is now a hybrid political structure, where MEPs appear alongside industrialists in a framework designed and run by the latterii. Elected to defend the public interest, they become de facto members of a private initiative whose agenda is to shape a regulatory environment that is more favourable to the biotechnology industry. Will European policy in this area be the result of a pluralistic democratic debate or a strategy of influence fuelled by lobbyists?An initiative tailored for and by industryTo understand the scope of this Alliance, we need to look at who is pulling the strings. It describes itself as a "European parliamentary interest group founded to gather members of the European Parliament interested in biotechnology across sectors". Behind this institutional facade – such parliamentary interest groups are commonplace – the organisation is anything but neutral, as it is supported and orchestrated by EuropaBio (European association for Bioindustries), the leading lobby group for European biotech giants. This support appears discreetly at the bottom of the page on the Alliance's website: "Secretariat and funding - EuropaBio, the European association for bioindustries, supports the Group's secretariat". It is confirmed by the presence of Claire Skentelbery, Director General of EuropaBio, at the launch of the Alliance on 7 July 2025 in Strasbourgiii.On its website, the EU Biotech and Life Sciences Alliance logically acts as a spokesperson for the industry. In a section entitled "The EU Biotech Mandate : A Path to global Leadership and Resilience", its position is unequivocal. In particular, it emphasises the need to "maximise impact from a broad cluster of EC legislation and strategies, led by the Biotech Activ”. Since its inception, this legislative project has been actively supported by the European biotech industry, through its representative EuropaBiov vi.The members of the AllianceThe twelve MEPs who are members of the EU Biotech and Life Sciences Alliance include representatives from various political groups – S&D (5), Renew (4), EPP (2) and Patriots (1). Of particular note is the presence of Stine Bosse (Renew), founder and co-chair of the Alliance alongside Eszter Lakos (EPP). Danish MEP Bosse, who is also vice-chair of the Committee on Public Health Committee and a member of the Committee on Environment, states on social mediavii that the Alliance "covers the diversity of political groups in Parliament, for a truly representative group working together to advance understanding and policymaking".The 12 MEPs who are members of the EU Biotech and Life Sciences Alliance.No explicit past or current links to the biotechnology or life sciences industry have been declared by these MEPs in their "Declaration of Private Interests". Only Stine Bosse, who initiated the Alliance, declaresviii that she has worked for investment consulting firms and in the oil industry. However, the proximity of key parliamentary players to industry in the context of such an "alliance" cannot fail to influence their views, decisions and parliamentary activities. While it may be accepted that this is "part of the political game", one may nevertheless question the real scope of this representativeness when EuropaBio's lobbying agency, APCO, whose total lobbying costs in 2024 amount to nearly three million eurosix, is also involved in providing the secretariat for the Alliancex?From lobbying to decisive influenceWe contacted the EU Biotech and Life Sciences Alliance to understand how it works. They replied that it was "founded at the request of MEPs, and EuropaBio does not play a role in its delivery. MEPs are the drivers of topics and activities carried out by the Alliance. EuropaBio is funding the Secretariat of the Alliance, provided by APCO at present, as stated on the website. APCO is an independent service provider to the Alliance. APCO acts as the Secretariat of the Alliance and delivers activities as requested, approved and initiated by the MEPs".By funding the Alliance's secretariat, which is run by a lobbying firm, EuropaBio is no longer content to influence elected representatives from the outside. It is establishing itself at the very heart of the parliamentary system. In parliamentary proceedings, a secretariat performs the important function of providing logistical support for, among other things, organising meetings, preparing minutes or briefing notes, communications (website, newsletter, events, etc.), administrative follow-up with MEPs and their assistants, and so on.As the Alliance tells us, the APCO lobbyist can even, as secretary, more broadly "carry out activities requested, approved and initiated by MEPs", with EuropaBio providing APCO with the financial resources to carry out these activities. Thus, although the Alliance's MEPs are not themselves paid by EuropaBio, the interest group, which has no official institutional budget, relies on this private funding to exist. In concrete terms, thanks to this funding, Alliance MEPs have a space for meetings, events and exchanges... and consequently an agenda and priorities influenced by EuropaBio.The challenge of biotechnologyThis Alliance is not an isolated exception. Many sectors use comparable systems, such as the European Internet Forum for digital technologyxi. But this practice is particularly sensitive in the field of biotechnology, where European institutions' decisions affect crucial societal issues. Examples include the protection of biodiversity (particularly pollinators), the right to organic and non-GMO food, food sovereignty, public health, the patent economy, the financialisation of life... and, of course, the subject of new genomic modification techniques (NGTs), at a time when the trilogue on the proposed Regulation is underwayxii.It is also a highly concentrated sector controlled by the largest multinationals in the life sciences, agriculture and food industries – often the same companies – which hold a large share of the patents on marketed or developing products and related technologiesxiii. The influence of traditional biotech lobbying on legislators is already strongxiv, but it becomes even stronger when elected representatives engage in alliances and parliamentary interest groups whose agenda can be influenced by industrial lobbying structures. On the specific subject of NGTs, one consequence is an increased risk of deregulation, which favours agro-industrial multinationals, but also an understandable erosion of public confidence in institutions and their role in protecting public health and the environment.Lifting the veil of secrecy on a common practiceUnlike the European Parliament's "official intergroups"xv (informal forums for discussion between political groups, MEPs and civil society or businesses), which must comply with strict rules on transparency and fundingxvi, alliances or "parliamentary interest groups" seem to escape public scrutiny to a large extent. Reports are rare, funding is opaque, communication is possibly controlled by industry, and the people of the European Union have little or no information about them.As several of these groups are structured around industry funding, this raises a global issue of transparency and conflicts of interest. How can MEPs remain impartial arbiters of regulation in a sector if they participate in an initiative set up by and for the defence of the interests of those they are supposed to regulate? This proximity fuels a well-known risk called "regulatory capture", which means that the rules end up being written, directly or indirectly, by those who want to profit from them.For years, NGOs such as Corporate Europe Observatoryxvii and Transparency Internationalxviii have been denouncing this parallel system, which allows lobbies to gain political legitimacy without submitting to the framework imposed on official parliamentary structures. But the problem remains: does Europe want to be a place where public policy is made transparently and in the public interest, or a place where industry itself organises parliamentary alliances that shape the law?i EU Biotech and Life Sciences Alliance, "About Biotechnology and Life Sciences".ii EU Biotech and Life Sciences Alliance, "Biotech Takes the Spotlight: New EU Biotech and Life Sciences Alliance Launches in Strasbourg," 11 July 2025.iii Ibid.iv Denis Meshaka, "The European Commission postpones its 'biotech law once again" Inf'OGM, 3 June 2025.v Europabio, "EuropaBio's Vision for a Bold EU Biotech Act", 19 January 2025.vi Europabio, "The EU Biotech Act." vii LinkedIn, " ' EU Biotech and Life Sciences Alliance".viii European Parliament, Declaration of interests of Stine Bosse, 24 September 2024.ix Apco Worldwidex EU Biotech and Life Sciences Alliance, "About Biotechnology and Life Sciences."LobbyFacts, "APCO Worldwide".xi European Internet Forum.xii Denis Meshaka, "The scientific lobby joins the trilogue on the deregulation of GMOs/NTGs", Inf'OGM, 5 August 2025.xiii Charlotte Krinke and Denis Meshaka, "Crispr/Cas9: access to a minefield?", Inf'OGM, 21 June 2022.xiv Claire Robinson and MPhil, "Behind the smokescreen, Vested interests of EU scientists lobbying for GMO deregulation," The Greens/EFA, September 2022.xv European Parliament, "Intergroups in the European Parliament".xvi European Parliament, "Lobbying and transparency".xvii Corporate Europe Observatoryxviii Transparency International Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [89] => Array ( [objectID] => 13908 [title] => Deadlock on digital sequencing information within the ITPGRFA [timestamp] => 1759104000 [date] => 29/09/2025 [annee] => 2025 [url] => https://infogm.org/en/deadlock-on-digital-sequencing-information-within-the-itpgrfa/ [image] => https://infogm.org/wp-content/uploads/2026/03/Ana-Kova-dna_ai.webp [extrait] => New negotiations on digital sequencing information within the framework of the ITPGRFA are reigniting tensions between "developing" and "developed" countries. The latter are imposing guidelines that weaken the claims of the other side and strengthen their control over plant genetic resources. Their weapon? Maintaining "free access" to digital sequencing information and parallel and optional benefit sharing, as agreed by the Convention on Biological Diversity. [chapo] => New negotiations on digital sequencing information within the framework of the ITPGRFA are reigniting tensions between “developing” and “developed” countries. The latter are imposing guidelines that weaken the claims of the other side and strengthen their control over plant genetic resources. Their weapon? Maintaining “free access” to digital sequencing information and parallel and optional benefit sharing, as agreed by the Convention on Biological Diversity. [texte] => The 14th meeting of the ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) Working Group was held from 7 to 11 July in Lima (Peru). This was the last step before the November session of the Governing Body, which is to set the framework for the reform of the Multilateral System (MLS) of this Treaty. The discussions only served to confirm the imbalance of power between "developed" and "developing" countriesi, particularly with regard to DSI/GSD (digital sequence information/genetic sequence data): the former reject any binding framework and advocate misleading "free access" and "benefit sharing".The Multilateral System (MLS)The ITPGRFA (Treaty), adopted in 2001 by the FAOii and entered into force in 2004, is a binding legal instrument that aims to ensure the conservation and "sustainable" use of plant genetic resources for food and agriculture (PGRFA). In line with the Convention on Biological Diversity (CBD), the ITPGRFA seeks to ensure the fair and equitable sharing of benefits arising from the use of such resources through the Multilateral System (MLS). The MLS provides access, througha network of public gene banks, to more than 2 million samples of genetic resources belonging to 64 essential crop species, which cover approximately 80% of human food consumption.This facilitated access to certain agricultural plant genetic resources (for research, breeding and training) removes the need for prior consent from providers and bilateral sharing of benefits under the Convention on Biological Diversity (CBD) between farmers who have provided their seeds to MLS gene banks and their users (mainly the seed industry). It is replaced by a prohibition on claiming intellectual property rights (IPRs) that limit access to the PGRFA provided and by an obligation to pay into a Multilateral Benefit-Sharing Fund when commercialising seeds or plants derived from their use.Limitations of the MLSThis mechanism was put in place to guarantee commercial actors easy access to the MLS. At the same time, this system must not restrict farmers' rights to save, use, exchange and sell their seeds, but with one caveat, interpreted by "developed" countries as allowing them to adopt laws that contravene these rights: "in accordance with national laws and as appropriate". To date, these two provisions have not been respected, according to the International Planning Committee for Food Sovereignty (IPC)iii - the only organisation of food producers (farmers, fishers, pastoralists and indigenous peoples) accredited as an observer in this working group - the "developing" countries and the Governing Body of the Treaty, which has set up several working groups over the past ten years to address this issue.The MLS is mainly used by researchers, who are not required to share benefits as they are not commercial actors, except in the case of IPR licensing. The results of the research are passed on to industry, which has already built up its own collections of PGRFA (particularly before the adoption of the Treaty, when seeds were still considered to be the "common heritage of humanity" and freely accessible, outside the scope of IPR). The industry only uses the MLS to obtain new PGRFA. US companies, which dominate the market, have free access to the US public collections – the largest in the world – without traceability or benefit sharing.The ITPGRFA recognises that it cannot control the traceability of PGRFA exchanges between companies, which claim that it is bureaucratically impossible to track the hundreds of crosses required to create commercial seeds. This is why the benefit-sharing fund has remained almost empty, apart from a few symbolic contributions, such as that of the French Semae, intended to demonstrate "good conduct".The rhetoric of the developed countries of the "global North" is that the MLS is not "attractive" to companies, even though it is mandatory, and they are calling for an amendment to the ITPGRFA to include all ex situ resources (conserved outside their natural environment or on farms) and public domain resources (notably soya and tomatoes, which are currently excluded). However, companies already use it indirectly, as researchers sequence the genomes of MLS samples and deposit digital sequence information (DSI) in open-access databases, thus escaping the control of the ITPGRFA. The industry can then exploit this data to obtain patents on genetic traits, limiting access to the original MLS resources and undermining the rights of the farmers who provided them.A process of 'improving' the MLS blockedA process to 'improve' the MLS began in 2013 with the creation of a dedicated working group. In 2022, after a few years' hiatus following the United States' accession to the Treaty, the Governing Body commissioned a new working group to "finalise the improvement of the MLS's functioning" by its 11th session in November 2025. The 13th meeting of this working group, held last April, revisited the expansion of the list of crops covered by the MLS and the revision of the standard material transfer agreement (SMTA) governing their use.The "developing" countries had expressed their opposition to any inclusion of new species in the list until an agreement had been reached on the establishment of an effective mechanism for sharing benefits. They had also voiced their fears that free access to farmers' and traditional seeds, of which they are the main source, would be undermined without any commitment to benefit sharing and a ban on claiming IPRs on these seeds, their parts and genetic components. This would effectively facilitate the obtaining of patents or other IPRs without any real benefit sharing, to the detriment of these countries and the rights of farmers.ivThis 13th working group remained particularly divided on the issue of sharing the benefits arising from the use of IPRs/GSDs, as well as on another important issue, namely whether access to the MLS should be by subscription only or through a dual system allowing users to choose between a subscription option and a single access optionv . No consensus has yet been reached on the terms of payment to the Benefit-sharing Fund, and the amount has not yet been discussed.Deadlock on DSI/GSD governanceThe discussions of the 14th working group last July did not resolve the issue of DSI/GSD governance, which therefore remains a major point of disagreement between "developed" countries, the main users of this data, and "developing" countries, which are the main providers. DSI/GSD represent a major strategic issue for industrial research. Everyone agrees on the establishment of a subscription system for unlimited access to all PGRFA in the MLS, or only to certain species, subject to mandatory payment based on the sales turnover of subscriber companies (seeds and licence fees). This mechanism could guarantee a real sharing of the benefits derived from the use of PGRFA by including them (like physical resources) in the SMTA, thus preventing biopiracy (illegitimate appropriation) of such resources. This sharing is indeed provided for in Article 13.2 of the ITPGRFA on benefits related to the use of resourcesvi. However, "developed" countries, such as the United States, European countries and Japan, also advocate a "single access" approach to the physical PGRFA of the MLS without any binding legal commitment to pay for the use of DSI/GSD, which remain freely accessible on the internet.By refusing to include DSI/GSD in the SMTA, the MLS's operational tool for resource transfer, "developed" countries would thus avoid any binding obligation to share, whether monetary or non-monetary. This divergence led to a deadlock at the 14th meeting of the working group in July 2025. Proposals by "developing" countries to include DSI in the SMTA were left in brackets in the final document, a sign of this persistent disagreement, which is nevertheless supposed to be resolved by next November.Furthermore, although the issue raised by the decisions of the last CBD meeting was mentioned, its consequences have not yet been discussed. The CBD considers that DSI/GSD are not components of genetic resources, in which case they would fall within the exclusive competence of the Treaty for PGRFA, but rather products of research. The CBD has therefore decided to set up its own Multilateral Benefit-Sharing Fund for all sales made by sectors using DSI/GSD, including the seed sector, to which all companies that do not already fulfill their obligations to another fund, such as the Treaty fund, should contribute. However, these payments will be optional: between an optional payment and a mandatory payment, it is highly likely that companies will choose the CBD option and will only turn to the MLS for the rare physical PGRFA that they do not already have in their own collections, those of the United States, which do not require the signing of a SMTA, or through private exchanges with other companies or prospecting and research organisations similar to NGOs.Controlled "open access"The issue of "open access" to DSI/GSD is hypocritical or, at the very least, paradoxical. Behind this reassuring language lies the continuation of a system already established by other international instruments, in particular the CBD. Although the CBD recognises countries' sovereign rights over the genetic resources within their territory, the countries that supply "genetic resources" – mainly "developing" countries – actually benefit only minimally from the exploitation of these resources by companies in "developed" countriesvii . On the one hand, the provisions of the SMTA are virtually impossible to enforce, and access to DSI/GSD is already largely free on public or private databases, often without any indication of origin or applicable legislation. Supplier countries therefore have no means of ensuring equitable benefit sharing, and 'developed' countries are merely legitimising an existing situation.Furthermore, the issue of control over these DSI/GSD databases exacerbates this divide. Funded and hosted by "developed" countries, they give them arbitrary power over access to the DSI/GSDs they host, which is therefore no longer truly guaranteed. For example, restrictions imposed for political reasons and without any possibility of appeal penalise "developing" countries, as was recently the case in the medical fieldviii.A situation reinforced by patentsThis privileged control over DSI/GSD only exacerbates the issue of the appropriation of PGRFA by multinationals in "developed" countries through patents based on this information and data. Allowing this situation to continue encourages massive hoarding by these multinationals, effectively restricting access by farmers and local communities to vital resources, prohibiting them through patents or other IPRs from using those they have selected, produced and maintained for generations, depriving them of the benefits of the industrial use of these resources and marginalising them in official discussions.The refusal of "developed" countries to accept binding commitments for genuine benefit sharing that supports farmers, indigenous peoples and gene banks in developing countries and prohibits the patenting of PGRFA (their genetic parts and components) constitutes a further setback for the ITPGRFA. If this trend continues, the MLS will become nothing more than a label allowing "developed" countries to consolidate their monopoly on the exploitation of PGRFA, whether physical or virtual, while maintaining a veneer of cooperation. Developing countries, farmers and indigenous peoples will remain suppliers of free data and will be deprived of real means to protect and enhance their resources and rights. According to the farmers' organisations grouped within the CIP, which have been following the ITPGRFA negotiations for years, it is necessary for the Contracting Parties, in particular the "developing" countries, resolve the issue through national legislation, prohibiting the patentability of DSI corresponding to PGRFA included in the MLS and protecting farmers' rights, their seeds and their knowledge against new digital biopiracyix.i These terms are commonly used to refer to these categories of countries. Other terms that may also be encountered include, for example, "countries of the North (global)" and "countries of the South (global)".ii Food and Agriculture Organisation of the United Nationsiii International Planning Committee for Food Sovereignty, "Twelfth meeting of the Ad Hoc Open-ended Working Group on Improving the Functioning of the Multilateral System, Rome, Italy, 16-19 September 2024", October 2024.iv Denis Meshaka, "ITPGR works on controversial reform", Inf'OGM, 10 June 2025.v Ibid.vi FAO, "International Treaty on Plant Genetic Resources for Food and Agriculture," 2009.vii Denis Meshaka, ""ITPGR works on controversial reform" Inf'OGM, 10 June 2025.viii Richard Stone, "Researchers from China and five other 'countries of concern' barred from NIH databases" Science, 10 April 2025.Liu, H., Liu, Y., Zhao, Y. et al., "A scoping review of human genetic resources management policies and databases in high- and middle-low-income countries" BMC Med Ethics, 15 March 2025.ix International Planning Committee for Food Sovereignty, "IPC shows the way to stop digital biopiracy", 28 August 2025. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [90] => Array ( [objectID] => 13903 [title] => Origin of Covid 19: the laboratory leak is the most likely (part 3) [timestamp] => 1758758400 [date] => 25/09/2025 [annee] => 2025 [url] => https://infogm.org/en/origin-of-covid-19-the-laboratory-leak-is-the-most-likely-part-3/ [image] => https://infogm.org/wp-content/uploads/2026/03/pandemic-5023590_1920-768x576.jpg [extrait] => Having described the complexity of the question of the origin of Sars-Cov2, the main players and their research (GOF, etc.), then the history of the pandemic (part 1 and part 2), we can give the opinions of the various parties, without any of them being totally convincing. [chapo] => Having described the complexity of the question of the origin of Sars-Cov2, the main players and their research (GOF, etc.), then the history of the pandemic (part 1i and part 2ii), we can give the opinions of the various parties, without any of them being totally convincing. [texte] => What are the arguments in favour of the zoonotic theory?The Chinese Communist Party (CCP) is categorical, although it provides no scientific evidence and has had samples destroyed from the first contaminated individualsiii, which weakens its argument. From the outset, it has considered several theories.The first is that the pandemic is a zoonosis that occurred at the Wuhan animal market. Admittedly, one article maintains that the epicentre of the contamination was the Wuhan animal market (and not the WIV)iv. But the destroyed samples make the story fragile and the collection biased. One article proves that two different lineages are possible ancestors of SARS-CoV2v. Other publications emphasise the very low diversity of infecting viruses, which would suggest a non-natural source. In any case, the best candidate (RATG13) is too distant to have evolved `naturally’. As a consequence what we have here is an evolutionary leap that cannot be explained by `natural’ evolution.The other theory put forward by the PCC is that the contamination came from frozen food imported from the United States, Europe, New Zealand, etc. However, the World Health Organisation (WHO) examined the imported batches and found ‘rare and isolated’ traces. However, the World Health Organisation (WHO) examined the imported batches and found "rare and isolated" traces. So they were not necessarily from third countries (i.e. the United States), but perhaps the batches were contaminated afterwards. However, according to the Chinese state media, "all available evidence suggests that the coronavirus [...] did not start in central China in Wuhan"vi.A spokesman for the Chinese embassy in the United States, Liu Pengyu, dismissed the laboratory leak out of hand, claiming to be basing himself on the WHO report, whose "conclusions should be respected". But they are not conclusive! The spokesman continued: "From the very beginning, China has had a scientific, professional, serious and responsible attitude to monitoring the origin of the virus". He added that American politicians and journalists were distorting "the facts and the truth" and that the United States should "stop using the epidemic for political manipulation"vii. The CCP is victimising itself. In 2023, it also talks of "the lowest mortality rate from COVID19 of any state" and adds that "China has created a miracle in human history"viii.Absence of proof is not proof of absenceLike The Lancet and Daszak’s article, the journals Science and Nature were very inclined not only to deny the laboratory leak, but also to associate this thesis with "conspiracy" or with the ideas of the US Republicans. What is more, they inferred support for the zoonotic thesis and for the scientists who felt they were victims of a "conspiracy" omerta. Thus, in June 2023, Science wrote an article subtitled "Ben Hu denies that he was ill in late 2019 or that his work on coronaviruses led to COVID-19, and recently declassified documents give no substance to the allegations against him"ix. Ben Hu calls the accusations "fake news". In fact, the declassified documents do not deny the accusations. Indeed, they give substance to them and point out that Ben Hu was working on GOFs applied to coronaviruses and that some of this work was funded by the US federal governmentx.Overview of some of the positions takenOn 26 March 2021, Dr Robert Redfield, former director of the US Centers for Disease Control, stated that he "continues to believe that the most likely etiology of this disease in Wuhan is a laboratory leak"xi.A WHO report concluded on 30 March 2021 that a laboratory leak was "extremely unlikely"xii. China welcomed this conclusion. However, in a second report on 9 June 2022, the WHO stated that "key data have not yet been made available for a full understanding of how the COVID-19 pandemic began". Furthermore, "no new data have been made available to assess the laboratory as a route of dissemination in the human population"xiii. The WHO Director "called for additional studies to be conducted". On 27 June 2025, the WHO’s Scientific Advisory Group on the Origins of New Pathogens (known as SAGO) issued a report on the same issue, which provided no further information. This group stated that "most of the information needed to assess the hypothesis [of] an accident linked to a laboratory [...] has not been communicated to the WHO or to SAGO. The WHO has made several requests to the Chinese government [...]. Without information to fully assess the nature of the work on coronaviruses in the Wuhan laboratories, or information on the conditions under which this work was carried out, it is not possible for SAGO to assess whether the first human infection(s) may have been the result of a research-related event or a breach of laboratory biosafety. This cannot therefore be ruled out, or proven, until further information is provided "xiv.In May 2021, A. Fauci, public health advisor to eight US presidents, testified before the US Senate that "the NIH [National Institutes of Health] has never funded and does not fund gain-of-function research at the Wuhan Institute of Virology"xv. This has been contradicted above and by many people.FBI Director Christopher Wray stated on 28 February 2023 that his agency "has believed for some time that the origin of the pandemic is most likely a laboratory incident in Wuhan"xvi.On 8 March 2023, Matt Hancock, Secretary of State for Health in the Biden government, considered that the theory of a natural origin "did not hold water", but the government’s central secretariat told him to tone down his remarks for fear of angering Chinaxvii.The US Intelligence Community (ODNI) updated the opinions of the country’s various agenciesxviii. According to this report, dated June 2023, and therefore predating Trump’s election, but subsequently made public, "The Department of Energy and the Federal Bureau of Investigation assess that a laboratory-associated incident was the most likely cause of the first human infection with SARS-CoV-2". The CIA and another unnamed agency "remain unable to determine the precise origin of the COVID-19 pandemic as both theories are based on significant assumptions or face challenges with conflicting reporting". It goes on to say that "almost all agencies consider that SARS-Cov2 was not genetically engineered. Most consider that SARS-Cov2 was not laboratory-adapted. Some are unable to make a determination. All believe that it was not developed as a biological weapon". This statement is partly contradictory, because a debate is underway in these institutions.Identifying traces of genetic modification is difficult. Indeed, the thesis of a WIV student in 2017 "proved that reverse genetics techniques [...] left no trace of genetic modification of SARS-like coronaviruses"xix. This makes a proof of genetic modification perhaps impossible without other clues. Such clues could be provided by the virus genomes in the WIV database, to which the laboratory cut off access on 3 September 2019.In June 2024, an EcoHealth Alliance (EHA) press release statedxx that with the WIV they were "studying bat coronaviruses that have never been shown to be capable of infecting humans; in fact, the degree of difference between SARS-CoV-2 and the closest bat coronavirus studied [RATG13] is about the same as the difference between human and chimpanzee DNA. Therefore, by this definition, the EHA and its subrecipient, the Wuhan Institute of Virology, were not conducting gain-of-function research, which was confirmed by a letter from the NIH to the EHA dated July 7, 2016, after reviewing our proposed research." Let us take these claims back. We proved that WIV had tested that its modified viruses "were capable of infecting humans", since they were tested on human cells or humanised mice. The close proximity between RATG13 and SARS-CoV2 is true, but only proves that natural evolution cannot explain the switch from one to the other, without ruling out the possibility that evolution was directed (GOF). False arguments do not lead to the conclusion that EHA and WIV "were not conducting research on gain of function". Finally, the letter from the NIH cited shows precisely that it is a gain of function, whereas EHA claims the oppositexxi. This is the Newspeak, or communication of industrial companies.The report by the subcommittee of the US Parliament (4 December 2024), already mentioned above, concludes that SARS-CoV2 "probably emerged as a result of a laboratory or research-related accident"xxii. It gives five arguments in favour of a laboratory leak:The virus has a biological characteristic (furin site) that does not exist in nature.The data show that all cases of COVID-19 originate from a single introduction into humans. This is in contrast to previous pandemics where there were multiple introductions.Wuhan is home to China’s leading SARS research laboratory, which has a history of conducting gain-of-function research at inadequate biosafety levels.Researchers at the Wuhan Institute of Virology (WIV) were sickened with a COVID-like virus in autumn 2019, a few months before COVID-19 was discovered on the food market.By almost any scientific standard, if there were evidence of a natural origin, it would have surfaced more than five years ago.The Biden administration decided that from 20 January 2025, under President Trump, Daszak would be barred from federal fundingxxiii. Yet Daszak claims that "the experiments at WIV are not GOFs because the coronaviruses in the bats involved had not infected humans"xxiv. The semantic manipulation is crude. He therefore denies that the WIV made GOFs because the coronaviruses did not infect humans (because they did not leave the laboratory?). But it is not necessary for modified viruses to have "infected humans" to be the result of a GOF. It only has to be able to do it.On 26 January 2025, the CIA "believes that the most likely cause of this pandemic [...] is an incident related to the Wuhan laboratory. The CIA believes that the virus responsible for the COVID-19 pandemic is most likely to have originated in a laboratory"xxv. John Ratcliff, Director of the CIA, pointed out that his report had been endorsed under President Biden, but revealed under President Trump, brushing aside any accusation of political intent. However, he had "little confidence" in his answer and both hypotheses remained possible.On 12 February 2025, Gio Jiakun, spokesman for the Chinese Foreign Ministry, reaffirmed that the WIV "has never engaged in gain-of-function studies of the coronavirus. It has never designed, manufactured or leaked COVID-19"xxvi. Beijing maintains that "SARS-Cov2 appeared naturally". It is enough to recall that a 2015 article, signed in particular by Shi and Baric, states: "we generated and characterized a chimeric virus expressing the spike of bat coronavirus SHC014 in a mouse-adapted SARS-CoV backbone"xxvii to prove that this is false. Here, they call chimeric virus a GOF-modified virus. In February 2016, Daszak described the work in question: "you create pseudo particles, you insert the spike proteins from those viruses, see if they bind to human cells. […] So you narrow down the field, you reduce the cost, and you end up with small number of viruses that really do it like killers."xxviii.On 12 March 2025, two German newspapers (Die Zeit and Sueddeutscher Zeitung) revealed that the German Intelligence Agency (BND) estimated an 80-90% probability that the coronavirus at the origin of the COVID-19 pandemic had been accidentally released by the WIVxxix. The BND was aware of numerous security flaws in the WIV laboratories (P3 and P4).On 1 April, the French National Academy of Medicine issued an opinionxxx mentioning "biosafety and bioprotection problems in the Wuhan laboratories", but calling for the development of a "culture of risk control in biosafety" at global level and taking advantage of the opportunity to request more funding. It therefore defends its work and the public funding of its members. It was the French government that supplied the plans and planned to build the P4 laboratory in Wuhan. China refused to allow French companies to be present, but kept the plans. The Académie also refers to "the A/H5N1 avian flu virus modified by directed mutagenesis, which has been made contagious in humans by the respiratory route". This is the example of Ron Fouchierxxxi, who proves that only five mutations in an avian virus make it deadly and capable of spreading through the air between mammals. Similarly, in 2015, Shi and Baric proved that a virus that cannot enter human cells can do so by simply forcing two modifications (or four amino acids) into it. And it’s precisely these two mutations that the MERS virus possessesxxxii. In its proposal for new regulations on GMO/NTG plants, the European Commission considers as "equivalent to conventional breeding" either an infinite number of base substitutions, or up to 20 modifications of 20 bases (i.e. 400 bases, possibly repeated)xxxiii. The pseudovirus manufactured by Shi and Baric would therefore, according to the position defended by the European Commission, be largely equivalent to nature and therefore risk-free. Yet MERS has killed humans. The NGT1 criterion devised by the European Commission therefore guarantees neither naturalness nor, above all, the absence of risk, at least as far as viruses are concerned.The US government has made publicxxxiv an analysis that includes some excellent arguments, even if its aim is also to harm the Chinese government. It also reveals that Biden signed a "full and unconditional pardon for any offenses against the United States which he may have committed" in favor of Fauci, former director of the National Institute of Allergy and Infectious Diseases (NIAID) and public health advisor to eight presidents. It appears that several Americans refused to testify or lied. In fact, these investigations have been a battle between scientists and elected Democrats against elected Republicans. This aspect of the issue cannot be overlooked, even if it raises serious questions about the `independence’ of research and politics.It cannot be ruled out that if the political authorities of any country (China, but also the United States, France, etc.) continue to tell only part of what they know, this will further undermine public confidence in our politicians, but also in our scientists. In particular, as long as GOF operations are carried out on Earth, citizens may feel at risk because of certain irresponsible scientists, who know that a virus can come out, even from a P4 laboratory, but who want to work to advance their careers and "Science" and because of the politicians who cover up for them. Should the GOF be regulated? If not, should they be tolerated? Should they not be banned across the board, from all laboratories, military or otherwise?i Olivier Leduc, « Origin of Covid-19: laboratory leak is the most likely scenario part1 », Inf’OGM, September 10th 2025.ii Olivier Leduc, « Origin of Covid-19: laboratory leak is the most likely scenario part2 », Inf’OGM, September 15th 2025.iii T. O’Connor, « China Acknowledges Destroying Early Coronavirus Samples, Confirming U.S. Accusation », Newsweek, 15 May 2020. The Chinese government admits that it destroyed virus samples (not yet isolated) because only P4 laboratories could store viruses. But only some samples were destroyed, not all. What's more, the destruction of samples did not continue afterwards. So the two parties are not talking about the same thing.iv Michael Worobey et al., « The Huanan Seafood Wholesale Market in Wuhan was the early epicenter of the COVID-19 pandemic », Science, Vol 377, Issue 6609, pp. 951-959, 26 July 2022.v Jonathan E. Pekar et al., « The molecular epidemiology of multiple zoonotic origins of SARS-CoV-2 », Science, Vol 377, Issue 6609, pp. 960-966, 26 July 2022.vi S. Yan, « Beijing mega-market shut down as regime unleashes wave of Covid propaganda blaming West », The Telegraph, 26 November 2020.vii K. Eban et J. Kao, « COVID-19 Origins: Investigating a “Complex and Grave Situation” Inside a Wuhan Lab », Propublica, 28 October 2022.viii Press release of China, « China achieves major, decisive victory in COVID response: CPC leadership »,17 February 2023.ix Jon Cohen, « ‘Ridiculous,’ says Chinese scientist accused of being pandemic’s patient zero », Science insider, 23 June 2023.x Hu B et al., « Discovery of a rich gene pool of bat SARS-related coronaviruses provides new insights into the origin of SARS coronavirus », PloS Pathog, 30 November 2017.xi S. Newey, « Former CDC director suggests Covid-19 ‘escaped‘ from Wuhan lab », The Telegraph, 26 March 2021.xii WHO, « WHO-convened Global Study of Origins of SARS-CoV-2: China Part », 30 March 2021.S. Newey, A. Gulland and S. Yan, « WHO team rules out China ‘lab leak‘ theory in Covid origins investigation », The Telegraph, 9 February 2021.xiii WHO, « Scientific Advisory Group for the Origins of Novel Pathogens (SAGO): preliminary report », 9 June 2022. Geneva: World Health Organization; 2022.xiv WHO, « Independent assessment of the origins of SARS-CoV-2 », 27 June 2025.xv « Dr. Fauci and CDC Director Walensky Testify on Efforts to Combat COVID-19 », C-SPAN, 11 May 2021.S. Lerner, M. Hvistendahl and M. Hibbett, « NIH Documents Provide New Evidence U.S. Funded Gain-of-Function Research in Wuhan », The Intercept, 9 September 2021.xvi A. Sabes, « FBI director says COVID pandemic ‘most likely‘ originated from Chinese lab », Fox News, 28 February 2023.xvii I. Oakeshott, « Upsetting China is the Government’s biggest taboo, as I found out the hard way », The Telegraph, 8 March 2023.xviii Office of the Director of National Intelligence (ODNI), « Potential links between the Wuhan Institute of Virology and the origin of the COVID-19 pandemic », June 2023 (declassified later).xix ODNI, « Updated Assessment on COVID-19 Origins »,29 October 2021.xx Press Release « EcoHealth Alliance’s Response to Recent Allegations », 3 June 2024.xxi S. Lerner, M. Hvistendahl and M. Hibbett, « NIH Documents Provide New Evidence U.S. Funded Gain-of-Function Research in Wuhan », The Intercept, 9 September 2021.xxiiSubcomitee of the US Parliament, « After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward », 4 December 2024.xxiii S. Knapton, « ‘Corrupt’ British zoologist sanctioned over Wuhan experiments that may have sparked Covid », The Telegraph, 20 January 2025.xxiv Letter from P. Daszak quoted in S. Knapton, « No lab had virus close enough to Covid to spark pandemic, claims zoologist funding Wuhan research », The Telegraph 14 March 2023.xxv E. Banco, « CIA says COVID-19 more likely to have come from lab than nature », Reuters, 25 January 2025xxvi W. Echols, « China’s denial of coronavirus tinkering at Wuhan lab misleading », VOA News, 19 February 2025.xxvii Menachery, V., Yount, B., Debbink, K. et al., « A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence », Nat Med 21, 1508–1513, 9 November 2015.xxviii W. Echols, « China’s denial of coronavirus tinkering at Wuhan lab misleading », VOA News, 19 février 2025.xxix « German spy agency concluded COVID virus likely leaked from lab, papers say », Reuters, 12 March 2025.xxx Académie nationale de médecine, « De l’Origine du SARS-CoV-2 aux risques de zoonoses et de manipulations dangereuses de virus », 1st April 2025.xxxi Hervé Le Meur et Caroline Lemerle, « Gain de fonction : l’art de créer des supervirus », Inf’OGM, le journal, n°164, July/September 2021.Olivier Leduc, « Gain of function” in viruses: research in question » Inf’OGM, 11 March 2024.xxxii More precisely fouraminoacid are changed in two locations. Yang Y, Liu C, Du L, Jiang S, Shi Z, Baric RS, Li F., « Two mutations were critical for bat-to-human transmission of Middle East respiratory syndrome coronavirus », Journal of Virology, Vol. 89, No. 173, pp. 9119 –9123, August 2015.xxxiii Éric Meunier, « Scientific manipulations, a basis of the future GMO/NGT law? » Inf’OGM, 19 July 2024.xxxiv The White House, « Lab Leak: The True Origins of Covid-19 ». Olivier LEDUC [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [91] => Array ( [objectID] => 13846 [title] => Origin of Covid-19: laboratory leak is the most likely scenario (part 2) [timestamp] => 1757894400 [date] => 15/09/2025 [annee] => 2025 [url] => https://infogm.org/en/origin-of-covid-19-laboratory-leak-is-the-most-likely-scenario-part-2/ [image] => https://infogm.org/wp-content/uploads/2026/03/pandemic-5023590_1920-768x576.jpg [extrait] => After describing the main issues and key players (part 1)i, we will now trace the prehistory of Covid-19, followed by its history, which has received more media coverage. [chapo] => After describing the main issues and key players (part 1)i, we will now trace the prehistory of Covid-19, followed by its history, which has received more media coverage. [texte] => What research does the WIV conduct?All we know about the research carried out by the Wuhan Institute of Virology (WIV) is what has been published in articles, since this research is partially covered by military secrecy. In 2015, Shi and Baric published an articleii to prove that they had genetically modified a SARS-CoV virus to make it more suitable for humans than bats. The technique they describe is a Gain of Function (GOF) and its product is a GMO. It should be noted here that the Editor of the article added a subsequent statement: "We are aware that this article serves as the basis for unverified theories that the new coronavirus responsible for COVID-19 was manufactured. [...] Scientists believe that an animal is the most likely source of the coronavirus". The scientific debate is in fact much more nuanced than the Editor suggests. The article even acknowledges that "scientific reviewers may consider similar studies constructing chimeric viruses from circulating strains too risky to pursue".Each species has receptors on its cells, which are like locks that may be specific to that species. These receptors allow viruses, with molecules on their surface which are like keys, to enter these cells or not. If the virus key fits the cell receptor, it can infect the cell and then multiply there. Often, a receptor is found in one species and not in another, meaning that viruses are virulent against certain species and not against others. Differentiation between species protects certain species. This is the same argument as the one against genetic clones and standardised lines in industrial agriculture. Because they are too similar, they expose the entire field to eradication. Difference protects.In 2018, P. Daszak, Z. Shi and R. Baric proposed a project (called DEFUSEiii and worth $14 million) to insert a furin siteiv into the spike protein of SARS-CoV. What does this involve? Returning to our image of the ‘key’ and the ‘lock’, the spike protein has a small part (RBD, or Receptor Binding Domain) which is in fact the ‘key’ for the virus to the cell. But the furin site also allows the virus to better activate the opening of the cell’s lock. Not only is the ‘key’ (RBD) adapted to the ‘lock’ (receptor), but it also turns in the ‘lock’ thanks to the furin site. In short, the virus is therefore much more infectious. It is also a GOF. Such research was prohibited in the United States, and the funding request was therefore rejectedv. However, the WIV still had the means to conduct these experiments and EcoHealth Alliance to fund them. We may never know whether they did so or not. In any case, it turns out that the SARS-CoV2 of Covid sequenced at the end of 2019 in Wuhan has just such a furin site and that in the very large family of sarbecoviruses, which includes SARS, it is the only one to have it.A preliminary version of the DEFUSE project proposed that this project be carried out not in the P4 section, but in the P2 section of the WIV so that it would be "highly cost-effective"vi. However, Baric had pointed out that "US researchers will likely freak out." because of its safety conditions. The same Baric wrote to Daszak after the pandemic began: "I have no doubt that they [the WIV researchers] followed the rules set by the state and carried out the work under BSL2. Yes china has the right to set their own policy. You believe this was appropriate [experimental] containment if you want but don’t expect me to believe it. Moreover, don’t insult my intelligence by trying to feed me this load of BS." vii.Genetic data suggests that the SARS-CoV2 virus only recently acquired this furin siteviii. Although scientists in Wuhan published the first sequencing of the virus on 3 February 2020ix, it should be noted that they did not mention this site at that time. On the same day, 3 February 2020, French and Canadian researchers revealed the existence of this furin sitex. Other Chinese scientists submitted an article on 11 April 2020, published on 6 May, studying its rolexi.A history of the COVID-19 pandemicThe Wall Street Journal revealed that several scientists on Dr Shi's team, including one of the scientists in charge of the DEFUSE project in Wuhan (Dr Ben Hu), fell ill in November 2019 with symptoms similar to those of COVID-19xii. However, when this was revealed, Dr Hu denied having been illxiii.In February 2023, Republican members of the US Senate wanted to create a subcommittee to investigate the historical origins of SARS-CoV2. Their (highly political) logic was to prove that China was the cause, without, of course, asking whether the United States and its laboratories had funded this research and trained Chinese researchers, or whether US laboratories were conducting or had already conducted the same research. Even though their logic was biased against China and in favour of protecting US researchers and funding, they investigated, which others refused to do because they defended official ‘science’. The subcommittee was able to retrieve the contents of some WIV computers through espionage and was able to show that WIV members had fallen ill, as reported by the Wall Street Journal and denied by Chinese researchersxiv. It found a great deal of other information.Daszak testified before this committee that he was unaware of the existence of viruses collected after 2015 by the WIVxv and that he had not asked the WIV whether it had begun research on furin site insertionxvi, even though he was funding this work and should therefore have received reports on it. The US administration (under President Biden) was not entirely convinced and suspended all federal funding for Daszak and his association, EcoHealth Alliance.This subcommittee showed that, on 12 November 2019, WIV researchers sent a memorandum to their Chinese supervisory authority in very vivid administrative language. This memorandum showed that they were facing a very big problem that needed to be solved: "these viruses arrive without a shadow and leave without a trace"xvii. The subcommittee recruited Toy Reid, a specialist in Chinese translation. He explains that the Chinese Communist Party has created a language (called pishi) that is difficult to understand, even for a native Mandarin speaker. According to him, the sentence quoted above is indeed a sign of a serious flaw.Following this memorandum of 12 November 2019, Ji Changzheng, Director of Technology Safety and Security at the Chinese Academy of Sciences, visited the WIV on 19 November to "deliver the oral instructions and written requests of the government and the Party Central Committee regarding security, and the need to implement the important security instructions of General Secretary Xi Jinping and Premier Li Keqiang." He "presented an in-depth analysis [...] that strikingly revealed the complex and serious situation in which your work on [bio]security currently finds itself"xviii. Inspections are annual, and the last one at the WIV was in April 2019. In Chinese language and culture, references to Xi Jinping and Li Keqiang convey a very strong argument from authority. Nine other safety inspections do not use this line of communicationxix. On the same day, the WIV issued a call for tenders for an air incinerator that kills all organisms in air that is to be rendered germ-freexx. This is a palliative measure to compensate for normal safety conditions (HEPA), which are not working.In search of patient zero...The information reveals contradictions between the few truths and the statements made by governments. We do not know the truth.The first case of a COVID-19 patient documented by the Chinese government is a resident of Hubei province (where Wuhan is located, without further details on the exact location), who is believed to have contracted the virus on 17 November 2019xxi. However, as early as mid-October, the US consulate in Wuhan knew that the city had been hit by an unusually virulent seasonal fluxxii. Was it COVID-19?In France, thirteen French patients who had undergone routine testing during the week of 4 November 2019 were found to be carriers of the virusxxiii. The first French cases would therefore predate the first reported Chinese cases!In Italy, researchers at the Istituto Superiore di Sanità (National Institute of Health) analysed wastewater samples. They found SARS-CoV2 in Milan and Turin from 18 December 2019xxiv. Other Italian researchers analysed blood samples taken between September 2019 and March 2020. They found antibodies associated with the SARS-CoV2 ‘key’ (RBD) in patients as early as 3 September 2019 in the Venice region, 4 September in Emilia-Romagna and 5 September in Liguriaxxv. This measurement is reliable and it can be assumed that the virus was circulating in Italy as early as the beginning of September. However, the first two officially recognised Italian patients were recorded on 30 January 2020. They were two tourists returning from China.The first reported case in the United States returned on 15 January 2020 from Wuhan, where he had not visited the animal market. He developed a characteristic cough on the 15th and consulted the hospital on 19 January. He had SARS-CoV2 (confirmed by PCR test) and survivedxxvi.The failure of China and other countries to detect and report the disease led to the assumption that it was spreading very quickly, when in fact it had already been present for some time...... that no country wants to identifyThe military laboratory at Fort Detrick (Maryland, United States) was closed in 2009 because it stored viruses not listed in its database. On 5 August 2019, it was closed again by the Army Medical Institute for Infectious Disease Research (NIAID) because it did not have "sufficient systems in place to decontaminate wastewater"xxvii. The problem dated back to May 2018. However, a disease called EVALI, which causes respiratory distress, had been developing in the surrounding area, as well as in many US states, since 2012. At first, it was thought that this disease was COVID-19, but the cause was later found: it was an ingredient in cannabis (THC) in vaping oilsxxviii. Once this ingredient was removed, the symptoms disappeared. This disease is not transmissible. EVALI is therefore not COVID.Chinese government spokespeople quoted Larry Romanoff, supposedly a leading American scientist (although he is Canadian, not leading and not scientist) teaching at Fudan (where he cannot be found), to accuse the Fort Detrick laboratory of a laboratory leak. In fact, Larry Romanoff is nothing more than a propagandist replicating the methods of the USSR (the Soviet INFEKTION or Denver project to claim that the same Fort Detrick laboratory was the cause of the HIV virusxxix). He is well described in a France Television documentary analysed by Paul Charon, which shows that he has lied several timesxxx. This lead does not seem solid to us.In October 2019, sports games between military personnel from different countries were organised in Wuhan. Members of the US delegation fell ill with suspicious coughs. Was this an illness apparently linked to an ingredient in vaping liquidsxxxi, COVID that the US military imported into China from Fort Detrick, or COVID that the Chinese transmitted to military personnel from other countries? Chinese spokespeople quoted a journalist, George Webb, who supported the second theory. US newspapers then defended their country by explaining that "Chinese state-run media are citing an American conspiracy theorist to push claims that coronavirus was brought to China by a U.S. military athlete"xxxii. Clearly, journalists have a national bias, using accusations of conspiracy to discredit an individual and the country (China here) that quotes him. Neither side bothers to present arguments. However, George Webb does not provide any solid evidence about these military games. In particular, no military personnel have been diagnosed with or had COVID-19. One might even think that the military knows if its troops have had COVID. What is hidden by the fact that they are not saying so? A US State Department investigator, David Asher, also claims that this hypothesis is certain according to his sources... which he does not disclosexxxiii. Logically, China asks, "when did patient zero appear in the United States? How many people are infected? In which hospitals? It could be the US military that brought this epidemic to Wuhan. Be transparent! Make your data public! The United States owes us an explanation!"xxxiv. The media is a tool for States to avoid answering each other and to hurl insults at each other.An article in Le Mondexxxv takes up this line of thinking and concludes that states would have something to gain by declaring that their military personnel had contracted the disease upon returning from Wuhan. They would then be considered victims. Why has no state announced anything? Neither the United States nor China.Since there were patients in Italy as early as 3 September 2019, these theories are probably insufficient. Furthermore, it has been noted that some Chinese samples from the first cases were destroyedxxxvi. China identified 260 cases in December 2019, but only reported 174 to the World Health Organisation (WHO) in 2021xxxvii. Those reported were linked to the animal market. Why report only cases linked to the animal market, unless the intention was to steer the interpretation of the origin of COVID towards it?The WHO confirmed that the first cases appeared in early December 2019, "however, these cases had no direct link to the Wuhan animal market and could have been infected in November by undetected cases from the animal market"xxxviii. Therefore, if cases do not fit the WHO's interpretation of a zoonosis originating in the Wuhan market, China does not report them. This is a huge statistical error. The WHO requires its members (including China) to report any information of international significance within 24 hours (Art. 6) and to provide all information relevant to public health (Art. 7). However, as early as 30 December 2019, doctors in Wuhan were warning of an ongoing epidemic. Dr Li Wenliang was one of the Chinese whistleblowers. He died a few weeks later from COVID. Before his death, he had been arrested for reporting the cases observed in his hospitalxxxix. Journalist Zhang Zhan said that "without the truth, nothing makes sense"xl. She was imprisoned for four years. So there were other whistleblowers in China besides Li Wenliang.On 30 December 2019, at 3:10 p.m., the Wuhan Municipal Health Commission issued an ‘urgent notice’ to healthcare facilities to monitor cases of "pneumonia of unknown origin". Then, at 6:50 p.m., a second notice was issued, warning "not to disclose information to the public without authorisation"xli. It was not until 31 December 2019 that China reported the Wuhan outbreak to the WHOxlii, without providing the genome or mode of transmissionxliii.On 1 January 2020, the Wuhan animal market was closed, but the outbreak continued. On 3 January, the Chinese Communist Party (CCP) banned scientists from sharing information about SARS-CoV2. On 5 January, Zhang Yongzhen, a virologist at the Shanghai Public Health Clinical Centre (SPHCC), published the SARS-CoV2 virus sequence on a website in the United States, but with an embargo until July 2020. On 7 January, he submitted an article commenting on this sequence (without noticing the furin site). Under pressure, he disobeyed the CCP and the Chinese state and finally shared the genome with a co-author, who made it immediately available on a British website on 11 Januaryxliv. He claimed that he had not been informed of the CCP's ban on sharing it. As late as 14 January, the WHO assured (based on Chinese information) that there was no evidence that the virus was transmitted from human to human. However, on 20 January, China acknowledged human-to-human transmission and ordered a lockdown of the population of the largest cities from 24 January. Zhang Yongzhen received a "rectification" from the government prohibiting him from working on this virusxlv. On 28 April 2020, he found the door to his laboratory closed by the Chinese state. He then fought to regain his position.The viruses found in the first infected individuals have very little genetic diversityxlvi. It is therefore more likely that there was a single emergence of the virus, rather than an entire population of viruses that co-evolved naturally with humans (zoonotic theory)xlvii. Indeed, a zoonosis implies several passages back and forth from animals to humans, which generates a certain genetic diversity before any passage from animal to human, allowing for high transmissibility between humans.Meanwhile, on 19 February 2020, the medical journal The Lancet published a letter signed by 27 prominent scientists in which the authors (including Daszak) stated: "We stand together to strongly condemn conspiracy theories suggesting that COVID-19 does not have a natural origin." and "Scientists from multiple countries [...] overwhelmingly conclude that this coronavirus originated in wildlife, [...]. Conspiracy theories do nothing but create fear, rumours, and prejudice that jeopardise our global collaboration in the fight against this virus" and declare "no conflict of interest"xlviii. Richard Horton, editor-in-chief of The Lancet, acknowledged that "Peter Daszak should certainly have declared his conflicts of interest from the outset"xlix. In addition to his own funding, Daszak was funding the co-signatories of this letter, who were therefore indebted to him.From 14 January to 10 February 2021, the WHO sent a team to China to investigate the origin of SARS-CoV2. This required the agreement of China, which also demanded that certain participants, including P. Daszak, be included. The mission was to "identify the zoonotic source of the virus"l (sic). Half of the researchers, who were Chinese nationals, had access to Chinese datali. The other half only could discuss the Chinese reports on these data. The WHO study concluded that zoonosis was "likely to very likely" and a laboratory incident "extremely unlikely"lii. Similarly, the conclusion of the mission leader (Peter Embarek) is that "the hypothesis of a laboratory incident is extremely unlikely to explain the introduction of the virus"liii. Less convinced, the Director-General of the WHO "called for further studies to be conducted"liv. Scientistslv also voiced strong criticism. Similarly, the United States, along with 13 other countrieslvi, as well as the European Unionlvii, have stated that greater clarity and transparency are necessary and feasible in order to move forward. In contrast, the spokesperson for the Chinese Ministry of Foreign Affairs has taken refuge behind the scientific conclusion of this expert committeelviii. Journalists note that "the evidence points to bats as the likely reservoir animal."lixIn this second part, we have provided numerous details on the history of the COVID-19 pandemic and several possible explanations. The errors and falsehoods of various parties are evident. In the third part, we will therefore address the question of the origin of SARS-CoV2 and the positions of the various parties.i Olivier Leduc, « Origin of Covid-19: laboratory leak is the most likely scenario », Inf’OGM, September 10th 2025.ii Menachery, V., Yount, B., Debbink, K. et al., « A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence », Nat Med 21, 1508–1513, 2015.iii S. Lerner and M Hibbett, « Leaked Grant Proposal Details High-Risk Coronavirus Research », The Intercept, 23 septembre 2021.iv Indeed, this is a furin cleavage site, but we prefer to shorten it so as not to weigh down this technical section.v The Drastic collective published the DARPA assessment: DARPA, « Project DEFUSE: Defusing the Threat of Bat-borne Coronaviruses ».vi "highly cost-effective" and "US researchers will likely freak out". Quoted in :Alina Chan, ‘Why the pandemic probably started in a lab in 5 key points’, New York Times, 3 June 2024. Alina Chan and Matt Ridley, Viral – The Search for the Origin of Covid-19, Harper Collins Publishers, 28 June 2022.United States Department of the Interior, « U.S. Geological Survey (USGS) Freedom of Information Act (FOIA) Tracking #DOI-USGS-2023-000257 – Response », 5 December 2023.vii K. Eban, Ralph Baric, « Whose Virology Techniques Were Used in Wuhan, Testified That Lab Leak Was Possible », Vanity Fair, 1st May 2024.viii H. Choe and M. Farzan, « How SaRS-COv2 first adapted to humans », Science, Vol. 372 Issue 6541, 30 April 2021.ix Zhou, P. et al., « A pneumonia outbreak associated with a new coronavirus of probable bat origin », Nature 579, 270–273, 2020).x B. Coutard et al., « The spike glycoprotein of the new coronavirus 2019-nCoV contains a furin-like cleavage site absent in CoV of the same clade », Antiviral Research 176, 2020.xi Xia, S., Lan, Q., Su, S. et al., « The role of furin cleavage site in SARS-CoV-2 spike protein-mediated membrane fusion in the presence or absence of trypsin », Sig Transduct Target Ther 5, 92, 2020.xii M. Gordon, « U.S.-Funded Scientist Among Three Chinese Researchers Who Fell Ill Amid Early Covid-19 Outbreak », Wall Street Journal, 20 June 2023.M. Shellenberger, M. Taibbi and A. Gutentag, « First People Sickened By COVID-19 Were Chinese Scientists At Wuhan Institute Of Virology, Say US Government Sources », Public, 13 June 2023.xiii J. Cohen, « ‘Ridiculous,’ says Chinese scientist accused of being pandemic’s patient zero », Science Insider, 23 June 2023.xiv Ibid.xv GOP Oversight, « A Hearing with the President of EcoHealth Alliance », Dr. Peter Daszak », 1st May 2024.xvi Ibid.xvii K. Eban et J. Kao, « COVID-19 Origins: Investigating a “Complex and Grave Situation” Inside a Wuhan Lab », ProPublica, 26 October 2022.Wuhan Institute of Virology, « 牢记责任，坚守使命做我国高等级生物安全领域的开拓者——中科院武汉病毒所郑店实验室党支部事迹 », 20 October 2022.xviii Ibid.xix Ibid.xx Ibid.xxi J. Ma, « Coronavirus: China’s first confirmed Covid-19 case traced back to November 17 », South China Morning Post, 13 March 2020.xxii R. Westergard, « Surviving the Outbreak », State Magazine, April 2020.xxiii Fabrice Carrat, « Evidence of early circulation of SARS-CoV-2 in France: findings from the population-based “CONSTANCES” cohort », European Journal of Epidemiology, no 36,‎ 219-222.xxiv Redaction, « A Milano e Torino il virus circolava già da dicembre. La conferma in una ricerca dell’ISS », Sanità informazione, 19 juin 2020.xxv Apolone G, Montomoli E, Manenti A, et al., « Unexpected detection of SARS-CoV-2 antibodies in the prepandemic period in Italy », Tumori Journal, 107(5):446-451, 2020.xxvi Michelle L. Holshue et al., « First Case of 2019 Novel Coronavirus in the United States », N. Engl. J. Med., Vol. 382 No. 10 pp. 929-936, 31 January 2020.xxvii Denise Grady, « Deadly Germ Research Is Shut Down at Army Lab Over Safety Concerns », The New York Times, 5 August 2019.xxviii Outbreak of lung injury associated with e-cigarette use, or 'vaping' (Report). Centers for Disease Control and Prevention (CDC). February 11, 2020. More general source on Wikipedia. https://en.wikipedia.org/wiki/Vaping-associated_pulmonary_injuryxxix Wikipedia, Operation Denverxxx N. Le Fustec, Covid, le secret des origines, EverProd/France Television, 30 March 2025.xxxi Rebuli ME, et al., « The E-cigarette or Vaping Product Use-Associated Lung Injury Epidemic: Pathogenesis, Management, and Future Directions: An Official American Thoracic Society Workshop Report », Ann Am Thorac Soc, January 2023.xxxii T. Hoonhout, « Chinese State Media Falsely Claim U.S. Army Athlete Brought Coronavirus to China », National Review, 26 March 2020.xxxiii N. Le Fustec, Covid, le secret des origines, EverProd/France Television, 30 March 2025.xxxivD. Gilbert, « China Is Now Blaming a Lone U.S. Cyclist For Coronavirus », Vice, 26 March 2020.xxxvH. Thibault, N. Guibert and C. Guillou, « Ce que l’on sait des Jeux mondiaux militaires de Wuhan, après lesquels plusieurs athlètes disent être tombés malades », Le Monde, 12 May 2020.xxxviEditorial, « Wuhan’s early covid cases are a mystery. What is China hiding? », Washington Post, 17 November 2022.xxxviiG. Demaneuf, « Arrested Development: The number of Wuhan cases of COVID-19 with onset in 2019 », October 2022.Editorial, « Wuhan’s early covid cases are a mystery. What is China hiding? », Washington Post, 17 November 2022.xxxviiiWHO, « Origin of SARS-COv2 », 26 March 2020.xxxix« Associated Press China exonerates doctor reprimanded for warning of virus », AP News, 20 March 2020,xl M. Sharma, « ‘Made in Wuhan, shipped by Beijing’: A story of how Communist Party of China gave world Covid-19 pandemic », First Post, 31 December 2024.xli Editorial, « Wuhan’s early covid cases are a mystery. What is China hiding? », Washington Post 17 November 2022.xlii M. Sharma, « ‘Made in Wuhan, shipped by Beijing’: A story of how Communist Party of China gave world Covid-19 pandemic », First Post, 31 December 2024.xliii D. Cyranoski, « Nature’s 10: ten people who helped shape science in 2020 », Nature 15 December 2020.xliv Ibid.xlv Ibid.xlvi WHO, « Origin of SARS-COv2 », 26 March 2020.xlvii Alina Chan, « Why the pandemic probably started in a lab in 5 key point », p.9, New York Times, 3 juin 2024.Alina Chan et Matt Ridley, Viral – The Search for the Origin of Covid-19, Harper Collins Publishers, 28 juin 2022.The White House, « Lab Leak – The true origin of Covid-19 ».xlviii Calisher C, et al., « Statement in support of the scientists, public health professionals, and medical professionals of China combatting COVID-19 », The Lancet, March 2020.xlix House of commons, « Science and Technology Committee – Oral evidence: Reproducibility and Research Integrity, HC 606 », 15 December 2021.lWHO, « WHO calls for further studies, data on origin of SARS-CoV-2 virus, reiterates that all hypotheses remain open » 30 March 2021li Jesse D. Bloom et al., « Investigate the origins of COVID-19 », Science 372, 694-694, 2021.lii WHO, « WHO-convened global study of origins of SARS-CoV-2: China part », p. 9, 2021.Annick Bossu, « Covid-19 : un expert de l’OMS parle juste avant la pandémie », Inf’OGM, 13 avril 2021.liii « Covid-19: la théorie d’une fuite d’un laboratoire chinois «hautement improbable», d’après les experts de l’OMS », Le Figaro TV, 9 February 2021.liv WHO, « WHO calls for further studies, data on origin of SARS-CoV-2 virus, reiterates that all hypotheses remain open » 30 March 2021.WHO, « WHO director-general’s remarks at the Member State Briefing on the report of the international team studying the origins of SARS-CoV-2 », 2021.lv Jesse D. Bloom et al., « Investigate the origins of COVID-19 », Science 372, 694-694, 2021.lvi US Department of State, « Joint statement on the WHO-Convened COVID-19 origins study », 2021.lvii Delegation of the European Union to the UN and other International Organizations in Geneva, « EU statement on the WHO-led COVID-19 origins study », 2021.lviii « Covid-19: la théorie d’une fuite d’un laboratoire chinois «hautement improbable», d’après les experts de l’OMS », Le Figaro TV, 9 February 2021.lix S. Newey, A. Gulland and S. Yan, « WHO team rules out China ‘lab leak‘ theory in Covid origins investigation », The Telegraph, 9 February 2021. Olivier LEDUC [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [92] => Array ( [objectID] => 13820 [title] => Origin of Covid-19: laboratory leak is the most likely scenario [timestamp] => 1757462400 [date] => 10/09/2025 [annee] => 2025 [url] => https://infogm.org/en/origin-of-covid-19-laboratory-leak-is-the-most-likely-scenario/ [image] => https://infogm.org/wp-content/uploads/2026/03/pandemic-5023590_1920-768x576.jpg [extrait] => A Covid-19 epidemic (acronym for ‘coronavirus disease 2019’) was officially declared in January 2020 in the city of Wuhan, then quickly turned into a pandemic spreading throughout the world. The rapid spread of the SARS-CoV-2 virus (for ‘Severe Acute Respiratory Syndrome’), responsible for this pandemic, led to lockdowns being imposed on everyone, regardless of age group or susceptibility to the disease. It has disrupted the lives of billions of people. But where did the virus come from? This three-part article aims to describe what is known about the origin of this virus and why it should matter to us, here and now. All those involved in this pandemic story are undoubtedly hiding part of the truth.In the first part, we explain the issue and why it may be of interest to us, even after the pandemic is over, and describe its main players. In the second part, we will review the history of this pandemic. In the third part, we will give the opinions of various institutions on its origin. [chapo] => A Covid-19 epidemic (acronym for ‘coronavirus disease 2019’) was officially declared in January 2020 in the city of Wuhan, then quickly turned into a pandemic spreading throughout the world. The rapid spread of the SARS-CoV-2 virus (for ‘Severe Acute Respiratory Syndrome’), responsible for this pandemic, led to lockdowns being imposed on everyone, regardless of age group or susceptibility to the disease. It has disrupted the lives of billions of people. But where did the virus come from? This three-part article aims to describe what is known about the origin of this virus and why it should matter to us, here and now. All those involved in this pandemic story are undoubtedly hiding part of the truth.In the first part, we explain the issue and why it may be of interest to us, even after the pandemic is over, and describe its main players. In the second part, we will review the history of this pandemic. In the third part, we will give the opinions of various institutions on its origin. [texte] => Where could Covid-19 have come from?It is important to remember that a virus cannot multiply on its own, but only inside the cells of other species, which it must first be able to penetrate. There are two theories about its origin.The first theory is known as the zoonotic origin theory (disease linked to animals in ancient Greek), according to which the virus was transmitted from animals to humans. This complex term actually covers two very different sub-theories.The first sub-theory is that an ecosystem (swamp, cave, etc.) was colonised by humans who were then exposed to a virus they were not accustomed to and which spread among humans. It could also be that an animal, an intermediate host, was infected and facilitated the transmission to humans, for example through wild animals commonly eaten in China (pangolins, raccoon dogs, etc.).The second sub-theory is linked to industrial farms in China, which mix thousands of pigs and tens of thousands of chickens. The risk that a virus specific to pigs could, by chance, be adapted to chickens and, at the same time, that there could be a chicken nearby is high in such a farm. Having been selected to jump a species barrier (from pigs to chickens), it will multiply all the more quickly due to the concentration of thousands of animals in the same enclosed environment. Such an origin is not natural, but industrial. Very often, the state imposes the slaughter of animals in the event of contamination, including small-scale outdoor farms, which do not present the same risks and are not sources of contamination. Thus, even this second sub-thesis (industrial farming) is politically interesting and should not be overshadowed by the first. A zoonosis necessarily involves several passages back and forth between animals and humans, which generates a certain genetic diversity before any passage from humans to humans.The second theory is that of a leak from one or more laboratories. It has been reported that researchers are conducting experiments known as ‘gain-of-function’ (GOF) experiments to produce viruses that are more or less dangerous than the original virusi.What is a GOF?In brief, GOFs refer to techniques that enable a virus to gain or lose a function. These are either genetic modification techniques (resulting in GMOs) or in vitro culture techniques in which viruses are exposed to cells of a type other than that for which they are adapted by evolution. In vitro cultures change the selection pressure so that the virus gains or loses a function as it is gradually multiplied. This is also known as ‘serial passage’, where viruses are successively exposed to cells, culture media or animals with the intention of selecting a genetic change without producing it (as in the case of GMOs). For example, scientists genetically modify mice so that some of their cells have a human-type receptor. These are ‘humanised’ GMO mice. They then inject these GMO mice with viruses adapted to bats. The viruses that survive are those that are more adapted to attack ‘humanised’ cells. Little by little, they select viruses capable of attacking humanised cells, and therefore human cells too. The most frequent case is a mixture of these two techniques.Professor Simon Wayn-Hobson (virology department, Institut Pasteur, Paris) argues that "the consequences of an accident could range from a few infections to a catastrophic pandemic"ii. Professor Anton van der Merwe (Oxford University) argues in the Financial Times that "researchers are doing and want to continue doing precisely those experiments that make laboratory leaks more likely. This includes GOFs"iii. According to him, there are "few justifications for such experiments except scientific curiosity and the desire for prestige"iv. Proponents of these gains of function put forward the argument of preparing a vaccine to deal with any possible ‘natural’ passage of an animal virus to humans…Can the intermediate host be found?The SARS virus of 2002, different from SARS-Cov2, took five months to be isolated and sequencedv. The origin is SARS from bats, passed on by civets, then to humansvi. It should be noted that this first episode of SARS was of zoonotic origin. But the next two outbreaks, in 2003, were the result of laboratory leaksvii, since all the people contaminated were working in a laboratory that was storing the virusviii.MERS appeared in June 2012. A Saudi doctor asked the Dutch virologist Ron Fouchier (a specialist in GOF), who obtained the sequencing of the virus published on 8 November 2012ix, i.e. in five months. From the outset, the intermediate host was known to be the camel. Today's resources are non-comparable with those of 2003 or 2012. For example, a virus can now be sequenced in 4 or 5 days. SARS-Cov2 was sequenced at the end of 2019 in 5 days and released on 11 January 2020. However, 5 years after the official start of Covid-19, several intermediate hosts have been accused without justification. According to some, it weakens the zoonotic theory, without prohibiting it.Who are the main protagonists?Zhengli Shi did her PhD in Montpellier, then held several positions in the United States. For more than 10 years, she has run the P3 laboratory in Wuhan, designed by the Institut Pasteur and built with plans offered by France, and she co-directs its P4 laboratoryx (the P4 type is the most closely monitored), receiving funding from the US government via a US NGO, EcoHealth Alliance. Unfortunately, even P4 laboratories are exposed to leaks from laboratoriesxi. In 2005, Zhengli Shi was part of the team that proved that the SARS outbreak of 2002 and 2003, which killed 774 people worldwide, was caused by a batxii.Ralph Baric co-directs the virology laboratory in North Carolina (USA) with military personnel. It was Baric who taught Zhengli Shi how to genetically modify viruses.Peter Daszak, President of the NGO EcoHealth Alliance, is a central figure. Over the past 20 years, he has collected more than 80 million dollars from research organisations in the United States to harvest viruses and carry out GOF experiments on them. He promises that, thanks to his virus collections and GOF work, other researchers will then find vaccinesxiii. His funding goes mainly to the North Carolina laboratory and Ralph Baric, as well as the Wuhan Institute of Virology (WIV) and Zhengli Shi laboratories (P3 and P4).Antony Fauci was public health advisor to eight US presidents and director of the National Institute of Allergy and Infectious Diseases (NIAID) from 1984 to 2022. He promoted major advances in the chemical fight against HIV. He defended the GOF, the zoonotic thesis and supported Daszak and Baric. He is the state guarantor of scientists like Daszak.Tales from the prehistory of the SARS-CoV2 epidemicIn 2012, six miners (aged between 30 and 63) were working in a mine in Mojiang (Yunnan province, China) where bats were living. A few weeks later, they were admitted to hospital in Kunming with persistent coughs, fever and difficulty breathing. Three of them died. This mine is located 1,500km from Wuhan. A group of researchers (DRASTIC) has made this information publicxiv. Between 2012 and 2015, researchers at the Wuhan Institute of Virology (WIV) identified 293 coronaviruses in and around the mine, including one called RATG13. All these viruses were sequenced and could be consulted in a database that the WIV made available to everyone on the Internet. According to the WIV and Zhengli Shi, none of them is suitable for transmission between humans; the miners died from an infection by a fungusxv. But while this database would have helped researchers get an idea of the viruses sequenced and the history of viruses obtained by the WIV, it denied public access from 3 September 2019. Why?It turns out that RATG13 is, according to Zhengli Shi, the closest ancestor of SARS-CoV2, as it is 96.2% identical. But this is not enough to be an ancestor that would have evolved so ‘naturally’ (3.8%) in only 6 years. Scientists can estimate the speed of mutation by natural reproduction. So, either it is not the real ancestor and we need to look elsewhere, or it did not evolve ‘naturally’. Furthermore, according to the zoonotic theory, if RATG13 is the ancestor, it would have travelled 1,500km from Mojiang to Wuhan without causing an epidemic. It would have miraculously reappeared six years later, having mutated much faster than in the wild, in the vicinity of the WIV, which was working on this very type of virus and carrying out GOF on SARS, or potentially in the Wuhan animal market, on the other side of the river, around 13.5km away...We have therefore seen that the origin of SARS-CoV2 raises a number of questions and hypotheses, involves several key players and could come from techniques that create GMO viruses. In the second part, we will describe the practices of the Wuhan Virology Laboratory (WIV) and the prehistory and history of Covid-19.i Hervé Le Meur and Caroline Lemerle, « Gain de fonction : l'art de créer des super viruses », Inf'OGM, le journal, n°164, July/September 2021.ii S. Wain-Hobson, « The irrationality of GOF avian influenza virus research », Front. Public Health, Volume 2, 2014.iii A. van der Merwe, « Scientists dismissed lab leak theory due to conflict of interests », Financial Times 10 March 2023.iv Jamie Johnson, « Joe Biden may be forced to declassify intelligence into Covid-19 origins », The Telegraph, 10 March 2023.v SARS appeared in November 2002. Its sequence is published in: C. Drosten et al., « Identification of a Novel Coronavirus in Patients with Severe Acute Respiratory Syndrome », N Engl J Med, Vol. 348, No. 20, 348:1967-1976, 15 May 2003.vi Y. Guan et al., « Isolation and Characterization of Viruses Related to the SARS Coronavirus from Animals in Southern China », Science, Vol 302, Issue 5643, pp. 276-278, 10 October 2003.vii R. Ebright quoted in :Y. Rui et al., « Wuhan Virology Lab Deputy Director Again Slams Coronavirus Conspiracies », Caixin Global, 7 February 2020.viii "The index cases were systematically described in people working in laboratories studying the virus responsible for severe acute respiratory syndrome (virology students, contract researchers). These index cases were the source of contamination for the other people affected (parents, nurses, etc.)".Wikipedia contributors, « Severe acute respiratory syndrome », Wikipedia, the free encyclopaedia.ix Ali M. Zaki et al., « Isolation of a Novel Coronavirus from a Man with Pneumonia in Saudi Arabia », N Engl J Med, Vol. 367, No. 19, pp.1814-1820, 8 November 2012.x Laboratories handling viruses or infectious agents are classified in ascending order of safety standards, from P1 to P4. P4 laboratories are the only ones authorised to handle viruses that are lethal to humans and for which there is no vaccine or treatment. Even in P3 laboratories, scientists are provided with an individual air supply. But viruses are so small that mistakes are the rule, not the exception. Inf'OGM has already documented the very many leaks. In any case, military laboratories escape the law and rarely report on their leaks. A British military scientist, Geoffrey Bacon, died of the plague in January 1962 in the UK. We can assume that he was working on the plague bacillus.xi Christophe Noisette, « Pathogènes en laboratoire : la sécurité absolue est un leurre », Inf’OGM, le journal, N°164, July/September 2021.xii Wendong Li et al., « Bats Are Natural Reservoirs of SARS-Like coronaviruses », Science, Vol. 310, Issue 5748, pp. 676-679, 28 October 2005.xiii Annick Bossu, « Covid-19 : un expert de l’OMS parle juste avant la pandémie », Inf’OGM, 13 April 2021.xiv Li Xu, « The Analysis of Six Patients With Severe Pneumonia Caused By Unknown Viruses », May 2013 (translated by Drastic in June 2020).xv D. Stanway, « Explainer: China’s Mojiang mine and its role in the origins of COVID-19 », Reuters, 9 June 2021. Olivier LEDUC [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [93] => Array ( [objectID] => 13739 [title] => The scientific lobby joins the trilogue on the deregulation of GMOs/NGTs [timestamp] => 1754611200 [date] => 08/08/2025 [annee] => 2025 [url] => https://infogm.org/en/the-scientific-lobby-joins-the-trilogue-on-the-deregulation-of-gmos-ngts/ [image] => https://infogm.org/wp-content/uploads/2026/03/Jekabs_Kazaks_-_Three_Old_Ladies_-_Google_Art_Project.jpg [extrait] => As the European Union attempts to move forward with its trilogue on the deregulation of plant GMOs derived from new techniques (NGT), the French Association for Plant Biotechnology (AFBV) and its German counterpart (WGG) are stepping up to the plate. In a joint statement, they highlight the disagreements between the European Parliament and the Council, while arguing, on the basis of what they claim to be "scientific" arguments, for the deregulation of these GMOs, to the benefit of the biotech sector. [chapo] => As the European Union attempts to move forward with its trilogue on the deregulation of plant GMOs derived from new techniques (NGT), the French Association for Plant Biotechnology (AFBV) and its German counterpart (WGG) are stepping up to the plate. In a joint statement, they highlight the disagreements between the European Parliament and the Council, while arguing, on the basis of what they claim to be “scientific” arguments, for the deregulation of these GMOs, to the benefit of the biotech sector. [texte] => On 4 July, the French Association for Plant Biotechnology (or AFBV for Association Française des Biotechnologies Végétales) and the Scientific Circle for Genomics and Genetic Engineering (or WGG for Wissenschaftskreis Genomik und Gentechnik) jointly published a notei presenting their analysis and the main points of divergence between the positions of the European Parliament and the Council of the European Union on the regulation of GMOs derived from NGT. In this technical document, these two associations, which bring together people convinced of the benefits of plant biotechnology (including scientists linked to industryii), defend an agricultural model centred on biotechnology and the industrial interests that go with it. This sectoral position on NGTs relegates the precautionary principle, food sovereignty and transparency to the background.Four outstanding issues in the triloguekastThe AFBV and the WGG base their position on an information note published on 13 June 2025 by Poland, whose Presidency of the Council of the European Union ended on 30 Juneiii, which identified four outstanding issues in the trilogue. It should be noted that the trilogue is taking place even though the Council has not yet finalised its position at first reading, although it has already given the Presidency a mandate to negotiate. We reproduce here the AFBV and WGG's presentation of the Polish Presidency's note, as well as the recommendations of the two associations.Regarding the conditions for obtaining "NGT1" status – a status for GMOs presented as similar to non-genetically modified organisms or derived from so-called "conventional breeding" – this opens the way for marketing authorisation without risk assessment, without labelling (beyond the marketing of seeds and plants), without traceability, without the obligation to present the means to detect and identify them, and without post-marketing monitoring. The AFBV and WGG argue that Parliament wants to reserve the "NGT1" status for plants with "sustainable" traits and exclude herbicide tolerance, while the Council favours a broader approach based on the "principle of equivalence". It thus declares GM plants whose genetic modifications meet supposedly strict but in fact very permissive criteria to be equivalent, with the sole exclusion of herbicide tolerance. The AFBV and the WGG are calling for an "acceptable compromise", which consists of incorporating the sustainability assessment into other texts concerning varieties, in this case the proposal for a regulation on plant reproductive material (PRM)iv, or "seed regulation"v, currently under discussion. A proposal by the AFBV would allow this debate to be dropped without ensuring that it takes place in other texts.On the traceability and labelling of products derived from NGT1, the two associations reiterate the Parliament's request to label all such products up to the consumer, whereas the Council's request is limited to plant reproductive material genetically modified by these techniques. The AFBV and the WGG support the Council's version, arguing – on the basis of semantic confusion dressed up in scientific language, as in the European Commission's case – that genetic modifications generated by NGT1 cannot be distinguished from natural mutations and should therefore not be subject to specific labelling.Third outstanding issue: the derogation ("opt-out" or "safeguard clause") allowing Member States to refuse the cultivation on their territory of plants derived from NGT2 authorised at European level. The Council wants to maintain this national "opt-out" option, while the Parliament wants to repeal it while giving Member States responsibility for coexistence. The AFBV and the WGG support the Parliament's position, arguing that this option to refuse makes the use of NGTs "unpredictable, therefore discouraging their development and use".Finally, with regard to measures to "address the impact of patents on NGT plants", a major point of disagreement between the European institutions, the Parliament proposes to exclude all plants genetically modified by NGT from patentability. The Council prefers to encourage transparency and promote "equitable" licensing. Unsurprisingly, the AFBV and the WGG strongly defend patent protection, which they consider essential for start-ups in the sector.The specific issue of equivalence criteriaIn the second part of their note, the AFBV and the WGG compare the amendments proposed by the Council and the European Parliament to the Annex to the Commission's proposal on the criteria for regulatory equivalence of plants genetically modified by NGT1 with plants obtained by "conventional breeding".Both associations support the Council's position to maintain the criterion of fewer than 20 genetic modifications by adding the words "per monoploid genome" (one copy of each chromosome) to “take useful account of the need for flexibility for polyploid plants". Like the European Food Safety Authority (EFSA)vi, they consider this position to be scientifically justified. With this proposal, the AFBV and the WGG propose to mathematically increase the number of genetic modifications, paving the way for "NGT1" status. The "twenty" modifications proposed by the European Commission concern, in fact, each genetically modified plant. In the case of wheat, whose genome contains six different sets of chromosomes, the AFBV and WGG proposal would therefore mean considering 20*6 modifications, or 120 genetic modifications, potentially all different. In addition, the Commission has already proposed to take into account only certain categories of genetic modifications and to ignore all othersvii.The two associations also argue for a reformulation of these criteria to avoid an overly rigid separation between targeted mutagenesis and cisgenesis techniques, claiming that this could lead to confusion, and for the abandonment of the consideration of endogenous gene disruption. The proposed amendments aim to further broaden access to "NGT1" status so as to cover – under the guise of a complex scientific explanation – the lack of technical control by companies. The AFBV and WGG also defend the retention of the Parliament's definition of "chimeric proteins", proteins encoded by the fusion of two or more genes or parts of genes that originally encoded distinct proteins. These would only be authorised if they already exist in a species in the breeders' genetic poolviii.Ideological orientations and lobbyingAlthough intended to be constructive, this technical note from the AFBV and WGG remains marked by ideological bias. Under the guise of scientific discourse, the recommendations of the AFBV and WGG are in fact lobbying objectives. The clear support of these two associations for the proposals of the Parliament or the Council in favour of deregulating GMOs/NGTs demonstrates their unconditional support for these techniques.The AFVB and WGG's recommendations to deregulate GMOs/NGTs are based on scientific arguments for which they themselves have established the criteria. However, this choice puts them at odds with certain opinions of official institutions in their respective countries. In fact, in both France and Germany, reports have highlighted the risks and shortcomings of such deregulation of GMOs/NGTs: the March 2024 report by ANSES (the French Agency for Food, Environmental and Occupational Health & Safety) calling for appropriate regulation of NGTsix, and the April 2025 report by the German government on the compatibility of this deregulation proposal with the Cartagena Protocol on Biosafetyx.In one of the main points of their note, the AFBV and WGG argue that plants genetically modified by NGT1 would not be GMOs, as their modifications are, in their view, similar to those that can occur naturally. However, the German government report, which itself supports the development of NGTs, concluded in 2024 that the proposed European regulation was incompatible with the Cartagena Protocol on Biosafety (which the European Union has nevertheless ratified). This international convention requires a risk assessment for all living modified organisms (LMOs), regardless of the technique used, including NGT. The AFBV already stated in December 2024 that GMOs/NGT1 should not be considered LMOs under the Cartagena Protocolxi.The AFBV and WGG present themselves as scientific collectives, and are therefore, in theory, independent, neutral and objective. However, as mentioned above, their commitments show that they have focused their discourse on defending agricultural biotechnologies, particularly transgenic ones. The WGG had nevertheless retained the term "green genetic engineering" in its name until 2022. They have thus consistently supported an approach favourable to the industry, which is now seeking to deregulate GMOs/NGTs, privatise them through patents and restrict access to plant traits for small and medium-sized farmers and seed producers.The Franco-German note from the AFBV and the WGG sheds light on the technical issues at stake in the ongoing discussions on the regulation of GMOs/NGTs. However, it mainly sets out a sectoral position supported by actors in favour of agriculture based on technical developments that are incompatible with organic farming, which is mentioned only once in relation to the labelling of NGTs1: "We agree with the Polish Presidency and the Commission that labelling plant reproductive material is an adequate and sufficient measure to address the concerns of the organic sector". Yet another opportunity to reinforce the misleading idea that GMOs/NGT1 are "close to nature" products.By advocating permissive criteria and minimal or even no regulation of GMOs/NGT1, the AFBV and WGG are relegating to the background – unsurprisingly but bluntly, and backed by the scientific credibility they have granted themselves – the principles of precaution, food sovereignty, transparency and easy access to genetic resources, which are fundamental to a fair and protective European Union for all.i AFBV and WGG, “Update on Trilogue discussions on the regulatory proposal of the European Commission on New Genomic Techniques ("NGTs") », 4 July 2025.ii The AFBV's board of directors and scientific committee include individuals who have held senior positions at Syngenta, Calyxt and Limagrain. Its new president is Thierry Langin, director of research at the CNRS in Clermont-Ferrand. The WGG is a member of VBIO, the "umbrella organisation for life sciences in Germany" and representative of the interests of biotech and agro-industry companies, such as Bayer Crop Science, which is a member.iii Council of the European Union, Information note from the Polish Presidency, "Regulation on plants obtained by certain new genomic techniques and their food and feed products – state of play", 13 June 2025.iv The term "PRM" covers all material used for the reproduction or multiplication of plants (agricultural crops, vegetables, vines and fruit plants).v Denis Meshaka, "EU – 'Seeds': the other proposal in the legislative package", Inf'OGM, 22 September 2023.vi Eric Meunier, "French Anses experts : GMO deregulation has “no scientific basis” ", Inf'OGM, 16 January 2024.vii Eric Meunier, "Scientific manipulation a basis of the future GMOs/NGT law?", Inf'OGM, 29 November 2023.viii Eric Meunier, "The breeders' gene pool: a semantic trap?", Inf'OGM, 15 January 2024.ix Eric Meunier, "French Anses experts : GMO deregulation has “no scientific basis” ", Inf'OGM, 16 January 2024.x Silja Vöneky, Constantin Born, Laura Tribess and Silke Weller, "Compatibility of the EU proposal for a regulation on plants based on certain new genomic techniques with the Cartagena Protocol on Biosafety", April 2025.xi AFBV, "Update on ongoing discussions on the regulatory proposal of the European Commission on New Genomic Techniques ("NGTs") : recommendations to reach the Trilogue", 20 December 2024. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [94] => Array ( [objectID] => 13731 [title] => Illegal cultivation of GM soybeans in Tunisia revealed by DNA tests [timestamp] => 1754438400 [date] => 06/08/2025 [annee] => 2025 [url] => https://infogm.org/en/illegal-cultivation-of-gm-soybeans-in-tunisia-revealed-by-dna-tests/ [image] => https://infogm.org/wp-content/uploads/2026/03/Cover-Soja-OGM-DSK-768x432.jpg [extrait] => Presented as a response to the feed crisis, a new crop is quietly taking root in Tunisian fields. Behind the soybeans, genetically modified seeds are being introduced without regulation and amid total institutional silence. [chapo] => Presented as a response to the feed crisis, a new crop is quietly taking root in Tunisian fields. Behind the soybeans, genetically modified seeds are being introduced without regulation and amid total institutional silence. [texte] => "Surprise of the season: first experiment with soybean cultivation in Tunisia, in the governorate of Zaghouan." In June 2023, Mohamed Ben Khalifa, vice-president of the URAP, the regional branch of the Tunisian Union of Agriculture and Fisheries (UTAP) – the country's leading agricultural union – in Zaghouan, proudly posted on his Facebook account photos of lush green soybean plants, sown for the first time a few months earlier in the fertile soil of Bir Mecherga (Zaghouan), in the north-west of the country.A young agricultural technician, Atef Jemli, who supervised the experiment, also shares his optimism on his page, posing with a smile in front of the same field: "To all those who doubted the success of the experiment [...] the results are fantastic".The news quickly spread on social media. For several months, the trend took hold and online agricultural circles seemed to be snapping up these new seeds. The reason given by the promoters of this new culture is to respond to the crisis in fodder resources used to feed livestock, which has been affecting the agricultural world for several years."The message we want to send is that it is possible to grow soybeans locally in Tunisia at low cost [...] we are calling on the Tunisian government to invest in this sector," said the representative of the regional union of agriculture and fisheries (URAP) of Zaghouan in a filmed interview. "We use drip irrigation, which requires very little water," he added. The promotion of this promising crop is even being relayed by public television. What everyone fails to mention, however, is that these seeds are in fact genetically modified (GMOs) and resistant to various herbicides, as revealed by laboratory analyses carried out by Christophe Noisette, a journalist specialising in GMOs, and journalists from inkyfada. Cultivated since the late 1990s, genetically modified crops (GMOs) are a new tool for intensive agriculture. Limited to a few species (maize, soya, cotton and rapeseed), they are mainly grown in North and South America and banned in most European countries due to their proven negative impacts1 . These herbicide-tolerant varieties have de facto increased the amount of herbicides sprayed, with all the consequences this has for human health, fauna and flora.GM soybeans in Tunisia: silence, they're growingThe experience in Zaghouan is not an isolated case. Across the country, particularly in the fertile regions of Béja and Jendouba, initiatives to introduce soybean cultivation multiplied between 2023 and 2024. These foreign seeds are readily available on market stalls, with no controls in place.Information meetings and press conferences are also being organised by the URAP in several regions, such as Sidi Bouzid, with a view to encouraging farmers to grow soybeans to combat "difficult fluctuations [...] and achieve self-sufficiency in livestock feed". In its response to requests from inkyfada, the national office of the UTAP, through Mnawar Sghairi, director of the animal production unit, nevertheless distanced itself from this emerging practice: "These are isolated and amateur initiatives". Mohamed Ben Khalifa, from URAP Zaghouan, did not wish to respond to inkyfada's requests.Through laboratory analyses carried out in Tunisia and then in France on three samples of soybeans taken from the regions of Boussalem (Jendouba), Zaghouan (Bir Mcherga) and Sfax, our investigation reveals the GMO nature of these seeds distributed to the Tunisian farmers we met.There are two types of genetically modified crops currently grown worldwide: those that are genetically modified to tolerate herbicide spraying (e.g. Roundup) and those that produce an insecticide (Bt plants).The first analysis, carried out in Tunisia, confirms the transgenic nature of these batches. The second, carried out in France, identifies the modifications more precisely and determines that the soybean samples harvested are tolerant to several herbicides (glyphosate, glufosinate-ammonium, 2, 4-D and dicamba) and produce several insecticides against lepidoptera (butterflies). These transgenes belong to several multinational biotechnology companies: Monsanto (Bayer), BASF and Dow AgroSciences.France, for example, has banned the cultivation of Bt GM maize, arguing that it has too broad an insecticidal effect, since non-target insects are still killed. Specifically, it is currently impossible to draw any conclusions about human health, as the assessment protocols are not designed to determine safety or harmfulness. The Ministries of the Environment and Agriculture have not responded to requests from inkyfada.The sorcerer's apprentices of GMO soybean cultivationAmong the distributors of these GMO seeds in Tunisia, one "company" in particular is the subject of much praise from apprentice soybean farmers: WA Soja Tunisie, a supplier of "original Brazilian seeds", as the organisation describes itself. Based in the governorate of Jendouba, it promotes its genetically modified Intacta RR2 Pro soy seeds, imported from Brazil, via its Facebook page, which has now been deleted. This brand was developed by Monsanto – since acquired by the agrochemical multinational Bayer – and contains two of the transgenes detected in our analyses. Intacta RR2 Pro is a GMO that enables "tolerance" to glyphosate, the active ingredient in Roundup, and produces an insecticide against lepidoptera, the main butterfly pests in South America. The cultivation of Intacta RR2 Pro seeds is only authorised in South America (Argentina, Brazil, Paraguay and Uruguay). In Brazil, it now accounts for around two-thirds of the soybean country's genetically modified crops2 .Soybean seeds collected by Inkyfada in northwestern Tunisia.At WA Soja Tunisie, Amal Sallami, a young woman from Jendouba, has an academic profile that is unusual for a farmer: she has a degree in climate change from Earth University in Costa Rica and Georgetown University in Qatar, is an adjudicator at the International Centre for Dispute Resolution (ICDR) and a category A judge at the International Court of Justice.The young farmer had published a soybean cultivation training certificate issued by FEMARH (Foundation for the environment and water resources of the state of Roraima) in Brazil – a document of dubious authenticity, as the stamp differs from the one on the official copy available online.In 2020, she participated in a symposium organised by the "Strategic Committee for Soybeans in Brazil" and was also invited to speak remotely at a symposium organised in Paraguay and funded by multinational agro-industrial companies, such as Corteva, a giant in the production of plant protection products and agricultural seeds.During 2023-2024, she also hosted a number of events organised by regional branches of the UTAP to raise awareness and encourage farmers to grow soybeans, before disappearing from social media and ceasing all promotional activities. When interviewed by inkyfada, she never wished to reveal the precise origin of the seeds distributed to farmers, nor the identity of her "boss".Just as opaque as its manager, WA Soja Tunisie also abruptly disappeared from social media in 2024, after having been very active. Its existence can no longer be found online, it has no official premises and is not listed in the national register of companies.Institutional uncertainty on GMOs: a door open to a fait accompli In Tunisia, there is currently no legal framework governing the use of GMOs, and the few attempts to regulate the import and use of these transgenic seeds have all failed. A draft law on biosafety was proposed in 2014, resulting from a joint programme of the United Nations Environment Programme and the Global Environment Facility, for which the country received nearly $1 million3. Despite these significant resources, no law has been formally adopted. However, Tunisia ratified the Cartagena Protocol on Biosafety in 2002 and is therefore required to control the use of GMOs and reduce the risks posed by biotechnology to biodiversity4 .But in the absence of a regulatory framework, legal uncertainty persists and raises the question of the legality of GMO imports, which, in the European Union and many other countries, must be assessed and authorised before importation."In the absence of regulation, there is no obligation to carry out such controls or to put in place measures to prevent the risks that GMOs may pose," comments Rim Mathlouthi, an activist for sustainable and responsible agriculture and former president of the Tunisian Permaculture Association.The National Gene Bank, one of whose main missions is to preserve biological heritage, has been approached on several occasions. Although it has received, on a voluntary basis, samples of GM soybeans collected by inkyfada teams, it has not followed up or communicated any analysis results. Soybeans are strictly prohibited from cultivation, regardless of their nature: no soybean variety is listed in the official seed catalogue. "It is therefore not supposed to be grown in Tunisia," says Fethi Ben Khelifa, spokesperson for the UTAP, a farmer who can only grow varieties that have been previously analysed by the state services.Tunisia already imports large quantities of soybeans – nearly 400,000 tonnes in 2024 – mainly from Brazil, the United States and Argentina, where more than 95% of soybeans grown are genetically modified, making it highly likely that imported soybeans are GMOs.These beans are destined to be processed into meal (for animal feed) and edible oil by Carthage Grains, the only company capable of processing them.Soybeans are unique in that they are both the seed and the final product. Are the seeds found in the fields of north-western Tunisia the result of a diversion of imported beans? Do they come from another import network? In the recent history of GMOs, several countries have authorised their cultivation due to the massive presence of illegally introduced transgenic varieties, such as GM cotton in India and GM soybeans in Brazil5 . After years of illegal cultivation, Brazil has become the world's second largest producer of GMOs. In Tunisia, the institutions remain silent: "We have proof of the presence of GMOs in our fields for several years, but the issue is very sensitive and we prefer to deal with it discreetly," said a former official at the Gene Bank.For his part, Leith Ben Becheur, farmer and former president of the Tunisian Farmers' Union (SYNAGRI), is categorical: "Whether it is GMO or not, soybean cultivation is not suited to our climate, requires too much water and is not economically viable. It has no future in Tunisia". "Quels sont les risques des OGM pour l’environnement ?" Inf'OGM. ↩︎ Denis Meshaka, "Brésil : fin de partie pour un brevet soja OGM de Bayer ?", Inf'OGM, 6 March 2023. ↩︎ United Nations Environment Programme, "Capacity Building for the Implementation of the National Biosafety Framework." ↩︎ "Le Protocole de Cartagena sur les OGM", Inf'OGM. ↩︎ Eric Meunier and Christophe Noisette, "2002 – OGM : le calme avant la tempête", Inf'OGM, 31 December 2002. ↩︎ inkyfada et Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [95] => Array ( [objectID] => 13717 [title] => Only three GMOs/NGTs are cultivated [timestamp] => 1754265600 [date] => 04/08/2025 [annee] => 2025 [url] => https://infogm.org/en/only-three-gmos-ngts-are-cultivated/ [image] => https://infogm.org/wp-content/uploads/2026/03/Screenshot-2025-07-29-at-18-52-33-market-report-2025_05-06-25-New_GMOs_Market-report-2025.pdf-768x539.png [extrait] => At first glance, this finding may seem surprising. Only three GMOs obtained through new techniques of genetic modification are currently being cultivated and their harvest commercialised. The many promises of their benefits for health, the environment, and “competitiveness”, as well as the argument that they are already deregulated in many countries around the world, would suggest that these “miracle” products would have been more widely adopted. Clearly, this is not the case. [chapo] => At first glance, this finding may seem surprising. Only three GMOs obtained through new techniques of genetic modification are currently being cultivated and their harvest commercialized. The many promises of their benefits for health, the environment, and “competitiveness”, as well as the argument that they are already deregulated in many countries around the world, would suggest that these “miracle” products would have been more widely adopted. Clearly, this is not the case. [texte] => In early June, a report published by the German Association of Non-GMO Industries (ENGA), Non-GMO Projecti, and Eva Gelinskyii listed the plant GMOs obtained through new techniques of genetic modification (GMOs/NGTs) that are currently being cultivated and marketed. It also lists GMOs/NGTs that are not yet authorized for cultivation or are already authorized but whose harvest is not commercialized (under development), as well as those that have been withdrawn from the marketiii. For the authors, this report shows that “new GMOs are often a promise, but not a market reality”.Three “new GMOs” grown commercially worldwidePresented as a “concise overview of which New GMOs [operators in the GMO-free food chain] may need to deal with today and in the near future” the report lists three GMO plants, obtained through new techniques of genetic modification, that are grown and their harvests actually marketed.Of these three GMOs/NGTs, two are corn varieties that have been made tolerant to herbicides (VrTH) and produce insecticides. Obtained through complex genetic modification protocolsiv using notably the CRISPR tool, these two varieties also contain transgenes. These are Corteva's DP915635 and DP910521 corn varieties, both of which are authorized for import into the human and animal food chains in Europe.The third GMO/NGT listed in the report is found in Japan. It is a tomato genetically modified by Sanatech using the CRISPR tool to produce a higher level of the amino acid γ-aminobutyric acid (known as GABA)v. However, this tomato is not authorized for import into the European Union, even though it appeared on supermarket shelves in Japan in 2024vi.49 “new GMOs” in developmentWith regard to GMOs derived from new techniques of genetic modification and currently under development, the report provides a list of 49 GMOs/NGTs belonging to 20 different plant species (see Table 1), the vast majority of which were obtained using protocols involving the CRISPR tool.According to the authors, these GMOs/NGTs are the work of a wider variety of companies (see Table 2) than those developing GMOs as we know them today, which are overwhelmingly the work of Corteva, Bayer, BASF, and Syngenta. While these multinationals are involved in the development of GMOs using new techniques of genetic modification, the report also identifies “many other companies and public institutions”. Another notable difference, according to the authors, is that these GMOs/NGTs are intended for human consumption, whereas until now, the vast majority of GMOs have been intended for use in “animal feed, processed food ingredients, fuel or clothing”. Above all, the authors emphasize that while the contribution of these GMOs/NGTs to the fight against climate change is a widely used argument for calling for their deregulation in Europe, only two of the 49 under development claim to have drought or salinity tolerance characteristics.With regard to the United States, the authors of the report point out that this country accounts for 30 of the 49 GMOs/NGTs identified. Although several have already obtained commercial authorization, none of these 30 GMOs are currently being cultivated for commercial purposes. Many of these GMOs, moreover, “may never reach the market” the report states.“New GMOs” already withdrawn from the marketAs the authors of the report point out, it should be noted that “the first two New GMOs ever introduced to the market [...] were economic flops”. These were a GMO rapeseed from Cibusvii and a GMO soybean from Calyxt. In addition to these commercial failures, the authors point out that Calyxt was acquired by Cibus, which is itself the subject of ongoing proceedings in the United States for “deceiving investors by ‘over-hyping’ its technology”.The conclusion drawn by the authors of the report is quite simple and runs counter to the impressions suggested by the European Commission or multinationals in order to obtain the deregulation of GMOs/NGTs. For the authors, "new GMOs are often a promise, but not a market reality. Up to now, not a single plant contributes to sustainability. At the moment, the food sector is by no means faced with a flood of New GMOs, but only with individual plants".This report should provide interesting insight for European legislators pushing for the urgent deregulation of “new GMOs” on the grounds of their undeniable contribution to the fight against climate change, biodiversity loss, and even loss of competitiveness compared to countries that have supposedly adopted them.PlantsNumberGMOs obtained by new genetic techniques and grown commerciallyMaize2Tomato1GMOs obtained by new genetic modification techniques under development (not cultivated or harvest not marketed)Maize10Soya9Rice6Wheat3Potato3Camelina3Sugar cane2Horsetail2Lettuce2Sorghum1Alfalfa1Avocado1Almond1Banana1Grape1Strawberry1Blackberry1Watermelon1GMOs obtained by new genetic modification techniques withdrawnCanola1Soya1Table 1: Number of plants in commercial cultivation or under development, obtained by new techniques (summary by Inf OGM of tables presented in the report).CompaniesNumber of dossiersGMOs obtained by new genetic techniques and grown commerciallyCorteva2Sanatech1GMOs obtained by new genetic modification techniques under development (not cultivated or harvest not marketed)Corteva5Embrapa4Inari3Suzhou Qihe Biotechnology3Green Venus3Simplot3Yield10 Bioscience3GDM2Cibus2Bioheuris2Pairwise2Covercress2Origin Agritech1Weimi Biotechnology1Amfora1Shandong BellaGen Biotechnology1KWS1China Seed Group1Insignium1Biotechnology Company1Indian Institute of Rice Research1Indian Agricultural Research Institute1Instituto Nacional de Tecnología Agropecuaria1Calyxt1Ohalo Genetics1Tropic Bioscience1Eto Life Sciences1GMOs obtained by new genetic modification techniques withdrawnCibus1Calyxt1Table 2: Companies involved in the commercial cultivation or development of GMOs obtained by new techniques (summary by Inf'OGM of tables presented in the report).i The Non-GMO Project was established in 2007 in the United States by two grocery stores wishing to organize themselves for a GMO-free supply chain and inform consumers through labeling.ii Eva Gelinsky is as a freelance scientist. She is also co-coordinator of the Initiative for GMO-free Seeds and Plant Breeding (Germany, Austria, and Switzerland) and a member of the Federal Ethics Committee on Non-Human Biotechnology in Switzerland.iii Hans Eisenbeis, Eva Gelinsky et Heike Moldenhauer, « New GMOs Market Report », Edition 01, June 2025.iv For the GM maize DP915635, see :Eric Meunier, « Transgenèse, Crispr/Cas9, ARNi… package total pour deux maïs OGM ! », Inf’OGM, 29 October 2024.v Christophe Noisette, « Japon : des nouveaux OGM débarquent dans les assiettes », Inf’OGM, 22 November 2021.vi Testbiotech, « CRISPR tomatoes now on the shelves », 5 February 2024.vii Eric Meunier, « Colza Cibus : une mutation aux origines mystérieuses », Inf’OGM, 29 September 2020.Eric Meunier, « Canola OGM : le gouvernement canadien au secours de Cibus », Inf’OGM, 10 November 2020. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [96] => Array ( [objectID] => 13700 [title] => The EU’s “life sciences” strategy: a pro-industry strategy [timestamp] => 1754006400 [date] => 01/08/2025 [annee] => 2025 [url] => https://infogm.org/en/the-eus-life-sciences-strategy-a-pro-industry-strategy/ [image] => https://infogm.org/wp-content/uploads/2026/03/Ursula_von_der_Leyen_during_the_Choose_Europe_for_Science_event_at_La_Sorbonne_-_2025_2-768x512.jpg [extrait] => Under the guise of making the continent a world leader in "life sciences", the European Commission has confirmed its clearly pro-industry vision in its strategy published in early July. With a resolutely competitiveness-focused approach, it minimises the potential consequences for other social actors. [chapo] => Under the guise of making the continent a world leader in “life sciences“, the European Commission has confirmed its clearly pro-industry vision in its strategy published in early July. With a resolutely competitiveness-focused approach, it minimises the potential consequences for other social actors. [texte] => On 2 July, following several announcements in 2025 concerning the biotech sectori, the Commission unveiled its "Choose Europe for Life Sciences" strategyii. Its ambition is to build on "Europe’s excellence in health, biotech, agriculture, food and environmental science [...] to position the EU as the world’s most attractive place for life sciences by 2030". This is a project that pays little attention to the concerns of civil society."Unlocking the potential of life sciences"The Commission proposes to "stimulate innovation in the life sciences" through three pillars of action:"optimising the research and innovation ecosystem","enabling rapid market access for life sciences innovations","Boosting trust, uptake and use of innovation".These three pillars, considered strategic, aim to "unlock the potential of life sciences" to promote market access and competitiveness in the European economy in the health, agriculture and food sectors.The R&D ecosystem envisaged by the Commission is based on the creation of "new knowledge", in particular by facilitating research partnerships (€100 million for the microbiome, for exampleiii), financing "innovative" therapies, supporting clinical trials and simplifying the rules for medicines and medical devices. The Commission also encourages a cross-sectoral approach (health, food, agriculture, forestry, aquaculture, etc.) and the use of "artificial intelligence" and digital (health) data.With regard to market access, the Commission is committed to promoting lighter regulation by proposing "a European law [the "Biotech Law", actually a regulation scheduled for 2026] on biotechnology that will create a more innovation-friendly regulatory framework across biotech sectors". The health sector is not the only one concerned, as the agriculture and food sectors are cited by the Commission as examples of "hubs for innovation".Finally, the Commission intends to "stimulate public procurement for innovation in life sciences such as climate change adaptation, next-generation vaccines and affordable cancer solutions".The Commission specifies that the progress achieved through this strategy will be measured in terms of tangible growth in sectoral indicators: employment, value added, business expenditure on research and development, and the number of multinational clinical trials. The Commission adds that its strategy is based on a public consultation and data from the Joint Research Centre (JRC), showing that the EU remains a major player in life sciences, accounting for 17% of global patentsiv. However, no specific policy is outlined in the event that this "progress" is not deemed sufficient, if indeed it ever is.Easier access to the 'market' and competitivenessThis Commission initiative is part of its overall strategy for EU competitiveness. The institution believes that, in the current life sciences landscape, Europe "would lose ground to other global players" (North American and Asian) and would have to respond to three challenges:the fragmentation of innovation ecosystems,the under-use of data and "artificial intelligence",the slow adoption of "innovations" by the market.The objectives that the Commission seems to want to achieve at a rapid pace are clear: easier access to the "market" and competitiveness. Since early 2025, the Brussels-based institution has been developing a heavy and complex pro-biotech package, which, however, poses many challenges and requires a great deal of caution – particularly in terms of semantics – on ethical, environmental and democratic groundsv.Civil society takes a back seatThe core of the plan, the future "Biotech Law" expected by 2026, remains vague and far from adoptionvi. Nevertheless, the Commission sets the tone in its strategic document on life sciences: "Regulatory systems need to be responsive to emerging technologies and keep pace with scientific progress. Future legislation should integrate experimentation clauses, derogations and the use of test environments such as regulatory sandboxes... This provides the flexibility needed to test new solutions, gather evidence and ensure that regulatory frameworks remain responsive and supportive of innovation".It is striking to note that these desired regulatory systems, which one might think would be implemented after the Commission announced its current general policy, have in fact been under negotiation since 2023. That year, the European Commission put forward proposals to deregulate most GMOs in order to "harmonise and streamline authorisation procedures for gene therapy medicinal products", facilitate access to human genetic, genomic and proteomic data, and extend the duration of patents granted for plant protection productsvii...By focusing solely on the industrial sector, the Commission fails, among other things, to provide the transparency or independent assessment mechanism it plans to put in place to address the potential legal problems arising from such regulatory flexibility, particularly with regard to civil society.In a short and general provision entitled "Building public trust and outreach", the Commission proposes "better means to engage with citizens to beat disinformation and build trust, and to work closer with end-users to ensure adequate solutions for their specific needs". To this end, it will mobilise financial assistance – which appears to be purely symbolic – of €2 million under the Horizon Europe 2026-2027 programme to "support life science stakeholders and policy makers in public outreach by setting up a repository of tools and best practices in responsible R&I, risk and science communication, and pilot public outreach measures". This public awareness will obviously focus less on the issues or problems raised by such a pro-industry policy than on its supposed benefits, of which the Commission already seems convinced.In a context of heated controversy over GMOs, gene therapies, health data and cell-based meat, the Commission's distancing itself from civil society is significant: the text seems to view science and innovation as neutral, when in fact they are eminently political. This distance is all the greater given that regulatory negotiations to facilitate the development of these controversial areas have already been underway since 2023.i Denis Meshaka, "The European Commission wants its 'biotech revolution' ", Inf'OGM, 11 February 2025.Denis Meshaka, "The European Commission postpones its 'biotech law' once again" ,Inf'OGM, 3 June 2025.ii European Commission, "Choose Europe for Life Sciences: A Strategy to Position the EU as the World's Most Attractive Place for Life Sciences by 2030", 2 July 2025.iii In its strategy document, the Commission defines microbiomes as follows:"Microbiomes are communities of microorganisms such as bacteria or fungi living together in a specific environment, with deep interconnections. A thorough understanding of microbiomes and their interactions will improve and create new products for health, food, sustainable agriculture and forestry, aquaculture and ecological restoration".iv LASARTE LOPEZ, J., GONZALEZ HERMOSO, H. and M`BAREK, R., "The Life Sciences sectors in the EU: drivers of economic growth and innovation", European Commission, Seville, 2025, JRC142396.v Denis Meshaka, "The European Commission postpones its 'biotech law' once again", Inf'OGM, 3 June 2025.vi Ibid.vii Eric Meunier, "The European Commission's legal initiatives on the Living", Inf'OGM, 7 November 2024. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [97] => Array ( [objectID] => 13694 [title] => 2024, another year contaminated by illegal GMOs [timestamp] => 1753833600 [date] => 30/07/2025 [annee] => 2025 [url] => https://infogm.org/en/2024-another-year-contaminated-by-illegal-gmos/ [image] => https://infogm.org/wp-content/uploads/2026/03/rasff-logga.png [extrait] => In 2024, the European Union once again recorded alerts of GMO contamination. Of the 24 alerts, the vast majority concerned unauthorised GM rice, but also papaya, soybean, flax and corn. Two cases of contamination by genetically modified microorganisms were also reported, one of which even forced the Belgian authorities to issue a public statement recalling a product. In three cases, the nature of the illegal GMO was not specified. [chapo] => In 2024, the European Union once again recorded alerts of GMO contamination. Of the 24 alerts, the vast majority concerned unauthorized GM rice, but also papaya, soybean, flax and corn. Two cases of contamination by genetically modified microorganisms were also reported, one of which even forced the Belgian authorities to issue a public statement recalling a product. In three cases, the nature of the illegal GMO was not specified. [texte] => If GMOs are detected illegally on their territory because they are not commercially authorised, Member States can alert the Rapid Alert System for Food and Feed (RASFF). The other Member States and the European Commission are then alerted. Such detections may occur once a product has already been placed on the market or at the border, often resulting in a refusal of entry into the European Union. Although not exhaustive, the RASFF online databasei provides information on the various cases of contamination by illegal GMOs as they are reported.GM rice from China, again and againGM rice from Asian countries is the most commonly found illegal GMO every year. In 2024, this is once again the case, with illegal GM rice accounting for more than half of the cases of contamination detected (see Table 1). China and Vietnam are the two countries most responsible for these GM rice contaminations, with China alone accounting for 8 out of 14 cases. Vietnam is responsible for 5 cases of GM rice contamination. The third and final country responsible for such contamination is Pakistan.Since 2006, the European Union has been confronted with illegal occurrences of GM rice every year. Historically, this has involved LL rice from the United States or Bt rice from China. As the RASFF system does not provide details on the rice detected, it is not possible to know which GM rice was involved in 2024.Four other GM plants found illegallyWhile three cases of illegal GMOs in Europe do not specify the nature of the GMO, one GM maize, one flax, two papayas and one soybean were also found in 2024, either on European territory or at its border. The countries of origin of these contaminations vary geographically, including Mexico, Russia, Ukraine, Romania and Thailand (see Table 2).Like the cases of rice contamination, GM papaya from Thailand has been a long-standing contaminant in Europe, with the first cases reported in 2004 following an alert by Greenpeace. However, it is more rare for illegally imported GM papaya to come from Mexico, a country where, like Thailand, no GM papaya is authorised for cultivationii.OrganismsNumber of casesRice14Not detailled3Papaya2Micro-organism2Soybean1Flax1Maize1Total24Table 1 : GMOs contaminating Europe in 2024.Two cases of contamination by GM microorganismsGM plants are not the only organisms to have been found illegally in Europe. Two cases of illegal presence of genetically modified microorganisms (GMMs) have also been reported. These cases originated in China and the United Kingdom.In the latter case, the RASFF system reports that the alert was considered "serious", even prompting a public statementiii from the Belgian authorities to inform consumers and withdraw the product concerned, capsules of lactase (an enzyme) intended for human consumption.Compared to previous years, 2024 was therefore marked by almost twice as many alerts for the illegal presence of GMOs on European territory or at its borders. At a time when the European Commission and multinationals are pushing to end the traceability of many GMOs, this figure shows that the control of supply chains commonly claimed by these actors is not being achieved.YearGeographical originOrganismNumber of casesTotal number of cases2024ChinaRice824GMM1Not detailled2UkraineSoybean1South CoreaNon detailled1VietnamRiz5PakistanRiz1United-KingdomGMM1RomaniaMaize1RussiaFlax1MexicoPapaya1ThailandPapaya12023VietnamRice813ChinaMaize1ThailandPapaya2NetherlandsRice1IndiaRice12022CambodiaPapaye313ThailandPapaya2Rice1BrazilPapaya1United States of AmericaSoybean1VietnamRice2ChinaRice1SingaporeRice1Belgium / BulgariaGMM12021UkraineSoybean213ChinaRice2Not detailled1France / ChinaGMM2Belgium / ChinaGMM1Belgium / IndiaRice1ThailandPapaya1FranceRice1NetherlandsRiz1UnknownGMM1Table 2 : annual summary of contamination cases since 1st January 2021.i European Commission, « RASFF window ». ii ISAAA Inc., « GM Approval Database – Advanced Search: 4 events with country approvals found – Papaya », July 2025.iii Afsca, « Rappel de Holland & Barrett », 16 September 2024 (published in french and dutch only). Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [98] => Array ( [objectID] => 13669 [title] => Some European laboratories call for traceability of GMOs/NGTs [timestamp] => 1753228800 [date] => 23/07/2025 [annee] => 2025 [url] => https://infogm.org/en/some-european-laboratories-call-for-traceability-of-gmos-ngts/ [image] => https://infogm.org/wp-content/uploads/2026/03/Two_rows_of_microscopes-768x524.jpg [extrait] => The need to be able to detect and identify GMOs obtained through new genetic modification techniques is a request that is being made more and more frequently. Following in the footsteps of associations, farmers' unions, organic and non-GMO producers and processors, as well as supermarkets, it is now the turn of some laboratories specializing in analyses to make such a demand. At a time when European legislators are discussing the possible complete deregulation of such GMOs, these positions could carry more and more weight. [chapo] => The need to be able to detect and identify GMOs obtained through new genetic modification techniques is a request that is being made more and more frequently. Following in the footsteps of associations, farmers’ unions, organic and non-GMO producers and processors, as well as supermarkets, it is now the turn of some laboratories specializing in analyses to make such a demand. At a time when European legislators are discussing the possible complete deregulation of such GMOs, these positions could carry more and more weight. [texte] => At a time when the European Commission, the European Parliament and the Council of the European Union are discussing the Commission's proposal to deregulate a large number of GMOs by 2023, twelve laboratories in Germany, Poland, Spain, Ukraine and France have published a letteri calling for all releases of GMOs in the environment to be accompanied with the methods and materials needed to detect and identify GMOs obtained by new techniques.Essential traceabilityThis open letter is addressed to the European legislators who are currently discussing the deregulation of GMOs ; a deregulation which would mean, among other things, that requests for authorization to release GMOs would no longer be accompanied by the obligation to provide the methods needed to detect and identify GMOs, contrary to current legislation. Initiated by Spanish laboratory Imegen Agro, the open letter underlines the concern of the twelve signatory laboratoriesii that “neither the EU Commission's legislative proposal nor the position adopted by the EU Parliament provides for detection methods for category 1 NGTs”.Involved in GMO analyses requested by their customers, these laboratories would be unable to meet the demands of customers who follow specifications that exclude all GMOs. These customers, the laboratories point out, are not only organic or non-GMO.Assuming that the legislator may not answer this question, the laboratories ask that he at least allows them "to develop [their] own detection methods. This requires the obligation for developers and manufacturers of category 1 NGTs to disclose reference material and information about the genetic modification, its sequence and its location" in the genome.In the case of category 2 GMOs/NGTs, the Commission is already proposing to make the provision of this information compulsory, so that they can be detected and identified. It does, however, provide for an exemption if manufacturers argue that it is impossible to provide such a method. The twelve laboratories support the European Parliament's position that the « Union reference laboratory shall carry out its own research and analyses to confirm the claimed unfeasibility. In that case, the decision of the Union reference laboratory shall be motivated and be made public ».A repeated requestThis open letter from laboratories specializing in the detection and identification of GMOs is part of a series of repeated requests from other players - associations, farmers' unions, organic and non-GMO producers and processors, supermarketsiii - that tools enabling the analytical traceability of GMOs/NGTs be provided on a mandatory basis.In May and June 2025, for example, a number of French and European organizations sent letters to the European legislator. With these letters, they wished to publicly ask French and European legislators “not to abolish labelling and traceability requirements for GMOs produced using new techniques”iv. According to these organizations, the stakes are high, because maintaining these obligations is the only way to protect seed growers and farmers from contamination or claims of patent rights on living organisms by plant breeders, and to guarantee freedom of choice for farmers and consumers.At European level, while the European Commission is proposing the end of the currently compulsory supply of methods for detecting and identifying GMOs/NGTs, arguing that it is supposedly impossible to differentiate them from other organisms that may occur naturally, it decided in December 2023 to fund two research programs. While these two programs, Darwin and Detective, aim to develop methods for the detection and identification of GMOs/NGTs, the Detective program is the work of pro-deregulation players such as Euroseeds and the European Commission itselfv. The Commission claims that detection and identification are impossible, but funds and participates in research programs aimed at answering this question. Not so easy to follow…i Enga, « European Laboratories Join Forces To Make Urgent Call To EU Policy Makers on New GMOs », 27 June 2025.ii Signatory laboratories : FoodChain ID Testing GmbH, Cotecna Ukraine Limited GmbH, CARSO - Laboratoire Santé Environnement Hygiène de Lyon (LSEHL), SGS Analytics Germany GmbH, Gen-IAL GmbH, NSF Erdmann Analytics GmbH, J.S. Hamilton Poland Sp. z o.o., SAN Group Biotech Germany GmbH, Impetus GmbH & Co. Bioscience KG, Imegen Agro - Health in Code S.L., AGQ Labs International SL, AGROLAB Ibérica S.L.U.Among the signatories is the French laboratory CARSO - Laboratoire Santé Environnement Hygiène de Lyon (LSEHL). This laboratory is accredited for a wide range of analyses in the agri-food, environment, chemical and biological products and medical equipment sectors.iii Eric Meunier, « French retailers want GMO/NGT to be regulated », Inf'OGM, 3 April 2024.iv Eric Meunier, « Detection and identification of GMOs still demanded », Inf'OGM, 25 June 2025.v Eric Meunier, « Traçabilité des OGM/NTG : deux programmes de recherche concurrents », Inf’OGM, 19 March 2024 (in French). Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [99] => Array ( [objectID] => 13633 [title] => “Animal proteins” without animals [timestamp] => 1752105600 [date] => 10/07/2025 [annee] => 2025 [url] => https://infogm.org/en/animal-proteins-without-animals/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Animal proteins without animalsMilk proteins without cows, fish without fish, meat without animals and even egg proteins without eggs or chickens: welcome to the realm of "precision fermentation" for our future food. Three start-ups in the sector have obtained approval for their milk-free milk proteins from the US health authorities, enabling them to sell them to food manufacturers.The industry and certain institutions are presenting these innovations as a step forward in reducing the carbon impact of livestock farming and meeting the food needs of human populations. Above all, it is a promising market: these "advances" are already attracting investors. [chapo] => Milk proteins without cows, fish without fish, meat without animals and even egg proteins without eggs or chickens: welcome to the realm of “precision fermentation” for our future food. Three start-ups in the sector have obtained approval for their milk-free milk proteins from the US health authorities, enabling them to sell them to food manufacturers.The industry and certain institutions are presenting these innovations as a step forward in reducing the carbon impact of livestock farming and meeting the food needs of human populations. Above all, it is a promising market: these “advances” are already attracting investors. [texte] => These non-animal proteins are produced by genetically modified micro-organisms. For several decades, such micro-organisms (bacteria, yeast and filamentous fungi) have been used in confined environments (in bioreactors) to produce molecules of industrial interest. These concern the medical sector (production of human insulin or vaccine proteins by genetically modified bacteria) and the agri-food sector (production of enzymes, mainly, but also vitamins and food additives)i. It used to be called "moleculture"; nowadays it's called "precision fermentation". But beyond this semantic change, which makes sense, another difference needs to be highlighted in this case: we are talking about nutrientsii, sources of energy and molecules that make up organisms.Are these non-animal proteins, substitutes for animal proteins, and the processes used to produce them, sufficiently well researched to guarantee their safety?This is an important question at a time when, in Europe, the deregulation of GMOs is likely to affect GM micro-organismsiii."Precision fermentation": how does it work?At Wageningen University in the Netherlands, the yeast Pichia pastoris, a close relative of baker's yeast, has been genetically modified to produce these proteins. For casein, for example, a DNA fragment coding for casein is integrated into the yeast genome. This is transgenesisiv. It should be noted that the vocabulary used by the Académie des technologies is different: it speaks of "rewriting the genome of micro-organisms"v. An euphemism...In a bioreactor, the yeasts are fed sugars and nitrogenous substances (supposed to replace the grass grazed by the cow). They then develop and produce casein proteins, which are isolated and separated from the rest of the medium. "This stage is important to avoid ending up with genetically modified yeast residues in the feed", explains Etske Bijl, a researcher at Wageningen University. The powder obtained is mixed with water, vegetable fat and salt. Finally, the 'cocktail' is poured into moulds and placed in the fridge for an hour to obtain the so-called 'cheese'vi.The Israeli start-up that has just obtained FDA (Food and Drug Administration) approval in the United States for its whey proteins claims: "These proteins are identical to cow's milk proteins in that they have the same taste, texture, functionality and nutritional value, while being hormone-free"vii.This technique has also been developed to obtain other milk proteins, such as lacto-globulins, hen egg white proteins (ovalbumin) or myoglobin, a vertebrate muscle protein.In fact, the term "fermentation" is a misnomer. The micro-organisms genetically reprogrammed to produce these proteins are yeasts and micro-algae that breathe. They are grown aerobically. The error stems from the fact that bioreactors are also called fermentersviii.Furthermore, "precision fermentation" should not be confused with "biomass fermentation", which is based on micro-organisms (filamentous fungi, micro-algae or bacteria that are ultimately edible), but which are not genetically modified to produce animal proteins.Will these "animal proteins" soon be marketed in Europe?In the European Union, start-ups are lining up to manufacture and produce these animal proteins without animals. In France, Standing Ovation, Bon Vivant (now Verley) and Nutropy are investing in this field.But in Europe, these start-ups are coming up against two stumbling blocks.The first is GMO legislation, which governs the marketing of products obtained from GMOs, which are transgenic micro-organisms. The deregulation of GMMs (genetically modified micro-organisms) in Europe is currently only proposed for algae. However, the European Parliament has called for this to be extended to other GMMs. If this deregulation becomes effective one day, it could give these micro-organisms non-GMO status, reshuffling the cards.The second stumbling block is the Novel Foods framework. Under this framework, the European Commission only authorises a novel foodix if it "presents no risk to health, taking into account the scientific data available" and if "the intended use of the food does not result in a nutritional imbalance"x.The French Academy of Technology also deplores this regulation: "The regulatory hurdle in Europe is the "novel foods" framework, which requires a high level of proof at a high cost, takes a long time and is therefore a brake on the market. The "Ferment of the Future" project has positioned itself to improve fermentation technologies for food purposes without having to apply for "novel foods" authorisation"xi.As a result, start-ups are turning to the American market and selling their products outside Europe, under cover of a "status" called "Fat": "generally recognised as safe"xii.Do these proteins present any health risks?Are the proteins produced by GMMs really purified? This is a recurring question for this type of technique, and examples have shown that contamination is possible and can be a source of allergies, some with serious consequences. For example, batches of vitamins have been marketed while the GMMs that produced them were still presentxiii.Are the structures and properties of these animal proteins produced by micro-organisms really the same as those of animal proteins? Some people are asking questions. "Many questions remain, whether about the digestibility of these products or their effects on health, and regulators need to be certain of their safety", says Karen Polizzi, Professor of Biotechnology at Imperial College London (UK) and Co-Director of the National Alternative Protein Innovation Centre (Napic)xiv.What can we say, too, about these isolated ersatz animal proteins used as nutrients when the real proteins are in a complex animal food, such as milk, meat or eggs?Biotechnology, nourished by a restrictive vision of the genome and living organisms, approaches food with the same vision. They forget the complexity of whole foods and the slow evolution of organisms' physiology. A natural nutrient is not isolated. It is part of a complex, evolving whole that scientists call the "matrix" and which the industry ignores: the assimilation and tolerance of nutrients such as casein, for example, will not be the same isolated from milk or in milk. The calcium in milk, another nutrient, will not be the same as that in almonds... Failure to take these new scientific factors into account can only have an adverse effect on the health of those who eat preparations based on these animal protein substitutes.There are also more philosophical problems. Admittedly, we need to review and reflect on a diet that is more respectful of animals, and our relationship with animals needs to be rethought. But should we rush headlong into unnatural biotechnologies, which consume a lot of energy because they are produced in bioreactors and depend on complex computer networks, when these same technologies claim to be environmentally friendly?When will the living being be considered as something other than a machine, and a machine that can be controlled?i Eric Meunier, "Des usines de production bien discrètes", Inf'OGM, le journal, n°174, January-March 2024.ii A nutrient is an organic or mineral molecule contained in food that can be assimilated by the body.iii "Micro-organismes OGM, l'offensive cachée", Inf'OGM, le journal, n°174, January-March 2024.Eric Meunier, "The European Commission’s proposal to deregulate GMOs does cover some GMO micro-organisms", Inf'OGM, 19 March 2025.iv "Agroalimentaire : du lait et de la viande sans vache", Sciences et avenir, 3 May 2025.v Académie des technologies, "L'avenir des protéines alternatives", 21 July 2023.vi "Agroalimentaire : du lait et de la viande sans vache", Sciences et avenir, 3 May 2025.vii Sharon Wrobel, "FDA authorises Imagindairy to produce non-animal milk proteins", The Times of Israel, 5 January 2024.viii Yves Le Loir, "Les fermentations : des savoir-faire traditionnels et empiriques aux procédés maitrisés, porteurs d'innovations", Inrae, Lamballe, France, February 2024.ix A food is said to be new if it was not consumed in any significant way before May 1997 (source: Anses).x Anses, "What are novel foods and food ingredients?", 22 January 2013.xi "Agri-food: milk and meat without cows", Sciences et avenir, 3 May 2025.xii Amelie Dereuder, "Fermentation de précision: Bon Vivant change de nom et s'attaque au marché américain", Process alimentaire, 12 May 2025.xiii As an example of contamination:Eric Meunier, "Vitamine B2: contamination en cours par une bactérie transgénique", Inf'OGM, 7 December 2018.xiv "Agroalimentaire : du lait et de la viande sans vache", Sciences et avenir, 3 May 2025. Annick BOSSU [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [100] => Array ( [objectID] => 13601 [title] => A showcase for “new genomic techniques” in Europe [timestamp] => 1751414400 [date] => 02/07/2025 [annee] => 2025 [url] => https://infogm.org/en/a-showcase-for-new-genomic-techniques-in-europe/ [image] => https://infogm.org/wp-content/uploads/2026/03/38629331786_9856cb0bf6_c-768x512.jpg [extrait] => In an article published in April 2025, Euronews highlights "new genomic techniques" using the example of a wheat genetically modified by Crispr/Cas9 in the UK. This wheat, developed by a team of biologists from Rothamsted Research at the University of Bristol, has been tested in a field north of London since October 2021. Although this trial is being carried out without any environmental, agricultural or health precautions, it does provide a good showcase for potential investors. [chapo] => In an article published in April 2025, Euronews highlights “new genomic techniques” using the example of a wheat genetically modified by Crispr/Cas9 in the UK. This wheat, developed by a team of biologists from Rothamsted Research at the University of Bristol, has been tested in a field north of London since October 2021. Although this trial is being carried out without any environmental, agricultural or health precautions, it does provide a good showcase for potential investors. [texte] => This wheat, which is expected to be on the market within the next 5 to 10 years, has been genetically modified using Crispr to extinguish the expression of a gene coding for a protein involved in the synthesis of an amino acid, asparagine. When this amino acid is cooked above 120°C, it generates the carcinogen acrylamine.An essential technology?In an article published in 2021i , Inf'OGM already questioned the relevance of this genetic modification of wheat. In it, we described simple alternatives for growing, baking and eating wheat that would produce little of the potentially carcinogenic acrylamine. In that article, Inf'OGM reported that for Dr Jacques Fradin, of the Paris Environmental Institute, the quantity of acrylamide finally found is proportional to the quantity of gluten in the cereals, because "it is therefore a priori in the gluten proteins that the excesses of the amino acid asparagine reside". This position is open to debate, but it does raise questions about the strategy of the British researchers.Particularly as other articles show that asparagine is broken down to a greater extent in sourdough-based bread-making. Inf'OGM reported the work of Claire Micheaux, an engineer at Lesaffre, who indicated that the reduction in asparagine "can be 20 to 70% depending on the micro-organisms living in the sourdough".Manipulating semantics to avoid GMO regulatory statusIn their presentation, the researchers explained that they had first carried out transgenesis for the Crispr part (the guide RNA) and the Cas part (the enzyme). This transgenesis step, which is very common when the Crispr/Cas tool is used for genetic modification, makes this wheat a regulated GMO.In order to avoid this GMO regulatory status and pass this wheat under the possible future new status of "NTG1", the researchers state: "once the modification is complete, the genetically modified elements are eliminated by selection, resulting in a plant whose genome has been modified but which is not GMO".This is consistent with the distinction they make between GMOs and NTGs: "whereas GMOs involve the insertion of genes from one organism into another, whatever their origin, NTGs do not introduce DNA from sexually incompatible organisms". Is it still necessary to point out that restricting the definition of a GMO to transgenesis alone is nothing more than a semantic ploy on the part of the pro-GMOs? In fact, current legislation on GMOs has never been limited to transgenesis and covers any genetic modification carried out in a non-natural way. Need we also point out that NTGs are techniques that produce GMOs?The erroneous position taken by the researchers is all the more problematic given that they themselves acknowledge in their presentation that "the elimination of genetically modified elements has, however, proved difficult". So we won't know whether this elimination is complete.Uncontrolled genetic modification?In addition to the lack of control over European legislation on GMOs, it would appear that the genetic modifications carried out are not totally under control either. The authorisation for this field trial, issued by the UK government in 2021, was amended, suggesting that the authorisation obtained should be extended to cover all existing genetic modifications. In August 2021, the authorisation issuedii stated that the field trial could be conducted on "Triticum aestivum wheat plants that have been genetically modified by Crispr-Cas9 to contain mutations in the asparagine synthesis gene TaASN2". But a year later, in October 2022, without any new application being made public, the authorisation was changediii. This time, the new authorisation specified that the field trial could be conducted on "Triticum aestivum wheat plants that have been genetically modified by Crispr-Cas9 to contain mutations (including changes, insertions and/or deletions of one or more DNA bases) in one or more asparagine synthesis genes, TaASN1 and TaASN2".This means that both the targeted genetic sequences and the nature of the genetic modifications have been changed in the authorisation granted.What about undesirable effects?It has also been observed that Crispr/Cas9 can cause DNA damage and uncontrolled genotoxic effects, some of which are thought to be carcinogeniciv. Crispr/Cas that prevents cancer or Crispr/Cas that generates cancer? The Euronews presentationv cannot answer this question, as it makes no mention of genotoxic effects.No matter! These crisped wheats, which are genuinely genetically modified, are already being grown in open fields without any study of their potential consequences, as a German researcher deplores at the very end of this article. For Katja Tielbörger, from the University of Tübingen (Germany), the proposed deregulation of GMOs raises particular concerns. In particular, she is concerned about the potential environmental and agricultural impact of these new plants genetically modified using new techniques. In her view, "we cannot claim equivalence between NTG1 (plants) and normal plant breeding". In response to the European Commission's proposal to divide genetically modified organisms into two categories based on a theoretical number of modifications, she also points out that "even molecular biologists would agree that the distinction between NTG1 and NTG2 has no scientific basis. It's just a random number and doesn't make sense". In fact, this theoretical number of less than 20 modifications for "NTG 1" and more than 20 for "NTG 2" opens the door to an infinite number of modificationsvi and makes no scientific sense, which was also the opinion of Ansesvii.i Christophe Noisette, "Grande-Bretagne - Un blé OGM " bon pour la santé" bientôt expérimenté", Inf'OGM, 11 May 2021.ii Department for Environment, Food and Rural Affairs, "ENVIRONMENTAL PROTECTION ACT 1990, SECTIONS 111 AND 112: CONSENT TO RELEASE GENETICALLY MODIFIED ORGANISMS REFERENCE21/R08/01", 3 August 2021.iii Department for Environment, Food and Rural Affairs, 'ENVIRONMENTAL PROTECTION ACT 1990, SECTIONS 111 AND 112: CONSENT TO RELEASE GENETICALLY MODIFIED ORGANISMS REFERENCE21/R08/01", 1st October 2022.iv Annick Bossu, "OGM: quand la biologie met Crispr au pas", Inf'OGM, 10 November 2022.Eric Meunier, "OGM - Crispr/Cas peut "éclater" les génomes", Inf'OGM, 28 October 2021.v Alice Carnevali and Farhan Rafid, "NGTs: Inside the first European gene-edited wheat field trial | Euronews Tech Talks", Euronews, 18 April 2025.vi Eric Meunier, "Scientific manipulations, a basis of the future GMO/NGT law?", Inf'OGM, 29 November 2023.vii Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (Anses).Eric Meunier, "French Anses experts : GMO deregulation has « no scientific basis »", Inf'OGM, 16 January 2024. Annick BOSSU and Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [101] => Array ( [objectID] => 13593 [title] => Detection and identification of GMOs still demanded [timestamp] => 1750809600 [date] => 25/06/2025 [annee] => 2025 [url] => https://infogm.org/en/detection-and-identification-of-gmos-still-demanded/ [image] => https://infogm.org/wp-content/uploads/2026/03/Screenshot-2025-06-17-at-10-46-37-Freedom-of-Choice-only-possible-through-labeling-and-traceability-final-counterstatement-freedom-of-choice-only-possible-through-labelling-and-traceability.pdf.png [extrait] => Three groups of French and European organizations have publicly called on political leaders not to abolish labelling and traceability requirements for GMOs produced using new techniques. In their view, maintaining these obligations is the only way to guarantee freedom of choice for farmers and consumers, and to protect the seed and peasant sectors from contamination and attempts by multinationals to take control of living organisms. [chapo] => Three groups of French and European organizations have publicly called on political leaders not to abolish labelling and traceability requirements for GMOs produced using new techniques. In their view, maintaining these obligations is the only way to guarantee freedom of choice for farmers and consumers, and to protect the seed and peasant sectors from contamination and attempts by multinationals to take control of living organisms. [texte] => Since the beginning of the year, the European Parliament, the European Commission and the Council of the European Union have been discussing a project to deregulate the release and marketing of most GMOs in Europe. With the current Polish presidency of the Council hoping to bring the round of negotiations to a close at the end of June, a number of organizations have issued statements or written letters to make their voices heard on one particular subject: the traceability of GMOs.A European farmers' union considers traceability as "essential"In a statement published on its website on May 14, 2025i, the European Coordination of La Via Campesina (ECVC) considers that the publication of detection and identification methods for GMOs obtained by new techniques of genetic modification (known as NGT, for “new genomic techniques”) is “absolutely essential to protect farmers and small traditional seed producers from several abuses made possible by the draft NGT Regulation”, as well as to “ensure the right of consumers to information on the quality and origin of the products they buy” and to also ”protect human health and the environment in the event of damage occurring post-marketing and release of these GMOs, which would require the withdrawal of these products".These detection and identification methods are, as ECVC points out, the only means of identifying any genetic modifications present in an organism, and therefore “necessary to identify the presence of patented traits resulting from NGTs in seeds, plants and products”. If these methods are published, they are also the only tools available to seed companies, farmers or other operators to defend themselves in the event of illegitimate infringement proceedings. Indeed, ECVC details that, in its view, “without the publication of detection and identification methods, it will be impossible for farmers to prove that they have not used patented seeds, that the traits of their peasant or traditional seeds differ from any patented trait, or that their crops have been contaminated”. What's at stake? The risk for these farmers of having their crops and products seized in the event of a claim for counterfeiting.Pointing out that documentary traceability is also important for sectors with labels such as the organic sector, ECVC has formulated four formal demands. For the union, these are:« To maintain the provisions of the current GMO legislation on the publication of detection and identification methods »;« That the European Commission publishes urgently regulatory protocols for the detection and identification of GMOs obtained with NGTs »;« To ensure transparency for farmers and breeders by clearly indicating on the seed label and in the catalogues whether the seeds are obtained by NGTs and/or covered by patents »;« To ensure the same transparency for consumers ».French organizations write to MEPsBy mid-June, 17 French organizationsii and groups sent a letteriii to the French Prime Minister and MEPs, asking them to oppose the text currently under discussion, which, if adopted, would “almost completely deregulate the new GMOs, allowing them to enter our food supply on a massive scale in a totally opaque manner”. This total opacity stems from the fact that the text under discussion could abolish the requirement of “traceability, labelling and identification methods for GMOs, three essential pillars for safeguarding the rights of farmers, agricultural sector operators, distributors and consumers”.The French organizations consider that the measures imposing GMO traceability and labeling, publication of detection and identification methods, risk assessment, the possibility given to member states to ban the marketing of a given GMO on their territory, post-marketing monitoring and a “traceability system for seeds and products covered by patents” are a response to the questions inherent in the marketing of GMOs. These questions concern, for example, their lack of impacts, of which it is “impossible to prejudge”, and the need for the State to equip itself with the means of traceability enabling a product to be withdrawn in the event of health or environmental problems arising after its release. Another example is patents on plants or the genetic information they contain, which, according to the organizations, entail major risks of “concentration of the seed sector in the hands of a few multinationals who will thus control the entire food chain and privatize living organisms, abusive legal proceedings against small seed companies and farmers, sharp increases in seed prices, negative impacts on food sovereignty...”. The final risk cited was the threat to GMO-excluded sectors such as organic farming, protected designation of origin products, controlled designation of origin of products, geographical indication products and so on.European organizations speaking with one voiceAt the beginning of June, fifty European organizations also published a letteriv making the same demands as ECVC. Defending freedom of choice for European citizens, whether they be consumers, seed growers, operators in the agri-food chain, farmers... these organizations write that “labelling and traceability of NGT-plants and products are essential requirements […] for maintaining transparency, accountability and freedom of choice”.Like ECVC, the organizations also stress the risks associated with the potential unregulated marketing of GMOs through rules on traceability, labeling, risk assessment, etc. For these organizations, failure to equip themselves with the technical and legal means to trace and label “NGT-GMOs undermines not only the fundamental rights of 450 million EU-citizens, but also the integrity of NGT-GMO-free agriculture”.i ECVC, « Traceability of GMOs obtained with new genomic techniques: The mandatory publication of detection and identification methods is essential », 14 May 2025.ii Amis de la Terre Landes, Bio Consom’Acteurs, Collectif Vigilance OGM et Pesticides 16, Confédération Paysanne, Demeter France, Fédération Nature & Progrès, FNAB, Foll’avoine, Foodwatch, France Nature Environnement, Générations Futures, GIET, Mouvement de l’agriculture biodynamique, Natexbio – La Maison de la Bio, Objectif Zéro OGM, Pollinis, Synabio, UFC-Que Choisir.iii « Lettre ouverte au Gouvernement et aux eurodéputé.e.s – Nouveaux OGM, ne sacrifions pas notre agriculture et notre alimentation », 11 June 2025 (in French). iv Collectif, « JOINT STATEMENT, Freedom of Choice only possible through labelling and traceability of NGT-GMOs », May 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [102] => Array ( [objectID] => 13577 [title] => The ITPGR is working on a controversial reform [timestamp] => 1750204800 [date] => 18/06/2025 [annee] => 2025 [url] => https://infogm.org/en/the-itpgr-is-working-on-a-controversial-reform/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => At the beginning of April, the Tirpaa again discussed the expansion of the list of crops covered by the multilateral system and the revision of the contract governing their use. While some Member States of the Treaty are invoking the need to guarantee global food security, fears are being voiced that there will be a drift in widespread access to peasant and traditional seeds. This would facilitate their patenting, without any real sharing of the benefits, to the detriment of the countries of the "South" and the rights of the peasants. [chapo] => At the beginning of April, the ITPGR again discussed the expansion of the list of crops covered by the multilateral system and the revision of the contract governing their use. While some Member States of the Treaty are invoking the need to guarantee global food security, fears are being voiced that there will be a drift in widespread access to peasant and traditional seeds. This would facilitate their patenting, without any real sharing of the benefits, to the detriment of the countries of the “South” and the rights of the peasants. [texte] => From 1st to 4 April 2025, in Rome, the thirteenth meeting of the ad hoc working group (WG13) of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) revived a substantive strategic debate: is it necessary, under cover of food security, open access to all agricultural seeds or " plant genetic resources for food and agriculture" (PGRFA). Species as important as soybeans or tomatoes, and many others, are not covered by the ITPGR Multilateral System (MLS). In response to this pressing demand from the seed industry supported by the countries of the "North" and strengthening international cooperation, Tunisia risks penalizing the countries of the "South", potential first victims of food insecurity.Proposals to modify the ITPGR in depth The WG13 of the Tilapa formulated in its reporti proposals that would profoundly transform the functioning of the multilateral system (MLS). This system allows facilitated access to certain agricultural plant genetic resources (for research, breeding and training), eliminating bilateral benefit-sharing under the Convention on Biological Diversity (CBD) between the peasants who provided their seeds to the MLS gene banks and their users (the seed industry essentially)ii. In exchange, it provides for a ban on claiming any intellectual property rights relating to these seeds (PGRFA), their genetic parts and components, as well as a multilateral sharing of the benefits arising from their use to be contributed to an international fund managed by the Treaty. Its functioning is however criticized, in particular by farmers' organizations, who consider that their rights are insufficiently protected against the increasing appropriation of their seeds by the patents of multinationalsiii. The countries of the "South" and NGOs denounce the lack of sharing of benefits. Three "sensitive points" were more specifically addressed by WG13: the expansion of the list of crops covered by the SML (Annex 1 of the Treaty) to all RPGAAiv, the revision of the Material Transfer Agreement (MTTA) and the adoption of a resolution dealing in particular with the issue of digital sequence information, commonly known as "DSI" (Digital Sequence Information).List of PGRFA The most significant proposal concerns the abandonment of the closed list in Annex 1, which currently includes 64 plant species, for its opening to "all other PGRFA", subject to limited exclusions as may be decided by States. The list in the current Annex 1 was built in 2001 on a political and scientific compromise that saw the exclusion, for strategic reasons, of certain species. This was the case, for example, with tomatoes and soya under pressure, particularly from Brazil and Chinav, which thus wanted to keep control of access to these species.DSI Without a text having been finalized, the WG13 proposed a framework for sharing the benefits related to the use of DSI or GSD (Genetic Sequence Data), whether monetary or not, major subject in the context of new genetic modification techniques and patents concerning themvi. The integration of so-called "non-monetary" benefits (technology transfer, capacity building...) is still under debate. Among the important points: i) continuation of the provisional use of the terms « digital sequencing information/sequencing data », ii) integration of the subject DSI/GSD in a draft resolution, and not in the revised ATTM, which greatly weakens its legal scope,iii) focus on the commercialization of PGRFA regardless of the source of the ISD/GSD,iv) general support for open access to this digital sequencing data.But since access to the ISD/GSD of PGRFA is now free on the independent electronic databases of ITPGR, users of these ISD/GSD are not bound by any of the obligations resulting from access to these PGRFA, nor prohibition to patent, nor benefit sharing, which can only be voluntary.ATTM The co-chairs of WG13 propose, in the revised draft ATTM, a new payment structure focused on subscription with advance payment, as supported by the "South" countries and NGOsvii. This modality is considered the basic option for benefit sharing. There are two other options before the working group: a deferred payment (with a higher rate) and a triggered payment upon commercialization of the product from a particular PGRFA (" single access option"). The scheme also provides for the possibility of voluntary contributions deductible from the amount of mandatory payments, in particular to cover profits derived from the use of ISD/GSD information associated with PGRFA. The revised ATTM would come into effect as of July 1, 2026, which will also be the date of opening of the subscription option.A reform that would broaden access without guaranteeing fair sharingThis reform of the ITPGR says it wants to make the multilateral system (MLS) more attractive and accessible, particularly in the face of climate challenges and biodiversity loss. It will be discussed by the Governing Bodyviii of the Treaty at the end of 2025, but is already giving rise to strong criticisms, particularly regarding the enlargement of Annex 1 and the patentability of the DSI/GSD. The WG13 working group talks about expanded access to new resources (PGRFA) held mainly by the countries of the "South" (58% only for Africa and Latin America)ix. Apparently favorable to these countries pending an effective sharing of benefits, this measure may however worsen the existing imbalances. These countries risk being further excluded from any sharing of the profits generated from their own resources through free access to DSI/GSD databases. This runs counter to the objectives of the CBD, which promotes fair and equitable sharing of benefits arising from the exploitation of genetic resources, a principle that Peru is helping to implement in the agricultural sector. In practice, profit-sharing obligations are rarely enforced. Although the ATTM is designed to frame any use of PGRFA from the SML, the effective implementation of clauses intended to protect the suppliers of these resources, particularly in terms of intellectual property and benefit-sharing, is almost impossible to control. Since its establishment, the multilateral system has allowed more than 112,000 transfers representing 6.7 million samplesx. Yet, in 2021, only 5 companies, including Nunhems/Bayer (91%) and Bejo Zaden, contributed to the Sharing Fund for a total of less than 400,000 dollarsxi. The ATTM has many flaws, including the difficulty of linking PGRFA and final product as well as the lack of traceability of multiple exchanges and effective use of each PGRFA. Indeed, research can use a genetic resource from the SML only in an initial phase, without integrating it directly into the final product. Thus, even if the resource has been useful in the process that ends with the selection of a new PGRFA, its use will not be counted in the calculation of benefit sharing. Moreover, these resources are often solicited by the research community, which is not required to contribute to the benefit-sharing fund. In addition, however, researchers frequently collaborate on projects with private companies. There is then a risk that they will use the resources beyond the project’s objectives, in particular to develop commercial seeds protected by intellectual property rights, without declaring their origin, thus bypassing benefit-sharing obligations.Moreover, the current development of a "digital biopiracy", via open access to DSI/GSD contained in public or private databases, further penalizes the countries of the "South", the main suppliers of PGRFA. This data can be used to develop new varieties and patent traits without direct access to the original PGRFA, thus escaping the IPR ban and any benefit sharing. This flaw calls into question the integrity of the multilateral system.How to reform while respecting sovereignty ?The ITPGR reform raises an essential political question: to whom do the seeds belong, and according to what rules can they be shared on a global scale? The Treaty was originally conceived as an instrument of international solidarity aimed at rejecting the appropriation by IPRs of an apparent "common heritage of humanity" in order to preserve agricultural diversity and ensure food security in a spirit of cooperation. If they are not rectified, is this reform initiative not likely to further aggravate the imbalances generated by the historical misapplication of the ITPGR?To avoid this, the members of the ITPGR could impose several obligations on themselves. For example, real transparency on the use of PGRFA, explicit and rigorous integration of DSI/GSDs into the scope of benefit sharing, and a ban on confiscating PGRFA along with IPRs on the contained DSI/GSDs. The countries of the "South" as well as local and indigenous communities could also be given a central place in the governance of the system. Only under these conditions can the proposed expansion of Annex 1 to the Tipaa be accepted by all countries.The GT13 continues an open negotiation cycle in 2013 with a deadline now set for the end of the year 2025. The Treaty could come out of it deeply reworked. In an ideal scenario – although unlikely – the Treaty would achieve its objectives of equitable seed sharing, without becoming, as many actors denounce it, an instrument of appropriation of plant genetic resources hidden behind a semblance of solidarity.i FAO/ ITPGR, "THIRTEENTH MEETING OF THE AD HOC OPEN-ENDED WORKING GROUP TO ENHANCE THE FUNCTIONING OF THE MULTILATERAL SYSTEM", April 2025.ii The ITPGR is the particular application of the CBD for plants.iii Guy Kastler, "DSI: dematerialised biopiracy", Inf'OGM, le journal, n°176, July – September 2024.iv Article 2 of the ITPGR defines PGRFA as "genetic material having actual or potential value for food and agriculture".v FAO et Bioversity International, "Plant Genetic Resources and Food Security stakeholder perspectives on the international treaty on plant genetic resources for food and agriculture", p. 11, 2011.vi Guy Kastler, "Interconnections between new biotechnologies and DSI or GSD", Inf'OGM, July 11, 2024.vii Third World Network, "Info Service on Biodiversity and Traditional Knowledge", 4 April 2025.viii The Governing Body brings together all the countries that have ratified the Treaty.ix Third World Network, "Info Service on Biodiversity and Traditional Knowledge", 1st April 2025.x Ibid.xi FAO, "The Benefit-sharing Fund: 2020–2021 report", 2022. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [103] => Array ( [objectID] => 13520 [title] => The European Commission postpones its “biotech law” again [timestamp] => 1749427200 [date] => 09/06/2025 [annee] => 2025 [url] => https://infogm.org/en/the-european-commission-postpones-its-biotech-law-again/ [image] => https://infogm.org/wp-content/uploads/2026/03/P059940-620457-768x512.jpg [extrait] => The European Commission's postponement of its "biotech law" until the end of 2026 is raising questions. Presented as a future "regulation", this law must be coordinated with other legal acts still under discussion, in particular the one on new genomic techniques (NGT). But the regulation on health data (known as "EHDS"), adopted in February 2025, could also be a reason for this postponement. [chapo] => The European Commission’s postponement of its “biotech law” until the end of 2026 is raising questions. Presented as a future “regulation“, this law must be coordinated with other legal acts still under discussion, in particular the one on new genomic techniques (NGT). But the regulation on health data (known as “EHDS“), adopted in February 2025, could also be a reason for this postponement. [texte] => Via a consultation (a "call for evidence") published in April 2025i, the European Commission confirmed that its proposal for a "biotech law"ii - which it now calls the "Biotechnology Regulation" - initially expected for 2025, would not finally be presented until the third quarter of 2026. This postponement could be aimed at bringing the future biotech law more into line with, among other things, the regulation on the "European Health Data Space" (EHDS), adopted on 11 February 2025iii. But beyond a technical readjustment, this postponement could actually be aimed at making it easier to take the industry's interests into account, at a time when data protection requirements are becoming more stringent.A forced postponement?On 13 May, Olivér Várhelyi, the European Commissioner for Health and Animal Welfare, endorsed the postponement of this regulation on biotechnology in front of the European Coalition for Biosolutions, a panel of European companies in the field of "biosolutions"iv. "Bio" refers to the term "biotechnology" and not "biological", as confirmed in Várhelyi's speech entitled "Perspectives and priorities for the new European biotechnology law"v. In it, he explains that the Commission "intends to adopt an ambitious and robust biotech law in 2026", and that it is in the "preparatory phase" of this law, during which it is "examining several key areas for the biotech sector".In order to "make the most of the biotechnology revolution in all sectors", the Commission has announced, via Olivér Várhelyi, that it intends to examine the following key areas: regulatory environment, access to capital and venture capital, existing infrastructures, human capital, supply chains and... digital tools. The work still to be done by the Commission to draw up its biotech law would therefore be substantial. Didn't the Commission simply feel obliged to postpone the "Biotechnology Regulation" because, in its haste, it had failed to anticipate the scale of the examinations to be carried out, particularly on the issue of health data?The challenge of health dataReferring to the examination of the "digital tools" area, Olivér Várhelyi refers to the EHDS regulation of February 2025. "Access to data, storage services and IT resources will of course be essential for research and innovation in the field of biotechnology. In this respect, we believe that the European Health Data Space will provide very important support," Várhelyi told the industry panel on 13 May. The scheme, which will come into force in March 2027, is of crucial importance to the Commission, as digital health data is a valuable "raw material" for biomedical research.It is for this reason that the Commissioner also reassured the panel of industrialists about the exploitation of such data: "We are therefore seeking to facilitate the development and adoption of digital solutions and artificial intelligence in all sectors of biotechnology. And of course, we need to use this wealth of data that we have in a very strategic way. In a strategic way that will ensure Europe's global leadership.” The growing role of artificial intelligence in the management and exploitation of healthcare data is undoubtedly attracting the interest of many economic playersvi.The EHDS regulationThe hypothesis that the framework imposed by the EHDS is one of the main reasons for the postponement of the biotech regulation seems plausible. This very recent regulation - February 2025 - governs the use of primary and secondary digital health data in Europe. Primary use refers to the collection and use of data in the context of patient care (article 2.1). Secondary use concerns the exploitation of data collected and produced in the course of care, for scientific research and in the health sector (article 50 et seq.).According to the EHDS, secondary use may be authorised without the patient's explicit consent, provided that the processing has an established legal basis, such as the public interest, public health or scientific research (GPDR Regulation, Article 9)vii, and is accompanied by appropriate safeguards (such as anonymisation, pseudonymisation or secure access). The EHDS Regulation also calls for transparency of processing, data portability, a framework for secondary use of data and technical standards for interoperability. Access to data is only authorised under these conditions, for public, private or not-for-profit entities, as well as for individual researchers. This secondary use may be for the purposes of scientific research, innovation, health policy development, patient safety, regulatory activities or personalised medicine, in particular on the basis of (epi)genomic or molecular data, etc. (recitals 56 and 61, and articles 51 and 61 of the EHDS Regulation).The EHDS Regulation explicitly states that health data may be used for the development of medicinal products, medical devices or artificial intelligence systems (Article 53(e)), i.e. uses with high commercial and technological potential. In theory, such processing is only authorised where it is intended to "contribute to the general interest" (recital 61) and is subject to a number of conditions set out in Article 54. These include in particular the prohibition of uses that are expressly prohibited, such as targeted marketing, discrimination or the abusive exploitation of data, as well as respect for intellectual property rights and commercial secrets.An agenda driven by economic interestsThe actual strength of the guarantees proposed by the EHDS regulation raises questions. Their practical application will largely depend on the rigour of the controls exercised by a health data access body (HDAB), national interpretations and the ability to detect and punish misuse. In the absence of explicit consent from the individuals concerned, the massive re-use of data, including sensitive or genetic data, calls for particular vigilance, both from an ethical and legal point of view.In this context, the future "Biotechnology Regulation", a key lever in the Commission's health strategy, will necessarily have to be coordinated with the EHDS Regulation. While the EHDS Regulation imposes constraints on the use of health data, it also opens up a wide range of possibilities for the biotechnology sector in terms of access to health data. Do biotech companies see the EHDS framework as sufficiently flexible to support their ambitions? Or are they afraid of coming up against a regulatory environment that is too rigid for them to evolve freely? Postponing the "Biotechnology Regulation" until the end of 2026 would in any case give the Commission the opportunity to adapt it to offset or smooth out any obstacles posed by the EHDS.The emergence of a democratic riskThis postponement could be more of a political opportunity to review the interests of the market than a simple measure of legal prudence. If the Commission wishes to introduce measures in this future text that will make it even easier for industry to access and/or use health data, it will have to accept the consequences: this would mean redefining the very status of this data, no longer as a protected extension of the individual, but as a shared economic resource subject to transaction.The EHDS regulation does not offer absolute protection for health data. It would be worrying if the European Union were to increase this fragility by taking the future regulation on biotechnology in the same direction. The risk would then be not only legal but also democratic. For example, by granting industrial players privileged access to data from public health systems, the EU runs the risk of compromising public confidence in its ability to protect personal data. The European model, based on the primacy of people's fundamental rights, would be weakened in the name of competitiveness.Health data: US, Swiss and Israeli practices [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [104] => Array ( [objectID] => 13513 [title] => When algorithms decide on the genetic modification of living organisms [timestamp] => 1749081600 [date] => 05/06/2025 [annee] => 2025 [url] => https://infogm.org/en/when-algorithms-decide-on-the-genetic-modification-of-living-organisms/ [image] => https://infogm.org/wp-content/uploads/2026/03/Nature_by_Alan_Warburton-768x432.jpg [extrait] => For many years now, multinationals have been collecting an increasing amount of genetic, proteic sequences and epigenetic informations. They are reducing living organisms to data compiled in digital databases. Using "artificial intelligence" algorithms, they claim to have the tools to determine which genetic modifications will produce a given new characteristic. In a society where genetic modification techniques and patents are intimately linked, these algorithms will above all accelerate the claim to own living organisms. [chapo] => For many years now, multinationals have been collecting an increasing amount of genetic, proteic sequences and epigenetic informations. They are reducing living organisms to data compiled in digital databases. Using “artificial intelligence” algorithms, they claim to have the tools to determine which genetic modifications will produce a given new characteristic. In a society where genetic modification techniques and patents are intimately linked, these algorithms will above all accelerate the claim to own living organisms. [texte] => In the field of genetic technologies, the digitisation of living beings and the computer processing of the data derived from them are growing rapidly. Using sequences of genomes present in biodiversity, the owners of "artificial intelligence" algorithms now claim to be able to predict the genetic modifications required for new characteristics.A still partial reading of a large number of genomesIn 2023, an article reported how researchers at the Wellcome Sanger Institute (UK) had fed algorithms factories to make them predict "the best fix for a given genetic flaw"i. The researchers established 3,064 DNA sequences of variable length to be inserted into a genome. After implementing a method for inserting each of these sequences, they sequenced the modified genome obtained to see whether the genetic modification had been carried out correctly. Using their results, they fed an algorithm used in 'machine learning' so that it could "detect patterns that determine insertion success, such as length and the type of DNA repair involved".Others go further in their ambitions for such algorithms. In 2024, Science published an articleii reporting on the work of US researchers to develop an algorithmic model of "artificial intelligence" (AI). According to the article, this algorithm can "interpret and generate large-scale genomic sequences". Called Evo, it is capable of analysing "millions of microbial genomes" and then "generate realistic genome-length sequences". Without any modesty, the authors explain that the Evo algorithm "has developed a comprehensive understanding of life’s complex genetic code, from individual DNA bases to entire genomes". According to the researchers, Evo is therefore capable of predicting how small changes in DNA could modify the characteristics of organisms, just as it can "generate realistic genome-length sequences, and design new biological systems", if a biological system is defined solely by its genetic sequences.According to a report by the German association Save Our Seeds, published in January 2025iii, this dynamic of feeding algorithms with genetic sequence information is shared by several companies. Among the given examples is the algorithmic model developed by the company Inari, called FloraBERT. According to the report, the algorithm was fed with the regulatory sequences of 93 plant species and 25 different maize varieties. The expected use of this algorithm is that it will be able to predict how genetic modifications to regulatory sequences in the maize genome may alter the characteristics of this plant. A partnership between Google and Instadeep has also resulted in an algorithm, AgroNT (for Agronomic Nucleotide Transformer), finalised at the end of 2023. Fed with genetic sequences from 48 plant species, the algorithm is said to have been used to simulate more than 10 million mutations in cassava, with a prediction of changes in characteristics.Combining genetic modifications and algorithmsThe use of algorithms by researchers aims to establish which genetic modifications in which sequences would be the most effective in obtaining a given characteristic. This combination is the result of the work described above, namely the analysis by these algorithms of a growing number of genomes. But, as the Save Our Seeds reportiv points out, such work is still in its infancy, having been carried out after 2022.To date, the genetic modifications envisaged with the use of algorithms mainly concern so-called regulatory sequences. These sequences regulate the expression of other genetic sequences according to internal or external signals received. Genetically modifying these regulatory sequences can be aimed at turning off the expression of a sequence rather than removing it. Other work using algorithms aims not to switch off the expression of a genetic sequence, but to modulate its level of expression. The iCREPCP algorithm from Huazhong University (China) is being used to identify promising sequences and suggest the most 'promising' genetic modificationsv. Other sequences are also targeted: those of the small RNAs used in Crispr complexes.“Artificial intelligence" algorithms are also being used to predict genetic modifications that could potentially alter protein structures. Work on genetic modifications to increase tomato resistance to the fungus Phytophthora infestans has been identified. This research was carried out using the AlphaFold algorithm, which led to the targeting of two building blocks of a protein to be modified in the hope of increasing resistance. Other researchers have used the same algorithm to increase the viscosity of potatoes. For maize, the aim is to modify the architecture of the plants so that they can be grown more densely in the fields. In the case of wheat, proteins are targeted to make wheat more easily 'workable' in the food industry...Algorithms to replace laboratory assistantsRather than remain confined to the role of work tools, some people are working to ensure that AI algorithms become laboratory assistants. At the end of 2024vi, a press article reported how Google DeepMind and BioNTech were working on developing automated systems to help choose the scientific experiments to be carried out, from their protocols to the collection and analysis of results. For Karim Beguir, CEO of BioNTech, such assistants would be "productivity accelerator" for researchers.As we have already seen, assistant projects are being developed to analyse genetic sequences or predict the structure of proteins. Others could also be used to "design, plan, and execute complex chemistry experiments". Anthropic's Claude 3.5 could even be used further upstream, this time to generate ideas for experiments. As the author of the 2024 articlevii points out, this use has yet to be tested against the actual usefulness of such experimental proposals.Multinationals in the front rowBayer, BASF, Syngenta, Corteva... these multinational seed companies are already using their algorithms to genetically modify plants. Save Our Seedsviii points out that these companies have been collecting vast quantities of genetic and protein data for several years, precisely to feed their algorithms.Corteva, for example, has developed its own algorithm using Google's BigBird software. To obtain predictions of genetic modifications, in this case mutations, to be carried out in regulatory sequences, Corteva has provided its algorithm with sequence information from 14 plant species, including barley, rice, wheat, maize, canola (a rapeseed) and soya. Corteva is also working with Tropic Bioscience in the hope of being able to carry out genetic modifications to resist disease.For its part, like BASF, Bayer is working with Evogene and its algorithm to define the genetic modifications needed to obtain disease resistance in various plants. Save Our Seeds adds that it has also invested in two companies that use algorithms and the Crispr/Cas genetic modification tool, Ukko and Amfora.Finally, Syngenta has developed its own algorithm, AgroNT, which we have already mentioned, in conjunction with InstaDeep and Google. With this tool, the company is now seeking to establish genetic modifications to be carried out in maize and soya.The algorithms used predict genetic modifications solely on the basis of knowledge of genetic sequences, without taking into account the cellular context within the organism, or the diversity of environments in which the organism is disseminated. This approach is reductive, to say the least, and the reliability of its results depends on the data it is proposed to process, which in no way constitutes all the data concerning living organisms. This data is going to be produced at an ever-increasing rate, and is taking precedence over data derived from direct observation of living organisms, which necessarily takes place over a slower but more collaborative period...i "Prime Editing and Machine Learning Aid Researchers in Determining the Best Fix for Genetic Flaws", Genetic Engineering & Biotechnology News, 17 February 2023. ii Eric Nguyen et al., "Sequence modeling and design from molecular to genome scale with Evo", Science, Vol 386, Issue 6723, 15 November 2024.iii B. Vogel, "When chatbots breed new plant varieties", Save Our Seeds, January 2025. iv Ibid.v Deng, K. et al., "iCREPCP: A deep learning-based web server for identifying base-resolution cis-regulatory elements within plant core promoters", Plant Communications, Volume 4, Issue 1, 9 January 2023.vi Edd Gent, "DeepMind and BioNTech Bet AI Lab Assistants Will Accelerate Science", SingularityHub, 7 October 2024.vii Ibid.viii B. Vogel, "When chatbots breed new plant varieties", Save Our Seeds, January 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [105] => Array ( [objectID] => 13503 [title] => French organisations concerned about GMO deregulation [timestamp] => 1748995200 [date] => 04/06/2025 [annee] => 2025 [url] => https://infogm.org/en/french-organisations-concerned-about-gmo-deregulation/ [image] => https://infogm.org/wp-content/uploads/2026/03/Antipub-OGM-14-768x512.jpg [extrait] => As the trialogue on the proposed deregulation of GMOs got underway on 6 May between the European Commission, the European Parliament and the Council of Member States of the European Union, French organisations are once again warning of the potential "serious and irreversible consequences of this text".Alternatiba Rennes, one of the signatories of this letter, has also taken action in the public arena. [chapo] => As the trialogue on the proposed deregulation of GMOs got underway on 6 May between the European Commission, the European Parliament and the Council of Member States of the European Union, French organisations are once again warning of the potential “serious and irreversible consequences of this text“.Alternatiba Rennes, one of the signatories of this letter, has also taken action in the public arena. [texte] => On 5 May, on the eve of the start of the trialogue that will discuss a proposal to deregulate a number of GMOs, with the aim of exempting them from the rules currently in force in the EU, around twenty organisationsi published a collective opinion piece in the columns of Politisii. Pointing out that they had already alerted the French government and the European institutions on numerous occasions, they felt that their "questions and concerns have so far received no satisfactory response". Concentration of the seed market as a result of patents, loss of food sovereignty, lack of risk assessment, disappearance of the right to information and freedom of choice for citizens, the right to produce without GMOs, endangerment of non-GMO and organic sectors... these are just some of the notable impacts listed by the signatory organisations.Patents as a central issueMost of the organisations behind this French tribune were also signatories of the European declaration of February 11iii, which brought together more than 200 NGOs, trade unions and associations. As they did 3 months ago, the signatories point out that while the European institutions are rushing to reach a final text, "the thorny issue of patents is a central point in the negotiations, and no adequate response has been provided".In their arguments, the organisations stress that "in the absence of any obligation to publish methods for detecting and identifying these new patented GMOs [...], they will contaminate the agri-food sector and expose it to major risks:The impact on the integrity of the GM-free and organic sectors, which will no longer be able to guarantee the absence of GMOs;Extending the scope of patents to farmers' or conventional seeds contaminated by a gene patented by an NTG process or naturally containing a gene wrongly declared to be similar to this patented gene;Legal uncertainty for farmers, breeders, processors and distributors, who will have no way of knowing whether they have used or marketed patented genes, which could lead to legal proceedings and threaten the continuation of their business;The loss of diversity in the food on offer to the public, and the end of their freedom of choice due to the absence of labelling;The reduction in cultivated biodiversity and the ecological imbalances linked to the uncontrolled dissemination of these "new" GMOs in the environment;The loss of food sovereignty by strengthening the already suffocating grip of multinationals on our agri-food systems".Deconstructing the false promises of the "new GMOs".Far from believing the promising announcements made by the promoters of the "new GMOs", the signatories reject out of hand the "sustainability" argument put forward by the seed multinationals. The first reason for this is an agronomic reality: "no plant can be sustainable in its own right. Only a farming system as a whole can offer a degree of sustainability, based on a variety of factors over which genetic manipulation has no control: farming practices, local climatic conditions, soil quality, presence of pollinators, biodiversity, etc.".Secondly, taking into account "30 years' hindsight on the industry's false promises concerning the first GMOs", the signatories state that the vast majority were developed to resist herbicides or produce insecticides. If the few varieties already developed and cultivated in the Americas are anything to go by, the "new GMOs" are pursuing the same rationale of a headlong rush towards industrial agriculture using chemical inputs and biotechnologies. For the group publishing the article, "this is proof that they are not sustainable".In view of the risks mentioned, which are currently being ignored, the signatory organisations are therefore asking "the European institutions to maintain the measures that are essential to protect farmers, sectors, citizens and the environment: prior risk assessment, traceability and labelling up to the consumer, obligation to publish detection and identification methods, safeguard clause, post-marketing monitoring".Alternatiba also mobilises in the public spaceThe Alternatiba collective, which signed the above-mentioned petition, also took to the streets of Rennes. On Friday 25 April, members of the organisation carried out "an action of civil disobedience by taking over advertising hoardings in the city centre to warn the general public about the possible future deregulation of GMO plants"iv. But the aim was "also to have communication material to send to the media", which Alternatiba finds "very discreet on the subject".In its press release, Alternatiba begins by paying tribute to the activists who "fought" to obtain "the world's strictest regulations on GMOs (Directive 2001/18/EC)" and whose legacy is under threat following "the adoption of the European Commission's draft regulation of 5 July 2023 on the deregulation of New Genomic Techniques (NGTs)", which has been under negotiation in the trialogue since 6 May. For Alternatiba, "as well as flouting the precautionary principle", this deregulation of GMOs "would deprive consumers of their freedom to eat what they want". The free and uncontrolled dissemination of GMOs would also entail "dangers of irreversible contamination for wild and cultivated biodiversity and thus a serious threat to GMO-free agriculture" and would further extend the monopoly of a few seed multinationals under the guise of "false promises of adaptation to climate change". And the members of Alternatiba conclude that this is a glaring example of "the sinister turn in agriculture that Emmanuel Macron is aiming for - robotic, digital and genetic".Although the vast majority of GMOs are likely to be deregulated in the EU with the start of negotiations in the trialogue, civil society organisations are still trying to raise the alarm and highlight the risks this would entail...i Agir pour l'environnement, Alternatiba Rennes, Amis de la Terre France, Aspro Pnpp, Bio Consom'acteurs, Collectif Objectif Zéro OGM, Collectif Vigilance OGM et Pesticides 16, Confédération paysanne, CSFV49, Demeter France, Fédération Nature & Progrès, Foll'avoine, France Nature Environnement, Générations Futures, IFOAM-France, Mouvement de l'Agriculture Biodynamique (MBAD), OGM Dangers, Objectif Zéro OGM (OZO), POLLINIS, Réseau Semences Paysannes, Synabio.ii Collective platform, "Nouveaux OGM : fausses promesses, vrais risques et précipitation coupable", Politis, 5 May 2025.iii Joint statment, "Protect the business of small and medium size breeders, farmers, and the organic and non GMO sectors in the EU", 11 February 2025.Antoine Vépierre, "In 2025, more and more organisations are opposed to the deregulation of GMOs", Inf'OGM, 12 March 2025.iv Alternatiba Rennes, "Alternatiba Rennes se mobilise contre le projet de dérégulation des "nouveauxOGM", 28 April 2025. Antoine VEPIERRE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [106] => Array ( [objectID] => 13500 [title] => A farmer’s opinion on agritech [timestamp] => 1748563200 [date] => 30/05/2025 [annee] => 2025 [url] => https://infogm.org/en/a-farmers-opinion-on-agritech/ [image] => https://infogm.org/wp-content/uploads/2026/03/stephane-galais-768x768.webp [extrait] => Inf'OGM interviewed Stéphane Galais, a farmer in Ille-et-Vilaine (Brittany, France) with a 25-hectare farm producing milk and cheese. He is also national secretary of the Confédération paysanne. In this interview, he explains and analyses what agritech means to him. [chapo] => Inf’OGM interviewed Stéphane Galais, a farmer in Ille-et-Vilaine (Brittany, France) with a 25-hectare farm producing milk and cheese. He is also national secretary of the Confédération paysanne. In this interview, he explains and analyses what agritech means to him. [texte] => Inf'OGM - First of all, what does the word "agritech" mean to you?Stéphane Galais (SG) - For me, agritech is the combination of agriculture and technology. Agritech, or precision agriculture, another term that's currently gaining ground, is all about robotics, digital technology and genetic transformations. But for us at the Confédération paysanne, the political project we've been pursuing since the 1990s is peasant farming. And in this political project, there is a desire for autonomy on farms, i.e. decision-making autonomy and technical autonomy. In our view, this political project is incompatible with the technological approach. But this is not a new phenomenon. For a long time now, we've been witnessing over-mechanisation on farms, which leads to a dependence, I would almost say an allegiance to an agro-mechanical, agro-industrial ecosystem that we don't want. We don't reject technology on principle, but it must be at the service of farmers and, more broadly, at the service of a societal project aimed at food sovereignty.When we talk about technical autonomy, we basically mean having the capacity to repair, maintain and manage our machines... This know-how exists and could be threatened by the arrival of ultra-modern, super-powerful machines.Agritech, then, is a far cry from farming know-how as we know it. Admittedly, it's conceivable that these new skills could be acquired, but we're still a long way from the skills and know-how of farmers, which are more closely linked to the management of living organisms or knowledge of living organisms, or knowledge of animals and their relationship with them.In concrete terms, we're already seeing this loss of autonomy with the arrival of robotisation, particularly on dairy farms. We see it because we have less control over the tools. These are complicated tools, some of which are patented and owned by certain companies that we will never be able to access.Inf'OGM - Milking robots are a precursor to agritech. Do you have any feedback from farmers who use them?SG - The first piece of information we have is that these robots don't reduce the workload. It changes the working hours, without eliminating them completely. It changes the need to be at milking twice a day at a given time. The second feedback we often get is that these tools bring work into the home. In practical terms, this means that when you go home, you haven't finished working, because the robot can send out work instructions. In the old days, when you'd finished milking, you'd go home. That's it. Unless you had a sick animal. But there used to be a very clear dividing line between when you worked and when you were at home with your children. But now, at lots of times, the robot sends you messages to deal with malfunctions, such as a problem with cows that don't want to 'come in' to the robot, so the robot sends an alert... So that really changes the perception of work and the relationship with time.This relationship with time is fundamental for us at the Confédération paysanne. For us farmers, time is conditioned by life, and is in direct opposition to capitalist time and Taylorism. The machine changes this relationship with time.Inf'OGM - Another advantage put forward by the promoters of agritech is better weed management...SG - In fact, what creates a real problem with weeds? Or, more broadly, the health issue? It's the intensification of agriculture, the intensification of production. In other words, we want to produce a lot on a small area or on a large area, but with few people. We are witnessing a real concentration of agriculture. And that inevitably creates management problems. So we're trying to find solutions to these problems through technology. But in fact, that's not the problem. The problem lies with the system of concentration and intensification. We can see that in a more extensive system, a more rural system, a more agro-ecological system, we manage to deal with these problems outside the field of technology, because we manage to put the human element back in. We can also work on the synergies between living organisms, so that the system is more in balance. In this context, in concrete terms, technology is a false solution to a fundamental problem, a systemic problem. It's a band-aid on a wooden leg.I always take the example of carrots. It's a complicated crop because it's very difficult to manage in terms of competition with weeds. But on my farm, I grow 30 metres of carrots in a diversified system. So I can weed as I go along, spending just two hours on it in the end. So in a system like that, it's not a problem. But if you have 30 hectares of carrots in monoculture, you have a real weed management problem. So either you hire an army of people and their work is degraded, because it's monotonous and hard work, often poorly paid, or you use technology.The political project is to install a million farmers and also to have this approach to work effort, to rethink work in a system that is certainly more complex, but also more humane. The priority is to get farmers settled and to ensure that they are properly paid on the basis of the price of their produce, i.e. a price that covers production costs, income and social protection.Inf'OGM - One of the criticisms of agritech that we often hear is that it's expensive...SG - Technology is never neutral, unless it emanates from a desire, from a farmers' collective. But this is never the case. In fact, the initiative for technique and technology always comes from the agro-industry and is put at the service of their profits. The aim of technology is to maintain a productivist system and guarantee profits and margins for the industry. It's a kind of vicious circle, since it also creates a dependence on mechanics or robotics and increases investment in farms. Yes, it's clear that all these new tools are costing farmers crazy amounts of money. Not only is there the initial investment, but also the running costs of these tools. As a result, their income is what it is, but it's also very closely linked to a price determined by the market and by the powerful. In fact, you find yourself trapped in a kind of proletarianisation of agriculture: you no longer really control your production tools. And we see it every day: over-investment creates unhappiness. It's another vicious circle: to recoup these investments, you also have to increase your productivity, increase volumes... This is where we come back to the problem mentioned earlier: it encourages the intensification and enlargement of farms... In the end, there are fewer and fewer people on the farms. All this contributes to the disappearance of farmers from the countryside.And this is nothing new! As the agronomist Marcel Mazoyer has shown, with each technical and technological revolution, a large number of farmers disappear. There's a simple reason for this: only those with the capital can access the new technology. So it's also a way of pitting farmers against each other in terms of access to techniques and technology.What's more, we're also forgetting one historical fact, which is that the advent of mechanisation was to the detriment of farmers and often even against their will. At the end of the [Second] World War, food production was completely balanced. It was really a desire for industrialisation that was put in place, not a desire on the part of farmers.Inf'OGM - But doesn't technology that improves productivity also improve farmers' incomes and lower prices for consumers?SG - And who benefits from increased productivity? You have to look closely at what a price is. In the price of a carrot, for example, the share of agricultural materials is not essential. The rest is linked to processing and distribution. At the Confédération paysanne, we believe that increasing productivity and lowering production costs in no way guarantees a better distribution of value. In fact, the problem of the price paid by the consumer also stems from the distribution of value between distributors and processors. And there is no guarantee that they are prepared to share this value. I don't see any direct correlation between lower [production] costs and lower shopping-cart costs. In any case, that's not what we're seeing. It's not a direct effect, in any case, until we have properly distributed the value between everyone and better controlled the margins of distributors and processors.Inf'OGM - So you're opposed to all forms of technology?SG - In the political project of the Confédération paysanne, there is this desire to control production tools, to reappropriate them and, therefore, to be at the initiative of these tools. In fact, we want the tools to be of real use to the farmers and to be thought out by them. So yes, we're getting closer to the project put forward by the Atelier paysan, which is a real political project for society and a real reflection on mechanisation. I'll say it again: technology is never neutral! That's a myth.I'd like to share a very personal reflection with you. I keep imagining what agriculture might have looked like today if we'd been able to limit tractor power to 60 horsepower. But just by doing this mental exercise, you can see very quickly that we could have maintained a completely different bocage, a completely different size of farm, a completely different type of production. The mastery of tools, of technical tools, is also the aim of agriculture. And that's a collective choice, one that must also and above all be made by farmers.Technology must be combined with a real reflection on the meaning of work and on the arduousness of work.I was also saying that mechanisation was neither desired nor organised by the peasants, but on the other hand, the peasants jumped on the bandwagon. Behind mechanisation was a promise of emancipation, particularly social emancipation. Farmers have always been somewhat downgraded and devalued by society. Mechanisation was modernity. In any case, this was the association that was made, that was promoted. It was also necessary to get people away from the animals. It's clear that on livestock farms, particularly in Brittany, people have gradually moved away from where the animals live. And this distance is a real cause of suffering.When you're a farmer, you're also motivated by this desire for intimacy or proximity with living things. And, on the contrary, this link with living things prevents the extractivist relationship with living things that agriculture has become. It's very complicated to create intimacy with your animals and at the same time over-exploit them.In concrete terms, all the people who are trying to re-create agro-ecological systems that take greater account of and have a better understanding of living things are gradually moving away from industrial farming. Bringing the emotional, the sensitive, back into the relationship that we can have in our profession as farmers inevitably distances you from the extractivist and exploitative relationship that we know in the agro-industrial world. In industrial pig farms, the animals are so treated as objects that we no longer talk about animals. We talk about weight, we talk about livestock units, we talk about indices, and so on. So there is a commodification of living things in the industrial context. Conversely, there is a reawakening of awareness of the link in the agro-ecological farming environment. Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [107] => Array ( [objectID] => 13490 [title] => Bioengineered poplars to save the climate? [timestamp] => 1748390400 [date] => 28/05/2025 [annee] => 2025 [url] => https://infogm.org/en/bioengineered-poplars-to-save-the-climate/ [image] => https://infogm.org/wp-content/uploads/2026/03/Schaerbeek_-_Placette_du_Peuplier_3-768x1024.jpg [extrait] => A few months ago, Living Carbon, a US start-up, announced that it had developed and planted genetically modified poplar trees in 2023. These trees are said to absorb more quickly carbon dioxide, one of the greenhouse gases whose current accumulation in the atmosphere and oceans is causing problems for the Earth's climate. As part of this program, Living Carbon is acquiring carbon credits to finance its work. The aim is to reduce the photorespiration of poplar and pine plants. What is photorespiration? What would be the ecological repercussions of this modification of photosynthesis? [chapo] => A few months ago, Living Carbon, a US start-up, announced that it had developed and planted genetically modified poplar trees in 2023. These trees are said to absorb more quickly carbon dioxide, one of the greenhouse gases whose current accumulation in the atmosphere and oceans is causing problems for the Earth’s climate. As part of this program, Living Carbon is acquiring carbon credits to finance its work. The aim is to reduce the photorespiration of poplar and pine plants. What is photorespiration? What would be the ecological repercussions of this modification of photosynthesis? [texte] => Based on evolutionary considerations about the fossilization of carbon that sequestered atmospheric carbon dioxide in the past, Living Carbon claims, in an article written by its co-founderi, that thanks to its start-up, in “three hundred million years from now, a similar story could be told about today; an era of carbon sequestration so massive the rocks will tell our story”. This refers to a time scale out of all proportion to the anthropogenic evolution of atmospheric carbon over the last 200 years.To reach this time scale, Living Carbon uses biotechnologies to genetically modify trees in order to increase their photosynthesis and thus subtract more carbon dioxide (CO2) from the atmosphere. On closer examination, we learn that the trees in question are the product of bioengineering combined with artificial intelligenceii. They are said to be “climate-intelligent”.Living Carbon also takes advantage of scientific knowledge to propose bioengineering solutions that reduce the decomposition and mineralization of carbon in the soil (which produce carbon dioxide) and, they claim, restore life to destroyed soils.Photorespiration of plants considered a “waste”In an articleiii written by researchers almost all working at Living Carbon, we read that “harnessing the power of synthetic biology to enhance the natural ability of carbon sequestration in plants, especially non-annuals, provides a biological approach to further reduce CO2 levels in the air. Here, we selected a photorespiration bypass pathway and tested its effectiveness on photosynthetic enhancement in a hybrid poplar, INRA717-IB4”.These INRA717-IB4 hybrid poplars were obtained in France, at Inrae in Versaillesiv. They were then donated by Oregon State University to the American start-upv. Engineering to reduce photorespiration will be applied to these plants.A few biological considerations [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [108] => Array ( [objectID] => 13389 [title] => Limagrain, a “cooperative” that has always bet on GMOs [timestamp] => 1747008000 [date] => 12/05/2025 [annee] => 2025 [url] => https://infogm.org/en/limagrain-a-cooperative-that-has-always-bet-on-gmos/ [image] => https://infogm.org/wp-content/uploads/2026/03/Limagrain-768x576.jpg [extrait] => Behind its label as an agricultural cooperative from Auvergne (France), Limagrain is now a global player in GMOs. The Group has been promoting GMOs for many years. Last March, its CEO, Sébastien Chauffaut, was optimistic about the forthcoming deregulation of GMOs/NGTs, which he hopes to market from 2029. Here's a look at Limagrain's GMO strategy, combining state privilege and lobbying. [chapo] => Behind its label as an agricultural cooperative from Auvergne (France), Limagrain is now a global player in GMOs. The Group has been promoting GMOs for many years. Last March, its CEO, Sébastien Chauffaut, was optimistic about the forthcoming deregulation of GMOs/NGTs, which he hopes to market from 2029i. Here’s a look at Limagrain’s GMO strategy, combining state privilege and lobbying. [texte] => Founded in 1965, the Limagrain agricultural cooperative has become a major player in the seeds industry: the world's fourth largest seed producerii and number one in vegetable seeds, thanks in particular to the acquisition of Vilmorin (1975) and Clause (1996). While cultivating an image of proximity and tradition, the cooperative has long been a pro-GMO advocate. This is hardly surprising, since in the 90s, Limagrain applied for patents relating to transgenesisiii. Limagrain's commitment to biotechnology goes back even further, with the creation of Biocemiv in 1986, then its participation in the creation of Biogemma in 1997, a plant biotechnology research company.A unique cooperative built with the StateIts creation by farmers from the Puy-de-Dôme region has helped Limagrain to build its image as a model of cooperative success. But the cooperative has undergone a metamorphosis over the years. With its seeds subsidiaries, its investment in biotechnological research and its international alliances, Limagrain now acts as a multinational company established in 53 countries on every continent. This transformation is reflected in its hybrid governance: on the one hand, a cooperative operation based on the participation of farmer-members, and on the other, a global industrial strategy that follows economic logic similar to that of large private companies.This trajectory has also been made possible by decisive support from the French governmentv. From the 1950s onwards, the INRA (France's National Research Institute for Agriculture, Food and Environment, now INRAE) - a public institution - worked closely with Limagrain to develop hybrid seed varieties adapted to the earliness of the northern hemisphere. This partnership led to the creation of LG11, the first maize hybrid to be included in the official catalogue in 1970.Backed by this public support, Limagrain has structured its growth around a model that integrates research (more than 100 centres), production, transformation and marketing. While the acquisitions of Vilmorin and Clause have made a major contribution to Limagrain's international development, it is its long history of acquisitionsvi that has enabled it to be present today on more than 90% of the world's surface area cultivated with cornvii. At the same time, Limagrain has tightened its grip on agricultural practices through a system of hybrid seeds (still under developmentviii) which cannot be resown, and very strict specifications imposed on its members. Limagrain has also strengthened its presence in the plant biotechnology sector by participating in the creation of Innolea in 2019, a new company dedicated to research into oilseed species, initially led by Biogemma. Innolea brings together three major players in plant breeding in France (Lidea Seeds, Limagrain and RAGT Semences) as well as the plant oil and protein innovation fund managed by Sofiprotéol. At the same time, through its subsidiary Vilmorin, in 2019 Limagrain acquired licensing rights for NGTs (Crispr-Cas 9 and Crispr Cpf1) as part of a strategic partnership with Corteva and the Broad Instituteix. These developments illustrate a significant evolution for Limagrain, whose historical activity as a traditional seed company is now expanding into biotechnological tools that are far removed from its original business. Although it was not originally a player in the chemical sector, Limagrain now has the ambition, when possible, to take over the sale of pesticides, particularly in connection with the development of NGTsx.We can also see that, with a view to diversifying its activities beyond seeds, Limagrain has, over time, invested in the agri-food sector by buying up several emblematic brands in the sector, such as Brossard, Jacquet and Crêperie Le Breton.A planned strategy of influenceFrom the beginning of 2010, Limagrain has been promoting GMOs obtained by "new" genetic modification techniques in the French and European decision-making arenas. Since then, following the example of the major seed multinationals, the company has been trying to convince as many players as possible that GMOs/NGTs should be distinguished from transgenic GMOs, with the aim of exempting them from Brussels regulations.In France, Limagrain signed up in February 2018 to the register of "interest representatives" of the “Haute autorité pour la transparence de la vie publique” (HATVP) (the High Authority for transparency of public life)xi. The company from Auvergne contacted the HATVP on several occasions on the subject of "NBT" (New Breeding Techniques, former name of NGT) and then NGT. On 9 October 2020, Limagrain approached the HATVP to "share its concerns about the consequences of the [french] Conseil d'État's decision of 7 February 2020", which required that VRTH (herbicide-tolerant varieties) obtained by "in vitro mutagenesis" comply with GMO regulationsxii.As part of its influence strategy, Limagrain contributes to public consultations, participates in expert panels, publishes opinion pieces and position papers, and more. In 2016, eight organizations, including the Confédération paysanne, France Nature Environnement and Greenpeace, suspended their participation in the “Haut Conseil des Biotechnologies” (HCB) – the High Council for Biotechnology - to denounce the seed industry's growing control of the Council and its lack of impartialityxiii. At the same time, a number of organisations were highlighting another weapon used by the multinational seed companies: semantics. By claiming that new genetic modification techniques do not result in GMOs and that they merely mimic natural mutations, the seed industry decided to stop using the term GMO. The Commission adopted this strategy until it was overturned by the CJEU in July 2018, and again in 2023.Limagrain is not content to simply act in France. The group is an influential member of Euroseeds, the seed industry's main lobby in Brussels. In 2022, during the consultation launched by the European Commission on NGTs, the majority of positive contributions came from such organisations or from experts linked to the industryxiv. In addition, some members of the GMO scientific panel of the European Food Safety Authority (EFSA) have had past links with Limagrainxv. The German association Testbiotech, for its part, has revealed that some of these experts have filed patentsxvi on plants derived from NGTxvii, a situation that fuels suspicions of conflicts of interest.Well-honed argumentsIn an appeal published in December 2023xviii, Limagrain Chairman, Sébastien Vidal, called on France to support NGTs, deeming them "essential to support the transition towards a resilient economy and a sustainable food system". The message was clear: "Far from the scarecrows that people are trying to conjure up, plants derived from NGTs are not "hidden GMOs" as some people claim: there is no introduction of foreign DNA". These are erroneous statements, but they are taken for granted in the agricultural press and in public speeches. In March 2025, in an interview with the Association Française des Journalistes Agricoles (AFJA), Limagrain's CEO, Sébastien Chauffaut, drove the point home by declaring: "seeds represent a major strategic lever: they are not limited to a productive role, but are part of a logic of power and influence".Limagrain uses arguments of efficiency, food sovereignty and competitiveness in the face of international competition. It's a line of argument that is sure to find favour with certain members of parliament and ministries, anxious to show their support for "French research" and food sovereignty.As AFJA points outxix, Limagrain has been using NGTs in research since 2017, and expects the first commercialisations in 2029 for wheat and maizei. It should be noted that Limagrain already markets wheat varieties tolerant to Clearfield herbicides, particularly in North America, where its subsidiaries in the United States and Canada offer wheat adapted to local conditions, in partnership with BASF.A multinational like any otherLimagrain's story raises a central question: is it possible to be a cooperative and lobby like a multinational? With its thousands of cooperative members, its international holdings and its political influence, the group embodies a hybrid form, that of a so-called cooperative controlling a multitude of industrial companies.Limagrain has become just another player in the agro-industrial complex, more concerned with protecting its market share than the interests of farmers. A striking symbol of this change is that its subsidiary Vilmorin, long the national emblem of traditional seeds, now also holds major patents on genetic modifications. For example, patent EP3629711 covering a resistance/tolerance trait to the brown tomato rough fruit virus (ToBRFV). Given the importance of this genetic trait for many tomato growers, this patent (or others) could, as the NGO No Patent on Seedsxx suggests, be opposed in order to defend the rights of such users of genetic resources.Presented by its supporters as a national champion with an international vocation, Limagrain is nonetheless required to be rigorously transparent about its often opaque lobbying practices. However, the multinational has recently chosen to free itself even further from such obligations by taking its subsidiary Vilmorin off the stock exchange, by buying back all its shares, which means that it can no longer publish details of its accounts.i Mouhamed Ben Diene, "Les semences ... de véritables armes diplomatiques", JA Mag, 19 March 2025.ii Limagrain, "Key figures for Limagrain’s 2023-2024 financial year and our businesses", 5 December 2024.iii INPI, Limagrain patent application FR2709496 of 30 August 1993, "Process for producing transgenic plants, fully transformed in T0 generation from meristems".iv Biocem's aim was to apply advances in biotechnology to seed improvement, particularly for maize and wheat, by developing better-performing, disease-resistant varieties.v Christophe Bonneuil and Frédéric Thomas, "Semences: une histoire politique. Amélioration des plantes, agriculture et alimentation en France depuis la Seconde Guerre mondiale", pp. 89-90, ECLM, 2012.vi Limagrain, "Bold and passionate for nearly 60 years".vii Fabien Benoît and Antoine Boureau, "Comment la coopérative Limagrain a bâti un empire des semences avec l'aide de l'État", Reporterre, 11 May 2024.viii In 2021, Limagrain published an article in the journal Nature describing the discovery of genes that could facilitate the creation of hybrid wheat:Melonek, J., Duarte, J., Martin, J. et al, "The genetic basis of cytoplasmic male sterility and fertility restoration in wheat", Nat Commun 12, 1036 (2021).This work is the subject of PCT patent applications: WO2019086510 dated 31/10/2018 and WO2020161261 dated 6/02/2020 covering the use of orf279, Rf1 and Rf3 in the control of male fertility in wheat for the production of hybrids.ix Chris Lusvardi, "Vilmorin & CIE Signs A New Agreement On Genome Editing Techniques With Corteva Agriscience and The Broad Institute," Seed Today, December 12, 2019.x "NGT, pesticides: Limagrain's roadmap", Agra Presse, 20 March 2025.xi The High Authority for Transparency in Public Life (HATVP) is an independent administrative authority (AAI) with a public service remit: to promote probity and exemplarity among public officials.xii HATPV, Limagrain (see "Action" tab)xiii Christophe Noisette, "HCB : une neutralité très relative sur le dossier des nouvelles biotechnologies", Inf'OGM, 10 March 2016.xiv European Commission, Consultation "Legislation for plants produced by certain new genomic techniques", April 2022.xv Charlotte Krinke, "AESA: une agence assez peu indépendante et transparente", Inf'OGM, 28 April 2023.xvi According to a search carried out on the Lens.org database, Limagrain holds 278 patent families, the first dating back to 1978.xvii Testbiotech, "NGT plant developers take over the EFSA GMO panel", 5 September 2024.xviii Pleinchamp, "NGT : le plaidoyer de Limagrain", 12 December 2023.xix Mouhamed Ben Diene, "Les semences ... de véritables armes diplomatiques", JA Mag, 19 March 2025.xx No patents on seeds, "Tomato (Jordan Virus)", 2024. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [109] => Array ( [objectID] => 13375 [title] => “Biotech Act” 2025: high-tech against farmers? [timestamp] => 1746576000 [date] => 07/05/2025 [annee] => 2025 [url] => https://infogm.org/en/biotech-act-2025-high-tech-against-farmers/ [image] => https://infogm.org/wp-content/uploads/2026/03/51875728325_842113f16b_c-768x544.jpg [extrait] => In 2025, the European Union is expected to adopt a "biotech act" aimed, among other things, at modernising agriculture through new technologies. At the same time, public policies, in particular the Common Agricultural Policy (CAP), are guiding farmers towards ever more expensive and sophisticated mechanisation. As a result, a “high-tech” and soil-less agricultural model is taking shape in Europe, with the risk of increasing farmers' indebtedness and marginalising small-scale farming. [chapo] => In 2025, the European Union is expected to adopt a “biotech act” aimed, among other things, at modernising agriculture through new technologies. At the same time, public policies, in particular the Common Agricultural Policy (CAP), are guiding farmers towards ever more expensive and sophisticated mechanisation. As a result, a “high-tech” and soil-less agricultural model is taking shape in Europe, with the risk of increasing farmers’ indebtedness and marginalising small-scale farming. [texte] => Beyond the European Commission's promises of innovation and competitiveness, the Biotechnology Act planned for 2025 will undoubtedly have a major impact on the European agricultural model. Commission President Ursula Van Der Leyen commented in July 2024: "this [initiative]will be part of a broader Strategy for European Life Sciences to look at how we can support our green and digital transitions and develop high-value technologies"i. However, by favouring digital solutions, and in fact biotechnological solutions rather than "green" ones, the Commission is accentuating the divide between large farms and small farms, while making farmers more dependent on technology.A law that worries...The "biotech act" of 2025, currently being prepared by the European Commission, is presented as a response to the climatic and economic challenges affecting agriculture. In a March 2024 communication, the Commission expressed its ambition to position Europe as a world leader in biotechnology. Margrethe Vestager, executive vice-president of the Commission, stated on this occasion: "We want to leverage Europe's clear scientific edge in biotech, and turn it into commercial success "ii. To achieve this, the Commission plans to raise awareness of these technologies, speed up access to funding via the European Innovation Council and put in place an appropriate regulatory framework (i.e. in layman's terms: less restrictive).Among the promises of these technologies are the creation of new disease-resistant varieties, the optimisation of yields thanks to NGTs (New Genomic Techniques), notably Crispr-Cas9, and the reduction in the use of chemical inputs. However, behind these promises lies a less ideal reality. Biotechnology, particularly because it is protected by patents, increases farmers' dependence on multinationals and threatens the very existence of farmers' seeds. What's more, the emphasis on digitisation and the "technologisation" of agriculture is pushing aside agro-ecological practices and solutions based on local know-how. This undermines sustainable agricultural models that are adapted to specific local contexts. This is particularly true of public support, such as that provided under the CAP, which is currently unevenly distributed. According to a report by France Stratégie, they should be redirected to give priority to supporting farms that adopt ambitious agro-ecological practices, such as organic farming. The idea is to align economic support more closely with environmental objectives, by rewarding farmers who limit their impact on nature while ensuring the long-term viability of their business. In France, the government is following a similar path by promoting digital agriculture, notably through the "Agriculture et Numérique" roadmap presented in March 2022, which aims to integrate digital technology as a pillar of the third agricultural revolutioniii. This policy includes tax incentives for the acquisition of connected equipment, as part of the France 2030 planiv. However, there is opposition to this approach. Farmers' unions, such as the Confédération paysanne, are voicing their dissatisfaction with policies that they believe are unfavourable to small farmsv.A CAP that drives people into debtAt the same time, public policies, in particular the CAP, are massively directing subsidies towards farms capable of investing in cutting-edge technologies: connected tractors, farm robots, drones and data analysis tools. These colossal investments are presented as necessary to improve productivity and make agriculture "intelligent"vi.But for many farmers, this race for technology comes at a price: debt. According to recent figures, the level of lending to the agricultural sector continues to rise. Between 2021 and 2022, for example, it rose by 13%vii. These financial burdens often force small farms to sell their land to industrial operators, reinforcing land concentration and speeding up the disappearance of family farms. This logic of industrialisation is pushing Europe even further away from small-scale, diversified agriculture.Disconnecting land and peopleThis new digital and biotechnological agriculture is also radically transforming the farming profession. Far removed from ancestral practices, farmers are becoming data managers, users of algorithms and robotised equipment. This gradual disconnection from the soil and nature poses a fundamental problem: can we really aspire to sustainable, robust agriculture by eliminating the direct link between man and his environment?From an environmental point of view, the consequences of such a disconnection can be dramatic. The intensification of industrial monocultures, favoured by these technologies, is accentuating soil degradation due to the increased use of chemical inputs and is leading to an alarming reduction in biodiversity. In 2020, a reportviiiby the French Ministry of Ecological Transition and Solidarity showed that between 2009 and 2018, pesticide use had increased overall. Sales of insecticides have increased by a factor of 3.5, fungicides by 41% and herbicides by 23%. To date, agricultural technological innovations have not demonstrated their ability to support agriculture that respects regional specificities and natural cycles.Alternatives for resilient small-scale farmingFaced with this technological headlong rush, there are alternatives. Agroecology, for example, offers practical solutions tailored to the challenges of climate change. Based on mixed farming, extensive livestock rearing and local know-how, it promotes sustainable, diversified and resilient agriculture.To support this model, public funding needs to be channelled towards farms on a human scale, short distribution channels and the promotion of farmers' seeds, rather than towards large-scale industrial farms. Some local initiatives, such as organic farming cooperatives and agroforestry projects, show that another path is possible.Finally, a strict framework for biotechnology seems essential to preserve people's food sovereignty. This means regulating patents, ensuring total transparency on environmental and health impacts, and genuine consultation with the public.Choosing the future of agricultureThe biotechnology 2025 act and current public policies are pushing European agriculture towards a technological, digital and industrial model that is far removed from soil and people. This theoretical model, disconnected from the realities on the ground, guarantees neither the future of European agriculture nor the preservation of the environment.Europe has a choice to make: to support small-scale farming that is rooted and resilient, or to persist in an above-ground approach dominated by technology and multinationals. This choice will determine not only the future of farmers, but also that of Europe's food sovereignty and environment. Reinventing agriculture can be done by means other than robots and GMOs, by drawing inspiration from the soil, nature and the people who have worked it for centuries.i European Commission, "Political guidelines for the next European Commission", 18 July 2024.ii European Commission, "Communication from the commission to the european parliament, the council, the european economic and social committee and the committee of the regions, Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU", 20 March 2024.iii Ministère de l'Agriculture, Dossier "Le numérique au service de la 3e révolution agricole".iv PACA Chamber of Agriculture, "Plan France 2030: a financial support scheme for the acquisition of innovative equipment", 12 April 2022.v Objectif Gard, "La Confédération paysanne démonstra le plan France 2023 de Macron", 19 February 2022.vi Ministry of Agriculture, "Launch of the France 2030 scheme to support investment by farmers "Equipment for the third agricultural revolution": a tool to promote food sovereignty and ecological planning", 1er March 2023.vii Novethic, "Faced with the profession's colossal debt, Coordination Rurale targets the banks", 29 January 2024.viii Ministère de la Transition écologique et solidaire, "Plan de réduction des produits phytopharmaceutiques et sortie du glyphosate: état des lieux des ventes et des achats en France en 2018", May 2020. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [110] => Array ( [objectID] => 13321 [title] => AI creates new legal challenges in the field of patentability [timestamp] => 1745366400 [date] => 23/04/2025 [annee] => 2025 [url] => https://infogm.org/en/ai-creates-new-legal-challenges-in-the-field-of-patentability/ [image] => https://infogm.org/wp-content/uploads/2026/03/31923281141_ac2023cd3e_c-768x512.jpg [extrait] => "Artificial intelligence" (AI) is used to extract and restructure information from raw or unstructured data. Companies are using it to identify phenotypic traits associated with genetic sequences. Referring to a recent patent application by the company Inari, the German NGO Testbiotech points out the risks associated with the combination of new genomic modification techniques (NGT) and AI. It condemns the possible abuses of patentability and the need for robust GMO regulations. However, Inari has already filed other similar applications, which raises questions about the legal impact of such rights and their adaptation to AI-driven technologies. [chapo] => “Artificial intelligence” (AI) is used to extract and restructure information from raw or unstructured data. Companies are using it to identify phenotypic traits associated with genetic sequences. Referring to a recent patent application by the company Inari, the German NGO Testbiotech points out the risks associated with the combination of new genomic modification techniques (NGT) and AI. It condemns the possible abuses of patentability and the need for robust GMO regulations. However, Inari has already filed other similar applications, which raises questions about the legal impact of such rights and their adaptation to AI-driven technologies. [texte] => The imperfectly named "artificial intelligence" is gradually overturning all sectors of research and development, including biotechnology, particularly genetic modification of genomes. In this context, intellectual property strategies must adapt to inventions whose genesis and logic are partly or entirely algorithmic. The patent application WO2023250505i by the US company Inariii , entitled "Prediction of effects of gene regulatory sequences on endophenotypesiii using machine learning", analysed by the NGO Testbiotechiv, is a revealing example of this trend. This article examines Inari's patent application in turn, while extending the reflection to the broader issues of AI in the field of patents.An ambitious technologyInari's patent application WO2023250505 concerns the identification of combinations of genetic modifications designed to improve agronomic traits. It focuses on the use of "machine learning models" to predict which combinations of mutations are most likely to produce a desired effect. This approach exploits the ability of AI to rapidly explore different genetic hypotheses.More specifically, Inari's patent application would give it a monopoly on numerous methods for identifying small regulatory units in plant genomes (without restriction to a particular plant species or agronomic trait) by exploiting genetic databases, including public ones, such as those hosting DSI (digital sequencing information). These units are, for example, promoters for the transcription of DNA, RNA or enhancers to which gene activating proteins are attached. These regulators are then used to form "machine learning models" capable of identifying, on a genome-wide scale, genetic variants that could be of interest in varietal selection.However, at the current stage of a simple patent application (and not a granted patent), Inari will still have to demonstrate that its invention meets the requirements of current legislation, which does not normally allow the granting of patents that are overly broad or relate to subject matter excluded from the scope of patentability. Obtaining protection as broad as Inari's stated technological ambitions is therefore a challenge.Unclear and uncertain protectionThe claims of Inari's patent application WO2023250505 are drafted in very broad and speculative terms, making the scope of the intended protection uncertain and legally imprecise. If we take the first claim of the patent applicationv as an example, it contains rather functional (as opposed to "structural") and very general terms, such as "machine learning models" - i.e. algorithms - and "prediction of effects". Similarly, the expression "gene regulatory sequences", which are to be used by said learning model, is also functional and has a very broad meaning. Such claim wording is therefore intended to protect any process "for modifying an endophenotype type in a plant", regardless of the automatic learning model or the regulatory sequence, and for predicting indeterminate effects. Although the claims of a patent must be read in the light of the description provided therein, the language used by Inari creates a form of opacity, making the interpretation of this claim complex. Similar comments can be made about other claims in the patent application, the exact scope of which remains difficult to assess or justify.The uncertain nature of the protection associated with this Inari patent application is also due to other facts. According to the EPO register, patent application WO2023250505 is "deemed withdrawn"vi, Inari having failed - whether voluntarily or not - to comply with a procedural step, resulting in a loss of rights. Although these rights can be reinstated, Inari does not seem to be very diligent to support this case, since it has limited the territory of its rights to Europe, Canada and the United States. One of the reasons for this may lie in the fact that the preliminary examination of the international application carried out by WIPO raised objections in terms of novelty and inventive step. In addition, the fact that the patent application refers to "artificial intelligence" means may be assessed differently by national jurisdictions and thus influence Inari's territorial protection strategy.A patent portfolio dedicated to an AI-based platformInari also holds several other patent rights, particularly in Europe. This is the case for European application EP4018450, entitled "Processes and systems for evaluating genetic variants" and filed on 21 August 2020. Although it does not explicitly mention "artificial intelligence", this application concerns the use of IT tools to select and predict the effects of genetic variants using databases incorporating a number of genetic variants of organisms. According to a search of the Lens database, Inari holds nearly forty patent familiesvii using IT tools for predictive purposes in the field of genomics. Inari's policy is in line with its desire to protect the technological foundations of its SEEDesign™ platform. It defines it as a device capable of "exploiting recent advances in genomics, artificial intelligence and multiplex gene editing [editor's note: on several genes] [...] to deliver transformative improvements in yield and resource use efficiency".This proliferation of patent rights by Inari suggests an ambitious, even aggressive, strategy of technological appropriation, whereby the company seeks, via its proprietary platform, to lock in the use of approaches combining genomics, AI and genetic modification. However, this dynamic raises a fundamental question: to what extent does AI contribute to the technical nature of Inari's “inventions”, as required under French law? Is there a qualitative inventive leap? According to the EPO, "patents can be granted when AI goes beyond the abstract domain of mathematical algorithms and computer models and is used to solve a technical problem in a technological field". If Inari limits itself to using AI to screen genetic combinations according to pre-existing or already known criteria, can it still be considered a genuine invention within the meaning of patent law?The question would arise less if the same French and European legislation were strictly applied, which also requires that the claims defining the technical means used by the invention be "clear and concise". This would be the case, for example, by specifying in the claims the "regulatory sequences" enabling the result sought by the process in patent application WO2023250505 to be achieved.Framing patentability in the age of AIThe emergence of "artificial intelligence" in the research and innovation process therefore calls for a more precise definition of certain fundamental criteria of patent law. When the invention comes from an algorithm capable of exploring an immense number of genetic variants, for example, can we still talk about inventive activity in the legal sense? The line between discovery and invention, which is often difficult to draw in the life sciences sector, becomes even more blurred. This context could justify re-examining the criterion of inventive step, in particular so as not to attribute excessive protection to results derived mainly from calculations, whether automated or not. It is not enough for the results of these calculations to remain unverified for those who implement the algorithms to have an inventive step. On the contrary, the fact that the results of these calculations have not been verified implies a subsequent selection process, which is not patentable, even if it is assisted by markers or AI.However, since the various patent systems have now generally incorporated "artificial intelligence"viii, safeguards should be maintained and new ones provided (transparency of applications involving AI, publication of source code, access to training data, etc.). There should also be a clear definition of what constitutes an AI-based process that is effectively patentable, and a clear distinction between this and subsequent stages that are essential to the industrial development of the invention but are not patentable, such as selection. In the absence of these elements, there is a high risk that patents will be granted for objects that cannot be verified or even reproduced, in contradiction with the fundamental principles of patent law.In the agri-food sector, the uncontrolled appropriation of patent rights resulting from "artificial intelligence" would dramatically affect access to plant genetic resources, such as seeds, for small and medium-sized breeders and farmers. Over and above Testbiotech's protests, other civil society organisations, such as ECVC (European Coordination Via Campesina), are sounding the alarm about the need to ban patents in the field of life and the urgent need to at least limit their scope in order to prevent excessive appropriation, which is legally questionable and contrary to the principles of food sovereignty and biodiversity.Case law on AI as "inventor"Artificial intelligence" calls into question the very notion of inventor, as international case law has shown. Several rulings have attempted to clarify the place of AI in patent systems, with sometimes divergent approaches, notably around the case of DABUS, an AI system created by Stephen Thaler who is said to have designed two inventions: a plastic food container based on fractal geometry and an alert device based on a light signal (or "neural flame") triggered in the event of an emergency.In 2019, two patent applications filed with the EPO named DABUS AI as the inventor. The EPO rejected them in 2020, taking the view that an inventor must be a natural person, a position upheld on appeal in 2021ix. The Office does not rule out the use of an AI in the invention process, but requires that a human always be named as inventor.In the US, the Court of Appeals for the Federal Circuit ruled in 2022 that, under the US Patent Act, only a human can be designated as an inventorx. The DABUS machine, developed by Stephen Thaler, which was the subject of 2019 patent applications, could not therefore be recognised as such. A similar position was adopted in the UK in 2021, with the Supreme Court confirming that the Patents Act 1977 requires an inventor to be a natural person, effectively excluding "artificial intelligence" systemsxi.In 2024, the German Federal Court of Justice (Bundesgerichtshof) ruled that it was possible to patent an AI-generated invention, provided that a human person was designated as the official inventor. This implicit recognition of the role of AI in the inventive process is, however, accompanied by a formal requirement of human activityxii.Finally, South Africa has broken new ground by becoming the first jurisdiction to recognise an AI as an inventor, by accepting the patent application filed on the DABUS system in 2021xiii. This decision was widely publicised and represents a major departure from traditional patent law doctrine, although it has not yet been followed by other major jurisdictions.iOMPI, "PCT application WO2023250505 - Prediction of effects of gene regulating sequences on endophenotypes using automatic learning", filed 23 June 2023 by Inari, 28 December 2023.iiInari Agriculture is a biotechnology company based in Cambridge (Massachusetts, USA), which uses artificial intelligence and the new techniques of genomic modification (NGT) to “design seeds for a more sustainable global food system”.iiiAccording to the French National Academy of Medicine, an endophenotype is "a measurable, heritable biological or psychological characteristic associated with a gene and a disease (whatever the stage of the disease) that is found in family members not affected by the disease".Dictionnaire médical de l'Académie de Médecine, "endophenotype", 2020.ivChristoph Then, "Could just one NGT company take control of all plant breeding?", Testbiotech, 11 February 2025.vPatent application WO2023250505 / Inari Agriculture; Claim 1 :" 1. A method of modifying an endophenotype in a plant, the method comprising, by one or more computing devices:obtaining a plurality of gene regulatory sequences;inputting the plurality of gene regulatory sequences into a machine-learning model trained to obtain a plurality of effect predictions corresponding to a plurality of endophenotypes;selecting one or more desired endophenotypes based on the plurality of endophenotypes;selecting a gene regulatory sequence in accordance with the one or more desired endophenotypes, andintroducing the selected gene regulatory sequence into the plant, thereby modifying the endophenotype of the plant."viRegister of the European Patent Office, "Notification of loss of rights (rule 112.1) for patent application WO2023250505", 14 February 2025.viiA "family" covers several patent applications filed in different countries based on the same invention.viiiOMPI, "Generative Artificial Intelligence", 2024.ixEPO, "Artificial intelligence cannot be named as the inventor in a patent application", 6 July 2022.xJohn Villasenor, "Patents and AI inventions: Recent court rulings and broader policy questions", Brookings, 25 August 2022.xiJenny Gibbs and Katie Simmonds, "Supreme Court confirms AI cannot be an inventor under the Patents Act", Womble Bond Dickinson, 16 May 2024.xiiUniversity of Surrey, "German court allows patents for AI-generated inventions", 4 July 2024.xiii"Recent Developments in Artificial Intelligence and IP Law: South Africa Grants World's First Patent for AI-Created Invention", The National Law Review, 3 August 2021. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [111] => Array ( [objectID] => 13304 [title] => “Artificial intelligence” to digitize genomes [timestamp] => 1744934400 [date] => 18/04/2025 [annee] => 2025 [url] => https://infogm.org/en/artificial-intelligence-to-digitize-genomes/ [image] => https://infogm.org/wp-content/uploads/2026/03/7096373457_eb135cfd0c_o1-768x576.jpg [extrait] => The digitization of living organisms is the subject of a growing number of projects. Computer data, generated and stored in ever-larger “data centers”, are used by “artificial intelligence” matrices. These data are of all kinds: genetic sequences, proteins, etc. In these fields, which require increasing natural resources, investments are multiplying. [chapo] => The digitization of living organisms is the subject of a growing number of projects. Computer data, generated and stored in ever-larger “data centers”, are used by “artificial intelligence” matrices. These data are of all kinds: genetic sequences, proteins, etc. In these fields, which require increasing natural resources, investments are multiplying. [texte] => The use of computer algorithms, brought together in real factories, to exploit ever-increasing amounts of information is one of the topics of the year 2025. Inaccurately named “artificial intelligence”, these computer factories require ever-larger computer servers, which in turn consume increasingly problematic water and energy resources. But it is above all their use in the digitization of living organisms that deserves a closer look for those following the GMO dossier. At a time when multinationals are stepping up their efforts to appropriate living organisms, in what way are these algorithms becoming tools of monopolization?Exponential growth in the amount of data to be generated and processedSince 2008, the Earth BioGenome Project aims at sequencing the genomes of the 1.84 million known eukaryotic species (organisms with cells possessing a nucleus), out of the estimated 12 to 15 millioni. The cost? At least five billion dollars... When you consider that, by December 2024, the genomes of 3,039 species had been sequenced, the initial target of 10 years seems a tall order. But the ambition for sequencing is there, and the amount of data expected is staggering. In a report published in January 2025ii, the organization Save our seeds gives several telling figures. The sequences of 13.8 million proteins from 342 different plant species are stored in a computer database created by university researchers and named PlantMWpIDB. Another public database, PlantExp, contains the sequences of 131,400 transcriptomes, i.e. all the RNA molecules identified in a genome. Another database, Pmhub, contains descriptions of 188,837 plant metabolites. These figures are given as examples. Having an idea of the total amount of information generated and stored is impossible. For the ABS Biotrade project, the observation is that “the sequencing of genetic information became such a common practice in all fields of biological sciences that it led to an enormous amount of information being generated and stored every day”iii.From a technical point of view, the generation of this data has been made possible by the lower cost and increasing speed of sequencing methods. As Save our Seeds details in its report, the first sequencing of a complete genome, that of Arabidopsis Thaliana, published in 2000, required 10 years' work at a cost of $100 million. 25 years later, in 2025, sequencing the genome of a plant will take just one week, at a cost of less than $1,000. In addition to these sequencing methods are the so-called “omics”, which study all types of molecules present in a cell: protein and RNA are two examples. The aim of several companies today is to draw up a map of the molecules produced and present in a cell, a sort of “Google Map of plants”, as Save our Seeds calls it. In 2021, a conference on the first plant cell atlas brought together 500 representatives from governments, research institutes and companies such as Bayer, Google and Syngenta.Energy- and water-hungry technical capabilitiesTo process this growing quantity of data and to fulfil the tasks required, algorithms need hardware, energy and water. The numbers here take on a dimension that is hard to fathom. If we take the example of Elon Musk's company, xAI, which claims to “accelerate scientific discovery”, its Colossus server, based in Memphis (USA), has requirements that have rarely been met. These servers run on 100,000 processors supplied by Nvidia. These 100,000 processors on the Colossus server require the equivalent of 150 megawattsiv /hour to operate, equivalent to the needs of 100,000 homes for the same duration. To obtain this amount of energy, xAI's server is currently powered by methane-fuelled turbines. For the years to come, players in the field are working on mini atomic power plants. In France, EDF has launched a subsidiary, Nuward, to design and build such reactorsv in 2023.Energy is not the only problem to be solved. These servers, like all IT installations, need to be cooled continuously. To do this, the water requirements are also staggering. If we look again at the xAI server, it requires over 3.5 million liters of water per dayvi. Relative to the population of France, for example, this corresponds to the average daily consumption of over 22,300 peoplevii... And in the autumn of 2024, xAI announced plans to double the size of its Colossus server.GAFAM mobilizedThe amount of “omics” or sequence data is set to grow exponentially. The Earth BioGenome Project is mobilizing more than 60 projects worldwide, on land and at sea, to take samples of organisms and sequence as many, if not all, of the molecules making up these organisms as possible. The data will then be stored in computerized form on servers. For some years now, the term “digital sequence information” (DSI) has been used for all data concerning molecular sequences (DNA, RNA, proteins, etc.). This “digitized” status is at the root of current attempts by multinationals to evade international texts such as the Convention on Biological Diversity (CBD), which aims to protect biodiversity. It also opens the door to the possibility of patents for inventions using ISDs as raw material, but which, once obtained, will be extended by their holders to the physical matter making up biodiversity.Several cases illustrate that private algorithms are increasingly being used to feed off this digital data, in particular to imagine genetic modifications that multinationals' laboratory researchers would like to implement, as we'll see in a forthcoming article. For several years now, IT companies have been mobilized at the crossroads of algorithms and biotechnologies. A reportviii published in September 2024 by the African Center for Biodiversity, ETC Group and Third World Network, for example, details that Google, Microsoft, Amazon and Nvidia have invested in and developed projects concerning the Living. For example, Google has set up a company with Gigko Bioworks to create new proteins using its Google DeepMind algorithms. Amazon founder Jeff Bezos, meanwhile, has invested $100 million via the Bezos Earth Fund to create new proteins using his algorithms.Growing investmentsIn recent years, the development of the computing capacity to run these algorithms has been the focus of a growing search for funding. As the latest example, on February 11, 2025, the European Union launched an initiative to raise 200 billion euros for investment in this field. According to JP Morgan, over $1,000 billion could be invested between 2024 and 2027ix. At the crossroads of informatic and biotech, investments are also substantial. While the fields concerned range from molecules used in medicine to genetically modified plants used in agriculture, agri-food, agrofuels... the value of the biotech market was estimated, in 2023, at 1,500 billion dollarsx.At a time when the European Commission has been proposing to deregulate many GMOs since 2023, the emergence of this (mis)named “artificial intelligence” technology appears to be a complete shift in the existing technical paradigm. The very landscape of the multinationals involved in the agri-food chain could continue to be turned upside down in the years to come. As for citizens, their place in this technological choice is, for the moment, that of mere spectator, when they are not themselves suppliers of personal data.i Eric Meunier, « The genome of 1.8 million species is being sequenced », Inf'OGM, 11 December 2024.ii B. Vogel, « When chatbots breed new plant varieties », Save our seeds, January 2025.iii ABS Capacity Development Initiative, BioInnovation Africa and ABioSA, « Digital Sequence Information on Genetic Resources ».iv Magna, « Elon Musk’s xAI Receives Approval For 150MW, Allowing 100,000 GPUs To Operate Simultaneously », AI Secret, 27 November 2024.v Kevin Champeau, « Pour accélerer son mini réacteur nucléaire, EDF lance une nouvelle filiale », Révolution Énergétique, 10 April 2023 (in French) .vi Magna, « Elon Musk’s xAI Receives Approval For 150MW, Allowing 100,000 GPUs To Operate Simultaneously », AI Secret, 27 November 2024.vii Misitia Ravaloson, « Consommation moyenne eau : estimation par personne et usage », Selectra, 9 August 2024 (in french).viii African Centre for Biodiversity (ACB), Third World Network (TWN) and ETC Group, «‘Black Box’ Biotechnology – Integration of artificial intelligence with synthetic biology », September 2024.ix Karen Ward et al. , « AI investing: More broadening than bubble », J.P. Morgan, 19 November 2024.x Monica Johnson, « The Outlook for Global Biotechnology: AI Expected to Drive Market Growth », International Banker, 6 December 2024. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [112] => Array ( [objectID] => 12494 [title] => The European Union discusses its definition of a GMO [timestamp] => 1744761600 [date] => 16/04/2025 [annee] => 2025 [url] => https://infogm.org/en/the-european-union-discusses-its-definition-of-a-gmo/ [image] => https://infogm.org/wp-content/uploads/2026/03/e1f20f0c-e294-4350-ac2b-8371b01564f3-768x512.jpg [extrait] => At the end of 2024, the Netherlands initiated a process of reflection on the meaning to be given to the legal definition of a GMO, discussing the definition word by word, expression by expression. A purely intellectual exercise? Far from it! The result of this work could change the way the definition of a GMO is read... without changing the definition itself. The expected outcome of these reflections is, of course, a lighter regulatory framework. [chapo] => At the end of 2024, the Netherlands initiated a process of reflection on the meaning to be given to the legal definition of a GMO, discussing the definition word by word, expression by expression. A purely intellectual exercise? Far from it! The result of this work could change the way the definition of a GMO is read… without changing the definition itself. The expected outcome of these reflections is, of course, a lighter regulatory framework. [texte] => There are many fronts against the current European regulation of GMOs. In July 2023, the European Commission proposed the deregulation of a large number of GMOs. In 2025, it could propose a “biotechnology law” aimed at simplifying existing regulatory frameworksi. But these projects are not the only dynamics underway. While Inf'OGM has already listed the various legislative projects launched by the European Commission since 2023ii, a new, more unexpected subject was put on the table by the European Union on December 11, 2024.Semantics as a political issueIn December 2024, a meeting of the Regulatory Committee of Directive 2001/18 was held in Brussels, bringing together representatives from EU member statesiii. On this occasion, the Netherlands presented a study on the interpretations given by each State to the current definition of a GMO, including a GM micro-organism (GMM). The definitions are set out in two European legislative texts: Directive 2001/18 and Directive 2009/41.Directive 2001/18 defines an organism as “any biological entity capable of replication or of transferring genetic material”. Hence, a GMO is “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”.With regard to GMMs, Directive 2009/41 defines a micro-organism as “any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture”. A GMM is defined as “a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”.On its own initiative, the Dutch government commissioned a private service provider, Perseus, to produce a report on member states' interpretation of this definition. The results of this study were presented to the member states on December 11, 2024, and published online on January 20, 2025iv. According to the summary of December 11, 2024, Perseus identified “certain challenges linked in particular with new scientific and technical developments”. On this basis, the Netherlands considers that discussions should be initiated at European level. The aim of these discussions would be “to exchange views and align approaches in the application of the GMO definition”. The same meeting minutes indicate that this Dutch proposal has received the support of “certain member states”, without specifying which ones. If necessary, the regulatory committee for Directive 2001/18 will be the forum for these discussions, according to the European Commission.Word by word, phrase by phraseTo carry out its study, Perseus received contributions from 17 member states, who responded on their interpretation of the definitions of GMO and GMM. These member states are: Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Ireland, Lithuania, Luxembourg, Latvia, Romania, Slovenia, Spain and Sweden. Without going into an analytical commentary, Inf'OGM reports here on the responses received to a number of terms in the two definitions.The term “genetic material”, present in both definitions, obviously concerns DNA and RNA, but “could also concern other molecules [editor's note: without specifying which], even synthetic ones”. An important potential inclusion, notably in the field of vaccines or plant treatment, “the injection of small interfering RNAs or messenger RNAs” into the body of a host (human or not) might not be considered as a transfer of genetic material, thus not resulting in a GMO.The expression “has been modified” is subject to two different interpretations, with fairly clear issues at stake. For some respondents, it implies that all the offspring of a GMO are also GMOs. But others considered, conversely, that the offspring could be considered non-GMO.An important phrase in both definitions is “in a way that does not occur naturally”. Perseus reports having observed two different readings of this expression. The first is that it refers to “the technique which is different from a natural way of mating and/or natural recombination”. The second states that the genetic modification obtained could not be obtained naturally or by recombination. Both readings are considered possible by the responding states.Can human beings be GMOs?It would not be wrong to assert that, since 2001, human beings cannot legally be considered as GMOs, as the definition seems quite clear on this point. From this would follow the understanding that human beings cannot be the subject of genetic modification. But the responses received on this point are surprising, to say the least. The report states that several states have replied that human cells and tissues can be considered GMOs if genetically modified. One of the explanations given is that human cells, like human tissues, are not “human beings” in the strict sense of the term.Concrete cases were also presented to member states, involving various genetically modified bacteria or viruses. As these are micro-organisms, Inf'OGM will go into more detail on these cases in a future article. Work on the semantic interpretation of these definitions - GMOs and micro-organisms - could therefore begin later this year. The results of this work could be decisive, since they concern current legislation on GMOs and the proposed deregulation currently under discussion. With a view to a possible new interpretation to feed the current political will to lighten the regulatory framework for biotechnologies.i Denis Meshaka, « The European Commission wants its “biotech revolution” », Inf'OGM, 19 February 2025.ii Eric Meunier, « The European Commission’s legal initiatives on the Living », Inf'OGM, 13 November 2024.iii European Commission, DG Sante, « Regulatory Committee 2001/18/EC », 11 December 2024.iv Government of the Netherlands, « Interpretation of the GMO definition in EU Member States », 20 January 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [113] => Array ( [objectID] => 12475 [title] => Reproducibility of biotechnological inventions [timestamp] => 1744329600 [date] => 11/04/2025 [annee] => 2025 [url] => https://infogm.org/en/reproducibility-of-biotechnological-inventions/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => At the European Patent Office (EPO), one of the key principles for patentability of inventions is that the invention must be described in sufficient detail for any “person skilled in the art” to be able to reproduce it. In biotechnology, where living systems are manipulated, this requirement poses a particular challenge. The notion of "reproducibility" of the invention thus becomes an essential criterion, which can take on different meanings depending on the context. This article explores the subject of the reproducibility of biotechnological inventions according to the practice of the EPO, in particular the case law of its Boards of Appeal. [chapo] => At the European Patent Office (EPO), one of the key principles for patentability of inventions is that the invention must be described in sufficient detail for any “person skilled in the art” to be able to reproduce it. In biotechnology, where living systems are manipulated, this requirement poses a particular challenge. The notion of “reproducibility” of the invention thus becomes an essential criterion, which can take on different meanings depending on the context. This article explores the subject of the reproducibility of biotechnological inventions according to the practice of the EPO, in particular the case law of its Boards of Appeal. [texte] => Biotechnology poses challenges in terms of patentability, particularly with regard to the requirement of sufficient disclosure. Unlike mechanical or chemical innovations, biotechnological inventions involve complex and unstable living systems, making their reproducibility uncertain. This raises the question of the appropriateness of this requirement for living organisms and the justification for patents on inventions that are insufficiently described, including those based on processes with unpredictable results, such as mutagenesis, described by some as "random". Reproducibility may relate to the technical execution or validation of the claimed effects, and its absence may lead to the rejection or invalidation of a patent.This article addresses the issue of the reproducibility of inventions in the field of living organisms according to the European Patent Office (EPO), whose practice is consistent with the principles of Directive 98/44 on the legal protection of biotechnological inventions (see box).What is meant by "reproducibility" in patent law?Although the notion of "reproducibility" of an invention is not explicitly mentioned in the European Patent Convention (EPC)i, it is implicitly targeted by Article 83 EPC and recognised in case law and EPO guidelines as an implicit condition of sufficiency of description. This concept can cover at least two different aspects.Reproducibility is first and foremost a direct consequence of Article 83, which states that "an invention shall be disclosed in the European patent application in a clear and complete manner so that it can be carried out by a person skilled in the art", without excessive experimentationii. This fundamental legal requirement aims to ensure that the monopoly conferred by a patent is justified by a genuine contribution to the state of the art and is not limited to a mere idea that cannot be put into practice.Reproducibility can also be understood as the ability to obtain identical results, guaranteeing that the invention generates stable and predictable effects, a particularly crucial criterion in biotechnology. However, in this field, these two requirements are put to the test by biological variability and the fact that certain processes are not fully controlled. An invention may be technically feasible, but with fluctuating “results”, making patentability more uncertain.Technical implementation of an inventionThe requirement in Article 83 EPC for sufficient disclosure of the invention to enable it to be put into practice without excessive experimentation remains subjective, leading to varied interpretations and a wealth of case law, which can be illustrated with examples.In its decision T 617/07iii, the EPO held that a patent on "monoclonal antibodies and synthetic and biotechnological derivatives thereof", defined by structural and functional characteristics, was valid, as the person skilled in the art "could produce variants of antibodies meeting the functional criteria indicated in the claim, using a possibly lengthy but simple procedure". Conversely, in T 727/95 (Cellulose/Weyershaeusr)iv, the Board of Appeal held that a claim defining Acetobacter micro-organisms by their ability to produce cellulose covered not only the strains filed but also others with similar characteristics. However, the invention was not reproducible throughout the claim without unreasonable effort, as the patent did not make it easy to identify or obtain all the variants covered, thereby compromising the sufficiency of description required by Article 83 EPC.In June 2021, in decision T 420/19 (Barley derived beverages/Carlsberg)v, the EPO Board of Appeal referred to this decision T 727/95 to assess the reproducibility of a method based on the technique sometimes referred to as "random mutagenesis" (in this case by irradiation or chemical means) for identifying barley mutants. The Board considered that, unlike in case T 727/95, the claimed method consisting of randomly inducing mutations in barley seeds and then using a rapid screening method to screen the mutants obtained in generation M3 using the technique described in the patent was reproducible “without undue burden”. According to the Board, the person skilled in the art knew from the information in the patent that the barley plants contained the MMT gene to be inactivated in order to obtain the desired phenotype, and also knew the probability of obtaining a relevant mutation.However, case law relating to Article 83 EPC also seeks to distinguish between sufficient disclosure and strict reproducibility. Thus, an invention may be considered to be sufficiently described even if there are minor variations in the results obtained, provided that these variations do not call into question the technical core of the invention. This is what the EPO said in its decision T 292/85 (Polypeptide expression/Genentech): "an invention (here biological) is sufficiently disclosed if at least one way is clearly indicated enabling a person skilled in the art to carry out the invention. In assessing whether or not the disclosure is sufficient, it is therefore irrelevant that, in the case of an element of the invention defined in terms of function, certain particular variants are not available or that certain other unspecified variants are not suitable, provided that the person skilled in the art knows, from the disclosure of the invention or from general knowledge common in his technical field, suitable variants producing the same effect for the invention. It is not necessary for the disclosure to include specific indications on how to obtain all the possible variants of an element covered by the functional definition".Reproduction of "results”The main objective of those drafting patent applications is to establish a legal framework guaranteeing the widest possible monopoly on an invention, and to achieve this they employ a variety of approaches and even tricksvi. Patents are therefore not scientific documents in the traditional sense of the term, but legal documents often based on one or more scientific publications, particularly in the biotechnology sector. In addition, patents are not assessed by scientific peers (peer review) but by an examiner from a patent office. The fundamental principle of the validity of a scientific result, reproducibility "all other things being equal", guarantees that experimental results can be obtained consistently by different operators under the same conditions. However, a patent examiner cannot assess this reproducibility in the same way as a committee of scientific peers.In the case of a process invention, the question of reproducibility may arise for the process itself or for the resulting product. In the biotechnology sector, mutagenesis, known as "random" mutagenesisin the scientific world, is an interesting illustration. Behind this name lie techniques that use ionising radiation (X-rays, gamma rays, UV rays, etc.) or chemical compounds to induce genetic mutations in plants or cell cultures, which are then selected according to the new characteristics that emerge. The EPO considers it to be a technical process, and therefore patentablevii. While the so-called "random" "basic" mutagenesis technique is no longer patentable (because it is not new), new "parameterisations" of this technique could make it new, or even inventive, and therefore patentable: new types of ionising radiation, use of particular frequencies or new chemical compounds that induce specific mutations, etc. in a way that is sufficiently reproducible to be susceptible to industrial exploitation, and therefore legally non-random. A "person skilled in the art" could then reliably reproduce this technique, this process, by precisely applying these parameters. However, no so-called "random" mutagenesis process currently offers this quality of reproducibility.This reproducibility of the process does not necessarily apply to the resulting product, a fortiori in the case of so-called "random" mutagenesis. The product resulting from a process that randomly modifies a genetic sequence would therefore have to show random modifications in its genetic sequences, and could therefore not be clearly defined, as required by Article 84 EPC. However, the arrival of the new genomic techniques (NGT) has changed the situation. While continuing to use "random" mutagenesis, the agro-industry may be granted patents on products that it claims to have obtained via NGTs, while it may have used NGTs a posteriori to artificially reinforce the technical perception of the "invention". But, here again, while these NGTs, such as Crispr/Cas 9, are described as "targeted" or "directed", they offer only relative reliability, by making precise nucleotide modifications, but at random in the genome.Complex biological systemsAccording to Rule 31 EPC, " if an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in the European patent application in such a manner as to enable the invention to be carried out by a person skilled in the art, the invention shall only be regarded as being disclosed as prescribed in Article 83 if: (a) a sample of the biological material has been deposited with a recognised depositary institution on the same terms as those laid down in the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28 April 1977 not later than the date of filing of the application..."viii. Also, according to the EPO's guidelines, "for living matter to be patentable, it must be possible to reproduce it in a way that has exactly the same technical features. Reproducibility can be assured: 1) by a deposit of the living matter... 2) by disclosing in the application as filed the gene sequence responsible for the claimed trait." ix.While it is easy to describe a gene sequence in a patent application in order to reproduce it, this is not the case for "living matter", complex and variable biological systems that are difficult to describe in textual form in order to reproduce them. This is the case, for example, with micro-organisms, which include bacteria, fungi, yeasts, viruses and specific cell lines such as hybridomas, etc.To overcome this problem of sufficient description/reproducibility of the "living matter" described in a patent, a system for depositing biological material was set up under the Budapest Treatyx, administered by WIPO (World Intellectual Property Organisation). This Treaty, which covers more than 90 countries, allows patent applicants to deposit a sample of biological material with an "International Depositary Authority" (IDA), such as the Institut Pasteur in France, the DSMZ in Germany or the ATCC in the United States. This material can be consulted and used by other researchers to ensure that the invention is put into practice, even after the patent has expired. Above all, it can also be used by the patent holder who wishes to pursue possible infringements of his invention.On 8 March 2021, EPO decision T 1045/16 (Melon resistant virus/Monsanto) confirmed that the deposit of biological material is an essential condition for meeting the requirement of sufficiency of description, even where the biological material is already known and publicly available. In this case, although the melon variety PI313970 was publicly available, the Board considered that this did not guarantee that the biological material would remain accessible throughout the term of the patent. Thus, without filing in accordance with the requirements of Rule 31(1) EPC, the invention was not considered sufficiently disclosed under Article 83 EPC.Reproducibility and uncertain monopoliesThe reproducibility of biotechnological inventions poses major challenges, both for the adequacy of the description and for the assessment of infringement. For example, the biological material deposited is not always stable, although this is necessary to ensure the feasibility of the invention. By way of illustration, spontaneous mutations in hybridomas can affect the production of antibodies, complicating their industrial exploitation. Decision T 418/89 (monoclonal antibody/Ortho Pharmaceutical Corporation)xi clearly evokes these difficulties: the monoclonal antibodies produced by the hybridoma filed differed from those claimed in the patent, making their reproduction uncertain using the recommended techniques. This problem also applies to registered plant cell cultures, which can mutate, making it more difficult to examine a situation of possible infringement. The stability of the biological material thus becomes a key criterion for judging the validity and enforceability of a patent as long as the description of the production process alone remains insufficient to dispense with the deposit of a sample.At international level, the WIPO Standing Committee on Patentsxii explains, in its studies on the sufficiency of disclosure, the importance of a clear, complete and reproducible description of the invention, an essential condition for the grant of a patent. Inadequate disclosure undermines the balance between the proprietor's exclusive rights and the protection of third parties, exposing the patent to legal risks. This danger is all the more worrying when patents relate to sensitive areas such as biological resources or living organisms: in the absence of a rigorous framework, monopolies founded on vague scientific or technical bases can lead to the abusive capture of knowledge or natural elements, to the detriment of legal certainty, research and the public interest.Adequate disclosure and Directive 98/44 on biotechnological inventionsEuropean Directive 98/44 on the legal protection of biotechnological inventionsxiii refers to the principle of sufficient disclosure, without explicitly using the term "reproducibility". This principle, based in particular on Article 83 EPC, is set out in Article 13 of the Directive. In general terms, the latter states that when an invention cannot be sufficiently described in a patent application "to enable a person skilled in the art to make the invention", in particular concerning "biological material not accessible to the public", this material may be deposited with a recognised institution (Budapest Treaty). This deposit guarantees concrete access to the invention and thus satisfies the disclosure requirement. The requirement of sufficient disclosure is repeated in Article 5.3 of the Directive, which requires the inventor to specify the function of a gene sequence or partial sequence, in order to justify its usefulness. Directive 98/44 therefore also lays down a framework designed to prevent the granting of patents based on insufficiently characterised "biological material" and technical processes.i The only mention of reproducibility in the EPC does not concern the skills of the person skilled in the art, but the definition of biological material (rule 26.3): " ‘Biological material’ means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system".ii The concept of "excessive experimentation" has been established by EPO case law, in particular T 409/91 and T 435/91 (Detergents v Unilever).iii EPO, Board of Appeal, "Decision T 0617/07 (Monoclonal NGF-antagonist antibodies/LAY LINE)", 4 August 2009.iv EPO, Board of Appeal, "Decision T 0727/95 (Cellulose/WEYERSHAEUSER)", 21 May 1999.v EPO, Board of Appeal, "Decision T 0420/19 (Barley derived beverages/CARLSBERG)", 8 June 2021.vi Denis Meshaka, "Prophetic but misleading: fictitious examples in patents", Inf'OGM, 24 January 2024.Denis Meshaka, "Brevets sur les séquences génétiques : démesure et fragilité", Inf'OGM , 7 July 2023.vii EPO, Guidelines, "5.4 Plant varieties and animal breeds, essentially biological processes for obtaining plants or animals".viii CBE, Rule 31, "Deposit of biological material".ix EPO , Guidelines, G II, 5.4 "Plant varieties and animal breeds, essentially biological processes for obtaining plants or animals".x WIPO, "Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure".xi EPO, Board of Appeal, "Decision T 0418/89 (Ortho monoclonal antibody/Ortho Phamaceutiaal corporation)", 8 January 1991.xii WIPO, Standing Committee on the Law of Patents (SCP).xiii European Union, "Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions", Official Journal of the European Union, L 213/13, 30 July 1998. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [114] => Array ( [objectID] => 12433 [title] => Xenotransplantation: and the pig? [timestamp] => 1744156800 [date] => 09/04/2025 [annee] => 2025 [url] => https://infogm.org/en/xenotransplantation-and-the-pig/ [image] => https://infogm.org/wp-content/uploads/2026/03/xenotransplantation-cochon.avif [extrait] => Xenotransplantation in humans is the subject of one announcement after another. This involves transplanting an organ or tissue from a genetically modified animal into a human, to alleviate the shortage of human organs. The “new genomic techniques” are used to genetically modify donor animals. Does the use of these techniques raise new questions of animal ethics? [chapo] => Xenotransplantation in humans is the subject of one announcement after another. This involves transplanting an organ or tissue from a genetically modified animal into a human, to alleviate the shortage of human organs. The “new genomic techniques” are used to genetically modify donor animals. Does the use of these techniques raise new questions of animal ethics? [texte] => The US Food and Drug Administration (FDA) has just authorised clinical trials of kidney transplants from genetically modified (GM) pigs in patients suffering from kidney failure for which there is no treatmenti. We can read in a small article in Le Mondeii that the pigs are “produced” by two American companies, United Therapeutics and eGenesis.The reification of animals for the benefit of the human species continues in the wake of intensive livestock farming. So why not take a look at the animals themselves?In Switzerland, an independent committee, the Federal Ethics Committee on Non-Human Biotechnology, commissioned an expert report asking whether “recent developments in the field of xenotransplantation after the introduction of genome editing technologies” raise new ethical questions for the animal. This report replied, in December 2024iii, that there were no new qualitative issues raised by these new tools. However, it points out, “contemporary biotechnological developments must be taken as an opportunity to discuss existing ethical issues in an urgent and intensified manner, particularly regarding the significance of animals' moral standing. The lack of consideration of animal-related aspects and the neglect of current developments and the state of the art of animal ethics in the recent discussion about xenotransplantation is a scientific, ethical, and political issue because animals are most negatively affected by xenotransplantation”.Xenotransplantation, "new genomic techniques" and "cloning"Biotechnological tools, such as nucleases (enzymes) like Crispr/Cas, are increasingly being used to genetically modify pigs so that they produce organs available for these transplants. Primates have long been the preferred donors for xenotransplants, as they are the most similar mammals, immunologically speaking, to humans. However, for ‘manufacturers’, pigs are now preferable. It is, they say, more fertile and, in terms of size, anatomy and physiology, its organs are similar to those of humans.The fact remains that humans are not pigs. The pig therefore needs to be genetically modified if the xenotransplant is to have any chance of success. Specific pig genes (which are recognised by antibodies naturally present in humans, which would cause graft rejection) have to be deleted and human transgenes (which facilitate graft acceptance) inserted. The growth hormone receptor geneiv is also inactivated so that the organ does not undergo undesirable rapid growth in the animal. These modifications to the animal's genes can be carried out by transgenesis or mutagenesis using nucleases. The pig must also be free from specific pathogens. The “new genomic techniques” (NGT) would make it possible to prevent viral transmission between species. For example, the pig supplied by eGenesis has undergone 69 genetic modifications, many of which involve inactivating a retrovirus endogenous to the pig (viral sequences integrated into the genomev) that would become dangerous if transmitted to humans via the graftvi !All these modifications are made in vitro to a single female pig cell obtained in a special way. A somatic cell with very little differentiation is extracted from an adult female and the nucleus is removed. The nucleus is then inserted into an enucleated ovum taken from another sow. Genetic manipulation is carried out on the cell thus obtained. This GM cell divides several times. The resulting cells, which share the same genetic heritage, are separated and each produces a GM embryo. These embryos are implanted in a third sow, the surrogate mother. She will give birth to piglets carrying the genetic modificationsvii. This technique is known as “somatic cell nuclear cloning”. This is the technique used for the sheep Dolly.Health problems and pig welfareFor the last 20 years or so, in the field of xenotransplantation, the medico-technical debate has dominated the debate on human ethics and, even more so, the debate on animal ethics. In Switzerland, the Federal Ethics Committee on Non-Human Biotechnologyviii points to the total absence of reflection on animal ethics. Yet animal ethics has developed around concepts such as animal dignity and integrity, based on scientific research into consciousness in animalsix, and going beyond the simple traditional concept of animal welfare, which is highly subjective.As the swiss expert reportx tells us, “certain modifications could have negative side effects on the health and welfare of GE animals. The more the animal genome is interfered with, the higher the risk of unforeseen interactions between the various interventions”.The use of the new genetic tools would, according to the promoters of these xenografts, limit off-target effects, i.e. effects on other organs of the pig. However, the same report states: “While this method [CRISPR/Cas9] is generally considered to be much more efficient and specific compared to other approaches, any accurate, definitive, quantitative estimation of the efficiency of CRISPR is difficult to find, as estimates vary considerably and are affected by many factors, including the nature of the target site and the CRISPR molecule used”.The technique known as “nuclear cloning” used to give birth to these animals is not without consequences for their health and well-being either. The Swiss report states that "the live birth rate (live born animals per transferred embryos) in pigs persists at a value of circa 6% and a range between 0.6% and 7%. Some of the clones born alive suffer from health-related strains, which can be lethal ".The report acknowledges that the combination of NGTs and the production of embryos by “nuclear cloning” makes it possible to minimise the number of laboratory animals (e.g. for testing off-target effects), but that, from the point of view of animal ethics, the question arises as to whether this combination is sufficiently safe for pigs, i.e. neither dangerous nor suffering.The concept of "animal dignity"In Swiss regulations, the concept of ‘animal dignity’ is defined as the “inherent worth of the animal that has to be taken into account when handling it”. This inherent worth refers to "the claim that we should behave morally toward them for their own sake. Hence, moral agents would not behave morally toward animals if they only value them based on their aesthetic, culinary, social, or other instrumental values and treat them well accordingly. Every being that has an inherent worth thus has to be respected independently of its benefit to others".Consequently, the report adds that “any harm must be justified on morally relevant grounds [...] in particular if pain, suffering or harm is inflicted on the animal, if it is exposed to anxiety or humiliation, if there is [a] major interference with its appearance or its abilities, or if it is excessively instrumentalized”.In the present case, the rearing conditions take account of devices to avoid any contamination of the pigs by pathogenic micro-organisms that could be transmitted to the organs to be grafted. For example, piglets are born by caesarean section to avoid any contact between the piglets and both the sow and sow's milk, and piglets are reared in sterilised islets and fed a sterilised feed. The Swiss report is explicit: “it is doubtful whether [these] conditions will satisfy the natural behaviors and needs of pigs, whose broad behavioral repertoire and complex cognitive and emotional abilities are comparable to those of dogs and chimpanzees”. In other words, there is the problem of significant damage to animal dignity.Non-sentient damage affecting the animal's appearance or capacities is observable. They are significant (particularly as regards all the organs) in the case of these GM pigs and, the report continues, the instrumentalisation of pigs is at its maximum.As a result of these sensitive or non-sensitive prejudices, the Swiss report tells us that respect for animal dignity should prohibit these practices.Human interests and animal ethics are therefore weighed against each other. The same applies to the Enlarged Board of Appeal of the European Patent Office (EPO)xi in the case of animal-human chimeras. For the time being, this remains a debate between experts, but it is positive to note that the subject of animal ethics is beginning to be taken into account.The Swiss report goes on to explain that "while xenotransplantation affects important human interests such as quality of life and health, it is difficult to determine whether and, if so, for how long the xenografts will function in the human body. Data on the quality of life of xenotransplant recipients is also not yet available. Even if the dignity of creature approach is a hierarchical approach in which human interests count more than those of animals, human interests do not always outweigh those of animals".The same report adds that "animals are regarded as an economic and scientific resource, whereby they are systematically institutionalized and legally harmed and killed. This presents a profound moral problem. Instead of claiming a relationship of morally condemnable instrumentalization or exploitation with animals, it is also possible to understand animals as friends, neighbors, fellow creatures, or companions (as can be the case with cats and dogs) or even fellow citizens with whom we should be able to share the resources of this planet and live together with as little conflict as possible".This report is surprising and, while it does not settle the question, it concludes that “due to the international interdependence of science, a comparative global study of ethical xenotransplantation regulations and their relation to the current state of animal ethics would be beneficial”.In the case of xenotransplants, concerns about animal ethics are well-founded and open up an even wider field of philosophical reflection: as we instrumentalise all living things (plants, animals, micro-organisms), what anthropological future are we heading for? What will remain of our original link with nature?i United Therapeutics Corporation, « United Therapeutics Corporation Announces FDA Clearance of its Investigational New Drug Application for the UKidney Xenotransplantation Clinical Trial », 3 février 2025.ii Le Monde, Science et Médecine, p.3, 12 February 2025 (in French) .iii Samuel Camenzind, « Xenotransplantation in the Age of Genome Editing: Results From the Expert Report for the Federal Ethics Committee on Nonhuman Biotechnology With a Special Focus on Animal Ethics », Xenotransplantation, Volume31, Issue 6, November/December 2024.iv A molecule inserted into the membrane of certain cells which binds the hormone, triggering reactions in the cell.v Annick Bossu, « Vaccins à ARN messager : un peu de lumière sur l’ombre », Inf’OGM, 21 April 2022 (in French).vi eGenesis, « Xenotransplantation ».Alex Knapp, « The Startup Behind The First Pig-Human Kidney Transplant Is Targeting Hearts And Livers Next », Forbes, 2 avril 2024.According to CEO Mike Curtis, eGenesis has raised $291 million in venture capital to date. It aims to take its gene-editing technology for kidney, liver and heart transplants to the clinical trial stage within the next two years, making it a key player in a market estimated to be worth around $15 billion.vii Samuel Camenzind, « Xenotransplantation in the Age of Genome Editing: Results From the Expert Report for the Federal Ethics Committee on Nonhuman Biotechnology With a Special Focus on Animal Ethics », Xenotransplantation, Volume31, Issue 6, November/December 2024.viii Ibid.ix See for example the works of Inrae: « Animal consciousness: new knowledge », 12 May 2017.x Samuel Camenzind, « Xenotransplantation in the Age of Genome Editing: Results From the Expert Report for the Federal Ethics Committee on Nonhuman Biotechnology With a Special Focus on Animal Ethics », Xenotransplantation, Volume31, Issue 6, November/December 2024xi Denis Meshaka, « The European Patent Office outlines a fragile ethical frontier », Inf'OGM, 20 mars 2025. Annick BOSSU [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [115] => Array ( [objectID] => 12412 [title] => Towards the start of the trilogue on GMO deregulation? [timestamp] => 1743552000 [date] => 02/04/2025 [annee] => 2025 [url] => https://infogm.org/en/towards-the-start-of-the-trilogue-on-gmo-deregulation/ [image] => https://infogm.org/wp-content/uploads/2026/03/Jekabs_Kazaks_-_Three_Old_Ladies_-_Google_Art_Project.jpg [extrait] => On 14 March 2025, the Member States of the European Union achieved a fragile qualified majority to launch a discussion with the European Commission and the European Parliament on the deregulation of GMOs. It took the member states almost two years to reach this majority, as there are still many disagreements. Negotiations between the three European decision-making bodies - known as a “trilogue” - could now get underway, subject to the vote of a final formal mandate by the European Parliament's Environment Committee. [chapo] => On 14 March 2025, the Member States of the European Union achieved a fragile qualified majority to launch a discussion with the European Commission and the European Parliament on the deregulation of GMOs. It took the member states almost two years to reach this majority, as there are still many disagreements. Negotiations between the three European decision-making bodies – known as a “trilogue” – could now get underway, subject to the vote of a final formal mandate by the European Parliament’s Environment Committee. [texte] => Since July 2023, the member states of the European Union (EU) have been discussing the European Commission's proposal to deregulate many GMOs. Numerous disagreements have arised, whether on the Commission's desire to abolish risk assessment, labeling as the obligation to provide a method for detecting and identifying GMOs obtained through new techniques of genetic modifications, or - above all - on the issue of patents associated with these techniques and/or GMOs. While Spain, Belgium and Hungary had failed to reach an agreement on a text amended by the member states, on Friday March 14, 2025, Poland obtained a qualified majority granting the country holding the presidency of the European Union a mandate to negotiate with the European Commission and the European Parliament.A fragile qualified majorityAccording to Contextei, the EU member states voted by a qualified majority for the compromise text proposed by Poland at a meeting of the states' permanent representatives. This qualified majority was achieved despite opposition from Austria, Croatia, Hungary, Romania, Slovakia and Slovenia. While Germany abstained, Greece and Belgium voted in favor of the text. The change of vote by these two member states enabled a qualified majority.While Belgium has formally voted in favor of the Polish compromise text, it has nonetheless accompanied its vote with a statement that puts its political support into perspective. In a document that Inf'OGM was able to read, it explains that it will oppose the potential future text that will emerge from negotiations with the European Commission and the European Parliament if it does not guarantee, firstly, the possibility for consumers to choose to eat without or with GMOs ; secondly, the absence of health or environmental risks linked to the commercial use of these GMOs; and, lastly, a total ban on the patentability of GMO plants obtained by these new techniques, their traceability throughout the agri-food chain and a ban on these GMOs in the organic sector. Belgium's vote on March 14 is therefore paradoxical: by supporting Poland's compromise text, Belgium has given its voice to the EU Council Presidency to start inter-institutional negotiations on the basis of a text that does not reflect its position.A non-binding textIn fact, Poland's latest compromiseii is broadly in line with the European Commission's proposal. Since July 5, 2023, the Commission has been proposing that plants and certain micro-organisms genetically modified by new techniques of genetic modification should be defined as “NGT” for new genomic techniques. There would be two categories: category 1, for organisms whose genetic modifications are presumed to be similar to those that can be obtained by “conventional” selection (substitutions, deletions, insertions) and of virtually infinite number, and category 2, for organisms not classified in category 1, if any remain. To sum up, the European Commission is proposing that GMOs declared a NGT category 1 could be authorized without risk assessment, without publication of detection and identification methods (thus preventing traceability), without labeling (except for seed lots) and without post-market monitoring. This category 1 could concern an unlimited number of GMOs.The compromise text proposed by Poland was intended to respond to the issues raised by member states during the two years of discussions, particularly, if not especially, the question of patents. Indeed, many had voiced their disagreement with such deregulation, given that genetically modified organisms can still be patented, a patentibility which could extend to non-genetically modified organisms. Although it had initially proposed a system of declaration and verification of the presence of patents, a system which had already been deemed insufficient by a number of players, Poland succeeded in obtaining a qualified majority on a text which makes this procedure purely declaratory, without verification. To put it another way, Poland put forward an initial proposal to regulate patents, which was rejected by the other member states (even though it had rejected all patentability when it was not President). It has therefore further watered down its position. As for risk assessment, detection methods, identification and labeling, Poland has not in any way modified the European Commission's proposal, which is to get rid of them.Players reactMany players reacted to the vote on Friday March 14, 2025. Representatives of multinationals said they were pleased with the vote, such as Olivier de Matos, Managing Director of CropLife Europe, who believes it provides farmers with better seeds, strengthens food systems and promotes sustainabilityiii.The European Coordination of La Via Campesina (ECVC), on the other hand, believes that Poland's compromise text “does not solve the problem of patents”iv. The coordinating group of farmers' organizations therefore calls on the members of the European Parliament, the European Commissioners for Health and Food Safety and for the Internal Market, and the representatives of the Member States not to allow “the confiscation of peasant and traditional seeds by the patents of a few seed multinationals”. Recalling that the European Parliament itself voted in April 2024 for a text rejecting the patentability of these genetically modified organisms through new techniques, ECVC calls on the members of the European Parliament's Environment Committee not to “approve the negotiating mandate allowing the opening of the trilogue on this dossier”.Pollinis denouncesv both a decision by the representatives of the Member States “which greatly threatens the future of European agriculture” and “the position of the French government, which has chosen to ignore the repeated warnings of civil society, farmers and scientists, and to condemn to failure the necessary transformation of our agricultural model”. In particular, the association recalls ECVC's often expressed position that “in the absence of any obligation to publish methods of detection and identification of NTG-derived plants, [farmers] will have no means of defending themselves” if they were to be “sued for infringement in the event of genetic contamination, or if their crops have characteristics similar to patent-dependent traits, but have been obtained independently”.At European level, Friends of the Earth Europe talk about a dark day for farmers, consumers and Naturevi. The association believes that with this vote, “governments have voted in favor of the profits of a few big companies, rather than protecting the right of European farmers and consumers to transparency and safety”. It adds that this vote “nullifies the regulatory framework and eliminates any responsibility for new, untested GMOs [...] that don't even exist yet”.Trilogue to be launched in April?In February 2024, the European Parliament voted its own version of potential future legislation on GMOs. In so doing, it declared itself ready for negotiations with the European Commission and the Council of the European Union (trilogue) to take place. For the European Parliament, Jessica Polfjärd MEP, member of the Environment, Climate and Food Safety Committee, was appointed rapporteur for the text on July 24, 2024. A rapporteur who has already declared herself to be pro-deregulation and who will therefore represent the Parliament in these negotiations. It is probably because of this forthcoming role that the MEP has already met several times with representatives of multinationals, such as Syngenta on November 18, 2024 and March 6, 2025, Corteva on January 30, 2025, and Euroseeds on September 18, 2024 and January 22, 2025, as Inf'OGM has been able to verify. For its part, the European Commission has been de facto ready for discussions since July 5, 2023, the day it made its proposal.With the vote on March 14, 2025 giving a mandate to the Member State occupying the role of President of the Council of the European Union to hold discussions with the Commission and Parliament, the steps required to get this trilogue underway have almost all been completed. All that remains is for the European Parliament's Environment, Climate and Food Safety Committee to formally vote on its acceptance of the mandate. This vote could take place as early as April.The coming weeks and months could therefore see the start of inter-institutional negotiations. As these are negotiations, none of the representatives is strictly bound by the position of the institution they represent (Commission, Parliament, Council). They represent the voice and positions of their institution, but this in no way prejudges the final content of any text negotiated between the three institutions. By June 30, 2025, Poland will be in the round table. From July 1 to December 31, 2025, Denmark, an openly pro-deregulation country, will take part in the negotiations. The positions negotiated will ultimately require a new formal agreement from each institution once the negotiations are over. The story isn't over yet.i « Plus d’un an après le Parlement européen, les États trouvent un accord sur le texte concernant les nouvelles techniques génomiques », Contexte, 17 march 2025, followed by « Erratum : la Belgique a soutenu le mandat du Conseil sur les nouvelles techniques génomiques », Contexte, 18 March 2025 (in French).ii Council of the European Union, « Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 – Mandate for negotiations with the European Parliament », 7 March 2025.iii « UE Les parties prenantes se tournent déjà vers les négociations interinstitutionnelles concernant les plantes NGT », Contexte, 17 March 2025 (in French).iv ECVC, « Open letter to the Member States of the European Union, Members of the European Parliament and the European Commission », 19 March 2025.v Pollinis, « Nouveaux OGM : l’accord du Conseil de l’UE menace l’agriculture et la biodiversité », 14 March 2025 (in French).vi Friends of the Earth Europe, « EU ambassadors back new GMOs deregulation: a dark day for farmers, consumers, nature », 14 March 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [116] => Array ( [objectID] => 12317 [title] => The European Patent Office outlines a fragile ethical frontier [timestamp] => 1742428800 [date] => 20/03/2025 [annee] => 2025 [url] => https://infogm.org/en/the-european-patent-office-outlines-a-fragile-ethical-frontier/ [image] => https://infogm.org/wp-content/uploads/2026/03/pexels-anh-nguyen-517648218-21274242-768x960.jpg [extrait] => In September 2024, the European Patent Office (EPO) refused a patent for human-pig chimeras on the basis of the ethical rules governing patentability in biotechnology. By invoking the protection of "human dignity", the EPO is drawing a sometimes fluctuating line between innovation and respect for fundamental values. This decision sets a - perhaps fragile - precedent for inventions affecting human identity, and highlights the complexity of an ethical framework in the era of unbridled biotechnology. [chapo] => In September 2024, the European Patent Office (EPO) refused a patent for human-pig chimeras on the basis of the ethical rules governing patentability in biotechnology. By invoking the protection of “human dignity“, the EPO is drawing a sometimes fluctuating line between innovation and respect for fundamental values. This decision sets a – perhaps fragile – precedent for inventions affecting human identity, and highlights the complexity of an ethical framework in the era of unbridled biotechnology. [texte] => In line with ethical considerations that concern only the animal world (including human beings) but not the plant world, Article 53 a) of the European Patent Convention (EPC)i excludes from patentability inventions deemed to be "contrary to ordre public or morality", in particular those that offend against human dignity. This provision is intended as an ethical safeguard in the biotechnology sector. This was the case for a patent application from the University of Minnesota, filed in March 2016, concerning the production of a human-pig chimera by integrating human pluripotent stem cells into genetically modified pig embryos. This application was ultimately refused by the European Patent Office (EPO) in September 2024 after a lengthy appeal procedure. EPO decision T1553/22ii is a reminder of the limits to the appropriation of living matter when humans are directly concerned.The EPC aligned with Directive 98/44Behind the vague and subjective concepts of "ordre public" and "morality", Article 53 a) seeks to provide a framework for the appropriation of scientific developments, particularly in the field of living organisms, which could compromise fundamental ethical values. In Europe, this article echoes Directive 98/44/EC on the legal protection of biotechnological inventions, which excludes from patentability processes that directly infringe human dignity. Although this Directive is not directly applicable to the EPC, it nevertheless provides, via whereas 38, an ethical and legal framework that may influence the EPO's interpretation of Article 53 a). This contributes to a harmonised approach to the patentability of biotechnological inventions in Europe.Recital 38 of Directive 98/44 provides "an illustrative list of inventions excluded from patentability so as to provide national courts and patent offices with a general guide to interpreting the reference to ordre public and morality". This list, which is described as non-exhaustive, cites "processes, the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals". These are the legal bases on which the EPO based its decision T 1553/22.A decision that raises ethical issuesThe patent application entitled "ETV2 and uses thereof"iii filed by the University of Minnesota covered a method for producing a human-pig chimera by integrating human pluripotent stem cells into pig embryos genetically modified by deleting the ETV2 gene. This gene enables the pig to produce these cells and blood vessels. This chimera is expected to generate humanised blood vessels and blood cells for therapeutic applications. According to the University of Minnesota, the production of chimeric animals containing a mixture of human and pig cells would also make it possible to harvest organs that are immunologically compatible with human recipients, thereby addressing the critical shortage of organs.The EPO's Examining Division considered that this technology raised ethical issues, in particular due to the integration of totipotent human stem cells into animal embryos. In application of Article 53 a), the Examining Division therefore refused the patent application in February 2022, a decision which the University of Minnesota has appealed.The EPO's Board of Appeal therefore followed suit and examined the ethical implications of the University of Minnesota's invention, focusing in particular on issues of human dignity and biological identity. In its brief, the Board of Appeal confirmed the Examining Division's position, finding that the invention "relates to human-animal chimeras in which human cell participation in the brain or germ cells is a realistic possibility rather than only a hypothetical one" and that “the claims [of the patent] are not drafted to exclude embodiments in which human cells are present in the brain and/or germ cells of the chimera". The Board of Appeal therefore held that, in the light of Article 53(a) of the EPC and Recital 38 of Directive 98/44, the exclusion from patentability could be justified.This decision sets a precedent by clarifying the ethical limits for the patentability of human-animal chimeras and emphasising the protection of human dignity in the face of biotechnological advances.Fluctuating case lawPrior to the chimera case, Article 53 a) was the basis for other EPO decisions, but apart from the specific subject of stem cells (see box), most of these concerned the issue of animal suffering. In 1992, in decision T 19/90iv (the "Oncomouse/Harvard University" case), following rejection of the patent application by the Examining Division and an appeal by Harvard University, the EPO Board of Appeal examined the patentability of a genetically modified mouse for cancer research. The Board of Appeal considered that the Examining Division's decision on the exclusion of patentability "depend mainly on a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention's usefulness to mankind on the other."v. On this basis, the Examining Division concluded that the invention was not contrary to morality or public policy. More specifically, it found that the production of an animal suitable for experimentation in cancer research, which makes it possible to reduce the number of tests carried out on animals, while involving fewer risks thanks to the use of qualified personnel, can generally be considered to be beneficial to humanity. This decision laid the foundations for ethical analysis under Article 53 a) EPC.In 2012, in decision T 1262/04, the Board of Appeal considered the patentability of an invention relating to methods of detecting tumour cells in non-transgenic mice using light-generating proteins to measure the photons emitted. The Board had to decide whether Article 53 a) should be applied with the test of rule 28 d) of the EPC. This rule excludes from patentability "processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes". The Board of Appeal concluded that Rule 28 d) does not apply to non-transgenic animals, but that Article 53 a) still requires an ethical assessment based on a balance between animal suffering and the benefits for humanity. Although the mice received tumour cells, the method was promoted as reducing the total number of animals used and accelerating drug discovery through improved imaging techniques. The Board of Appeal therefore ruled that the medical benefits outweighed the animal suffering, making the invention patentable.More recently, in September 2020, decision T 1553/15 examined the patentability of a pharmaceutical preparation obtained from rabbits into whose skin the vaccinia virus is injected to create inflammation, the rabbits then being killed to recover the skin. Six to ten rabbits were needed to prepare a single tablet. Given the very low yield and the sacrifice of many rabbits to exploit the invention, the Board considered that "that the benefit to mankind brought by the present invention is not such as to weigh up against the suffering of animals which is necessary to produce the claimed pharmaceutical composition". On the basis of Article 53 a), the Board of Appeal established that patentability must be refused if the impact on animal welfare exceeds the expected scientific benefits. It also specified that this case is not comparable to the Oncomouse/Harvard case, "which opened up new research avenues in the field of oncology at the cost of the suffering of a limited number of animals". This decision is a reminder of the need for an ethical balance between animal suffering and scientific progress.Début encadréPatentability of stem cellsThe patentability of stem cells is also governed by Article 53 a) of the EPC. Rule 28 c) of the EPC specifies that, in accordance with Article 53 a), patents shall not be granted for "uses of human embryos for industrial or commercial purposes".European case law has clarified these provisions in a number of key decisions. In case G 2/06vi (use of embryo/WARF) of 25 November 2008, the EPO's Enlarged Board of Appeal ruled that any invention requiring the destruction of human embryos is not patentable, even if such destruction is not explicitly mentioned in the patent claim. This position of the EPO was confirmed by the CJEU (Court of Justice of the European Union) in its decision C 34/10 (human embryo - definition - patent) of 18 November 2011.However, not all stem cells are subject to the same restrictions as human embryonic stem cells. Pluripotent stem cells, which can differentiate into various cell types without being able to develop into a complete individual, are not considered to be embryos. Inventions involving these cells may be patentable, provided they meet the other criteria for patentability, such as novelty, inventive step and industrial application.Fin encadréA not necessarily reassuring outlookThis EPO case law shows the importance of interpreting the exclusion of "morality" provided for in Article 53 a), over and above the specific cases mentioned in recital 38 of Directive 98/44. It also underlines the need to preserve fundamental ethical guidelines and recalls the persistent tension between scientific innovation and the legal framework. In so doing, it raises questions about the interaction between patentability, regulation and societal acceptability.Over and above the question of animal suffering, recent biotechnological developments, illustrated by the case of human-pig chimeras, raise fundamental questions about the appropriation and control of living organisms, particularly as regards the ownership of chimeric organisms and patent rights over partially human life forms. The EPO guidelines provide clarification on this pointvii : "Although the human body, at the various stages of its formation and development, and the simple discovery of one of its elements [...] cannot constitute patentable inventions, an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application[...] may constitute a patentable invention, even if the structure of that element is identical to that of a natural element". The EPO guidelines also refer to recital 21 of Directive 98/44/EC, which states that such an element "is not excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to reproduce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself".Article 53 a) and its notions of "ordre public" and "morality" are proving to be an uncertain safeguard in the face of biotechnological advances. Biomedical ethics and standards may evolve under the influence of economic and political forces. If respect for "human dignity" were to become the last bastion, there is no guarantee that it would be sufficient, especially as it could be argued that it has already been weakened by contemporary society.i European Patent Convention (EPC), "Article 53, Exceptions to patentability".ii EPO, Technical Board of Appeal, "Decision T 1553/22 (Human-pig chimeras/UNIVERSITY OF MINNESOTA) 04-09-2024", 4 September 2024.iii World Intellectual Property Organization (WIPO), "PCT Patent Application No. WO 2016/141234", 9 September 2016, from which European application EP3264891 is derived.iv EPO, Technical Board of Appeal, "T 0019/90 (Souris oncogène) 03-10-1990", 3 October 1990.v EPO, Official Journal, "DECISIONS OF THE EXAMINING AND OPPOSITION DIVISIONS - Grant of European patent No. 0 169 672 (Onco-mouse/Harvard)", p. 588-593, 31 October 1992.vi EPO, Enlarged Board of Appeal, "Decision G 0002/06 (Use of embryos/WARF) 25-11-2008", 25 November 2008.vii EPO, Guidelines, "5.2 Patentable biotechnological inventions". Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [117] => Array ( [objectID] => 12305 [title] => The European Commission’s proposal to deregulate GMOs does cover some GMO micro-organisms [timestamp] => 1742342400 [date] => 19/03/2025 [annee] => 2025 [url] => https://infogm.org/en/the-european-commission-is-already-proposing-to-deregulate-gmo-micro-organisms/ [image] => https://infogm.org/wp-content/uploads/2026/03/49565892277_a83c9fac79_c-768x492.jpg [extrait] => In July 2023, the European Commission's proposal to deregulate GMOs was presented and understood as concerning only plants. Micro-organisms, animals and fungi would not be concerned. However, a careful reading will show that, contrary to what the European Parliament seems to have understood, some micro-organisms are indeed concerned... because they are considered to be plants! [chapo] => In July 2023, the European Commission’s proposal to deregulate GMOs was presented and understood as concerning only plants. Micro-organisms, animals and fungi would not be concerned. However, a careful reading will show that, contrary to what the European Parliament seems to have understood, some micro-organisms are indeed concerned… because they are considered to be plants! [texte] => Laws are written in words. A truism, one might say... and yet! It is common for everyone to want to give the words in a legal text the meaning that suits them best. Ultimately, if there are different interpretations, only the courts can decide. This situation renders fundamental the understanding of the words used by a legislator to determine the meaning of a law. Who, for example, could have imagined in 2001 that the ‘mutagenesis’ cited in Directive 2001/18 as having an history of safe use also concerned, for the European Commission, some of the ‘new’ mutagenesis techniques? Which will force the Court of Justice of the European Union (CJEU) to remind it, in 2018 and then 2023, that this is not the case? Who could have imagined, in 2004, that the Member States themselves would be willing to ‘clarify’ their own regulatory text adopted a year earlier? They did so in order to decide that additives produced by genetically modified micro-organisms were not covered by the regulations on GMOs adopted in 2003, on the grounds that they were produced with GMOs and not from GMOs. These semantic debates are not without importance. In the last example cited, the change from ‘produced from’ to ‘produced with’ has enabled the enzyme, colouring agent, vitamin and other additive industry to avoid being labelled ‘produced from GMOs’.Deregulating plant GMOs, but... which plant GMOs?In July 2023, when it proposed to deregulate a large number of GMOs, the European Commission wrote that “this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is more limited”. Things seem clear: only plants would be concerned. But, as we have already seen in two previous articlesi, plants are not just terrestrial, as marine and freshwater algae are also concerned. The taxonomic groups Archaeplastida and Phaeophyceae cover land plants as well as so-called ‘green’, ‘red’ (Archaeplastida) and ‘brown’ (Phaeophyceae) algae, some of which are consumed by humans.Things become blurred when we realise that algae can be multicellular or unicellular. A unicellular organism is commonly considered to be a micro-organism. European law itself, in Directive 2009/41 on genetically modified micro-organisms, defines a micro-organism as “any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture”. A cellular microbiological entity capable of reproducing or transferring genetic material, that covers unicellular algae.Are unicellular algae plants affected by the proposed deregulation or are they micro-organisms excluded from this proposal? More generally, are micro-organisms belonging to the taxonomic groups mentioned affected by the proposal because they are ‘plants’ or excluded because they are micro-organisms? According to Inf'OGM's information, the wording adopted by the European Commission should be read as covering all organisms belonging to the two taxonomic groups mentioned, whether they are multicellular or unicellular. Micro-organisms belonging to the Archaeplastida and Phaeophyceae groups are therefore affected by the proposed deregulation.Not all legislators read the same thingEuropean experts classify certain algae as micro-organisms. In January 2023, in an opinionii on the safety of micro-organisms, the European Food Safety Authority (EFSA) specifically cited certain micro-algae, such as Chlamydomonas reinhardtii and Galdieria sulphuraria, two unicellular algae belonging to the Archaeplastida taxonomic group. Chlamydomonas reinhardtii is one of the most studied unicellular algae for genetic modificationiii. This EFSA letter of January 2023 confirms, if confirmation were needed, that some micro-organisms belong to the two taxonomic groups mentioned.The MEPs do not seem to have the same understanding of the terms as the European Commission. While retaining the reference to the two taxonomic groups, they modified the proposed wording. On 24 April 2024, the final text voted on first reading by the European Parliament proposed that “this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae. Available knowledge on other organisms, such as microorganisms, fungi and animals should be reviewed with a view to future legislative initiatives on them”. Here, micro-organisms as defined by Directive 2009/41 are excluded as such from the proposal. Unicellular algae are therefore not covered by the text voted by the European Parliament. Any other interpretation would be tantamount to making European law say anything and everything.A non-intuitive definition of micro-organisms…Outside any legislative framework, the term micro-organism usually refers to microscopic organisms. The french Larousse dictionary defines a micro-organism as “a microscopic living being such as bacteria, viruses, unicellular fungi (yeasts) and protists”. Historically, however, European legislators have taken what might be described as a ‘broader’ view. In 1990, in Directive 90/219iv adopted that year on the contained use of genetically modified micro-organisms, the Commission, Parliament and Council of the European Union agreed to define a micro-organism as “any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material”. This definition was taken up and clarified in 2009 in Directive 2009/41v, which replaced Directive 90/219 and is still in force. Under this directive, a micro-organism is defined as “any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture”.In the same year, Directive 1107/2009vi concerning the placing of plant protection products on the market defined micro-organisms as ‘any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material’. A final legal definition is provided by Regulation 528/2012vii, which covers the placing on the market and use of biocidal products. According to this regulation, a micro-organism is defined as ‘any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths’.Leaving aside the examples of micro-organisms given in each definition, which may vary from one definition to another, it is clear that, according to European legislation, a micro-organism is “any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material”. Viruses, bacteria, lower fungi (microscopic), protozoa, etc. are all micro-organisms. So are microscopic algae, which belong to the plant kingdom covered by the two taxonomic groups cited by the European Commission. Finally, both plant cells and animal cells are legally micro-organisms. What remains to be understood here is what a micro-organism could be, defined as a non-cellular microbiological entity. European patent law provides the answer....but which overlaps with patent lawFor European law, micro-organisms are microbiological entities that are capable of replicating or transferring genetic material. The term ‘entity’ suggests that micro-organisms are not necessarily organisms in the eyes of the European legislator.To understand this, we need to look at patent law as followed by the European Patent Office (EPO). Its guidelinesviii state that “he term "microorganism" includes bacteria and other generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory (see T 356/93), including plasmids and viruses and unicellular fungi (including yeasts), algae, protozoa and, moreover, human, animal and plant cells”. In the list of examples provided, the presence of plasmids (circular DNA molecules) makes it clear that micro-organisms are not necessarily organisms, but can also be molecules.This definition was clarified in 1995, in a decision that clarified precisely what was covered by the term ‘micro-organism’. The EPO was keen to have a reading of the term which, in patent law, responded to industrial practice, as it noted in specifying that “this practice [the interpretation of the term micro-organism] takes clearly into account the developments of modern industrial microbiology”ix. This approach enabled the EPO to conclude, as early as 1995, that “processes [...] carried out on vegetable cells may be defined as "microbiological processes" and their products, namely genetically-modified vegetable cells and their cultures, may be defined as "the products thereof"”. The conclusion is important because, under patent law, microbiological processes are patentable, unlike essentially biological processes.A whole commercial field that would escape GMO legislationThe term ‘micro-organism’ covers living organisms, isolated cells and molecules such as plasmids. In the case of the proposed deregulation, these micro-organisms, when qualified as ‘plants’ and belonging to the two taxonomic groups already mentioned in the GMOs to be deregulated, are indeed concerned, as are multi-cellular organisms such as land plants, trees, algae, etc.The example of algae speaks for itself, since this market, worth several billion euros a year, is the subject of growing industrial interestx. The field of micro-algae, which are among the micro-organisms included in the deregulation proposal, is in fact one of the industrial fields whose potential the European Commission wishes to ‘exploit to the full’…i Eric Meunier, « GMO algae: a future raw material for industry », Inf’OGM, 4 February 2025.Eric Meunier, « Object of all desire, do GM algae really exist? », Inf’OGM, 7 February 2025.ii EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), Koutsoumanis K. et al., « Scientific Opinion on the update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA », EFSA Journal, 2023; 21(1):7747, 23 pp.iiiS ee the table of the genetic modifications of micro-algae in :Eric Meunier, « Object of all desire, do GM algae really exist? », Inf’OGM, 7 February 2025.iv « Council Directive 90/220/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms », Official Journal L 117 , 08/05/1990, p.0001 - 0014, article 2.v « DIRECTIVE 2009/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 on the contained use of genetically modified micro-organisms (recast) », Official Journal of the European Union n°L 125/75, article 2, 21 May 2009.vi « REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC », Official Journal of the European Union n°L 309/1, article 3, 24 November 2009.vii« REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2012 concerning the making available on the market and use of biocidal products », Official Journal of the European Union n°L 167/1, article 3, 27 June 2012, https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32012R0528viii EPO, « Guidelines for Examination in the European Patent Office », version of March 2024, part G, chapitre II-46, point 5.5, Microbiological processes.ix EPO, « T 0356/93 (Plant cells) 21-02-1995 », 21 February 2025.x Eric Meunier, « GMO algae: a future raw material for industry », Inf’OGM, 4 February 2025.Eric Meunier, « Object of all desire, do GM algae really exist? », Inf’OGM, 7 February 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [118] => Array ( [objectID] => 12247 [title] => Self-amplifying messenger RNA “vaccine”: after the human, the duck [timestamp] => 1741910400 [date] => 14/03/2025 [annee] => 2025 [url] => https://infogm.org/en/self-amplifying-messenger-rna-vaccine-after-the-human-the-duck/ [image] => https://infogm.org/wp-content/uploads/2026/03/seringues-injectant-de-l-encre-768x467.jpg [extrait] => A year and a half ago, France made it compulsory to vaccinate farmed ducks against the avian influenza virus, in order to protect its meat and foie gras industries. To date, France is the only country to have taken this vaccination route. One of the two vaccines used, the self-amplifying messenger RNA (mRNA) vaccine, raises questions. [chapo] => A year and a half ago, France made it compulsory to vaccinate farmed ducks against the avian influenza virus, in order to protect its meat and foie gras industries. To date, France is the only country to have taken this vaccination route. One of the two vaccines used, the self-amplifying messenger RNA (mRNA) vaccine, raises questions. [texte] => In a November 2024 publication from the French Ministry of Agriculturei, we learn that since October 1, 2023, France has made it compulsory to vaccinate farmed ducks against highly pathogenic avian influenza (HPAI). This obligation applies to all farms with more than 250 birds, with the exception of breeding duck farms whose production (day-old birds or hatching eggs) is destined for the European market or for exportii. Between October 1, 2023 and September 30, 2024, 61 million ducks were vaccinated against HPAI. On October 1, 2024, this campaign was repeated with two different vaccines, including one of a new type: the self-amplifying mRNA vaccine (which had not been chosen for October 1, 2023 because of its low-temperature transport conditions).Inf'OGM has already taken an interest in the self-amplifying mRNA “vaccine” against Covid in humans and its potential dangers for human healthiii. In the case of veterinary vaccines against avian influenza, the Ministry claims that “the consumption of products from vaccinated animals does not entail any danger. The vaccines are authorized by the French Veterinary Medicines Agency (ANMV), which guarantees their safety“iv. But is this really true?Emergency management of the avian influenza epizooticSince the early 2000s, the avian influenza epizootic has spread from Asian to European countries via the industrial breeding system and accelerated communication channels. The virus responsible for this epizootic is an RNA virus, known by the acronym A(H5N1), where A stands for avian, H for hemagglutinin (the surface protein that enables the virus to attach itself to the cell it infects) and N for neuraminidase (the enzyme that enables the virus to leave the cell once replicated)v. This virus mutates and recombines extensively. As a result, there are many different subtypes. Data sheet 1vi published by the French Ministry of Agriculture specifies that the most widely circulating virus belongs to clade 2.3.4.4b.In justifying the need to vaccinate ducks, the same sheet explains that this epizootic is causing major economic losses and poses a permanent threat to wild birds and mammals, including humans.The Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (Anses) states that “the highly pathogenic avian influenza virus (HPAI) subtype H5N1 has been circulating intensively worldwide for several years, mainly in wild birds (such as ducks and geese) and domestic poultry (chickens, ducks, turkeys). It is also capable of infecting numerous species of wild mammals (foxes, seals, sea lions, etc.) and domestic animals (cats, dogs, pigs). The virus has also been detected for the first time in dairy cows in the USA. The virus can occasionally be transmitted to humans, in which case it is known as avian flu. The international situation, particularly in the United States, is cause for concern, but no human-to-human transmission has been observed to date. In France, no human case of avian flu has yet been detected“vii.In May 2023, the World Organisation for Animal Health (WOAH) opened the way for vaccination against the influenza virus in ducks, considering that conventional control measures “of biosecurity, stamping out and movement restrictions” were no longer sufficientviii.However, with regard to this vaccination, the Anses had previously (on March 30, 2023) issued an opinion following a referral from the DGAL (Direction générale de l'alimentation)ix. This opinion was extremely cautious. Indeed, on numerous occasions, it is noted that the expert opinion is “based on hypotheses that will have to be verified”.The mRNA injection used on French ducksTo be marketed in France, any industrially-produced drug or vaccine must have received a marketing authorization (MA) from the European Medicines Agencyx (EMA) or, failing this, a temporary authorization for use (ATU in French). For veterinary vaccines, the ATU is issued by the Agence nationale du médicament vétérinaire, which is the case for the two vaccines used against the avian influenza virus. The two ATUs concerned can be found on the Anses websitexi.The first vaccine, VOLVAC B.E.S.T. AI + ND, is not a “genetic” vaccine, i.e. an RNA or DNA vaccine. It is a recombinant protein vaccine (or viral subunit vaccine: in this case, the modified H5 hemagglutinin of the avian influenza virus). It was used in the first vaccination campaign, from October 2023 to September 2024, and is being renewed for the vaccination campaign starting on October 1, 2024.The second vaccine, with self-amplifying mRNA, named CEVA RESPONS A1 H5, has been in use since October 1, 2024. On the Anses website, under the heading ATU, we read that “(In view of a health situation requiring emergency vaccination), the present temporary authorization for use (ATU) was granted taking into account a benefit-risk balance judged to be positive for the vaccine in view of the elements provided, but with a limited level of evidence concerning the information available”. In addition, the validity date of this ATU is April 1, 2025, whereas vaccination with this product began on October 1, 2024 for a one-year period.Inf'OGM has requested clarification from Anses. With regard to the assessment, we asked about the risk assessment carried out, which led to the conclusion that the benefit/risk balance was positive. Inf'OGM has asked Anses for the opinion setting out these conclusions. No reply has yet been received at the time of publication of this article.As for the benefits, the efficacy of vaccination has been the subject of a joint study by Anses and the Toulouse National Veterinary Schoolxii. This efficacy is relative: digestive and respiratory excretion of the virus by vaccinated animals is only reduced compared to that of non-vaccinated animals. It is not eliminated. As a result, transmission of the virus between vaccinated ducks is possible: collective immunity has not been established. Further work is required.The ATU for the self-amplifying mRNA vaccine has been issued to the French company CEVA Santé Animalexiii. Its “vaccine” contains a long molecule of artificial mRNA encoding the antigenic H protein against the virus, but it also contains other sequences coding for replicases (enzymes). These replicases will dramatically increase the amount of artificial mRNA produced, and hence of antigenic proteinxiv, without it being known whether or how this replication is likely to stop.These risks of self-amplification of modified mRNA in the body of the animal (hen and various duck subspecies) are likely to be the same as in humansxv. But as this mRNA is destined here for an animal that has to be slaughtered to be eaten, its health does not seem to be a problem, if it allows the ducks to survive until slaughter.The vaccine also contains excipients: iron oxide in the form of nanoparticles coating the mRNA, and squalene, whose safety has not been proven. But then again, the health of the vaccinated animal is irrelevant if it survives to slaughter.Another problem: immunology has shown that vaccines can exert selection pressure on circulating viral strains. Strains not targeted by the vaccine are favored and, among them, a variant with increased pathogenicity potential may emerge. This is one of the major risks of vaccines, both for the species vaccinated and for other species, including humansxvi.What are the risks for human health?In an organism vaccinated with mRNA, it is excreted from the cells that synthesized it, then distributed throughout the body's tissues. This has been demonstrated in the case of mRNA injections against Covid in humansxvii.In the case of the CEVA RESPONS A1 H5 “vaccine”, self-amplification will also increase this distribution of modified mRNA (encapsulated or naked) in the organs, as well as that of the synthesized H antigenic protein. Muscles and liver will be affected. The question then arises: have pre-clinical studies assessed the possibility of transmitting self-amplifying mRNA to humans when they eat duck meat and fatty liver? Especially since duck is often eaten half-cooked.It is said that the “vaccination” is stopped, as with other vaccines, a few weeks before the ducks are slaughtered. Is this sufficient in this case? Is the residual presence of self-amplifying mRNA carefully and systematically checked after slaughter?Can we also guarantee that the vaccine's excipients will not be transmitted to humans via the consumption of meat or foie gras? It should be remembered that the safety of squalene in the vaccines used against the human H1N1 influenza epidemic in 2009 has been called into question, and that no assessment of nanoparticles has been carried outxviii.None of these considerations are mentioned in the temporary authorization form for this “vaccine”. Only the accidental danger of the vaccine for the person performing the injection is considered. In the same file, ATU n° 90053, the special precautions concerning environmental protection are not mentioned.The Anses websitexix states that: “Vaccines intended for livestock species are unique in that they are used on animals whose products (milk, eggs, meat, offal, etc.) are consumed by humans. A further step in the assessment is added with an in-depth evaluation to guarantee the safety of the vaccine for people consuming these products. This means that every component of the vaccine, whether the active ingredient or any adjuvants and excipients, is carefully checked to ensure that it poses no risk when an animal product is consumed”.Where can we find the details of all this painstaking verification work? And, in particular, where is the scientific evidence that “when a product from a vaccinated animal is consumed [by humans], any residual mRNA is destroyed in the stomach by digestive enzymes and acidic conditions”xx ? In the case of Covid, vaccine RNA has been found in all human organs, without exceptionxxi. Admittedly in small quantities, but what will happen in ducks with the self-amplification of the messenger RNA replication process?In the absence of data on the food and environmental safety of these self-amplifying mRNA vaccines, shouldn't we apply the precautionary principle and lift the requirement for this type of duck vaccination in France, or even ban these “vaccines”?In any case, we urgently need to think about simple strategies for combating avian influenza: maintain the genetic diversity of ducks on farms, whereas they are currently all bred from a very small number of lines; reduce the size and density of farms, which is precisely what the ENVTxxii suggests, as small (and open-air) farms are much better able to resist avian influenzaxxiii. Several small structures are more resilient than one large one.Behind these questions of vaccines for animals, it's industrial agriculture that we need to question.i French ministry of Agriculture and Food Sovereignty, « Avian Influenza : the French vaccination action plan », 13 November 2024.ii Ministère de l’Agriculture et de la souveraineté alimentaire, « 10 informations à retenir concernant la vaccination contre l’IAHP », October 2024 (in french).iii Annick Bossu, « Une deuxième vague de vaccins à ARNm arrive sur le marché », Inf’OGM, 5 November 2024 (in french).iv Ministère de l’Agriculture et de la souveraineté alimentaire, « 10 informations à retenir concernant la vaccination contre l’IAHP », October 2024 (in french).v Isabelle do O’Gomes, « Qu’est-ce que la grippe aviaire ? », Sciences et avenir, 20 June 2022 (in french). vi French ministry of Agriculture and Food Sovereignty, Direction Générale de l’Alimentation, « Data sheet 1 – the grounds for vaccination », October 2024.vii Anses, « Virus Influenza aviaire hautement pathogène (IAHP) : les autorités sanitaires françaises poursuivent leurs actions et renforcent leur coopération face au risque de circulation d’un virus adapté à l’Homme », 6 February 2025 (in french).viii WOAH, « Resolution n°28 – Strategic challenges in the global control of high pathogenicity avian influenza », May 2023.ix Anses, « AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à « l’élaboration d’une stratégie nationale de vaccination au regard de l’influenza aviaire hautement pathogène en France métropolitaine » », 30 March 2023 (in french).x French ministry of Agriculture and Food Sovereignty, Direction Générale de l’Alimentation, « Fiche 4 – Presentation of the authorised vaccine », October 2024.xi Anses, « Annexe à l’ATU n° 90055 » (in french).Anses, « Annexe à l’ATU n° 90053 » (in french).xii Anses et ENVT, « Expérimentation de vaccination des canards mulards en élevage contre un virus influenza aviaire hautement pathogène A(H5N1) clade 2.3.4.4b – Rapport intermédiaire : « Évaluation expérimentale de la protection clinique et de l’excrétion virale » », 7 April 2023 (in french).xiii First French company of animal health, fifth at the worldwide level, Ceva Santé animale has 7,000 employees in 47 countries. Its historic headquarters are based in Libourne (33). Its sales in 2024: 1.77 billion euros.Valérie Deymes, « Ceva Santé animale inaugure un laboratoire génomique pour les crises sanitaires de demain », Sud Ouest, 9 February 2025 (in french).xiv Annick Bossu, « A second wave of mRNA vaccine coming to the market », Inf’OGM, 5 November 2024 (in french).xv Ibid.xvi Iwami S, Suzuki T, Takeuchi Y., « Paradox of vaccination: is vaccination really effective against avian flu epidemics? », PLoS One, 2009.xvii Annick Bossu, « Biotechnologies médicales à ARN : nouveau Graal ? », Inf’OGM, 30 March 2023 (in french).xviii Mathilde DETCHEVERRY, « Nanotechnologies in the field: nothing new in twenty years? », Inf'OGM, 28 février 2025.xix Anses, « Update on the assessment and authorisation of veterinary vaccines », 29 January 2025.xx Ibid.xxi Annick Bossu, « Une deuxième vague de vaccins à ARNm arrive sur le marché », Inf’OGM, 5 November 2024 (in french).xxiiENVT, « Avian influenza: need to rethink management strategies in livestock farming », 22 October 2024.xxiii GRAIN, « Bird flu: a bonanza for 'Big Chicken' », 5 April 2007. Annick BOSSU [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [119] => Array ( [objectID] => 12225 [title] => In 2025, more and more organisations are opposed to the deregulation of GMOs [timestamp] => 1741737600 [date] => 12/03/2025 [annee] => 2025 [url] => https://infogm.org/en/in-2025-more-and-more-organisations-are-opposed-to-the-deregulation-of-gmos/ [image] => https://infogm.org/wp-content/uploads/2026/03/Screenshot-2025-06-17-at-10-46-37-Freedom-of-Choice-only-possible-through-labeling-and-traceability-final-counterstatement-freedom-of-choice-only-possible-through-labelling-and-traceability.pdf.png [extrait] => In February 2025, two statements opposing the European Commission's proposal to deregulate GMOs were published. On 11 February 2025, more than 200 organisations, including farming unions, NGOs, small and medium-sized breeders, and players in the organic and non-GMO sectors, published a "joint declaration on the deregulation of new GMOs". On 21 February 2025, more than 70 French players in the organic sector published a collective opinion piece online in Mediapart. [chapo] => In February 2025, two statements opposing the European Commission’s proposal to deregulate GMOs were published. On 11 February 2025, more than 200 organisations, including farming unions, NGOs, small and medium-sized breeders, and players in the organic and non-GMO sectors, published a “joint declaration on the deregulation of new GMOs“. On 21 February 2025, more than 70 French players in the organic sector published a collective opinion piece online in Mediapart. [texte] => In quick succession in February, two collective position papers were published opposing the deregulation of the "new GMOs". Firstly, a major common front in European society called on the European institutions to stop the dialogue on a proposal for the deregulation of GMOs initiated by the European Commission in 2023. Secondly, ahead of the Paris International Agricultural Show, 70 players in the organic sector have called on professionals, activists and scientists in the sector to discuss, cooperate, fight and organise themselves "around an ambitious policy involving all the players in the industry" to "ourselves provide now with the means to meet the food and environmental challenges at stake".A major common front for European societyOn 11 February, on the initiative of Greenpeace, Centro Internazionale Crocevia, the European Coordination of La Via Campesina (ECVC), IFOAM Organics Europe, Nordic Maize Breeding and Pollinis, over 200 organisations published a "joint statement on the deregulation of new GMOs" aimed at "protect the business of small and medium size breeders, farmers, and the organic and non GMO sectors in the EU"i. Since July 2023, when the European Commission published its proposal for the deregulation of many GMOs, none statement or petition has been signed by so many organisations. The document was published at a time when successive EU presidencies (Spain ii, Belgium iii, Hungary iv, Poland v) were attempting to "to rush an agreement in the Council and negotiations between the Council and theParliament", leaving many problematic issues unresolved.Drawing on detailed arguments, the organisations say they are concerned about "human health and nature and [...] patents, identification and detection methods, price of seeds, seed diversity, coexistence, negative socioeconomic impacts and risk of further corporate control of the food chain". As we can see, the European Commission's proposal has a number of grievances. In addition to the environmental risks and the lack of transparency for consumers, the signatories stress what they consider to be the dangerous effects of deregulating many GMOs for farmers, the organic and non-GMO sectors and small and medium-sized breeders in the European Union:" 1_ Patents on living organisms leading to biopiracy.2_ Increased legal uncertainty for breeders and farmers and increased risk of lawsuitsagainst them, putting their business in danger.3_ Threat to the viability and existence of the organic and GMO free economic sectors.4_ Irreversible increase of farmers’ dependence on few seed companies with expectedincrease in their production costs.5_ Less seed diversity adapted to local conditions and climate change and risks tofood security.6_ Likely increase of the EU’s food chain vulnerability."Faced with these concerns, the more than 200 signatory organisations are calling on "European countries to protect their farmers and breeders, as well as citizens and nature" by stoping "the de-regulation of new GM plant".In France, a collective opinion of organic stakeholdersOn 21 February, at the initiative of the Minga Faire ensemble association, more than 70 companies and organisations decided, two days before the opening of the Paris International Agricultural Show, to publish the opinion column "Produire dans le respect du vivant : un enjeu vital" vi. With this letter, the signatories recall that "the basis of organic farming is above all an agricultural commitment to the fact that it is impossible to produce quality food sustainably by mistreating ecosystems". Then, acknowledging the scientific reality of climate change, the signatories take a hard line against climate sceptics and techno-solutionists: "The war against life is lost in advance. Artificial and soilless agricultural crops, GMOs, new genomic techniques vii, the questioning of the precautionary principle and the privatisation of living organisms - all these attempts will not change a thing". Referring to the French political context of recent weeks, he adds that "the attempt to close the Agence Bio, [...] the systematic attacks on the French Biodiversity Agency (OFB) [...], the Senate's desire to reintroduce the use of neonicotinoids [...] reveal an irresponsible policy that confuses the interests of the strongest with the general interest".However, the signatory organisations are no less self-critical of their own shortcomings, stating that "this headlong rush by the proponents of productivist agriculture is also the result of too long a period of depoliticisation of the subject of organic farming by the players themselves". That's why they conclude by stressing the need to mobilise and give themselves "the means to meet the food and environmental challenges at stake [...] around an ambitious policy involving all the players in the industry [...]. Not just from "field to plate", but from "seed to plate", from the artisan seed growers who select tomorrow's seeds in the field, to the growers and breeders, researchers, teachers, local authority officials, processors, cooks, distributors and consumers".These two positions are published at a time when some of the signatory organisations have also launched petitions calling on "the European Commission and the EU Member States to adopt a firm position against any attempt to exclude new GMOs from existing European legislation on GMOs" viii or asking the French government "to adopt a firm position during the forthcoming discussions against any attempt to exempt new GMOs from existing European regulations on GMOs"ix. These simultaneous calls come at a time when Poland has put a proposal on the table of EU Member States aimed at "resolving" patent issues, the sticking point in discussions on the proposed deregulation of GMOsx. An increasing number of European civil society organisations seem determined to keep up the pressure on national and European authorities to abandon this proposal to deregulate GMOs.i Greenpeace, Centro Internazionale Crocevia, ECVC, IFOAM Organics Europe, Nordic Maize Breeding and Pollinis, « JOINT STATEMENT ON THE DEREGULATION OF NEW GMOS », 11 February 2025.ii Eric Meunier, « Le législateur est prié de ne pas trop discuter », Inf’OGM, le journal, n°175, avril/juin 2024 (in french).iii Eric Meunier, « Les États membres bloquent la déréglementation des OGM », Inf’OGM, 8 February 2024 (in french).iv Eric Meunier, « La Hongrie tente de faire bouger les États membres », 1er October 2024 (in french).v Eric Meunier, « Polish proposal on patents and GMOs casts doubts among Member States », Inf’OGM, 28 January 2025.vi Minga Faire ensemble, « Produire dans le respect du vivant : un enjeu vital », 21 February 2025 (in french).vii Remember that products derived from these “new genomic techniques” are considered GMOs under European law, and are therefore governed by Directive 2001/18.viii Biodynamic Federation Demeter International, WeMove Europe, Friends of the Earth EUrope, ECVC, Slow Food Europe and CEO, « Keep GMO food regulated and labelled! ».ix Pollinis, « Contre un monde génétiquement modifié, exigez du gouvernement qu’il dise non à la dérégulation des nouveaux OGM ».x Eric Meunier, « La proposition polonaise sur les brevets et les OGM plonge les États membres dans le doute », Inf’OGM, 28 janvier 2025. Antoine VEPIERRE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [120] => Array ( [objectID] => 12211 [title] => Despite negotiations in 2024, disagreements over DSI persist [timestamp] => 1741305600 [date] => 07/03/2025 [annee] => 2025 [url] => https://infogm.org/en/despite-negotiations-in-2024-disagreements-over-dsi-persist/ [image] => https://infogm.org/wp-content/uploads/2026/03/46838709741_114892f714_c-768x512.jpg [extrait] => In 2024, digital sequence information (DSI) derived from genetic resources was at the heart of international negotiations. Discussions focused mainly on the sharing of the benefits generated by the industrial and commercial use of this DSI, and the mechanisms required to implement it. These developments could redefine governance and influence the future regulation of DSI, but persistent differences between countries are holding back progress. [chapo] => In 2024, digital sequence information (DSI) derived from genetic resources was at the heart of international negotiations. Discussions focused mainly on the sharing of the benefits generated by the industrial and commercial use of this DSI, and the mechanisms required to implement it. These developments could redefine governance and influence the future regulation of DSI, but persistent differences between countries are holding back progress. [texte] => The crucial issue of DSIs linked to genetic resources was addressed at two meetings in 2024: in September in Rome, as part of the working group on improving the multilateral system of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA or Treaty), and then in November in Cali, during COP16 of the Convention on Biological Diversity (CBD).The Tirpaa applies the CBD to crops, as the CBD was initially unable to regulate the majority of plant genetic resources already held in the collections of former colonial powers and the Consultative Group on International Agricultural Research (CGIAR), often without traceability of their origin. Although the ITPGRFA and the CBD deal with DSI under different legal frameworks, their implications in terms of conservation, access, use and benefit-sharing remain intertwined. Solutions to the problem of DSI were proposed at these meetings, but disagreements, including semantic disagreements, remain.DSI, an undefined conceptNo officially agreed definition of DSI has yet been adopted. Some consider that DSI is limited to the digital representation of raw sequences (of DNA, RNA, etc.), while others also include information on the proteins linked to these sequences and their functions, their molecular structures and ecological metadata (contextual information describing the environmental characteristics associated with the biological data)i. Biological samples and certain functions or traits of selected and identified organisms (plants, animals, etc.) ("traditional" knowledge), mostly from farmers, have been collected for many years. They are then entered into databases along with certain traits. The concept of DSI is based on the separation between the biological sample and the digital sequence, considering that the DSI results from the creative interpretation of the researcher through his computer. This is incorrect.Although DSI are not formally considered to be physical genetic resources, notably by the CBD ii, they are nevertheless treated as derivatives requiring benefit sharing, particularly when they are exploited for commercial purposes. This interpretation has given rise to heated debate. On the one hand, there are the countries of the Global South and farmers, the main providers of genetic resources, who argue that DSI should be considered as genetic resources subject to the obligations of the Treaty. On the other hand, the countries of the Global North believe that DSI are the products of research and therefore not subject to these obligations.To make matters more complex, another acronym, GSD (genetic sequence data), was used in 2017 by the United States at the FAO. The US argued that "GSD is neither genetic material nor a genetic resource, and that a conceptual and definitional distinction should be maintained between the genetic material itself and the data describing that material". However, as some, such as Guy Kastler of the European Coordination Via Campesina( ECVC), assert, "DSI and GSD refer to the same reality"iii. This lack of consensus on the precise meaning of the term DSI is holding back the development of legal mechanisms for regulation, access to DSI and the sharing of the benefits arising from their use. However, in 2024, the ITPGRFA and the CBD continued their separate negotiations in an attempt to find solutions.ITPGRFA : DSI at the heart of negotiationsAt the ITPGRFA meeting in Rome in September 2024, discussions again focused on the integration of DSI into the Multilateral System of access and benefit-sharing (ABS)iv. The working group emphasised the growing role of DSI in agricultural research and development and examined the ways in which they could be taken into account in the context of benefit sharing.A major point of discussion was the possibility of introducing two options for benefit sharing: an annual payment option and a deferred payment option. In the first case, known as "subscription", a sum would be paid each year from the year following the first accession to a plant genetic resource in the Multilateral System (MLS). In the second case, known as "single access", this sum would be paid when the product developed from this accession is marketed. The working group has included DSI in the deferred payment option, which is simply a continuation of the current benefit-sharing mechanism, which is totally flawed because industry rarely declares the origin of the resources it uses. This circumvention will be further facilitated by the free access on the Internet to multiple DSI databases, which exempt the industry from signing all its commitments resulting from the signing of "material transfer agreements" each time it accesses physical seed samples from the MLS. The working group also examined how the mechanism for subscribing to the MLS could better meet expectations in terms of sharing the monetary benefits arising from DSI. For the majority of countries in the "South", this should be the only possible option. This "subscription", consists of a company paying each year a share of its sales turnover to a benefit-sharing fund managed under the responsibility of the Treaty in exchange for unlimited access to all the plant genetic resources of the MLS. This percentage would then be much lower than the percentage paid for single access. The working group's discussions on these two mechanisms must continue, with the aim of reaching a consensus at the next meeting of the Treaty’s governing body, which will take place from 13 to 15 December 2025.The working group also stressed the need to coordinate the proposals with the mechanisms developed under the Convention on Biological Diversity (CBD) in order to avoid redundant payments. The group also encouraged the contracting parties, the co-chairs and the secretariat to raise awareness among delegations and stakeholders of the importance of the multilateral system and the prospects for strengthening it.COP16: between progress and uncertainty COP16 in Cali focused on DSI governancev. It started from a mixed assessment of COP15 (2022) on the financing of projects and the sharing of benefits from genetic resourcesvi. The compromise reached in Montreal in December 2022 only laid down general principles, including the creation of a multilateral mechanism for sharing the benefits arising from the use of DSIvii.COP16 aimed to implement this multilateral mechanism and create a global fund. The objective was also to determine the purposes for which the benefits from DSI will be distributed, in order to meet the global challenges of biodiversity and equity. While the scope of the multilateral mechanism was broadly defined, no definition of DSI was established due to the deep disagreements over this major issue. This point is due to be discussed again at a follow-up conference to COP16, to be held from 25 to 27 February in Romeviii.A decision has nevertheless been taken with the creation of the Cali Fund, which aims to ensure "an equitable sharing of the benefits arising from the use of DSI". Under this fund, users of DSI (pharmaceutical, biotechnology, cosmetics, plant and animal breeding, etc.) are required to contribute 0.1% of their turnover or 1% of their profits each year. The funds collected will in theory be earmarked for conservation programmes and the collection of new biological resources, with priority given to the main supplier countries, involving indigenous peoples or local communities legally recognised for their role in conserving biodiversity. Whether corporate contributions to the Cali Fund should be mandatory or voluntary remains open to debate, but the question seems almost ironic, given the substantial benefits they derive from DSI. The actual implementation of the multilateral mechanism also remains uncertain: it is crucial to succeed in guaranteeing the active participation of the companies concerned, and to put in place precise monitoring systems to identify DSI users who should contribute to the fund. The lack of a definition of DSI further complicates the implementation of the fund.The issue of the governance of the Cali Fund also requires particular attention to ensure that funds are distributed transparently and equitably, particularly in terms of how they are paid out to indigenous peoples and local communities. The experience of the Treaty’s Benefit Sharing Fund shows us that these funds are never allocated directly to indigenous peoples and local communities, but are always channelled through gene banks, NGOs, researchers, natural parks, etc., which are responsible for facilitating the ex situ collection and conservation of new resources and associated knowledge, the first foodstuffs for the artificial 'intelligence' responsible for identifying DSI. The success of this mechanism will depend on the ability of the stakeholders to overcome these obstacles and establish effective operational structures before COP17, scheduled to take place in Armenia in October 2026.What are the prospects for balanced governance?DSI facilitate access to genomes and the identification of plant traits, thereby encouraging the sharing of information without requiring access to physical biological organisms. This raises the question of the fairness of benefit sharing, particularly in the absence of a clear legal framework. It does away with the free, prior and informed consent of the CBD, which makes any access to genetic resources conditional on the beneficiary's not claiming intellectual property rights over these resources, their genetic parts and/or components, and the Treaty’s formal prohibition on claiming such intellectual property rights. This effectively legalises the tools of biopiracy, which are now dematerialised. This also explains the differences in the legal status of DSI, with countries in the global North considering them to be patentable products of research, while countries in the global South regard them as genetic components of unpatentable physical organisms, blurring the obligations of consent and benefit sharingix.The use of DSI is closely linked to the new genomic modification techniques (NGT), which make it possible to use DSI to modify genomes while claiming not to introduce foreign genetic material. This approach, which is widely used by multinational seed companies, increases the risks of biopiracy x, as NGTs enable genetic diversity to be exploited without recognising the rights of the countries of origin of the resources or those of indigenous peoples and local farming communities. This situation therefore primarily benefits economic players in the Global North to the detriment of countries in the Global South, which are the main suppliers of genetic resources and sources of DSI.These "innovations" are also widening inequalities of access, with some countries lacking the infrastructure and technical capacity to make full use of DSI, particularly IT resources. In the absence of appropriate legal tools, these technologies reinforce the control of living organisms by a few multinationals and weaken existing frameworks for the protection of genetic resources and traditional knowledge.The future of DSI governance is now in the hands of international bodies that claim to want to reconcile "innovation", equity and the preservation of biodiversity. The effective implementation of the Cali Fund, the clarification of companies' obligations and the link between equitable access and patents, the main tool used to enhance the value of DSI-derived "innovation", are major challenges. Similarly, the balance between open access, the prohibition on claiming intellectual property rights and benefit sharing under the ITPGRFA will require adjustments to ensure fair recognition of the providers of genetic resources and their knowledge relating to these resources.i Brink M., "Practical consequences of digital sequence information (DSI) definitions and access and benefit-sharing scenarios from a plant genebank's perspective", 2 May 2021.ii Convention on Biological Diversity, "Decision 16/2 - Digital sequencing information", 1st November 2024.iii Guy Kastler, "DSI: dematerialised biopiracy", Inf'OGM, le journal, n°176, July/September 2024.iv FAO, Tirpaa, "Twelfth meeting of the ad hoc open-ended working group to enhance the functioning of the multilateral system", 16 to 19 September 2024.v Convention on Biological Diversity, "Conference of the Parties to the Convention on Biological Diversity - Sixteenth meeting, Cali - Digital sequence information on genetic resources", 1 November 2024.vi Denis Meshaka, "COP16 : les pays se réunissent pour « protéger la biodiversité »'", Inf'OGM, 25 October 2024 (in french).vii Denis Meshaka, "COP 15: accord a minima sur les ressources génétiques", Inf'OGM, 22 December 2022 (in french).viii Convention on Biological Diversity, "Countries to Resume Crucial Biodiversity Discussions in Rome, 25-27 February 2025", 27 November 2024.ix Denis Meshaka, "COP 15: accord a minima sur les ressources génétiques", Inf'OGM, 22 December 2022 (in french).x Guy Kastler, "DSI: dematerialised biopiracy", Inf'OGM, le journal, n°176, July/September 2024. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [121] => Array ( [objectID] => 12200 [title] => Male mosquitoes genetically modified to produce poison [timestamp] => 1741132800 [date] => 05/03/2025 [annee] => 2025 [url] => https://infogm.org/en/male-mosquitoes-genetically-modified-to-produce-poison/ [image] => https://infogm.org/wp-content/uploads/2026/03/5000-768x461.jpg [extrait] => Mosquitoes carry pathogens that cause diseases such as malaria and dengue fever, and are therefore known as vector-borne diseases. As part of the fight against these mosquitoes, researchers at Macquarie University (Australia) are considering a new genetic strategy. The idea is to genetically modify male mosquitoes so that their sperm produce molecules that will poison female mosquitoes. [chapo] => Mosquitoes carry pathogens that cause diseases such as malaria and dengue fever, and are therefore known as vector-borne diseases. As part of the fight against these mosquitoes, researchers at Macquarie University (Australia) are considering a new genetic strategy. The idea is to genetically modify male mosquitoes so that their sperm produce molecules that will poison female mosquitoes. [texte] => Mosquito-borne diseases are mainly controlled by “mechanical” methods (mosquito netting, stagnant water management) or chemical methods (repellents, insecticides). These methods are still used today. However, it has been observed that insecticides are losing their effectiveness: mosquitoes have acquired a strong resistance to many molecules. It is against this backdrop that the idea of rendering male mosquitoes sterile has emerged, a strategy we have already discussed extensively in our columns. Sterility can be achieved by irradiation or transgenesis. But, as we have also pointed out, the results have not been encouraging. Australian researchers are proposing a new approach: transferring a spider or sea anemone genetic sequence encoding a toxic molecule into male mosquitoes, so that they produce it in their sperm.Insects that poison their fellow creaturesFor the time being, researchers at Macquarie University (Australia) have not genetically modified mosquitoes but male Drosopĥila melanogaster flies, as detailed in an article published in Nature Communicationsi. Drosophila is a well-known laboratory model, often used as a precursor to research on other insects. In their project, the researchers wanted to express venom proteins in the “accessory glands” of male Drosophila, the glands where seminal fluid proteins are produced. These proteins are derived from two living organisms: a Brazilian spider (Phoneutria nigriventer) and the sea anemone (Anemonia sulcata). This choice is based on the theory that the proteins encoded by the spider or sea anemone transgenes will not pass into the males' hemolymph (the equivalent of blood) and will therefore not be toxic to these transgenic flies. The transgene is injected into the insects' eggs and, in theory, will only be expressed as a toxic protein in the insects' seminal glands.The idea is that transgenic males mate with wild females and the latter “receive” venom via the seminal fluid. In short, the males poison the females. In concrete terms, the toxic proteins must be of low molecular weight if they are to pass from the female's sexual organs to vital organs: “It has been demonstrated in Drosophila melanogaster that several low molecular weight (seminal fluid proteins) can pass through the female reproductive tract and enter the circulatory system (haemolymph), and even to act on receptors in the central nervous system”. Once in the central nervous system, these venoms target specific receptors and thus have a neurotoxic effect. The researchers found that in mosquitoes, these seminal fluid proteins “also act on receptors found within the CNS, with 30% of radiolabelled Culex SFP localising to the female head and thorax”. Theoretically, males would not be affected by this leakage of toxic molecules from seminal vesicles to nerve receptors.The article points out that this approach reduces “the median lifespan of mated females by 37 − 64% compared to controls mated to wild type males”. Using mathematical models, the authors also compared the performance of this strategy with that of the sterile male insect by irradiation, Wolbachiaii or transgenesis: “These results suggest that compared to [the Oxitec strategy (fsRIDL)], TMT (toxic male technique) may reduce the incidence of blood feeding during the release period by a further 40–60% under most scenarios, which has significant epidemiological implications”. To achieve a significant rate of females dying during mating, the authors specify that their toxic males must be fertile... Paradoxically, they also state that “sterilisation of the males to mitigate the risk of transgene escape” will probably be required. But all this is based, again, on estimates and mathematical models, and no one knows what might actually happen once these genetically modified toxic males are widely disseminated in the environment.The researchers point out that males are not affected by the venom because the chosen transgenic protein acts on a targeted receptor, which is not present in the male reproductive system. They also claim that the chosen venom proteins cannot interact with receptors present in mammals. In fact, not all poisoned females die, so the survivors can continue to bite and transmit the venom to mammals...Female mosquitoes targetedFor the authors of the study, the advantage of their strategy over the sterility strategy used in previous techniques is that it targets not the offspring between modified males and wild females, but wild females directly. They write: “for example, wild female Ae. aegypti have a median adult lifespan of 2–3 weeks, will typically mate within 24–48 h of emerging, and on average will take 0.63–0.76 blood meals per day. Females that mate with (genetic biocontrol technologies) males may not produce viable offspring, but they can continue to spread disease or damage crops”.However, the question of mosquito resistance to these poisons cannot be ruled out. The researchers' strategy is designed to circumvent the acquisition of pesticide resistance in mosquitoes, but it too could be circumvented. As the authors of the study put it: “Co-expression of multiple toxins could help to mitigate the emergence of resistance alleles, as well as potentially resulting in synergistic toxicity from affecting multiple ion channel targets”iii.Other unanswered questionsThe researchers consider that the impact of these venoms on the mosquito's natural predators, such as birds, bats and certain amphibians, also needs to be determined. The authors are reassuring, immediately pointing out that “the oral toxicity of venom proteins is typically between 1 and 2 orders of magnitude lower than when they are directly injected, and venom proteins can be selected which have greater toxicity for the target species relative to natural predators”. Again, this is theory. These GM mosquitoes have not been studied under real conditions in a complex ecosystem.In an article in the British newspaper The Guardianiv, Professor Philip Weinstein, an infectious disease researcher at the University of Adelaide (Australia), who was not involved in the study, is reported having said that “an ideal solution would be to control the insects without eradicating them, given that mosquitoes were pollinators and an important food source for fish and bats”. There is also the question of the purpose of these genetic technologies. Vector-borne diseases are fatal in certain socio-political contexts, and for children under the age of five who are often malnourished at the same time. The implementation of water management systems and the fight against insecurity and poverty are important elements not to be neglected. While eradicating mosquitoes is not desirable, achieving this objective seems impossible today.i Beach, S.J., Maselko, « M. Recombinant venom proteins in insect seminal fluid reduce female lifespan », Nat Commun 16, 219 (2025).ii Technically, the sterility is obtained by inoculating Wolbachia bacteria to mosquito, see :Christophe Noisette , « Google also eradicates mosquito », Inf’OGM, 27 July 2017 (in french) ;Christophe Noisette, « Wolbachia : the bacteria which renders mosquito inoffensiv », Inf’OGM, le journal, n°158, January / March 2020 (in french).iii An ion channel is a membrane protein that allows the high-speed passage of one or more ions. Ion channels are present in the membrane of all cells.iv Petra Stock, « Male mosquitoes to be genetically engineered to poison females with semen in Australian research », The Guardian, 7 janvier 2025. Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [122] => Array ( [objectID] => 10497 [title] => Nanotechnologies in the field: nothing new in twenty years? [timestamp] => 1740700800 [date] => 28/02/2025 [annee] => 2025 [url] => https://infogm.org/en/nanotechnologies-in-the-field-nothing-new-in-twenty-years/ [image] => https://infogm.org/wp-content/uploads/2026/03/Veillenanos-par-AVICENN.jpg [extrait] => Patents involving the use of nanos* in agriculture have multiplied over the last 20 years. However, there has been no improvement in the availability of information in this field. A recent report, commissioned by AVICENN and published by the European Chemicals Agency (ECHA), re-emphasizes the need to change European regulations in order to better identify, assess and manage nanos in the fields and the food. AVICENN is calling for greater transparency on the marketing and risks of nanomaterials that have long been used in agriculture. [chapo] => Patents involving the use of nanos* in agriculture have multiplied over the last 20 years. However, there has been no improvement in the availability of information in this field. A recent report, commissioned by AVICENN and published by the European Chemicals Agency (ECHA), re-emphasizes the need to change European regulations in order to better identify, assess and manage nanos in the fields and the food. AVICENN is calling for greater transparency on the marketing and risks of nanomaterials that have long been used in agriculture1. [texte] => In November 2004, in Canada, the ETC Group, a group of expert activists, published “Down on the Farm: The Impact of Nano-scale Technologies on Food and Agriculture”[cm_simple_footnote id=2], a report as documented as it was explosive, dealing with the rise and impact of nanotechnologies developed for agriculture and food. Among its recommendations was a ban on the release into the environment of agricultural inputs containing nanos (whether pesticides, fertilizers or soil treatment products) whose safety has not been established. This needed, de facto, the creation of new regulatory provisions requiring specific risk assessments of these new products. At the time, BASF, Bayer, Monsanto, Syngenta, etc. were already filing patents for these products.In 2024, almost no data publicly availableTwenty years later, there are now over 1,000 patents[cm_simple_footnote id=3] on the use of nanos in agriculture, and hundreds of scientific articles on the issue. But no specific regulatory provisions have been deployed. In November 2024, the European Chemicals Agency (ECHA) published a rapport[cm_simple_footnote id=4], whose conclusions, less radical at first glance than the 20-year-old ETC Group report, ultimately concur with this NGO's recommendations.Before going into detail, it should be pointed out that the report published by ECHA was not written by an environmental NGO, but by an Italian company, Innovamol, which specializes in the analysis and synthesis of scientific data using artificial intelligence (AI) and machine-learning (ML).On the basis of nearly 11,000 documents, 3,052 were deemed relevant. 1,872 were finally selected and analyzed in detail (mostly scientific articles, but also 140 patents, a few books, theses, institutional reports, web pages, forums, etc.). 75 contributions were also collected as part of a consultation launched by Innovamol, in which some sixty researchers took part (five chemical manufacturers, four representatives of regulatory agencies and six NGOs, including our association AVICENN, which initiated the process[cm_simple_footnote id=5]).Among the substances most commonly cited in the scientific literature for agricultural applications are metal nanoparticles (silver, zinc, copper, iron), silica nanoparticles, polymer and hybrid nanoparticles[cm_simple_footnote id=6], carbon nanoparticles[cm_simple_footnote id=7], chitosan nanoparticles, and so on.Innovamol also reports on the (expected) benefits of using nanotechnologies in agriculture, including improvements in :antifungal properties (for copper or zinc oxide nanoparticles, for example),disease resistance (for silica nanoparticles in particular),nutrient absorption (for iron and zinc nanoparticles),controlled release mechanisms for agrochemicals (nanovectors are designed to lengthen the release of nutrients and pesticides, at lower doses that are claimed to be supposedly more effective and less harmful to the rest of the environment),plant defense (improved response to stress and resistance to pathogens through the induction, via nanoparticles, of antioxidant enzymatic activities and a strengthening of cell wall integrity), andthe biodegradability of certain components (with the use of biodegradable nanocomposites).What's interesting about the report is that it also points out the many gaps in knowledge concerning both the marketing and use of nanos in agriculture, and human and environmental exposure and associated hazards. It also points out that existing European regulations, in particular, contain no specific provisions concerning nanos in pesticides or fertilizers. Regulation (EU) no. 528/2012 does require (nano)-labeling of nanomaterials in biocidal products, as well as a pre-market risk assessment... but it doesn't apply to agricultural products, covered by regulations (EC) no. 1107/2009 on plant protection products and no. 2019/1009 on fertilizers, which make no mention of the particle size used in pesticides and fertilizers (and this, whether concerning active substances or their adjuvants). In practical terms, not taking molecule size into account in the regulations means ignoring this issue and relying on assessments of the “bulk” substance, which in most cases is less reactive and therefore less toxic than the same nano-scale substance. This is what happened with the European REACH regulation: for years, industry and European authorities claimed that this regulation applied by default to nanos. But when ECHA asked manufacturers for precise data on the “nanoforms” of their chemical substances, the industries contested these requests with ECHA's Appeals Office, which ruled in their favor, legally speaking, as there was no definition of the term “nanoform”. It took several additional years to obtain, via a revision of the REACH annexes, a definition and the requirement for additional data and a nano-specific assessment. In short, more than 10 years lost! Without taking into account the fact that the definition adopted is highly unsatisfactory and lets many nanos slip through the net…One nanometre = 10-9 metres = 0.000 000 001 m = 1 billionth of a metreWhen chemical substances are used at this size, “extraordinary” properties (in the true sense of the word) appear: either new properties, or properties that are exacerbated compared to substances of conventional size (micro or macroscopic). These properties are due to the higher proportion of surface atoms (relative to volume) than for substances used on a larger scale: there are more exchanges and interactions with their environment. Add to this the fact that nanos, because of their small size (on the order of a virus or the diameter of DNA), more easily cross physiological barriers and infiltrate all environmental compartments, resulting in widespread, diffuse contamination...When can we expect a change?In this respect, the report's recommendations deserve to be passed on, as they are highly relevant:update European legislation to include a definition and specific provisions for nanomaterials in the regulations on plant protection products and fertilizers;establish a framework for standardized instructions for use;create a database of nanos used in EU agriculture and set up a mandatory notification system for manufacturers;call for systematic literature reviews and mandatory toxicity and ecotoxicity tests to back up claims of efficacy and enable public authorities to fulfill their duties.What happens next? What will become of these recommendations? Will the ECHA and public authorities take them on board? At the French level, AVICENN has asked the French Health Safety Agency (Anses) to invite Innovamol to present this work to the “nanomaterials dialogue committee” convened by Anses[cm_simple_footnote id=8]. In 2016, this agency initiated a survey of pesticide and fertilizer manufacturers and users, before launching tests on plant protection products in 2018, the results of which are still not public. And yet, every year for the past ten years, agriculture has topped the list of nano-use sectors declared in the r-nano[cm_simple_footnote id=9] register managed by Anses! Despite the initial aim of this register - to strengthen traceability and public information, and contribute to risk assessment - no details of the characteristics, locations and risks of the nanos concerned are publicly available.Tired of waiting for answers from high-ranked people to our questions, AVICENN made several attempts to apply for funding to work with researchers on the identification and risk assessment of nanomaterials in plant protection products, notably from the French National Research Agency (ANR). But our project was not selected, on the grounds that we are not allowed to access the r-nano register (neither AVICENN, nor researchers... who work for public research organizations[cm_simple_footnote id=10]). The ANR selection committee said it was “convinced by the quality of the scientific question”, but not by the “feasibility of the project” considering “the availability of product information is not assured”.How much longer will it be before data on nanoparticles in plant protection products is finally demanded of manufacturers and made available, so that the associated risks to humans and the environment can be assessed?* The term nanos refers here to active substances of nanometric size (also known as “nanoparticles” or “nanomaterials”), as well as the nano-encapsulations and nano-vectors designed to protect them and deliver them to plants. It does not include the “nanotechnologies” contained, for example, in the sensors used in so-called "precision" agriculture, or “agritech”. The terminology surrounding the term “nano” and its derivatives is the subject of ongoing expert debates and negotiations at European level, which go beyond the agricultural sector alone. Anses and AVICENN in France, BEUC, Foodwatch and MEPs at European level, have all contributed to preventing the adoption of the wrong definition, in 2024, in the Novel Foods Regulation[cm_simple_footnote id=11]. In the coming months, the semantic and regulatory debates will focus on cosmetics. Mathilde DETCHEVERRY (General Delegate of AVICENN) [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [123] => Array ( [objectID] => 10457 [title] => Patents and GMOs: different stakeholders, different solutions [timestamp] => 1740528000 [date] => 26/02/2025 [annee] => 2025 [url] => https://infogm.org/en/patents-and-gmos-different-stakeholders-different-solutions/ [image] => https://infogm.org/wp-content/uploads/2026/03/266302501_ad15b41ab7_w.jpg [extrait] => Since July 2023, the issue of patents on living organisms has been at the heart of debates in the European Union. These debates were sparked by the European Commission's proposal to stop assessing the risks associated with GMOs, to stop labelling them as such, and to put an end to their detection and identification. In December 2024, a conference allowed several stakeholders of the debate to express their opinion. [chapo] => Since July 2023, the issue of patents on living organisms has been at the heart of debates in the European Union. These debates were sparked by the European Commission’s proposal to stop assessing the risks associated with GMOs, to stop labelling them as such, and to put an end to their detection and identification. In December 2024, a conference allowed several stakeholders of the debate to express their opinion. [texte] => On December 9, 2024, German MEP Martin Häusling organized an online conferencei on the issue of patents and new genetic modification techniques. Stakeholders such as the European Coordination of Via Campesina (ECVC), the No Patent on Seeds (NPoS) coalition and Copa-Cogeca were able to compare their point of viewii. Multinationals also had the opportunity to express their view via the Euroseeds structure. The conference provided an opportunity to weigh up the different approaches to the issue of patents.Copa-Cogeca, ECVC, NPOS... solutions at opposite ends of the spectrum!For Copa-Cogeca, a body representing professional agricultural organizations and agri-food cooperatives, the issues of GMO deregulation and patents must be dealt with separately. Its proposal is therefore simple: adopt GMO deregulation as quickly as possible, and postpone the discussions on the issue of patents until a later date. Copa-Cogeca also believes that consideration should be given “to find an intelligent way how to mix [the] two plant variety rigths systems” existing in Europe, namely the Plant Variety Certificate (PVC) on the one hand, and patents on the other.As it recently reiterated in response to a proposed solution put forward by Polandiii, ECVC, the European farmers' union, believes that one of the major problems with the deregulation proposed by the European Commission concerns the risk to have a “corporate control of all cultivated biodiversity and the food chain to a handful of seed companies via the patents they hold”. ECVC has argued that one of the key points is to maintain the existing obligation for GMO producers to provide detection and identification methodes enabling products obtained by new techniques to be traced. Otherwise, “farmers and traditional seed producers who use or market seeds containing a genetic sequence that is similar to a patented sequence obtained by NGT, either naturally or as a result of contamination, will no longer have any means of opposing abusive patent infringement proceedings”.For the European coalition No Patents on Seeds, the European Union's objective should at least be “to [...] completely exclude conventionally-bred plants from patent law”iv. NPoS believes that there is sufficient leeway “to enforce a ban on the patenting of plants obtained from random mutagenesis”. Although the notion of “random mutagenesis” is not legally defined, the coalition proposes that this technique of genetic modification should be considered as an essentially biological process and, as such, should be unpatentable, just like the products obtainedv.Euroseeds proposes an imprecise solution, to say the leastDuring the conference, another player had the opportunity to express its view. This was Euroseeds, an organization representing multinational seed companies. Through the voice of Petra Jorasch, Euroseedsvi presented its point of view, with proposals that had already been published in July 2024vii, but which had gone rather unnoticed at the time. In connection with the issue of genetic modification techniques, the multinational seed companies are proposing a number of measures which, in their view, would make it possible to guarantee a system of intellectual property protection, while maintaining access to plant material for seed companies.For example, one of the proposals put forward by the multinationals represented by Euroseeds is directly linked to the GMO issue. Stating that it has long supported the principle of excluding so-called “essentially biological” processes from patentability, Euroseeds proposes that this exclusion be extended to all “breeding methods yielding non-repeatable results (such as random mutagenesis based on chemicals or irradiation and protoplast fusion)”. In simpler terms, the multinationals want a genetic modification technique they call “random mutagenesis” (without defining it) to be considered unpatentable, being submitted to the same consideration as the one on essentially biological processes. They specify that the resulting products should also be excluded from patentability. It is important to emphasize here that this proposal, combined with the absence of any obligation to provide a GMO detection and identification method as proposed by the European Commission, would enable multinationals to market patented GMOs without having to declare them as such. The case of Cibus and its canola 5715 is one example. Initially presented and authorized in Canada as obtained by oligonucleotide-directed mutagenesis, this GM canola was declared in Europe to have in fact been obtained by “random mutagenesis”. Thanks to this move, Cibus hoped to escape a 2018 decision by the Court of Justice of the European Unionviii.Another proposal is to limit the scope of a patent. Euroseeds considers it important that “the effect of a product patent on biological material must not extend to any biological material which has the same properties but has occurred naturally or results from undirected and thus not repeatable processes like random mutagenesis and protoplast fusion”. However, the organization does not demand that the obligation to provide a method for the detection and identification of GMOs be maintained - the one and only condition under which such a proposal might seem feasible.More broadly, and in line with Copa-Cogeca's analysis, Euroseeds believes that the two intellectual property systems which are the plant variety certificate (Euroseeds talks about plant breeders’ right - PBR) “to protect a plant variety and [the] patents to protect technologies and characteristics obtained through biotechnological processes” need to be supported and improved. The organization proposes, for example, that “the PBR system must be strengthened and improved” to enable seed companies to resolve the difficulties they encounter in asserting their rights to farm-saved seed (information from farmers and collection of the “fair remuneration” that these farmers must pay).A final example is the proposal made for seed companies. Euroseeds recommends that the breeder's exemption provided for in patent law in certain countries “such as France, Germany and the Netherlands” be adopted by other countries. This exemption gives seed companies access to patented varieties in the case of varietal improvement work. An exemption which applies to the research phase, but not to the marketing phase, as explained by RAGT and Florimond Desprez in 2023ix.i Martin Häusling, « Freier Zugang zu Saatgut- Für ein krisensicheres Ernährungssystem », December 2024.ii To read about ECVC and NPoS’ opinions, see :https://infogm.org/en/gmo-patents-is-it-possible-to-break-the-deadlock/To read about Copa-Cogeca’s opinion, see :https://infogm.org/en/copa-cogecas-ambiguities-on-the-issue-of-plant-patents/iii ECVC, « New GMOs and patents: Poland’s IIlusory Solutions », January 2025.iv NPoS, « What can be achieved at EU level against patents on seeds? », 9 December 2024.v Christoph Then (No Patents on Seeds!), « Short comment on the expert opinion: “Legal options for changing the patent protection of plants in Germany, Europe and international law – Expert opinion commissioned by the Bundestagsfraktion Bündnis 90 /Die Grünen” », December 2024.vi Martin Häusling, « Freier Zugang zu Saatgut- Für ein krisensicheres Ernährungssystem », from 57min50sec to 1h59, December 2024.vii Euroseeds, « Euroseeds View on Intellectual Property », 4 June 2024.viii Eric Meunier, « Colza Cibus : une mutation aux origines mystérieuses », Inf’OGM, 29 septembre 2020 (in french).Eric Meunier, « Canola OGM : le gouvernement canadien au secours de Cibus », Inf’OGM, 10 novembre 2020 (in french).ix Eric Meunier, « Des semenciers dénoncent les brevets, mais… », Inf’OGM, 21 mars 2023 (in french). Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [124] => Array ( [objectID] => 10416 [title] => The European Commission wants its “biotech revolution” [timestamp] => 1739923200 [date] => 19/02/2025 [annee] => 2025 [url] => https://infogm.org/en/the-european-commission-wants-its-biotech-revolution/ [image] => https://infogm.org/wp-content/uploads/2026/03/5c23cc4c-6980-4a64-b8e3-1bd1477a94b6-768x512.jpg [extrait] => In March 2024, the European Commission announced measures aimed at driving what it called a "biotechnology revolution", including a proposal for a "law" in 2025. This announcement came at a time when a number of legislative dossiers relating to biotechnology had already reached an impasse, such as the deregulation of plant GMOs. As Denmark, a fervent supporter of biotechnology, prepares to take over the Presidency of the Council of the EU from July 2025, is the Commission planning to bring everything together in a general "biotech law" to complicate political debates and force the issue through? The European Parliament has just taken up the issue on its own initiative. [chapo] => In March 2024, the European Commission announced measures aimed at driving what it called a “biotechnology revolution“, including a proposal for a “law” in 2025. This announcement came at a time when a number of legislative dossiers relating to biotechnology had already reached an impasse, such as the deregulation of plant GMOs. As Denmark, a fervent supporter of biotechnology, prepares to take over the Presidency of the Council of the EU from July 2025, is the Commission planning to bring everything together in a general “biotech law” to complicate political debates and force the issue through? The European Parliament has just taken up the issue on its own initiative. [texte] => 2025 could be a busy year for legislation in the European Union. Discussions on the proposal to deregulate plant GMOs obtained by new genetic modification techniques1 , launched in July 2023, will continue. Similar proposals on micro-organisms and animals have been requested by the European Parliament. Above all, as announced in March 2024 by Margrethe Vestager i , then Vice-President of the European Commission, "action to boost biotechnology and biomanufacturing", including a proposal for a "Biotech Act", are on the agenda. On 23 January 2025, the plenary session of the European Parliament announced that it was referring the matter to itself, instructing its Industry, Research and Energy Committee to study the issue. The lead rapporteur will be German MEP Hildegard Bentele (European People's Party - EPP) ii . If they were to be put on the EU table this year, these measures could be discussed under the Danish Presidency of the EU, a country whose government is resolutely "pro-biotech".Launching the "biotech" eraThe press release of 20 March 2024 is clear on the European Commission's analysis. It states that "advances in life sciences, supported by digitalisation and artificial intelligence (AI), and the potential of solutions based on biology to solve societal issues, make biotechnology and biomanufacturing one of the most promising technological areas of this century. They can help the EU to modernise its agriculture, forestry, energy, food and feed sectors and industry". But, according to the European Commission, a number of obstacles need to be removed.The measures announced by Margrethe Vestager in March 2024 are now the responsibility of the European Commissioner for Health, Olivér Várhelyi. This relatively heterogeneous list of proposals, presented under the slogan "Building the future with nature", would "address several challenges: research and technology transfer to the market, regulatory complexity, access to finance, skills, barriers along the value chain, intellectual property, public acceptance and economic security". For those following the current debates on GMOs, patents and the digitisation of life, this list echoes the criticisms levelled at the regulation of plant GMOs. To respond to these "challenges", the Commission proposes a number of actions. Firstly, the simplification of the regulatory framework would be prepared by a study with a view to a proposal for a "possible Biotech Act to harmonise and rationalise legislation". As Ursula von der Leyen, then candidate for re-election as President of the Commission iii , pointed out in July 2024, the aim of this proposed "law" is to "to make it easier to bring biotech from the laboratory to factory and then onto the market". It is not yet known whether this proposed "law" will be limited to setting out the Commission's general guidelines or whether it will take the form of a more binding legal instrument, imposing specific measures impacting on each current dossier, such as that of plant GMOs/NTGs. It should be noted, however, that the Commission refers to the desire to "simplify the regulatory framework", suggesting that this proposed "Biotech Act" could take the form of a regulation directly applicable to all Member States, rather than a directive to be transposed nationally. Would this also mean that political discussions on the proposed deregulation of plant GMOs/NTGs would be extended to the other economic sectors concerned? This hypothesis seems all the more likely given that one of the European Commission's stated objectives is to “shorten the time for biotech innovations to reach the market; as well as regulatory obstacles that arise at national or other governance levels which impede an effective single market”. The Commission would simplify the regulatory framework... by drastically reducing it. Another measure: the creation of a European biotechnology cluster, planned for the end of 2024 and finally launched on 30 January 2025 iv , to help companies navigate the multiple rules and find "the necessary assistance" to do so. International cooperation would also be stepped up, with partners identified as strategic, such as the United States, to stimulate research and technology transfer. The EU's bioeconomy strategy would also be revised in 2025 to better integrate industrial, environmental and societal challenges, while strengthening its links with biotechnologies. The Commission also intends to develop methodologies that will enable bioproducts to be assessed on an equal footing with fossil fuels, in particular by refining the analysis of their environmental footprint. The stated aim is to "accelerate the substitution of fossil feedstock and to stimulate the demand and market uptake of bio-manufactured products". Measures would be taken to encourage investment, in particular by including bioproduction in the 2025 programme of the European Innovation Council Accelerator v . Finally, the adoption of artificial intelligence will be supported by the GenAI4EU initiative vi , with easier access to EuroHPC supercomputers vii , to support innovation in the field.A "biotech law" as Plan B...In March 2024, when it published its communication, the European Commission proposed making the biotechnology sector a strategic lever for innovation and industrial competitiveness in the EU, in line with the objectives of the United States and China. In this resolutely "pro-biotech" stance, the Commission believes that regulatory simplification, the creation of a dedicated cluster, support for investment, etc. would position the EU as a major player in biotechnology on a global scale.However, this “pro-biotech” orientation seems to be fuelled by a desire to favour the work of multinationals by, for example, implicitly deregulating the biotechnology sector. The mention of a possible “Biotech Act” could therefore be interpreted as a back-up solution, a Plan B envisaged by the Commission to harmonise and regulate biotechnology if its current plans for regulatory changes continue to meet with political reluctance. This is currently the case for the deregulation of plant GMOs/NTGs, and potentially for other issues relating to living organisms on which there is no consensus for political, economic, social acceptance or institutional (and ethical) reasons....to bypass the legislative projects currently at a standstillThe European Commission's "pro-biotech" strategy may have an impact on a series of legislative initiatives concerning living organisms, such as the deregulation of GMO/NTG plants, the digitisation of living organisms (DSI or "digital sequence information"), the issue of patents, the possible deregulation of GMO micro-organisms and animals, etc. viii . While the Commission presents these forthcoming measures as aimed at simplifying the regulatory framework and "stimulating innovation", they will undoubtedly raise concerns about the possible increased appropriation of living matter by companies with significant resources. The example of DSI illustrates these concerns in particular, as this field, dominated by large companies that already have considerable financial and logistical resources at their disposal, could benefit from EU support to pursue controversial developments. These developments are often based on the exploitation of genetic resources with no recognised origin, fuelling accusations of biopiracy and raising ethical and legal questions ix.By facilitating and speeding up access to biotechnologies, and thereby reducing certain obligations, is the Commission seeking to avoid an in-depth debate on the ethical, health, environmental and socio-economic issues associated with these technologies? And is it trying to force through the legislation against Parliament's wishes? In the agricultural and environmental fields, this approach could reduce the ability of national authorities to trace GMOs and regulate the sector effectively, thereby strengthening the power of multinationals over biodiversity and genetic resources.i European Commission, "Commission takes steps to boost biotechnology and biomanufacturing in the EU", 20 March 2024.ii European Parliament, "The future of the biotech and biomanufacturing sector in the EU: putting research to work, boosting innovation and increasing competitiveness", 23 January 2025.iii European Commission, "Europe's choice, Political guidelines for the next european commission 2024-2029", 18 July 2024.iv European Commission, "Commission launches new Biotech and Biomanufacturing Hub to support innovative companies", 30 January 2025.v The European Innovation Council Accelerator is a Horizon Europe funding programme offering support to start-ups and SMEs.vi European Innovation Council, "GenAI4EU: Creating European Champions in Generative AI".vii EuroHPC, "Leading the Way in European Supercomputing".viii Eric Meunier, "The European Commission’s legal initiatives on the Living", Inf'OGM, 13 November 2024.ix Guy Kastler, "DSI: dematerialised biopiracy", Inf'OGM, le journal, n°176, July/September 2024. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [125] => Array ( [objectID] => 10368 [title] => Object of all desire, do GM algae really exist? [timestamp] => 1739750400 [date] => 17/02/2025 [annee] => 2025 [url] => https://infogm.org/en/objet-of-all-desire-do-gm-algae-really-exist/ [image] => https://infogm.org/wp-content/uploads/2026/03/8096375794_92b259a8b4_c-768x511.jpg [extrait] => Algae are the surprise guest in the European Commission's deregulation proposal. How are these organisms used by the industry? In which countries are they produced? And above all, what genetic modifications are being made for which comercialisation? This overview is of importance because, according to the European Commission, their deregulation - like that of other plant GMOs - would be justified by the "evidence [...] on the safety" of these GMOs. However, these GM algae do not exist, as the technical protocols are not yet mastered... [chapo] => Algae are the surprise guest in the European Commission’s deregulation proposal. How are these organisms used by the industry? In which countries are they produced? And above all, what genetic modifications are being made for which commercialisation? This overview is of importance because, according to the European Commission, their deregulation – like that of other plant GMOs – would be justified by the “evidence […] on the safety” of these GMOs. However, these GM algae do not exist, as the technical protocols are not yet mastered… [texte] => When algae will be genetically modified using new techniques, they may no longer be subject to the same rules governing GMOs, just like terrestrial plants. This is the wish of the European Commissioni, which deregulation proposal made in July 2023 contained two Latin terms into the description of organisms covered by its proposal. It wrote that "based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae".This article outlines the current commercial uses of algae and existing genetic modification projects. The terminology used - algae, macroalgae, microalgae - is based on usage as found in various reports. As to whether all or some of the families of algae described below are covered by the European Commission's proposal, the question remains open and will be the subject of a future article. But in any case, given the difficulties to genetically modify algae, including them in the deregulation proposal seems premature, to say the least.Red, green, brown, macro, micro algae...Whether in unicellular (microalgae) or multicellular (macroalgae) form, algae have recently become the object of considerable international and European interest, with the European Commission's 2022 Blue Bioeconomy Plan being a prime example. A year earlier, in 2021, the Food and Agriculture Organization of the United Nations (FAO) published a reportiii on the state of play in this field, based on figures from 2019. That year, total world production of algae was almost 36 million tonnes, almost all of which was macroalgae (99.84%). If asian countries accounted for over 97% of this production, little was done in Europe (0.8% of world production), Africa (0.41%) and the two American continents (1.36%).Harvested from the sea or cultivated in marine facilities close to the coast, macroalgae can be classified as red, green or brown. Brown seaweed accounts for almost 50% of the world's seaweed production and is used in human food (such as Kombu soup or Wakame salads) or animal feed (abalone in particular). They are also a source of various substances used in human and animal nutrition, as fertiliser in agriculture, in pharmaceuticals and as packaging. The two main brown seaweeds used are Laminaria and Undaria.Red algae make up the other half of the world's production. They are used in human food to produce agar or in animal feed (abalone). The red algae Kappaphycus is used to obtain molecules used by the food and non-food industries. Porphyra is a source of food for soups and sushi. The main species are Kappaphycus, Gracilaria and Porphyra.Finally, green seaweed is also used, although in smaller quantities than brown and red seaweed, at just under 17,000 tonnes a year. This algae is used as food (salad, for example), but also to feed abalone, as an agricultural fertiliser, in pharmaceuticals, cosmetics or for waste treatment.Microalgae, named this way because they are microscopic, can be found in both marine and fresh waters. Several are used by industry, with the FAO giving as examples chlorella, diatoms, Nannochloropsis, Schizochytrium, Crypthecodinium and spirulina, which is in fact a cyanobacterium which is "usually deemed part of microalga". In 2019, more than 56,000 tonnes were produced internationally, the vast majority of which was spirulina. China, with almost 55,000 tonnes, is the main producer of microalgae. Commercial uses for these algae, as listed by the FAO, include human food (in the form of chlorella or spirulina powder, for example), food supplements (carotenes, astaxanthin, etc.) and cosmetics (with polysaccharides or colourants). Projects involving the use of microalgae for "wastewater treatment, algae meal and algae oils, carbon sequestration and biofuels" are also cited as rapidly expanding markets in the near future.A "promising" future for industryIn addition to their use in human food and animal feed or as fertilisers in agriculture, algae are also of interest to the industry because of their metabolic capacity to capture nitrogen and phosphorus based compounds. These capabilities captured the attention of the industry for use as a bioremediation or carbon capture agent. Their use as a feed supplement for animals is also touted as potentially helping to reduce methane emissions.However, these uses are subject to a number of limitations for the industry. Among these limits, the FAO lists competition for coastal space with urban areas, fishing or fish farming activities, pollution of surrounding waters and rising ocean temperatures. The "quality" of algae seedlings is also listed among the limitations encountered. The "deteriorating farming environments, such as rising seawater temperatures and more frequent and severe disease outbreaks" are thought to contribute to this loss of quality. Poor management or constraints in the production of strains are also involved, leading to "trait degeneration and the consequent loss of agronomic value of a farmed type". But the FAO cites genetic improvement of these strains as a possible solution! It writes that "genetic improvement technologies, such as strain selection, selective breeding, hybridization, micropropagation (also known as tissue culture) and genetic markers, can help improve seedling quality and production efficiency".But what are the uses of these "genetic improvement technologies", and more specifically those of genetic modification, even if they are not specifically named by the FAO? Two scientific articles provide further information on the current state of research. One of the two articlesiv warns at the outset that, in 2019, when researchers "assessed about 100 genomes of micro and macroalgae, they found that over 50% of the genes were of unknown function"! While they point out that the study of mutants "that occur either naturally or by induction" enabled researches aiming at associating functions with genes, they add that in 2024, the date of publication of their article, "for most of these mutants the causative mutations remain unknown".Genetically modified microalgae that can be disseminated?The scientific articlev by Austrian and German researchers, published in June 2024, reviews the projects for genetic modification of microalgae, whether by transgenesis or using new techniques of genetic modification. On the basis of a scientific bibliography and the reading of various reports (grey bibliography), the authors have identified 36 projects for the genetic modification of microalgae that could involve dissemination in the environment other than via confined environments (such as fermenters for microorganisms). As details of the techniques used are not provided, it is not possible to identify projects involving new techniques and therefore potentially resulting in GMOs that the Commission would like to deregulate. Nevertheless, the panorama is impressive to observe. Of these 36 projects (see table below), only four are described as "market development" and only involve transgenic algae, i.e. GMOs that would remain regulated despite the deregulation envisaged by the European Commission. The authors state that they have not identified any algae modified by new genetic modification techniques.According to the research carried out, the majority of projects involving the genetic modification of microalgae concern the agrofuels sector. Of the 36 projects (see table below), 20 are designed to induce traits in microalgae that are of interest to this sector, 3 of which are in the commercial development phase. 7 projects are in the field of biocontrol, with, for example, genetic modifications carried out to enable GMO algae to be used as a vaccination agent, particularly in shrimp farming; or the expression of a transgene encoding an interfering RNA that will prove insecticidal when Aedes Aegypti larvae feed on these algae. 5 other projects are in the field of what is promoted as environmental decontamination using living organisms. 3 projects involve carbon capture or the production of an animal feed additive.As the authors of the article point out, these 36 projects are destined to lead to the marketing and production and/or dissemination of GMO microalgae in the environment. While it is not possible, as they indicate, to know whether this production and dissemination will take place in confined or open areas, the latter possibility is not ruled out.What about GMO macro-algae?Another scientific articlevi, also published in 2024, provides more specific information on the use of new techniques of genetic modification on macroalgae. As the authors explain, the use of these techniques is clearly in its infancy in a few macroalgae.This applies to transgenesis itself. This technique, used on macroalgae, has only enabled transient expression of transgenic sequences, with the authors adding that "there is a paucity of reports describing successful stable transformation in macroalgae". Among the difficulties encountered are the ability of algae to switch off the expression of inserted transgenes and a lack of knowledge of the genetic sequences involved in regulatory activity.As far as new techniques of genetic modification are concerned, the situation is no more advanced, with "successful reports of genome editing in macroalgae [being] very scarce, much like stable transformation protocols". At the time of publication of their article, the authors note that only the Crispr/Cas tool had been tested on macroalgae. They list 3 articles reporting success with brown and green algae, but these protocols did not go through a transgenesis stage, injecting the Crispr/Cas protein complex directly. This approach is explained by the constraint of not being able to achieve stable transgene expression in these organisms. Above all, the authors state that these 3 articles constitute "proofs-of-concept". In other words, they show that a genetic modification protocol using the directly injected Crispr/Cas tool is possible. But "further research is needed to increase the mutation efficiencies and broaden the applicability of targeted mutagenesis systems in seaweeds".Reading the requirements listed by the authors for a potential successful use of genetic modification techniques on macroalgae, such a prospect still seems remote. The researchers need "more genomes of seaweed species [...] available". Species that, ideally "should have life cycles that can be completed in laboratory settings, allowing genetic transformation protocols to be developed". Another limitation to be resolved is the very limited number - just one in fact - of genetic sequences that can be used as markers (the equivalent of antibiotic resistance genes introduced in transgenic form for use as markers in plants). Lack of knowledge about the interactions between genetic sequences is also a problem. Last but not least, the authors stress that a major limitation is the very low mutagenesis efficiency observed. Their conclusion is therefore quite clear, with the authors considering that "as the genome editing field is developing at a rapid pace, new tools are also continuously being developed, which could offer benefits in terms of efficiency, adaptability, and precision".To sum up, the genetic modification of macroalgae in the laboratory is an approach that is still a long way from commercial reality. According to the authors of the article on macroalgae published in 2024, only 3 species of macroalgae, the 2 brown algae Ectocarpus spp and Saccharina Japonica, and the green alga Ulva Prolifera, have been the subject of a fundamental research article showing possible genome modification using "new techniques". No article has yet reported such a possibility for red algae. However, the European Commission is including these organisms in its deregulation proposal for July 2023…Table 1 : Genetic modifications of microalgae (based on Miklau et al.vii)StageGM organismArea of useTraitBasic researchChlamydomonas reinhardtiiBioremediationmetal absorption (Copper)Chlamydomonas reinhardtiiBioremediationmetal absorption (Nickel)Chlamydomonas reinhardtiiCarbon sequestrationCO2 removal efficiencyChlamydomonas reinhardtiiAgrofuelEnhanced triacylglycerol biosynthesisChlamydomonas reinhardtiiAgrofuelIncreased lipid contentChlamydomonas reinhardtiiAgrofuelFatty acid secretionChlamydomonas reinhardtiiAgrofuelIncreased lipid contentChlamydomonas sp.AgrofuelLipid accumulationFistulifera solaris (m)AgrofuelIncreased lipid contentChlamydomonas reinhardtiiAgrofuelModification of the CrACCase geneNannochloropsis salinaAgrofuelIncreased growthPhaeodactylum tricornutumAgrofuelIncreased lipid contentChlamydomonas reinhardtii iAgrofuelEnhanced hydrogen productionChlamydomonas reinhardtiiAgrofuelEnhanced hydrogen productionAdvanced researchChlamydomonas reinhardtiiBioremediationHerbicide removal (Penoxsulam)Chlamydomonas reinhardtiiBioremediationMetal absorption (Cadmium)Chlamydomonas reinhardtiiBioremediationCyanide removalChlamydomonas reinhardtiiBiocontrolInhibited development and molting of Aedes AegyptiChlamydomonas reinhardtiiBiocontrolOral vaccine delivery for shrimp culturesChlamydomonas reinhardtiiBiocontrolProduction of antimicrobial peptideChlamydomonas reinhardtiiBiocontrolExpression of antiviral dsRNA against shrimp virusChlorella sp.BiocontrolProduction of antimicrobial peptideNannochloropsis oculataBiocontrolProduction of bovine antibiotiquesNannochloropsis oculataFeed additiveProduction of fish growth hormoneDunaliella salinaBiocontrolExpression of a viral proteinChlorella sp.Carbon sequestrationCarbone sequestrationChlamydomonas reinhardtiiAgrofuelAltered fatty acid profileChlamydomonas reinhardtiiAgrofuelIncreased fatty acid and lipid contentSpecies not specifiedAgrofuelHyrdrogen production from waterChlamydomonas reinhardtiiAgrofuelIncreased lipid productionChlamydomonas reinhardtiiAgrofuelIncreased lipid contentPhaeodactylum tricornutumAgrofuelIncreased lipid contentMarket developmentChaetoceros gracilis (m)Production / ContainmentUtilization of phosphite as a sole source of phosphorusScenedesmus dimorphusAgrofuelIncreased fatty acid productionNannochloropsis oceanicaAgrofuelaltered fatty acid compositionPrototheca morimorfisAgrofuelTriglyceridei Eric Meunier, « GMO algae: a future raw material for industry », Inf'OGM, 12 February 2025.iii Cai, J. et al., « Seaweeds and microalgae: an overview for unlocking their potential in global aquaculture development. FAO Fisheries and Aquaculture Circular », No. 1229, Roma, FAO.FAO, « Global seaweeds and microalgae production, 1950–2019. WAPI factsheet to facilitate evidence-based policy-making and sector management in aquaculture », June 2021.iv De Saeger Jonas et al., « Genome editing in macroalgae: advances and challenges », Frontiers in Genome Editing, vol. 6, 2024.v M. Miklau et al., « Horizon scanning of potential environmental applications of terrestrial animals, fish, algae and microorganisms produced by genetic modification, including the use of new genomic techniques », Frontiers in Genome Editing, June 2024.vi De Saeger Jonas et al., « Genome editing in macroalgae: advances and challenges », Frontiers in Genome Editing, vol. 6, 2024.vii M. Miklau et al., « Horizon scanning of potential environmental applications of terrestrial animals, fish, algae and microorganisms produced by genetic modification, including the use of new genomic techniques », Frontiers in Genome Editing, June 2024. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [126] => Array ( [objectID] => 10359 [title] => GMO algae: a future raw material for industry [timestamp] => 1739318400 [date] => 12/02/2025 [annee] => 2025 [url] => https://infogm.org/en/gmo-algae-a-future-raw-material-for-industry/ [image] => https://infogm.org/wp-content/uploads/2026/03/Algue.jpg [extrait] => The algae that live in rivers and the sea have been the focus of a great deal of attention in recent years. Whether micro, macro, green, brown, red... they are currently at the heart of an industrial development project for which the European Commission is active. These GMO algae could be deregulated if the European Commission's July 2023 proposal were to be approved, as they will undergo genetic modification to be transformed into production facilities for pharmaceuticals, cosmetics, food and agrofuels. This article is a first dive into a world that has gone unnoticed until now. [chapo] => The algae that live in rivers and the sea have been the focus of a great deal of attention in recent years. Whether micro, macro, green, brown, red… they are currently at the heart of an industrial development project for which the European Commission is active. These GMO algae could be deregulated if the European Commission’s July 2023 proposal were to be approved, as they will undergo genetic modification to be transformed into production facilities for pharmaceuticals, cosmetics, food and agrofuels. This article is a first dive into a world that has gone unnoticed until now. [texte] => If they don't buy certified products that exclude GMOs, consumers of chlorella, spirulina, agar agar or other marine algae products may well have to read labels more carefully to find out whether their products are GMO-free or produced from GMOs. Unless this information is no longer compulsory tomorrow. Because in July 2023, the European Commission proposed to deregulate GMOs, or at least a very large proportion of themi. Since then, debates have taken place in the European Parliament, the Council of the European Union, Member States, the business world and civil society. The stakes in these discussions are high because, if adopted, this text would remove many GMO plants from the scope of current legislation, allowing them to be marketed without prior risk assessment, authorisation, labelling or traceability by analytical and/or documentary methods, while at the same time allowing them to be patented. Although, in the proposed text, as in its communication, the Commission insists that this proposal only concerns plants, the latter term is broader than everyone thinks, by including also algae.Algae, a focus of attention for the European CommissionAs stated in recital 9 of the Commission's proposal, "this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae". These two Latin terms cover terrestrial plants, but also so-called green, red (Archaeplastida) and brown algae (Phaeophyceae).This specific inclusion of algae is achieved by this one and only reference in a recital. The term "algae" itself is never mentioned in the text. The reason why Directive 2001/18 and Regulation 1829/2003 make no reference to algae is that they both concern genetically modified organisms, whatever the nature of the organisms. As the Commission's proposal for a regulation relates only to plants, the Commission felt it was important to refer specifically to algae. But why this particular care, albeit very discreetly to say the least, to ensure that the proposal covers both marine and freshwater algae? The answer lies in the use of these organisms and the plans to use the techniques of genetic modification to adapt them to industrial production and manufacturing processes.Numerous commercial applications envisagedIn March 2023, four months before the European Commission made its proposal to deregulate GMOs including algae, the European Parliament's Committee on Fisheries received a report on the "future of the EU algae sector"ii. This report followed on from a communication from the European Commission, published in November 2022, entitled "Towards a strong and sustainable EU algae sector"iii.According to these report and communication, some 70,000 species of algae have been identified, 50 of which are used industrially, either as a source of food for humans or animals, or as a source of energy. It goes on to give a long list of examples of commercial applications, including "animal/fish feed and feed additives; pharmaceuticals; nutraceuticals; plant biostimulants; bio-based packaging; cosmetics or biofuels and services provider for wastewater treatment; for example, carbon and nutrients fixation etc.’, adding that seaweeds, ‘when being cultivated at sea, removes carbon, thereby reducing ocean acidification" (editor’s note, they do not remove the carbon but capture it). While, according to the Commission, demand for algae in the EU is expected to reach €9 billion by 2030, with demand for chlorella for example, expected to grow by "6.4% by 2025" and for spirulina by "8.7% by 2025", it adds that "the EU’s growing vegetarian and vegan population, currently estimated at around 75 million, and increasingly environmental and health-conscious consumers will also increase the demand for plant-based food and non-food products, including algae".The European Commission is on the moveThe European Commission believes that "now is the time to fully harness the potential of algae as a renewable resource in Europe". In its view, doing everything possible to facilitate what the Commission calls the exploitation of algae is part of the Green Deal for Europe, the "Farm to Fork" strategy and its communication on a sustainable blue economy. The Commission therefore believes it has "a central role to play in creating the conditions that make it possible to do something about the impediments the EU algae sector currently faces". This is because the algae industry is facing a number of problems, including high production costs, production on small scale that does not make use of the opportunities provided by Europe's maritime coastline, and too many pieces of legislation applying to algae. While this communication from the European Commission, published at the end of 2022, does not mention GMO legislation as one of the obstacles, it does state that its objective is to define a "coherent and streamlined governance throughout the EU, including simplified procedures and a monitoring and quality framework, with the ultimate aim of placing on the market sustainably sourced and safe biomass algae-based products". This objective would be in line with what the European Parliament's Committee on Fisheries has identified as future opportunities for the algae sector, including their "applications in biotechnology and biorefinieries, ranging from food, feed, to cosmetics, bioremoval and biofuel [...] source of essential nutrients such as vitamins, minerals, antioxidants, and amino acids".Genetically modified algae?The use of genetic modification techniques on algae is one of the ongoing projects to transform them into production factories. But it is only recently that these genetically modified algae seem to have come under increasing scrutiny. In April 2022, an articleiv summarised that "only recently microalgae attracted significant attention". Recent because, until then, ‘"the development of economically viable production processes entails resolving certain limitations of microalgal biotechnology, and fast evolving genetic engineering technologies have emerged as new tools to overcome these limitations". Indeed, the authors state that "although genetic engineering of microalgae is proved to be very effective in boosting performance of production in laboratory conditions, only limited success was achieved to be applicable to industry so far". Among the difficulties encountered, the authors list the low quantities of products obtained, the slow growth of algae, high production costs, frequent contamination and high energy consumption. The new techniques are seen as usable, for example, to increase the production yields of algae or accelerate their growth. The article also shows that the new techniques of genetic modification, the sequencing and the digitalisation of plant life form the matrix behind the announcements of increased industrial use. The authors explain that developments in sequencing techniques and the existence of genomic data on strains of microalgae have given researchers a greater capacity to explore commercial uses.In early 2024, another scientific articlev explained the same trend, pointing out that microalgae are naturally rich in carbohydrates, lipids, proteins, pigments, minerals and vitamins, making them "a renewable and sustainable source of bioactive compounds" for nutraceuticals, human food, animal feed (especially aquaculture) and agrofuels. The authors of the article consider that "genetic engineering of the existing strains remains crucial in utilising and upscaling microalgae-based biorefineries". The genetic engineering they refer to are the techniques of genetic modification using Crispr/Cas, zinc finger nucleases, Talen... what the European Commission calls the "new genomic techniques".European Commission documents and scientific articles reveal a certain industrial excitement about the commercial use of algae. Such industrial ambitions may well be the reason why the European Commission has been so careful to include these future genetically modified algae in its proposal to deregulate GMOs. Such a deregulation had already been asked to the Commission, notably by EuropaBio, a lobbying organisation with a long history of involvement in GMO plant issues. This organisation, which recently intervened on GMO micro-organismsvi, had more than strongly suggested deregulation of GMO algae in 2021. That year, in response to a European Commission public consultation on the blue bioeconomy, EuropaBio wrote that "to explore the full potential of algae products [...]. An additional aspect to consider is how the development of innovative approaches to improve the characteristics of algae (such as for example gene technology and new genomic techniques) can be supported, for instance through ensuring a proportionate regulatory framework as well as generating public trust and support for such developments"vii.i Regulation proposal by the European Commission, « REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 », 5 July 2023.ii Policy Department for Structural and Cohesion Policies, European Parliament, « The future of the EU algae sector », February 2023.iii European Commission, « Towards a Strong and Sustainable EU Algae Sector », 15 novembre 2022.iv S.B. Grama et al., « Emerging Trends in Genetic Engineering of Microalgae for Commercial Applications », Marine Drugs, 24 avril 2022.v A. Kamal et al., « Genetically engineered microalgae for enhanced bioactive compounds », Discov Appl Sci 6, 482 (2024).vi Eric Meunier, « Prochaine étape de la déréglementation : les MGM », Inf’OGM, le journal, n°175, avril/juin 2024 (in french).vii EuropaBio, « EuropaBio comments on the public consultation on blue bioeconomy », 10 August 2021. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [127] => Array ( [objectID] => 10353 [title] => GMO patents: is it possible to break the deadlock? [timestamp] => 1739145600 [date] => 10/02/2025 [annee] => 2025 [url] => https://infogm.org/en/gmo-patents-is-it-possible-to-break-the-deadlock/ [image] => https://infogm.org/wp-content/uploads/2026/03/50719409216_bd31888ee7_c-768x576.jpg [extrait] => In July 2023, the proposal to deregulate GMOs obtained using new genetic modification techniques (known as "new genomic techniques" - NGTs) highlighted a sensitive issue that is still under discussion: patents. Patents are fiercely criticised for their many negative effects on the rights of farmers and traditional seed producers, as well as on biodiversity. A report commissioned by the European Green Party addresses this issue and suggests ways out of the impasse. [chapo] => In July 2023, the proposal to deregulate GMOs obtained using new genetic modification techniques (known as “new genomic techniques” – NGTs) highlighted a sensitive issue that is still under discussion: patents. Patents are fiercely criticised for their many negative effects on the rights of farmers and traditional seed producers, as well as on biodiversity. A report commissioned by The Green/EFA addresses this issue and suggests ways out of the impasse. [texte] => In Europe, patents are causing problems for various players in the agricultural sector. This is the conclusion drawn from current discussions on the European Commission's proposal to deregulate GMOs/NGTs. Patents create difficulties, in particular:access to plant genetic resources, since a patent means that reproduction is prohibited without payment of royalties;legal uncertainty, as it is currently impossible for breeders and farmers to know whether there are patents on a plant they could use;and, more generally, the widespread appropriation of living organismsi.In December 2024, The Greens/EFA published a reportii commissioned from Axel Metzger, a law professor at the University of Berlin. This document analyses the legal options for resolving these problems, taking into account international law (Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS)iii , the European Patent Convention (EPC) and European law (Directive 98/44/EU).Different solutions, different difficultiesThis report therefore analyses the possible options for excluding certain elements from patentability or limiting the scope of the protection conferred by patents. These options vary in complexity.Ban patents on plants and genes?According to the report, it is unrealistic to hope for a rapid ban on patents on plants and/or their components derived from technical processes, such as the new techniques of genetic modification (NGTs). Such a ban would require amendments to the European Patent Convention (EPC), and therefore the unanimous agreement of the 39 signatory states, not all of which are members of the European Union. A condition that seems impossible to meet within the timeframe of the legislative discussions currently underway on the possible deregulation of GMOs derived from NGTs.The report refers to a proposal put forward by Belgium when it held the presidency of the Council of the European Union (from January to July 2024), aimed at making the deregulation of GMOs/NGTs1 (presented as "similar" to what nature or traditional breeding can do) conditional on the renunciation of patents. This proposal was recently taken up by Poland, the current President of the Council of the EU, but Metzger believes it raises legal objections, in particular because of the principle of proportionality (Article 5(4) TEUiv). According to this principle, the legislator may not refer to considerations extraneous to the subject matter - in this case patent law - as a basis for regulatory measures that are not supported by a risk assessment. This is undoubtedly why Poland is proposing, as an alternative, a labelling requirement indicating that so-called "category 1 NGT" seeds are patented.Through the Euroseeds organisation, the multinationals have proposed excluding from patentability plants obtained by what Euroseeds calls "random mutagenesis", an expression that has no legal definition. For Axel Metzger, this proposal is open to debate. Excluding such plants without amending the text of the EPC does not seem feasible to him. He adds that while an amendment to this effect to Directive 98/44 by the European Union could influence the EPC's implementing regulation, the EPO's Enlarged Board of Appeal's support for this change remains uncertain. Axel Metzger therefore remains sceptical about such a reform without a revision of the EPC. It should also be remembered that, in order to avoid any subsequent abuse of semantics, such an approach would first require a precise definition of "random mutagenesis", as the expression currently has no legal basis and is of no use.A. Metzger therefore believes, in summary, that prohibiting or rapidly restricting the scope of these patents on plants and/or their components derived from technical processes, such as NGTs, is unrealistic because of the legal and institutional obstacles.Preventing the granting of patents on naturally occurring elementsOn the other hand, according to the report, it would be legally possible to prevent patents being granted on naturally occurring plants and on genetic sequences present in such plants (the author refers to "genetic sequences", not "genetic information" or "biological material"). This would be compatible with TRIPS, but would require an amendment to Rule 27 of the Implementing Regulations of the EPC, which declares patentable "biological material isolated from its natural environment or produced by means of a technical process, even where it existed in a natural state". Such an amendment does not require unanimity among the 39 members of the EPC, but only a decision by the Administrative Council of the EPO with a three-quarters majority, and without ratification by national parliaments. In order to obtain such a majority, however, it would be necessary to amend European Directive 98/44 beforehand, since rules 26-34 of the EPC Regulation derive directly from it.Another option analysed would be to impose systematic disclosure of the origin of biological material in patent applications, in line with the theoretical obligations of international treaties on genetic resources. Although it has been analysed that these recent obligations can easily be circumventedv, Axel Metzger believes that, on paper, these measures would provide breeders with greater legal certainty, theoretically eliminating the risks of litigation and the costs associated with exploiting patented resources. The rapporteur points out that these obligations could also be introduced by decision of the EPO Administrative Council, as there is a basis for this in recital 27 of EU Directive 98/44.To sum up, A. Metzger considers that preventing the patentability of natural plants is possible, but would require a reform of the EPC implementing regulation, or even an amendment to European Directive 98/44.Limiting the scope of current and future patentsAccording to the report, there are ways of limiting the scope of existing and future patents. For example, it would be possible to specify explicitly in Directive 98/44 that "the protection conferred by a patent on a product consisting of or containing genetic information shall not extend to plant material in which that product is incorporated and in which the genetic information is contained and fulfils its function, but which is not distinguishable from plant material obtained or which can be obtained by essentially biological process". This new Article 9.3 was proposed in February 2024 by the European Coordination Via Campesina (ECVC) to the European Parliament, which adopted it in its amendments to the European Commission's proposal for the deregulation of GMOs. Axel Metzger points out that this will make it possible to exclude from patent protection NGT plants considered to be "equivalent" to those derived from conventional breeding. But isn't that the elephant in the room: equivalent (according to certain criteria and not others) does not in fact mean identical.Metzger's report also proposes a change to the rule on the burden of proof in cases of alleged infringement - which would then rest solely with the patent holder - for products derived from specific NGT processes. These clarifications would help to reduce - not eliminate - breeders' and farmers' fears of potential disputes arising from the use of plants containing traits similar to those patented.A. Metzger therefore considers that it would be possible to restrict the scope of patents, in particular by clarifying their scope and reversing the system of the burden of proof.Extending the breeder's privilegeAnother possible option is to extend the breeder's privilege, allowing breeders not only to continue breeding on the basis of patented varieties, but also to market the new varieties obtained. But Axel Metzger believes that a complete exemption for breeders is difficult to implement, as it may be incompatible with Article 13 of the TRIPS Agreement (limitations and exceptions for rights holders). In his view, such a reform of breeders' privilege would require amendments to both Directive 98/44 and TRIPS, which could pose legal challenges that are unattainable in the short term.Increasing the transparency of existing patents and forcing their holders to take out patentsA final possibility analysed by A. Metzger is the adoption of measures aimed at increasing patent transparency and limiting abuses by rights holders, without however being able to exclude them completely. For example, the European legislator could make it easier to obtain compulsory licences, along the lines of the Swiss model, and introduce a compulsory transparency register for patents on plants (other than the Pinto database, which operates on a voluntary basis), their varieties and the techniques used. It would also be possible, in his view, to restrict the rights of patent holders in the event of blocking or delaying the provision of necessary information to other breeders.A. Metzger argues, in short, that increasing transparency and regulating patents would make it possible to limit certain abuses without eliminating them altogether.The position of the organisations At a round table organised by The Greens on 9 December 2025vi on the Metzger report, ECVC reiterated the importance of appropriate regulation to prevent patent abuse. However, ECVC highlights a shortcoming in the report, which fails to address a key point: the removal of any obligation on GMO producers to provide detection and identification procedures enabling products obtained using new techniques to be traced. In ECVC's view, the only way to restrict abusive patent claims in the first instance is to maintain such an obligation under current GMO legislation. The organisation also deplores the fact that the report does not propose any concrete solutions - other than the disclaimer provided for by the EPO, which it considers ineffectivevii - to counter the abusive extension of patents to natural plants or plants derived from farmers' or traditional selections.The European coalition No Patents on Seeds (NPOS) also welcomes the Metzger reportviii in its analysis of the patent issues surrounding NGT-derived products. However, it criticises the report for not making a sufficiently clear distinction between "genetic engineering" and "conventional breeding". According to NPOS, this could limit the opportunities for prohibiting patents on plants obtained by essentially biological processes. NPOS, which, like Euroseeds, includes "random mutagenesis" (without defining it) in these processes, believes that there is sufficient room for manoeuvre at EU level to implement such a ban. The coalition adds that such a ban would be left to the interpretation of the EPC, which would not therefore need to be amended, something Metzger doubts.NPOS and ECVC have on several occasions expressed their differences on, in particular, the patentability of "random mutagenesis", for which there is no legal definition. ECVC refutes the position of NPOS, which considers it to be an essentially biological process (EBP). The two organisations are currently at odds over the strategy to be adopted to break the legislative deadlock on the issue of patents. While NPOS is essentially focusing its position on changing the legal status of "random mutagenesis", which it wants to see classified as an EBP, ECVC would like to amend Directive 98/44 with a minimum provision: making it compulsory to publish the identification and detection procedures for patented products in order to trace them and avoid abusive prosecution of small seed producers and farmers, failing which the validity of the patent would be called into question.While the proposed deregulation of GMOs/NGTs continues to generate intense debate, the issue of patents remains a major obstacle to balanced reform. The Metzger report highlights the legal complexities and differences of approach between stakeholders, illustrating the tensions surrounding fair access to genetic resources. While solutions do exist to regulate these patents and limit their effects, they require strong, concerted political decisions to ensure that this deregulation does not work to the detriment of farmers and biodiversity.i Denis Meshaka, "Les brevets : une réponse insatisfaisante", Inf'OGM, le journal, n°175, April/June 2024 (in french).ii Metzger, A., "Legal options for changing the patent protection of plants in Germany, Europe and in international law", 4 December 2024.iii TRIPS, or the Agreement on Trade-Related Aspects of Intellectual Property Rights, aims to define minimum protections for intellectual property rights in member countries of the World Trade Organisation (WTO).iv Article 5(4) TEU: "In accordance with the principle of proportionality, the content and form of Union action shall not exceed what is necessary to achieve the objectives of the Treaties. The institutions of the Union shall apply the principle of proportionality in accordance with the Protocol on the application of the principles of subsidiarity and proportionality".v However, there are loopholes in this obligation that allow it to be circumvented.K.M. Gopakumar, "WIPO opens more widely the door to biopiracy", Inf'OGM, 31 October 2024.vi Martin Häusling, "Freier Zugang zu Saatgut - Für ein krisensicheres Ernährungssystem", 9 December 2024.vii ECVC, "European Commission proposal on "new GMOs": Towards the appropriation of all seeds by the patents of a few multinationals", 18 July 2023.viii NPOS, "What can be achieved at EU level against patents on seeds? The Green parliamentary group in the Bundestag presents an expert opinion", 9 December 2024. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [128] => Array ( [objectID] => 10333 [title] => Polish proposal on patents and GMOs casts doubts among Member States [timestamp] => 1738713600 [date] => 05/02/2025 [annee] => 2025 [url] => https://infogm.org/en/polish-proposal-on-patents-and-gmos-casts-doubts-among-member-states/ [image] => https://infogm.org/wp-content/uploads/2026/03/50396417013_deec0407a0_c-768x512.jpg [extrait] => In January 2025, Poland, president of the Council of Europe, put a proposal on the table of EU member states to “solve” the patent problem that had arisen in the debate on deregulating GMOs obtained by new techniques. Complex and of uncertain effectiveness, the Polish proposal has plunged everyone into doubt. Discussions on this text may therefore not be concluded before Denmark, whose government supports total deregulation of GMOs, takes over the presidency of the European Union. [chapo] => In January 2025, Poland, president of the Council of Europe, put a proposal on the table of EU member states to “solve” the patent problem that had arisen in the debate on deregulating GMOs obtained by new techniques. Complex and of uncertain effectiveness, the Polish proposal has plunged everyone into doubt. Discussions on this text may therefore not be concluded before Denmark, whose government supports total deregulation of GMOs, takes over the presidency of the European Union. [texte] => After Spain, Belgium and Hungary, Poland is the fourth country to hold the presidency of the Council of the European Union since the publication, in July 2023, of the Commission's proposal to deregulate non-transgenic GMOs. It is now Poland's turn to lead discussions between EU member states until June 30, 2025. On January 7, 2025, Poland proposed a text on which it hopes to reach a compromise.Maintaining the idea of deregulationThe proposal put forward by the European Commission in July 2023 stipulates that the vast majority of GMOs will no longer be assessed, labeled or traced... Poland does not go back on these points, and therefore makes no proposal to restore risk assessment, for example. Some member states had nonetheless requested this. Similarly, Poland does not propose the restoration of compulsory labelling to inform citizens of the genetically modified nature of products on the market.Last but not least, and especially in view of the current debates, Poland is not proposing to reintroduce an obligation for companies to provide a method for detecting and identifying their GMOs obtained through new techniques of genetic modification.Know your patents before marketing a deregulated GMO plantThe Polish proposal, on the other hand, addresses the issue of patents, concerned from the outset that GMO deregulation should not open the door to too much corporate power via patents associated with techniques or products. Poland has therefore put forward a proposal to the member states. In theory, it's a fairly straightforward proposal, but its legislative wording and practical feasibility is uncertain.In absolute terms, Poland's wish is simple: a plant genetically modified by a new technique could be granted NTG1 status - the status leading to deregulation - provided that the presence of patents on process or product is verified beforehand. If patents are present, these NTG1 plants would, for example, have to be labeled to indicate this “presence” of patents.It therefore proposes, as a first step, that the procedure to verify NTG1 status carried out by the authorities of a Member State should include information supplied by the petitioner, indicating the absence of patents or declaring that it renounces all patents. These declarations would be verified by the European Commission. If no patent is claimed, or if the petitioner has renounced all claims, the NTG1 plant would be marketed without labelling, risk assessment, traceability, etc. On the other hand, if patents are present and/or the petitioner does not renounce their claim, NGT1 plants could still be marketed, but with compulsory “patent protected” or “patent pending” labelling. In the same situation, Poland also proposes that a member state should be free to prohibit the cultivation of such plants.It should be pointed out here that this verification procedure can only be carried out by public authorities (national or European) if the necessary information exists. At present, patents are granted without any obligation to declare the genetic or proteinic information covered by the patent. Furthermore, the absence of any obligation to provide a method of detection and identification will in fact constitute a major limitation on the proper conduct of post-market controls.An oversight by Poland…In addition to the complexity of the wording, Poland forgot to close a door that would allow the patent procedure to be dispensed with. As drafted, the proposal imposes this procedure in the case of an administrative procedure aimed at commercializing a plant genetically modified by a new technique. But its implementation in the case of administrative steps to conduct field trials is more uncertain. Poland writes that “the person intending to place on the market reproductive material of a category 1 NGT plant shall submit to the Commission [a ‘patent verification request’]”i. However, in line with the European Commission's proposal, Poland has maintained the principle that a request for verification of NTG1 status should only be made with a view to marketing if it has not already been made for a field trial. If the patent verification is only required for a marketing application, it will be sufficient to make the same request for a field trial, and the company will then not be subject to this obligation... It will, however, still be required to label its seeds as being covered by one or more patents.... and a problematic difference in treatmentWhile Poland's proposal focuses on so-called NTG1 plants, there is no proposal to modify the framework for so-called NTG2 plants (defined as all plants obtained by new techniques not classified as NTG1). For example, while the Commission had proposed labelling NTG2 plants in line with current GMO legislation, Poland does not propose “patent” labelling as for NTG1 plants. Yet these NTG2 plants are indeed organisms covered by patents.Mixed reactionsMeeting in a working group of the Council of the European Union on January 20, 2025, representatives of the member states expressed their doubts about the Polish proposal. According to comments collected by Politicoii, the Polish solution poses more problems than it solves. Faced with the proposed wording, some member states appears to have doubts regarding the legal validity of the polish proposal many reservations were therefore expressed.Reactions from associations and unions opposed to GMOs are no less dubious. The European Coordination Via Campesina (ECVC) believes that, on the question of patent risks, “the solutions proposed by Poland will not address these risks any better than Belgium's previous proposal”iii. The union believes that Poland should have proposed first and foremost to re-establish the obligation to provide detection and identification procedures for plant GMOs obtained by new techniques. This would have been more effective than proposing “very complex procedures that will allow the majority of GMOs derived from NGTs to be authorised without it being possible for farmers and traditional seed producers to identify them in fields and supply chains, or for States to ban their cultivation in their territory”. ECVC also points out that “many of these measures are also contrary to European competition law, which allows restrictions on trade only based on ethical, health or environmental issues, and not on concerns related to intellectual property”.For Friends of the Earth Europe, the Polish proposal continues to pose the same problems as the proposal made by the European Commission in 2023iv. The problem of patents remains unresolved, and the absence of labelling and risk assessment obligations is still present, which is highly problematic for the association. However, the absence of liability for companies marketing these GMOs means that the costs of protecting the conventional and organic sectors are borne by organic or “GM-free” processors and distributors, who do not want them. For Friends of the Earth Europe, “If this proposal succeeds, it could trigger a wave of patented plants across Europe’s fields, handing unprecedented power to agribusiness giants. Meanwhile, consumers will lose their right to know what’s in their plates, and farmers will bear the costs of preventing contamination”.i Council of the European Union, 2023/0226(COD), « Regulation on new genomic techniques (NGT) – Revised Presidency text », Article 7bis point 1, 7 January 2025.ii « Poland’s gene-editing gamble leaves EU countries baffled », Politico, 21 January 2025.iii ECVC, « New GMOs and patents: Poland’s Illusory Solutions », 14 January 2025.iv Friends of the Earth Europe, « New Polish draft on new GMOs: who wins and who loses », 9 January 2025. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [129] => Array ( [objectID] => 10288 [title] => Copa-Cogeca’s ambiguities on the issue of plant patents [timestamp] => 1738108800 [date] => 29/01/2025 [annee] => 2025 [url] => https://infogm.org/en/copa-cogecas-ambiguities-on-the-issue-of-plant-patents/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => For a year and a half, the Council of the European Union has been unable to reach an agreement on the deregulation of GMOs, mainly because of the problems posed by patents on those GMOs or on the techniques used to obtain them. According to Copa-Cogeca, those two issues should be dealt with separately. Its proposal is to adopt the deregulation of GMOs as quickly as possible and postpone the study of the problem posed by patents. Even if it means forgetting that farmers are indeed affected by patents. [chapo] => For a year and a half, the Council of the European Union has been unable to reach an agreement on the deregulation of GMOs, mainly because of the problems posed by patents on those GMOs or on the techniques used to obtain them. According to Copa-Cogeca, those two issues should be dealt with separately. Its proposal is to adopt the deregulation of GMOs as quickly as possible and postpone the study of the problem posed by patents. Even if it means forgetting that farmers are indeed affected by patents. [texte] => On 9 December 2024, the member of the European Parliament Martin Haüsling organised an online conference on the issue of patents and new techniques of genetic modification. During this conferencei, Thor G. Kofoed, from Copa-Cogeca, the organisation representing professional agricultural organisations and agri-food cooperatives, presented his organisation's position. His voice is of importance for two reasons. Thor G. Kofoed is the Chairman of Copa-Cogeca's working group on seeds and he is Danish. Yet, Denmark will hold the presidency of the European Union from 1 July to 31 December 2025, and will therefore lead the debates on the European Commission's 2023 proposal for deregulation, debates that have been stalled for the last year and a half over the issue of... patents!NGTs, necessary techniques for Copa-CogecaThor G. Kofoed was direct. The representative of the agricultural organisation explained that “better plant breeding and more plant breeding than we have seen in the last fifty years” are needed. He put this position in the context of climate change, with “more water and more rain more humidity in some time of the year at certain times and longer dry period at some other times”. For Copa-Cogeca, a huge plant breeding programme is therefore essential, a programme that must include the new techniques of genetic modification (so-called new genomic techniques - NGT - at the instigation of the European Commission, which no longer wants to use the acronym GMO).But, he points out, these “new techniques […] have nothing to do with patents”. This is not to say that patents are not an issue, but Copa-Cogeca believes that they are also an issue for conventional and organic varieties. In this sense, it is not specific to new techniques of genetic modification. This line of argument leads Thor G. Kofoed to affirm Copa-Cogeca's fundamental position, namely that the two debates should be separated and that “we need to adopt the NGT proposal as soon as possible”.What intellectual property regime for NTGs?While the issue of new techniques is not linked to that of patents for Copa-Cogeca, the question of fair remuneration for breeders nevertheless arises according to Thor G. Kofoed. Remuneration, he believes, is already guaranteed, in Europe, by “a very good plant breeding innovation system”, namely the Community Plant Variety Certificate (PVC). According to Thor G. Kofoed, this system means that, while Europe does have a few internationl breeding companies, it also has the largest number of plant breeders in the world. This situation is all the more important given that Copa-Cogeca considers it impossible for just a few breeders to supply all the needed new seeds for the various crops produced. An “open plant breeding sustem” is therefore imperative for Copa-Cogeca. All the more so since, according to Thor G. Kofoed, the current European system ensures that farmers “fields will not battlefields for lawyers because of patents”.On patents more specifically, Copa-Cogeca's position is both simple and vague. From the outset, Thor G. Kofoed explains that Copa-Cogeca “does not find that patents are needed and we do not want patents in plants”. As to whether this rejection of patents in plants only concerns patents on plants (known as ‘product patents’) or also patents on processes (which extend to products), Thor G. Kofoed did not go into detail. The fact remains that, faced with the questions raised by numerous organisations and certain Member States about patents and the risk of appropriating living matter, Copa-Cogeca is relying on the impact studyii that the European Commission has yet to publish “by the end of 2025 or beginning of 2026”, as it has announced and as the European Parliament has already requested. The study will have to be taken “very seriously to see what is needed from a patent system, what can we just use in the european community plant variety rights system and make it better, or put the patent system under the legislation of the Community plant variety rights system so that we don’t have the negative issues from a patent in Europe”. Thor G. Kofoed considers that this approach is all the more justified given that patents on plants exist in the rest of the world. Copa-Cogeca's objective is therefore “to find an intelligent way how to mix these two plant variety rigths systems”, so as to have intellectual property for breeders and the “tech industries” entering the seed business, and “a huge diversity of breeding systems” for farmers.Listenning carefully to Thor G. Kofoed, Copa-Cogeca's position is to ensure that breeders are able to work without coming up against patents. But farmers were quite absent from the Copa-Cogeca speech delivered by Thor G. Kofoed on 9 December 2024. Yet the problem of patents affects everyone, from farmers to plant breeders. Above all, the proposal to separate the two debates reveals a risky strategy. Copa-Cogeca wants new techniques to be deregulated as proposed by the European Commission (no risk assessment, no traceability methods, no labelling, etc.) and the problems linked to patents to be studied at a later date. This is risky because once deregulation is in place, it will surely be too late to deal with the related patent issues.i Martin Häusling, « Freier Zugang zu Saatgut- Für ein krisensicheres Ernährungssystem », from 1h20 to 1h26, 9 December 2024.ii For the European Parliament, this study to come « should address in particular the role and impact of patents on breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as on innovation and in particular on opportunities for SMEs ».European Parliament, « Plants obtained by certain new genomic techniques and their food and feed », see point 45bis, 24 April 2024. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [130] => Array ( [objectID] => 10194 [title] => Seeds regulation: the industry weighs in the balance [timestamp] => 1736380800 [date] => 09/01/2025 [annee] => 2025 [url] => https://infogm.org/en/seeds-regulation-the-industry-weighs-in-the-balance/ [image] => https://infogm.org/wp-content/uploads/2024/12/31923281141_ac2023cd3e_c-768x512.jpg [extrait] => At a time when the European Union is preparing new regulations on seeds, a look at the meetings between MEPs and the various stakeholders indirectly shows the weight of the multinationals in these procedures. This raises questions about the imbalance in the representation of these parties and the potential consequences for small seed companies, farmers and peasants. [chapo] => At a time when the European Union is preparing new regulations on seeds, a look at the meetings between MEPs and the various stakeholders indirectly shows the weight of the multinationals in these procedures. This raises questions about the imbalance in the representation of these parties and the potential consequences for small seed companies, farmers and peasants. [texte] => In July 2023, the European Commission launched a reform of the regulations on plant reproductive material (PRM), known as the "seeds regulation"i. If adopted, the text proposed by the Commission would impose new practices on small non-industrial players and influence crop diversity. During the tripartite negotiation process - still ongoing between the European Parliament, the Council of the EU and the European Commission - various "interest groups" (industrialists, NGOs, trade unions, etc.) meet MEPs to defend their positionsii. These exchanges are recorded in a public registeriii, which is intended to guarantee transparency, but which reveals nothing about the content of the exchanges. This register reveals a clear predominance of industrialists (or their affiliates and representatives) over NGOs, organic farming players and farmers' unions, raising questions about the balance and impartiality of decisions.Typology of interest groupsThe interest groups that met with MEPs in connection with the MRV regulationiv can be divided into two categories, depending on whether they belong to or are associated with multinationals, or traditional seed production and farming.The first category includes companies such as KWS and Limagrain, and trade unions or professional organisations close to agricultural industries, such as Copa-Cogeca (a European farmers' union), Euroseeds (representing the European seed industry) and the Bayerische Pflanzenzucht- und Saatbauverbände (BPS, an organisation bringing together Bavarian plant breeders and seed multipliers). It also includes, on the fringes, the Association Générale des Producteurs de Blé et autres céréales (AGPB), which represents the interests of French straw cereal producersv. In its position on the new MRV rules, Euroseeds, for example, which also represents KWS, Limagrain and other major companiesvi, defends a standardised industrial seed production systemvii. Also in this category are consultants such as the Hungarian firm PRM CE Kftviii, which specialises in lobbyingix. Although this firm states that it works for industry, particularly agri-business, it does not mention its clients.The second category includes players defending non-industrial (or less industrial) agriculture, such as Arche Noah and the Demeter federation, associations of small non-industrial players, such as the Irish Seed Savers, and those promoting organic agriculture (OA), such as IFOAM. A farmers' union, ECVC, also took part in these meetings. This category of players defends more local models, centred on the environment and the rights of small seed growers and farmers.Between these two poles, certain players who contributed to the meetings, such as the Community Plant Variety Office (CPVO)x, although officially neutral, tend to favour industrial interests, while the European institutions, such as the Commission, often oscillate between different interests depending on the subjects dealt with. We have also placed the ONF (Office National des Forêts) in this category.Imbalance in stakeholder representationThe data available on the European Parliament's transparency platform reveals an imbalance in stakeholder representation (see figure below). Of the 58 meetings listed, MEPs met more frequently (32 times) with industry and its representatives (trade unions, professional organisations and consultants, in blue) than with NGOs, organic farming representatives or farmers' trade unions (in purple) with 24 meetings. This imbalance is accentuated by the European institutions, the CPVO and the Commission, which, as mentioned above, are more inclined to defend the interests of industry than small seed producers or farmers. Like the International Union for the Protection of New Varieties of Plants (UPOV), of which it is a member, the CPVO favours the seed industry and 'commercial' breeders by protecting their 'innovations' through plant breeders' rights. This position, criticised by small seed companies and farmersxi, reinforces the power of large companies to the detriment of small seed companies and farmers.Herbert Dorfmann, the rapporteur on this draft MRV regulation, held 18 meetings with industry and its representatives, compared with 9 meetings with NGOs. Herbert Dorfmann is a member of the European People's Party (EPP), historically favourable to the interests of agribusiness and regularly positioned to defend positions aligned with those of industry. This position can be seen in discussions around regulation, where industry representatives campaign for simplified rules favouring the standardisation of seeds and their protection by patents.This asymmetry in the number of meetings also illustrates a dynamic in which industrial groups, thanks to their resources, networks and ability to mobilise, are able to carry more weight in discussions. Such industrial influence could have a major influence on the direction of legislation, which would mainly benefit large companies, to the detriment of environmental concerns and small-scale farmers. The power of the lobbies risks marginalising the latter in a system that favours standardisation and intellectual property to the detriment of diversity and fair access to seeds.Financial inequality of forcesIn Europe, organisations such as Corporate Europe Observatory (CEO) highlight the issue of lobbying by producing reports, such as "Loud Lobby, Silent Spring", which denounce the influence of industrial interest groups on European environmental and agricultural policiesxii. CEO has developed a tool, Lobby Facts, indicating the lobbying expenditure of various players. For example, in 2022, Euroseeds spent between €1.75 and €2 millionxiii and Cogeca between €700,000 and €800,000xiv. In 2019, Euroseeds was already spending nearly €1.13 millionxv, while in the same year Arche Noah spent around €75,000 (no data for subsequent years). In other parts of the world, lobbying practices may be governed by what are reputed to be stricter transparency rules. In the United States, for example, the Lobbying Disclosure Actxvi imposes detailed reporting obligations on lobbying activities, more frequent declarations of such activities and stronger penalties, thus allowing for stricter public controlxvii .Impact on "small players" and biodiversityRegulations that are too favourable to the practices of industrial multinationals alone could have serious consequences for farmers, non-industrial seed companies and peasants. Rules that directly or indirectly favour patented seeds would increase or even complete farmers' dependence on large companies, compromising their autonomy and economic sustainability. Furthermore, limited access to traditional seeds would reduce their options, while biodiversity, a key element in agriculture, would be threatened by standards favouring standardised and patented varieties.By favouring standardised and patented varieties, regulations could reduce the use of local seeds, which are essential for maintaining the phytogenetic diversity of crops. This diversity is crucial to the resilience of agriculture in the face of various biotic and abiotic stresses. Players such as La Via Campesinaxviii and IFOAM are warning of these risks and calling for regulations that protect traditional seeds and encourage agro-ecology, rather than reinforcing the monopoly of multinationals.Regulations with crucial issues at stakeWith the European Commission's proposed regulation, small farmers risk losing essential rights to protect, select and exchange their own seeds and associated knowledge, and to access a commercial supply of seeds adapted to the diversity of their needs and contexts. This situation would directly threaten their livelihoods and compromise agricultural biodiversity, which is crucial to global food security. It is imperative that European legislation protects these key players, who are indispensable to sustainable and diversified agriculture.Following its adoption at first reading by the European Parliament, the text on seed regulation has now passed into the hands of the Council of the EU, which has just issued a revised version. A "trilogue", a negotiating mechanism bringing together the European Commission, the European Parliament and the European Council, could now be launched, although a second reading in Parliament is still possible.i Denis Meshaka, "EU – “Seeds”: the other proposal in the legislative package", Inf'OGM, 3 October 2023.ii Concerning the publication of meetings between the Member States of the Council of the European Union and interest groups, this information is generally available on the official websites of the Permanent Representations concerned.iii European Commission, Transparency Register.iv Legislative Observatory, "Production and marketing of plant reproductive material in the EU" , Transparence (consulted on 29 November).v AGPB (Association Générale des Producteurs de Blé et autres céréales - General Association of Wheat and Other Cereal Producers).vi Euroseeds, Members (accessed on 10 December 2024).vii Euroseeds, "Euroseeds raises serious concerns over COMAGRI vote on new rules for Plant Reproductive Material", 19 March 2024.viii PRM.ix Lobby Facts, PRM Cee Kft (consulted on 2 December 2024).x CPVO: Community agency that implements and applies the Community plant variety rights system. It issues plant variety certificates or PVCs.xi Frédéric Prat, "Quand la loi paralyse les paysans... au-delà de son contenu", Inf'OGM, 20 October 2022 (in french).xii CEO, "A loud lobby for a silent spring - The pesticide industry's toxic lobbying tactics against Farm to Fork", March 2022.xiii Lobby Facts, "Euroseeds", 2022 (accessed on 2 December 2024).xiv Lobby Facts, "Cogeca" (accessed on 2 December 2024).xv Lobby Facts, "Euroseeds", 2019 (accessed 2 December 2024).xvi Government of the United States, "Lobbying disclosure", 19 December 1995.xvii Haute Autorité de la Transparence de la Vie Publique, "Tableau extrait de l'étude comparative des dispositifs d'encadrement du lobbying", October 2020 (in french).xviii Guy Kastler, "Seed marketing reform: freeing cultivated biodiversity or patented GMOs?", Inf'OGM, 22 February 2024. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [131] => Array ( [objectID] => 10127 [title] => Ongoing european legal initiatives (GMO, patents, DSI, seeds, biotech…) [timestamp] => 1734566400 [date] => 19/12/2024 [annee] => 2024 [url] => https://infogm.org/en/10127-2/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => A number of legal initiatives concerning living organisms are currently underway at European level. Inf'OGM has already published an article taking stock of these initiatives. Here we summarize the various procedures in the form of tables. These will be updated as work progresses. [chapo] => [texte] => A number of legal initiatives concerning living organisms are currently underway at European level. Inf'OGM has already published an article taking stock of these initiatives. Since 2023, many proposals were made by the European Commission and a working group on the definition of a GMO launched in the Council of the European Union. Here we summarize the various procedures in the form of tables. These will be updated as work progresses.Summary of the ongoing European Commission’s legislative initiatives and other ongoing work relating to living organismsGMOBiocontrolPurposeDeregulation of numerous GM plants (including micro-algae)Deregulation of numerous GM animalsRegulatory status of products containing traces of GMM’s DNAOmnibus X (food / feed)Authorising the dissemination into the environment of GMM according to 2001/18 (and deregulation)Establishing an “harmonised” interpretation of the GMO definition according to Directive 2001/18Authorisation of biocontrol products (microorganisms, molecules…)Procedure reference2023/02262025/04102025/0405Report(presented by the Netherlands in 2025)Ongoing thoughts in a group of member states. Follow-up by the 2001/18 regulatory committee2025/0410PreparationRequested by the European parliament on 07/02/24Following the consultation(End : 14/10/2025)Following the consultation(End : 14/10/2025)Proposal from ECText of the proposal(05/07/2023)Expected in 2026Text of the proposal(16/12/2025)Text of the proposal(16/12/2025)Text of the proposal(16/12/2025)EU Economic social committeeOpinion(26/10/23)Opinion(29/04/2026)Opinion(18/03/26)Opinion(29/04/2026)EU Committee of RegionsOpinion and amendments (17/04/24)Renunciation to produce an opinion(04/02/26)Renunciation to produce an opinion(04/02/26)Renunciation to produce an opinion(04/02/26)EP’s committeeCommittee EnvironmentText of the report(24/01/2024)Committee EnvironmentCommittee Agriculture(13/03/2026)Work in progressDeadline for amendments in Committee Envi / Agri : 01/07/2026Committee EnvironmentCommittee Public Health(24/03/2026)Work in progressDeadline for amendments in Committee Envi / Public Health : 03/09/2026Committee EnvironmentCommittee Agriculture(13/03/2026)Work in progressDeadline for amendments in Committee Envi / Agri : 01/07/2026EP’s opinion(1st reading)Text amended(07/02/2024)Indicative date for discussion and vote in plenary : 11/11/2026EP’s 2nd vote(1st reading)Text voted(24/04/24)EU Council opinion(1st reading)/Work in progressPartial compromise text of the Presidency(19/03/2026)Other compromise texts are proposed but not available onlineWork in progressPartial compromise text of the Presidency unavailable online(22/05/2026)Work in progressPartial compromise text of the Presidency(27/03/2026)Other compromise texts are proposed but not available onlineEU Council negotiations mandateMandate(07/03/25)Mandate for negotiation(16/06/2026)Trilogue compromise textText of compromise(04/12/2025)EU Council opinionText agreed(19/12/2025)EP’s committee opinionVote of agreement28/01/2026EU Council’s opinion(1st reading)Text adopted21/04/26EP’s committee opinionRecommendation to adopt the text(15/06/26)EP’s opinion(2nd reading)Text adopted(17/06/26)EU Council opinion(2nd reading)/Conciliation/EP’s opinion(3rd reading)/EU Council opinion(3rd reading)/Final adoptionRegulation 2026/1388(26/06/2026)EU ratification//////Entry into force2028Digitisation of the Living (DSI)SeedsUNCLOSEuropean Health Data SpaceGenetic resources and benefits sharingPlant reproductive materialForest reproductive materialPurposeSignature of the UNCLOS agreement (Genetic resources and DSI in international waters)Access to human genetic, genomic and proteomic dataAssessment and potential updating of the 511/2014 regulation (Nagoya protocol)Production and marketing of plant reproductive materialProduction and marketing of forest reproductive materialProcedure reference2023/03532022/01402023/02272023/0228PreparationCall of evidence(End : 11 February 2026)Proposal from ECText of the proposal(12/10/2023)Text of the proposal (03/05/22)Announced for the 1st quarter of 2027Text of the proposal (05/07/23)Text of the proposal(05/07/23)EU Economic social committee/Opinion(22/09/22)Opinion(13/12/23)Opinion(13/12/23)EU Committee of Regions/Opinion and amendments (08/02/23)Opinion and amendments(17/04/24)/EP’s committeeCommittee EnvironementText of the report(19/04/24)Committee EnvironementCommittee on civil libertiesText of the report(05/12/23)Committee AgricultureText of the report (22/03/24)Committee AgricultureText of the report(21/03/24)EP’s opinion(1st reading)Text voted(24/04/24)Text amended(13/12/23)Text amended (24/04/24)Text amended(24/04/24)EP’s 2nd vote(1st reading)////EU Council opinion(1st reading)Text voted(17/06/24)//Mandate(10/06/25)EU Council negotiations mandate/Mandate(10/12/2025)Text of compromise(05/09/25)Trilogue compromise text/Text of compromise (22/03/24)Text of compromise(17/06/2026)Text of compromise(19/12/2025)EU Council opinion/Text agreed(19/12/2025)EP’s committee opinionPosition of agreement(14/07/2026)Vote of agreement(24/02/2026)EU Council’s opinion(1st reading)/Text voted(21/01/25)Text adopted21/04/2026EP’s committee opinionRecommandation adopted(08/05/2026)EP’s opinion(2nd reading)/Text voted(24/04/24)Texte adopted(19/05/2026)EU Council opinion(2nd reading)///Conciliation///EP’s opinion(3rd reading)///EU Council opinion(3rd reading)///Final adoptionDecision 2024/1830(19/07/2024)Regulation 2025/327(11/02/2025)Regulation 2026/1392(26/06/2026)EU ratificationText of announcement(20/09/2025)////Entry into force17/06/202626/03/2027Industrial Property (IP)BiotechnologyPhytopharmaceutical productsMedicinal productsPlant variety rightsBiotech Act IBiotech Act IIInnovation ActPurposeUnitary supplementary protection certificate for plant protection productsUnitary supplementary certificate for medicinal productsAssessment and potential update of the EU plant variety rights frameworkStimulating innovation via optimising research and facilitating a fast access to the market for the biotechnological innovationsTo guarantee that innovative biotech products and processes can quickly enter and freely circulate within the EUSet of legal intersectorial measures with an impact on Life Sciences and BioeconomyProcedure reference2023/01262023/01272025/0406PreparationCall of evidence(End : 14 March 2025)Public consultation(End : 20 avril 2026)Consultation (End : 10/11/2025)Public consultation(End : 05 August 2026)Call of evidence(End : 10 June 2026)Call of evidence(End : 03/10/2025)Public consultation(End 03/10/2025)Proposal from ECText of the proposal (27/04/23)Text of the proposal (27/04/23)Announced for the 4th quarter of 2026Text of the proposal(16/12/2025)Announced for the 3rd quarter of 2026EU Economic social committeeOpinion(20/09/23)Opinion(20/09/23)Opinion(18/03/26)EU Committee of Regions//Renunciation to produce an opinion(04/02/26)EP’s committeeCommittee on legal affairsText of the report (24/01/2024)Committee on legal affairsText of the report (31/01/2024)Committee Public HealthCommittee Industry Research and EnergyWork in progressDeadlin for amendments in Committee : 07/07/2026Committee report planned for 01/10/2026EP’s opinion(1st reading)Text amended (26/02/24)Text amended (28/02/24)EP’s 2nd vote(1st reading)//EU Council opinion(1st reading)//EU Council negotiations mandateText 1 of the Presidency(as of 29/10/2025)Text 2 of the Presidency(as of 29/10/2025)Trilogue compromise textEU Council opinionEP’s committee opinionEU Council’s opinion(1st reading)EP’s committee opinionEP’s opinion(2nd reading)EU Council opinion(2nd reading)ConciliationEP’s opinion(3rd reading)EU Council opinion(3rd reading)Final adoptionEU ratification//////Entry into forceHealthPurposeHarmonising the authorisation procedures of medicinal products (Pharma package)Authorisation and supervision of medicinal products for human useProcedure reference2023/01322023/0131PreparationProposal from ECText of the proposal(26/04/2023)Texte de la proposition(26/04/2023)EU Economic social committeeOpinion(25/10/23)Opinion(25/10/23)EU Committee of RegionsRenunciation to produce an opinion(04/07/23)Renunciation to produce an opinion(04/07/23)EP’s committeeCommittee Public healthText of the report(21/03/2024)Committee Public HealthText of the report(21/03/2024)EP’s opinion(1st reading)Text amended(10/04/2024)Text amended(10/04/2024)EP’s 2nd vote(1st reading)//EU Council opinion(1st reading)//EU Council negotiations mandateMandate(04/06/2025)Mandate(04/06/2025)Trilogue compromise textText of compromise(11/12/2025)Text of compromise(11/12/2025)EU Council opinionEP’s committee opinionVote of agreement18/03/2026Position of agreement18/03/2026EU Council’s opinion(1st reading)Text adopted21/04/2026EP’s committee opinionEP’s opinion(2nd reading)Indicative date for discussion and vote in plenary : 11/11/2026EU Council opinion(2nd reading)ConciliationEP’s opinion(3rd reading)EU Council opinion(3rd reading)Final adoptionEU ratification/Entry into force [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [132] => Array ( [objectID] => 10124 [title] => Legal watch [timestamp] => 1734566400 [date] => 19/12/2024 [annee] => 2024 [url] => https://infogm.org/en/legal-watch/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => 1. Rrad the interview of AVICENN : Christophe Noisette, « Des nanos en agriculture ? », Inf’OGM, le journal, n°142, septembre/octobre 2016. https://infogm.org/article_journal/des-nanos-en-agriculture/ [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [133] => Array ( [objectID] => 10016 [title] => The genome of 1.8 million species is being sequenced [timestamp] => 1733875200 [date] => 11/12/2024 [annee] => 2024 [url] => https://infogm.org/en/the-genome-of-1-8-million-species-is-being-sequenced/ [image] => https://infogm.org/wp-content/uploads/2024/12/pnas.1720115115fig01-768x839.jpeg [extrait] => Can biological diversity escape any risk of biopiracy when part of it is digitised in computers? The answer depends on ongoing negotiations within international bodies. In the meantime, an international project to sequence the genome of all known eukaryotic species is making progress. Financed indirectly by players in the IT and artificial intelligence fields, this project even hopes to be able to bypass certain rules thanks to more powerful working tools. [chapo] => Can biological diversity escape any risk of biopiracy when part of it is digitised in computers? The answer depends on ongoing negotiations within international bodies. In the meantime, an international project to sequence the genome of all known eukaryotic species is making progress. Financed indirectly by players in the IT and artificial intelligence fields, this project even hopes to be able to bypass certain rules thanks to more powerful working tools. [texte] => The sequencing and recording in computer databases of the genome of living organisms that make up biological diversity is one of the keystones of the ongoing appropriation of living organisms. This information, known as “digital sequence information” (DSI), is the subject of international negotiations within the Convention on Biological Diversity (CBD), the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and the World Intellectual Property Organisation (WIPO). The aim of these negotiations is to define their legal status and the conditions needed to protect biodiversity from biopiracy. Far from being a subject of fantasy, the Earth BioGenome Projecti, which has been underway since 2008, illustrates the enormous stakes involved in these ISDs.A costly and overdue international projectIn 2019, Inf'OGM published an article (in French) presenting the Earth Biogenome Project, an international project launched the previous yearii. Whether it was an announcement or not, the project seemed excessive from the outset, since its aim was to sequence the genomes of the 1.84 million known eukaryotic species (organisms with cells that have a nucleus), out of the estimated 12 to 15 millioniii. In 2008, it was announced that the project would take 10 years to complete, at an estimated cost of 4.7 billion dollars.The project is now four years away from the end of its theoretical timetable, and the goal of sequencing the 1.5 million genomes of known eukaryotic species still seems a long, long way off. According to the project website, the genomes of only 3,039 species have been sequencediv.A network of projectsThe Earth BioGenome Project is not an entity in its own right, but an umbrella project covering many other projects. There are 64 of these projects, which may differ from one another for geographical reasons or because of the organisms sequenced. The list of projects published onlinev includes the “1,000 Chilean Genomes”, which aims to “decipher the genomes of animals, plants, and microorganisms endemic to Chile”. The “African Biogenome Project” covers the whole of the African continent, with the aim of building “capacity (and infrastructure) to generate, analyze and deploy genomics data for the improvement and sustainable use of biodiversity and agriculture across Africa”. The European Union is of course present with its “European Reference Genome Atlas Umbrella”, which is “a pan-European community initiative to coordinate the generation of reference genomes representing European eukaryotic biodiversity”.Participating projects can also target types of organisation rather than geographical areas. In this area, we need to think big. The “Ocean genomes” project aims to “accelerate and scale the production of openly accessible reference genome assemblies for marine vertebrates” present in all oceans. The depths of the ocean have not been forgotten, as the "Deep-ocean genomes project" will be exploring and collecting specimens for sequencing. The "Polar Genomes Project" aims to “foster research on the unique features and functions of the genome that enable unique and powerful biological processes in polar organisms”. Primates, fish, birds, insects, crabs, butterflies, ants, amphibians, bees, bats,... are also the focus of numerous dedicated projects.A project for "indigenous peoples and local communities"The “Wise ancestors” project is somewhat original among the affiliated projects. Its mission, as set out on its websitevi, is to co-create and develop “species-specific research projects (ie. “Conservation Challenges”) with Indigenous Peoples (IP) and Local Communities (LC) for the purpose of producing genomic information, strengthening IP and LC conservation efforts, and supporting Indigenous data sovereignty”. Put simply, this project coordinates the work of researchers and local communities to sequence the genome of species known and used by these local communities, and to gather the associated traditional knowledge. This knowledge is essential if we are to know the characteristics of a particular organism that has been harvested.As well as being a concrete example of the risks of biodiversity appropriation through the use of ISDs and the collection of associated traditional knowledge, this project is highly original in terms of its funding.On its website, it states that its only source of funding is the Future of Life Institutevii. In the European Union, this institute is registered in the Transparency Registerviii because of its meetings with members of the European Commission and the European Parliament, between 2021 and 2024, concerning the legislation on artificial intelligence, which was adopted last Julyix. As the institute itself explains, its financial resources come from donations received and then redistributed in the form of grants. Donors include Vitalik Buterin, co-founder of the Ethereum cryptocurrency, Jaan Tallinn, founder of Skype, and, in 2015, Elon Musk, co-founder of Space X, Tesla, PayPal and OpenAIx.Done in reverse, the path described here shows that players in artificial intelligence and cryptocurrencies are indirectly investing in the sequencing of the genomes of species that make up biodiversity, mobilising researchers and local communities to do so.Risks of biopiracy?Why does the Earth BioGenome Project raise questions? One of the issues is intellectual property. Genome sequencing feeds computer databases that will store ISDs. These ISDs are in themselves a source of information that can be used by some to develop an ‘invention’ and claim an associated patent. In the field of life, patents have the particularity of covering the information constituting an invention and any organism containing this information. The recent case of a KWS patent on cold-resistant maize plants, unsuccessfully challenged before the European Patent Office (EPO) and threatening the commercial exploitation of the work of breeders who had selected cold-resistant maize prior to the patent application, shows thisxi. This is also demonstrated by the recent adoption within the WIPO of an international treaty in which every effort has been made to ensure that the origin of the ‘material’ (in our case, organisms or ISDs) does not have to be provided, thereby making it easier to extend the scope of a patent beyond the sole ‘invention’ claimedxii.In the case of the Earth BioGenome Project, recommandations have been set out to reassure that all sampling of terrestrial biodiversity is carried out in compliance with international rules. The general approach of this project is that “sample collectors should ensure that all local and national permissions for collection are in place, and that there is a record of these permissions that can be referred to if any questions arise as to whether a specimen was legally obtained”xiii. The conditional clause used in this sentence, as in the rest of the recommandations for collecting samples, nevertheless raises questions, as compliance with national or international rules is rarely an option. This conditional clause is only slightly in keeping with the reminder to collectors that the Nagoya Protocol imposes an established procedure for the collection and transport of specimens: obtaining prior consent and a benefit-sharing agreement, while overlooking the essential material transfer agreement. This omission may be explained by the fact that this guide to good practice includes a hope that the work can be simplified by artificial intelligence tools. In fact, it is detailed that the Earth Biogenome Project “encourage activities that simplify and streamline standard operating procedures and protocols to make it easier to “containerize” extraction, sequencing, and assembling activities. Containerization means a world in which a simple portable lab could house everything needed to go from sample to sequence [...]. This relieves pressure on Nagoya Permit requirements and the budget spent on expensive shipping costs to maintain the cold-chain”.This desire is based on the absence of a legal definition and status for CIO information. Numerous negotiations are underway at international level, and some players, particularly in Europe and North America, are pushing for ISDs not to be subject to the rules governing the exploitation of biodiversity. While today it is necessary to obtain an agreement for the transfer of material in order to take an organism out of the country where it is located, several countries consider that this should not be the case for ISDs. From this angle, the Earth BioGenome Project raises the question of the risks of biopiracy in an even more exacerbated way. This is all the more true given that access in violation of any material transfer agreement obligation is already irreversible in the case of many freely accessible electronic ISD databases, as well as for public collections of genetic resources that do not document the origin of the physical organisms sequenced or made available in physical form, just like many private collections.i Website of the Earth Genome Project: http://www.earthbiogenome.org/ii Frederic PRAT, « Séquencer le génome de l’ensemble des êtres vivants sur Terre », Inf’OGM, 27 august 2019 (in French).iii The figures given here for the total number of genomes to be sequenced were given in 2020 in the following article: H.A. Lewin et al., « The Earth BioGenome Project 2020: Starting the clock », Proc. Natl. Acad. Sci. U.S.A., 119 (4) e2115635118, 2022. In 2018, the figures given were 1,5 million of eucaryotes’ genomes.iv GoaT, « Earth Biogenome Project (EBP) ».v GoaT, « pages for the Earth Biogenome Project (EBP) and EBP-affiliated projects ».vi Wise Ancestors, « Our Mission ».vii Website of the Future of Life Institute: http://futureoflife.org/viii According to the European Union, “the Transparency register is a database listing ‘interest representatives’ (organisations, associations, groups and self-employed individuals) who carry out activities to influence the EU policy and decision-making process. It is designed to show the public which interests are being represented at EU level, by whom and on whose behalf – as well as the resources devoted to these activities (including financial support, donations, sponsorship, etc.)”.EU, Transparency Register, "organisation detail for Future of Life Institute".ix Parlement européen, Observatoire législatif, « 2021/0106(COD) – Législation sur l’intelligence artificielle ». x FLI, « Finances ».xi Denis Meshaka, "EPO throws cold water on opposition to KWS patent", Inf'OGM, 20 november 2024.xii K.M. Gopakumar, "WIPO opens more widely the door to biopiracy", Inf'OGM, 6 november 2024.xiii Earth BioGenome Project, Mara K. N. Lawniczak et al., « Best Practice Guidance for Earth BioGenome Project Sample Collection and Processing: Progress and Challenges in Biodiverse Reference Genome Creation », october 2024. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [134] => Array ( [objectID] => 9971 [title] => Pro-GMO multinationals indirectly manage the Svalbard seed bank [timestamp] => 1733270400 [date] => 04/12/2024 [annee] => 2024 [url] => https://infogm.org/en/pro-gmo-multinationals-indirectly-manage-the-svalbard-seed-bank/ [image] => https://infogm.org/wp-content/uploads/2026/03/42891078034_f24f3f0059_c-768x512.jpg [extrait] => The Svalbard Global Seed Vault (Svalbard, Norway), often nicknamed the "seed vault", plays a special role in preserving genetic biodiversity. Its main mission, focused on the long-term conservation of seed samples, is officially to preserve the diversity of plant genetic resources and ensure their accessibility in the event of disasters. However, a closer look at how it works reveals the considerable influence and interests of pro-GMO players in its governance. Who will really benefit from Svalbard, the multinationals or the farmers? [chapo] => The Svalbard Global Seed Vault (Svalbard, Norway), often nicknamed the “seed vault“, plays a special role in preserving genetic biodiversity. Its main mission, focused on the long-term conservation of seed samples, is officially to preserve the diversity of plant genetic resources and ensure their accessibility in the event of disasters. However, a closer look at how it works reveals the considerable influence and interests of pro-GMO players in its governance. Who will really benefit from Svalbard, the multinationals or the farmers? [texte] => On 22 October, the Svalbard Global Seed Vault (Svalbard, Norway) welcomed over 30,000 new seed samples from 21 countries. This news provides an opportunity to revisit the sometimes controversial workings of this global seed vault located on the island of Spitsbergen, halfway between Norway and the North Pole. This geographical location was chosen for the conditions required for long-term seed conservation. Opened in 2008, Svalbard's official aim is to preserve millions of seed samples from a very large number of crop species and to ensure that they are available to those who supplied them in the event of natural or man-made disasters. For example, Icarda, which used to manage the Syrian seed bank, recovered samples that it had deposited in Svalbard in 2011 following the military conflicts that had threatened them, and sent them to Morocco and Lebanon, where it transferred its research activities in 2015i.Functioning and governance of Svalbard Svalbard operates under a tripartite agreement between the Norwegian government, the Nordic Centre for Genetic Resources (NordGen) and the Crop Trust, a private organisation comprising governments, foundations and private companies forming a "Donor Council" (see diagram below). Although Norway owns the Seed Vault, the building housing the collections, funding and assistance with day-to-day operations are provided by the Crop Trustii, while NordGen manages the repository database.Diagram: tripartite management of the Svalbard The seeds are deposited voluntarily by the collection managers according to a "black box" principle, i.e. they remain the property of the depositors and only they can access and share them. This "duplicate" of the seeds deposited at Svalbard is therefore intended as a safeguard. Svalbard only accepts seeds that are shared in accordance with the rules of the multilateral system or article 15 of the ITPGRFAiii or, as mentioned above, seeds from the depositing country, which must be the place of origin of the seeds it wishes to deposit. Genetically modified (GM) seeds cannot be deposited in Svalbard. As Crop Life points out, Norwegian legislation currently prohibits the import and storage of GM seeds on its territoryiv . These rules are designed to ensure that saved seeds comply with international agreements on biodiversity and food safety. On paper, the seeds deposited in Svalbard can only be returned to the depositors. The depositors can then agree to share the seeds in accordance with article 12 of the ITPGRFA. This involves the signing of Material Transfer Agreements (MTAs) including provisions on intellectual property and benefit sharing, which are supposed to protect the States, the depositors and, possibly, the farmers supplying the seeds and, in this case too, to remunerate themv. Despite these provisions, players such as the farmers' union Via Campesina claim that these MTAs give private companies access to seeds collected from farmers' fields. They can then use them to develop new varieties covered by intellectual property rights. This infringes farmers' rights to use their own seeds, without sharing the benefits vi . In addition to this potential facilitation of biopiracy, the governance of Svalbard also raises questions.Influence of pro-GMO playersThe Crop Trust, which plays a central role in the financial and operational management of Svalbard, includes a number of members who advocate pro-GMO agriculture. For example, the Chair of the Crop Trust's Board of Directors, Catherine Bertini, has been associated with the Bill and Melinda Gates Foundation, known for its support for GMOs. Jean-Christophe Gouache, who has held senior positions at Limagrain, a French champion of GMO development, is another influential executive member.Donors to the Crop Trust ("Donor Council") include agrochemical multinationals, such as Dupont-Pioneer, Syngenta and Bayer, involved in GMO production. This strong presence of industrial interests within the Crop Trust makes it a pressure point influencing seed conservation and access policies, and potentially favouring projects aligned with the commercial interests of these multinationals. What is particularly noteworthy is the lack of direct representation of farmers, despite the fact that they are the main suppliers of seeds, within the governance of an institution such as the Crop Trust. Organisations are also pointing to the risks of inequity and loss of sovereignty for local farming communities. This represents a violation of farmers' right to seeds (guaranteed by article 9 of the ITPGRFA), as well as the dangers of biopiracy and excessive commercial influence. When Svalbard was set up in 2008, Via Campesina's message to the seed multinationals was unequivocal: "Whether through patents, plant breeders' rights or GMOs, the aim of the seed multinationals is to impose their right of ownership on all existing seeds, by eliminating most of the cultivated biodiversity that could compete with them. Is it because they intend to carry out their project to totally wipe out all the biodiversity cultivated in the fields that they are today financing the storage of seeds stolen from farmers and Indigenous Peoples in the Svalbard gene bank"?viii.Possible impact on conservation policiesThe influence of agrochemical multinationals creates a risk of conservation policies being biased. Although Svalbard is intended to conserve non-GMO seeds, pro-GMO donors can exert pressure to align conservation policies with their interests, for example by limiting access to certain seeds and favouring the conservation of seeds resistant to herbicides marketed by these multinationals. The risk of decisions going against the interests of local farming communities, the peasant seed system and conservation initiatives based on traditional seeds cannot therefore be totally ruled out. Yet it is one of Svalbard's stated missions to protect these farmers' access to this diversity.However, it is worth asking whether this issue of conservation should not be reconsidered in the light of the digitisation and dematerialisation of seeds. In addition, the emergence of "new GMOs", presented as non-traceable because they are "identical" to traditional seeds and could be excluded from the official category of GMOs in the EU, accentuates this questioning. The significant inequality of financial support between Svalbard and ITPGRFA is a worrying development in the field of conservation. Svalbard has received substantial funding (around 30 million dollars [23 million euros] spread over 6 years starting in 2007) from the Bill and Melinda Gates Foundation. The ITPGRFA Benefit Sharing Fund (BSF), designed to support the collection and conservation of plant genetic resources in the fields and in the national banks of developing countries, does not receive the same level of financial support. In May 2023, ITPGRFA's secretary, Kent Nnadozie, announced that contributions from donors, which do not include the Gates Foundation, totaled $11 million to fund projects worldwideix. This disparity affects the effectiveness of ITPGRFA to the detriment of farmers, who are the traditional custodians and main producers of genetic resources. These farmers very rarely benefit from this conservation work, while their seeds are often collected by researchers and NGOs, deposited in Svalbard and then used to develop seeds covered by intellectual property rights that deprive them of their rights.A Holy Grail for multinationalsThe large presence of agrochemical multinationals on the Crop Trust's Board of Donors raises the question of a potential conflict of interest. Decisions taken within this Council are normally taken by consensus. However, in the event of disagreement, they are put to the vote, with each member having one vote. In such a mode of governance, despite the presence of governments and foundations (some of which are openly pro-GMO), the commercial interests of the multinationals, which are also present, may prevail. If so, what would be the worst-case scenario?Svalbard provides invaluable access to "digitisable" genetic biodiversity. This is all the more true given that collections are often made with information on specific phenotypic traits from farmers. In other words, the genetic information contained in each of the seed samples kept in the vault can be sequenced and the information derived from such sequencing used as the basis for a patent application covering a characteristic of interest in the variety. The information collected on this characteristic can be associated with a gene by means of a biotechnological process and form the basis of a patent application (which, to date, does not have to indicate the origin of the material on which the "invention" is based). For an agro-industry fervent about NTGs (new genomic techniques) and adept at an intellectual property policy using this sequencing information (or DSI) - as is the case for most Crop Trust members - the contents of this vault therefore represent a Holy Grail.The risk cannot be ruled out that requests from industry for access to seeds stored at Svalbard could lead to the appropriation of these plant genetic resources. If this happens, Svalbard's original mission of protecting seed diversity could be hijacked by the commercial interests of its managers, to the detriment of the farmers who are the original producers of these seeds.A number of questions need to be asked: is it legitimate for a seed deposit bank managed by a consortium of seed companies and industrial foundations to be supported by governments and intergovernmental organisations such as ITPGRFA? Is it acceptable for a structure that is supposed to be cooperative to mainly benefit multinationals, particularly in the form of exploitable genetic sequences, while the main contributors to these deposits, i.e. farmers, derive only marginal benefits, and only in the event of major disasters such as climatic hazards or conflicts? i ICARDA Communication Team, "ICARDA's seed retrieval mission from Svalbard Seed Vault", 1st November 2015.ii Crop Trust, Endowment Fund. iii ITPGRFA: International Treaty on Plant Genetic Resources for Food and Agriculture.Its multilateral system encourages the sharing of seeds between countries to preserve agricultural biodiversity. Article 15 deals with ex situ collections, managed by the Consultative Group on International Agricultural Research (CGIAR) and other recognised institutions, which must be accessible in order to support the objectives of the ITPGRFA. iv Crop Trust, "Frequently asked questions about the Svalbard Global Seed Vault". v Frédéric Prat, "Des semences partagées, mais des droits paysans théoriques", Inf'OGM, le journal, N°125, November/December 2013 (in french). vi Via Campesina, "Defending peasants' rights to seeds and genetic resources, against the biopiracy", 17 July 2023. viii Via Campesina, "Political documents", May 2009. ix FAO, "Twenty-eight projects approved for funding", 12 May 2023. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [135] => Array ( [objectID] => 9934 [title] => Through its silence, the European Commission has been keeping Mon810 maize authorised since 15 years [timestamp] => 1732665600 [date] => 27/11/2024 [annee] => 2024 [url] => https://infogm.org/en/through-its-silence-the-european-commission-has-been-keeping-mon810-maize-authorised-since-15-years/ [image] => https://infogm.org/wp-content/uploads/2024/11/ISO_7001_PI_BP_001.svg_.png [extrait] => Mon810 maize is the only transgenic GM plant authorized for commercial cultivation in the European Union. This authorization was initially granted, via France, almost 30 years ago, in 1998, for an initial period of 10 years. A renewal application was submitted in 2007. Since then, no decision has been taken by the European authorities. How this maize, which authorization theoretically expired in 2008, can still be grown legally in Europe? Simply because European law accepts that, as long as the European Commission has not responded to a request for renewal, the initial authorization remains valid. To date, it’s been 15 years that the Commission fails to respond to Bayer/Monsanto's request. [chapo] => Mon810 maize is the only transgenic GM plant authorized for commercial cultivation in the European Union. This authorization was initially granted, via France, almost 30 years ago, in 1998, for an initial period of 10 years. A renewal application was submitted in 2007. Since then, no decision has been taken by the European authorities. How this maize, which authorization theoretically expired in 2008, can still be grown legally in Europe? Simply because European law accepts that, as long as the European Commission has not responded to a request for renewal, the initial authorization remains valid. To date, it’s been 15 years that the Commission fails to respond to Bayer/Monsanto’s request. [texte] => On July 4, 2024, the European Commission renewed for the 3rd time the commercial authorization to import Mon810 transgenic maize for food or feed usei. Less than 6 months after receiving a favorable opinion from its experts, the European Commission issued the authorization, demonstrating its speed. But when it comes to authorizing the commercial cultivation of this same maize, the European Commission is taking its time. Bayer/Monsanto has been waiting for 15 years for the European Commission to renew the initial authorization obtained in 1998... which expired in 2008!European law imposes a timetable for applicationsOld times, old procedures. On April 22, 1998ii, the European Commission gave France, the country that had received the initial application, the green light to authorize the commercial cultivation of Mon810 transgenic maize on a European scale. This authorization had been requested by Monsanto, which had genetically modified a maize line to produce an insecticidal protein against the European corn borer and Mediterranean corn borer. On August 3, 1998iii, the French government issued its consent for this commercial cultivation. Monsanto was granted a 10-year authorization, valid until 2008.Subsequently, European legislation on GMOs changed, with the adoption of Directive 2001/18 and Regulation 1829/2003. The latter became the reference in the case of Mon810 maize, as Monsanto chose to follow the administrative procedure established by this regulation. Regulation 1829/2003 required Monsanto to apply for renewal of its 1998 authorization no later than one year before it expired, i.e. by August 2, 2007iv. The company met this deadline, submitting its application for renewal of the authorization to cultivate Mon810 maize to the European Commission on May 4, 2007v. From this date onwards, the European Commission rapidly forwarded the application for renewal of authorization to the European Food Safety Authority (EFSA), on June 18 2007vi.Two years to assess the risks... and ten for a vote !The EFSA took “only” two years to assess the risks associated with the cultivation of Mon810 maize, adopting a positive opinion on June 15 2009, officially published on June 30 2009vii. On the basis of this opinion, the European Commission was in a position to decide whether to submit an authorization decision or a refusal decision to the Member States. At this stage, the timetable followed by the European Commission is beginning to slip. On the basis of the experts' opinion, the procedureviii provides that the Commission may propose to the Member States a refusal or acceptance to grant authorization. If the Member States fail to reach a majority, the proposal is presented to them a second time. If, once again, no majority is reached, the European Commission takes the final decision. It may adopt its own proposal or reject it.In the case of the application to renew the authorization for the commercial cultivation of Mon810 maize, it will, from the EFSA's opinion in 2019, take 8 years for member states to receive a proposal of authorization from the European Commission. It’s true that, in the meantime, many Member States had decided to request the exclusion of their territory from the geographical scope covered by the 1998 authorizationix. By the end of 2015, 18 member statesx had requested and obtained such an exclusion. The concomitance of these numerous bans is linked to the adoption of directive 2015/412xi. While Member States could previously ban GMO cultivation (via safeguard clauses - Directive 2001/18 - or emergency measures - Regulation 1829/2003), in 2015 the Council of the European Union and the European Parliament deemed it “appropriate to grant Member States, in accordance with the principle of subsidiarity, more flexibility to decide whether or not they wish to cultivate GMOs on their territory”xii.The French government, for example, which granted the initial authorization in 1998, asked on September 15, 2015 “to exclude the entire French territory from the authorization granted to MONSANTO following Commission Decision 98/294/EC and the final consent granted on August 3, 1998 for genetically modified maize MON810, as far as cultivation is concerned”xiii. The same number of countries, including Francexiv, have already asked to be excluded, in whole or in part, from any renewal of their authorization.As these 18 Member States represent at least a 71.5% majority within the Council of the European Union, the European Commission was in a position to assume that a proposal to renew the initial authorization could therefore be rejected. The initial authorization to cultivate the one and only transgenic plant would then have lapsed. However, in 2017, 10 years after receiving Monsanto's initial request to renew its 1998 authorization, the European Commission chose to have the Council of the European Union vote on the matter. Paradoxically, on January 27, 2017xv, the member states failed to reach a majority to refuse to renew the authorization of Mon810 maize for cultivation. This lack of a majority was again noted on March 27, 2017, following a second votexvi.A legal provision to the advantage of Bayer/MonsantoThe authorization to import Mon810 maize, like those issued this summer for two Corteva maize plants, show that the European Commission knows how to manage a timetable of less than 6 months between receiving the opinion of European experts on the risks associated with a GMO and its final authorization decisionxvii. But when it comes to renewing the authorization for the cultivation of Mon810 maize, the Commission is following a different timetable. With the European experts having delivered their opinion in June 2009, the Commission could submit a proposal to the Member States in the following two months, either for or against the renewal. As we have seen, it will take 10 years…Following the two formal votes by member states in 2017, which resulted in a non-decision, the European Commission is now free to make the final decision. It can decide to renew the authorization or refuse to renew it. It has had this freedom since March 27, 2017. But to date, almost 8 years later, no decision has been taken. Questioned by e-mail by Inf'OGM, the European Commission replied on October 24, 2024, that it “reflects on the way forward”, specifying that “in accordance with Regulation (EC) No 1829/2003, the period of authorisation is automatically extended until a decision is taken on its renewal”.Article 11 of Regulation 1829/2003 states that “where, for reasons beyond the control of the authorisation-holder, no decision is taken on the renewal of an authorisation before its expiry date, the period of authorisation of the product shall automatically be extended until a decision is taken”. Once again questioned by Inf'OGM to find out why the Commission had decided not to take a decision in 7 years, the Commission reaffirmed on October 28, 2024 that it was continuing “to work assessing the best way forward”, adding it “cannot to share further information at this stage”. A fundamental point needs to be made here: the European Commission is not bound by any legal deadline for making its decision. In fact, there is no legal requirement for the European Commission to take a decision within a given timeframe once the member states have voted. This situation is all the more worrying given that, if the Commission were to issue a renewal of authorization for the commercial cultivation of Mon810 maize, it would do so in 2024 on the basis of a dossier submitted in 2007, containing 17 years old scientific data…As with the procedure applied to pesticidesxviii, whether the European Commission issues a formal authorization renewal or does not respond to Bayer/Monsanto's application submitted in 2007, the initial authorization remains valid and Mon810 maize can continue to be cultivated in member states that have not banned it. However, on the one hand, the European Union hardly receives applications for authorization to commercially cultivate GMOs, and on the other, the Commission has proposed deregulation of a large number of them in 2023. In view of these two facts, it seems that the Commission has decided not to take the risk of crystallizing the debate by appearing to defend the cultivation of transgenic GMOs in a European Union that has largely chosen to have them grown elsewhere. It’se ven more true given that, as long as it does not respond, the commercial cultivation of this maize is still legal, even if the surface area is decreasing from year to yearxix. Silence is golden for the Commission (and Bayer/Monsanto).Other requests for 1st authorization in the hands of the CommissionThe European register of applications for GMO cultivation authorization under the 2001/18 procedure also lists three “pending” applications. Amylogène's application for its transgenic potato with modified starch composition, filed in 1996, has been withdrawn by the company. But Syngenta is still awaiting a response to its 1996 application for its Bt11 maize. Dow Agrosciences (now Corteva), for its part, has been waiting since 2001 for its TC1507xx maize. In both cases, the EFSA issued its (favorable) opinions on the risks associated with the cultivation of these maize varieties in 2005.Unlike Mon810 maize, it took the European Commission not 10 but 12 years to submit a positive response to these two requests for authorization to the votes of Member States in 2017. However, on January 27xxi and March 27 2017xxii, no qualified majority could be obtained from the Member States. The European Commission is therefore now in the position to take the final decision to authorize or refuse to authorize the commercial cultivation of these two transgenic maize plants.i European Union, « Commission Implementing Decision (EU) 2024/1828 of 2 July 2024 renewing the authorisation for the placing on the market of feed containing, consisting of and of food and feed products produced from genetically modified maize MON 810 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and repealing Commission Implementing Decision (EU) 2017/1207 (notified under document C(2024) 4493) », 4 July 2024.ii European Commission, « 98/294/EC: Commission Decision of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220/EEC (Text with EEA relevance) », Official Journal L 131, 5 May 1998.iii French Republic, « Arrêté du 3 août 1998 portant consentement écrit, au titre de l’article 13, paragraphe 4, de la directive 90/220/CEE du 23 avril 1990, des décisions 98/293/CE et 98/294/CE du 22 avril 1998 concernant la mise sur le marché de maïs génétiquement modifiés (Zea mays L. T 25 et MON 810) », JORF, 5 August 1998 (in French).iv Regulation 1829/2003, article 11, « Renewal of authorisations - Authorisations under this Regulation shall be renewable for 10-year periods, on application to the Commission by the authorisation-holder at the latest one year before the expiry date of the authorisation ».v Monsanto Company, « Application for renewal of the authorisation for continued marketing of existing MON 810 maize products that were authorized under Directive 90/220/EEC (Decision 98/294/ EC) and subsequently notified in accordance to Article 20(1)(a) of Regulation (EC) No 1829/2003 on genetically modified food and feed », May 2007. Letter_Renew_Mon810_May2007vi European Commission, « Applications for renewal of authorisation for continued marketing of existing feed consisting and/or containing MON810 maize for feed use (including cultivation) that were authorized nder Directive 90/220/EEC (Decision 98/294/EC) and subsequently notified according to Article 20(1)(a) of Regulation (EC) No 1829/2003 on genetically modified food and feed », 29 June 2007.Letter from EC to EFSA june 2007vii « Scientific Opinion of the Panel on Genetically Modified Organisms on applications (EFSA-GMO-RX-MON810) for the renewal of authorisation for the continued marketing of (1) existing food and food ingredients produced from genetically modified insect resistant maize MON810; (2) feed consisting of and/or containing maize MON810, including the use of seed for cultivation; and of (3) food and feed additives, and feed materials produced from maize MON810, all under Regulation (EC) No 1829/2003 from Monsanto », The EFSA Journal, Volume7, Issue6, p.1–85, June 2009.viii Pauline Verrière, « UE – Nouvelle comitologie : le changement dans la continuité », Inf’OGM, 22 March 2016 (in French).ix European Commission, « Restrictions of geographical scope of GMO applications/authorisations: EU countries demands and outcomes ».x Austria, Region of Wallonia (Belgium), Bulgaria, Croatia, Cyprus, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Slovenia. They were 19 in 2015 but the United Kingdom has since left the European Union.xi European Union, « Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory Text with EEA relevance », Official Journal of the European Union, 13 March 2015xii Ibid. (see whereas 8 of Directive 2015/412)xiii French Republc, « NOTE DES AUTORITÉS FRANÇAISES – OBJET : Mise en culture d’OGM – Demande d’exclusion du territoire français », 15 September 2015 (in French).xiv French Republc, « NOTE DES AUTORITES FRANÇAISES – OBJET : Mise en culture d’OGM – Demande d’exclusion du territoire français », 15 September 2015 (in French).xv European Commission, Health and Food Safety Directorate General, « SUMMARY REPORT OF THE JOINT MEETING – STANDING COMMITTEE ON PLANTS, ANIMALS, FOOD AND FEED – Section Genetically Modified Food and Feed and Environmental Risk and REGULATORY COMMITTEE under DIRECTIVE 2001/18/EC HELD IN BRUSSELS ON 27 JANUARY 2017 », 27 January 2017.xvi European Commission, Health and Food Safety Directorate General, « SUMMARY REPORT OF THE APPEAL COMMITTEE – Genetically Modified Food and Feed Regulatory Committee 2001/18/EC », 27 March 2017.xvii Concerning maize DP915635 and DP023211 of Corteva, see : Eric Meunier, « Transgenèse, Crispr/Cas9, ARNi… package total pour deux maïs OGM ! », Inf’OGM, 29 October 2024 (in French).xviii Pollinis, « PESTICIDES: THE DANGERS BEHIND THE EU’S ENDLESS EXTENSIONS - PESTICIDES : EU’S SYSTEM OF ENDLESS EXTENSIONS THREATENS BIODIVERSITY AND HUMAN HEALTH », February 2023.xix Christophe Noisette, « Les cultures transgéniques en voie de disparition dans l’UE », Inf’OGM, 8 April 2024 (in french).xx European Commission, « Deliberate Release and Placing on the EU Market of GMOs – GMO Register / Notifications authorized under Directive 2001/18/EC – GMO Part C ».xxi European Commission, Health and Food Safety Directorate General, « SUMMARY REPORT OF THE JOINT MEETING – STANDING COMMITTEE ON PLANTS, ANIMALS, FOOD AND FEED – Section Genetically Modified Food and Feed and Environmental Risk and REGULATORY COMMITTEE under DIRECTIVE 2001/18/EC HELD IN BRUSSELS ON 27 JANUARY 2017 », 27 January 2017.xxii European Commission, Health and Food Safety Directorate General, « SUMMARY REPORT OF THE APPEAL COMMITTEE – Genetically Modified Food and Feed Regulatory Committee 2001/18/EC », 27 March 2017. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [136] => Array ( [objectID] => 9899 [title] => EPO throws cold water on opposition to KWS patent [timestamp] => 1732060800 [date] => 20/11/2024 [annee] => 2024 [url] => https://infogm.org/en/epo-throws-cold-water-on-opposition-to-kws-patent/ [image] => https://infogm.org/wp-content/uploads/2026/03/29273458531_229afb2502_c-768x512.jpg [extrait] => On 15 October 2024, the European Patent Office (EPO) upheld KWS's patent for cold-resistant maize. This decision is likely to raise serious concerns among European seed breeders, who may now feel threatened in their breeding work. The patent covers maize plants containing a naturally occurring genetic sequence, which restricts the freedom of breeders to develop new varieties. The "oral proceedings", which took place before the EPO Opposition Division and which Inf'OGM attended by video-conference, gave rise to some unusual and revealing exchanges. This case shows once again that patents can indeed be tools for appropriating seeds developed by farmers and/or breeders. [chapo] => On 15 October 2024, the European Patent Office (EPO) upheld KWS’s patent for cold-resistant maize. This decision is likely to raise serious concerns among European seed breeders, who may now feel threatened in their breeding work. The patent covers maize plants containing a naturally occurring genetic sequence, which restricts the freedom of breeders to develop new varieties. The “oral proceedings“, which took place before the EPO Opposition Division and which Inf’OGM attended by video-conference, gave rise to some unusual and revealing exchanges. This case shows once again that patents can indeed be tools for appropriating seeds developed by farmers and/or breeders. [texte] => The No Patents On Seeds (NPOS) coalition has opposed a patent granted to KWS on cold-resistant maize, arguing that the patent should be revoked. On 15 October 2024, this opposition was discussed before the Opposition Division of the European Patent Office (EPO), a decision awaited by European farmers and plant breeders. Ahead of this oral proceedings, a demonstration was organised by NPOS in front of the EPO building, with the participation of a seed producer Grietje Raaphorst-Travaille, who feels threatened by this KWS patent.i. This Dutch seed producer, co-founder of Nordic Maize Breeding (NMB), contributed to the oral proceedings, pointing out in particular that it had developed a cold-resistant maize in 2008, well before the patent application was filed. But today, like other small breeders, she fears that she will be forced to abandon her work or submit to the conditions imposed by KWS and other large companies.A patent based on a natural genetic element KWS patent EP3380618, filed on 26 November 2016 and granted on 27 July 2022, covers maize containing a section of DNA correlated with cold tolerance. This section, called QTL (Quantitative Trait Locus), was not created by KWS, but identified using molecular markersii used to identify cold tolerance traits. Through this patent, KWS claims industrial property rights over maize plants containing this QTL, as well as the process for identifying and selecting this section of DNA through genetic analysis. This patent gives KWS exclusive control not only over its own maize varieties, but over all varieties containing this QTL in their genome, except those whose existence prior to the filing date of the patent application can be documented. Since 26 November 2016, this patent has prevented breeders from using this QTL for new varieties without obtaining a licence. This patent therefore restricts access to natural genetic resources and limits the genetic diversity available for agriculture.This KWS-patented 'invention' is based on a technique that involves establishing a statistical correlation between molecular markers and a phenotypic trait, in this case cold resistance. In other words, it involves identifying a characteristic that is naturally present in the genetic make-up of plants, without any direct genetic manipulation. This statistical process is sufficient for KWS to claim and obtain exclusive exploitation rights, given that it filed its patent application in 2016, i.e. before products derived from traditional breeding processes (known as "essentially biological") could no longer be patented. This situation is worrying small breeders like Grietje Raaphorst-Travaille, who see this patent as appropriating a genetic characteristic that has long been present in her maize.The EPO validates the technical nature of the "invention"...During the opposition proceedings, the No Patent on Seeds coalition raised several grounds for invalidating the KWS patent. In particular, it objected that the maize plant claimed was a conventional variety obtained using an essentially biological process. According to NPOS, cold tolerance is the result of cross-breeding methods, which are not patentable, and the molecular analyses which are the subject of the process claims cannot in themselves justify patentability. According to NPOS, only 'genetic engineering' inventions [editor's note: a term for which there is no legal definition] involving the direct modification of genes are patentable. However, this point is debatable, as there are many patentable inventions, known as 'genetic engineering' or biotechnological inventions, which do not involve the direct modification of genes. NPOS also points out that the ban on patenting plant varieties is supported by EPO case law, which strictly distinguishes conventional breeding from "genetic engineering".The EPO Opposition Division confirmed what it had already stated in a preliminary opinion preceding the oral procedure: "the plants claimed do not meet the definition of a plant variety (rule 26(4) of the European Patent Convention (EPC)) because they are defined by only one characteristic (cold tolerance). The other characteristics are not defined and must not be genetically stable. The plants defined in the claims do not therefore constitute a unit that can be multiplied without being modified (rule 26(4)(c) EPC). This would, however, be an essential characteristic of a plant variety.” Furthermore, the EPO Opposition Division can reject NPOS's argument that the claimed maize is a variety obtained under an essentially biological process for strictly legal and procedural reasons: "The Division notes [...] that it is bound by the interpretation of the Enlarged Board of Appeal published in decision G 3/19iii. Rule 28(2) EPC does not apply to the present patent, which is based on a patent application filed on 26 November 2016". In other words, Rule 28(2) EPC relied on by NPOS, which prohibits the patentability of plants obtained exclusively by biological processes, does not apply to patent applications filed before July 1st 2017, such as that of KWS.This legal fact raises serious questions and alarms small breeders. By validating this patent on the basis of the non-retroactivity of a decision by its Administrative Council, the EPO is legitimising a patent that would no longer be valid if applied for today. This situation highlights a major distortion in the patentability system in Europe, where injustices arising from the vagueness of earlier rules cannot be corrected until 20 years after they have been amended. A patent with a term of 20 years can no longer be revoked on the basis of a new rule, and the role of the Opposition Division is not to judge the relevance of the rules but to ensure that they are applied....which it considers to be new and inventiveThe No Patent on Seeds coalition also raised other grounds in an attempt to invalidate the KWS patent. In particular, it argued that the "invention" lacked novelty and inventive step, two conditions for the validity of a patent. According to NPOS, the genetic characteristics in question had already been discovered in maize plants widely used for breeding prior to the patent application. In particular, Nordic Maize Breeding had obtained its first cold-resistant maize variety for organic farming in 2008, 8 years before KWS filed its patent application. According to EPO guidelines, a genetic sequence - in this case the QTL - existing in its natural state prior to the patent application is not excluded from novelty. If it is isolated, identified and technically characterised, with an associated function, it can then be considered new within the meaning of patent law.iv. For example, patents can be granted for traits such as tolerance to cold (or drought, or increased productivity) even if these traits are known in older lines. This may come as a surprise given that patents are only granted for new objects. The Opposition Division therefore concluded that the QTL on which the granted patent is based was not "part of the state of the art" at the time the patent application was filed and confers novelty on the maize plant containing it. The EPO also confirmed the criterion of inventive step, considering that the claimed processes did not follow "in an obvious manner from the state of the art" (Article 56 EPC). Indeed, the Opposition Division "again sees no convincing argument to explain why a person skilled in the art would have produced the claimed plants or developed a process to identify them" using his or her general knowledge and in view of the state of the art.Nordic Maize Breeding has confirmed that it registered its cold-resistant maize in the Dutch and European catalogues of varieties before the KWS patent application was filed. The breeder points out that "cold resistance is, however, a general characteristic that is not clearly defined. Early vigour and the speed with which the [maize] crop covers the ground are related characteristics. These characteristics, as well as the way in which they are named, are decided within Plantum [editor's note: the Dutch association of the seed industry and breeders]". The EPO does not appear to consider these registrations as prior art against this patent.KWS steps up the pressureAt the hearing, the KWS representative proposed a "licensing offer" to Grietje Raaphorst-Travaille, suggesting that she could exploit the patented invention in return for royalties. This proposal, made publicly, was perceived as an attempt to put pressure on small seed companies to accept licensing conditions or abandon their varieties. As it is not the EPO's task to deal with infringement issues, KWS's comments were outside the scope of the hearing. Furthermore, by proposing a licence, KWS is implying that Nordic Maize Breeding's maize infringes its patent, which can only be judged by a national court.This licence offer can be interpreted as a commercial manoeuvre aimed at intimidating small breeders under the pretext of KWS's dominant position in plant breeding. In effect, KWS is trying to shift the debate towards economic negotiations, whereas the initial issue is purely legal.No Patent on Seeds has already announced its intention to appeal this decision, whose impact goes beyond the KWS case and concerns many players such as Nordic Maize Breeding. In order to hope to overturn this decision, NPOS will have to develop a more solid and substantiated argument, highlighting the legal and political inconsistencies in the legislation. The EPO - and not the Opposition Boards of Appeal, which simply apply the law - continues to maintain patents, for another fifteen years or so, which would probably be considered invalid if they were examined today. i Denis Meshaka, "A Dutch seed company faces up to KWS patents", Inf'OGM, 4 April 2024. ii Molecular markers are specific fragments of DNA that can be identified, located in very specific places in the genome. They can be used to locate a particular gene or to check whether an individual has inherited a particular characteristic from a parent organism. Individuals in which the molecular marker is present can be selected, since this marker indicates the presence of the characteristic being sought. iii Decision G3/19 states that products obtained from essentially biological processes are not patentable. It confirms the applicability of Rule 28(2) while limiting its effect in time in order to preserve the legal certainty of patents and applications prior to July 1st 2017. iv European Patent Office, "EPO Guidelines GII.5.2 - Patentable biotechnological inventions". An element of the human body "may constitute a patentable invention, even if the structure of that element is identical to that of a natural element" (Article 5 of Directive 1998/44). Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [137] => Array ( [objectID] => 9864 [title] => The European Commission’s legal initiatives on the Living [timestamp] => 1731456000 [date] => 13/11/2024 [annee] => 2024 [url] => https://infogm.org/en/the-european-commissions-legislative-initiatives-on-living/ [image] => https://infogm.org/wp-content/uploads/2026/03/Panneau_Chantier_Route_Druillets_St_Cyr_Menthon_2.jpg [extrait] => In less than a year and a half, from May 3, 2022 to October 12, 2023, the previous European Commission has launched a number of legislative initiatives concerning the Living. The deregulation of GMOs, the digitization of living organisms and even patents are just some of the issues on the table of member states and the European Parliament. If adopted, these projects will make it easier for companies with substantial financial, human and technical resources to take ownership of the Living. These initiatives do echo current international negotiations. [chapo] => In less than a year and a half, from May 3, 2022 to October 12, 2023, the previous European Commission has launched a number of legislative initiatives concerning the Living. The deregulation of GMOs, the digitization of living organisms and even patents are just some of the issues on the table of member states and the European Parliament. If adopted, these projects will make it easier for companies with substantial financial, human and technical resources to take ownership of the Living. These initiatives do echo current international negotiations. [texte] => Since July 5, 2023, attention has been focused on the European Commission's proposal to deregulate a large number of GMO plants. This would remove the risk assessment, traceability and labeling obligations (except for seed lots) along the entire production and processing chain, right up to consumers. But this deregulation of GM plants is by no means the only subject on the agenda of the European Parliament and the Council of the European Union.These initiatives have one thing in common with current international discussions. If adopted, they would remove the ability of national authorities to trace both a genetically modified product covered by a patent and the origin of the “material” at the basis of a patented invention. In this way, patents would become a tool for appropriating living organisms, all the more effective since claims could no longer be restricted to “invented” products.At the international level, facilitating the appropriation of the LivingMultinationals' strategy to take ownership of the Living through industrial property tools revolves around one imperative for these companies: to eliminate all traceability and information on the origin of the “material” on which their patented inventions are based. In the field of the Living, this “material” is the biodiversity, whether wild or cultivated. Knowing the origin of the living organisms used to develop a patented invention would, in theory, mean limiting industrial property claims to the organisms resulting from the invention. A prospect that does not meet the ambitions or industrial imperatives of seed, pharmaceutical, pesticide, micro-organism or digital companies.The computer-based tools was a key element in this strategy. It has made it possible to greatly accelerate the sequencing of the genomes of living organisms, and to set up computerized databases to compile digital sequence information (DSI). These databases can contain genetic sequences, but also information on the characteristics of the genetic resources that contain them, or other information linked to these data. These DSI are the subject of numerous regulatory debates, even though there is no agreed legal definition.Exploiting biodiversity using the “genetic resources” constituting it today requires authorization from local authorities to access these resources and, possibly, to transfer them from their place of origin to laboratories and markets. For plants, this means giving up any intellectual property rights relating to these resources, their genetic parts or components, and then to share the benefits derived from the exploitation of this biodiversity. In a number of international bodies, DSI issue is currently used as an opportunity to circumvent these obligations. Within the Convention on Biological Diversity (CBD)i, but also within the FAO’s Commission on Genetic Resourcesii or the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)iii, negotiations are underway to determine whether DSI are non-patentable genetic resources or patentable products of research. This last position is the one systematically taken in numerous international bodies (ITPGRFA, CBD...) by the “Europe group”, which includes a number of European countries that are not members of the European Union. If it were decided that they are not genetic resources, their use would not be subject to the rules summarized above. Another important point is that many DSI databases are already freely accessible on the Internet without any indication of the geographical origin of the sequenced material, and it is often no longer possible to trace this origin, as many very different “genetic resources” may contain absolutely identical DSI. This state of affairs undermines the ability to trace the natural origin of what becomes a patented “invention”.These DSIs enable companies to apply for patents on sequence information they claim to have developed using a particular patentable genetic modification technique. Obtained on the basis of DSI, the scope of these patents would nonetheless extend to all organisms containing the sequences concerned, on condition that the origin of the DSI is not indicated in the databases or required in the patent application, and that States are deprived of any effective capacity to control. The World Intellectual Property Organization (WIPO)iv has just completed its work on this issue. This issue is also of interest to the pharmaceutical industry, explaining why the World Health Organization (WHO) is also working on itv.The European Commission makes several movesCurrent European Union legislation on GMOs is a major obstacle to this ongoing international strategy. It requires labelling, documentary traceability and publication of analytical procedures for the detection and identification of any GMO released or marketed in Europe. If these traceability methods are provided, the very broad claims sought by patent-holding companies can no longer be met so easily, since they imply that anyone can identify a patented product and distinguish it from any other product not resulting from the patented invention. The same companies have therefore long been pushing the European Union and other countries to stop demanding GMO labelling and traceability, claiming that their genetic modification techniques do “the same thing as nature, or as traditional breeding” that cannot be patented, just faster, and therefore indistinguishable from it. This enables them to extend the scope of their patents to biological resources containing naturally, or as a result of unpatentable traditional selection, the same DSI as those covered by their patents.The European Commission has launched a number of legislative initiatives in Europe, over a short period of time to say the least, in response to industry's desire to get rid of all traceability obligations. These initiatives are also an opportunity to get rid of other requirements of current European regulations which are deemed unnecessary such as risk assessment. From May 2022 to October 2023, the Commission presented no less than seven proposals for regulations to the European Parliament and the Council of the European Union. The table below (which Inf'OGM will regularly update) summarizes these different procedures, as well as :the one still under informal discussion on a possible new interpretation of Regulation 1829/2003 ;the two requests from the European Parliament for two proposals for regulations to be formulated. But, what's the big picture?With regard to DSI, in October 2023 the European Commission presented a proposal (procedure 2023/0353) for the European Union to sign the agreement adopted within the United Nations Convention on the Law of the Sea (UNCLOS) and concerning “the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction”. The agreement quotes but does not define DSI, thus preventing any immediate progress in the debate. A year earlier, in May 2022, the European Commission turned its attention to the field of human health, formulating a proposal for a regulation (procedure 2022/0140) to regulate access to Europeans' health information, including their genetic, genomic and proteomic data. Gathered in digital form in databases, these information are human DSI, to which the proposed regulation proposes to give access to research and industrial players.In the case of GMO plants (including marine and freshwater algae), deregulation was proposed in July 2024 (procedure 2023/0226). The aim of this proposal is to no longer subject many GMO plants to risk assessment, labeling and traceability requirements, and thus to allow the scope of patents on DSI (“genetic information” or “biological material” associated with a particular “function”) to be extended to all organisms containing and expressing this function, whether or not they are derived from the patented invention.GMO micro-organisms are also the subject of discussions aimed at lightening the current framework. A still informal discussion has been initiated between the Member States and the European Commission on a potential new interpretation of Regulation 1829/2003, which could lead to an exemption from labeling and traceability for batches of food or feed additives contaminated with DNA from GMMs (genetically modified micro-organisms) used to produce these additivesvi. In April 2023, the European Commission also launched a legislative project in the medical field. It proposed (procedure 2023/0132) to harmonize and streamline authorization procedures for medical gene therapy products “containing recombinant nucleic acid sequence(s) or genetically modified microorganism(s) or virus(es)”, or GM cells. Finally, in February 2024, the European Parliament asked the European Commission to submit a proposal for the deregulation of GMMs obtained by new genetic modification techniques, along the lines of what it had proposed for plantsvii.Also in February 2024, the European Parliament called for a proposal in the animal sector similar to that requested for micro-organisms obtained by new genetic modification techniquesviii.Seeds are also the subject of an ongoing legislative initiative, launched in July 2023 (procedure 2023/0227). Adopted, the European Commission's proposed regulation could facilitate the identification of commercialized seeds by molecular markers, remove existing national protections of farmers' rights, pave the way for patented GMOs and facilitate the confiscation of all farmers' and traditional seedsix.Patents are the latest area to be affected by initiatives from the European Commission. In April 2023, it presented two proposals for regulations aimed at extending the duration of patents granted for plant protection products (procedure 2023/0126) and medical products (procedure 2023/0127). These proposals are currently being discussed among the European Parliament, the Council of the European Union and the European Commission.Summary of the European Commission's legislative initiatives relating to LivingGMO DEREGULATIONPlants obtained by "NGT"GMM obtained by "NGT"GMM DNA in lots of additivesPharmaceutical GMMAnimals obtained by "NGT"PurposeDeregulation of numerous GM plantsDeregulation of numerous GMMRegulatory status of products containing GMM DNA tracesHarmonization of the authorisation procedure for medicinal productsDeregulation of numerous GM animalsProcedure reference2023/0226Request from EP on the 07/02/242023/0132Request from EP on the 07/02/24Proposal from ECText of the proposal (05/07/2023)To follow the discussions (Last meeting to date : 20/09/2021)Text of the proposal (26/04/2023)EP’s CommissionText of the report (24/01/2024)Text of the report (21/03/2024)EP’s voteDecison adopted (07/02/2024)Decison adopted (10/04/2024)2nd EP’s voteText adopted (24/04/24)EU Council voteFinal textDSIPATENTSSEEDSUNCLOSEuropean Health Data SpacePhytopharmaceutical productsMedicinal productsSeed regulationPurposeSignature of the BBNJ agreement (GR and DSI in international waters)Access to genetic, genomic and proteomic human dataUnitary supplementary protection certificate for plant protection productsUnitary supplementary certificate for medicinal productsProduction and marketing of plant reproductive material in the UnionProcedure reference2023/03532022/01402023/01262023/01272023/0227Proposal from ECText of the proposal (12/10/2023)Text of the proposal (03/05/22)Text of the proposal (27/04/23)Text of the proposal (27/04/23)Text of the proposal (05/07/23)EP’s CommissionText of the report (19/04/24)Text of the report (05/12/23)Text of the report (24/01/2024)Text of the report (31/01/2024)Text of the report (22/03/24)EP’s voteDecision adopted (24/04/24)Decision adopted (13/12/23)Decison adopted (26 février 2024)Decison adopted (28/02/24)Decison adopted (24/04/24)Interinstitutional negociationsAgreement adopted (22/03/24)2nd EP’s voteText adopted (24/04/24)EU Council voteFinal textText adopted (19/07/2024)i Eric MEUNIER, « Négociations en cours sur la numérisation du vivant », Inf’OGM, 14 mai 2024.ii FAO, Commission on Genetic Resources for Food and Agriculture, « Digital sequence information ».iii Guy Kastler, « Interconnections between new biotechnologies and DSI or GSD », Inf’OGM, 4 September 2024.iv K.M. Gopakumar, « WIPO opens more widely the door to biopiracy », Inf’OGM, 6 November 2024.v Frédéric Prat, « Main basse sur les pathogènes par l’OMS ? », Inf’OGM, 11 February 2021.vi See the minutes of the meeting held on 20 September 2021, item A.07 :European Commission, Health and Food Safety Directorate General, « Standing Committee on Plants, Animals, Food and Feed Section Genetically Modified Food and Feed », 20 September 2021.vii Eric Meunier, « La Commission européenne veut en finir avec les OGM », Inf’OGM, 24 July 2023.viii Ibid.ix Guy Kastler, « Seed marketing reform: freeing cultivated biodiversity or patented GMOs? », Inf’OGM, 4 March 2024. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [138] => Array ( [objectID] => 9797 [title] => WIPO opens more widely the door to biopiracy [timestamp] => 1730851200 [date] => 06/11/2024 [annee] => 2024 [url] => https://infogm.org/en/wipo-opens-more-widely-the-door-to-biopiracy/ [image] => https://infogm.org/wp-content/uploads/2024/10/51254666456_dd544c4c72_c-768x512.jpg [extrait] => Understanding the absence of any obligation to disclose the origin of the material on which a patented “invention” is based is one of the keys to understanding the ongoing strategy of appropriation of living organisms by a few multinationals. In the field of patents, Inf’OGM has chosen to publish an article shedding light on a […] [chapo] => Adopted on May 24, 2024, after nearly 25 years of negotiations, the WIPO Treaty on Intellectual Property, Genetic Resources, and Traditional Knowledge aims to regulate the use of natural and cultural resources through mandatory disclosure of origin in patent applications. While intended to ensure fair benefit-sharing, loopholes in the disclosure requirements allows circumvention, raising concerns about the potential legitimization of biopiracy. [texte] => Understanding the absence of any obligation to disclose the origin of the material on which a patented “invention” is based is one of the keys to understanding the ongoing strategy of appropriation of living organisms by a few multinationals. In the field of patents, Inf'OGM has chosen to publish an article shedding light on a World Intellectual Property Organization (WIPO) treaty adopted in 2024. It is provided by K.M. Gopakumar, a legal advisor at the Third World Network (TWN) who has been following WIPO negotiations for many years. This legal insight may seem technical, but it is essential for understanding the inner workings of an international text presented as guaranteeing the effective protection of “genetic resources”i.For 25 years, discussions have occurred in WIPO among countries to establish a common legal instrument aiming at protecting the genetic resources and the associated traditional knowledge. Those talks occurred while in the same time, genetic sequences were subject to digitization, feeding more and more private and public databases. One of the key question to be answered was to know whether or not the geographic origin of the genetic resource is to be provided when claiming a patent on genetic sequences of this resource. A key question indeed as, without this information, countries will lack a possibility to counter possible biopiracies. The answer arrived in may 2024 when the WIPO adopted its new treaty.A mandate given in 2000…On 24th May 2024, the World Intellectual Property Organisation’s Diplomatic Conference adopted the Treaty on Intellectual Property (IP), Genetic Resources and Traditional Knowledge (the Treaty)ii. The adoption of the Treaty concluded nearly 25 years of deliberations within the Intergovernmental Committee (IGC)iii, which was established in 2000 by the WIPO General Assembly to discuss IP issues in the context of traditional knowledge, traditional cultural expressions and genetic resources (GR). In 2009, the mandate provided by WIPO General Assembly to the IGC was to lead text-basediv negotiations “with the objective of reaching agreement on a text of an international legal instrument (or instruments) which will ensure the effective protection of GRs (genetic resources), traditional knowledge and traditional cultural expressions." Thus, the text-based negotiations led to the development of three different draft legal instruments out of which only one has been adopted by the Diplomatic Conferencev, the one on Genetic RessourcesMandatory Disclosure and Benefit Sharing Under the TreatyThe adopted Treaty aims to check the misappropriation of genetic resources and traditional knowledge through patents. To this end it imposes legal obligation to the disclosure of the country of origin or source by the patent applicant while seeking patents on inventions based on GR and TK. The rationale for the mandatory disclosure regime is to enable countries especially those who are parties to the Convention on Biodiversity (CBD)vi or Nagoya Protocolvii to fulfill their obligations on equitable benefit sharing. The disclosure requirements of the source of GRTK or its country of origin would help the national biodiversity authorities. They could verify whether the patented invention on GRTK is obtained in compliance with the requirements of the biodiversity legislation on accessing GR and the associated TK such as prior informed consent. In the absence of such disclosure, the patent holder could escape from the benefit-sharing obligations, especially in foreign territories. Currently, there are around 35 national/regional legislations containing mandatory disclosures. The Treaty was expected to provide a minimum normative standard for the disclosure regime and sanctions in case of failure to disclose.The objective the Treaty has missedHow far the Treaty provisions achieve their primary purpose of complimenting the national and international access and benefit-sharing (ABS) regime ?TheArticle 1 sets out the following objectives of the Treaty. “(a) enhance the efficacy, transparency and quality of the patent system with regard to genetic resources and traditional knowledge associated with genetic resources, and (b) prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge associated with genetic resources.”. Thus, the suggested objectives of the Treaty are to enhance the efficacy and transparency of the patent system related to GRs and associated TK, and to prevent “erroneous” grant of patents on GR and associated TK, which are not novel and inventive. The text thus ignores the very purpose of the Treaty i.e., and clearly formulated in the mandate given to the IGC, to reconcile the gap between the CBD and IP regime and to facilitate the effective implementation of benefit sharing from the utilization of GR and associated TK.As mentioned, both CBD and Nagoya Protocol obligate parties on benefit sharing emanating from the utilization of GR and associated TK. But International IP legal instruments allow the IP holder to monopolize the benefits without creating any obligation to part the benefits with people who conserve GR and TK. The earlier version of the draft treaty explicitly mentioned the reconciliation between the CBD regime and IP regime. Towards this purpose, the first objective mentioned in the earlier negotiating text stated: “Ensuring mutual supportiveness with international agreements relating to the protection of genetic resources and/or traditional knowledge associated with genetic resources and those relating to IP”viii.A blur line about DSIThe treaty makes the mandatory disclosure of GR, TK and its origins. Article 2 provides the following definition of GR. “Genetic resources” are genetic material of actual or potential value”. The definition of genetic material states: “Genetic material” means any material of plant, animal, microbial or other origin containing functional units of heredity”. Thus, the definition of genetic materials could be interpreted to exclude the digital sequence information (DSI) from the scope of the definition of genetic resources. As a result, the mandatory disclosure requirements under the Treaty could apply only to inventions based on the physical forms of the genetic material. Such an interpretation would drastically reduce the application of disclosure requirements only to those patent applications based on the physical genetic resources that fall within the scope of the Treaty. However, most of the GR-based patents are using DSI instead of the physical forms of genetic materials and therefore emerging as a new form of biopiracyix. There is nothing in the Treaty that prevents a party from making mandatory disclosure of the source of DSI. However exclusion of DSI from the scope of the Treaty would seriously undermines the effectiveness of the Treaty to achieve its purpose of complementing the ABS regime.Disclosure of information ? Only if possibleThe trigger for the mandatory disclosure is set by Article 3 of the Treaty. This article establishes when the patent applicant has to disclose the country of origin or the source of GRTK to the patent office. According to this Article whenever a claimed invention in a patent application is based on GR or TK the applicant has to disclose the country of origin of the genetic resources or, if he doesn't know the country of origin, the source of the genetic resources.Article 2 of the Treaty defines the term “based on”, which states: “Based on” means that the genetic resources and/or traditional knowledge associated with genetic resources must have been necessary for the claimed invention and that the claimed invention must depend on the specific properties of the genetic resources and/or on the traditional knowledge associated with genetic resources”. Thus, the disclosure becomes mandatory only upon satisfaction of two conditions. First, GR and/or ATK must have been necessary for the claimed invention. Second, the claimed invention must depend on the specific properties of the genetic resources and/or on traditional knowledge associated with genetic resources. As a result, one could argue that disclosure requirements would be applicable only when the patent claim is linked to GR. There is no need to make the disclosure when the patent specification contains the GR used in the invention but is not part of the patent claim. This narrow scope of the trigger for the disclosure requirement allows parties to avoid derivatives from the scope of mandatory disclosure. For instance, an active ingredient separated from GR and further produced by synthetic methods could be excluded from the disclosure regime. There are many natural product derivative patents in the pharmaceutical and agrochemical fieldsx. Nagoya protocol defines a derivative as “a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity”.The following provisions under Article 3 further compromise the effectiveness of the disclosure. First, paragraph 3 allows the patent applicant to not make any disclosure by making a declaration “affirming that the content of the declaration is true and correct to the best knowledge of the applicant”xi. Similarly, according to Para 5, parties cannot oblige the national patent offices to check the content of the disclosurexii. The legal prohibitionxiii against the verification of disclosure made by the patent applicant seriously affects the invoking of sanctions in case of nondisclosure or wrongful disclosure.Any sanctions, just in case ?What would happen if this fragile obligation to disclose the geographic origin was not respected ? The treaty undermines the capacity of countries to act. Its Article 5 limits the freedom of countries to revoke the patent in case of failure to disclose only on the grounds of fraudulent disclosure. Para 3 of Article 5 prohibits parties to “revoke, invalidate, or render unenforceable the conferred patent rights solely based on an applicant’s failure to disclose the information specified in Article 3 of this Treaty”. Para 4 provides the exception to Para 3 and states that “Each Contracting Party may provide for post-grant sanctions or remedies where there has been fraudulent intent in regard to the disclosure requirement in Article 3 of this Treaty, in accordance with its national law.” This means that parties have the freedom to revoke the patent only in the case of a disclosure with fraudulent intent. A strict interpretation of this provision means a patent cannot be revoked merely because of a wrongful or non-disclosure. It can be revoked only if there is proof on fraudulent intent. Proving the fraudulent intent creates a burden of proof on the part of authorities and makes the revocation of the patent extremely difficult. This drastically reduces the effectiveness of sanctions. One way to overcome this is that national law can introduce the concept of presumption of fraudulent intent in case of wrongful disclosure or non-disclosure. In other words, national law can state that non-disclosure or inaction on the wrongful disclosure after a reminder from the Patent Office could be presumed to be a fraudulent act and result in the revocation of patent.Database on GR and Associated TKArticle 6 of the treaty states: Contracting Parties may establish information systems (such as databases) of genetic resources and traditional knowledge associated with genetic resources, in consultation, where applicable, with Indigenous Peoples and local communities, and other stakeholders, taking into account their national circumstances”. The plan to establish such a database could expose the Gr and associated TK to the danger of biopiracy in the base of safeguards. However, the Parties of theTtreaty have the freedom to develop a database on GR and associated TK and there is no obligation to do so. Further, it also provides the freedom to Parties to make the database available to the patent office for search and examination with appropriate safeguards.What links with the Patent Cooperation Treaty ?Patent Cooperation Treaty (PCT) is an international agreement to facilitate the filing of patent applications in multiple countries, which are parties to PCT through a single patent application. Currently, 157 countries are party to PCT. Though PCT allows the filing of patents in multiple countries through a single application, the grant of a patent is subject to the substantive patent examination under the national patent law. Hence and does not guarantee the grant of patents in all countries filed through PCT. The application of the treaty provisions in the PCT context is doubtful.Article 27(1) of the PCT rules that ‘no national law shall require compliance with requirements relating to the form or contents of the international application different from or additional to those which are provided for in this Treaty and the Regulations’. Therefore, the application of mandatory disclosure to PCT application is doubtful. Since a large number of applications are through the PCT route many applicants may use the PCT route to bypass the disclosure requirements. To address this issue a footnote to Article 7 i.e. dealing with the relationship with other international agreements states: "The Contracting Parties request the Assembly of the International Patent Cooperation Union to consider the need for amendments to the Regulations under the PCT and/or the Administrative Instructions thereunder with a view towards providing an opportunity for applicants who file an international application under the PCT designating a PCT Contracting State which, under its applicable national law, requires the disclosure of genetic resources and traditional knowledge associated with genetic resources, to comply with any formality requirements related to such disclosure requirement either upon filing of the international application, with effect for all such Contracting States, or subsequently, upon entry into the national phase before an Office of any such Contracting State”. There are two hurdles to implementing the proposal in the footnote. First, the CoP of the Treaty needs to reach a consensus and the conference of parties is to take place only after entry into the force of the treaty. Second, there is no guarantee that the PCT Assembly would accept the proposal from the CoP. Therefore there is no assurance that the disclosure requirement could apply to patent applications filed through the PCT route immediately after the entry of the Treaty.The original purpose of the Treaty was to address the gap in the patent law, which allows the patent holder to enjoy the statutory monopoly on the invention without even parting the benefit that emerged from the utilization of GR and associated TK. Nearly 25 years of deliberations and negotiations led to the conclusion that the Treaty had not succeeded in creating an effective disclosure regime to achieve its original purposes. On the contrary, the treaty sets norms, which provide various loopholes for the patent applicant to bypass the disclosure requirements and undermine the ABS regime. Thus, the treaty bears the danger of legitimizing the biopiracyxiv.i Annick Bossu et Christophe Noisette, « « Ressource génétique » : une mauvaise expression », Inf'OGM, le journal, janvier/mars 2021(in french).ii WIPO, « Diplomatic Conference to Conclude an International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources - Geneva, May 13 to 24, 2024. WIPO TREATY ON INTELLECTUAL PROPERTY, GENETIC RESOURCES ANDASSOCIATED TRADITIONAL KNOWLEDGE », May 24, 2024.iii WIPO, « Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) ».iv TWN, « TWN Info Service on Intellectual Property Issues (Oct09/01) », 6 October 2009.v WIPO, « Diplomatic Conference to conclude an International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources », May 13 to May 24, 2024.vi CBD, « The Convention on Biological Diversity ».vii Secretariat of the Convention on Biological Diversity, « Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization », 2011.viii WIPO, « Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore Fortieth Session. Geneva, June 17 to 21, 2019. CONSOLIDATED DOCUMENT RELATING TO INTELLECTUAL PROPERTY AND GENETIC RESOURCES », April 9, 2019.ix Sara Dal Monico, « A New Horizon in Biopiracy Trends? Preliminary Considerations on Digital Sequence Information on Genetic Resources », OpinioJuris, 3 January 2024. x US6069146 : example of a patent in which halimide is an aromatic alkaloid isolated from the fermentation of a marine fungus, Aspergillus sp. CNC139, which was collected in the waters off the Philippine Islands and has been deposited with the American Type Culture Collection as Accession No. 74434, date deposited Apr. 10, 1998 (Rockville Md.). Halimide is a diketopiperazine composed of two amino acid residues and represents the first cytotoxic molecule having anticancer activity discovered from this Aspergillus sp. As disclosed herein, the compounds of the invention, including halimide and derivatives thereof, can reduce or inhibit the progression of cells through mitosis of the cell cycle and, therefore, can reduce or inhibit cell proliferation and cell viability.xi Article 3 point 3.3xii Article 3 point 3.5xiii National offices remains “free” to conduct such a verification but no legal obligation can be put on them to do so.xiv Edward Hammond, « Biopiracy Watch - A compilation of some recent cases », Vol. 1, 2013. K.M. Gopakumar - Legal advisor and researcher at Third World Network (TWN) on Global intellectual property regime and its impact on developing countries [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [139] => Array ( [objectID] => 9775 [title] => GreenLight Biosciences or the RNA at every level [timestamp] => 1730678400 [date] => 04/11/2024 [annee] => 2024 [url] => https://infogm.org/en/greenlight-biosciences-or-the-rna-at-every-level/ [image] => https://infogm.org/wp-content/uploads/2026/03/GreenLight_Master_Logo_OnWhite_RGB-with-TM-768x432.png [extrait] => After genetic sequences and DNA, here comes RNA, the new flagship molecule in biotechnology that is supposed to solve agricultural and health problems. Companies in this field are flourishing. Among them is GreenLight Biosciences, a company that was on the verge of bankruptcy when it was bought by the investment fund Fall Line Capital. [chapo] => After genetic sequences and DNA, here comes RNA, the new flagship molecule in biotechnology that is supposed to solve agricultural and health problems. Companies in this field are flourishing. Among them is GreenLight Biosciences, a company that was on the verge of bankruptcy when it was bought by the investment fund Fall Line Capital. [texte] => GreenLight Biosciences is a US company founded in 2008 whose aim, as stated on their website, is ‘to create a safer, more equitable food system using nature. By providing effective and easy-to-use RNA-based products to farmers and beekeepers around the world, GreenLight Bio is working to enable more resilient food production and doing right by the environment.‘1. Its aim is to develop RNA-based products that it hopes to market for use in agriculture, beekeeping but also human health.There are several versions of RNA-based products. In the agricultural world, RNAi are small molecules which, once ingested by a plant pest, are supposed to kill it. In the medical world, mRNA are used as components of vaccines or in gene therapy.Numerous RNAi-based biosolutions soon to hit the agricultural marketGreenLight Biosciences is one of the first companies to market products based on RNA interference (RNAi) for the agricultural sector. It markets an insecticide spray against the Colorado beetle, called Calantha. Other products using this technology could come on the market, including insecticides, fungicides and herbicides. For example, its product varroa mites, which are partly responsible for the decline in bee colonies, is currently being examined by the US authorities.GreenLight Biosciences is also developing an RNAi spray against botrytis, a fungus that can damage grapes, strawberries and tomatoes for example. This spray is currently being tested in fields in the United States. At less advanced stages of development, the company is talking about ‘solutions’ against mildew, Plutella xylostella (the diamondback moth), fusarium (a fungus) and Tetranychus urticae (a mite).Human health also targetedIn human health, GreenLight Biosciences' aims at marketing a vaccine against Covid: an application has been submitted to the US authorities. It is also working on a vaccine to protect against zonas (or herpes zoster)2 or cancer. The company has received more than €2.7 million from the Bill & Melinda Gates Foundation to develop gene therapies and ‘to explore new, low cost capabilities for the in vivo functional cure of sickle cell and/or durable suppression of HIV in developing countries’3. With regard to ‘cancer vaccines’ (sic)4, GreenLight Biosciences and Epivax Therapeutics have signed an exclusive collaboration agreement5.In this medical field, the company uses nanoparticles as a vector for a vaccine messenger RNA: ‘one such delivery system consists of encapsulating mRNA in lipid nanoparticles (LNPs). We work with several established companies that have extensive experience in clinical LNPs for our vaccine candidates. We are able to routinely produce our mRNA-containing LNPs to support our research and development efforts’.6An international presenceOn its website7, the company states that it has carried out more than 100 field trials in the agricultural sector over the last four years. In Europe, it states several countries: Germany, Belgium, France, Spain, the Netherlands and Poland, for a total of 11 trials on this continent8. In Spain, GreenLight Biosciences has set up a subsidiary (registered in the European register of companies under the ‘veterinary’ category9) and, in 2022, it has announced that it is going to lease around 20 hectares to study crop problems caused by powdery mildew, botrytis, fusarium and Colorado potato beetle10. Trials against Plutella xylostella have already taken place in Spain11. In an internal document, GreenLight Biosciences also mentions field trials of RNAi spray, in Italy in 2021, against the Botrytis fungus.In Africa, GreenLight Biosciences has teamed up with One Acre Fund, an agricultural NGO based in East Africa12 to carry out field trials of ‘biosolutions’ against the Fall armyworm.In the field of human health, GreenLight Biosciences is also expanding internationally. GreenLight Biosciences has signed a licensing agreement with Serum Institute of India13, which in 2020 produced the largest number of vaccine doses in the world14. ‘Under the agreement, the Indian drugmaker will have access to GreenLight's technology platform to develop and manufacture up to three messenger RNA-based products, and then commercialise them in markets such as Africa, Latin America, the Middle East and parts of Asia’ the company said. ‘Serum Institute of India will also have the option to extend the licensing agreement to two additional messenger RNA vaccines or therapies’, GreenLight Biosciences15 added. The company has also signed a partnership for the large-scale production of mRNA vaccines with Korea's Samsung Biologics. GreenLight Biosciences is also trying to establish its Covid vaccine in Africa. It has already obtained authorisation from Rwanda16 and South Africa to carry out clinical trials. In 2021, it initiated a partnership with a scientific research organisation, IAVI, also based in Africa, ‘to accelerate the timeline for manufacturing and deployment of GreenLight’s COVID-19 vaccine candidate to Africa and potentially for export from Africa’17.Technology purchased from Bayer and a large number of patentsGreenLight Biosciences' RNAi-based agricultural products were developed following a technology transfer agreement signed with Bayer CropScience18 in December 202019, ’to which [GreenLight Biosciences] acquired from Bayer certain intellectual property rights related to (i) RNA technology used to control Varroa mites, Nosema, and bee viruses, [...] and (ii) technology used to control the Colorado potato beetle and canola flea beetle, [...]. Under the Bayer Acquisition Agreement, [the company was] obligated to make a closing payment to Bayer equal to $2,000,000 [€1.8 million] as well as certain milestone payments equal to up to $2,000,000 [€1.8 million] in the aggregate, in the event that certain regulatory approvals are achieved with respect to the aforementioned technologies‘20. Bayer is therefore increasing its profits by granting licences, but is not taking the economic risk of developing these RNAi-based ‘biopesticides’ itself. Is the risk too great? If so, would the aim be to disappear behind these start-up screens?GreenLight Biosciences owned ‘as of March 10, 2023, [...] approximately 40 patent families [editor's note: the term “patent family” refers to patents for specific applications of the same generic patent] in various fields of our business. Of those patent families, approximately six families relate to RNA production; approximately seven families relate to other human health-related technologies; approximately 18 families relate to crop protection and bee health; approximately three families relate to production of sugars; and approximately six families relate to process control and compound production’.No profits in 14 yearsSince its creation in 2008, GreenLight Biosciences has raised at least €216 million to develop its products. Despite investor support, the company wrote at the end of December 2022: ‘We have not generated any product revenues to date and expect to incur losses and negative cash flow for the foreseeable future. We have generated substantial accumulated losses since inception. Our net losses were $167.1 million, $112.3 million and $53.3 million for the years ended December 31, 2022, 2021, and 2020, respectively. As of December 31, 2022, we had an accumulated deficit of $420.6 million [€383 million]"21. And it goes on to say that ‘it is possible we will never generate revenue or profit’. In its 14 years of existence, the company has not generated any profits and has no plans to do so. This does not prevent it from having been valued at 1.5 billion dollars, as we will see.This economic report prepared by the company for the Securities and Exchange Commission (Form 10-K for the fiscal year ending 31 December 2022) states that the company ‘derived substantially all of [its] revenues through license and collaboration agreements as well as grants and research partnerships with third parties’. Among the licensing agreements, we have already mentioned the one signed in 2022 with the Serum Institute of India22 , as well as the one with Acuitas Therapeutics, Inc.23.Public fundings are also involved. The European Union (EU) is supporting the company via its Spanish subsidiary, which has received just over 300,000 euros from the EU as part of the ‘NextGenBioPest’24research project. This project gives the company access to the research of numerous European public institutes, including INRAE. In June 2024, the European Investment Bank (EIB) provided €35 million in support for its Spanish subsidiary, which it considered to be in line with the objectives of the Green Deal and the Farm2Fork strategy25.On 9 August 2021, the company was listed for the first time on the stock exchange via a takeover by the Environmental Impact Acquisition Corp, which was set up solely to raise funds26. At the time, it was ‘valued at 1.5 billion dollars’27. On that day, the CEO of GreenLight Biosciences - whose annual base salary was $575,000 in 2022 - said: ‘We are thrilled to partner with Environmental Impact Acquisition Corp. to accelerate our vision and advance the delivery of our solutions to where they are needed most, with shared goals to pave the way for a sustainable planet through widely available and affordable RNA’. It would appear that the listing in the stock exchange was not enough to turn around the company's accounts.Following this merger, GreenLight Biosciences became GreenLight Biosciences Holding, PBC. But two years later, on 30 May 2023, GreenLight Biosciences Holdings, PBC left Wall Street. The company was bought by a group of financiers led by the investment fund Fall Line Capital for $45.5 million (€42.3 million)28. Fall Line's portfolio includes other biotech companies, such as Guardian Agriculture (which sells input spraying drones), Granular (a subsidiary of Corteva, a leader in agricultural software), Impossible Foods (which markets GMO-derived vegetable steaks), Lithos Carbon (which proposes spreading basalt on fields to capture carbon), Sound Agriculture (which works on soil micro-organisms29), etc30. Fall Line is also an investor in Toulouse-based MicroPep Technologies31. The fund has injected $8.8 million (€8.2 million) in 2022, then $27 million (€25 million) in 202432 and is buying up farmland in the United States, which it calls ‘mineral assets’ on its website...In its 14 years of existence, the ‘simple’ start-up GreenLight Biosciences has faced nothing but financial losses, despite public and private investment. It is owned by an investment fund which itself invests in many areas of agricultural technology. In the case of GreenLight Biosciences, the much-vaunted benefits to humanity of its products (which are hardly ever marketed) have given way to financial interests…RNAi, vaccines, GMMs... organic linksGreenlight Biosciences was founded in 2008 by Andrey Zarur33, a senior lecturer at the Martin Trust Center for MIT Entrepreneurship. He has co-founded or managed more than a dozen companies in the health and energy sectors. These include Solid Biosciences, which is working on a gene therapy to treat Duchenne muscular dystrophy, and Lumicell Surgical, which ‘offers advanced imaging solutions for cancer surgery’.Most of the company's directors have historic links with multinational companies. For example, Carole Beth Cobb34, one of the directors of GreenLight Biosciences, was vice-president of several major companies from 1999 to 2008, including Genencor International (a subsidiary of Danisco, now IFF) and DuPont Nutrition Biosciences (also IFF), which produce, among other things, micro-organisms (some of them genetically modified), and Cobalt Technologies, which produces agrofuels, also using GMMs35.In the current board, the presence of former executives from multinationals like Monsanto is no longer visible. But before June 202336 there were Martha Schlicher37 and Ganesh Kishore38, who had worked for Monsanto for many years.1GreenLight Biosciences’s website : https://greenlightbiosciences.com/our-story/2Bhattacharya A, Jan L, Burlak O, Li J, Upadhyay G, Williams K, Dong J, Rohrer H, Pynn M, Simon A, Kuhlmann N, Pustylnikov S, Melo MB, Dey AK, « Potent and long-lasting humoral and cellular immunity against varicella zoster virus induced by mRNA-LNP vaccine », NPJ Vaccines, April, 4, 2024.3Bill et Melinda Gates Foundation, « Committed grants – GreenLight Biosciences : to explore new, low cost capabilities for the in vivo functional cure of sickle cell and/or durable suppression of HIV in developing countries », July 2020.GreenLight Bioscences, « GreenLight Biosciences Receives $3.3 Million Grant to Develop Sickle Cell Disease Cure Using mRNA Gene Therapy », PR Newswire, September, 15, 2020.4An important semantic precaution: a vaccine does not cure, it is not a medicine, but it does protect. The expressions ‘cancer vaccine’ or ‘anti-cancer vaccine’ are gradually insinuating that a vaccine cures.5UNITED STATES SECURITIES AND EXCHANGE COMMISSION, « FORM 10-K : GreenLight Biosciences Holdings, PBC », 2022.6Ibid.7GreenLight Biosciences, « Colorado potato beetle trial locations worldwide, 2018-2021 », 2022.8Annick Bossu, « L’ARN interférent : une face cachée du biocontrôle », Inf’OGM, le journal, octobre-décembre 2024 (under publication)9European Medicines Agency (EMA), « Greenlight Biosciences España, S.L. », 2022.10« Greenlight Biosciences Holdings Pbc », Zonebourse.11UNITED STATES SECURITIES AND EXCHANGE COMMISSION, « FORM 10-K : GreenLight Biosciences Holdings, PBC », 2022.12Post LinkedIn from GreenLight Biosciences, April 2024.One Acre Fund has received several million dollars from the Bezos Earth Fund.See : Bezos Earth Fund, « Bezos Earth Fund Announces $110 Million to Conserve and Restore Nature and Advance Climate Science, Monitoring and Governance », December, 14, 2022.The NGO also received $11.6 million (€8.8 million) in 2013 from the Bill & Melinda Gates Foundation to significantly increase smallholder adoption of existing and effective technologies, followed by $6 million (€5.5 million) in 2016 and $1 million (€938,000) in 2023.13It is a subsidiary of the Poonawalla Investment and Industries group.14Reuters Staff, « Serum Institute to focus on supplying COVID-19 vaccine to India first », Reuters.15« GreenLight Biosciences et le Serum Institute of India concluent un accord de licence pour développer des produits d’ARN messager », Zonebourse.16« GreenLight Biosciences décroche l'approbation de la FDA du Rwanda pour l'essai clinique COVID-19 », Zonebourse.17IAVI, « GreenLight Biosciences (ENVI) partners with IAVI to accelerate COVID-19 vaccine trial in Africa », November, 30, 2021.18Bayer acquired this varroa mite technology when it took over Monsanto, which in 2012 bought it from Beelogics, an Israeli company (linked to the University of Jerusalem) that owned the patents.Patent n° US8962584B2, « Compositions for controlling Varroa mites in bees », 2012.19GreenLight BIosciences, « GreenLight acquires Bayer’s topical RNA Intellectual Property portfolio », May, 20, 2021.20UNITED STATES SECURITIES AND EXCHANGE COMMISSION, « FORM 10-K : GreenLight Biosciences Holdings, PBC », 2022.21Ibid.22Serum Life Sciences, une filiale du Serum Institute of India, avait investit plus de 10 millions de dollars (8,6 millions d’euros) dans GLB en novembre 2021.GreenLight Biosciences, « Serum Life Sciences invests in RNA biotech GreenLight by joining expanded financing for Environmental Impact Acquisition Corp. », november, 23, 2021.23Annick Bossu, « L’ARN interférent : une face cachée du biocontrôle », Inf’OGM, le journal, octobre-décembre 2024.24Commission européenne, « “NextGenBioPest” – Next Generation Biopesticides for the control of the most “difficult-to-manage” pests and pathogens in fruits and vegetables », november, 24, 2024.25Banque européenne d’investissement, « GREENLIGHT BIO (IEU LS) », June, 6, 2024.26Investors in ENVI include S2G Ventures, Cormorant Asset Management, Morningside Venture Investments, Hudson Bay Capital, BNP Paribas Ecosystem Restoration Fund, The Jeremy and Hannelore Grantham Environmental Trust, Continental Grain Company, Pura Vida Investments LLC, Xeraya.« GreenLight Biosciences Announces Business Agreement With Environmental Impact Acquisition Corp. to Become Publicly Traded Company, Allowing It to Better Harness Its Breakthrough Platform to Develop and Produce RNA for Human Therapies and Agriculture », Business Wire.27« GREENLIGHT BIOSCIENCES : vers une entrée en bourse via un SPAC », Zonebourse, August, 11, 2021.28US Securities and Exchange Commission (SEC), « Offer to Purchase for Cash All Outstanding Shares of Common Stock of GreenLight Biosciences Holdings, PBC at $0.30 Net Per Share by SW MergerCo, Inc. A wholly-owned subsidiary of SW ParentCo, Inc., an affiliate of Fall Line Endurance Fund, LP », July, 19, 2023.29This company is also financed by Bayer's investment unit, Leaps.Leaps by Bayer page on the company's website.30GreenLight Biosciences, « GreenLight Biosciences Enters into Definitive Merger Agreement with Consortium Led by Fall Line Endurance Fund for Go-Private Transaction », Yahoo! finance, may, 30, 2023.31« Entreprises>Micropep », Maddyness.32« Fall Line Capital », Maddyness.33MIT Sloan School of Management, « Andrey Zarur ».« André Zarur », Zonebourse.GreenLight Biosciences, « Andrey J. Zarur, Ph.D ».34« Carol Cobb », Zonebourse.35The Energy Blog, « Biobutanol – Cobalt Biofuels Raises $25 Million to Accelerate Commercialization of Biobutanol Process », november, 14, 2008.36« Greenlight Biosciences Holdings annonce la démission de ses administrateurs », Zonebourse, july, 24, 2023.37« Martha Schlicher », LinkedIn.38Spruce Capital Partners, « Ganesh Kishore, Managing Partner ». Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [140] => Array ( [objectID] => 9726 [title] => 25 years later, insecticidal GMOs face insect resistance [timestamp] => 1729641600 [date] => 23/10/2024 [annee] => 2024 [url] => https://infogm.org/en/25-years-later-insecticidal-gmos-face-insect-resistance/ [image] => https://infogm.org/wp-content/uploads/2024/10/abeille-monsanto-768x487.jpg [extrait] => 43 detections of insects having acquired resistance to the Bt proteins supposed to kill them were listed in a scientific article in 2023. 43 cases out of 73 studied, i.e. more than half. For the authors of the article, the use of insecticidal GMOs has been crowned with success, as in several cases it has made it possible to reduce or even eradicate local pests. But failures also occurred due to resistance. The authors believe that the future lies in a combination of technologies, among which is RNA interference. [chapo] => 43 detections of insects having acquired resistance to the Bt proteins supposed to kill them were listed in a scientific article in 2023. 43 cases out of 73 studied, i.e. more than half. For the authors of the article, the use of insecticidal GMOs has been crowned with success, as in several cases it has made it possible to reduce or even eradicate local pests. But failures also occurred due to resistance. The authors believe that the future lies in a combination of technologies, among which is RNA interference. [texte] => The scientific article appeared in early 2023 in the Journal of Economic Entomologyi. Its authors, three researchers from the University of Arizona, reviewed 25 years of cultivation of plants genetically modified to produce insecticidal proteins. The question posed is whether or not resistance to these insecticidal proteins has actually developed in insect populations exposed to them. This is a crucial question, as it concerns the effectiveness of these GMOs or, on the contrary, their contribution to increasing the problem they were intended to solve.Some “successes” noted or not reported?On the basis of the information analyzed by the researchers, several cases of insect pests that have been contained, or even eradicated, thanks to the cultivation of Bt transgenic plants are reported. They detail cases of P. Gossypiella in the USA, where commercialized Bt cotton crops have, they claim, “facilitated eradication of this invasive pest from the cotton-growing regions of the U.S. and northern Mexico”. They also mention the less certain case of Bt cotton, which “is probably also the key factor that dramatically reduced (C. virescens) density in the U.S. and Mexico”. With regard to the European corn borer, the authors also mention a reduction in insect density to “historically low levels in several midwestern states including Wisconsin”. On another continent, they report that Bt cotton “remained effective” against H. armigera and H. punctigera insects in Australia, and H. armigera and P. gossypiella insects in China.In Europe, where Mon810 insecticidal corn has been grown since the late 90s, the authors do not report any reduction in insect pest populations. They simply state that there is no data showing a decrease in the susceptibility of corn borer and sesamia to the Bt protein produced by Mon810 maize. This information is surprising considering that, in 2021, a case of damage to Mon810 maize crops by sesamia was reported. Apparently, no scientific article has been published on this case, but the European Food Safety Authority (EFSA) considers possible that this may be a case of appearance of resistance. They even deplore the fact that Bayer has not collected enough solid data to answer this questionii.As the authors of the article have based their work on a scientific bibliography, an important limitation is that cases which have not been documented by researchers will escape their review. In the case of the European Union, they based their review on a scientific article published shortly before theirs, also in early 2023iii. This article does not mention the case in Spain, the one worrying European experts, not even to say it exists. This potential case of resistance is therefore not in the US authors' review, nor even in their “early warning” table.Resistance failuresOut of a total of 73 cases studied, the researchers list no fewer than 26 cases of resistance acquired by insects to a Cry transgenic protein produced by a GMO plant. These cases occurred a few years after the development of areas cultivated with insecticidal GMOs (see graph). Among the most problematic cases, P. gossypiella in India and D. v. virgifera in the United States of America are two insects that have become resistant “to all Bt toxins produced by currently available Bt crops targeting each pest”. For H. Zea in the USA, only one transgenic protein remains effective to date, the Vip3Aa protein.Curve showing changes in cultivated areas and curve showing the number of cases of resistance.This graph was produced by Inf'OGM by ‘simply’ superimposing two graphs from the scientific article.Of the 26 reported detections of resistance cases, 18 concern insecticidal GM maize in South Africa, Canada, Argentina, Brazil and, above all, in the United States where 10 of the 18 cases are reported. The other insecticidal GMO Bt plants are cotton and soybean, in the same countries as for maize, plus India and Pakistan. To these 26 cases, the authors add 17 for which “early warnings of resistance” were observed. In other words, insects targeted by insecticidal transgenic proteins are less and less sensitive to these proteins. If nothing is done to restore this susceptibility within the target insect population, these cases will become cases of acquired resistance. These 17 cases are found on sugarcane, maize and cotton, all of which are transgenic. The countries concerned are the same as for the confirmed cases, with the addition of China and the Philippines.No questioning of the approach adoptedAlthough the number of cases of acquired or incipient resistance (43, see table) is higher than the number of cases where insects continue to be completely killed by the transgenic protein (30), the authors remain confident in a type of agriculture where one technology complements or replaces another that begins to fail. They thus consider that the next steps will not involve new transgenic proteins, but rather a combination of “Bt toxins with RNA interference”. Interferent RNA are molecules that disrupt the production of a particular molecule. Although they are increasingly promoted directly and indirectly by multinationals, they are not a panacea, as the researchers themselves point out. For them, the characteristics obtained by RNAi technology “are generally not as potent as Bt toxins and are vulnerable to evolution of broad-spectrum pest resistance to RNAi”. They also report on the possible use of non-Bt soil bacteria that show some “promise against Bt-resistant D. v. vivgifera”. Far from questioning, or even calling into question, the approach adopted, these cases of the appearance of insect resistance to insecticide GMOs once again serve the technological headlong rush being pursued in agriculture. It's a story with no end in sight.Table : The 43 insects resistant orstarting to resist, the country and the GM plant involved(in blue, the cases for which early warnings of resistance exist)CountryNumberGM PlantsInsectsCountryNumberGM PlantsInsectsUSA16MaizeD. barberiArgentina6MaizeD. saccharalisUSAMaizeD. barberiArgentinaMaizeP. gossypiellaUSAMaizeD. v. virgiferaArgentinaMaizeS. frugiperdaUSAMaizeD. v. virgiferaArgentinaMaizeS. frugiperdaUSAMaizeD. v. virgiferaArgentinaMaizeS. frugiperdaUSAMaizeD. v. virgiferaArgentinaMaizeS. frugiperdaUSAMaizeH. zeaCanada4MaizeO. nubilalisUSAMaizeH. zeaCanadaMaizeS. albicostaUSACottonH. zeaCanadaMaizeO. nubilalisUSACottonH. zeaCanadaMaizeO. nubilalisUSACotton & MaizeH. zeaPakistan4CottonP. gossypiellaUSAMaizeS. frugiperdaPakistanCottonE. vittellaUSAMaizeS. albicostaPakistanCottonH. armigeraUSAMaizeD. saccharalisPakistanCottonS. exiguaUSAMaize & cottonH. zeaIndia3CottonP. gossypiellaUSAMaizeS. frugiperdaIndiaCottonP. gossypiellaBrazil7SoyaC. aporemaIndiaCottonH. armigeraBrazilSoyaR. nuSouth Africa1MaizeB. fuscaBrazilMaizeS. frugiperdaChina1CottonH. armigeraBrazilMaizeS. frugiperdaPhilippines1MaizeO. furnacalisBrazilSugracaneD. saccharalisBrazilSugracaneD. saccharalisBrazilMaizeS. frugiperdai Bruce E Tabashnik et al., « Global Patterns of Insect Resistance to Transgenic Bt Crops: The First 25 Years », Journal of Economic Entomology, Volume 116, Issue 2, Pages 297–309, Avril 2023.ii Eric Meunier, « In Spain, are some insects beginning to resist GM maize? », Inf’OGM, 16 october 2024.iii García, M., C. García-Benítez, F. Ortego, and G. P. Farinós, « Monitoring insect resistance to Bt maize in the European Union: update, challenges and future prospects », Journal of Economic Entomology, Volume 116, Issue 2, Pages 275–288, Avril 2023. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [141] => Array ( [objectID] => 9666 [title] => In Spain, are some insects beginning to resist GM maize? [timestamp] => 1729036800 [date] => 16/10/2024 [annee] => 2024 [url] => https://infogm.org/en/in-spain-are-some-insects-beginning-to-resist-gm-maize/ [image] => https://infogm.org/wp-content/uploads/2024/10/512px-Corn_borer.jpeg [extrait] => For almost 15 years, European and French experts have been recommending that Bayer improve environmental monitoring of commercial Mon810 corn crops in Spain and Portugal. This improvement is necessary, they say, to prevent target insects such as the European corn borer and sesamia from developing resistance to the insecticide produced by this transgenic corn. But year after year, Bayer only partially responds to these requests. Yet concerns are becoming increasingly serious and concrete, as demonstrated by the latest EFSA opinion, published in August 2024. [chapo] => For almost 15 years, European and French experts have been recommending that Bayer improve environmental monitoring of commercial Mon810 corn crops in Spain and Portugal. This improvement is necessary, they say, to prevent target insects such as the European corn borer and sesamia from developing resistance to the insecticide produced by this transgenic corn. But year after year, Bayer only partially responds to these requests. Yet concerns are becoming increasingly serious and concrete, as demonstrated by the latest EFSA opinion, published in August 2024. [texte] => Mon810 transgenic maize, genetically modified to produce a Cry insecticidal protein, has been approved for cultivation in Europe since 1998. Since 2010, these crops have been monitored for any environmental impacts that may have been overlooked in the risk assessment. First Monsanto, then Bayer since the takeover of Monsanto, sends its annual report, which then passes into the hands of the experts. These reports give an account of the establishment of buffer zones around transgenic crops, as well as the general monitoring carried out to detect any unanticipated impacts. Since 2010, European experts have been repeatedly calling for improvements, but these have never been entirely implemented by the companyi. The opinion of the EFSA, like the one of the Ansesii, on the report concerning cultivation of 2022 in the only two countries where this maize is still grown, Spain and Portugal, is no exception to this rule.Refuge zones respected, on paperIt is mainly on the basis of data supplied by Bayer that the European experts are attempting to assess the impact of Mon810 transgenic maize crops. They have also taken into account a scientific article on the appearance of teosinte in Spainiii.The European expertsiv note that the refuge zones to be set up around or in Mon810 maize crops appear to have been better respected in Spain than in previous years. In detail, it should be noted that monitoring on this point is carried out via a questionnaire drawn up by Bayer asking farmers whether they have complied with the obligations to have refuge zones. Above all, the EFSA points out that Bayer only questioned Spanish farmers, but should have questioned Portuguese ones too. It recommends more extensive monitoring in the coming years, a surveillance to be carried out by Bayer as it is already the case today.The beginning of resistance in insectsIn their report, the experts do not state with certainty that resistance has been acquired by the European corn borer and the Mediteranean corn borer (sesamia), both targets of the Cry transgenic insecticide protein in Mon810. However, certain informations alert them to a potential onset of resistance. This concern dates back to 2015 and the first findings of methodological flaws in monitoringv. In 2024, the experts noted that in northeastern Spain, “a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded”. This finding is reinforced by the observation in the field of “unexpected damage by (sesamia) to maize MON 810 reported in 2021 in Girona”, which the experts had mentioned in their report on 2021 crops. While EFSA welcomes the fact that this region is now included in the geographical area monitored, it nevertheless considers that the monitoring carried out by Bayer is insufficient.Indeed, the experts detail that “Monitoring activities should not be limited to the sampling of (sesamia) populations from conventional maize fields in Girona. They should include the development and implementation of a protocol to collect (sesamia) populations close to the field where unexpected damage was reported”. Bayer should also do more to search for any resistant sesamia in the area concerned. The experts also ask Bayer to warn local farmers of this possible presence of resistance, so that they inspect their fields more regularly.More astonishingly, the European experts write that none of the measures taken by Bayer, following the observation of damage to Mon810 maize plants and the potential presence of sesamia resistant to the transgenic Cry insecticide protein, were designed to reduce the spread of this resistance. Bayer considered that there was no need to reduce the spread of this resistance because, according to the company, the resistance did not concern an entire population and the neighboring fields had already been harvested... This approach is not in line with that of the EFSA, which considers that the measures to be taken should include stopping the sale and cultivation of Mon810 maize in the region when resistance evolves, increasing communication with farmers, implementing different control measures and increasing the size of refuge areas. They conclude their report on this point by explaining that they “welcome the consideration by the consent holder of these recommendations”. The report of cultivation in 2023 to be analyzed by the EFSA next year will detail the actual measures taken to effectively study and try to curb the emergence of this resistance in insects.Potential problems with transgenic teosinte contaminationBased on the opinions of European and French experts published in 2021, Inf'OGM explained at the beginning of 2024 that potential agronomic problems linked to Mon810 corn crops were likely to arise. These agronomic problems concern teosinte, an ancestor of corn of Mexican origin, which is increasingly present in Europe. Found in particular in fields of transgenic Mon810 maize, these teosinte require, for the experts, more precise monitoring “to avoid losing control over the spread of insecticidal proteins produced by this maize”vi. Indeed, the primary risk is the possible hybridization of Mon810 maize plants with teosinte plants, the latter acquiring the transgene from Bayer's maize. This would lead to an uncontrolled increase in the number of plants producing the insecticide protein, and thus the risk of insects developing resistance to it. A situation which could become all the more problematic given that in 2023, in response to the experts, Bayer/Monsanto had explained that it was opposed to reinforcing this monitoring!One year later, the European experts note in their opinion that the situation is still... problematic! They had asked that the questions sent to farmers be supplemented by questions on the possible presence of teosinte, that a bibliographical review of scientific articles be carried out, that information from Bayer and the Spanish authorities be passed on regarding teosinte sightings, and that monitoring activities be stepped up. Unfortunately, the experts wrote in this year's report that “no specific information on the occurrence of teosinte (...) was collected with the farmer questionnaire”, because Bayer had simply not modified it. Likewise, bibliographical research is considered to be lacking. As for the work of the Spanish authorities, the experts note that their analysis indicates the presence of teosinte only in conventional maize fields, and an absence of hybridization between plants. But with the information received, the experts are not in a position to know whether the monitoring protocols followed have been sufficiently effective to be reliable. Politely, the European experts “encourages that the research/monitoring activities pertaining to teosinte be continued and expanded”. All of these are comments that the experts will no longer have the opportunity to make in the case of GMOs that will be deregulated if the European Commission succeeds in its project initiated in 2023. This is because, in this deregulation of the majority of GMOs, environmental monitoring and prior risk assessment would no longer be carried out.i Eric Meunier, « Europe – Surveillance post-commercialisation : mal menée », Inf’OGM, le journal, n°150, May/June 2018 (in french).ii Anses, « NOTE d’appui scientifique et technique du Groupe de travail (GT) « Biotechnologie » de l’Anses relative à la demande de commentaires sur le rapport annuel (2022) de surveillance environnementale de la culture du maïs génétiquement modifié MON810 en Espagne et au Portugal », 27 December 2023.iii Arias-Martín, M., Escorial Bonet, M. C., & Loureiro Beldarraín, I., « Teosinte introduced into Spain and Bt maize: Hybridisation rate, phenology andCry1Ab toxin quantification in the hybrids », Revista de Ciências Agrárias, 47(1), 297–301, 2024.iv EFSA, « Assessment of the 2022 post‐market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU », 22 August 2024.v Eric Meunier, « UE – Maïs MON810 : des pyrales résistantes peut-être déjà là », Inf’OGM, 3 juillet 2015 (in french).vi Eric Meunier, « Problems ahead due to cultivation of GMO maize in Europe? », Inf'OGM, 6 February 2024. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [142] => Array ( [objectID] => 9645 [title] => Making salmon sterile… and able to reproduce [timestamp] => 1728864000 [date] => 14/10/2024 [annee] => 2024 [url] => https://infogm.org/en/making-salmon-sterile-and-able-to-reproduce/ [image] => https://infogm.org/wp-content/uploads/2026/03/poisson_grafff_byNoisette-1-768x512.jpg [extrait] => In Norway, the Institute of Marine Research (IMR)i has filed a trial application, in 2023, for genetically modified salmon (VIRGIN® salmon). These salmon, bred in cages in the open sea, would be sterile to prevent them from interbreeding with wild populations in the event of accidental dissemination. The Norwegian Environment Agency asked the Norwegian Scientific Committee for Food and the Environment (VKM) to assess the associated environmental risks. VKM's opinion was highly critical, stating that there was insufficient evidence to consider the trial safeii. In April 2024, after having considered new data, VKM reiterated its negative opinion on this GM salmon trial. [chapo] => In Norway, the Institute of Marine Research (IMR)i has filed a trial application, in 2023, for genetically modified salmon (VIRGIN® salmon). These salmon, bred in cages in the open sea, would be sterile to prevent them from interbreeding with wild populations in the event of accidental dissemination. The Norwegian Environment Agency asked the Norwegian Scientific Committee for Food and the Environment (VKM) to assess the associated environmental risks. VKM’s opinion was highly critical, stating that there was insufficient evidence to consider the trial safeii. In April 2024, after having considered new data, VKM reiterated its negative opinion on this GM salmon trial. [texte] => Norway is the world's leading salmon producer. This economic sector ranks first in exports after the oil sector. In 2018, its sales revenue - up 4.4% on 2017 - amounted to 6.46 billion euros for a production of almost 1.3 million tonnes of salmonidsiii. But this industry raises numerous environmental problems. Norway is also the genetic cradle of many wild salmon populations. But these are under threat from the fish farming industry. On the one hand, intensive farming leads to a significant increase in pathogens (notably lice), which can contaminate wild populations. Secondly, cross-breeding between farmed salmon that have escaped from the farm and wild salmon is causing changes in the life cycle of the latter. The newspaper Le Monde notes that « [...] more than anything else, their defenders fear their hybridisation, in other words their bastardisation. There are still 450 wild salmonid rivers in Norway, with slightly different genetics in different places. Two-thirds of these rivers are already contaminated by fish escaping from farms by the thousands every year »iv.GMO salmon to protect wild salmon?To avoid, or at least try to limit, the impact of farmed animals, it has often been suggested to create sterile salmon. Historically, researchers and companies have used triploidy to make farmed salmon sterile. However, triploid salmon are highly sensitive to their environment and can develop spinal deformities and cataracts. These negative effects have raised concerns about the welfare of the fish. The project of the Public Institute for Marine Research (IRM) in Bregen (Norway) is to develop diploid salmon genetically modified to be sterile by another method... while preserving a certain fertility. These salmon are strangely named « VIRGIN ».Genetic manipulation involves two methods. The first involves knocking out (KO) a gene in the fertilised egg of the Atlantic salmon Salmo salar. This gene, called dead end (dnd), is responsible for the development of germ cells that produce ova in female fish, or spermatozoa in male fish. GM fish will be sterile. The tool used here to carry out this genetic manipulation is Crispr/Cas. The genetic construct is introduced into the egg by microinjection, but could also be introduced by electroporation, nanoparticles or liposomes, as the patent covering this « innovation » explain detailsv. This manipulation is performed on both versions of the gene. As a result, the fish will be homozygous for the gene.However, sterile fish cannot reproduce. This first manipulation would have to be repeated for each generation... hence the idea of using a complementary method that would allow some fish to be fertile, while retaining the initial genetic modification (sterility): a sort of temporary, non-inherited fertility rescue that would allow the sterile trait to be passed on. Researchers inject high doses of reconstructed messenger RNA, normally produced by the unmodified gene that enables germ cell development, into salmon eggs. It is expected that these sterile individuals with restored fertility will be able to reproduce and pass on the modified genes, causing sterility in their progeny.In November 2021, two male and four female salmon, all genetically modified to have restored sterility, were crossed. A total of 2,400 offspring (F1 generation) were produced. Of this total, 303 F1 fish were considered by the Institute to be genetically sterile (modified), with 485 individuals considered to be genetically fertile wild-type (WT). The experiments will be continued by releasing the 788 individuals thought to be homozygous into sea cages at the age of one and a half year, in September 2023, to monitor the behaviour and development of these fish. The many other offspring show mosaics of mutations depending on the germ cells and are of no interest to this industry. Mendelian genetics is showing its limitations here.An experiment contested on more than one countBut for the Norwegian Scientific Committee for Food and the Environment (VKM), the trial in question « is associated with a potentially high risk for wild Atlantic salmon populations ». More than a paradox for a genetic modification project aimed precisely at protecting these wild salmon.One of the heads of VKM, Martin Malmstrøm, is highly critical. Some of his comments concern the method itself, for example the low number of parents, the use of homozygotes and the reliability of genotyping. He explains to Inf’OGM: « In this case, they only carried out one round of genotyping (gene sequencing), which (not surprisingly) resulted in a few individuals being genotyped incorrectly (20%), compared with the second round that we ordered ».Numerous inaccuracies in the dossier were revealed. In its first opinion, issued in 2023, VKM considered that « the data provided in the application is not sufficient to confirm that the genotypes of the 303 homozygous F1 VIRGIN salmon (mut/mut) and the 485 homozygous fish (WT/WT) are correct for all individuals », « not sufficiently documented that all genotypes identified among the 303 F1 VIRGIN salmon indeed result in germ cell free and/or sterile individuals ». In short, VKM is not convinced that the 303 salmon intended for open sea testing are truly sterile. It even writes that the applicant « assumes » that these 303 salmon are sterile but that « this assumption is not supported by confirmative experimental data in the application ».Too great a risk for wild salmonThis creates a significant and paradoxical risk for the wild population if heterozygous fish are hidden among the homozygotes. VKM details that « if heterozygote fish (with one fertility allele and one sterility allele in the dnd gene) escape, they could introduce the sterility allele into wild salmon populations by vertical gene transfer to the offspring generation and to the following generations. The spread of the sterility allele would go unnoticed as it would be recessive in heterozygote individuals. The recessive homozygote offspring (two sterility alleles) of heterozygote pairs would compete for food and space in rivers as juveniles and thereby reduce population productivity and reduce the viability in vulnerable populations. VKM assesses this as a potentially high risk ».The impact on wild populations in the event of « escape » also exists if the farmed fish are sterile. In fact, sterile individuals that have escaped can potentially act as predators on juvenile wild Atlantic salmon or brown trout (Salmo trutta). VKM writes that « this risk is low [but that it] is associated with a high degree of uncertainty, as the necessary experiments have not been carried out ». Farmed salmon are also very often carriers of pathogens... which they can therefore transmit to wild populations.VKM also notes other scientific shortcomings in terms of risk assessment. In its opinion, it points out that « crosses between F0 VIRGIN rescued or F1 VIRGIN salmon and wild salmon have to our knowledge not been carried out for studies of behaviour, reproduction, and offspring survival ». For VKM, carrying out these crosses in confined facilities is necessary to assess the possible risks to wild salmon if potentially fertile fish escape. Another shortcoming highlighted by the VKM is that « the feeding behaviour of F1 VIRGIN salmon has to our knowledge not been studied incontained facilities. This could have informed the risk assessment with respect to feeding behaviour in sea water and fresh water, especially with respect to potential predation on juvenile salmonids ». Finally, VKM highlights the absence of immunological studies on these GM fish.New evidence, same conclusionIn April 2024, VKM received new information from the Marine Research Institute. It therefore updated its opinion. It should be noted at the outset that between the two opinions, the Institute reduced the number of animals considered to be sterile as a result of genetic modification, and therefore to be tested, from 303 to 163. However, VKM notes that the genetic modification remains unclear: the re-sequencing of 276 individuals carried out by the Institute showed « genetic differences » compared to the original sequencing. The Institute's new data changes the sterile/non-sterile proportions. This shows the rush to use knowledge that is still poorly understood.As a result of this new data, therefore, VKM concludes that it « considers all research trials which could introduce heritable sterility into wild salmon populations as having a potentially high risk due to the inherent possibility of causing a massive negative environmental impact. Therefore, VKM upholds the conclusion of risk category “potentially high risk” even though the likelihood (“very unlikely”) of the genome-edited salmon having a negative impact on wild salmon has been reduced »vi.As for the other negative effects specified in the original opinion, linked in particular to the escape of sterile salmon, VKM considers that they are reduced only because the number of individuals tested is reduced. In other words, if fewer fish are tested, fewer may escape, so the impact will be reduced, but the theoretical risk is the same. However, this reasoning is somewhat curious. In the long term, this salmon is supposed to be marketed, so the number of GMO animals in cages should increase...i Coastal matters : https://www.hi.no/enii Norwegian Scientific Committee for Food and Environment, Kjetil Hindar et al., « Environmental risk assessment of genetically modified sterile VIRGIN® Atlantic salmon for use in research trials in aquaculture sea-cages », 6 october 2023.iii Martine Valo, « Le saumon, industrie à grande échelle et filon pour la Norvège », Le Monde, 4 september 2019 (in french).iv Ibid.v Anna TROEDSSON-WARGELIUS et Rolf Brudvik EDVARDSEN, brevet WO2021198424A1, « Modified salmon which produce sterile offspring ».vi VKM, Martin Malmstrøm, « Biological Hazards – Genetically Modified Sterile Salmon – Risk Assessment of Field Trials », 2023. Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [143] => Array ( [objectID] => 9418 [title] => Interconnections between new biotechnologies and DSI or GSD [timestamp] => 1725408000 [date] => 04/09/2024 [annee] => 2024 [url] => https://infogm.org/en/interconnections-between-new-biotechnologies-and-dsi-or-gsd/ [image] => https://infogm.org/wp-content/uploads/2024/07/ITPGRFA-WG11_ENB-IISD_Anastasia-Rodopoulou-5098-768x512.jpg [extrait] => What are the links between new techniques of genetic modification, digitization of genetic sequences information and patents? Inf'OGM publishes here an analysis presented in June 2024 at a regional workshop organized by the African Center for Biodiversity, in Durban (South Africa). It was written by Guy Kastler, representative of the international farmers' organization La Via Campesina at various ITPGRFA and CBD meetings. [chapo] => What are the links between new techniques of genetic modification, digitization of genetic sequences information and patents? Inf’OGM publishes here an analysis presented in June 2024 at a regional workshop organized by the African Center for Biodiversity, in Durban (South Africa). It was written by Guy Kastler, representative of the international farmers’ organization La Via Campesina at various ITPGRFA and CBD meetings. [texte] => Author's introductory remark: the explanations on patents developed in this article take as an example the current evolution of GMO regulation in the European Union, which applies equally the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) annexed to the rules of the World Trade Organization (WTO), the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), the Convention on Biological Diversity (CBD), the Nagoya and Cartagena Protocols... There may be some nuances with the rules for applying these same international agreements in other countries or regions, but the general principles remain the same. On the other hand, in countries that have not ratified the Cartagena Protocol, such as the United States of America and Canada, the risks of widespread biopiracy denounced in this article are no longer risks, but already a reality.New biotechnologies, what is it ?The new biotechnologies are all “modern biotechnologies” as defined by the Cartagena Protocol. The CBD classifies them as “synthetic biology”. The European Commission uses the term “new genomic techniques” or, for plants, “new breeding techniques”. The proliferation of new names with no internationally recognized definition is intended solely to create confusion in order to exclude these techniques from the scope of the Cartagena Protocol, which would then apply only to transgenesis. The same confusion from proliferation of new names applies to so-called “bio-fortified” seeds. There are some rare traditional bio-fortified seeds, but the vast majority are genetically modified.The industry also wants to exclude from this scope certain products derived from modern biotechnologies, such as RNAi pesticides, vaccines, viruses... because they are not themselves living organisms, even though they are disseminated with the aim of modifying the genome or epi-genome of living organisms. To date, the CBD has not concluded its discussions on this subject.The genetic information, what is it ?The gene is not an organism, but it is an essential building block of living organisms. It is made up of nucleic acids, which are tangible chemical molecules. The gene is therefore a physical, tangible substance. Some genes are considered to carry information that determines a particular biological characteristic of the organisms that contain them. Today, we know that the same biological trait often depends on several genes and that, in different contexts, the same gene can generate different traits or no traits at all. But international law doesn’t bother with these subtleties.Information is not a material substance. Yet genetic information is defined only by its material support, the genetic sequence and the phenotypic character resulting from its expression. Geneticists say that “the gene codes for a protein”, while jurists speak of its “function”. However, this material support can also be dematerialized into computer data, which can travel around the planet and be displayed on computer screens in the form of an ordered succession of 5 letters (A, C, T, G and U), symbolizing the nucleic acids of the DNA or RNA making up the genetic sequences. But these letters alone say nothing about the function of the genetic sequence they represent. This function must be specified elsewhere.Two new expressions are now overlapping in all international legal debates: digital sequence information (DSI) and genetic sequence data (GSD). But neither has an agreed legal definition to determine whether it refers to the physical genetic sequence, an integral part of physical biological resources, or only to its dematerialized digital representation produced by research.The genetic information, the Cartagena Protocol and the patentsThe first patents on genes were granted in the USA in the 1980s, after much controversy concerning the privatization of living organisms. In 1998, the European Union adopted its Biotech Directive 98/44/EC, according to which (Article 9), “The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material in which the product in incorporated and in which the genetic information is contained and performs its function”. For the European legislator, genetic information is therefore contained in a product or constitutes the product itself, and can confer an exclusive right to use the materials containing it. Although immaterial, it remains an integral part of these biological materials.The European directive does not specify that this exclusive right of use is limited solely to materials derived from the technical process justifying the patented invention. It may therefore extend to products derived from traditional or farm breeding which naturally contain genetic information similar in description to that of the genetic information claimed by the patent and expressing its function. To date, only the Cartagena Protocol has limited the risk of abusive extension of the scope of such patents to “native traits”. Its Annex II e) requires the disclosure of “any unique identification” of LMOs (Living Modified Organisms) intended for food, feed or processing. A unique identification makes it possible to distinguish the patented LMO from any other product. Consequently, the scope of a patent on a LMO can only extend to that LMO and to products derived from or contaminated by that LMO, and not to the native genes of traditional products. The rich countries that are home to the biggest industrial companies want to remove this obstacle to biopiracy. To this end, they develop a number of fanciful stories claiming that new biotechnologies are not modern biotechnologies in the sense of the Cartagena Protocol.The patent on the genetic information and the new biotechnologiesWhile regulatory protocols for the detection and identification of transgenic LMOs have been adopted internationally, the same cannot be said for LMOs obtained through new biotechnologies. All patent holders have the process allowing to identify and prosecute anyone infringing their invention. These processes could meet the Protocol's obligation of unique identification. But under patent law, they are confidential information protected by industrial secrecy. This confidentiality allows the European Commission to ignore their existence, to claim that nothing is allowing to distinguish GMOs derived from new biotechnologies from organisms derived from traditional techniques not subject to the Protocol's obligations, and consequently to propose excluding them from the Protocol's scope of application.While the numerical description (GSDs) of the single modified gene may not be sufficient to establish this distinction, the same cannot be said of the description of the entire modified organism, with the genetic, epigenetic, molecular and other signatures of the unintended on-target or off-target effects of the genetic techniques used, enabling the organism to be uniquely and indisputably identified. This is why the industry and the European Commission want to limit regulation to the genetic character claimed in the patent, without taking into account the totality of the genetically modified organism.Reversing the burden of proofA patent holder can have his competitors' products seized by the authorities on the sole basis of presumed infringement. It is then up to the alleged infringer to prove that his products were not obtained from the patented invention. He can only do so if he has published in an official document, before the first claim of the patent, that his product already contained the genetic information claimed in the patent, and deposited in an official collection a sample enabling him to prove this. Peasants and small local seed companies do not sequence or deposit in official collections the millions of new seeds they save and select every year. If those seeds naturally contain genetic information described as similar to the one which is patented, only the obligation to publish the LMO's unique identifier can enable them to prove that they have not copied the patented invention. Excluding new LMOs from the scope of the Cartagena Protocol would remove this obligation and thus legalize biopiracy, in flagrant violation of the rights of peasants and indigenous peoples enshrined in the ITPGRFA and the United Nations Declaration on the Rights of Peasants (UNDROP).2014: ITPGRFA collides with the patent on genetic informationIn July 2014, the ITPGRFA held a ceremony dedicated to the 10th anniversary of its entry into force. Its Secretary, Shackel Batthi, announced on this occasion that he had signed the Treaty's commitment to the new program, DivSeek, designed to publish in open access on the Internet the genetic sequences of the two million seed samples stored in the genebanks made available to the Treaty's Multilateral System of Access and Benefit Sharing (MLS).The full sequencing of the first plant, rice, which began in 1993 in Japan, was only completed 12 years later, in 2005, one year after the the Treaty was signed. It mobilized hundreds of researchers from 11 different countries and millions of dollars. In 2014, sequencing a plant sample already required just a few days and a few dozen dollars. Today, it is fully automated, takes just one or two days, depending on the precision required, and costs just a few dollars.This observation enabled the La Via Campesina representative to respond to Shackel Batthi, who was expecting compliments, by denouncing his initiative instead: “with the evolution of techniques, the linkage of genetic and phenotypic data of plant genetic resources facilitates the filing of patent applications on plant traits, including so-called ‘native’ traits that already exist in nature. Such patents enable the private appropriation of these resources. They herald the death of the facilitated access that underpins the Multilateral System. They also herald the end of the rights of peasants, who can no longer use or exchange their own seeds when a patent is registered on a gene that is already present naturally, or when they are contaminated by patented genes”.Access to plant genetic resources for food and agriculture (PGRFA) under the MLS is “facilitated”, meaning that it is exempt from any bilateral agreement between provider and recipient. It is not, however, free, as it remains linked to a benefit-sharing obligation and a prohibition on claiming any patent on the resource supplied, its parts or its genetic components (article 12.3.d of the Treaty). DivSeek's free Internet access to the genetic sequences of these resources therefore constitutes a breach of the Treaty. Shackel Batthi made a serious mistake in committing the Treaty to the DivSeek program, and moreover without seeking the agreement of its Board of Directors. He lost his position two years later and promptly returned to his former employer, the World Intellectual Property Organization (WIPO), which he had in fact never ceased to serve.In 2017, the new concept of DSI appeared on the agenda of the Treaty's Governing Body. The lack of traceability of the origin of patented DSI enables industry to claim that it has not used any PGRFA from the MLS. This exempts the industry from any benefit-sharing obligations and any prohibition on patenting the genetic components of PGRFA, and from extending the scope of such patents to “native” or traditionally-bred seeds containing the same DSI. This triggered heated debate between, on the one hand, the countries of the Global South and the peasants who are the main suppliers of PGRFA, who consider that DSI are genetic resources subject to the obligations of the Treaty, and, on the other hand, the rich countries of the Global North, who consider that DSI are products of research not subject to these obligations. This debate is still ongoing.DSI and new biotechnologies to produce new patents?A genetic sequence alone cannot be patented unless it is the result of a patentable invention, such as the new biotechnologies, and without indicating its function, which is the phenotypic character resulting from its expression. With the dematerialization of PGRFAs, benefit sharing becomes the main tool for determining these functions.Facilitated access to MLS’ PGRFA eliminates any possibility of bilateral agreement between the peasants who supplied their seeds and the beneficiary. This is why the Treaty has set up a multilateral Benefit-Sharing Fund, financed almost exclusively by a handful of States, well below the amounts that should be paid by the industry, which refuses to meet its obligations beyond a few rare alms. This Fund does not remunerate the peasants who supplied their PGRFA to the MLS, but rather the national seed banks of developing countries, followed by researchers and NGOs who collect new PGRFA selected by the farmers, as well as their knowledge associated with these PGRFA. Access to funding from the Benefit Sharing Fund obliges these national seed banks, researchers and NGOs to deposit these PGRFA in MLS collections and to publish the associated knowledge, which constitutes the functions of the genetic sequences they contain.DivSeek and other similar programs now offer free access to several billion of PGRFA’s genetic, epigenetic and protein sequences. Scientific publications, NGOs’ publications and those of the Treaty's information system enable the creation of databases of traits associated with each PGRFA. The powerful computing search engines of a few industry majors are now capable of processing millions of data to identify which genetic sequence in a PGRFA sample “codes” for which function. All they have to do is mobilize their geneticists to tell the story of how to introduce this genetic information into laboratory varieties by means of a new patentable biotechnology, and then their lawyers to translate this geneticist's tale into the legal language of a patent application for plants containing this genetic information. They can then announce new promises to solve all actual agricultural and food problems, while at the same time prohibiting their competitors from using the biotechnology and genetic information patented in this way, or requiring them to pay substantial licensing fees.Only after this first step do they attempt to introduce genetic information into their elite commercial varieties. But this second stage is rarely successful, because the real living world does not operate according to the laws of dematerialized artificial intelligence. It does not obey the probability calculations of computing modelling, which defined the patented genetic information and then programmed the technical process to insert it into real plants. Only a handful of random successes have made it possible to develop new seeds from these new biotechnologies and bring them to market. This difficulty in making the transition from the virtual world of artificial intelligence to the real living world is the reason of the gap between the thousands of patents and publications on new GMOs and the few plants already on the market. However, this does not prevent these patents from fuelling the exponential acceleration of the concentration of the seed industry in the hands of the world's four or five major seed companies, which hold the largest portfolios. Most of these major seed companies are also chemists, and some are pharmacists, who are also investing in new “bio-control” pesticides, medicines, veterinary products, micro-organisms and robotized animals... derived from the same new biotechnologies.What solutions ?In the absence of funding for its Benefit Sharing Fund, the Treaty set up a working group in 2013 to improve its functioning. Following systematic blockages by the industry and the few wealthy countries that support it, it suspended it in 2019, awaiting a possible solution proposed by the CBD.To date, the CBD has still not reached agreement on the definition of DSI. Instead, it has added the new, also undefined concept of “genetic sequence data”. It did, however, raise the possibility of replacing bilateral benefit-sharing with a multilateral fund financed by a levy on any commercialization of products derived from the use of DSI from biological resources. However, it did not explain how it would identify such use. Industry will still be able to circumvent its payment obligations by claiming patents not on genetic information from biological resources (DSI/GSD), but on biological materials obtained by chemical or genetic synthesis, as it has long been the case for chemically synthesized copies of natural substances, which make up many patented medicines.In early 2023, ITPGRFA re-established its working group on the MLS’ functioning. The CBD's proposal leads it to favor a levy on all seed sales by companies using MLS access (subscription), without however excluding optional recourse to its current totally inefficient system of payment for the marketing of products resulting from the use of MLS PGRFA only (single access). This mechanism will spare large companies that only use their own collections and/or public collections that are still open access, such as those in the USA. What's more, unlike the CBD, which is constrained only by a benefit-sharing obligation, the Treaty also prohibits any patenting of the genetic components of MLS PGRFA. If ever finalized, the CBD solution, which does not take this prohibition into account, will therefore not be sufficient on its own to comply with the Treaty.Wouldn't it be simpler to admit that the huge investments in new biotechnologies aim solely at the profits to be made from patents, and offer no solution to actual food, social, climatic, health and environmental challenges... which, on the contrary, they are likely to exacerbate? Wouldn't the solution be to ban all patents on living organisms? Guy Kastler, from Confédération paysanne (a union member of the Via Campesina) [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [144] => Array ( [objectID] => 9356 [title] => De Bolster: another Dutch SME under patent threat [timestamp] => 1721606400 [date] => 22/07/2024 [annee] => 2024 [url] => https://infogm.org/en/de-bolster-another-dutch-sme-under-patent-threat/ [image] => https://infogm.org/wp-content/uploads/2026/03/De-Bolster-768x512.png [extrait] => In April 2024, Inf'OGM reported on its interview with a Dutch seed company feeling threatened by KWS patents. This is not an isolated case since De Bolster, another Dutch seed company, has had to apply constant legal vigilance for several years to prevent its varietal varieties from being covered by an ever-increasing number of patent rights, otherwise its survival would be jeopardized. Frans Carree, Director of De Bolster's Variety Development Department, answered our questions. [chapo] => In April 2024, Inf’OGM reported on its interview with a Dutch seed company feeling threatened by KWS patents. This is not an isolated case since De Bolster, another Dutch seed company, has had to apply constant legal vigilance for several years to prevent its new varieties from being covered by an ever-increasing number of patent rights, otherwise its survival would be jeopardized. Frans Carree, Director of De Bolster’s Variety Development Department, answered our questions. [texte] => Editor's preamble: all mutagenesis techniques legally produce GMOs. Whether or not they are regulated GMOs is a question to which the answers vary according to the players involved, particularly with regard to the technical protocols followed, including the cultivation of cells isolated and multiplied in vitro. Following a ruling by the Court of Justice of the European Union in February 2023, the Conseil d'Etat's interpretation on this point is still awaited in France.Inf’OGM - Can you tell us about the history of De Bolster?Frans Carree - The company was founded in 1978 as a developer of organic plant varieties for the local market and for several different types of vegetables and flowers. At that moment we were only working for the home-grown market.The current owners bought the company in 2007 and started breeding programs for, pumpkins, courgettes and tomatoes. The aim was to enter the professional market. Today we have 330 varieties in our catalogue, which we sell in our webshop and via dealers all over the world.Today we have 50 employees, 9 of whom work in breeding and the rest in seed production seed cleaning, quality control and sales. So we remain a relatively small company. We are a family owned company and a cooperation with around 1000 members.Most of our business is in the Netherlands, but we also have a production subsidiary in Moldova. We chose Moldova because the climate is fairly similar to Italy, so good for producing seeds.. Moldova is also a poor country, relatively untouched by pesticides. Which is good if you are working in organic because you have less chance of contamination of our seeds with chemicals.I have headed the variety development department at de Bolster since 2017. Before that I was a breeder at Rijk Zwaani.Do you have any flagship varieties?In recent years we've been very successful with our pumpkin varieties, particularly in Western Europe, but we're currently growing fast in 'rootstock' pepper, which is resistant to soil Nemathodes (also Verticillium and Pyrenochaeta) and which is an F1 hybrid. Growers of pepper take the roots of this plant and graft them onto a normal pepper. This makes it possible to market peppers that are resistant to such soil pathogens.We've grown quite rapidly over the last few years, mainly in the professional market. The good thing is that we can now see that certain varieties, such as this pepper variety that we've developed, are of interest to certain conventional growers who have problems caused by the substrate in which they grow them. So even conventional growers are switching to our organic rootstock pepper.At de Bolster you've been dealing with a patent issue for several years. Can you tell us about it?In the mid-2010s, when De Bolster had been bought out three years earlier by the new owners, discussions on the issue of gene and plant patents took place within the company when it decided to move into breeding. Many of the companies concerned have done the same. Our vision is that granting patents on plant material is unethical. We do not want to claim patents on our material and we don’t want to sell varieties with patents.Then came the famous decision of the European Patent Office (EPO) on the non-patentability of products obtained by essentially biological processes in May 2020 [Editor's note: decision G3/19 of the EPO's Enlarged Board of Appeal]. Yet patents are still being granted for invalid inventions, some of which are based on essentially biological processes. A recent Nunhems patent [Editor's note: EP3464333B1] issued in May 2024 claims a mutant gene found in a population of watermelons treated with mutagenic agents. There is no longer any inventive step, which is a condition for patentability. Such mutants could also be found in wild populations. Another patent issued in May 2024 to KWS [Editor's note: EP3041345B1] claims the incorporation into a maize plant of a gene from a wild ancestor that can be obtained from a gene bank. As far as I know, all you have to do is cross this ancestor with conventional corn. Furthermore, some of the patents granted on products obtained by essentially biological processes remain valid despite the G3/19 decision if they were filed before July 2017.So, while we really thought that things were settled with this major decision, this is in fact not the case.We can really see that the European Patent Office is trying to grant as many patents as possible, even helping applicants to use the right wording to get a patent granted. In fact, the patent applications describe that the traits are indeed found in wild ancestors but that it is possible to insert this modification into a variety using techniques such as Crispr/Cas. The patent offices consider that the invention can therefore be obtained by a technical process and issue a patent. And that, of course, is what we don't want. We think a lot of companies don't want that, but it's still happening.We have the impression that we are starting again today with the same problem that was theoretically resolved by the decision of the Grand Board of Appeal in May 2020. That's why we are demonstrating and making our voices heard to convince the European Union that more needs to be done than has already been done. Many plant breeders and seed companies want all patents on plants and seeds to be banned, but it's difficult and complex. It's not moving fast.When and what prompted you to take action to make your voice heard?In fact, things went to extremes when the new deregulation of NGTs was proposed in July 2023 it was on 17 nov 2022 that there was a hearing with DG GROW about NGT’s . We then realized that the next step would be to patent all these NTGs and that we really had to start working again with other breeders like Bingenheimer, Sativa.... We launched a group action with the Dutch organisations Bionext, Demeter, organic supermarket chain Odin, and other small breeding companies (Bionext.nl, stichtingdemeter.nl, odin.nl) with whom we represent the organic movement in Holland. Bionext corresponds to IFOAM at national level. We have tried to convince other people to take action, such as Greenpeace Netherlands, Oxfam Novib and people from Wageningen University, so that we can have a different sound in the market from "we need NTG’s". We're working together to find out what we can do together to write opinions. I've also been to Brussels twice to inform the European Parliament about this issue and how patents affect small businesses like ours, but also what NTGs will do to the organic farming sector. So we're following the process of deregulation of NTGs at European level between the Commission, the Parliament and the European Council on patents... We've noted that the next presidencies are being entrusted to Hungary and Poland, who are , like us, more prudent about de-regulating, but Denmark, which will follow, is more pro-GMO. We're not saying that NTGs should be banned, but they should at least be regulated so that people can choose whether or not to buy or use them in their breeding program.Who are your main contacts in this mobilisation?We're trying to talk to everyone, including MPs like the Greens who are on our side, listening to organic farming and small businesses, and who are willing to talk to us. But the right is not inclined to talk. We're trying to keep the flame burning so that something other than the pro-GMO rhetoric is heard. In the Netherlands, the government is quite pro-genomic editing, like CRISPR-Cas. In fact, they used to be quite 'pro', but they're beginning to see the problems caused by patents and don't want to see multinationals holding all the patents on genetic resources, NTGs... We also like to show them that small companies like De Bolster can make a big difference on availability of different varieties on the market, also for particular markets that are not interesting for the big players. And thus help keeping biodiversity. We are also clear on the fact that if NTG’s are de-regulated and granting patents will be allowed, we might be forced to stop our activities.What do you think of the patent strategy of companies like Rijk Zwaan, for whom you have worked?They have a double face because they don't want patents on seeds and at the same time they are one of the biggest patent holders. In a way, this is understandable, because if you don't have patents but they are still granted, it can cost you a lot of money in terms of licences, for example. So companies that are basically not pro-patent protect themselves, But all company’s that work in this way increase the problem for companies like De Bolster, who don’t want any patents on their varieties.When the subject of plant patents came to the fore, the question for breeding companies was whether any traits could be patented, and if so, which ones. And it was here that a fundamental change in corporate strategy took place. It is important to understand that the companies seeking to obtain patents are not the same as those seeking to produce the right varieties for growers or consumers. They are mainly interested in obtaining patents on interesting traits in order to develop them through licensing or to sell them to other companies. This is really not the right way to develop good varieties, because you lose the agronomic objective. It's the wrong way of thinking. It reflects the way we look at our seeds and our gene banks: either we try to make the best variety for producers and consumers, or we look for the trait that could be patented. It's not just the traits that define a good variety; many parameters are interconnected and work together. You have to look at the system as a whole. There are interactions with the soil, the question of irrigation, etc. Developing the right variety is not just a matter of putting a new resistance gene in a particular variety... it's much more complex.There are also international licensing platforms created by various large companies such as Enza, Bejo, KWS and BASF. Syngenta has also created its own portfolio of licences with Bayer. Bayer and Syngenta state on their website that small companies with a turnover of less than €5 million, for example, can obtain licences free of charge. But this is "green-washing", because as soon as licensees leave the research stage or "small business" status, they have to pay. And it is maintaining the system of patents.How are you integrating these patent issues at de Bolster today?It actually started a few years ago in 2017with the case of the purple radish. The Koppert Cress company tried to obtain a patent on this radish. We helped opposing the Dutch patent office and won. That was the first time we had problems with a variety, which we sold to different growers. From then on, every time we used our gene-banks, we checked whether any patents existed on the elements contained in our banks. In particular, we look in the Pinto database, but not all patents can be found there. It is becoming more and more complex as the number of patents increases.Today, for our tomato breeding programme we have this patent issue. The big problem at the moment concerns the trait for resistance to the 'Tomato Brown Rough Fruit Virus' (ToBRFV), on which around 20 patent applications have been filed by various applicants, seven I believe. The NGO No Patent on Seeds has published on the subjectii. ToBRFV resistance is almost mandatory for new varieties to have. We are currently working on this resistance problem without knowing which patent will be granted or not. Nor do we really know what these patents cover.As a general rule, if we identify new resistances in our gene banks, we have to check for each one whether or not it has already been patented. If it hasn't, we have to make a note of the fact that we found it in such and such circumstances, on such and such a date, etc., and that it doesn't appear to be patented. But we know that there is a good chance that the resistance trait has been patented and that the patent applications may not yet have been published.So it's very difficult to know whether to continue or stop a programme. Can we take the risk of researching something for years if we're not sure that what we find in our own company's resources won't be patented? We'd be working for nothing. And this doesn't just apply to tomatoes; the same problem applies to all the varieties we work on. So it's becoming difficult for us to envisage continuing to work in breeding. These are really difficult times.It can't be easy to prove that you've actually discovered a new trait. How do you go about proving this? It must take you a lot of time, even though this isn't normally your job?We don't really have a choice in the matter. In practical terms, our computers contain our gene banks and all the cross-breeding information. We can indicate that we have found such and such an element in our gene bank, and when we did so. Our computers are like our legal assistants, proving that certain traits have been in our gene bank before a patent was filed.At this moment we have incorporated in our breeding software the possibility to track all varieties. Everything that goes into our gene pool is checked and registered, so we can always tell with what material our varieties are made. We exclude material that is GMO or that has patents. This doesn't take up much time at the moment. But it gets more complicated when more varieties come with patents, and we would like to incorporate genes from that material (that are not patented). Then we will have to check if the patented construct isn't bred into our material. Mostly this is done by marker assisted breeding. And this can become costly. At this moment we don't have a lab where we can run markers, so we do it at a third party. This makes is more costly. And this is the way it will go if NGT's are deregulated and patents will be granted on this material.As far as costs are concerned, we examine every patent filed to see if it is relevant to our breeding programs. Everything that enters our breeding gene pool has to be examined for patents. Everything has to be properly documented. This costs thousands of euros.Another thing that can happen now is the adventitious presence of patented genes. Adventitious presence is when a patented trait is unintentionally present in our breeding material. For example, because it was introduced by pollen from a neighboring field, or because it was present in material we used without knowing that such a trait was present. When we detect this, we have to destroy the seed lot, which can be very costly.To counter all this we need to be able to systematically oppose patents that cover traits that we ourselves have discovered. But that's not our job, it requires a lot of resources and it's extremely expensive. So it's not an option.Have you ever been approached or threatened by Bayer, KWS or another company?No, we haven't yet been approached in this way, probably because our varieties are not covered by patents. For the moment... The work we're doing to guarantee our freedom of exploitation, i.e. the fact that our varieties contain no patented elements, is apparently working quite well. We want to free ourselves from patents and GMOs, and we're working towards that goal. In practice, the threats come from the fact that patent applications remain unpublished for a year and a half after their filing date, and we may have launched a program during this period. What's more, it can take years for a patent to be granted, during which time we're not sure what's going to happen. If a patent is granted, it is always possible to oppose it, but the opposition may fail, as happened in a pepper case last year. Furthermore, the cost of oppositions is high, and we don't have a legal team at De Bolster. We have to hire lawyers to do this.As a result, in many situations, we may have worked for nothing, as we don't want to sell varieties that fall under patents. If we've missed something and one of our seeds contains a patented trait, we'll stop development immediately. It's already a nightmare, but with NTGs, it's going to explode.Do you have any other major programmes that could be threatened by patents?As I was saying, we are trying to keep our programmes patent-free, but they are all potentially under threat. There is, for example, the New Delhi virus programme, which concerns courgettes in particular, and which is about to be patented. There's also the programme concerning pumpkins and peppers, which we can work on for the moment, but which are still potentially under threat because someone could obtain a patent covering elements that all breeders will need.Do you know of any other companies in the Netherlands or elsewhere facing similar patent problems?I think all small breeding companies are impacted. Those who don’t have a big legal team or the expertise to work with patents. There is this case about the purple tomato of Baker Creek in the USAt this moment in The Netherlands there is the case of the Cold tolerant maize patent of KWS. For Nordic Maize Breeding, which cultivates cold tolerant maize it will be interesting to see what the outcome of the opposition to the KWS patent will be. For the moment, we haven't taken a close look at this case, but we are interested in what emerges from a legal point of view.iA Dutch company with numerous patent rightsii No Patents on Seeds, « Patents block breeding of tomatoes resistant to harmful virus », April 15, 2024. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [145] => Array ( [objectID] => 8608 [title] => Illegal GMO plants and micro-organisms in Europe [timestamp] => 1719273600 [date] => 25/06/2024 [annee] => 2024 [url] => https://infogm.org/en/illegal-gmo-plants-and-micro-organisms-in-europe/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Between 1 January 2021 and the present day, the European Union has had to deal with almost fifty cases of the illegal presence of GMOs on its territory. Most of the cases reported by the national authorities involve GMO plants originating in Asian countries such as Vietnam and Thailand, but also in other countries such as Ukraine, the United States and, more surprisingly, France... GMO micro-organisms have also been detected in batches of food additives used in human and animal nutrition. [chapo] => Between 1 January 2021 and the present day, the European Union has had to deal with almost fifty cases of the illegal presence of GMOs on its territory. Most of the cases reported by the national authorities involve GMO plants originating in Asian countries such as Vietnam and Thailand, but also in other countries such as Ukraine, the United States and, more surprisingly, France… GMO micro-organisms have also been detected in batches of food additives used in human and animal nutrition. [texte] => In the European Union, the market is monitored by the national authorities who, via the Rapid Alert System for Food and Feed (RASFF), alert the other Member States and the European Commission to cases of proven or potential illegal cross-border marketing (batches held at the border and returned). If these detections of illegal GMOs involve production and marketing in one and the same country, the alert is not necessarily issued. Although it does not cover all detections of illegal GMOs, the RASFF online database gives an idea of the various types of contamination, with information provided on both cases of contamination by an identified GMO and contamination by unidentified GMOs.Top contaminants: GM rice and papayaAccounting for half of all cases of contamination since 1 January 2021, GM rice is the plant most frequently found illegally in Europe or at borders (see table 1). The RASFF system does not specify the nature of the transgenic event(s) found in these rices. It is therefore not possible to carry out a more detailed analysis. Nevertheless, illegal GM rice has been a problem in Europe since 2006, i.e. for almost two decades now. As Inf'OGM pointed out in 2023, only the golden rice authorised for commercial cultivation in 2021 in the Philippines had been grown in small areas. Authorisation for this rice was revoked by the Supreme Court of the Philippines in early 20241. In addition to this rice, "several varieties of transgenic rice have been authorised for cultivation in the United States (LLRICE06, LLRICE601, LLRICE62), China (GM Shanyou 63, Huahui-1/TT51-1) and Iran (Tarom molaii)". But Inf'OGM stressed above all that, "according to our information, they have not been grown commercially". Although officially not authorised for cultivation, GM rice is nevertheless contaminating the European Union.The geographical origin of these GM rice contaminations varies between several countries, but the majority of cases originate on the Asian continent (see summary table 2 at the end of the article). Vietnam appears to be the main source of GM rice contamination in Europe, with 12 of the 24 cases involving rice. Next comes China, with 5 of the 24 cases. Thailand (1 case), Singapore (1 case) and India (2 cases) complete the list of Asian countries. As far as China is concerned, the situation has been the subject of several meetings between EU Member States and even on-site missions. The latest discussions on the subject, in 2022 and 2024, reflect simple administrative and analytical management, with no undue concern on the part of the Member States2.More surprising in terms of countries of origin of contamination, the presence in the RASFF of the Netherlands, Belgium and France. In the case of France3, this relates more specifically to the detection of GMOs in two rice-based products, "M&Ms Crispy" and rice flour in "cereals and bakery products". Although France is indicated as the country of origin, the contamination alert involves twenty other countries as operators, distributors or countries to be monitored, nine of which are not European Union countries4. This is evidence of the globalisation of the movement of food products and components.Like GM rice, transgenic papaya is also a GMO that has been contaminating the European Union for a long time. After Greenpeace warned in 2004 that a research station in Thailand was selling transgenic papayas without authorisation, the European Union is regularly faced with cases at its borders. Since 1 January 2021, ten alerts have been issued. The GM papayas detected came from Thailand (6 of the 10 cases), Cambodia (3 cases) and Brazil (1 case).OrganismsNumber of casesRice24Papaya10Micro-organism5Soya4Not specified3Corn1Total47Table 1: Contaminating GM organisms in Europe from 1 January 2021US and Ukrainian soya, GM micro-organisms...As well as the usual rice and papaya, transgenic soya has also been the cause of four alerts since 1 January 2021. While one case originated in the United States, the other three involved transgenic soya from Ukraine. Poland is the Member State that has issued the alerts following analyses of batches of soya intended for animal feed at its borders. While the two alerts carried out in 2021 showed no proportion, the alert carried out on 15 March 2024 showed 47,49% contamination in the batch or batches analysed.While three cases of contamination detected and reported to the European Union did not specify the organism involved, five other alerts concerned micro-organisms. In all five cases, these were genetically modified micro-organisms grown in fermenters to produce food additives. If the import or production of such and such an additive is authorised, the necessary condition for their marketing without GMO risk assessment or labelling is that the GMO micro-organism used to produce them is absent from the batches.France issued an alert in 2021 following the detection of illegal micro-organisms in batches of protease, an enzyme used as a food additive in human nutrition. The RASFF indicates that no batches were distributed by France5. France also issued another alert in 2021 for another protease, whose batches from China were found to be contaminated6. As the detection was made following checks "on the market", the RASFF specifies that products were recalled from consumers and batches withdrawn from the market. Three marketed products are indicated, all three in the field of "additives for human consumption" or "dietetic foods, food supplements and fortified foods". They are "PROTEASE 100,000 UNITS/KG" and "Mucopure" and "MCP30" food supplements. A third alert, also issued by France, also concerned batches of protease from China7. This time, the batches in question were exclusively "food additives" withdrawn from the market after being recalled from consumers.A fourth alert, issued in 2021, again by France, concerned another type of enzyme, transglutaminases8, used in the food industry such as baking, again from China. The incriminated products are indicated as having been "retained by the controller". The last alert in 2022 came from Belgium, which detected GMO micro-organisms in batches of phytase, an enzyme used as a food additive in animal feed9. The products were withdrawn from the market.Although these 47 alerts sent to the European Union by Member States appear to represent a small number of cases in three and a half years, they show that for rice and papaya, the passage of time does nothing to stop the contamination that appeared twenty years ago. At the same time, cases of contamination by micro-organisms are also on the increase, a situation that is all the more worrying given that some of them are found in marketed food products.YearGeographical originOrganismNumber - case per caseTotal number of cases2024ChinaRice28Not specified1UkraineSoya1South KoreaNot specified1VietnamRice2ThailandPapaya12023VietnamRice813ChinaCorn1ThailandPapaya2NetherlandsRice1IndiaRice12022CambodiaPapaya313ThailandPapaya2Rice1BrazilPapaya1United-statesSoya1VietnamRice2ChinaRice1SingaporeRice1Belgium/ BulgariaMicro-organism12021UkraineSoya213ChinaRice2Not specified1France / ChineMicro-organism2Belgium / ChinaMicro-organism1Belgium / IndiaRice1ThailandPapaya1FranceRice1NetherlandsRice1UnknownMicro-organism1Table 2: Summary of cases of contamination since 1 January 2021 Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [146] => Array ( [objectID] => 8442 [title] => Catalonia: GMO Clearfield rapeseeds do not have better yields [timestamp] => 1717545600 [date] => 05/06/2024 [annee] => 2024 [url] => https://infogm.org/en/catalonia-gmo-clearfield-rapeseeds-do-not-have-better-yields/ [image] => https://infogm.org/wp-content/uploads/2024/05/16524606093_2ede0d60ee_c-768x513.jpg [extrait] => In Spain, the public agronomy institute Irta regularly carries out evaluations of several varieties of rapeseed. Recently, they introduced into their evaluation some Clearfield rapeseed varieties, herbicide tolerant varieties modified via in vitro mutagenesis. Result: these GMOs, grown commercially in Europe outside the legal framework, do not have better yields than their conventional counterparts. [chapo] => In Spain, the public agronomy institute Irta regularly carries out evaluations of several varieties of rapeseed. Recently, they introduced into their evaluation some Clearfield rapeseed varieties, herbicide tolerant varieties modified via in vitro mutagenesis. Result: these GMOs, grown commercially in Europe outside the legal framework, do not have better yields than their conventional counterparts. [texte] => The question of yields in agriculture is always delicate to address. Indeed, there are two similar concepts that must be carefully separated: yield and profitability. Let's imagine a GMO plant which would have a 10% higher yield than its non-GMO counterpart but whose seed cost would be 20% higher, what about the profitability which integrates all the related costs and benefits to production (see box on the failure of Bt cotton in India)? Furthermore, the calculation of yields is often evaluated at the station, and not in the cultivated fields. However, the transition from the experimental station to the field often results in a significant loss of the value estimated under ideal conditions. Nevertheless, the question of pure yield remains interesting to look at. And it comes up regularly in debates on GMOs or NGTs.Clearfield rapeseed promoted for better yieldsClearfield is a BASF brand that the company may sell to other seed companies. This brand can concern several techniques for obtaining a variety (sunflower, rapeseed, wheat, rice, mainly) tolerant to herbicides (imazamox). In the case of Clearfield rapeseed, a report published by ANSES specifies that the technique used by BASF to produce its Clearfield rapeseed is in vitro mutagenesis. The Court of Justice of the European Union (CJEU), in 2018, took care to specify that the techniques of genetic modification mainly developed after 2001 are giving rise to regulated GMOs. A second complementary ruling by the CJEU in 2023 is still being interpreted, notably by the french Conseil d'état which decision is still expected. Clearfield oilseed rape are therefore GMOs but the question of whether they should be regulated as such has yet to be answered by the Conseil d'Etat.When the first Clearfield rapeseed arrived, BASF spoke on several occasions in agricultural newspapers to praise its technology. We could thus read BASF explaining in Terre-net.net that “Clearfield makes it possible to improve the competitiveness of rapeseed cultivation by reducing the number of herbicide interventions by 35%, an average saving of 20% in weeding costs and exploiting the maximum potential of the variety which results in a yield increase of 10% according to our trials"1. Or again: “farmers who have already tested Clearfield varieties have reduced on average their herbicide Ift [treatment frequency indicator] by 33% and the number of products used by 51%, […] The number of passes is reduced to 1.3 on average, compared to 1.9 in conventional weeding. Finally, still compared to a classic solution, it provides a yield gain of 3.2 to 4.2 q/ha, up to 5.9 q/ha compared to a control"2. Sophie Babinet, BASF's regional marketing strategy manager, indicated a +10% yield for Clearfield rapeseed "compared to a solution taken under similar conditions". This increase in yield absorbs, she underlines, the additional cost of the seeds, which, “depending on the varieties, oscillates between 10 and 20 euros/ha”, specifies Jérôme Brun, in charge of relations with seed companies for BASF Agro.The cost of the herbicide treatment would be comparable to the cost of treatment with traditional solutions in the case of difficult flora3. Amélie Lavoisier, journalist for Circuits Cultures, therefore legitimately wonders why with such results this technology, “on the market since 2012 and without direct competition, does not achieve a greater market share with regard to the potential 500,000 ha”. BASF's response is twofold: on the one hand, "this technology fundamentally changes farmers' practices, by introducing more agronomy and reasoning", but also because "the climate of opposition linked to the mutagenesis technique, although widely used in agriculture, including organic, does not promote the growth that this solution should have”4.We will not discuss the second “reason” for this flagging growth except to point out that in the specific case of BASF's Clearfield oilseed rape, contrary to what the company implies, it is not used in organic farming, since it has been genetically modified to resist chemical herbicides.. As for the first part of the answer, it has a slight contemptuous side for the farmers... But above all, BASF does not detail that the farmers also quickly understood that the Clearfield rapeseed could be problematic due to the regrowth of Clearfield rapeseed from a year after year and weeds (ravenella, wild mustard, etc.) become resistant to this herbicide. A fear raised on the farmers' Internet forum from the first plantings of Clearfield rapeseed5. And Arvalis titled one of his articles: “consume ALS inhibitors [Editor’s note: of which imazamox is one] in moderation”6 due to the rapid appearance of resistance in several weeds.Yields questionedThese improvements in the yield of these Clearfield rapeseeds, promised by BASF, have been undermined by several reports published by Irta7, the Catalan public institute for research in agri-food and technology. In 2023, Irta published the results of its evaluations of eight rapeseed varieties, three of which were Clearfield varieties (Vestal CL, Inv1266 CL, DK Imove CL)8. This evaluation was carried out over three years (2021, 2022 and 20239) in the district of Girona, in Spanish Catalonia. The conclusion is clear: "the results indicate that their production [that of CL varieties] is similar to or slightly lower than that of the main conventional hybrids". The differences overall remain quite small. In the end, no variety, neither hybrid nor Clearfield, exceeded the yields of the ES IMPERIO control (see table below).VarietyBreederProduction index (in %) (3 trials: 2021, 2022, 2023)Production index (in %) (2 trials: 2022, 2023)ES Imperio (témoin)Lidea Seeds100100HillicoFlorimond Desprez88,888,2MelodieID Grain89,184ArchitechLG Seeds86,484,7RGT JakuzziRAGT85,882,2Vesta CLMas Seeds91,890,4Inv1266 CLBASF90,989,9DK Imove CLBayer / Delkab81,6Average yields of conventional oilseed rape (ARCHITECT, ES IMPERIO, HILLICO, MELODIE and RGT JAKUZZI) compared with CLEARFIELD oilseed rape (DK IMOVE CL, INV1266 CL, VESTAL CL) in the 2022 and 2023 seasons.A previous evaluation on four campaigns (2018 – 2021), published in 2021 and also carried out by Irta, gave the same results. This institute had already evaluated 39 varieties of rapeseed, including several CL10 (Carlton CL, Clavier CL, Dax CL, DecibelL CL, DK Implement CL, DK Importer CL, Inv1266 CL, Nizza CL, PT279CL and Vestal CL). No CL variety tops the rankings in terms of yield. In this evaluation, the control variety was already ES Imperio, as it is currently widely cultivated in the Girona region (Catalonia). And the researchers also point out that "if we consider the three-year series, the conventional varieties (ES IMPERIO, HILLICO, DIFFUSION, SY FLORIDA, ES CESARIO, DK EXPRESSION, MELODIE, RGT JAKUZZI and ES AMADEO) on average outperformed the ' Clearfield' (DK IMPLEMENT CL, CARLTON CL and DECIBEL CL) by approximately 13% (643 kg/ha)”.Questioned by Inf’OGM, one of the person responsible for these reports, Joan Serra, told us that these tests were carried out “in a scenario where weeds were controlled”. In the tests, weeds were eliminated in the different plots with the same herbicide, metazachlor, as this researcher explains to us. Asked about the significant presence or not of cruciferous plants that are difficult to control in the plots, he replies: “We have not tested weed control strategies, but compared different varieties. These are variety evaluation trials and not comparisons of herbicide strategies”. Likewise, when asked whether, in the event of a heavy infestation of weeds from the cruciferous family, CL varieties will have a better yield than other conventional varieties, he specifies: "it is probable, provided that satisfactory control of these weeds is achieved – this is not always the case”.Clearfield varieties, like other varieties made tolerant to herbicides, regardless of the technique (genetic modification or conventional selection), have been developed to facilitate the work of farmers (easier management of herbicides initially) and to "be cultivated in plots with the problem of the presence of grasses resistant to the main herbicides authorized in cultivation, but sensitive to Imazamox, as many species of the cruciferous family can be”. It’s a technical solution that allows the farmer to get his head above water a little, but quickly it doesn’t works, or less well… and the seed companies will propose a new technical solution… and so on. HT crops are a simple technical headlong rush that create as many problems as they solve. There are also other ways of considering the “fight” against weeds of the cruciferous family: much longer rotations, systematic false seeding, mechanical weeding (hoe, harrow, weeder)11.Failure of Bt cotton in IndiaA recent scientific article, published in Environmental Sciences Europe in 2023, shows the failure of Bt cotton in India. India ranks at the bottom of the ranking in terms of cotton yield in kg/ha. Australia has a national annual average of 2011 kg/ha, China 1844 kg/ha… and India is only 466 kg/ha. The authors first note that transgenic Bt cotton has generated significant problems of resistance to the insecticidal toxins produced by this plant, developed by the main cotton pest, namely the pink bollworm (Pectinophora gossypiella). The immediate consequence of this resistance is a necessary increase in the quantities of chemical insecticides used. These insecticides cause, according to researchers, ecological disruptions and epidemics of very destructive secondary pests.The Indian cotton system. A Changes in the types of cotton grown during 1954–2017 B national pesticide use (97% active ingredient) during 1955 to 2017 [8, 9] with the inset in B showing the relative changes in total insecticide applied for bollworm and hemipteran control during 2002 to 2013 [10] C the simulated relative dynamics of irrigated non-Bt cottonsD relative dynamics of pink bollwormE relative dynamics of rainfed non-Bt cotton with the large bold arrow indicating infestation inoculum from irrigated cottonF daily precipitation (mm) in 1984. Panels C, D, and E are modified from physiologically based demographic models as driven by daily weather dynamics for the 1984 season (see [3, 4]).Second problem identified by the researchers, the technical difficulty in reusing seeds from one year to the next12. They write: “While hybrid cotton produces fertile seed, the resulting plant phenotypes are highly variable preventing farmers from replanting saved seed, forcing them to buy seed yearly”. Finally, to these technical problems, we must add the high cost of hybrid seeds. This cost leads to lower density crops, which limits the yield potential. For the authors, this “system” is therefore qualified as “sub-optimal”. The authors point out that there are non-hybrid, non-Bt varieties in India for high density sowing (HD13) and over a shorter season (SS for short season). These varieties, as well as indigenous varieties, are developed by the Central Institute for Cotton Research (CICR), but they have never been promoted or defended. They write that these varieties “can potentially produce more than double the yield compared to the current low-density hybrid Bt rainfed cotton system. Although the 7.5-fold higher seeding rate for non-hybrid HD-SS cotton would increase seed costs to ~ $56 ha−1 (i.e., $7.5 × 7.5), this would be offset by higher yields, avoidance of spring pink bollworm infestations, reduced buildup of late-season pests (i.e., pink bollworm, American' bollworm (Helicoverpa armigera), and others), lower pest control costs and pest damage, synchronized maturity for harvesting, seed saving for replanting, increased profit, and the facilitation of organic production”. They also add that “of course, high-yielding hybrid HD-SS Bt varieties have also been developed, but at current hybrid seed prices, the 7.5-fold seeding rates would cost ~ $236 ha−1 (i.e., $31.50 × 7.5) without commensurate increases in yield, and the hybrid technology would prevent seed saving for replanting. Due to its pest avoidance properties, the wide-scale planting of non-hybrid HD-SS rainfed cotton would render the Bt technology largely irrelevant as demonstrated in irrigated desert cotton in California where HD-SS pure-line non-hybrid varieties combined with early harvesting and plowing disrupted overwintering in PBW, saving the cotton industry from the ravages of this invasive pest”.The authors therefore conclude that "agricultural economists failed to recognize the inherent obsolescence of the Bt construct under Indian conditions as resistance to Bt toxins quickly evolved in PBW increasing costs, economic distress and systematic dispossession of resource-poor households, and appropriation of their meager resources by other economic actors. […] Indian cotton farmers have been paying a premium for a hybrid technology that is a value-capture mechanism protecting seed industry IPRs and profits—the economic plight of poor farmers appears to have been viewed as collateral damage". Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [147] => Array ( [objectID] => 8379 [title] => Synthetic Biology, talks are involving GMOs [timestamp] => 1716940800 [date] => 29/05/2024 [annee] => 2024 [url] => https://infogm.org/en/synthetic-biology-a-new-name-for-gmos/ [image] => https://infogm.org/wp-content/uploads/2024/05/52877037227_066c37dd52_c-768x512.jpg [extrait] => For the past fifteen years, governments have been discussing “synthetic biology” on an international level. If to date, an "operational" definition exists, the outlines of this field remain hard to draw. Are talks of “synthetic biology” simply a change of semantics, or a genuinely new frontier of the biotechnology field? For the moment, examples of organisms or molecules obtained by synthetic biology are accumulating: unnatural proteins, GMO plants, GMO bacteria, recreated viruses, modification of living organisms directly in the environment, GMO insects, xenobacteria... [chapo] => For the past fifteen years, governments have been discussing “synthetic biology” on an international level. If to date, an “operational” definition exists, the outlines of this field remain hard to draw. Are talks of “synthetic biology” simply a change of semantics, or a genuinely new frontier of the biotechnology field? For the moment, examples of organisms or molecules obtained by synthetic biology are accumulating: unnatural proteins, GMO plants, GMO bacteria, recreated viruses, modification of living organisms directly in the environment, GMO insects, xenobacteria… [texte] => Since 2010, the Convention on Biological Diversity (CBD) has been discussing the regulation of organisms, components and products obtained through synthetic biology. After years of discussions, this area has an operational definition which allows participants to discuss the issue based on information searches conducted within various bodies. For a recent meeting of the CBD, examples of organisms or molecules produced by synthetic biology can be found in the preparatory documents. In Europe, the European Food Safety Authority (EFSA) produced opinions on plants1 and micro-organisms2 between 2020 and 2022, which also list examples of what synthetic biology could entail.Talking about synthetic biology to avoid talking about GMOs?These documents show that, to this day, talking about organisms obtained by synthetic biology is in most cases tantamount to talking about GMOs. The EFSA sums things up clearly when it writes that “SynBio is a rapidly developing research field resulting in new techniques likely to be used for the design of GMOs”3. As we shall see, the vast majority - if not all - of the examples provided by the CBD or the EFSA of current synthetic biology products are GMOs or products obtained from GMOs. While the regulatory framework for GMOs has been in place for many years, companies have started using the Synthetic Biology expression in order to attract fundings and, if possible, to reduce the scope of existing legislation such as the one on Living Modified Organisms in the CBD. But in this semantic agglomerating several techniques, organisms or products already regulated as GMOs with achievements that are still theoretical, many people find it difficult to draw the outlines of synthetic biology, following the example of international and European experts.There are other, less institutional thoughts, perceptions or definitions of what synthetic biology is. Inf'OGM reported on these in a dossier (in french) in 2022, and will come back to them in other articles. In the present article, only the positions adopted by the official bodies - the CBD and the EFSA - about the current achievements of synthetic biology will be discussed, since these are the ones officially on the political table.Ongoing talks at the international levelFollowing up on the work of a previous Ad hoc Technical Expert Groups on Synthetcic Biology which was launched in 2013, a “multidisciplinary ad hoc technical expert group on synthetic biology” was set up at the end of 2022 within the CBD. Composed of experts nominated by certain signatory states, social organizations and local community organizations4, this group began its fact-finding work in mid-2023. Reading the preparatory documents for a recent meeting of this group of experts shows that defining synthetic biology is not a consensual exercice5. In 2014, the CBD wrote that “there is no internationally agreed definition of “synthetic biology””6. This situation had to be resolved in order to keep on discussions occurring in the CBD. An “operational definition” was then adopted to this end. In 2016, the CBD finally considered synthetic biology to be “further development and new dimension of modern biotechnology that combines science, technology and engineering to facilitate and accelerate the understanding, design, redesign, manufacture and/or modification of genetic materials, living organisms and biological systems”.The special group of experts thus inherited in 2022 a list drawn up in 2022 after multiple rounds of peer review by CBD and observers7 of 17 cases to be filled in as examples of the use of “synthetic biology”8. This list includes many of the GMOs or products obtained from GMOs that Inf'OGM recently reported on. These include “self-spreading vaccines for wildlife”, consisting of viruses genetically modified to reproduce in their hosts but with lower virulence; “self-limiting insect systems”, for insects modified by transgenesis (or new techniques of genetic modification) to be sterile; and “gene drives to control vector-borne diseases and invasive species”. Are also listed the “engineered bacteria for nitrogen-fixation and fertilizers”, plants genetically modified by new techniques (GMOs/NTGs), projects to modify the soil microbial population (microbiome), RNA interference to transiently modify agricultural plants, the development of “novel delivery systems and chemistries to modify organisms in the field or in nature”...Other fields are emerging because of the security and wider issues they directly raise. It has been identified that the synthetic biology approach is also being used to “recreate viruses by chemical DNA synthesis”, which obviously raises questions in terms of possible bioterrorism. As for “artificial intelligence and machine learning”, the international experts believe that this will “inform the engineering or creation of synthetic biology organisms, components and products”. But they underline that these tools are progressing faster, almost too fast, for experts to assess the associated risks and monitor them...GMO plants developed by synthetic biology...In 2018, the European Commission mandated its EFSA experts to obtain reports on synthetic biology in plants and micro-organisms fields. In this mandate, the European Commission recalled that it had listed six types of development using synthetic biology: “Genetic part libraries and methods; Minimal cells and designer chassis; Protocells and artificial cells; Xenobiology: DNA synthesis and genome editing […] Citizen science (Do- It-Yourself biology)9”.As a result, 27 cases of plants obtained by synthetic biology were identified and given as examples (see table 1 below for some of them). The EFSA listed plants genetically modified to have an optimised oil composition, to express bacterial genetic sequences to improve photosynthesis, resistance to abiotic stresses, such as salt, drought or heat tolerance... A genetic modification of wild tomato was also identified (the EFSA speaks of “de novo domestication”). It consists of a wild tomato species modified by new genomic techniques to increase yields and productivity. Other works on non-wild tomatoes has been identified, such as these aiming at modifying their nutritional value or making them produce pyrethrin insecticide molecules.PlantsCharacteristicsGenetic modificationPotatoDrought toleranceInsertion of a genetic sequence by transgenesisTomatoHigher yields and productivity of wild tomatoesSix mutations (nucleotides insertion/deletion type) via Crispr/Cas9 expressed by transient transgenesisProduction of insecticidal pyrethrineInsertion of three genetic sequences by transgenesisSugarcanneLowering lignin content and increasing simple sugar production for agrifuels productionDeletion of 107 genetic sequences via TALEN expressed by transient transgenesisBananaResistance to pathogen SigatokaInsertion of two genetic sequences by transgenesisCamelineModification of oil and fatty acid compositionInsertion of 5 to 7 genetic sequences by transgenesisTable 1: Examples of GMO plants considered as obtained by synthetic biologyRegarding prospects for commercialization, the EFSA notes that “only few of these projects are sufficiently advanced so that they can be considered as likely to lead to market releases in the near future”. For the EFSA, the future GMO plants derived from synthetic biology that are likely to reach the European market in the coming decade will most probably be obtained by “existing technologies including the insertion of transgenes and genome editing”.... and GMO micro-organisms tooWith regard to microorganisms obtained by synthetic biology, the EFSA has reached the same conclusion as for plants: they are GMOs10. An important observation is nevertheless added for these GMO micro-organisms (GMMs), namely that genetic modifications can “range from being very similar to the ones from GM technology assessed so far or can go (far) beyond with unfamiliar characteristics at the genotypic or phenotypic level, such as in the case of xenobionts”, organisms to which we will come back below.For its work on GMMs, the EFSA has also carried out an horizon scan. As a preamble, this review is announced as incomplete. The EFSA notes that microorganisms genetically modified by synthetic biology to produce organisms for medical purposes were not included. Such micro-organisms constituted “a significant number of publications found [...]. Details revealed that these microorganisms were designed for medical use (e.g. vaccination)”. As the mandate received by EFSA concerned agri-food uses, it did not address this issue. In the end, eleven cases of GMMs obtained by synthetic biology were identified. Of these eleven cases, EFSA gives four as examples, summarized in the table below.Micro-organismesCharacteristicsGenetic modificationCitrus tristeza virusResistance to a pathogen (bacteria)Insertion in the viral genome by transgenesis of three genetic sequences coding a spinach protein with anti-bacteria action by transgenesisBacteria Klebsiella oxytocaFixing atmospheric nitrogen in the soilDeletion of “non coding” DNA, of « non essential » and “regulating” genetic sequencesReorganisation, via “coding” DNA chemical synthesis, of the “essential” sequences and regulating factorsYeast Saccharomyces cerevisiaeProduction of raspberry’s ketone during beer fermentationInsertion of four genetic sequences (fused or not) by transgenesisBacteria (xenobionts)Different, depending on the modificationsGenetic modification to induce the production of protein inexistent in nature with non-natural synthetic amino acid (building bricks pf protein). Production of bacteria with a six-nucleotides DNA instead of four : the four natural nucleotides and two synthetic ones, inexistent in nature.Table 2: Examples of GMO micro-organisms considered as obtained by synthetic biologyThe case of “xenobionts”, on which Inf'OGM has already focused (In french), is very special. Xenobionts are non-natural organisms in the sense that they are not found in nature, since their genome or proteins contain, in addition to natural basic elements, elements derived from biochemical synthesis. The EFSA describes them as organisms “made up of non-natural products”. The idea is to produce micro-organisms with a xenoDNA molecule or xenoproteins composed of non-natural synthetic building blocks, in addition to natural ones.In terms of potential commercial use, the field is open: European experts note that “xeno-proteins acting as enzymes, therapeutic agents, toxins or with other activities could have a substantial potential for medical applications, industrial biotechnology or environmental engineering”. For their part, xenoDNAs are seen as potential “biocontainment or a genetic firewall”, since xenobacteria producing xenoproteins or having a genome composed of xenoDNAs can only multiply if the non-natural building blocks are provided in the environment in which they are found.Why all this talk about synthetic biology?Reading the preparatory documents for CBD meetings or the reports of the EFSA, leads to drawing conclusions that organisms obtained by synthetic biology are GMOs. The question remains though for the products obtained from such organisms as the international framework of the CBD concerns the living modified organisms. Some products obtained from GMOs such as RNA sprays (when produced from genetically modified cells/micro-organisms) may indeed not be considered organisms at all, or even non-living or non-autonomously reproducing organisms such as viruses. In Europe, such a question is theoricaly inexistant as products obtained from GMOs are covered by the UE legislation on GMOs.In the field of biotechnology and GMOs in particular, the industry is usually keen on trying to restrict the scope of a legislation to certain products in order to access the market with its “new products”. It’s been the strategy followed in Europe with the change of semantic aiming at calling GMO plants obtained by new techniques as “NGTs”. The first move from the industry in the CBD was therefore to refuse talking about Synthetic Biology as it considered it should not be under the scope of the CBD. Such a move was finally countered by civil society organisations which succeeded in making Synthetic Biology an issue to be discussed. Years after, iIt now remains to see how talks will move on... Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [148] => Array ( [objectID] => 8278 [title] => GMO viruses as laboratory tools to be spread in the environment ? [timestamp] => 1716336000 [date] => 22/05/2024 [annee] => 2024 [url] => https://infogm.org/en/gmo-viruses-as-laboratory-tools-to-be-spread-in-the-environment/ [image] => https://infogm.org/wp-content/uploads/2024/04/P35_structure_by_Fisher_1999_PDB_1P35.jpg [extrait] => In a recent article, researchers detail several ongoing projects for the genetic modification of viruses. Some of these could be deliberately released into the environment. On February 7, 2024, the European Parliament asked the European Commission to study the potential deregulation of these GMO viruses. A general overview of those projects seems therefore necessary. [chapo] => In a recent article, researchers detail several ongoing projects for the genetic modification of viruses. Some of these could be deliberately released into the environment. On February 7, 2024, the European Parliament asked the European Commission to study the potential deregulation of these GMO viruses. A general overview of those projects seems therefore necessary. [texte] => Like plants, bacteria, yeast and animals, viruses are also subject to genetic modification. As evidenced by a recently published article1, research and development projects involving GMO viruses are taking shape. While there are obvious questions about health, environmental and even bioterrorism risks, an initial overview of current projects is needed to gain a better understanding of the domain. Especially as, in the coming months, the European Union may find itself discussing the complete deregulation of GMO micro-organisms, including viruses.Use of genetically modified viruses: what are we talking about?Right at the start of their article, the researchers, who work for the Austrian Ministry of the Environment and the German Federal Agency for Nature Conservation, set the scene : « the spectrum of possible use scenarios for GM viruses is very broad » ! Indeed, the type and objectives of possible genetic modifications are extremely varied. Viruses can be genetically modified to :modify one or more of their characteristics (e.g. attenuate virulence),modify the organisms they infect, without these organisms being directly genetically modified (by stopping the expression of a protein, for example),or to induce genetic modifications in infected organisms (by providing the genetic sequences encoding a Crispr/Cas system, for example).GM viruses used as laboratory toolsThe first use identified by researchers is the use of viruses as laboratory tools. Certain viruses are used to silence the expression of genetic sequences in organisms (notably tomato, tobacco, pepper or Arabidopsis). The general principle is to use GMO viruses to introduce genetic sequences from the same plant's genome into a plant. This sequence is then expressed in "higher" quantities. In response, the plant switches off the expression of this sequence. Researchers can then study the effects of not expressing a particular plant genetic sequence.GM virus used as vaccinesConversely, rather than silencing protein expression, some viruses are genetically modified to express different proteins or protein parts. The authors detail that the desired proteins - transgenic by definition - can be subunits, parts of vaccines, protein nanoparticles and "virus-like" particles. Commercial applications are already envisaged. One example is a baculovirus genetically modified to express a protein from a virus infecting carp. This transgenic baculovirus will be used to infect insect cells grown in vitro. These cells will in turn express the carp-infecting virus protein. The fish will then be fed with the insect cells in the hope of inducing a preventive immune response. In this case, the virus is not the vaccine, but a tool to hopefully produce a protein that will induce a vaccine response.Finally, the authors report "various vaccine types for a wide range of animal species". Projects include GM viruses for direct use as vaccines in poultry, fish, pigs, cattle and industrially farmed fish, but also in wild populations. They also report having identified a number of vaccine projects using GM viruses for dogs, cats, sheep and rabbits. There is also a project to vaccinate a wild animal, the Steller sea lion, and another to vaccinate African rodents against Lhasa fever.Some of these projects may involve dissemination in the environment itself. Some vaccines, for example, consist of viruses genetically modified to have a lower replication rate, giving the immune system time to react before the virus multiplies too much. Others are used as vaccines, but still have the capacity to replicate. The researchers state that such vaccines are used "to prevent or treat zoonotic diseases".Viruses to modify other organismsAnother use of GMO viruses put forward by researchers is, this time, the one as a tool inducing genetic modifications. To this end, viruses can be used as vectors to enable the expression of "larger-sized recombinant constructs", which will cause genetic modifications. By way of example, researchers are talking about a "hypercompact CRISPR-Cas nuclease" for use in gene therapy. The idea is to have an adenovirus (widely used as a vector, i.e. a transporter, in this field) express a miniature Crispr system that fits into the small adenovirus genome. To be effective in eukaryotic cells (the type of cells found in animals and plants), the genetic sequences of the Crispr system are also genetically modified.To sum up, viruses are genetically modified to cause infected human cells to express a modified Crispr/Cas complex, which in turn modifies the genome of the infected cells.The authors of the paper also give the example of viruses that are genetically modified to express not the complete Crispr system, but "only" the RNA that serves as a guide for a Crispr/Cas system. These GM viruses then infect plants that have previously been genetically modified by transgenesis to express a Cas9 nuclease. The nuclease expressed by the transgenic plant will then use the guide RNA provided by the virus to genetically modify the plant so that it has "heritable mutations", i.e. mutations that will be passed on to subsequent generations.GM Viruses as “biocontrol agent”"Only a few publications addressing the use of GM viruses against plant pathogens" have been found by the researchers. An example is given for citrus trees. Based on the strategy of silencing the expression of a genetic sequence, researchers are infecting citrus trees with viruses genetically modified to change certain visual, olfactory or gustatory signals. This is said to attract the Asian citrus psyllid, a sap-sucking insect that attacks citrus trees by transferring a bacteria responsible for Huanglongbing disease. Having attracted the insects, these trees would act as insect traps, making it easier to remove the insects using insecticides or other means.Faced with the same disease affecting different citrus fruits (lemons and oranges, for example), researchers in the USA have been testing the use of genetically modified viruses since 2020. These viruses are genetically modified to express a small spinach protein with antimicrobial properties.Some projects, described as biocontrol for biotechnological control, aim to "control [...] agricultural insect pests" using GMO viruses. Such viruses could be used as insecticides. One example given concerns the development of Chilo iridescent viruses genetically modified to be transformed into "a more potent control agent by the insertion of a toxin gene". In the reported study, the toxin chosen, and expressed by the GMO virus, targets Galleria mellonella moth larvae. In 2015, a scientific article reported on GMO baculoviruses used as insecticides2. These viruses are genetically modified to produce various insecticide molecules, such as neurotoxins or degradation enzymes.Work using genetically modified viruses to infect bacteria (such viruses are called bacteriophages) have also been identified. GM bacteriophage virus projects are envisaged to modify the specificity of viruses for a host, to carry antimicrobial substances, in human and veterinary therapy as well as for industrial uses. Among the approaches envisaged, the researchers report on a proposal by researchers at the University of Wagenigen (Netherlands) to genetically modify bacteriophages so that they "to protect or cure crop and horticultural plants (e.g., olive trees and vine) against a bacterial plant pathogen, Xylella fastidiosa".In their bibliography, the researchers also cross-referenced approaches of animal population control using GM viruses. These strategies involve "immunocontraception", i.e. inducing an immune response that prevents either gamete production, fertilization by another gamete, or embryo development. Although pre-studies have been carried out to target rodents, rabbits, toads and carp in Australia, several problems linked to dissemination in the environment have arisen: "insufficient duration of sterility [...] ineffective transmission of the viral vector". The researchers point out that these approaches using GM viruses have since been abandoned.The range of uses for genetically modified viruses is therefore quite broad. From laboratory tools, these GM viruses are now used or can be used in human health (gene therapy) or animal health (vaccination, population control...). Tomorrow, their use in agriculture, with dissemination into the environment, could become a reality. A reality that would be all the more rapid if the European legislator were to decide that such releases of viruses (like those of GM bacteria or yeast) can take place without any regulatory framework... Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [149] => Array ( [objectID] => 8243 [title] => Novonesis, a new Danish industrial giant promoting “biosolutions”? [timestamp] => 1715731200 [date] => 15/05/2024 [annee] => 2024 [url] => https://infogm.org/en/novonesis-a-new-danish-industrial-giant-promoting-biosolutions/ [image] => https://infogm.org/wp-content/uploads/2024/04/5652689601_ab2e795cd6_c-768x576.jpg [extrait] => In January 2024, two Danish industrial giants of the microorganisms merged and Novonesis was born. This company sells “biosolutions” for all industrial and agricultural areas. “Bio” for biotechnological… and not biological, as it prefers to emphasize. This company uses microorganisms, often genetically modified, to make them produce enzymes. [chapo] => In January 2024, two Danish industrial giants of the microorganisms merged and Novonesis was born. This company sells “biosolutions” for all industrial and agricultural areas. “Bio” for biotechnological… and not biological, as it prefers to emphasize. This company uses microorganisms, often genetically modified, to make them produce enzymes. [texte] => A new agri-food industrial giant was born in January 2024 in Denmark: Novonesis1, resulting from the merger of the companies Novozymes2 and Chr. Hansen. This new entity will have an annual turnover currently estimated at 3.7 billion euros3. Its commercial playground? Products promoted as “biosolutions”… with the motto “the time for biological solutions is now”.When microorganisms become “biosolutions”By “biosolutions”, Novonesis refers to the use of microorganisms for the production of various molecules. The biosolution is therefore sold as an alternative to synthetic chemistry. “Bio”, quite simply because this “chemistry” uses living organisms to produce the molecules that synthetic chemistry constructed from scratch.In a short video, Novonesis explains that “tiny and powerful microorganisms are everywhere, transforming our world with their enzymes”. Novonesis intends to study them, to “improve” them, notably through genetic modifications, to use the potential of “these microscopic transformers”. Thanks to them, the company claims to solve everyday problems and, beyond that, “transform the way we produce and consume”.Several “biosolutions” are then highlighted. Novonesis claims that 80% of wasted yogurt is due to a short shelf life. To increase this duration by seven days, the company discovered “the ability of the good bacteria to absorb a specific nutrient in fermented milk that yeast and mold need to grow. […] By reducing the levels of manganese in the food product, the good bacteria effectively delay spoilage and thereby help improve quality and shelf life”4.Similarly, Novonesis claims to increase the durability of clothing by using enzymes produced by a bacteria that lives on the surface of algae. This enzyme, manufactured in their laboratory, is then integrated into detergents… so that it destroys “the sticky and odorous layer on our clothes”. The list of everything that microorganisms can produce in fermenters is very long.If the production mode of synthetic chemistry and that of GM microorganisms (MGM) are different, the purpose is the same: to manufacture medicines (prebiotics, probiotics), fertilizers, pesticides, food additives (vitamins, enzymes ), agrofuels (which they call “biofuels” or “biodiesel”) and many industrial products, such as solvents, detergents, “bioplastics”, etc. In agriculture, “biosolutions” are mainly of two types: the “control” of pathogenic organisms, called biocontrol (including biopesticides, see our article on MicroPep) and stimulants (including “biofertilizers”).Are biosolutions a “natural preparation of low concern”?The problem is that these words are catch-alls… However, in the field of “biosolutions”, there are two completely different paths. We have, on the one hand, the natural preparation of low concern (french expression for “préparation naturelle peu préoccupante”, PNPP), free of rights, reproducible on the farm (nettle or comfrey liquid manures, etc.) and, on the other, the molecules developed by industry, patented and whose recipes are carefully guarded. The professional Union of companies working in the field of biostimulant (Afaïa in French), whose current general delegate is a former Monsanto breeder, emphasizes that “for fertilizers made from natural substances […], these procedures must be simplified […] to open access more easily to innovative products”.Does this union defend positions close to those of Aspro-PNPP, which is fighting for the recognition of the PNPP? Not at all. Afaïa finds regrettable the confusion between biostimulant and PNPP and, unlike Aspro-PNPP, claims that biostimulants can be microorganisms, natural substances or of natural origin (humic acids, amino acids, algae extracts or plants) or synthetic substances. Aspro-PNPP and the Confédération Paysanne (peasants French Union) succeeded in obtaining specific legislation for PNPP. PNPP “are a category of plant protection products whose status has continued to evolve since their creation and […] defined by article L.253-1 of the rural code, modified by article key 50 of the law for the future of agriculture”5.PNPP are made up of two categories. First, basic substances, that is to say substances not initially developed for use in plant protection but which may have an interest for it (foodstuffs, etc.) which have no negative impact on human health or the environment. These substances are a category of plant protection products distinct from phytosanitary products. Second, natural substances for biostimulant use (in French SNUB) (fertilizing materials): at present, the list only includes medicinal plants sold freely, such as nettle. Afaïa has fought and continues to fight against separate regulations and prefers to put everything in the same bag, in order to consciously organize confusion. Moreover, Afaïa affirms that what is reproducible on the farm, what is “derived from ancestral empirical techniques and [the preparations which] are obtained by a process accessible to all” is a distortion of competition in the face of what is is “from industrial and controlled manufacturing, not reproducible for an individual”. The use of PNPP implies an evolution towards agroecology, while “industrial biocontrol” makes it possible to not change the mode of production and to go on with the current agricultural model.This dichotomy has been found since the beginning of modern biotechnology which, to establish its authority and legitimacy, conflates it with “ancestral biotechnologies”… but claims that the difference is in the control of the living, in its understanding and also its purity. Explanation: humans have developed many culinary practices based on fermentation. Beer, wine, bread, cheese, yogurt, kefir, kombucha, tempeh, etc. are foods resulting from the transformation of ingredients by microorganisms (yeasts, bacteria, etc.). Companies such as Novonesis, when talking about modern biotechnologies and biosolutions, want to walk in the footsteps of these ancestral techniques. They use the properties of life to produce molecules and enzymes. But there is a clear epistemological break between these two practices: in one case we use the entire living organism, in the other, we isolate the active agents and operate in an artificial environment.Links between chemical, oil and microorganism companiesLinks between the chemical and oil industry and the microorganism industry exist. Thus, the new CEO of Novonesis, Ester Baiget, was president of Dow Industrial Solutions0. In this capacity, she fullfilled lobbying functions within the EPCA (The European PetroChemical Association) as vice-president of this structure.Among competitors, we also find such links. Thus, Mike Herr is both a director at EOG Ressources and at Kerry Group, an Irish multinational in the agri-food sector (dairy products, flavor enhancers, food additives, etc.), whose subsidiary Kerry Bioscience develops GMMs and which recovered the “lactase” part of Novozyme and Chr. Hansen. (see the second box). However, EOG Resources specializes in the exploration and production of natural gas and crude oil.GMO biosolutions soon to be deregulated?Biosolutions can be produced from genetically modified microorganisms. As they are promoted as making it possible to reduce synthetic pesticides, greenhouse gas emissions, improve yields, etc. it is logical that these biosolutions are encouraged. However, for these companies, current regulations on GMOs are an obstacle to the development of sustainable biosolutions.The merger of two leading Danish companies in the field of microorganisms is far from trivial in the current context of the proposed deregulation of GMOs. Indeed, Novozymes or Chr. Hansen have been developing GMMs for several years. From 2022, certain companies have requested that the deregulation envisaged for GMO/NTG plants also be declined for micro-organisms. Letters written by several lobbies, such as EuropaBio, the Association of Manufacturers and Formulators of Enzymatic Products (Amfep) or the EU Association of Specialty Feed Ingredients and their Mixtures (Fefana, Fédération Européenne des Fabricants d’Adjuvants pour la Nutrition Animal,) and, more recently, Euroseeds stipulate that “knowledge about micro-organisms [be] recognized and taken into consideration when policy actions for NTG-derived plants are developed”.However, Novozymes and DSM-Firmenic are companies active in these lobbying organizations, since they are members of EuropaBio, Fefana and Amfep. Likewise, Chr. Hansen and Kerry Group are members of Fefana and Amfep.From 2020, in an article published in the Danish newspaper Altinget6, several Novozymes managers explicitly called for deregulation of all GMOs. “Current GMO regulations in the EU are an obstacle to progress”, writes the CEO and director of research of Novozymes. “The challenge in the EU is regulation of GMOs based on the logic of an era when technical breakthroughs were several years apart”, adds the executive vice president and director of research at Novozymes.These officials then thank the Danish government which, they specify, “wishes to take the lead in the green transition. This is good for Denmark’s international role, for growth through jobs and exports, while reducing the impact on nature and resources”. For them, GMOs, and in particular GMM, are excellent tools for a carbon-free, sustainable and ecological world. However, current regulations prevent these companies from offering “sustainable solutions” because, they insist, “the major challenges in terms of agriculture, food, resource consumption, pollution and CO2 emissions do not can only be solved using new technologies". And to continue: Crispr and “genome editing techniques”, used in microorganisms, allow us “to optimize culture conditions, reduce stress, gradually eliminate chemicals and promote health".The European Commission accepts the merger in its almost entiretyThis new economic entity, Novonesis, has been approved by the European Union's DG for Competition in 2023. The only thing that the European Commission noted was the concentration in the production of lactase. She writes in her opinion published in December 2023: “The Commission's investigation showed that the merger, as initially notified, would have reduced competition in the market for the manufacture of one specific enzyme, lactase, using genetic modification technology.[…] The Commission also found that post-merger there would not be sufficient potential competitors to exert sufficient competitive pressure on the merged entity”. Thus, to resolve the competition problems raised by the Commission, the parties proposed to sell their activities:the project of Chr. Hansen to enter the lactase manufacturing market;the lactase distribution activity of Chr. Hansen;the Novozymes lactase production plant.The “lactase” sector was sold to Kerry Biosience, a subsidiary of Kerry Group. However, among the companies present on the lactase market, we find DSM (recently DSM-Firmenich). And Novozymes established “an economic alliance” in 2021. As for the rest, notably Research & Development, the Commission writes: “after an in-depth examination and benchmarking, the Commission has established that the competitors of the merged entity have a equivalent capacity to invest in R&D and that the parties do not have specific R&D capabilities that their rivals could not otherwise access".A speech heard over and over since the ruling of the Court of Justice of the European Union, in July 2018, when it affirmed that GMOs derived from techniques with no history of safe use must be regulated according to the principles of Directive 2001/18. A speech which seeks to prepare minds for a possible extension of the deregulation of GMO plants to micro-organisms as already formulated by the European Parliament on February 7, 2024. A project which move forward when Denmark takes over the Presidency of the EU on July 1, 2025… Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [150] => Array ( [objectID] => 8187 [title] => Fungicide and herbicide micropeptides on Europe’s doorstep? [timestamp] => 1714953600 [date] => 06/05/2024 [annee] => 2024 [url] => https://infogm.org/en/fungicide-and-herbicide-micropeptides-on-europes-doorstep/ [image] => https://infogm.org/wp-content/uploads/2024/04/7154557756_aab638c497_c-768x633.jpg [extrait] => Toulouse-based Micropep Technologies has just had one of its fungicidal micropeptides approved in the United States. The technology, developed and patented by this CNRS spin-off, is aiming for European approval by 2030. However, these micropeptides are raising questions about their potential impact on ecosystems. [chapo] => Toulouse-based Micropep Technologies has just had one of its fungicidal micropeptides approved in the United States. The technology, developed and patented by this CNRS spin-off, is aiming for European approval by 2030. However, these micropeptides are raising questions about their potential impact on ecosystems. [texte] => "We are on a mission to build a more sustainable agriculture for future generations". This is the vision of Micropep Technologies, a Toulouse-based company spun out of CNRS, which has raised around €23 million since 2016 to develop micro-proteins called micropetides (miPEPs). On the strength of its first approval in the United States for what it calls a "biofungicide", it is aiming to enter the European market within 5 to 6 years. However, this technology raises major environmental issues and will have to comply with current European regulations.The “miPEPs” technology Micropep Technologies published its original research results in the journal Nature in 20151. Technically, these miPEPs are micro-proteins, small chains made up of 10 to 30 amino acids. They are distinct from proteins, which are also made up of amino acids, but are longer. Micropep is mainly interested in the fungicidal and herbicidal properties of these molecules, but is also developing miPEPs to selectively inhibit the growth and overcome the resistance of weeds to conventional treatments. In particular, the Toulouse-based biotech company is testing molecules against Palmer amaranth in North America, a weed that has become resistant to glyphosate (due to the excessive use of Roundup on GMOs), and field vulpine in Europe2. The miPEPs are involved in a range of biological processes, including the regulation of gene expression, the control of enzyme activity and cell signalling. Laurent Thomas, CEO and co-founder of the company, explains: "The miPEPs control the microRNAs that play an essential role in plant development. Some control microRNAs involved in fixing atmospheric nitrogen, while others are involved in the immune response. We can apply miPEPs directly to a plant and stimulate the expression of the corresponding microRNAs to help or protect the plants"3. According to the company, miPEPs, sprayed directly onto fields, would improve plant resilience to environmental stresses, enhance growth and development, and increase crop productivity.The miPEPs are developed using a patented platform based on IT tools. This system identifies potential miPEP sequences, and algorithms are used to select and rank candidate molecules according to a set of criteria predefined by the company. A few hundred candidates are then tested in internal efficacy trials. The selected miPEPs are then manufactured by chemical synthesis and studied to test their cell penetration properties to reach their target when sprayed on leaves or deposited in the soil.Micropeptides to “save the planet”Micropep Technologies' communication combines technological promise with environmental promise. Its miPEPs are said to be a less toxic and more targeted alternative for combating crop diseases, such as fungi and bacteria that thrive in field crops. The Toulouse-based company claims that its miPEPs are "safe, effective and sustainable natural solutions to help adapt our farming systems to the impact of climate change and save our planet... the next generation of sustainable crop protection and crop stimulation tools that farmers are looking for". A communication full of promise, on behalf of all farmers. Yet many farmers are questioning or even refusing to use patented products in their fields.Micropep entered the commercial phase in 2022, targeting the US market. With success, since its fungicide targeting, among other things, soybean rust and mildew, was classified as a "biochemical active ingredient" (MPD-01) by the EPA (Environmental Protection Agency) in February 2024. This approval gives it access to a simplified US regulatory route to registration by 2026, after further crop trials. The Toulouse-based company is also targeting the European market, where it will also have to follow a regulatory authorisation procedure.The European market: between regulations and environmental risksProducts must be marketed or even introduced into the European Union (EU) in compliance with the law. Among other things, this involves guaranteeing that they are harmless to the environment and to consumers, as well as being effective. There are a number of legal instruments that could affect miPEPs, such as the Regulation on plant protection products (no. 1107/2009), the Reach Regulation on the protection of human health and the environment against the risks related to chemical substances (no. 1007/2006) or the Directive on biocidal substances (no. 528/2012).Above all, according to MicroPep, these micropeptides are produced by bacteria. Therefore, while these micropeptides are not GMOs as such (they are not organisms), they are products of GMOs, genetically modified micro-organisms (GMMs) to be precise. They will therefore necessarily be subject to the requirements of European legislation on GMO micro-organisms.Although Micropep promotes its miPEPs as a 'safer and more sustainable' solution, their potential long-term impact on ecosystems is open to question. Because it is recent, this technology may lack data on the evolution of miPEPs, including their environmental degradation, their potential bioaccumulation, their effects on biodiversity, particularly on non-target organisms, etc.Asked to comment on these issues, the director of Micropep said: "It is necessary to obtain marketing authorisations in order to market products. That's where the problem lies: European regulations take twice as long as American regulations". Thomas Laurent goes on to praise the "pragmatic" spirit of the United States: "As long as they are new technologies,... that have environmental benefits compared to conventional chemistry,... as long as they are of natural origin, they are exempt from additional studies to demonstrate the environmental benefits. This is not always the case in Europe. Nevertheless, there has been some positive progress in Europe, where a project to redefine the term biocontrol is under way, and good progress has been made" 4. With regard to the redefinition of "biocontrol", the European Commission says it wants to better integrate sustainable practices and respond to environmental issues, in particular by funding research projects on "nature-based" solutions, such as macro- or micro-organisms, biopesticides, etc.5Patented "natural" micropeptides For some years now, the biotechnology sector has been trying to force through the idea that some of the molecules it develops are "close to nature", "conventional", or even "natural" or "biological". Examples include interfering RNA (iRNA)6 or GMOs/NTGs. Micropep adopts the same language, while emphasising, through the voice of its Managing Director, the potential profusion of miPEPs: "This is a new Eldorado of innovative active substances of natural origin, which have the property of degrading in the soil".However, the miPEPs technology is covered by patent rights in the United States and Europe. These cover the use of micropeptides to "promote plant growth" or "modulate gene expression". Some patents have been granted since Inf'OGM reported on these rights in 20187. The claims define, in particular, methods for detecting micropeptides, their use in a composition comprising a plant protection agent and, in the case of a US patent, compositions comprising micropeptides at specific concentrations. Although these patents do not explicitly cover natural micropeptides as such, the claims nevertheless cover the use of potentially natural micropeptides in particular applications. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [151] => Array ( [objectID] => 8065 [title] => “Essentially biological process”, a definition shaken up [timestamp] => 1713744000 [date] => 22/04/2024 [annee] => 2024 [url] => https://infogm.org/en/the-definition-of-essentially-biological-process-a-definition-shaken-up/ [image] => https://infogm.org/wp-content/uploads/2024/04/Juliie-Gon-Namestie-768x768.jpg [extrait] => During the parliamentary work on the proposal for a European regulation on plant reproductive material, known as the "seeds regulation", a question arose: should so-called "non-targeted mutagenesis" be considered as an "essentially biological process"? As these processes are excluded from patentability, the question may seem important. But such a decision would not be without consequences for the regulation of GMOs. [chapo] => During the parliamentary work on the proposal for a European regulation on plant reproductive material, known as the “seeds regulation“, a question arose: should so-called “non-targeted mutagenesis” be considered as an “essentially biological process“? As these processes are excluded from patentability, the question may seem important. But such a decision would not be without consequences for the regulation of GMOs. [texte] => On 24 April 2024, the European Parliament will vote in plenary on the European Commission's proposal to regulate the production and marketing of plant reproductive material (PRM), known as the "seeds regulation". The Parliament's Agriculture Committee, the lead committee on this dossier, will present its text with the amendments adopted on 19 March. In accordance with the procedure, initial proposals for amendments to the Commission's text were submitted in advance to the Environment Committee. These included a proposal tabled by Austrian MEP Sarah Wiener (Greens) to amend the definition of "essentially biological process" to include, in particular, "non-targeted" mutagenesis1. Although this amendment was not adopted in the end, it merits a brief analysis.Broadening the definition of "essentially biological process".According to Article 4 of European Directive 98/44 on biotechnological inventions, "essentially biological processes for the production of plants or animals" are not patentable. Article 2 of the same directive states that "a process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection".The amendment proposed by the Austrian Green MEP consisted of including so-called "non-targeted" mutagenesis techniques in the definition of "essentially biological process" (EBP). The aim was to prevent a possible interpretation of Article 2 that would limit the definition of non-patentable "natural phenomena" to crossing and selection. Although this amendment was not adopted, it could theoretically be re-submitted, worded in the same way or differently, at the plenary vote on 24 April, or at a later date in the context of new legislative initiatives.Taking the judicial debate to the political levelConsidering that "conventional" breeding includes so-called "non-targeted" mutagenesis is in fact a position that has been defended for several years by certain NGOs, such as the coalition No Patent on Seeds. It is also the position of the Austrian government, which incorporated it into its legislation in May 2023. The current European legislative procedure aimed at adopting a new regulatory framework for plant reproductive material was seized by the MEP as an opportunity to include in the definition of essentially biological processes the mutagenesis techniques often described as "random" (a vague notion not defined by law). Her proposed amendment brings into the political arena of parliamentary debate a request that is regularly rejected by the courts, in the name of the rules of the European Patent Office (EPO), for which all mutagenesis techniques constitute technical processes, not natural phenomena, and are therefore patentable. This new definition of EBP, if adopted, would de facto extend the exclusion from patentability to all mutagenesis techniques described as random, even though the most recent of them are in fact reproducible and therefore patentable2. This, at least, is the wish of some opponents of these patents: that plant products obtained through non-targeted mutagenesis, such as most varieties made tolerant to herbicides, should no longer be patentable.A boomerang effect? The consequences of this reasoning on the application of other legal texts in force, such as European Directive 2001/18, cannot be ignored. In the case of GMOs, Directive 2001/18 on the deliberate release into the environment of GMOs establishes that mutagenesis techniques are all techniques of genetic modification resulting in GMOs. In this sense, they are not conventional selection techniques, described as "essentially biological processes" or "natural phenomena" in the language of patent law. It is true that mutagenesis techniques "mainly developed before 2001" produce GMOs that are exempt from the application of GMO regulations. However, this is not the case for so-called random (i.e. non-targeted) chemical or physical mutagenesis techniques applied in vitro to plant cells. These techniques remain subject to GMO regulations. These techniques, like transgenesis, only began to be developed shortly before 20013.This clarification of exempted and non-exempted GMOs was obtained from the Court of Justice of the European Union (CJEU), after French organisations brought an action against the French government, the Fédération française des producteurs d'oléoprotéagineux (FOP) and the European Commission. The latter considered the techniques of "random in vitro mutagenesis consisting of subjecting plant cells to chemical or physical mutagenic agents" to be "conventional" breeding techniques excluded from the scope of the GMO regulations. For Guy Kastler, who represented the Confédération Paysanne, which is just as opposed to GMOs as it is to any patent on living organisms, "this legal victory has prevented the European Commission from exempting "new GMOs" from the application of GMO regulation 2001/18, and has forced it to propose new GMO-NGT regulations, which it has still not succeeded in having adopted, primarily because of the risks of abusive application of patent law that it could generate".By seeking a broad definition of "essentially biological processes", including mutagenesis, which she describes as "non-targeted", Sarah Wiener has created a problem that could run counter to this case law. The aim of extending the scope of exclusion from patentability is certainly laudable, but doing so in this way could lead to techniques of "random in vitro mutagenesis consisting of subjecting plant cells to chemical or physical mutagenic agents" being considered as "natural" (and therefore excluded from the scope of the GMO regulations). These techniques produce among other things the varieties made tolerant to herbicides at the root of the CJEU ruling that prevented the European Commission from also excluding all "new GMOs" from GMO regulation.Amendment or smoke and mirrors?This objective could also be legally complicated to achieve. Only the European Commission has the right of initiative, which is then subject to a vote by Parliament and the Council. However, the Commission has submitted a proposal to the Parliament concerning the marketing of PRM and not the intellectual property of plants, a subject on which it has announced the publication of a study in 2026. Parliament can formally request that the Commission publish this study, which is a prerequisite for any new initiative, as early as 2025. It has done so. But it cannot take this initiative itself. What's more, the European Union alone cannot change the rules on patentability without amending the directives of the EPO, which is an independent institution that also includes non-EU countries. These directives are well established with regard to crossing and selection processes. They consider the latter to be patentable if they "include within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced". This includes all mutagenesis techniques, which cannot be changed at the snap of a finger.Finally, doesn't this proposal to amend the definition of "essentially biological process" also raise an ethical question? Doesn't describing these mutagenesis techniques as "essentially biological processes" contribute to trivialising these methods of genetic modification? [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [152] => Array ( [objectID] => 7866 [title] => 2024, a year of vigilance on the GMO file [timestamp] => 1712707200 [date] => 10/04/2024 [annee] => 2024 [url] => https://infogm.org/en/2024-a-year-of-vigilance-on-the-gmo-file/ [image] => https://infogm.org/wp-content/uploads/2026/01/INFOGM_logo-768x409.jpeg [extrait] => The European Commission's proposal to deregulate GMOs made in 2023 will not have come to an end before the European elections, as its promoters had hoped. However, beside the fact that this proposal is not the only file concerning GMOs, the forthcoming period of suspension of European parliamentary work could be used for bilateral discussions. [chapo] => The European Commission’s proposal to deregulate GMOs made in 2023 will not have come to an end before the European elections, as its promoters had hoped. However, beside the fact that this proposal is not the only file concerning GMOs, the forthcoming period of suspension of European parliamentary work could be used for bilateral discussions. [texte] => Neither Spain or Belgium, which have successively held its presidency, have managed to secure a mandate from the EU Council to negotiate with the European Parliament on the proposed deregulation of GMOs. A recent briefing requested by Spain at the Council of Agriculture Ministers on Tuesday, March 26, 2024, did not make a difference. With MEP elections scheduled for June 2024, the planned trilogue between the two bodies and the European Commission may not get underway immediately.A new European Parliament at workThe 720 MEPs elected in June will find on their table a version of the deregulation proposal - a shaky one - already amended by their predecessors on February the 7th. The elected MEPs are expected to get to work after having formed their political groups, elected their chairmen, vice-chairmen and committee representatives, and after having validated the candidacy put forward by the member states of the European Union for the presidency of the European Commission.When they will start their work in the autumn - in addition to the informal exchanges beforehand - the MEPs should have a new element at their disposal. An opinion from the European Food Safety Authority is expected in July 2024. This opinion was requested by the Parliament, on February 22, 2024, on the opinion of French experts, who consider the criteria proposed by the European Commission "without scientific basis".Member states may continue to workThe EU Council is not concerned by the European elections. There is nothing to prevent it from continuing to negotiate a common position among the member states, a common position which does not exist today. From January 1 to June 30, 2024, Belgium holds the presidency of the European Union, followed by Hungary until December 31, 2024, and Poland until June 30, 2025. These two countries, reluctant to deregulate GMOs, could make the file move forward less quickly than pro-deregulation advocates would like.For the time being, discussions between member states may no longer involve their ministers or permanent representatives in Brussels (the equivalent of ambassadors). Mobilizing these players requires progress in bilateral negotiations, which to date remain blocked, notably on the issue of patents as raised by Poland. On March 26, 2024, Spain presented a note to member states. Supported by Denmark, Estonia, Finland, Italy, the Netherlands, Portugal, Sweden and the Czech Republic, this note stresses that for these countries, it is important "to continue joining efforts so that the Council can reach an agreement on this important proposal [the European Commission's July 2023], which could provide the Europen Union with a legal framework adapted to these techniques". Put on the agenda under « Any other business » points, this note did not require a vote.From now on, the possible meetings, if no surprise occur, could be the "Working Party on Genetic Resources & Innovation in Agriculture (GMO) & Other Innov. Rel. Agri", putting around the table officials from the member states, which could discuss matters in a more discreet way from April to September 2024.Other files than just the GMO plantsThe deregulation of GMO plants is not the only file to be monitored in Brussels. GMO micro-organisms, for which the European Commission has already mobilized its work force with a view to a possible proposal for similar deregulation, is another. GMO micro-organisms and pharmaceuticals produced by them are in fact already the subject of partial deregulation negotiations in medicine.Last but not least, a proposal put forward by the European Commission in 2023 on plant reproductive material continues to make its way through the institutional processes. If adopted, this text could, according to certain players such as the Confédération Paysanne, put an end to farm-saved seeds and "liberate" patented GMOs for example.The year 2024 is therefore a year of transition for the European Parliament. For its part, the Council of the European Union can continue to move forward, all the more discreetly as the focus shifts to the elections for MEPs and the appointment of a new European Commission. [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [153] => Array ( [objectID] => 7811 [title] => A Dutch seed company faces up to KWS patents [timestamp] => 1712188800 [date] => 04/04/2024 [annee] => 2024 [url] => https://infogm.org/en/a-dutch-seed-company-faces-up-to-kws-patents/ [image] => https://infogm.org/wp-content/uploads/2024/04/Grietje-Raaphorst-Travaille_fbk-768x529.jpg [extrait] => Inf'OGM interviewed a Dutch seed company that has developed a cold-resistant "organic" maize and that feels threatened by KWS patents. She tells us the story of her company Nordic Maize breeding, of her certified organic maize, of its likely future contamination by GMOs/NGTs... [chapo] => Inf’OGM interviewed a Dutch seed company that has developed a cold-resistant “organic” maize and that feels threatened by KWS patents. She tells us the story of her company Nordic Maize breeding, of her certified organic maize, of its likely future contamination by GMOs/NGTs… [texte] => Inf'OGM reported on how two seed companies now find themselves under threat of prosecution. Inf'OGM interviewed one of these two breeders, Grietje Raaphorst-Travaille, co-founder with her husband of Nordic Maize breeding (NMb). Originally a biochemist, then a chemistry teacher, she first worked in a laboratory and then in plant breeding from 1990 onwards. With her husband, they worked for VanderHave, a Dutch seed company, which they left in 1997 shortly after it was taken over by the British company Zeneca. They officially founded NMb in 2002.Inf'OGM - How does Nordic Maize breeding work?Grietje Raaphorst-Travaille - We work with certified organic farming. We don't have a farm as such, and we don't even own our own fields. We work with farmers. They sow the maize and we manage the seed production. But our varieties are protected by plant breeders' rights. As well as maize, we are also developing winter peas, which go very well with early-harvested maize. If you harvest your maize on time, you'll have plenty of time to plant your winter peas. These crops also protect the soil in winter and allow farmers to produce more protein themselves and feed their animals in a more diversified way. This is not so common in the Netherlands. Farmers generally stick to a single annual crop and aim for the highest possible yields.What motivated the creation of Nordic Maize breeding?Having moved to the north of the Netherlands, we found that maize was harvested in November and December, which is disastrous for the soil because, at that time of year, the soil is far too wet for harvesting. So we thought we could develop a maize crop that could be harvested earlier. This was the main objective of our regional breeding programme. So we started breeding maize with earliness as its main characteristic. To do this, we gathered genetic resources from different locations and established collaborations with other breeders. The seeds also come from seed banks and exchanges. By speeding up our selections, we were able to obtain our first cold-resistant maize variety for organic farming in 2008, in just 6 to 7 years. We don't need in vitro genetic modifications, which don't really develop any faster. It also depends on the traits you select, of course. We simply need more good breeders to develop certain traits quickly.Was this the first time that cold-resistant maize had been developed in the Netherlands? Was it made available to seed companies who could analyse it to identify cold resistance traits?Cold-resistant maize is a common characteristic of maize and has been described in the literature for a long time. It is very useful in the north of the Netherlands because of the short growing season. We are certainly not the only ones to select for cold hardiness.How did you find out about the KWS patents?No Patents on Seeds, a European coalition that opposes patents on seeds, was looking for contacts of maize breeders. They contacted me in October 2022 and informed me that the German company KWS held four patents: one on the digestibility of maize, and one on a genetic locus that KWS says is that of cold resistance. KWS claims to have worked on their inbred lines, 86% of which are said to contain this cold resistance 'gene' [Editor's note: inbred lines are used to create hybrid lines in order to take advantage of the effects of heterosis, i.e. an increase in the capacity and/or vigour of a hybrid compared with its parents]. The third and fourth patents relate to the screening of the genetic sequence of the patented genes.You said that, in your opinion, several characteristics need to be expressed by the plant for it to withstand the cold?Cold hardiness is not due to the expression of a single gene. The same applies to the other characteristic patented by KWS, digestibility. I find it very strange that a single characteristic of a maize plant can be patented. It's much more complex: it's the combination of several elements that makes a maize resistant to the cold or more digestible. [Editor's note: in theory, a patent can be limited to claiming a single gene as responsible for cold resistance, provided that it can be shown to be the essential characteristic for conferring this resistance trait on the plant].Do your winter peas have any particular resistance? Do you have any other crops that could be threatened by patents?Winter peas have particular characteristics, but this crop is not economically comparable to maize, and I don't think we're worried about that.What will you do if KWS takes action? Will you leave your maize on the market? Will you wait until the end of the opposition procedure in Europe? [Editor's note: the European Patent Office allows anyone to lodge a reasoned objection to the granting of a patent.]My aim is, of course, to leave maize on the market. I don't know what we'll do if we get a letter from KWS. I can't imagine what we'll do. We don't know if we'll go to court. I think it's really strange that we have to deal with these issues.Is this the first time you've had a problem with patents?I wouldn't say there's a problem yet. But yes, this is the first time we've heard of a patent on maize. But with the proposed deregulation of NGTs, there will be many more patents. I really have no idea what could happen. It's a real problem because we can't test the seeds we sell to farmers to see whether they are free of patent rights or not, or even whether they are free of new GMOs (NGTs) [editor's note: this would be possible - regardless of the costs though - if companies were to provide a method of detection, identification and traceability]. We test them to see if they contain old transgenic GMOs. This is a requirement of the organic sector, at least in Germany. The analyses have to be sent with the seeds. But with the new GMOs, we can't do that and we can expect the new GMOs to be patented. This poses an enormous risk to breeders and farmers, which they will not be able to reduce. There is also a major risk for our contractors who plant maize for farmers. They mix different varieties of maize in their machines. Our maize production fields can also be contaminated during the phase between harvesting and bagging, but the biggest risk is in the farmers' fields [editor's note: the farmers' fields would be contaminated by machines carrying GMO residues].Are you saying that you could fall victim to contamination because a machine that comes to work in your fields contains seed residues that are not yours?Yes, of course. We sometimes use the machines of our agricultural contractors to sow our seeds, and we regularly ask the users of these machines to guarantee that they have been cleaned. But at sowing time, contractors and farmers are so busy that they don't take the time to clean the machines. Every time I use a contractor's machine, I can easily find a handful of treated, non-organic seeds. They're red, so they're easy to spot. The same thing will happen with GMOs, only worse, because I won't be able to recognise them. However, the biggest risk is not in the field I'm working in, because of course I control our seed production. Our uncontrollable risk is that of the farmers who buy my seed varieties, when they use contractors. They don't clean their machines and put my varieties on whatever is left in their machines.Do you know of any other stories like yours that have affected other seed producers or farmers?Numerous patents exist on other plants such as peppers, cauliflower, lettuce and tomatoes [...]. Another Dutch company (De Bolster) is also involved in breeding and is facing patent issues.NTGs are patentable, so to say that patents on NTGs will be banned makes no sense [Editor's note: see our article explaining the scope of process patents: Denis Meshaka,"Excluding GMOs/NGTs from patentability would be an illusion" , Inf'OGM, 4 March 2024.]. The multinationals do not accept this. In fact, they want to obtain patents and say that they will grant licences free of charge. This is what Bayer does on its website, for example.Last week, I attended an online seminar on intellectual property issues organised by a group of European academics. I asked how I could keep my seeds free. The discussion was totally disconnected from what happens in practice. There was only talk of measures to be taken in the future, there was a total lack of urgency and they didn't realise that there are already a huge number of patents! The strategy of Bayer and other big seed companies is to deregulate NTGs and offer free licences. I think that either you have the rights or you don't and then you pay for them. I don't want a free patent licence. Even if I don't have to pay, I'll never have total freedom of choice, I'll remain dependent and that's neither acceptable nor desirable. In a situation of dependence, as a maize breeder, we would never have developed a maize as early as the one we have developed. True innovation requires creativity, and creativity can only be born of freedom. Because we are still the only ones to have been able to develop a maize that reaches maturity in 18 weeks.Could you explain why you would still be dependent on a free patent licence?A licence establishes a relationship of dependence with the patents of the multinationals, which will then decide how the selection is made. This is how it works. These multinationals select according to a marketing strategy and tell the agricultural sector what types of varieties are needed. They don't ask the sector what it needs. With our maize, we had a very simple breeding problem: maize harvests too late, so we had to breed maize that harvests earlier. This would never have been a breeding objective for a multinational.Are you afraid that a multinational, which has granted you a free licence, will disagree with you for one reason or another and take away your rights?Exactly, you're in a situation of dependence, you're bound by contractual obligations. We are in the process of losing our independence in food production in the Netherlands, which is a very bad thing. We met the Minister of Agriculture a few months ago to inform him of the relative situation of patents, but he remains very much in favour of NGTs and their deregulation. The European Commission will indeed carry out a study on patents next year, but that will be too late because many patents will already have been granted. And thousands of patents have already been filed for NGTs. It should also be pointed out that multinationals are also behind many of the problems with pesticides. Agriculture has to change if we want everyone to have enough to eat. The Dutch are increasingly aware of this and support us, which is a good thing. The real transition has to come from the bottom up, not the top down. [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [154] => Array ( [objectID] => 7767 [title] => French retailers want GMO/NGT to be regulated [timestamp] => 1712102400 [date] => 03/04/2024 [annee] => 2024 [url] => https://infogm.org/en/french-retailers-want-gmo-ngt-to-be-regulated/ [image] => https://infogm.org/wp-content/uploads/2024/03/fcd.png [extrait] => When it comes to GMOs, french retailers say they are guided by two main principles: the application of the precautionary principle, and the traceability and consumer information. In France, this stakeholder in the agri-food sector has reservations, to say the least, about the proposed deregulation of GMOs. In June 2023, at the invitation of Anses experts, the french trade and retailing federation (Fédération du Commerce et de la Distribution), currently chaired by the CEO of Carrefour, shared its thoughts. [chapo] => When it comes to GMOs, french retailers say they are guided by two main principles: the application of the precautionary principle, and the traceability and consumer information. In France, this stakeholder in the agri-food sector has reservations, to say the least, about the proposed deregulation of GMOs. In June 2023, at the invitation of Anses experts, the french trade and retailing federation (Fédération du Commerce et de la Distribution), currently chaired by the CEO of Carrefour, shared its thoughts. [texte] => It's not so often that they speak out. Yet retailers play an important role in the food industry. On June 30, 2023, when the European Commission's proposal was still only known following a leak, the french Trade and Retailing Federation (Fédération du Commerce et de la Distribution - FCD)[cm_simple_footnote id="1"] was interviewed by a french experts committee of Anses. The verbatim report of this hearing, published with the report made public at the beginning of March by Anses, provides an insight into the principles driving the retailers[cm_simple_footnote id="2"]. While bearing in mind that these are "not necessarily firm positions, they are more a matter of reflection".Represented at the hearing by Emilie Tafournel, Quality Director at the FCD, and Lionel Desencé, Quality Director in charge of scientific and regulatory affairs within the Carrefour group, the FCD was clear on the fact that, among its members, "knowledge of the subject [...] is not the same for everyone. At the moment, chains other than [Carrefour] are more in a wait-and-see mode, in terms of taking on board the subject and understanding it. So there's no clear positioning from one side or the other". This lack of formal positioning does not prevent the FCD and its members from reaffirming two principles which are "important" to them and which guide them: "the application of the precautionary principle and the notion of transparency and traceability". However, these two principles are not reflected in the European Commission's proposal, which plans, on the contrary, the end of risk assessment, labelling, traceability and post-market monitoring.On GMO/NGT detection and traceabilityFor the retailers, the detection and traceability of GMOs/NGTs are essential to "be able to detect the presence of NGTs, whether for control purposes [...] in relation to the various links in the chain, or for the detection of adventitious presence due to cross-contamination. For us, detection and traceability are essential in the context of these future developments". There are several reasons for this position.The main reason is transparency for consumers. The FCD has declared itself "opposed" to a general approach based on the principle that "any NGT product for which no detection method can be developed must be considered as similar to conventional". However, five days after the FCD's hearing with the Anses, this approach will be adopted by the European Commission to justify its deregulation proposal. In the FCD's view, "this is tantamount to saying that we are placing on the market a product which, from the point of view of the end consumer, is similar to a product which would be 'derived' from nature. Put yourself in the end consumer's shoes. It's not audible". This situation is all the more paradoxical in that the FCD anticipates, on the contrary, that if new genetic modification techniques are of significant interest to the end consumer, this information will be provided. "On the other hand, if nothing is said, there will be a certain amount of suspicion", adds Lionel Desencé. And suspicion has a negative impact on the perception and acceptability of these products by the end consumer.This desire to respond to consumers' wishes implies a certain organization of the agri-food sector. In this sector, there are producers, operators and consumers who do not wish to use and/or consume GMOs/NGTs. Product segregation will therefore have to be put in place to ensure that this demand can be met. For the FCD, the example of the current non-GMO soy supply chain, in which Carrefour has been a pioneer, is an important basis. Soy is mainly imported into Europe. Its production is essentially American. On this continent, non-GMO soya is produced in countries like Brazil, where GMO soya can account for "between 90 and 95%" of the production. The costs of segregation - whether in the field or in terms of port storage, for example - and traceability of non-GMO soya are already high. Today, retailers are concerned to note that the Commission has not provided any coexistence rules. In fact, the Commission wants to delegate the organization of coexistence to the Member States, while eliminating the traceability tools that are essential to its implementation. Such a scenario "could complicate the work of the various operators, wherever they may be in the product production chain. It would also entail costs". However, the FCD is clear that these costs, "in any case, at one time or another, will be passed on in the consumer sales price", whereas they should instead be borne by "the operators marketing these NGT-derived varieties".To enable such organization of production chains and a logical split of costs, traceability of GMOs/NGTs is an indispensable requirement. The FCD believes that a suitable traceability system would be based on documentary declarations and biological analyses, as is currently the case for GMOs. In any case, the FCD points out that "traceability means identifying all the batches concerned at every stage of the chain, indicating 'varieties derived from NGT', and possibly from a particular NGT if the categorization is confirmed". Lionel Desencé insists that current legislation on GMOs is perfectly adequate, pointing out that "the burden of proof lies with the operator who markets these GMOs. Tomorrow, the same must apply to an operator who markets products derived from NGTs".On the usefulness of NGT productsCould traits obtained through new genetic modification techniques be of interest to retailers, for example a product that can be kept longer in the can? The question, put to the FCD by the Anses, was answered directly: "not at this stage". In fact, the question did not even arise for the retailers, which believe that it is up to the industry to put forward evidence of gains, whether in terms of production or product quality. But, in any case, this can only be done "on condition that these characteristics are clearly highlighted and, above all - and this always comes back to the same thing - that consumers are clearly informed of the fact that the crop in question is derived from NGTs, so that they can draw a parallel between this information and the gains made".This is all the more true given that retailers are disappointed with the promises of gains made in the late 90s with transgenic GMOs. As Lionel Desencé points out, "you also have to look at what we've seen over the last 20 years with GMOs [...] between theprosects transgenesis carried and what it actually delivered". Echoing the term "economy of promises", the Carrefour representative warns that today "the future prospects on paper seem very attractive. In reality, we remain relatively dubious", and even worried when he hears promises of resistance to water stress, for which "we have to agree that it is not the techniques that will fall into the NGT category that will make it possible to have a significant impact on resistance to water stress".Emilie Tafournel sums up the FCD's perception by explaining that "today, we have not identified any interest, because everything remains to be done, everything remains to be proven; on the basis of the two arguments we have mentioned: precautionary principle, traceability and consumer information".On consumers’ informationIn the end, according to Lionel Desencé, retailers’ wish is clear. The "precautionary principle must apply, and there must be total transparency regarding the marketing of these products, so that our customers can make an informed choice". This transparency appears to cover both the information on the GMO/NGT nature of products and the benefits conferred by the modification. Thus, "if the nutritional quality of a product is improved, and this information is brought to the attention of the end consumer, we can imagine that the latter will be interested in this type of production".Emilie Tafournel confirms this position. Through her, the FCD explains that "depending on the choices made in the European Commission's final decision, there will be consequences for the promotion and identification of these products, which will be, as Lionel said, in our opinion, acceptable or not for the consumer". In other words, "it is the consumer, and therefore the market, who will consequently position himself and evolve on the basis of these choices made in the categorization and the obligations conferred on each of these categories". Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [155] => Array ( [objectID] => 7697 [title] => European and French experts consulted too late on GMO/NGTs ? [timestamp] => 1711324800 [date] => 25/03/2024 [annee] => 2024 [url] => https://infogm.org/en/european-and-french-experts-consulted-too-late-on-gmo-ngts/ [image] => https://infogm.org/wp-content/uploads/2024/03/Montre_J648-768x560.jpg [extrait] => While the European Union has been discussing GMO deregulation since July 2023, European and French scientific experts have been and continue to be quite ignored. In France, although the opinion of the Anses was required as early as 2021, its publication took place in March 2024, a month after the vote by MEPs. The latter decided to consult their european experts after the vote, rather than before. However, in order to deliver its opinion in July 2024, the EFSA will make an exception to its procedure: it will not organize a public consultation... [chapo] => While the European Union has been discussing GMO deregulation since July 2023, European and French scientific experts have been and continue to be quite ignored. In France, although the opinion of the Anses was required as early as 2021, its publication took place in March 2024, a month after the vote by MEPs. The latter decided to consult their european experts after the vote, rather than before. However, in order to deliver its opinion in July 2024, the EFSA will make an exception to its procedure: it will not organize a public consultation… [texte] => On February 7, 2024, following the European Parliament's vote on its own version of a regulatory text on GMOs obtained through new techniques (GMOs/NGTs), MEP Jessica Polfjärd hailed "a historic day when the European Parliament has voted in favour of science, of food safety and in support of European farmers". With this statement, the MEP concealed the fact that European and French experts had, on the contrary, seen their scientific opinions ignored, or even not solicited.The Commission will not consult its own european experts...To produce its proposal for the deregulation of GMOs in July 2023, the Commission states that it relied on several opinions from the European Food Safety Authority (EFSA)1, which recommended a risk assessment. Despite these opinions, the Commission will opt for no pre-market risk assessment for most GMOs/NGTs (those classified as "category 1"). Above all, to declare a plant an NGT (and no longer a GMO), the Commission has proposed a list of five criteria which it has not previously submitted to the EFSA for their scientific relevance or plausibility. As confirmed by EFSA, "the criteria proposed by the European Commission specifically for its proposal for NGT Cat 1 were developed by the European Commission itself". Questioned on January 12, 2024 by MEP Christophe Clergeau, the Commission confirmed on March 7 that it had no intention of consulting EASA on the relevance of its criteria. It stated that it had developped the criteria "based on a scientific literature analysis about the changes in plants’ genome obtained by conventional breeding methods", adding that the opinions produced by EFSA "underpin"those criteria2.Rather than directly questioning its experts on the scientific relevance of the criteria it is proposing, the European Commission prefers to consider that the opinions provided "underpin" these criteria. It goes even further, suggesting that French experts also support them. It states that "national agencies, including ANSES, engaged with EFSA in the context of this work, in particular through the EFSA GMO Network and the public consultations of the relevant EFSA scientific opinions". This interpretation by the Commission is a far cry from the two opinions produced by French experts in December 2023 and March 2024.... unlike the European Parliament, which consults them after having voted!While the Commission explicitly refuses to consult its experts, the European Parliament did so on February 22, 2024, by issuing a mandate to the EFSA. But this mandate does not relate to the criteria themselves, but to the opinion published in December 2023 by the French experts at Anses.The calendar is surprising, to say the least. Since July 5, 2023, the European Parliament and its Environment Committee have had on their table the deregulation proposal formulated by the European Commission with these famous scientific classification criteria. Until February 1, there was no thought of mandating EASA to find out what it thought of these criteria. On February 1st, a week after the adoption of the Environment Committee's report and a week before the European Parliament's plenary vote, the Chairman of the Environment Committee, Pascal Canfin, wrote to the President of the Parliament. On behalf of the Environment Committee, he asked her to mandate EFSA, not on the Commission's criteria or the criteria modified on January 24 by the Committee he chairs, but on the opinion of the Anses’ french experts, known since December 21, 2023.Finally, the European Parliament's mandate will be sent to EFSA on February 22, signed by Roberta Metsola, President of the Parliament. Inf'OGM questioned the Presidency of the Parliament to find out why it had decided not to mandate EFSA before voting, not to mandate EFSA on the criteria themselves, and not to mandate EFSA on the criteria as amended by the Parliament on February 7, 2024. In response, the Presidency press office told us that EFSA's opinion had been requested for July 2024, "considering the political calendar and the fact that the Council has not reached its position yet". No response was received from the coordinators of any of the political groups on the Environment Committee, or from the office of P. Canfin, Chairman of the Committee.The European experts to deliver their opinion in July 2024On the experts' side, an EFSA spokesperson confirmed to us that it had “received a request from the European Parliament to produce a scientific opinion on Anses' analysis of the criteria proposed by the European Commission". On March 18, 2024, EFSA formally accepted the mandate and replied to the Presidency of the European Parliament3. In this reply, EFSA points out that it has already adopted the principles of equivalence of certain GMO/NGT plants with conventional plants as proposed by the European Commission. Its work will therefore focus on the French experts' opinion of these principles, as well as their opinion of the criteria themselves. On the other hand, the EFSA has already announced that its working procedure will be different from the usual ones. As the Parliament has requested a response by July 2024, "there is insufficient time to run a public consultation on the EFSA-GMO panel endorsed opinion", as the usual procedure requires. This public consultation will therefore not take place.EFSA is therefore working to "produce this assessment by the given deadline of July 2024", with consultation of Anses if necessary. Anses' second opinion, published in early March 2024, will also be considered "carefully in the context of the strong cooperation we have on our respective scientific work". In his response to Inf'OGM, the EFSA spokesperson also clarifies that EFSA "continues to discuss the issue of NGTs with Anses and all other Member State partners in our GMO network". A clarification implying that all member states, via their national expert committees, are aware of the reflections and considerations on the scientific aspects of the deregulation proposal.French experts do not share the government's analysisWhen the French experts at Anses published their opinion on the criteria proposed by the European Commission, the matter caused quite a stir. Indeed, their opinion was the result of a self-mandate and was quite trenchant as it considered that these criteria had no scientific basis. However, this publication, of which the MEPs were aware, did not lead them to hear the Anses as part of their work. The European Parliament - and, before it, its Environment Committee chaired by Pascal Canfin - therefore did not hear the French experts on the lack of scientific soundness of their considerations.In March 2024, the same experts published their opinion on the proposal as a whole, this time on a request from the French government dating back to 20214. The report, published online on March 6, 2024, was signed by the Director General of Anses on January 22, 2024. The "Biological Risk Assessment in Food" (BIORISK) committee of experts, in charge of all the expert assessment work carried out, adopted its conclusions on December 11, 2023. On February 18, 2024, Marc Fesneau stated that he did not have this report on his desk, but above all that "the Anses report is a self-mandate aiming at looking at the consequences of new genomic techniques, particularly in terms of marketing authorization"5. The report published in March 2024 on which the Minister was questioned was in fact the result of a mandate sent to Anses by the Ministry of Agriculture, via the Directorate General for Food, and by the Ministry of Ecological Transition, via the Directorate General for Risk Prevention, on January 28, 2021.While the French government has already defended its position in the Council of Ministers in favor of the principle of deregulation, albeit with reservations about the patent issue, what do French experts think of the proposed lack of risk assessment, labeling and traceability?In the summary of their report - which Inf'OGM will detail in a future article - the experts recommend that GMO/NGT plants should be assessed "on a case-by-case basis, taking into account both the precision of the technique used and the characteristics of the plant obtained once the genome has been modified, while also considering all the potential toxicological, nutritional, agronomic and environmental consequences of the new characteristics". They propose a decision tree that would make it possible "to propose, depending on the case, the maintenance of the current assessment framework or a simplified or adapted assessment", this latter to be decided according to the plant's molecular, chemical, nutritional, agronomic and other characteristics. The principle of risk assessment has therefore not been abandoned by ANSES.In addition to this case-by-case risk assessment, the Anses strongly recommends that post-marketing surveillance be set up "to monitor the appearance of health and environmental effects, but also to observe changes in cultivation practices associated with these plants".In addition to health and environmental aspects, Anses experts also highlight the issues of consumer information, intellectual property and industry concentration that may emerge. Finally, Brice Laurent, Director of Social Sciences, Economy and Society at Anses, adds that "modifying the regulation to take into account the NGTs involves societal choices, as various economic and societal impacts are also in the balance. Anses' expert appraisal identifies all the questions that need to be asked, to ensure that the debate is as open and informed as possible".Since 2022, both European and French experts have issued opinions calling for a GMO/NGT risk assessment, the content of which may vary from case to case. In their view, a risk assessment is necessary, whether similar to or lighter than the current assessment requirements. This is a far cry from the European Commission's proposal, the position defended by several member states, or the European Parliament's vote of February 7, 2024... Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [156] => Array ( [objectID] => 7667 [title] => Patents pose a real threat to two plant breeders [timestamp] => 1710892800 [date] => 20/03/2024 [annee] => 2024 [url] => https://infogm.org/en/patents-pose-a-real-threat-to-two-plant-breeders/ [image] => https://infogm.org/wp-content/uploads/2024/03/2733962928_3bcc41aa8f_c-768x510.jpg [extrait] => Since autumn 2023, the issue of patents has come to the fore in the debates surrounding the deregulation of GMOs. Some Member States and MEPs are concerned about the impact of agro-industry patents on the rest of the agricultural sector. History shows that the threats they represent are very real indeed. Here are two examples of seed companies whose products are targeted by such threats. [chapo] => Since autumn 2023, the issue of patents has come to the fore in the debates surrounding the deregulation of GMOs. Some Member States and MEPs are concerned about the impact of agro-industry patents on the rest of the agricultural sector. History shows that the threats they represent are very real indeed. Here are two examples of seed companies whose products are targeted by such threats. [texte] => On 7 February 2024, the plenary of the European Parliament voted on amendments to the deregulation proposal put forward by the European Commission in July 2023. If, among these changes, the amendments on patents were to become definitive, traditional breeders, farmers and peasants would remain under threat of infringement actions from the few multinationals controlling patent rights in NGTs1. These threats could become a reality, as was already the case for the farmer Percy Schmeiser in 1998 and the French company Gautier Semences in 2004.Today, this sword of Damocles is such that some players might prefer to withdraw some of their plant products from the market rather than negotiate with powerful patent holders or end up in court. This is despite the ongoing debates initiated by certain Member States and MEPs who are clearly concerned about their fate.Rijk Zwaan, againIn 2004, the Dutch company puts pressure on Gautier Semences, which at the time opposed one of its European patents. This covered lettuces made resistant to an aphid, obtained using marker-assisted selection from a species of wild lettuce. The Provençal family business, for its part, had long since created lettuces resistant to this aphid, using conventional breeding methods. As Gautier Semences' customers for this lettuce had been threatened by Rijk Zwaan, Gautier Semences had been forced to withdraw from the opposition proceedings against the Dutchman's patent, negotiate a licensing agreement with him and pay him royalties so that it could continue to market its lettuce seeds2.In 2021, Frank Morton, a US seed grower based in Oregon, sold a customer a lettuce variety, 'Funny Cut Mix', developed by his company and certified for organic farming. The customer wanted to include it in his lettuce trials to assess its performance in a specific environment. When questioned by Inf'OGM, Franck Morton explained that the customer liked the variety, but found it too similar to one of the varieties he sells himself, which happens to be covered by a patent. The customer therefore no longer wanted to sell Franck Morton's "Funny Cut Mix" variety. Morton was astonished: "Well, the entire point for me breeding the Funny Cut Mix was to give growers a non-patented choice in a "multi-leaf" type lettuce. By eliminating my variety from consideration BECAUSE it is competitive with a patented product turns the argument in favor of patents on its head. Patents are claimed to spur competition, not preclude it. In this case, my intention to compete with patented lettuces is undermined by my success in doing so. Yes, I still sell Funny Cut Mix directly to customers, but not through other catalogs. »Franck Morton considers that, from his personal point of view, his work cannot infringe Rijk Zwaan's patents insofar as he did not use any patented material or parental lines to create his varieties: "I used the naturally occurring traits of my own lettuce lines to create 'Funny Cut Mix,' and I don't believe Rik Zwaan has any complaints they can use against me. I believe that genetic traits and the genes underlying them are the works of nature, not plant breeders. Plants breeders discover traits and their attendant genes, they don't invent them.” The Oregon breeder concludes: "So, I am not worried about Rijk Zwaan. They can come and get me. It would be a nice capstone to my career to illuminate the lack of foundation in plant patent law. I have a pure conscience, but I think they do not”. Franck Morton should perhaps not underestimate - and perhaps he does not - the capacity for legal action of patent holders, especially multinational seed companies. Protecting their industrial property costs them dearly, and the patents they obtain will in all likelihood be generally defended.KWS's patented maize raises eyebrowsThe Dutch company Nordic Maize breeding (NMB), which also works in organic farming, markets around a third of the organic maize seed sold in the Netherlands. Since 2023, it has been concerned about its cold-resistant maize, which it has been developing for some twenty years. Its co-owner, Grietje Raaphorst-Travaille, learned that in July 2022, the German company KWS (the world's sixth largest seed company) had obtained a European patent (EP3380618) on a genetic sequence that could be present in NMB's maize. The claims of the patent granted to KWS cover, among other things, a cold-tolerant maize plant, allegedly obtained by marker-assisted selection, which includes a specific nucleic acid (DNA) sequence conferring such resistance, as well as any sequences 98% identical to this specific sequence. In an article in Politico3 the Dutch entrepreneur states: "Plants with the characteristics claimed in the patent have been on the market for years. Granting these patents only increases the legal risks, costs and uncertainties [...] It could mean that Nordic Maize breeding will be the last company to launch a maize breeding programme and that freedom of breeding will come to an end." In an interview Inf'OGM had with Grietje Raaphorst-Travaille, she explained that her maize's resistance to cold is multifactorial and expressed surprise that KWS's patented maize plant needed only one gene to respond to this abiotic stress.This last aspect must be emphasised because, if confirmed, it could call into question the validity of such a patent. The claims of a patent must, in theory, define the essential means of the invention. In this case, they should therefore include all the genetic sequences involved in cold resistance. Since May 2023, this KWS patent has been contested in an opposition, still pending, filed with the European Patent Office (EPO) by No Patents On Seeds (NPOS). Grietje Raaphorst-Travaille has informed us that she is "obviously" continuing to grow her cold-tolerant maize for the time being, despite this patent. However, as she explained to Politico: "I am not convinced by the guarantees of the big seed companies that they will offer free or affordable licences on their patents [...] as a small breeder, you will never be free. [...] You will always have to listen to these bigger companies".These examples from Nordic Maize breeding and Franck Morton show the concrete effect of patents on breeders and farmers. French companies have also expressed reservations about patents on GMOs/NTGs. The fate of all cultivated biodiversity could well be in the hands of a few owners of patents on plant traits if GMO deregulation were to succeed as proposed by the European Commission. All the more so if, as proposed by the European Parliament, the European Union calls into question the patentability of products, but not that of NGT processes, which will extend to the products obtained if they have the claimed characteristics.Two concrete examples of the fears of certain Member States For several months now, the Member States have also been expressing their views on the subject of patents, in particular patentability, access to genetic resources and the insecurity generated for players in the agricultural sector. And the current inability of the European Council of Ministers to adopt the proposed NGT regulation is essentially due to a lack of consensus on this issue. The position of several Member States was communicated to the European Commission this autumn4.It would be difficult to summarise these positions, but a few can be highlighted. First of all, several European countries, notably France, Poland and the Czech Republic, are expressing concern about the negative impact of patents on small farmers and biodiversity. These countries are calling for accelerated impact studies (the date put forward in the text voted by Parliament is 2025). Other countries, such as Finland and Lithuania, are calling for better coordination between legislation on patents and plant variety rights (PVR), and for clarification of existing regulations. Poland and the Czech Republic are more outspoken in their opposition to the patenting of native traits in order, among other things, to protect varietal innovation. In addition, several countries are calling for unrestricted access to genetic material and NGTs in order to maintain a balanced intellectual property system. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [157] => Array ( [objectID] => 7607 [title] => “Gain of function” in viruses: research in question [timestamp] => 1710115200 [date] => 11/03/2024 [annee] => 2024 [url] => https://infogm.org/en/gain-of-function-in-viruses-research-in-question/ [image] => https://infogm.org/wp-content/uploads/2024/03/46408641284_9e956eb908_c-768x632.jpg [extrait] => A gain of function (GOF) is an action taken on a micro-organism to give it a new function. Similarly, loss of function is sometimes also sought using identical techniques. We will include this in GOF. What does gain of function mean? Let’s take an example. Suppose a virus is specific to an animal species and […] [chapo] => Several techniques can be used to genetically manipulate viruses, for both medical and military purposes (known as dual techniques). Some would like to ban them, while others argue that science in this field should not be held back, so as to improve vaccines. What are the advantages and disadvantages of such manipulations? Is the freedom of researchers compatible with a ban? [texte] => A gain of function (GOF) is an action taken on a micro-organism to give it a new function. Similarly, loss of function is sometimes also sought using identical techniques. We will include this in GOF. What does gain of function mean? Let's take an example. Suppose a virus is specific to an animal species and therefore unable to infect a human. A GOF, set up by a scientist, consists of growing this virus in a container with human cells and a suitable culture medium. Of course, a virus cannot reproduce if it cannot infect these cells. But viruses are never all identical. In fact, viruses have an enormous capacity for mutation. This is their selective advantage. It is therefore possible for a few viruses to infect a human cell, multiply there and go on to infect other human cells. These viruses then give rise to a population of viruses with a new function: the ability to infect human cells, and therefore to proliferate in the presence of human cells. The scientist can also cause the virus to lose its original ability (to infect the original animal species) in favour of another (to infect humans). There are two main methods for producing GOFs. The first has just been described: it involves changing the environment, the artificial culture medium, to acquire a new function (and lose one). The second involves genetically modifying the virus, as is done with plants and animals, using various techniques and tools (meganucleases, CRISPR, etc.). The example of SARS-CoV For example, in 2015, the Wuhan laboratory (China) and the laboratory of R. Baric (North Carolina) co-authored an article in which they explained that they had changed the site (Receptor Binding Domain, RBD) of the spike protein of SARS-CoV (not SARS-Cov2!) so that it could infect humans1. More specifically, they used a protocol known as "reverse genetics". Using SARS-CoV genome sequences recorded on a computer, the researchers chemically synthesised a viral DNA molecule. This DNA molecule is a chimera combining the genetic sequence of a mouse (mammalian) SARS-CoV with the genetic sequence encoding a spike protein from a bat coronavirus. Using this molecule, the researchers produced chimeric viruses in cultured monkey cells. The chimeric viruses obtained were then tested on human cells (in particular a mammal) and the researchers observed their ability to infect these cells. This research was partly funded by Peter Daszak's EcoHealth Alliance. Why give these details? Because there is an ongoing debate, which has not yet been settled and which we won't have time to address here, between those who believe that the disease is of zoonotic origin and those who believe that it originated from a leak from the Wuhan laboratory, specifically for SARS-Cov2. It was P. Daszak who collected American federal funds to finance research in Wuhan (including the research described in this article), even when American law prohibited such fundings on American soil2. This striking example justifies why research into gains in function is now a cause for concern in certain states of the United States of America and elsewhere in the world. What are the drawbacks and risks? Back in 1937, researchers found that the yellow fever virus cultivated on chicken embryo cells lost its ability to infect humans. Now, a virus that has been rendered inactive, when injected into a human, elicits an immune response. This is the principle behind inactivated agent vaccines. The process can be described as a GOF. A GOF is not necessarily harmful. But the techniques used to confer a new function are the same for making a vaccine or a biological weapon. These are known as dual techniques. The State can fund this research. At the very least, it can consider not funding it, limiting it or even banning it. In fact, Texas has considered banning GOFs without pursuing the procedure. Florida voted for a ban in May 2023. But an article argues that this will have no impact, as no Florida researchers are affected3. The symbolic nature of a ban is not discussed. The same article points out that it is "unclear whether the Democratic Senate or President Joe Biden would approve" such legislative proposals, which often come from Republicans. The US state of Wisconsin is also considering such a ban. Y. Kawaoka's laboratory is located at the University of Wisconsin. In 2012, like R. Fouchier's team, it explained how to increase the transmissibility of an H5N1 influenza virus between humans. In 2022, it emerged that numerous safety incidents had been reported in his laboratory. A committee of Republicans in the US Parliament asked him for explanations and "a long list of documents"4. This shocked the journal Science, which widely reported that a ban would limit the work of researchers5. This defence of researchers is supported, even if they are working on biological weapons or GOFs with the risk of laboratory leaks that could kill millions of people6. A ban "would significantly impede the ability of Wisconsin researchers to conduct research that is extremely important to the state" argued the University7. Is it really important for the state or for the researchers? The question is political. Shouldn't (researchers') freedom be restricted, at least in some cases? Furthermore, it should be pointed out that the United States is a liberal society where only federal or state funding is discussed. Private (or military) funding is out of the question for them. The law stops at what the state funds, not what is done! In this liberal ideology, the state does not interfere in the private sphere, even if a private individual or company is developing biological weapons. Research, whatever it takes? A continuation of this debate deserves attention. Some people even want to ban the possession of the smallpox virus (in public laboratories!). Others object that they can resynthesise the virus using only the computer sequence (DSI) of its DNA. In 2018, Prof. Evans' team demonstrated this possibility by synthesising the horsepox virus, which is especially large8. SARS-Cov2 has also been synthesised, following advances in synthetic biology9. It is sometimes argued that virus cultivation would make it possible to see and accelerate mutations, and therefore to know what the next generation of viral diseases will be (influenza, COVID, etc)10. This is why P. Daszak boasted that he had "found numerous coronaviruses linked to SARS [...], so there is a real potential for emergence"11. So, despite the withdrawal of some of his federal funding, he has continued to collect samples of viruses for his laboratories. But the next viral strain cannot be predicted. Evolution is not predictable. So mutating a virus is no guarantee of obtaining the future viruses that will appear in nature. The approach adopted is too simplistic. We have seen that the development of these GOFs creates a danger. Those who want to ban them are accused of holding back science, and society is therefore called upon to say whether it accepts such dual research. There is no denying that a local ban will not be enough. But the difficulty of moving beyond a local agreement to a global one should not be an argument for doing nothing. At the very least, we can set an example. Olivier LEDUC (OGM Dangers) [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [158] => Array ( [objectID] => 7582 [title] => GMO plants, bacteria, viruses and animals: can they all be deregulated? [timestamp] => 1709683200 [date] => 06/03/2024 [annee] => 2024 [url] => https://infogm.org/en/gmo-plants-bacteria-viruses-and-animals-can-they-all-be-deregulated/ [image] => https://infogm.org/wp-content/uploads/2024/02/Microbial_Ecology__Physiology_research_lab_50341723642-768x432.png [extrait] => When the European Commission proposed, on 5 July 2023, to deregulate GMOs, it specified that only plants would be concerned. It even asked to officially state that this deregulation would not apply to “microorganisms, fungi and animals for which the available knowledge [on safety] is more limited“. But it does not mention having begun to […] [chapo] => The current debate on the deregulation of GMOs does not just concern plants. In April 2023, the European Commission proposed a partial deregulation of GMO micro-organisms, fungi and viruses used in medicine. For GMO/NGT micro-organisms used in agriculture, as plant protection products applied to the environment for example, certain multinationals and the European Parliament are calling for a deregulation project to be considered. GMO/NGT animals could follow. [texte] => When the European Commission proposed, on 5 July 2023, to deregulate GMOs, it specified that only plants would be concerned. It even asked to officially state that this deregulation would not apply to "microorganisms, fungi and animals for which the available knowledge [on safety] is more limited". But it does not mention having begun to prepare the ground for possible future deregulation of these micro-organisms, as some multinationals are already asking it to do. Nor does it recall having already formulated - partial - deregulation for certain micro-organisms used in pharmaceuticals.Diverting attention with GMO/NTG plantsThe most visible deregulation project underway is obviously the one concerning plants. Formulated in July 2023 by the European Commission, the initial proposal was complete. End of risk assessment, end of authorisation for marketing or field trials, end of labelling, end of traceability, end of national measures to prohibit the cultivation of GMOs/NGTs and of environmental monitoring - everything has been deleted.Since then, however, the Council of the European Union has not agreed on a common position, due to too many points of divergence between the Member States. For several of them, following the example of Poland, it is not possible to deregulate GMO/NTG plants on the basis of a theoretical inability to differentiate them from conventional plants if, at the same time, they must continue to be patented on the grounds of novelty. For other countries, consumers, processors and distributors must continue to be informed of the nature of products via labelling. Many also want to continue to be able to decide to ban GMO/NGT crops from their soil. For its part, the European Parliament finally voted on 7 February 2024 to adopt a position written in a rather complex and unsettled text.The timetable imposed on Member States and MEPs has helped to focus attention on this project aiming at deregulating GMO/NTG plants. At the same time, however, companies have engaged in convincing the European Commission and some MEPs to initiate similar work on micro-organisms.Deregulating GMMs based on new techniques?Since 2022, a number of companies have been suggesting, or even demanding, that the deregulation envisaged for GMO/NTG plants should also apply to micro-organisms. The lobby groups EuropaBio, the Association of Manufacturers and Formulators of Enzyme Products (Amfep) and the EU Association of Specialty Feed Ingredients and their Mixtures (Fefana) are all keen for the European Commission to consider deregulation. EuropaBio, for example, wrote in 2022 that it wanted "a cohesive approach across sectors" and for "advanced knowledge on microorganisms [to] be recognised and considered when developing the policy action for plants developed using NGTs". According to information obtained by Inf'OGM, Euroseeds delivered a similar message in August 2023.Such a demand from the multinationals finally found a political echo in the European Parliament. On 7 February 2024, the text voted by MEPs surreptitiously mentioned micro-organisms1. It is requested that "available knowledge on other organisms, such as microorganisms […] should be reviewed with a view to future legislative initiatives on them" (recital 9). Similarly, an article adopted at the plenary session states that "By 2024, the Commission shall submit a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions evaluating the specificities of and needs for other sectors not covered in this legislation, such as microorganisms, including a proposal for further policy actions" (Article 30(5b)). It’s now up to the European Commission to decide whether it wishes to formulate such a deregulation proposal, which would include micro-organisms. In the meantime, it has begun to mobilise its experts on the subject. For example, the European Food Safety Authority (EFSA) has published an overview of existing GMO/NTG micro-organisms2. This is one of the documents needed by the Commission to draw up a legislative proposal. Similarly, the European expert committees on GMO detection and traceability have begun to examine the GMM issue3.Partial deregulation of transgenic micro-organisms also envisagedViruses, bacteria and other fungi genetically modified by new techniques (NTG) may not be the only ones to be deregulated. Transgenic micro-organisms could also be deregulated or, to be more precise, the genetic sequences of these transgenic GMMs. This idea was raised at a meeting of Member States in Brussels on 20 September 20214. The Standing Committee on Plants, Animals, Food and Feed discussed the issue of "Food and feed resulting from fermentation with genetically modified microorganisms in contained used". The discussion focused on batches of food or feed containing traces of GMM DNA that are not authorised other than in a contained environment. If such contaminated batches are to be withdrawn from the market, some Member States wanted to "discuss the matter".In February 2024, when questioned by Inf OGM, the European Commission made it clear that "the question has been raised whether products obtained by fermentation processes using genetically modified micro-organisms (GMMs) and containing DNA traces of the GMMs are produced ‘from’ or ‘with’ a GMO". This is a question with high implications, because if batches containing traces of GMM DNA were to be declared as produced "using" rather than "from", they would no longer have to be labelled and withdrawn from the market. Discussions are still ongoing, and "the Commission is examining the matter and will revert to the Standing Committee for further discussion".This questioning by certain member states was echoed by a response formulated by certain companies in 2022. In an article published in a scientific journal of the European Federation of Food Science and Technology5, certain companies6 proposed that the presence of GM DNA in batches of food additives should no longer lead to the withdrawal of contaminated batches or their labelling as GMO! On the political front, discussion of such partial deregulation is well underway.Pharmaceutical GMMs partially deregulatedRegarding GMMs themselves, in April 2023 the European Commission proposed the deregulation of certain GMMs, including GMO viruses. This is a proposal for partial deregulation in the field of medicines. While the legal text may be obscure to the uninitiated, consultancies have already produced informative analyses.The proposal submitted to the Member States and the European Parliament is a draft for a new directive on medicinal products for human use7. The proposal covers medicinal products known as gene therapy medicinal products "containing recombinant nucleic acid sequence(s) or genetically modified microorganism(s) or virus(es)", but also "containing genetically modified cells". Some private consultancies, such as Covington, believe that with this proposed directive, "the European Commission is streamlining the rules for clinical trials of medicines consisting of, or containing genetically modified organisms (“GMOs”)"8. Covington analyses that the Commission is proposing a simple, centralized system for clinical trials on GMO drugs. While industry will have to provide an environmental risk assessment for a commercial authorization application, "in turn, the Commission will exempt clinical trials from the scope of many GMO rules".For its part, Boyds writes that the proposed simplification of procedures for clinical trials is that "separate national applications under the GMO Directives would no longer be required. Instead, a single application in the form of a GMO risk assessment would be submitted alongside the clinical trial application using the same portal"9. According to the same consultancy, the proposal aims "at streamlining inclusion of the GMO risk assessment into the harmonised clinical trial applications". This semantics often means downgrading the assessments currently required, as analyzed by Covington.Microorganisms and viruses used as plant treatment productsIn addition to pharmaceutical products produced from or consisting of GMOs, including micro-organisms (and viruses), as we have just seen, GMMs used as plant treatment products are concerned by another proposed regulation. This time, it's not about deregulation, but about extending by five years the duration of patents granted on these GMMs.Still in April 2023, the Commission published a proposal for regulation 2023/0126 (COD)10. The aim of this proposal is to extend patent rights on a "plant protection" product by a maximum of five years. Justifying its proposal by the fact that "the period that elapses between the filing of an application for a patent for a new plant protection product and the authorisation to place that product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research", the European Commission publishes a text which mentions micro-organisms and viruses. The term "substance" refers to "chemical elements and their compounds, as they occur naturally or by manufacture". Any measures taken for active substances will, in this proposal, concern "substances or micro-organisms including viruses"!This draft regulation confirms that genetically modified micro-organisms (including viruses) could be considered and used as plant treatment products. They would therefore be disseminated into the environment as part of agricultural practices that choose to use them. When, on February 7 2024, MEPs called for a legal initiative to deregulate them, they opened the door to the environmental release of genetically modified bacteria, yeasts and viruses for agricultural models choosing to use them, and for others. While the companies would have already obtained an extension of their intellectual property rights for a maximum of five years, deregulation could even cancel out any assessment of the health and environmental risks associated with these GMMs.Animals have not been forgotten in this panorama of deregulation projects. The amendment to Recital 9, voted on February 7 2024 and calling for deregulation work to be initiated for micro-organisms, also concerns animals. The text adopted by the European Parliament calls for "available knowledge on other organisms, such as microorganisms, fungi and animals, should be reviewed with a view to future legislative initiatives on them". And the article calling on the European Commission to produce "by 2024 [...] a report [...] evaluating the specificities of and needs for other sectors not covered in this legislation [...] including a proposal for further policy action" may well concern animals. Indeed, being de facto an "other sector", GM animals could well be the subject of such a report, should the Commission decide to do so...Theoretical timetables for current legislative procedures« NGT » plantsPharmaceutical GMMsGMMs in the environmentGM animalsGMMs and patentsRequest by EP//7 february 20247 february 2024/Proposal by EC5 july 2023 (2023/0226(COD))26 april 2023 (2023/0132(COD))//27 april 2023 (2023/0126(COD))EP’s commission report24 january 202407 march 2024 (planned)//24 january 2024Vote in plenary EP07 february 202410 april 2024 (planned)//26 february 2024 (planned)Vote of the EU Council/////Start of trilogue///// Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [159] => Array ( [objectID] => 7557 [title] => Excluding GMOs/NGTs from patentability would be an illusion [timestamp] => 1709510400 [date] => 04/03/2024 [annee] => 2024 [url] => https://infogm.org/en/excluding-gmos-ngts-from-patentability-would-be-an-illusion/ [image] => https://infogm.org/wp-content/uploads/2024/02/476491177_c6e28e844f_c-768x576.jpg [extrait] => On 7 February 2024, the European Parliament proposed to make a distinction between products derived from NGTs, such as plants, their parts and the genetic information they contain, which would be excluded from patentability, and NGT processes for obtaining these products, which would not be excluded. However, this decision could not be adopted in the […] [chapo] => In its amendments adopted on 7 February 2024, the European Parliament drew a distinction between products derived from New Genomic Techniques (NGTs), which it wanted to exclude from patentability, and the NGTs used to obtain these products, which could still be the subject of so-called process patents. In addition to the legislative obstacles that this decision would create, particularly at the level of the European Patent Office, it would still leave farmers and small/medium-sized plant breeders at the mercy of infringement proceedings. Contrary to what the Parliament’s “reassuring” proposal suggests… [texte] => On 7 February 2024, the European Parliament proposed to make a distinction between products derived from NGTs, such as plants, their parts and the genetic information they contain, which would be excluded from patentability, and NGT processes for obtaining these products, which would not be excluded. However, this decision could not be adopted in the final regulation without also amending European Directive 98/44 EC and the European Patent Convention, which govern the patentability of biotechnological inventions in Europe.If these administrative hurdles were overcome, and only NGT processes were therefore patentable, would the legal context be very different for small and medium-sized breeders, farmers and peasants? Probably not, given the scope of process patent claims.Different categories of claimsA patent consists of two main parts: a "description", which describes the invention in sufficient detail to enable it to be reproduced, and "claims", which define the invention clearly and concisely. These claims delimit the invention and must mention its essential characteristics. For example, if a hammer were invented, the claim should at least mention a part that is held and a part that strikes. The invention defined must be novel, involve an inventive step and be industrially applicable.Different categories of claims are possible in the same patent, provided that the criterion of unity of invention is met. A patent may, for example, claim a plant (or plant material, such as a seed) modified with transgene X, a process for obtaining a plant containing this transgene X, a sequence claim for this transgene X or a new function associated with transgene X. In this case, the invention is based on transgene X. Patents in the field of NGTs similarly claim plant material modified by NGTs, processes for obtaining this modified material and genomic sequences (modified sequence, guide RNA, etc.).A "product" claim relates, for example, to a modified plant or seed. A "process" claim covers a sequence of steps enabling, for example, the production of such a plant or seed or consisting in a particular way in generating various genetic modifications of plants. In a situation of potential infringement - a patent is used to prevent a third party from infringing an invention - it is easier for the owner of the patent in question to take action on the basis of a product claim than on the basis of a process claim. A product claim enables the patent owner to demonstrate infringement simply by stating that an identical product is commercially available. On the basis of a process claim, he will have to prove that the production steps used to obtain this product infringe this claim. In theory, this is not so easy. But European law contains a provision that extends the scope of such process claims to products directly derived from the patented process. This provision reverses the burden of proof, forcing alleged infringers - seed producers, for example - to prove that they did not obtain their products directly from the patented process.Process patents and NGT Article 4a "Exclusion from patentability" passed by the European Parliament states that "NGT plants, plant material, parts thereof, genetic information and the process features they contain shall not be patentable"1. The exclusion therefore concerns NGT "products" and not NGT processes, which remain patentable. Under these conditions, the holder of an NGT process patent could not prohibit a third party from producing plants derived from this process because these plants are excluded from patentability? As mentioned above, European law contains provisions allowing the scope of a process patent to be extended to products obtained directly by that process. Article 64(2) of the European Patent Convention applied by the European Patent Office lays down this principle for all technical fields. Article 8(2) of Directive 98/44 EC does the same for biotechnological inventions2. In the latter case, the "resulting product" is "biological material" which, by its very nature, is liable to reproduce or multiply. Article 8(2) extends claims for the production of biological material with "specific characteristics as a result from the invention" to biological material obtained by reproduction or multiplication of this initial material and having the same characteristics.Article 9 of Directive 98/44 specifies that the protection conferred by a patent on a product (e.g. a product obtained under Article 8(2)) containing or consisting of genetic information (e.g. a DNA sequence) extends to any material... "in which the product is incorporated and in which the genetic information is contained and performs its function". For example, the protection conferred on a tomato sequence modified by a particular NGT extends to any tomato (or other biological material) whose genome contains this sequence, provided that it retains the function claimed in the patent.Breeders are presumed to be infringers What could happen in practice in the event of alleged infringement of an NGT process patent? If, for example, Corteva suspects a small breeder of having produced seeds directly using its patented process, this will have to be proven. One might imagine that a multinational seed company with substantial resources and powerful biotechnology tools might be asked to provide evidence to back up its allegations. This is not the case. The Unified Patent Court (UPC), set up by the European Union, states in Article 55 (Article 55 (UPC) - Reversal of the burden of proof)3 of its "Agreement relating to a Unified Patent Court" that, in the case of a process patent, it is up to the alleged infringer to prove that he is not. This is what the law calls the "reversal of burden of proof"4.In order to clear his name, a breeder would simply have to show that he had produced his seed by an essentially biological process or that it could have been produced by an essentially biological process. But how would he do this if it is impossible to distinguish - as the NGT developers themselves claim - between a seed obtained by an essentially biological process and a seed obtained using a patented NGT process?This is why the amended text voted by the European Parliament on 7 February took the "precaution" of specifying that "the protection conferred by a patent on a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process". This distinction is entirely possible. Yves Bertheau, former director of research at Inrae at the Muséum National d'Histoire Naturelle in Paris, has shown this in various publications, as have other scientists5. The European Union itself is also funding research programmes (Darwin and Detective) aimed at studying the development of tools for detecting, identifying and tracing NGTs and, ultimately, standardising such analyses6. Since the constraints are therefore not technical, but purely regulatory, it would make sense for patent holders to be responsible for publishing the process used to distinguish products resulting from their invention from any other product likely to resemble them. Publication of this process is compulsory under Directive 2001/18, but the European Commission is proposing to cancel it under the new GMO/NGT regulations.It is in fact by relying on the principle of "reversal of burden of proof" that the holders of patents on NGT processes hope to take legal action. If the alleged infringers (see box) are unable to demonstrate that their product is not directly derived from a patented NGT process, or from the reproduction of such products, they will have to stop production or negotiate a potentially onerous patent licence. Alternatively, they can challenge the validity of the patent. This will almost never happen, given the dissuasive cost of such procedures.In the event of the European Union finally deciding to exclude NGT-derived products from patentability, Corteva, Bayer, BASF, Syngenta and co. will still have a free hand to act against farmers and small and medium-sized plant breeders via process claims.Intentional or unintentional patent infringementDifferent situations can arise in which a process patent is infringed. For example, it may be a case of wilful infringement by simply reproducing the steps of a process claim, in which case the scope of the process patent extends to the product directly obtained by this process. Alternatively - particularly in the case of plants - it may involve contamination, i.e. the unintentional and unavoidable but effective copying, without authorisation, of a product identical to that resulting from the patented invention. However, in the latter case, infringement would not be recognised in France (Germany provides equivalent protection), due to the "fortuitous or accidental" nature of this contamination (Article 613-2-2 of the French Intellectual Property Code). However, Directive 98/44 EC does not provide for such 'immunity' in the event of contamination, and other European countries may therefore provide otherwise. It should also be remembered that this legal extension of the scope of process patents to the product obtained is compounded by the question of the scope resulting from the wording of claims which improperly cover "native traits" of plants. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [160] => Array ( [objectID] => 7547 [title] => Seed marketing reform: freeing cultivated biodiversity or patented GMOs? [timestamp] => 1709510400 [date] => 04/03/2024 [annee] => 2024 [url] => https://infogm.org/en/seed-marketing-reform-freeing-cultivated-biodiversity-or-patented-gmos/ [image] => https://infogm.org/wp-content/uploads/2024/02/7185975201_b71105fdf0_c-768x432.jpg [extrait] => While the proposed deregulation of GMOs is attracting a certain amount of attention, a proposal for a regulation on the marketing of seeds and other plant reproductive material is also being discussed in Brussels, albeit on a much more confidential basis. To shed light on what is at stake in these discussions, Inf’OGM is publishing […] [chapo] => For Guy Kastler of the peasants french union Confederation Paysanne, the proposal for a new regulation on “plant reproductive material” is presented as a response to the demands of many farmers, small seed companies, consumers and civil society. Their aim is to put an end to the drastic erosion of cultivated and food biodiversity resulting from the requirement for varieties to be uniform and stable. But abandoning the monopoly of these catalogue standards and plant variety rights does little to conceal the introduction of a new form of market control. This control is carried out by the molecular markers of patented modified genes and by the obligations to chemically and genetically control the collapse of the health of “improved” and genetically modified industrial plants. [texte] => While the proposed deregulation of GMOs is attracting a certain amount of attention, a proposal for a regulation on the marketing of seeds and other plant reproductive material is also being discussed in Brussels, albeit on a much more confidential basis. To shed light on what is at stake in these discussions, Inf'OGM is publishing a critical analysis by one of the players involved, Guy Kastler, of the Confederation Paysanne.On 5 July 2023, the European Commission proposed two new regulatory texts on the same day. The first concerns GMO plants and their deregulation. The second concerns "Plant Reproductive Material" (PRM)1. In the new industrial language, "PRM" refers to what farmers call seeds and seedlings, i.e. the reproductive organs of living organisms which deserve far more attention and respect than any other material.Removing all national protection for the rights of farmers, conservation networks and amateur gardenersThe European legal framework for the marketing of seeds and seedlings is currently based on ten or so directives, specific to each major plant family, which Member States can adapt in their national laws to suit their particular agricultural and cultural characteristics. The PRM proposal replaces these directives with a regulation that is de facto binding on all Member States and is therefore not open to national interpretation. It cannot be understood without considering its twin proposal on GMOs derived from "new genomic techniques" (NGT)2 and other regulations concerning, in particular, intellectual property, plant health and control of the food chain.If adopted, it would remove the possibility currently given to Member States to prohibit or define conditions for the cultivation of varieties which, like GMOs, could be harmful to the cultivation of other varieties, to health or to the environment.It would also regulate all exchanges of seeds and seedlings, including between farmers, biodiversity conservation associations and amateur gardeners, unlike the current directives which apply only to exchanges "with a view to commercial exploitation", and not with a view to selection and conservation on the farm or in the garden. This framework, hailed as a step forward in the few states that currently ban such exchanges, would be a major setback in those that do not regulate them.Since 2014, French law has explicitly authorised exchanges between farmers of seeds and seedlings not covered by a plant variety right, including against payment of costs, as part of mutual agricultural assistance, and therefore outside the obligations applying to their marketing. Its "amateur" catalogue, opened in 1998, is not compulsory for marketing seeds that are not intended for commercial cultivation. The PRM proposal defines all these exchanges as marketing and would therefore subject them to the specific constraints of global trade: obligations of "sanitary" sterilisation, analysis, bureaucratic registrations, controls, administrative approvals, etc. It would prohibit exchanges of seedlings between farmers and limit exchanges of seeds to restricted quantities not yet defined. It would subject them to the same health constraints as the global seed trade, which would be far more restrictive than those for agricultural cultivation.The obligation to multiply exchanged seeds in specific plots, separate from any agricultural cultivation, and to guarantee the absence of any trace of pathogens would remove the main interest of exchanges intended for selection and conservation on the farm, which is to encourage plants to adapt to local growing conditions in order to resist pathogens on their own. A plant can only learn to resist what it knows. This is why this adaptation can only take place in agricultural production plots intended for the market and without the total eradication of all pathogens, and not in conditions of cultivation hyper-artificialized by pesticides and other eradications, made compulsory by health regulations for commercial seed production.Opening up the market to patented GMOsAll genetic manipulation techniques profoundly destabilise the plant genome. Numerous backcrosses are then necessary to stabilise laboratory varieties - the only ones to be genetically manipulated - and then the elite commercial varieties with which they are crossed to incorporate the modified genes. The requirements for Distinctness, Uniformity and Stability (DUS) of commercial varieties, imposed by the catalogue and plant breeders' rights (PVR), make this tedious work longer and much more expensive, if not impossible.Patents on modified genes offer seed companies stricter intellectual protection than PVR, without imposing these DUS constraints. However, the catalogue must no longer impose them either, so that these patented genes can reach the market. European law has already opened up to non-DUS "heterogeneous material". But this is currently restricted to organic seeds, which reject all GMOs and therefore most patents. The draft PRM regulation wants to open it up to non-organic seeds and therefore to patented GMOs/NTGs. The same applies to new conservation or amateur varieties that are not subject to the DUS requirements of the official catalogue and the PVR3.Facilitating the confiscation of all peasant and traditional seeds by the patents of a handful of transnational companiesAccording to the Anses, the proposed GMO/NTG regulation is based on an assumption "with no scientific background" that GMOs derived from NTGs would be similar to plants derived from peasant or traditional breeding4. This assumption is used to justify the removal of the obligation to publish the GMO/NTG identification process. Consequently, the scope of patents covering these GMOs/NTGs would extend to all peasant and traditional seeds naturally containing traits similar to those claimed by these patents5.Only farmers or small seed growers who, before claiming such patents, have analysed and published all the genetic sequences of all their seeds and deposited a sample of each of them in official collections will then be able to prove that they are not the product of the patented invention. But none of them carry out such analysis, which are far too costly and not essential to their work. In the event of prosecution or seizure on the mere presumption of infringement, they will not be able to prove that they have obtained their seeds without using the patented process, and will be condemned. Opening up the market to GMOs/NTGs would thus facilitate the confiscation of all seeds by these pirate patents.And, when it comes to registration in the catalogue, the ongoing replacement of phenotypic characterisation of varieties by patented gene markers would make it easier to hunt down counterfeits, whether they are deliberate, the result of chance genetic contamination or the abusive extension of the scope of NTG patents to "native" traits. A test as simple as the Covid test makes it possible to identify a patented gene in the harvest and right up to the supermarket shelf, unlike the phenotypic characteristics of PVR on plants, which can, for the most part, only be identified by moving experts into the fields.Definitive ban on farm-saved seedFollowing strong farmers' protests, European regulations have recognised the right of farmers to use seeds from their own harvests of varieties covered by a PVR, even if some of their characteristics are patented (in return for royalties). But this right only applies to varieties covered by a PVR. It will not apply to heterogeneous material and new GMO/NTG conservation varieties covered by a patent and not by a PVR6. Farm-saved seed of these varieties containing patented genes, whether heterogeneous or conservation varieties, would therefore become illegal!Reject all patents on living organisms to liberate cultivated biodiversity!On 7 February 2024, the European Parliament proposed banning the patentability of plants derived from NTGs. But what's the point if it doesn't also ban the patentability of NTG techniques themselves? The scope of a patent relating to a process can extend to all the products resulting from this process and to their reproduction. And, as in the case of patents on plants derived from NTGs, the scope of a patent on an NTG could therefore extend to all plants naturally containing a trait similar to that claimed to have been obtained by that NTG.Banning all patents on living organisms and other infringements (regulatory, bureaucratic and so-called "sanitary") of farmers' rights to save, use, exchange and sell their seeds remains the only way to free cultivated biodiversity once and for all. Guy KASTLER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [161] => Array ( [objectID] => 7182 [title] => Credits and legal information [timestamp] => 1707436800 [date] => 09/02/2024 [annee] => 2024 [url] => https://infogm.org/en/7182-2/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Website published by the non-profit-making association under the French law of 1901 called “Inf’OGM – Veille citoyenne sur les OGM” (GMO Citizens’ Watch)38 rue St Sabin – 75011 Paris – FranceTelephone number: +33 7 66 22 02 76Inf’OGM has no share capital. Publication director: Annick Bossu Website host: Gandi SAS63-65 boulevard Masséna – 75013 Paris […] [chapo] => [texte] => Website published by the non-profit-making association under the French law of 1901 called "Inf'OGM - Veille citoyenne sur les OGM" (GMO Citizens' Watch)38 rue St Sabin - 75011 Paris - FranceTelephone number: +33 7 66 22 02 76Inf'OGM has no share capital.Publication director: Annick BossuWebsite host: Gandi SAS63-65 boulevard Masséna - 75013 Paris - FranceTelephone number: +33 3 66 72 17 61Simplified joint stock company with share capital of €630,000.Technical production: moduloo.net (Julien Villalard)CPPAP online press service number: 0626 Z 90928Valid until: 30/06/2026 [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [162] => Array ( [objectID] => 7324 [title] => GMOs/NGTs : a deceptive patent ban [timestamp] => 1707177600 [date] => 06/02/2024 [annee] => 2024 [url] => https://infogm.org/en/gmos-ngts-a-deceptive-patent-ban/ [image] => https://infogm.org/wp-content/uploads/2026/03/optical-illusion-155520_1920-768x768.png [extrait] => Since its publication on 5 July 2023, the European Commission’s regulatory proposal on “new genomic techniques” (NGTs) has been the subject of a complex and intense debate. A number of problems have been raised, such as the lack of a scientific basis, the proposed abolition of traceability for GMOs derived from these techniques, the abolition […] [chapo] => At its plenary session on 6 February 2024, the European Parliament’s Environment Committee will present its proposed amendments to the initial draft on the deregulation of GMO plants obtained using « new genomic techniques ». These include the non-patentability of « NGT plants ». But what could be behind such a proposal when it has been discussed upstream with the seed multinationals, which hold the majority of patent rights on NGTs ? [texte] => Since its publication on 5 July 2023, the European Commission’s regulatory proposal on "new genomic techniques" (NGTs) has been the subject of a complex and intense debate. A number of problems have been raised, such as the lack of a scientific basis, the proposed abolition of traceability for GMOs derived from these techniques, the abolition of the right of Member States to ban cultivation, and the end of public information. In recent weeks, however, the issue of patentability has come under the spotlight, with some Member States proposing to ban the patentability of GMO/NGT plants. A real political dissensus thus weighed on the vote of 11 December 2023 by the European Council of Agriculture Ministers, which therefore did not adopt the Spanish Presidency’s compromise proposal. Today, it is the turn of the European Parliament’s "agriculture" and "environment" committees to propose that these plants should not be patentable. However, farmers’ organisations and civil society groups have already warned that such a decision, which would not serve its purpose in its current form, would be a mere announcement.Reminder of the patent issueThe problem of patents has crystallised around a major thrust of the Commission’s initial text, which proposes the abolition of all traceability and labelling of plants derived from NGTs. Such a move would result de facto in the loss of information on the detection and identification procedures for patented GMOs/NGTs, and therefore on the possible presence of patented "biological material" or "genetic information" in various products : commercial seeds modified by NGTs, plants, seeds and products contaminated in the field or in the supply chain, farmers’ or traditional seeds containing biological material or genetic information that cannot be distinguished from the descriptions given in the patents, and in all the products derived from them. This loss of information would create legal uncertainty for farmers and small and medium-sized seed companies, processors and distributors of agricultural products. The latter do not have the means to know whether or not they are at risk of being sued for infringement of these patents, or to defend themselves against abusive lawsuits, nor do they have the capacity to ensure that no patent covers a plant before working with it.Although some patent databases, such as Pinto, proposed by Euroseeds, the representative of European seed companies, are available, they are incomplete because they are based on the voluntary principle. Information on seeds covered by patents is therefore at the discretion of the breeders alone. The "patent clubs" set up by the major seed companies, which hold the vast majority of NGT patent rights, are not a solution for small players in the sector either, as they too have little access to them1.Deregulating GMOs would therefore mean subjecting the entire farming and seed industry, as well as the processing and distribution of agricultural products, to the patents of a few multinationals. Contrary to appearances, however, the non-patentability of NGT plants, as proposed by MEPs on the European Parliament’s Environment and Agriculture Committees, would be far from sufficient to solve this problem.Parliamentary "convergence"On 13 December 2023, this Agriculture Committee had proposed, among other things, the non-patentability of "NGT plants and their parts" (without specifying NGT1 or NGT 2)2. It seems unambiguous on the non-patentability of GMOs/NGTs : "NGT plants, their seeds, plant material, associated genetic material such as genes and gene sequences, as well as plant characteristics should be excluded from patentability". However, this amendment is limited solely to the non-patentability of NGT products and does not concern processes.In its report voted on 24 January 2024, as Inf’OGM was able to read it, the Environment Committee, the lead parliamentary committee on this issue, proposes the following amendments to the European Parliament :- Exclusion from patentability (new Article 4a)The following will not be patentable : "NGT plants, plant material, parts thereof, genetic information and the process features they contain shall not be patentable.".- Evaluation report on the impact of patents (New article 30, par. 5 a)Submission, by June 2025, of a report by the European Commission assessing the impact of patents on breeders’ and farmers’ access to various plant reproductive materials, innovation, and opportunities for SMEs. This report, which will take account of Articles 4a (Exclusion from patentability) and 33a (Amendment of Directive 98/44 on biotechnology inventions) (see below) of the current regulation, will determine whether additional legal measures are required.- Amendment of European Directive 98/44/EC on biotechnological inventions (new Article 33a) of its Article 43The latter, which defines the elements excluded from patentability, would be supplemented by the exclusions of the new Article 4a of the NGT Regulation referred to above, as well as by the excluded subject matter of Directive 2001/18 : "plants, plant material, parts thereof, genetic information and process characteristics contained therein which are obtainable by techniques excluded from the scope of Directive 2001/18/EC, as listed in Annex IB to that Directive".According to Annex IB of Directive 2001/18, the techniques excluded from the scope of this directive because they have a history of safe use are "mutagenesis" (not on cells multiplied in vitro but on whole plants, for example) and "cell fusion" of plant cells from organisms that can exchange genetic material by traditional selection methods. Plants, plant material, parts thereof, genetic information and process characteristics contained therein" resulting from these techniques would therefore not be patentable. It should be noted that these amendment provisions are a far cry from the European Commission’s initial proposal for a regulation in July 2023. The latter contained no provisions relating to patents. But, above all, can this non-patentability be effective ?False pretenses and risks involvedIn proposing the non-patentability of "NGT plants, parts of plant material thereof, genetic information and process characteristics contained therein", Parliament’s two committees are concerned only with patents covering products. What remains are patents covering processes, which relate to the techniques themselves. The biotechnology industry retains the legal right to claim patent rights on all the processes and other "genetic scissors" it wishes. All the reagents that implement these processes are also patentable, such as new enzymes or Crispr systems. The very existence of these process patents renders null and void the proposal by the Parliamentary Committees to abolish patents on NGT plants. This reality of patent law was reiterated by ECVC and twelve French organisations on 25 January 2024, who wrote that "the promise to ban the patentability of GMO/NGT plants is nothing more than a smoke and mirrors scheme designed to mislead the public [...] such an amendment would be totally pointless as it would perpetuate the patentability of NGT techniques which it is not planned to abolish".The risks, for both seed companies and farmers, resulting from contamination or unintentional use for breeding of genetic resources covered by patents, would therefore remain. As do the risks of abusively extending the scope of patents to the resulting "native traits".In the case of infringement proceedings requiring a reversal of the burden of proof4 : seed growers who have registered their varieties or heterogeneous materials before filing a patent application, deposited a sample in an official collection and/or published their genetic sequences in an official journal, will be able to claim that their seeds have prior art and therefore that they have not made use of the patented invention. On the other hand, farmers and small amateur seed growers who do not register their seeds in the catalogue, do not sequence their genomes and do not deposit samples in official collections will not be able to provide this proof of anteriority enabling them to prove that their seeds are not counterfeits of the patented invention.Multinationals consulted upstreamThe seed multinationals were consulted by the Parliamentary Committees, as their "Transparency" pages show. Have the new provisions been endorsed by these multinationals ? And if so, what would that mean ? Just as medium-sized seed companies are looking at plant variety rights (PVR) rather than patents, multinationals could be satisfied with patent protection for their processes5. Because the very existence of the latter will enable them to claim rights over plants derived from NGT processes.They could also benefit from a PVC on genetic characteristics which, linked to process patents, would enable them to regain a form of genetic protection for their NGT-derived products. In addition, patent protection remains very expensive and may lead even the major seed companies to rationalise their patent portfolios. A fortiori, if NGT-derived products were no longer patentable. A single process patent can cover multiple varieties, and possibly multiple species, containing genetic traits obtained directly by this process. In order to make the most of their NGT developments, multinational seed companies would still be able to rely on their patents covering their processes. Legal action is possible on the basis of such rights.Directive 98/44 and European Patent ConventionFinally, if the non-patentability of "NGT plants, parts of plant material thereof, genetic information and process characteristics contained therein" were to be adopted, this would have consequences for the EU Biotechnology Inventions Directive 98/44/EC, which would have to be amended, as proposed in the amendment above. EU Member States will then have to incorporate the new provisions into their national legislation with adjustments in their national legal systems to ensure compliance. The "European Unitary Patent", which is dependent on the European Union, will also have to take account of the new provisions governing the patentability of plants derived from NGTs.Then, for these amendments to apply to European patents, the European Patent Convention (EPC) governing the operation of the European Patent Office (EPO), a body that does not depend on the European Union, will have to incorporate these new provisions on NGTs, as it did for essentially biological processes. But the official route for such an amendment is neither simple nor quick, and requires the approval of the members of the EPC, not all of whom are members of the European Union6. In addition, patent applications filed and patents granted prior to these amendments will not be cancelled but would be “further limited” (Recital 45a /amendments of the Environment Committee) to process claims. They will nevertheless remain valid until the end of the 20 years following the date on which they were filed. If we continue to leave the reins of European law in the hands of industry lobbyists, this will be enough time to force a vote on new changes to GMO regulations....Adoption and transpositionThe report is due to be presented to the plenary session of the European Parliament on 6 February, with a possible vote. Should the European Parliament vote on a text, it will follow the ordinary legislative procedure as part of a trialogue that also includes the Council (which has yet to propose its amended text) and the European Commission in the discussions to reach a final text. Many players and observers are beginning to doubt whether such a final text can be adopted before the election of a new European Parliament in June 2024 and the appointment of a new Commission. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [163] => Array ( [objectID] => 7310 [title] => Problems ahead due to cultivation of GMO maize in Europe? [timestamp] => 1707177600 [date] => 06/02/2024 [annee] => 2024 [url] => https://infogm.org/en/-6/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => At the beginning of January 2023, the Anses published its comments on the environmental monitoring report on the cultivation of transgenic maize Mon810 in Spain and Portugal in 2021 [[Anses, [“Note d’appui scientifique et technique de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relative à la demande de commentaires sur […] [chapo] => La téosinte, ancêtre du maïs d’origine mexicaine, est de plus en plus présente en Europe. Pour les experts français et européens, la situation pourrait devenir très problématique, car cette téosinte est retrouvée dans des champs de maïs transgénique Mon810, modifié génétiquement pour produire des protéines bactériennes insecticides. Selon eux, une surveillance plus précise s’impose pour éviter de perdre le contrôle sur la dissémination des protéines insecticides produites par ce maïs. Problème : Bayer/Monsanto s’oppose à renforcer cette surveillance ! [texte] => At the beginning of January 2023, the Anses published its comments on the environmental monitoring report on the cultivation of transgenic maize Mon810 in Spain and Portugal in 2021 [[Anses, ["Note d'appui scientifique et technique de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail relative à la demande de commentaires sur le rapport annuel (2021) de surveillance environnementale de la culture du maïs génétiquement modifié MON810 en Espagne et au Portugal"->https://www.anses.fr/fr/system/files/BIOT2022SA0226.pdf], 2 January 2023]]. Authorised for cultivation in the European Union since 1998, Mon810 transgenic maize produced by Bayer (since its acquisition of Monsanto) is subject to annual environmental monitoring reports. These reports, which are not compulsory, are sent by the company to the Commission, which then asks the Member States for their comments. In 2021, the crops monitored covered a cultivated area of around 100,927 hectares, including 96,606 ha in Spain and 4,321 ha in Portugal.Teosinte, a plant to keep an eye onTeosinte is the plant species which, when domesticated, gave rise to the maize grown today in many countries. Endemic to Mexico, this species has recently appeared in Spain and Portugal, as well as other European countries such as France, as we shall see. Naturally very close to maize, teosinte can easily hybridise with it. The cultivation of Mon810 maize in Spain and Portugal therefore inherently poses the risk of transgene transfer to teosinte. The French experts at the Anses criticise the monitoring protocol followed by Bayer for being inadequate. They write that "{the wording of the question put by the authorisation holder to farmers, asking them to list the three most abundant weeds in the plot surveyed, does not make it possible to identify the presence of teosinte if it is not among the most abundant species}". They therefore recommend that the presence of teosinte "{be the subject of a specific and explicit question in this survey}".This is an important point, because hybridisation in the field between transgenic maize and teosinte could lead to dissemination of the transgene producing the Cry1Ab insecticide protein. Studies of the potential impact on the environment, carried out almost thirty years ago, focused in particular on the effects of overexposure of corn borer to the insecticide protein. A transfer of the transgene from maize to teosinte would mechanically increase the presence of the insecticide protein in the environment. For the Anses, this would mean a possible "{change in the exposure characteristics of target insects in regions where MON810 maize is grown and teosinte is present}". Their request is therefore very clear: it is necessary "{to include the characterisation of this new source of exposure to the Cry1Ab protein in the next monitoring plan. This plan should therefore consider teosinte populations, as well as the search for the transgene in these populations}".{{{Bayer does not agree}}}As the French experts report, the European Food Safety Authority (EFSA) had also highlighted this potential problem linked to the presence of teosinte. The EFSA recommended, in 2022 as in 2021 and 2020, that all new scientific data on teosinte should be taken into account and that questionnaires for farmers should include a declaration on the presence of teosinte and the corresponding levels of infestation. However, Bayer refused to change its environmental monitoring practices and, in particular, the content of the questionnaires sent to farmers. The Anses stated that "{the authorisation holder considers that the appearance of teosinte in Spain is a general agronomic problem and that a report on the emergence or occurrence of teosinte as part of the safety assessment of MON810 maize is not justified}".Bayer has therefore not modified its general monitoring of Mon810 maize crops. As the EFSA experts noted at the end of 2023, this recommendation, which dates back to 2020 and has been repeated every year since, has still not been implemented since "{the farmer questionnaire template has not been revised yet}"[[EFSA, ["Assessment of the 2021 post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU"->https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.8411], 6 December 2023]]. However, they state that a generic question specifically asking about the presence of teosinte in or around fields of Mon810 maize "{may help to gather more targeted information on both the occurrence of teosinte and corresponding levels of infestation in maize MON 810 fields}".Bayer's disagreement with the EFSA is not limited to the monitoring of teosinte and the transfer of the transgene from Mon810 maize to this plant. On the contrary, the company has proposed lightening the monitoring of Mon810 maize crops by limiting "{general monitoring to bibliographic research and the system for reporting undesirable effects by farmers}", as explained by the Anses.{{{Potential problems to come}}}For the French experts, this company's refusal is problematic, as it makes it impossible to monitor and detect the transmission of the CryA1b transgene from Mon810 maize to teosinte in Spain and Portugal. Such a transfer of the genetic sequence encoding an insecticidal protein to teosinte would nonetheless raise major problems. The Anses lists three of them:- The first is "{the potential dispersal of a transgene likely to confer a selective advantage on a weed that forms spontaneous populations that are difficult to control}". A plant that has acquired the Mon810 transgene through contamination would in turn give rise to plants that produce insecticidal proteins, which would be resistant to attacks by corn borer, an unforeseen selective advantage that could allow them to proliferate.- The second problem concerns the transfer, in a second phase, "{of genes from Mon810 maize to conventional maize varieties}" {via} teosinte.- Finally, the third problem is that of "{the presence of hybrid plants in refuge zones, which could compromise the effectiveness of a strategy to prevent the appearance of resistance}". These zones must be free of genetically modified sequences in plants to prevent insects from being exposed to too many insecticidal transgenic proteins and thus acquiring resistance more quickly.In 2021, the European Commission gave EFSA a specific mandate on this issue. The response it received in May 2021 left no room for misunderstanding. The EFSA wrote to the Commission that Bayer should in particular take into account the scientific data specific to teosinte and that the questionnaire to farmers should be revised to include a question specific to the occurrence of teosinte and teosinte hybrids, as well as the levels of presence in the fields [[EFSA, ["Questions - Art 31 - Scientific and technical assistance, EFSA-Q-2021-00266"->https://open.efsa.europa.eu/questions/EFSA-Q-2021-00266], 20 May 2021]]. A position that the Anses also adopted in early 2023, requesting that the possible presence of the Cry1Ab transgene in these plants also be monitored. At the end of 2023, the EFSA will reiterate its request in its commentary on the Bayer report on crops in 2022.{{{The case of France}}}These recommendations from the Anses and EFSA do not directly concern France, where cultivation of Mon810 maize is banned. However, teosinte is already present in France. As Inrae explains in a text published in April 2021, the presence of teosinte in maize crops has been reported "{from the 1990s in the west of France, and from the 2010s in the north of Spain}"[[Inrae, ["La téosinte, une « {mauvaise herbe} » venue du Mexique qui se développe en Europe grâce à son évolution génétique"->https://www.inrae.fr/actualites/teosinte-mauvaise-herbe-venue-du-mexique-qui-se-developpe-europe-grace-son-evolution-genetique], 2020]].However, other herbicide-resistant maize varieties are grown in France, such as DUO maize from BASF. The study conducted by researchers[[ ["Adaptive introgression from maize has facilitated the establishment of teosinte as a noxious weed in Europe"->https://www.pnas.org/doi/full/10.1073/pnas.2006633117], 2020; V. Le Corre et al., PNAS, October 13, 2020, vol. 117, no. 41, pp25618–25627]] from Inrae, CNRS and IRD made the link between this DUO maize and teosinte. It "revealed genetic exchanges with maize varieties grown in Europe that have enabled teosinte to acquire [...] resistance to herbicides}". This resistance was acquired by the transfer between BASF's DUO maize and teosinte of a genetic sequence ACC1 containing a mutation conferring herbicide resistance. The company explains that it obtained this DUO maize by introducing "{a spontaneous mutation discovered in the 1980s [...] into maize hybrids by conventional breeding methods (successive backcrosses)}"[[BASF, ["Désherber le maïs en post-levée : DUO® System"->www.agro.basf.fr/fr/cultures/mais/desherbage_du_mais/desherber_le_mais_en_post_levee_duo_system.html].]].If it’s a GMO that is exempt from legislative requirements, this scientific data on BASF's genetically modified maize is an important reminder at a time when the European Commission is pushing for GMOs to be deregulated, and therefore no longer subject to monitoring. [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [164] => Array ( [objectID] => 7312 [title] => Problems ahead due to cultivation of GMO maize in Europe? [timestamp] => 1707177600 [date] => 06/02/2024 [annee] => 2024 [url] => https://infogm.org/en/problems-ahead-due-to-cultivation-of-gmo-maize-in-europe/ [image] => https://infogm.org/wp-content/uploads/2024/02/Teocinte_Oax_5_agosto_2008_063-768x515.jpg [extrait] => At the beginning of January 2023, the Anses published its comments on the environmental monitoring report on the cultivation of transgenic maize Mon810 in Spain and Portugal in 2021. Authorised for cultivation in the European Union since 1998, Mon810 transgenic maize produced by Bayer (since its acquisition of Monsanto) is subject to annual environmental monitoring […] [chapo] => Teosinte, an ancestor of maize of Mexican origin, is increasingly present in Europe. For French and European experts, the situation could become very problematic, as this teosinte has been found in fields of Mon810 transgenic maize, genetically modified to produce insecticidal bacterial proteins. In their view, more precise monitoring is needed to avoid losing control over the spread of insecticidal proteins produced by this maize. The problem is that Bayer is opposed to stepping up this monitoring! [texte] => At the beginning of January 2023, the Anses published its comments on the environmental monitoring report on the cultivation of transgenic maize Mon810 in Spain and Portugal in 20211. Authorised for cultivation in the European Union since 1998, Mon810 transgenic maize produced by Bayer (since its acquisition of Monsanto) is subject to annual environmental monitoring reports. These reports, which are not compulsory, are sent by the company to the Commission, which then asks the Member States for their comments. In 2021, the crops monitored covered a cultivated area of around 100,927 hectares, including 96,606 ha in Spain and 4,321 ha in Portugal.Teosinte, a plant to keep an eye onTeosinte is the plant species which, when domesticated, gave rise to the maize grown today in many countries. Endemic to Mexico, this species has recently appeared in Spain and Portugal, as well as other European countries such as France, as we shall see. Naturally very close to maize, teosinte can easily hybridise with it. The cultivation of Mon810 maize in Spain and Portugal therefore inherently poses the risk of transgene transfer to teosinte. The French experts at the Anses criticise the monitoring protocol followed by Bayer for being inadequate. They write that "the wording of the question put by the authorisation holder to farmers, asking them to list the three most abundant weeds in the plot surveyed, does not make it possible to identify the presence of teosinte if it is not among the most abundant species". They therefore recommend that the presence of teosinte "be the subject of a specific and explicit question in this survey".This is an important point, because hybridisation in the field between transgenic maize and teosinte could lead to dissemination of the transgene producing the Cry1Ab insecticide protein. Studies of the potential impact on the environment, carried out almost thirty years ago, focused in particular on the effects of overexposure of corn borer to the insecticide protein. A transfer of the transgene from maize to teosinte would mechanically increase the presence of the insecticide protein in the environment. For the Anses, this would mean a possible "change in the exposure characteristics of target insects in regions where MON810 maize is grown and teosinte is present". Their request is therefore very clear: it is necessary "to include the characterisation of this new source of exposure to the Cry1Ab protein in the next monitoring plan. This plan should therefore consider teosinte populations, as well as the search for the transgene in these populations".Bayer does not agreeAs the French experts report, the European Food Safety Authority (EFSA) had also highlighted this potential problem linked to the presence of teosinte. The EFSA recommended, in 2022 as in 2021 and 2020, that all new scientific data on teosinte should be taken into account and that questionnaires for farmers should include a declaration on the presence of teosinte and the corresponding levels of infestation. However, Bayer refused to change its environmental monitoring practices and, in particular, the content of the questionnaires sent to farmers. The Anses stated that "the authorisation holder considers that the appearance of teosinte in Spain is a general agronomic problem and that a report on the emergence or occurrence of teosinte as part of the safety assessment of MON810 maize is not justified".Bayer has therefore not modified its general monitoring of Mon810 maize crops. As the EFSA experts noted at the end of 2023, this recommendation, which dates back to 2020 and has been repeated every year since, has still not been implemented since "the farmer questionnaire template has not been revised yet"2. However, they state that a generic question specifically asking about the presence of teosinte in or around fields of Mon810 maize "may help to gather more targeted information on both the occurrence of teosinte and corresponding levels of infestation in maize MON 810 fields".Bayer's disagreement with the EFSA is not limited to the monitoring of teosinte and the transfer of the transgene from Mon810 maize to this plant. On the contrary, the company has proposed lightening the monitoring of Mon810 maize crops by limiting "general monitoring to bibliographic research and the system for reporting undesirable effects by farmers", as explained by the Anses.Potential problems to comeFor the French experts, this company's refusal is problematic, as it makes it impossible to monitor and detect the transmission of the CryA1b transgene from Mon810 maize to teosinte in Spain and Portugal. Such a transfer of the genetic sequence encoding an insecticidal protein to teosinte would nonetheless raise major problems. The Anses lists three of them:- The first is "the potential dispersal of a transgene likely to confer a selective advantage on a weed that forms spontaneous populations that are difficult to control". A plant that has acquired the Mon810 transgene through contamination would in turn give rise to plants that produce insecticidal proteins, which would be resistant to attacks by corn borer, an unforeseen selective advantage that could allow them to proliferate.- The second problem concerns the transfer, in a second phase, "of genes from Mon810 maize to conventional maize varieties" via teosinte.- Finally, the third problem is that of "the presence of hybrid plants in refuge zones, which could compromise the effectiveness of a strategy to prevent the appearance of resistance". These zones must be free of genetically modified sequences in plants to prevent insects from being exposed to too many insecticidal transgenic proteins and thus acquiring resistance more quickly.In 2021, the European Commission gave EFSA a specific mandate on this issue. The response it received in May 2021 left no room for misunderstanding. The EFSA wrote to the Commission that Bayer should in particular take into account the scientific data specific to teosinte and that the questionnaire to farmers should be revised to include a question specific to the occurrence of teosinte and teosinte hybrids, as well as the levels of presence in the fields3. A position that the Anses also adopted in early 2023, requesting that the possible presence of the Cry1Ab transgene in these plants also be monitored. At the end of 2023, the EFSA will reiterate its request in its commentary on the Bayer report on crops in 2022.The case of FranceThese recommendations from the Anses and EFSA do not directly concern France, where cultivation of Mon810 maize is banned. However, teosinte is already present in France. As Inrae explains in a text published in April 2021, the presence of teosinte in maize crops has been reported "from the 1990s in the west of France, and from the 2010s in the north of Spain"4.However, other herbicide-resistant maize varieties are grown in France, such as DUO maize from BASF. The study conducted by researchers from Inrae, CNRS and IRD made the link between this DUO maize and teosinte5. It "revealed genetic exchanges with maize varieties grown in Europe that have enabled teosinte to acquire [...] resistance to herbicides". This resistance was acquired by the transfer between BASF's DUO maize and teosinte of a genetic sequence ACC1 containing a mutation conferring herbicide resistance. The company explains that it obtained this DUO maize by introducing "a spontaneous mutation discovered in the 1980s [...] into maize hybrids by conventional breeding methods (successive backcrosses)"6.If it’s a GMO that is exempt from legislative requirements, this scientific data on BASF's genetically modified maize is an important reminder at a time when the European Commission is pushing for GMOs to be deregulated, and therefore no longer subject to monitoring. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [165] => Array ( [objectID] => 7309 [title] => Few micro-organisms modified by Crispr are already on the market [timestamp] => 1706572800 [date] => 30/01/2024 [annee] => 2024 [url] => https://infogm.org/en/-5/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => There are eleven bacteria, 22 yeasts, one endophytic fungus (living symbiotically inside plants) and one micro-algae. These 35 micro-organisms identified by the European Food Safety Authority (EFSA) are either in the pre-commercialization phase or, in the case of a minority, already on the market. They have been genetically modified {via} protocols using new genetic modification […] [chapo] => La Commission européenne veut-elle déréglementer les micro-organismes OGM modifiés par de nouvelles techniques, comme elle l’a proposé pour les plantes ? Si la réponse n’est pas encore connue, des comités d’experts européens sont en tout cas mobilisés pour produire les documents éventuellement nécessaires à une initiative légale de la Commission. Dans un rapport publié fin 2023, l’Autorité européenne de sécurité des aliments annonce ainsi avoir effectué un tour d’horizon des micro-organismes génétiquement modifiés par de nouvelles techniques existants. Son constat ? Une « adoption généralisée des NTGs pour produire des MGM à destination des secteurs alimentaires » serait en cours... [texte] => There are eleven bacteria, 22 yeasts, one endophytic fungus (living symbiotically inside plants) and one micro-algae. These 35 micro-organisms identified by the European Food Safety Authority (EFSA) are either in the pre-commercialization phase or, in the case of a minority, already on the market. They have been genetically modified {via} protocols using new genetic modification techniques[[EFSA, ["Horizon scanning on microorganisms and their products obtained by new developments in biotechnology->https://www.efsa.europa.eu/en/supporting/pub/en-8503]", 22 December 2023]]. The main tool used? The Crispr/Cas protein complex, in 33 out of 35 cases. At a time when companies are increasingly lobbying the European Commission to deregulate their GMMs [[.]], in the same way as the Commission is proposing for plants, this horizin scanning was actually requested from EFSA by the European Commission. It is a mandatory step if such deregulation is to be proposed.{{{GMMs that can be released into the environment}}}To carry out its research, EFSA chose to define "{new genomic techniques}" as "{techniques that can alter the genetic material of an organism, developed after the publication of EU Directive 2001/18/EC}". Thus, for example, EFSA did not look at micro-organisms obtained by "{classical mutagenesis}", according to its own words[[The notion of classical mutagenesis is vague. Above all, mutagenesis protocols for micro-organisms differ in several aspects from those for plants, but one is of particular importance: micro-organisms multiply as cells in nature, because bacteria and many yeasts are unicellular organisms. In the case of plants, which are multicellular organisms, work on cells requires isolation and multiplication stages that do not occur naturally]]. Similarly, EFSA has not studied cases where GMMs are used as a manufacturing plant for products such as food additives, which should not (except by accident) be present in the final preparation. These GMMs, on which {Inf'OGM} published [an investigation (in french)->www.infogm.org/-no174-janvier-mars-2024-] in 2023, can be obtained by various techniques, but must, legally speaking, be absent from the final product[[Eric Meunier et Christophe Noisette, [« Micro-organismes OGM : l'offensive cachée »->www.infogm.org/-no174-janvier-mars-2024-], {Inf'OGM le journal}, N°174, janvier-mars 2024.]].For its horizon scanning, EFSA has therefore only looked at cases where GMMs have been obtained by new modification techniques and are present, either as such, or their genetically modified sequences, in the marketed product. Examples include cultures of micro-organisms used to transform raw materials with prior heat inactivation (mainly for alcoholic fermentation), biomass protein preparations, cell extracts, live cultures, etc.After some difficult research due to the limited information available (see box), the European authority has identified 35 GMMs [[For a full list of the 35 GMMs, their characteristics and use, see note 1 on pages 44 to 65]]. Some of these are GMMs used to manufacture additives for food or feed, but for which the purification stage may be incomplete, leading to the presence of modified genetic sequences in the marketed product. Other GMMs are intended to be marketed directly as such, either in the field or {via} food. One example is a GM bacterium already marketed in the USA by Pivot Bio as a field fertilizer [[.]].A GM fungal endophyte developed by the University of Kentucky (USA) is said to be in pre-commercialization. It could be used {via} animal feed or directly in the environment to reduce ergot alkaloids, toxins produced by mould.On the purely food front, there is a GM bacterium for animal feed, designed to "{selectively removes unwanted bacteria (Salmonella) from animal guts}", which is already being marketed by Folium Science. A GM yeast is being developed by the University of North Carolina to increase the quantity of Beta-carotene, a yeast that can be used as a probiotic in food. Thirteen GMMs are also under development or close to commercialization for use in beer or wine production (mostly rice, in Asia).{{{Little risk assessment, detection under study}}}Of the 35 GMMs listed by EFSA, eight are indicated as already marketed and nine are in pre-marketing. But EFSA explains that "{only three identified GMMs have been subjected to an authorisation process by national or international authorities, and risk assessment studies are scarcely available}"! Among these rare cases of risk assessment, EFSA details that, [according to Folium Science’s website->https://foliumscience.com/products/], the bacteria genetically modified by this British company with the Crispr/Cas tool began, in 2023, to be assessed in Brazil "{where the first stage safety assessment has approved the technology as a Non-Genetically Modified Organism.}" (sic).These GMMs obtained by new techniques of genetic modification and intended for use as such are also the subject of some attention from expert members of the European Network of GMO Laboratories (ENGL). Although these experts have been planning to look into the question of the detection and traceability of these GMMs for some time, it has been difficult to make progress in implementing the analysis work. In March 2023, it was recalled that "{at the end of 2018 the ENGL agreed to provide a report on challenges ofdetection of GM plants, GMM and GM animals (GMA) produced by NGTs}" (NGTs, New Genomic Techniques). While the report on plants has been finalised, "{the one on GMM [...] is not proceeding because it is awaiting legal definitions}"[[ENGL, [« Report - 44^th ENGL Steering Committee Meeting »->https://gmo-crl.jrc.ec.europa.eu/ENGL/docs/ENGLSC44report.pdf], 9 March 2023.]]. This is surprising, given that the GMO regulations provide these definitions very clearly. The only explanation is that the Commission is currently considering this issue at the request of private companies in the sector. In fact, these companies are already working towards the possible deregulation of GMMs obtained using new techniques [[.]]. In June 2023, ENGL stated that the working group on "{new mutagenesis techniques}" had modified its mandate to include micro-organisms (and animals) and "{is evaluating if the report could be extended to cover them.}"[[ENGL, [« Report - 45^th ENGL Steering Committee meeting »->https://gmo-crl.jrc.ec.europa.eu/ENGL/docs/ENGLSC45_report.pdf], 20 June 2023.]].

EASA has collected little information

The research conducted by EFSA has come up against the lack of information available on GMMs intended to be marketed for direct consumption. The European authority points out, for example, that as early as 2021, the European Commission's study on the commercial uses of new genomic techniques "{underlined that collecting data on NGT-derived microorganisms was challenging in terms of identifying data sources}". As a result, there were few responses to the questions put to private companies, which themselves proved to be uninformative for "{confidentiality reasons}".In 2023, while EFSA's review was underway, the same situation occured again. EFSA indicated that for the few GM yeasts marketed in the United States for brewing beer, "{limited publicly available information is accessible regarding the specific risk assessment procedures conducted on these GMMs}".{{{A growing market}}}For EFSA, there is a "{significant activity}" in the development of marketable GMMs. While most of the marketing is done by private companies, notes the European authority, the research and development part is carried out by public bodies.[[List of the companies and public research institute identified by EFSA as the source of the 35 GMMs :- In China : University of Jiangnan, Institute of Animal Science, Chinese Academy of Agricultural Sciences, National Natural Science Foundation of China, National Natural Science Foundation of China, University of Hainan.- In South Korea : Kaist Institutes, National Research Foundation of Korea, Catholic University of Korea, Woese Institute for Genomic Biology.- In the USA : University of Kentucky, Proven40®/ Pivot Bio, Berkeley Brewing Science, Inc.- In the United Kingdom : BiomElix Guided Biotics® / FOLIUM Science.]]. Of the 35 GMMs obtained using new techniques and identified by EFSA, eight are already on the market, all of them by private companies. The US company Berkeley Yeast Company alone markets six of these GMMs.The conclusion drawn by the EFSA from its own report is that there is "{growing worldwide adoption of NGTs in producing GMMs for application in the food and feed sectors}". This observation explains the growing mobilisation of the sector's industries to obtain deregulation of these GMOs obtained by new techniques, along the lines of what the European Commission has proposed for plants in July 2023. [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [166] => Array ( [objectID] => 7330 [title] => Few micro-organisms modified by Crispr are already on the market [timestamp] => 1706572800 [date] => 30/01/2024 [annee] => 2024 [url] => https://infogm.org/en/few-micro-organisms-modified-by-crispr-are-already-on-the-market/ [image] => https://infogm.org/wp-content/uploads/2024/01/This_is_a_Microscope_for_Examination_of_Microscopic_Organisms.jpg [extrait] => There are eleven bacteria, 22 yeasts, one endophytic fungus (living symbiotically inside plants) and one micro-algae. These 35 micro-organisms identified by the European Food Safety Authority (EFSA) are either in the pre-commercialization phase or, in the case of a minority, already on the market. They have been genetically modified via protocols using new genetic modification […] [chapo] => Does the European Commission want to deregulate GMO micro-organisms modified by new techniques, as it has proposed for plants? While the answer is not yet known, European expert committees are mobilized to produce the documents that may be required for a legal initiative by the Commission. In a report published at the end of 2023, the European Food Safety Authority announced that it had carried out a horizon scanning of existing micro-organisms genetically modified by new techniques. Its findings? A « growing worldwide adoption of NGTs in producing GMMs for application in the food and feed sectors » would be going on… [texte] => There are eleven bacteria, 22 yeasts, one endophytic fungus (living symbiotically inside plants) and one micro-algae. These 35 micro-organisms identified by the European Food Safety Authority (EFSA) are either in the pre-commercialization phase or, in the case of a minority, already on the market. They have been genetically modified via protocols using new genetic modification techniques1. The main tool used? The Crispr/Cas protein complex, in 33 out of 35 cases. At a time when companies are increasingly lobbying the European Commission to deregulate their GMMs2, in the same way as the Commission is proposing for plants, this horizin scanning was actually requested from EFSA by the European Commission. It is a mandatory step if such deregulation is to be proposed.GMMs that can be released into the environmentTo carry out its research, EFSA chose to define “new genomic techniques” as “techniques that can alter the genetic material of an organism, developed after the publication of EU Directive 2001/18/EC”. Thus, for example, EFSA did not look at micro-organisms obtained by “classical mutagenesis”, according to its own words3. Similarly, EFSA has not studied cases where GMMs are used as a manufacturing plant for products such as food additives, which should not (except by accident) be present in the final preparation. These GMMs, on which Inf’OGM published an investigation (in french) in 2023, can be obtained by various techniques, but must, legally speaking, be absent from the final product4.For its horizon scanning, EFSA has therefore only looked at cases where GMMs have been obtained by new modification techniques and are present, either as such, or their genetically modified sequences, in the marketed product. Examples include cultures of micro-organisms used to transform raw materials with prior heat inactivation (mainly for alcoholic fermentation), biomass protein preparations, cell extracts, live cultures, etc.After some difficult research due to the limited information available (see box), the European authority has identified 35 GMMs5. Some of these are GMMs used to manufacture additives for food or feed, but for which the purification stage may be incomplete, leading to the presence of modified genetic sequences in the marketed product. Other GMMs are intended to be marketed directly as such, either in the field or via food. One example is a GM bacterium already marketed in the USA by Pivot Bio as a field fertilizer6.A GM fungal endophyte developed by the University of Kentucky (USA) is said to be in pre-commercialization. It could be used via animal feed or directly in the environment to reduce ergot alkaloids, toxins produced by mould.On the purely food front, there is a GM bacterium for animal feed, designed to “selectively removes unwanted bacteria (Salmonella) from animal guts”, which is already being marketed by Folium Science. A GM yeast is being developed by the University of North Carolina to increase the quantity of Beta-carotene, a yeast that can be used as a probiotic in food. Thirteen GMMs are also under development or close to commercialization for use in beer or wine production (mostly rice, in Asia).Little risk assessment, detection under studyOf the 35 GMMs listed by EFSA, eight are indicated as already marketed and nine are in pre-marketing. But EFSA explains that “only three identified GMMs have been subjected to an authorisation process by national or international authorities, and risk assessment studies are scarcely available”! Among these rare cases of risk assessment, EFSA details that, according to Folium Science’s website, the bacteria genetically modified by this British company with the Crispr/Cas tool began, in 2023, to be assessed in Brazil “where the first stage safety assessment has approved the technology as a Non-Genetically Modified Organism.” (sic).These GMMs obtained by new techniques of genetic modification and intended for use as such are also the subject of some attention from expert members of the European Network of GMO Laboratories (ENGL). Although these experts have been planning to look into the question of the detection and traceability of these GMMs for some time, it has been difficult to make progress in implementing the analysis work. In March 2023, it was recalled that “at the end of 2018 the ENGL agreed to provide a report on challenges of detection of GM plants, GMM and GM animals (GMA) produced by NGTs” (NGTs, New Genomic Techniques). While the report on plants has been finalised, “the one on GMM [...] is not proceeding because it is awaiting legal definitions”7. This is surprising, given that the GMO regulations provide these definitions very clearly. The only explanation is that the Commission is currently considering this issue at the request of private companies in the sector. In fact, these companies are already working towards the possible deregulation of GMMs obtained using new techniques8. In June 2023, ENGL stated that the working group on “new mutagenesis techniques” had modified its mandate to include micro-organisms (and animals) and “is evaluating if the report could be extended to cover them.”9.EFSA has collected little informationThe research conducted by EFSA has come up against the lack of information available on GMMs intended to be marketed for direct consumption. The European authority points out, for example, that as early as 2021, the European Commission’s study on the commercial uses of new genomic techniques “underlined that collecting data on NGT-derived microorganisms was challenging in terms of identifying data sources”. As a result, there were few responses to the questions put to private companies, which themselves proved to be uninformative for “confidentiality reasons”.In 2023, while EFSA’s review was underway, the same situation occured again. EFSA indicated that for the few GM yeasts marketed in the United States for brewing beer, “limited publicly available information is accessible regarding the specific risk assessment procedures conducted on these GMMs”.A growing marketFor EFSA, there is a “significant activity” in the development of marketable GMMs. While most of the marketing is done by private companies, notes the European authority, the research and development part is carried out by public bodies10. Of the 35 GMMs obtained using new techniques and identified by EFSA, eight are already on the market, all of them by private companies. The US company Berkeley Yeast Company alone markets six of these GMMs.The conclusion drawn by the EFSA from its own report is that there is “growing worldwide adoption of NGTs in producing GMMs for application in the food and feed sectors”. This observation explains the growing mobilisation of the sector’s industries to obtain deregulation of these GMOs obtained by new techniques, along the lines of what the European Commission has proposed for plants in July 2023. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [167] => Array ( [objectID] => 7052 [title] => Deregulation of GMOs: 13 organisations call for it to be rejected [timestamp] => 1706140800 [date] => 25/01/2024 [annee] => 2024 [url] => https://infogm.org/en/deregulation-of-gmos-13-organisations-call-for-it-to-be-rejected/ [image] => https://infogm.org/wp-content/uploads/2024/01/12109369_64dba5202d_c-768x576.jpg [extrait] => Since its publication on 5 July 2023, the proposal to deregulate GMOs/NGTs has come up against significant opposition from many stakeholders. Farmers’, environmentalists’, farmers’, processors’ and consumers’ organisations, as well as supporters of organic farming, are mobilising to ensure that the proposal is rejected or at least amended. On 11 January 2023, the European Coordination […] [chapo] => As a result of the highly critical opinion of the Anses and the political dissensus on the issue of patents, thirteen French organisations are urging MEPs to reject the proposed deregulation of GMOs/NGTs, which they consider, “under the guise of sustainable solutions”, to favour “industrial agriculture and a deadly productivist system, of which farmers are the first victims and consumers the guinea pigs”. [texte] => Since its publication on 5 July 2023, the proposal to deregulate GMOs/NGTs has come up against significant opposition from many stakeholders. Farmers’, environmentalists’, farmers’, processors’ and consumers’ organisations, as well as supporters of organic farming, are mobilising to ensure that the proposal is rejected or at least amended. On 11 January 2023, the European Coordination Via Campesina (ECVC) called on the Parliament and the Council of the European Union to suspend the examination of this proposal1. The “major events” which, according to ECVC, “have called into question the proposal for new regulation of GMOs obtained by new genomic techniques (NGT)” are the opinion of the French National Health Safety Agency (Anses) on the equivalence criteria between genetically modified plants and conventional or natural plants, and the dissensus on the question of patentability. On 25 January 2024, thirteen French organisations called on MEPs2.Reminder on equivalence criteriaThe French organisations base their arguments firstly on the Anses opinion published on 21 December which, they point out, had determined that the criteria used to determine that an NGT plant would be equivalent to a conventional plant (Category 1) had no scientific basis3. In mid-January 2023, ECVC explained, on the basis of the same Anses opinion, that “the criteria for defining GMOs to be excluded from any assessment, labelling and traceability, known as NGT 1, are not based on any scientific justification and their lack of clarity will make them unverifiable”.The criteria proposed by the European Commission to deregulate GMOs/NGTs have been the subject of serious criticism by the experts at Anses. Firstly, they consider that the basic assumption that equivalence between plants implies an absence of risk is “having no scientific basis”. The French experts also consider that the same criticism applies to the criteria proposed by the Commission for considering a GMO/NGT plant to be equivalent to a traditional plant. For ECVC, the European Parliament and the Council “cannot adopt a law that is contrary to science and, moreover, practically inapplicable. They must therefore demand a clarification of this scientific controversy before any resumption of their work”.This scientific controversy is not the sole responsibility of the Anses. For many years, other scientists have been pointing out that NGTs introduce genetic modifications in an uncontrolled or even uncontrollable way, and that the resulting GMOs have unpredictable effects, particularly on ecosystems and biodiversity. They argue that NGT-modified plants should be subject to a rigorous safety assessment similar to that applied to GMOs4. As Prof. Michael Antoniou (King’s College, London) recently explained to MEPs on 17 January 2023: “these techniques result in off-target and on-target mutations that can combine to alter the function of many genes, leading to changes in plant biochemistry, including the production of toxins and allergens”.Patentability issuesAny deregulation of GMOs derived from NGTs entails a risk of abusively extending the scope of patents on NGTs to traditional or farmers’ seeds as a result of the removal of all traceability of these GMOs and therefore of the data on the patents covering them. This risk has recently become one of the main causes of dissent within the Council of the European Union, as it threatens not only farmers, but also the European fabric of small and medium-sized seed companies. This issue led the European Parliament’s Agriculture Committee, in December 2023, and the Environment Committee of the same European Parliament, yesterday, 24 January 2024, to propose the non-patentability of GMO plants derived from NGTs in their amendments to the European Commission’s initial text.But even before yesterday’s vote by the Environment Committee, ECVC warned that a possible decision not to patent NGT plants would be legally blocked. First of all, the movement points out that “according to [the European Patent Convention ratified by the European Union - EPC], NGTs are unquestionably patentable processes and the scope of a patent relating to a process extends to all products resulting from the use of that process” [The European Patent Convention provides for an autonomous legal system for the grant of European patents using a single, harmonised procedure before the EPO]. A possible EU decision prohibiting the patentability of GMO/NGT products “is therefore simply inapplicable given the current state not only of European patent law, but also of the Union’s international commitments”. Furthermore, this type of amendment affecting the basic principles of the EPO (European Patent Office) patent system would require a consensus among the member states of the EPC, which also includes non-EU countries. This usually requires a diplomatic conference. For ECVC, this question of patentability justifies the suspension of work underway in the European bodies on the proposal to deregulate GMOs.In their press release of 25 January, following yesterday’s vote by the Environment Committee proposing the non-patentability of NGT plants, the thirteen French organisations point out that “the promise to ban the patentability of GMO-NGT plants is nothing but a smoke and mirrors operation designed to mislead the public [...] such an amendment would be totally pointless as it would perpetuate the patentability of NGT techniques which it is not planned to abolish. The scope of a patent on a technique extends to all plants derived from that technique”. These organisations consider that “even more scandalous is the removal of the traceability of ’new GMOs’ patented [which] will turn farmers’ and traditional seeds that naturally contain the genetic trait claimed in the patent into counterfeits that are prohibited or subject to the payment of royalties”.Preventing the irreversibleTaking the view that plants derived from NGTs are equivalent to those produced conventionally - which is clearly refuted by the Anses - allows the European Commission to propose eliminating all traceability. The absence of GMO traceability, and therefore of identification of the patents that go with them, puts European farmers and small and medium-sized seed companies at risk. In the event of infringement proceedings, they would lose all means of proving that their own seeds were not the result of the patented invention. This is the concern expressed by the French organisations, which are calling on MEPs to reject this proposal. ECVC had also appealed to the Council of the European Union, asking it to “pause [its] examination of the GMO/NGT deregulation proposal until these two essential questions have been resolved”.The text of the deregulation proposal, as amended by the Agriculture and Environment Committees, should now be debated at the plenary session of the European Parliament in early February 2024. In anticipation of this session, the French organisations are calling for a rally in Strasbourg on 6 February to urge MEPs to reject the text. [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [168] => Array ( [objectID] => 7326 [title] => Prophetic but misleading: fictitious examples in patents [timestamp] => 1706054400 [date] => 24/01/2024 [annee] => 2024 [url] => https://infogm.org/en/prophetic-but-misleading-fictitious-examples-in-patents/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => The latest news on patents covering “biotechnological inventions”, particularly GMOs/NTGs, reminds us that these legal tools are above all long and complex texts. Yet the content of these texts determines the scope of these patents. In addition to a general description of the invention, including its industrial applications, a patent must describe one or more […] [chapo] => Many patents in the field of “life sciences” contain fictitious examples, known as “prophetic”, of how the invention can be realised. Such imaginary examples enable applicants to increase the scope of their patents. This is a common practice that is now taking on significant proportions. At a time when multinationals are trying to obtain deregulation of their GMOs, an understanding of the broad outlines of this practice will give us a better grasp of the issues surrounding patents. [texte] => The latest news on patents covering “biotechnological inventions”, particularly GMOs/NTGs, reminds us that these legal tools are above all long and complex texts. Yet the content of these texts determines the scope of these patents. In addition to a general description of the invention, including its industrial applications, a patent must describe one or more examples of how the invention can be put into practice. However, at the time the patent application is filed, these examples may or may not have actually been realised. When they are not real, they are said to be “prophetic”, “phantom”, “hypothetical” or “fictional”... Anglo-Saxons also speak of “paper examples”. This practice, which is authorised in several jurisdictions, including the United States and Europe (EPO - European Patent Office), nevertheless raises legal issues, particularly in the field of “biotechnological inventions”.A practice permitted subject to conditionsThe broader the scope of a patent, the greater its potential economic value. But in order to claim broad scope, it is necessary, among other things, to demonstrate that the invention can be made in different ways. For example, a patent claiming genetic sequences with a minimum percentage - 80%, 90% or 95% - of identity with the sequence actually “invented” is very broad1. It would therefore take many examples of embodiments of the invention to show that it can be implemented over the entire scope of the claims. The number of examples required may be such that it is sometimes necessary to create fictitious ones. Providing a plurality of examples therefore helps to fulfil a fundamental requirement of patent law: an invention must be sufficiently described for “a person skilled in the art” - a biotechnology engineer, for example - to be able to reproduce it to its full extent using his or her general knowledge. The “biotech” sector is no exception to this requirement of sufficient description.The rapid development and strong competitiveness of this sector encourages its players to file numerous patent applications as soon as possible. This is the case even if, when the patent application is filed, the invention is not sufficiently supported by real examples. This is why applicants resort to “prophetic” examples. In the United States, since the early 1980s, the USPTO (the US Patent and Trademark Office) has accepted such examples under certain conditions, in particular that they are not misleading and that they have a reasonable scientific basis2. The USPTO also requires that they be distinguished from actual examples in the text of the patent. The EPO also allows prophetic examples, provided they are reproducible. But a 2021 survey shows that 75% of European patent applicants do not distinguish prophetic examples from real ones in their patent applications3.Examples in granted patents are by default presumed to be valid. While an examiner may, in the course of the examination procedure, request certain additional experimental data, it is not assumed that he or she is required or able to test the embodiments of the invention. A person challenging the validity of a patent on the grounds of inadmissible prophetic examples will have the burden of proof.A fiction that creates ripplesPatent offices may consider that certain prophetic examples in a patent application are purely speculative, without a solid scientific basis, or used to intentionally overestimate the scope of the invention. If this is the case, the patent will not be granted. If it were, however, by mistake, the patents could later be invalidated by the courts.This has been the case in the US, where the USPTO has dealt with several cases where prophetic examples have been misused. Patents have been revoked or have failed to survive litigation due to insufficient actual experimental data supporting the claims. US case law, including Supreme Court decisions, emphasises the need for adequate disclosure and a sound experimental basis for patent claims. In 2000, a decision of a Board of Appeal of the EPO opposing the company Dyax to Cambridge Antibody Technology Limited and Acambis Research Limited on a patent covering antibodies had set a precedent4. In its decision, the EPO confirmed that, in theory, a single “hypothetical” (another term for “prophetic”) example of an antibody production protocol could suffice for a “person skilled in the art” to put the invention into practice without an excessive burden of experimentation (Article 83 EPC on sufficiency of description). There is therefore no obligation to provide a real example. However, as the patent holder was ultimately unable to show that this prophetic example alone was sufficient, the patent was revoked in opposition.The frequency of patents containing prophetic examples is far from anecdotal. Law professor Janet Freilich, of Fordham University, has conducted a study of more than 2 million US patent applications in biology and chemistry5. “At least 17% of the experiments in this population [of patents] are fictional”, she concludes. Under the international patent system, an initial (so-called “priority”) patent application is filed in one country. The same text is then filed in the other countries to which this application is extended. If a US patent application includes prophetic, fictitious examples, its foreign equivalents will also include them. We can thus deduce that many of our European patents are tainted with such examples (and vice versa) designed to create illusions about the feasibility of the invention and to extend the scope of the patent.Legal certainty and ethical issuesAs far back as 2005, an article by the University of Berkeley (USA) entitled “Worthless patents” refers to the eagerness of the pharmaceutical and biotechnology industries to apply for patents even before knowing whether the inventions have any great utility or commercial value6. This is how patents based on prophetic examples of uncertain validity were and still are granted. Such an industrial strategy can, a fortiori if it is supported, unfairly place certain economic players in a situation of legal uncertainty. Think, for example, of small and medium-sized seed companies or farmers, who would be threatened by NTG (New Genomic Techniques) giants holding such patents. Given the cost and uncertain outcome of legal proceedings, these players would be in real danger.Prophetic examples are also surrounded by profound ethical issues, including the credibility of scientific research and the fairness of the patent system. Solutions, such as stricter guidelines for examining patent applications and greater transparency, should be put in place by national and regional systems to alleviate these problems. But the ethical question also arises at a more global level: that of the patentability of living matter.In addition to the ethical concerns linked to the granting of patents on living organisms and the resulting possibilities of appropriation, the presence of prophetic examples in such patents is, in principle, legally questionable. On the one hand, they may favour large companies filing patents by enabling them to set up artificial legal barriers. On the other hand, they also run the risk of further damaging innovation by other, smaller players in the sector.An ineffective or even losing strategyBut the most surprising part of the story, and even the most cynical, is explained by Janet Freilich in her study mentioned above. While the use of prophetic examples should in theory lead to stronger patents, this is in fact not the case overall. She speaks of a “surprisingly ambiguous - probably negative - correlation between the use of prophetic examples and the value of a patent”. She even concludes that, in the balance of benefits and costs, the latter prevail.To explain the lower value of such patents, the lawyer argues that prophetic examples are normally included in patent applications for which working examples do not exist. This may be an indication that the patent and the invention it covers are intrinsically weak. Another explanation could be that the rush to file a patent application does not leave enough time to construct working examples. And in certain sectors, including biotech, the dynamic of patent applications is a trademark and serves the image of the company, which can highlight its portfolio of patents.What then would be the point of applying for patents with such prophetic examples? One major explanation may lie in the classic “mass filing strategy”. For organisations that can afford it, filing a large number of patent applications allows them to “get their foot in the door” and drown them in the legal landscape in several technical fields. Many of these rights are subsequently abandoned. The result is that the smallest players in the sector concerned (for example, seed producers and farmers), neophytes on these complex issues, are faced with immense and opaque patent portfolios, and patents that appear broad and solid, when in fact they are not. A theatre of shadows serves to obscure a game of economic power and to facilitate the concentration of capital. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [169] => Array ( [objectID] => 6971 [title] => NewslettersENG [timestamp] => 1705968000 [date] => 23/01/2024 [annee] => 2024 [url] => https://infogm.org/en/newsletter-2/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [170] => Array ( [objectID] => 6968 [title] => Inf’OGM’s mission and values [timestamp] => 1705968000 [date] => 23/01/2024 [annee] => 2024 [url] => https://infogm.org/en/who-we-are/infogms-mission-and-values/ [image] => https://infogm.org/wp-content/uploads/2026/04/virugle_70-1.jpg [extrait] => Mission Inf’OGM is a citizens’ watchdog that deciphers world news and offers a unique French-language information service on GMOs, biotechnologies and, since 2013, also seeds.Its mission is to encourage and nurture democratic debate by providing critical, independent information that is accessible to the general public. Inf’OGM is working for genuine transparency in the GMO debate. […] [chapo] => [texte] => MissionInf'OGM is a citizens' watchdog that deciphers world news and offers a unique French-language information service on GMOs, biotechnologies and, since 2013, also seeds.Its mission is to encourage and nurture democratic debate by providing critical, independent information that is accessible to the general public. Inf'OGM is working for genuine transparency in the GMO debate.The Inf'OGM charterThe background to transgenic plantsGenetically Modified Organisms (GMOs) made their appearance in the United States in the early 90s and on the European market in 1996. Since then, many questions have been raised about their economic, health, environmental and ethical impact. To answer these questions, the European Union first decided to introduce a de facto moratorium on new GMO authorisations in 1999. Over the next five years, a number of scientific and political factors shed new light on the issue. The debate continues today, both within French society and at international level, as to whether the decision to develop and market this technology is well-founded, and what legislative framework should prevail.Inf'OGM's raison d'êtreIn order for public debate to take place and for society as a whole to be able to make informed decisions, it is vital to make information understandable and to disseminate it. In the absence of serious democratic debate, the development of GMOs will only meet the needs of biotech companies, which see a definite economic advantage in doing so. And the potential risks that this development represents for biodiversity, public health and traditional farming systems will not be taken into account in policy-making. Since 1999, Inf'OGM has been gathering and processing information on the GMO situation in France and around the world.Inf'OGM's position in the debateFaced with the novelty of transgenesis, Inf'OGM has always endeavoured not to take a position in the debate on the dangers and advantages of genetically modified plants (GMPs), believing that citizens first and foremost needed information that was as unbiased as possible in order to form their own opinions. But while information is never totally neutral, political decisions and economic choices are even less so. After several years of work, the evidence cannot be hidden on five major points:a) The assessment procedures put in place in countries that use GMPs are no guarantee of their harmlessness to human health and the environment, as the studies carried out are incomplete, biased and incompatible with scientific rigour.b) Contamination, whether through pollination, regrowth or the agro-industrial chain, is technically inevitable if GM plants are disseminated on a large scale. Traditional crops can never be totally protected from genetic pollution, which will inevitably cause harm to farmers who wish to grow crops without GM plants.c) The majority of political decisions concerning GM plants are taken against public opinion, sometimes under the guise of consultation procedures that are unacceptable from a democratic point of view.d) Plants derived from new biotechnologies (Crispr/cas9, meganuclease, zinc finger, directed mutagenesis, etc.) have been modified in a non-natural way: they therefore meet the definition of "GMO" in European directives and must therefore be subject to ad hoc legislation.e) The introduction into nature of GMOs (plants, animals or micro-organisms) or organisms resulting from "synthetic biology" artificializes living organisms and more often than not alters the dynamic equilibrium of the co-evolution of species. The time scales are not comparable.Finally, Inf'OGM believes that the technical debate tends to overshadow the social debate. Yet the current challenges - environmental, social and climate crises, etc. - call for a global vision that is incompatible with the technical reductionism that seeks to solve short-term problems. - require a global vision that is incompatible with the technical reductionism that seeks to solve problems in the short term.Inf'OGM's public service missionInf'OGM's main aim is to set up a public information service on genetically modified organisms. Inf'OGM is a non-profit organisation created in 1999 to establish a French-language citizen's watch on GMOs. Inf'OGM aims to be a French-language information centre that disseminates regular, verified, concise and referenced information on the various issues surrounding GMOs, in a language that everyone can understand. Inf'OGM works with all civil society organisations and its members come from the main organisations active in the GMO debate in France. However, Inf'OGM does not replace the initiatives and programmes of existing organisations. Its role is clearly upstream, identifying the right sources of information, structuring the data, formatting it and publishing it. Inf'OGM also wishes to act to ensure that the public authorities adopt a transparent approach to the provision of information.AimsThe purpose of the association is :a) to summarise, verify, clarify, contextualise, translate into French and disseminate all relevant news relating to GMOs, in a spirit of "service to the public" ;b) to give the various citizen movements of resistance, questioning and doubt that permeate society on the subject of GMOs, the building blocks of a genuine social dialogue, by insisting in particular on the dimension of the technological choice open to citizens;c) to urge the public authorities to ensure genuine transparency of information, and to set up an effective and reliable public information service on GMOs.Principles of actionThe only global action: Inf'OGM distributes summary information on current GMO issues. The Inf'OGM association has chosen several means to achieve its objectives:a) the publication of a quarterly newsletter for the general public and various other publications: brochures, books, etc. and the sale of publications from associations that are often partners;b) maintaining a reference website on GMOs;c) training courses;d) providing legal expertise to militant organisations. [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [171] => Array ( [objectID] => 6966 [title] => Le conseil d’administration 2005 [timestamp] => 1705968000 [date] => 23/01/2024 [annee] => 2024 [url] => https://infogm.org/en/who-we-are/team-and-board-2/le-conseil-dadministration-2005/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Le conseil d’administration d’Inf’OGM est composé de membres individuels. Il a été renouvelé en avril 2005 et le bureau a été élu, suite à cette AG.Le président : Jacques TESTARTLe trésorier : Robert Ali BRAC de la PERRIERELa secrétaire : Anne CHETAILLE Les autres administrateurs : Arnaud APOTEKER, Anne-Claude KIEFFER, Suzanne KOROSI, Laurent LEGUYADER, Jean-Pierre LEROY, Anne LIEBSKIND. [chapo] => [texte] => Le conseil d’administration d’Inf’OGM est composé de membres individuels.Il a été renouvelé en avril 2005 et le bureau a été élu, suite à cette AG.Le président : Jacques TESTARTLe trésorier : Robert Ali BRAC de la PERRIERELa secrétaire : Anne CHETAILLELes autres administrateurs : Arnaud APOTEKER, Anne-Claude KIEFFER, Suzanne KOROSI, Laurent LEGUYADER, Jean-Pierre LEROY, Anne LIEBSKIND. [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [172] => Array ( [objectID] => 6962 [title] => Shop [timestamp] => 1705968000 [date] => 23/01/2024 [annee] => 2024 [url] => https://infogm.org/en/shop/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [173] => Array ( [objectID] => 6960 [title] => Team and Board [timestamp] => 1705968000 [date] => 23/01/2024 [annee] => 2024 [url] => https://infogm.org/en/who-we-are/team-and-board-2/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => The Inf’OGM association is made up of a team of six employees and a maximum number of fifteen individual directors. THE TEAM Charlotte COQUARD: fundraising officerCarinne DUMONT: accounting secretaryDenis MESHAKA: journalist, in charge of legal monitoringEric MEUNIER: chief editorChristophe NOISETTE: journalistAntoine VEPIERRE: editorial secretary, in charge of promotion and communications THE BOARD OF DIRECTORS The […] [chapo] => [texte] => The Inf'OGM association is made up of a team of six employees and a maximum number of fifteen individual directors.THE TEAMCharlotte COQUARD: fundraising officerCarinne DUMONT: accounting secretaryDenis MESHAKA: journalist, in charge of legal monitoringEric MEUNIER: chief editorChristophe NOISETTE: journalistAntoine VEPIERRE: editorial secretary, in charge of promotion and communicationsTHE BOARD OF DIRECTORSThe Board of Directors in 2024 is :Arnaud Apoteker,Annick Bossu,Hervé Le Meur,Yanick Loubet,Jean-Pierre Masson,Franciska Soler,Ali de Goamma Tapsoba,Hélène Tordjman,Bruno Viennois,Sylvain Willig.The Board was elected at the Inf'OGM General Meeting, which took place on 26 April 2023 at 38 rue Saint Sabin, 75011 Paris. [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [174] => Array ( [objectID] => 6949 [title] => Inf’OGM is also a newspaper [timestamp] => 1705968000 [date] => 23/01/2024 [annee] => 2024 [url] => https://infogm.org/en/infogm-is-also-a-newspaper/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => 20 full-colour pages to help you delve deeper into a thematic dossier on the major issues currently facing GMOs, biotechnologies, patents and seeds. Some of the articles are accompanied by explanatory boxes and computer graphics to clarify specific, sometimes complex, terms and concepts. It’s an essential tool for fuelling democratic debate with critical, independent information […] [chapo] => [texte] => 20 full-colour pages to help you delve deeper into a thematic dossier on the major issues currently facing GMOs, biotechnologies, patents and seeds.Some of the articles are accompanied by explanatory boxes and computer graphics to clarify specific, sometimes complex, terms and concepts.It's an essential tool for fuelling democratic debate with critical, independent information that's accessible to the general public.Subscriptions ensure that we are partly self-financing and help to perpetuate our citizen information monitoring activities.A year's subscription costs €30.As an organisation, you can also opt for a collective subscription (5 copies) for €140.Subscribing to the journal automatically gives you access to the digital version of each article.If you prefer, you can take out a digital-only subscription for €15 a year.Journals that are more than one year old are freely available in digital format on our website.We publish 4 issues a year. Take the plunge today and receive Inf'OGM at home!Our subscription offers [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [175] => Array ( [objectID] => 6930 [title] => Team and Board [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/who-we-are/team-and-board/ [image] => https://infogm.org/wp-content/uploads/2026/04/virugle_grise_70.png [extrait] => The Inf’OGM association is made up of a team of six employees and a maximum number of fifteen individual directors. THE TEAM Charlotte COQUARD: fundraising officerCarinne DUMONT: accounting secretaryDenis MESHAKA: journalist, in charge of legal monitoringEric MEUNIER: chief editorChristophe NOISETTE: journalistAntoine VEPIERRE: editorial secretary, in charge of promotion and communications THE BOARD OF DIRECTORS The […] [chapo] => [texte] => The Inf'OGM association is made up of a team of six employees and a maximum number of fifteen individual directors.THE TEAMCharlotte COQUARD: fundraising officerCarinne DUMONT: accounting secretaryDenis MESHAKA: journalist, in charge of legal monitoringEric MEUNIER: chief editorChristophe NOISETTE: journalistAntoine VEPIERRE: editorial secretary, in charge of promotion and communicationsTHE BOARD OF DIRECTORSThe Board of Directors in 2024 is :Arnaud Apoteker,Annick Bossu,Hervé Le Meur,Yanick Loubet,Jean-Pierre Masson,Franciska Soler,Ali de Goamma Tapsoba,Hélène Tordjman,Bruno Viennois,Sylvain Willig.The Board was elected at the Inf'OGM General Meeting, which took place on 26 April 2023 at 38 rue Saint Sabin, 75011 Paris. [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [176] => Array ( [objectID] => 6928 [title] => My account [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/my-account/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => [woocommerce_my_account] [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [177] => Array ( [objectID] => 6926 [title] => The newspaper [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/the-newspaper/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [178] => Array ( [objectID] => 6924 [title] => Agenda [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/agenda-2/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [179] => Array ( [objectID] => 6922 [title] => Actions [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/who-we-are/actions-2/ [image] => https://infogm.org/wp-content/uploads/2026/04/virugle_orange_70.png [extrait] => > Inf’OGM’s main activity is to analyse and disseminate information on a regular basis via various information channels: THE QUARTERLY NEWSPAPER BOOKS AND BROCHURES Inf’OGM regularly publishes books and brochures that provide a comprehensive or summary analysis of the various issues surrounding GMOs. Find them in the shop! THE WEBSITE WWW.INFOGM.ORG Inf’OGM regularly updates its […] [chapo] => [texte] => > Inf'OGM's main activity is to analyse and disseminate information on a regular basis via various information channels:THE QUARTERLY NEWSPAPEREvery three months, Inf'OGM publishes a 20-page newsletter on GMOs, including news, special reports, technical data sheets and interviews. It is accessible to the general public and available by subscription or individually.BOOKS AND BROCHURESInf'OGM regularly publishes books and brochures that provide a comprehensive or summary analysis of the various issues surrounding GMOs. Find them in the shop!THE WEBSITE WWW.INFOGM.ORGInf'OGM regularly updates its website infogm.org. This site presents all the latest news on GMOs, as well as numerous thematic dossiers, technical fact sheets, interviews and debates. To guide web users, each topic (health, labelling, etc.) and each article is accompanied by questions (FAQ) that provide a simple and concise context.infogm.org has a free newsletter to which anyone can subscribe, so that you can be kept regularly informed of the latest events relating to GMOs.THEMATIC MONITORINGInf'OGM runs thematic monitoring services: a legal monitoring service and a Europe monitoring service. These monitoring groups provide a forum for the exchange of specialist information and aim to encourage the emergence of a public debate on GMOs.Legal watch: the legal watch on GMOs was set up in October 2002, in response to the need felt by many associations and lawyers to pool resources (particularly human and documentary resources) around the issue of "GMOs and the law". By gathering and exchanging information, the legal watch supports the associations that take part in it, in particular in order to :Develop stronger arguments on issues relating to GMO legislation.Ensure better coordination in monitoring current regulations at national, European and international level.Europe Watch: the aim of the Europe Watch project is to set up a European network of information sites on GMOs, and more specifically on Genetically Modified Plants (GMPs). The aim of this network is to help inform and build a European civil society to help democratise the implementation of research and innovation policies.> Inf'OGM regularly answers questions from civil society players (NGOs, citizens, journalists, elected representatives, etc.) and provides information and training on the various aspects of GMOs.> Inf'OGM also urges public authorities and decision-making bodies to be genuinely transparent, and to set up an effective and reliable public information service on GMOs. [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [180] => Array ( [objectID] => 6918 [title] => New GMOs [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/themes-en-anglais/gmos-generalities/new-gmos/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [181] => Array ( [objectID] => 6916 [title] => What is a GMO? [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/themes-en-anglais/what-is-a-gmo/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => Inf’OGM [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [182] => Array ( [objectID] => 6914 [title] => GMOs: generalities [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/themes-en-anglais/gmos-generalities/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [183] => Array ( [objectID] => 6911 [title] => News [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/news/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [184] => Array ( [objectID] => 6896 [title] => Who we are? [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/who-we-are/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Inf’OGM is an association under the law of 1901, founded in 1999, which publishes independent and critical information. Inf’OGM is a citizens’ watchdog that deciphers world news and offers a unique French-language information service on GMOs, biotechnologies, patents and seeds.Its mission is to encourage and nurture democratic debate by providing critical, independent information that is […] [chapo] => [texte] => Inf'OGM is an association under the law of 1901, founded in 1999, which publishes independent and critical information.Inf'OGM is a citizens' watchdog that deciphers world news and offers a unique French-language information service on GMOs, biotechnologies, patents and seeds.Its mission is to encourage and nurture democratic debate by providing critical, independent information that is accessible to the general public. Inf'OGM is working for genuine transparency in the GMO debate. [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [185] => Array ( [objectID] => 6894 [title] => Contact [timestamp] => 1705881600 [date] => 22/01/2024 [annee] => 2024 [url] => https://infogm.org/en/contact-2/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Inf’OGM38, rue Saint Sabin – 75011 ParisThis address is just a post box. Inf’OGM no longer has official premises as all our employees work from home. Email: infogm-AT-infogm.org (fight against address piracy: the letters AT are to be replaced by the @ symbol) Telephone: 07 66 22 02 76 (voice mail, leave a message and […] [chapo] => [texte] => Inf'OGM38, rue Saint Sabin - 75011 ParisThis address is just a post box. Inf'OGM no longer has official premises as all our employees work from home.Email: infogm-AT-infogm.org (fight against address piracy: the letters AT are to be replaced by the @ symbol)Telephone: 07 66 22 02 76 (voice mail, leave a message and we'll call you back as soon as possible)Website: https://www.infogm.org [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [186] => Array ( [objectID] => 6886 [title] => French Anses experts : GMO deregulation has « no scientific basis » [timestamp] => 1705363200 [date] => 16/01/2024 [annee] => 2024 [url] => https://infogm.org/en/french-anses-experts-gmo-deregulation-has-no-scientific-basis/ [image] => https://infogm.org/wp-content/uploads/2024/01/Column_Base_In_Warning_Colour_Paint.jpg [extrait] => Since September 2023, Member States and MEPs have been discussing the GMO deregulation proposal presented by the European Commission (EC) on July 5, point by point. In these discussions, the scientific basis of the proposed rules should be one of the points of attention. On this subject, the report by French experts of the Anses […] [chapo] => French experts from the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (Anses) are highly critical of the scientific criteria proposed by the European Commission to deregulate GMOs. In their report, published on December 21, 2023, they state that the basic assumption linking equivalence and absence of risk has « no scientific basis ». The same applies to the criteria proposed by the Commission to declare a GMO/NTG plant equivalent to a conventional plant. [texte] => Since September 2023, Member States and MEPs have been discussing the GMO deregulation proposal presented by the European Commission (EC) on July 5, point by point. In these discussions, the scientific basis of the proposed rules should be one of the points of attention. On this subject, the report by French experts of the Anses (in english), published in December 2023, is likely to fuel discussions in 20241. Regretting the lack of clarity in many terms, and even the absence of definitions (see box), the experts noted « certain scientific and health limitations in the construction of the criteria » proposed to deregulate GMOs.Equivalence between plants, equivalence of risks ?For the European Commission, if two plants are « equivalent », then so are the risks they present, and their regulatory framework should therefore be the same. It states that new techniques of genetic modification (called new genomic techniques, NTG) « can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods »2. The European Commission therefore asserts that NTG plants that could also occur naturally or be produced by conventional breeding techniques « and their progeny [...] should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation »3.This assumption, based on the conditional « could », is the keystone of the deregulation proposed by the European Commission. But for the experts at Anses, there is « no scientific justification [for declaring that] categories of plants that would be equivalent in type, size and number of genetic variations or modifications would be equivalent in type of traits and level of risk ». The European Commission’s main shortcoming is that it ignores « thousands of years of evolution, drift or natural selection » by asserting that genetically modified plants in the state of cells isolated on a laboratory bench are equivalent to plants selected naturally or by conventional methods on the sole basis of the number, size or type of genetic modifications carried out. The French experts believe that a comparison of « possible consequences on a biological function » should be made, i.e. that a risk assessment should not be put aside.Following this logic, they add that ignoring, as proposed by the EC, « unintended genetic modifications potentially located outside the targeted sites and similar sequences (apart from transgenic elements) is not justified ». An ignorance that could pose a problem, as such off-target modifications can be « insertions/deletions, reading frame shifts or any type of structural variations » with associated consequences. Should the proposed regulation be read in this way, it would be no more justified to count such effects among the claimed genetic modifications « without considering their possible negative effects ».Scientifically unjustified criteriaWhile they would prefer to see a study of the new biological functions obtained, the French experts see little scientific logic in the criteria proposed by the European Commission to declare a plant and its progeny equivalent to a conventional plant, and therefore « NGT category 1 »4. Such plants would be exempt from risk assessment, labelling, traceability and post-marketing monitoring5.Thus, the type 1 criterion proposed by the Commission, i.e. a « substitution or insertion of up to 20 nucleotides » is not the subject of any « scientific justification for accepting (in the sense of equivalence) substitutions or insertions on the basis of their size. Furthermore, the maximum threshold of 20 nucleotides for an insertion or substitution has not been shown to be particularly relevant for the definition of equivalence to conventional plants ».Type 2 criterion, concerning « deletions of any number of nucleotides », does not appear to be more justififed, since « regardless of their size, the functional consequences of these deletions should be characterized ».The very complex type 3 criterion is also the subject of comment. It covers cisgenesis, with « targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool » and « targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool ». In the case of cisgene insertions (cisgenesis), French experts consider that the NTG plant obtained can only be deemed equivalent to a conventional plant if the inserted sequence is positioned in the recipient plant at the same site as the one from which it originated in the donor plant (known as an orthologous site).For criterion type 4, i.e. « targeted inversion of a sequence of any number of nucleotides », the experts simply state that « this inversion criterion without size conditions does not seem justified ».Finally, criterion type 5, which looks at « any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (...) in a species from the breeders’ gene pool », seems to carry a lack of clarity and opens the door to possible deregulation of intragenic plants6. However, they believe that « a criterion leading to intragenic plants being exempted from the requirements of GMO legislation would not be justifiable ».Experts not consulted by politiciansApart from their opinion, it is striking to note that the French experts took the matter into their own hands. In other words, the French government, which only consulted them on the Commission’s preliminary draft, did not ask for their opinion on the criteria proposed by the European Commission, which were not included in the preliminary draft. This is quite a surprise from the French government, which has always claimed that decisions concerning GMOs should be based on science.The French government’s decision not to consult scientific experts is not original. The European Commission itself did not consult its experts at the European Food Safety Authority (EFSA) on the criteria it proposed for declaring plants equivalent. As the EFSA press service informed us, « The criteria proposed by the European Commission specifically for its proposal for NGT Cat 1 were developed by the EC itself ». It may well have based it on a 2022 EFSA opinion on the assessment of risks associated with the use of genetically modified plants through new techniques, as both EFSA and the European Commission have informed us. However, there has been no consultation of European experts on the criteria finally adopted and proposed by the European Commission.The European Commission’s press service has confirmed to Inf’OGM that it has asked the EFSA for its opinion on criteria for a risk assessment. Paradoxically, as Inf’OGM detailed in another article, the conclusions of this opinion will ultimately be ignored by the European Commission since, unlike EFSA, the Commission will propose that no risk assessment be carried out7.What is the origin of the criteria established by the European Commission ? Perhaps it lies in the latest source of information the Commission has indicated to Inf’OGM, namely that « The Commission also collected and considered evidence and views provided by a large range of stakeholders and experts in preparation of the impact assessment ».The year 2024 will see the continuation of the discussions begun in 2023 within the Council of Ministers and the European Parliament on the European Commission’s proposal. After negotiations between these political bodies and the European Commission, in what is known as a trilogue, a new legislation to deregulate GMOs may or may not be adopted. Indeed, the final decision on deregulation belongs to the European legislator. However, should this be the case, it will no longer be possible to claim that such a decision is based on « good science », so often invoked by governments and the European Commission.Vague or undefined termsThe experts felt that several scientific terms used in the legal text proposed by the European Commission are unclear. Such is the case of the « breeders’ genetic pool », which is, in their view, an expression lacking clarity. Similarly, they point out that in French, the expression used for type 3 genetic modifications and referring to the insertion of « contiguous DNA sequence » is not unambiguous. As they detail, « two objects, such as two nucleotides, can be contiguous, but one object cannot be contiguous alone ». Generously, they therefore felt that the European Commission meant « continuous DNA sequence »…Certain definitions are also missing. For example, the expression « conventional plants » is not defined by the European Commission. A troublesome point according to the experts, since the Commission proposes to classify GMO/NTG plants « on the basis of a comparison with ’conventional plants’, it appears to the WG [Working Group] quite necessary that they be explicitly defined ».Similarly, the experts write that a precise definition of the term « targeted site », used on several occasions, should be provided so that the nature of the sequences considered as target sites is clear to everyone. Failing this, the experts « warn of a risk of distortion between files, linked to the interpretation of each applicant ». [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [187] => Array ( [objectID] => 7328 [title] => The breeders’ gene pool: a semantic trap? [timestamp] => 1705276800 [date] => 15/01/2024 [annee] => 2024 [url] => https://infogm.org/en/the-breeders-gene-pool-a-semantic-trap/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Does the European Commission master all the scientific jargon used in its proposed deregulation of GMOs? Are the multinationals trying to take advantage of the complexity of the scientific concepts involved to get more than they bargain for? The European legislator, whether a Member State government or an MEP, is, like most citizens, unaware of […] [chapo] => If the European Union were to decide to deregulate GMOs by adopting the text proposed by the European Commission, it would be adopting a legislation that is highly favorable to multinationals. To achieve this objective, the European Commission uses a specialist scientific vocabulary whose meaning is bound to evolve over time. A concrete example that Inf’OGM analyzes here is the notion of “breeder’s gene pool”. It’s a fuzzy notion that’s hard to pin down in law! [texte] => Does the European Commission master all the scientific jargon used in its proposed deregulation of GMOs? Are the multinationals trying to take advantage of the complexity of the scientific concepts involved to get more than they bargain for? The European legislator, whether a Member State government or an MEP, is, like most citizens, unaware of the meaning of the scientific concepts used by the European Commission in its writings.What definition for « cisgenesis » and « transgenesis » ?To be taken literally the European Commission’s proposed regulation, “a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the breeders’ gene pool” would no longer be a GMO but a New Genomic Technique (NGT) product1. As such, it could be deregulated if it were found to meet certain criteria enabling it to be declared as NGT Category 1 and thus “considered equivalent to a conventional plant”. The proposed criteria are formulated in complex scientific terms.Among these criteria, we know that the number of substitutions of the chemical elements making up DNA likely to justify classification as category 1 is infinite, and not 20 as the Commission tried to make those who read its text too quickly believe2. But these criteria also include genetic modifications aimed at inserting genetic sequences into a genome. This is transgenesis if the genetic sequence inserted into a plant comes from a bacterium, for example, an interregnum transfer. If a sequence is inserted into a plant’s genome from a plant with which it naturally crosses, we speak of cisgenesis. At least, that’s how the two terms have been understood until now, without any scientific or legal definition. While the European Commission does not propose a formal definition of transgenesis via an article in the regulation, it does suggest one in the recitals. Transgenesis would be a technique of genetic modification aimed at “inserting genetic material from non-crossable species (transgenesis)”3. Conversely, cisgenesis is the subject of a concrete definition proposal in an article. It would be a technique “of genetic modification resulting in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool”4.Breeders’ gene pool : a central but vague notionThe expression “breeders’ gene pool” is absent from all the legislativ texts currently in force in the European Union regulating GMOs. However, in its July 2023 proposal to Member States to deregulate GMOs, the European Commission gives it a central place. According to the proposed text, it would be “the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses”5.Drafted in this way, this definition is vague, as pointed out by the French expert committee of Anses (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail)6.Is it all the genetic information on Earth? All the genetic information contained in a plant? A species? Depending on how this definition is understood, its scope may vary. The French experts who examined this question had to carry out a bibliographical study to give their understanding. A European expert opinion published in 2012 by the EFSA (European Food Safety Authority) gave them a key to their reading7. On this basis, the French experts concluded that it would be “genetic material originating from the whole of the genomes of plants with which the plant in question may cross, whether naturally or by means of more or less advanced conventional breeding techniques, outside the scope of Directive 2001/18/EC”. Whatever is the reading of the French experts, who reduce genetic information (the definition of which is not the subject of any scientific consensus) to its material support alone, it is important to focus on the definition proposed by the Commission, as vague it may be. This is the only definition that will be the law if the regulation is adopted!At the crossroads of the legal and the scientificThe definition starts with “one species and other taxonomic species”. A taxon is a group of organisms with a common set of characteristics. It can therefore be a lineage, a variety, a subspecies, a species, a genus belonging to a tribe, a family...8 On a purely semantic level, the definition proposed by the European Commission refers to crossbreeding between species. Nowhere does it specify that these species must be able to interbreed naturally (otherwise, they would belong to the same species in its original definition!), but that they can be interbred, i.e. as a result of human action. Strictly according to the European Commission, it is sufficient to say that, for example, it is theoretically possible to cross a rice plant with a maize plant by means of “advanced techniques” (other than techniques producing GMOs according to 2001/18) for a maize plant in which a rice genetic sequence is inserted to be a category 1 NGT plant. Such a cross does not necessarily need to have been obtained and verified. When it states that the species concerned “may be crossed”, the Commission is only asking that this crossing be possible, without specifying what criteria are used to decide whether this is possible.This understanding is important, as crosses between species can also involve plants with the same common name or even Latin name. There are several species of wheat, several species of maize, rice, cotton... Not all maize, for example, crosses naturally9. However, through “advanced techniques”, such as the one aiming at “saving” embryos obtained in a somewhat forced manner for example, offspring plants resulting from interspecies crosses that do not occur naturally can be obtained. Similarly, if two plant species A and B cannot cross with each other but can each cross with C, then species C can be used as a “bridge” species. A bridge can therefore be created between two plants, but it can also be two bridges, three bridges... ten bridges. On the Commission’s paper, as we saw above, nothing limits the number of possible bridges.A broader range of techniques to comeThe list of “advanced techniques” provided is an open one, and therefore not legally closed to any “improved” or future techniques. The techniques given as examples are not new. But the trick of having an open list is that if new techniques, unknown today, appear tomorrow and make it possible to force crossbreeding between organisms, these organisms will belong... to the breeders’ genetic pool. Let’s imagine that it becomes possible in the laboratory to force the crossing of a wild strawberry from the undergrowth with hybrid corn cells marketed in the USA by successive use of intermediate species acting as “bridges”: the plants obtained will be GMOs/NGTs of category 1 because they are “equivalent to a conventional plant”!This very notion of enlarging the list of “advanced techniques” to build up the breeders’ genetic pool is a reality acknowledged by the European experts themselves. In 2012, in their opinion already referred to by the French experts, they wrote that “breeders are continually expanding the [...] gene pool and will continue to do so in the future”.A copy-paste from the United States of Amercia?On the other side of the Atlantic, in the United States of America, the same deregulation of GMOs, depriving citizens of any information or depriving the sector of any ability to segregate, was put in place in 2020. In the text adopted in the United States, the scope of the breeders’ genetic pool is as broad as the European Commission’s proposal. Thus, this genetic pool is defined as “Germplasm within which sexual recombination is possible as a result of hybridization, including via methods such as embryo culture or bridging crosses (§ 340.3).”10. The term germplasm is itself defined as “the cells or tissues from which a new organism can be generated”11. The Commission’s genetic pool thus appears as vague in its definition as that of the United States.But there are two differences.The first is a clarification made by the United States, which makes their legislation less unambiguous than the European Commission’s proposal. Thus, when US legislation refers to the genetic pool, it specifically mentions “the plant’s genetic pool”12.The second difference is a further clarification in the footnote to the US legislation. Discussions prior to the adoption of the new rules in this country obviously led to the need of an important clarification. US policy states that “Transgenes from previously reviewed [...] combinations that have been determined not to be regulated are not considered part of the plant’s gene pool.”13. This US clarification raises the question of the scope of the definition proposed by the European Commission. Will the transgenes present in certain GMOs already commercially authorized in Europe be part of the breeders’ genetic pool? At first sight, this does not seem possible, since the definition provided for this pool limits its scope to plant genetic information, which is often not the case for accessory genetic material indispensable for transgene expression (promotor, terminator...). But will multinationals and the European Commission, which is already unaware of this for cisgenesis, say the same in a few years’ time if this proposal were to be adopted as an EU regulation? In any case, such a clarification appeared necessary in the United States. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [188] => Array ( [objectID] => 6502 [title] => Topics [timestamp] => 1704672000 [date] => 08/01/2024 [annee] => 2024 [url] => https://infogm.org/en/themes-en-anglais/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [189] => Array ( [objectID] => 6499 [title] => Shop Inf’OGM [timestamp] => 1704672000 [date] => 08/01/2024 [annee] => 2024 [url] => https://infogm.org/en/shop-infogm/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Blablablabla… [chapo] => [texte] => Blablablabla... [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [190] => Array ( [objectID] => 7248 [title] => Micro-organisms and industry : a very, very concentrated market [timestamp] => 1703116800 [date] => 21/12/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/micro-organisms-and-industry-a-very-very-concentrated-market/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Four industrial groups dominate the market for genetically modified micro-organisms. Of the 272 applications filed that strictly concern GMMs, 173 (64%) are from :– Novozymes (54 applications + 4 via its subsidiary Chr. Hansen) ; – DSM (42 cases + 1 via Biomin GmbH + 1 via Avansya, a joint venture between DSM and Cargill) ; – Danisco/IFF […] [chapo] => In the European Union, 137 « different entities » filed 768 applications for authorisation of micro-organisms to produce different molecules. 50 of these entities filed applications using genetically modified micro-organisms (GMMs) declared as such. Four companies (and their subsidiaries) submitted 64% of these applications : Novozymes, DSM, IFF and AB Enzymes. They have bought and taken stakes in a large number of companies. As a result, they have conquered every continent and are present in every industrial sector. Beyond this concentration, which resembles that seen in the seed sector, what is striking and what we are going to show, is that these companies, through alliances and partnerships, collaborate and organise a de facto monopoly. [texte] => Four industrial groups dominate the market for genetically modified micro-organisms. Of the 272 applications filed that strictly concern GMMs, 173 (64%) are from :- Novozymes (54 applications + 4 via its subsidiary Chr. Hansen) ; - DSM (42 cases + 1 via Biomin GmbH + 1 via Avansya, a joint venture between DSM and Cargill) ; - Danisco/IFF (40 cases + 1 via Dupont + 1 via Amyris + 2 via Finnfeeds Int’l) ; - AB Enzymes (21 cases + 6 via Roal Oy) [1].The above list relates exclusively to GMM dossiers but, of course, these companies have also filed dossiers for non-GM micro-organisms or micro-organisms of an unspecified nature. Here again, their subsidiaries are involved in these other dossiers. Novozymes has submitted a total of 76 dossiers, and DSM 73. Genencor, a subsidiary of Danisco (now IFF), has submitted 7 dossiers, the GMO (or non-GMO) origin of which is not specified. Similarly, Dupont Nutrition Bioscience has submitted three applications in the European Union (EU), only one of which is labelled GMO. These figures could be even higher, as several dossiers have been filed by specialist firms such as Intertek Scientific & Regulatory Consultancy (18 dossiers filed, three of which are clearly GMO and two clearly non-GMO).Novozymes, the undisputed leaderThe undisputed leader in micro-organisms is the Danish company Novozymes. Created in 2000, it was spun off from the pharmaceutical company Novo Nordisk, whose flagship product is insulin derived from MGM [2]. Together under Novo Holding, they are the world’s leading enzyme producer [3].Novozymes has acquired or taken major stakes in a number of companies. Thanks to its acquisitions, alliances and partnerships, it can offer molecules derived from micro-organisms (whether genetically modified or not) for all industrial sectors : household cleaning and maintenance products, food and feed, human health, energy, waste water treatment, textile, leather, pulp and paper industries, etc. Its already hegemonic position will be strengthened by the recent takeover of Chr. Hansen (9 dossiers, including 4 GMOs), another Danish company also present on most micro-organism markets. The merger was approved by the European Commission on 12 December 2023. To obtain this green light, they agreed to « sell off part of the combined company’s worldwide lactase enzyme business, claiming that a buyer had already been found » [4]. Indeed, « the Commission’s investigation showed that the merger, as initially notified, would have reduced competition in the market for the manufacture of a specific enzyme, lactase, using genetic modification technology » [5]. Chr. Hansen develops enzymes for food and feed, « biocontrol solutions », probiotics and other molecules for human and animal health.Novozymes is present on the probiotics market following the acquisition of Synergia Life Sciences Pte. Ltd [6] or Microbiome Labs [7]. This presence increased in 2015, when it joined forces with Adisseo (9 files, including 2 GMMs) to produce probiotics for animal feed [8]. Adisseo is part of the Chinese SinoChem Group, which bought ChemChina, a company that had previously absorbed Syngenta (1 MGM file).Novozymes has invested in the biocontrol market. In 2013, it formed an alliance with Monsanto (AgBio Alliance) to develop and distribute micro-organisms for use in agriculture [9] [10]. Monsanto paid the Danish company €218 million. With the takeover of Monsanto by Bayer, this alliance continued, but was extended to other companies, such as Univar Solutions [11] or UPL [12]. Novozymes also has a partnership for « biocontrol solutions » with Syngenta.In the food sector, Novozymes and Puratos formed an alliance in 2006. Puratos has filed 7 applications for GMMs in the EU, and one of its subsidiaries, Beldem, has filed 2. Puratos is a company mainly invested in sourdoughs for bakery and snack products [13]. This alliance began with the launch of a « cake improver » called Acti-Fresh : a product designed to make cakes more « fresh, moist and soft » [14]. This product uses an enzyme (amylase) from Novozymes. In 2020, Novozymes also teamed up with Swiss company Firmenich [15]. Together, they are marketing a « natural sugar reduction solution TasteGEM® SWL with Saphera® lactase » in order, the press release points out, « to reduce the sugar content of yoghurts and other dairy products by up to 50% without using sweeteners ».Finally, in 2021, Novozymes and DSM created « The DSM-Novozymes Feed Enzymes Alliance » [16]. As part of this, in 2021 the two companies announced the marketing of ProAct 360, a protease-based « feed solution » for the poultry industry [17]. In 2022, they launched another product, a phytase, sold under the trade name HiPhorius [18]. Other enzymes followed, such as a xynalase and an amylase.DSM, the challenger ?DSM (73 dossiers, including 42 for GMMs) is the second largest company in terms of GMM dossiers filed in the EU. This company is a leader in enzyme production. Since the late 90s, it has been acquiring companies specializing in this field, and even more broadly in the agri-food and health sectors. In 1998, for example, DSM bought Gist-brocades for 8.5 billion francs (1.8 billion euros), thus entering the world of biotechnology [19]. Gist-brocades had previously developed a phytase enzyme for pig and poultry feed. In 1995, Gist-brocades sold its North American bakery enzyme activities to Lallemand Boulangerie and its industrial enzyme division to Genencor (now part of IFF).Other DSM acquisitions in the food industry‍Buyout yearBuyout companyIndustrial sectorBuyout amount2003Vitamin division of Roche (Switzerland)Vitamin2011Martek Bioscience (United States)Nutritional products, notably derived from algae$1.1 billion [20]2011Vitane (Spain)Carotenoids from mushroom fermentation [21]2012Verenium (Cargill’s enzyme division) (United States)Enzyme so those needed for oilseed processing$37 million [22].This purchase enabled DSM to resume partnership agreements with the Bunge, Alfa Laval and Desmet Ballestra groups.2012Fortitech (United States)Nutrition (colorant, edulcorant, protein,etc.)634 million dollars [23]2012Ocean Nutrition Canada (Canada)Omega 3 and other fish-derived oils$530 million [24]2013Unitech2013Andre Pectin (China)texture ingredients [25]2013Tortuga (Brazil)Animal Nutrition$576 Million [26]2015Aland (China)Vitamin C [27]2015Jiangshan (China)Vitamin C2020Biomin et Romer Labs (Erber Group) (Allemagne)Gstion des risques liés aux mycotoxines, tests allergènes, etc.980 millions de dollars [28]2020Glycom (Danemark)Production d’une enzyme issue du lait maternel humain765 millions de dollars [29]2021Division Flavor & Fragrance de Amyris (Etats-Unis)DSM has also acquired pharmaceutical and resin companies. DSM has also set up various joint ventures, such as in 2011 with the Chinese Sinochem Group (DSM Sinochem Pharmaceuticals) or with Cargill (Avansya).In May 2023, DSM and Firmenich (which we have already crossed with Novozymes) will merge to create the DSM-Firmenich group. Together, they hold some 16,000 patents [30]. Fimenich is a market leader in flavors and fragrances. This merger is therefore also the merger of two industrial sectors. Firmenich had begun to take an interest in food additives in the 2020s [31]. This merger with DSM will bring it significant patents, skills and markets. But the same idea was to be found in the merger between Dupont and IFF...From Danisco to IFF, a series of takeoversThe third-largest company in terms of filings in the EU database, Danisco, another Danish company, no longer exists as such. Here again, the last 20 years have been marked by takeovers and mergers. In 2005, Danisco bought Genencor for $419 million [32] and FinFeeds (Finland). It invests heavily in several companies, including TMI Europe (France) [33] and Protos (Germany) [34]. In 2011, Danisco is acquired by Dupont for $6.3 billion [35]. In 2019, Swiss company IFF (International Flavors and Fragrances) and Dupont’s Nutrition & Biosciences" business will merge [36]. [37]. Danisco is now part of the multinational IFF. For a long time, IFF specialized in fragrances and food flavors. But the acceleration of the enzymes and additives market, and the strong concentration and competition in this market, prompted IFF to take an interest in this flourishing sector.Enzymes, an important sector for major food companiesTwo companies that have filed dossiers in the EU are subsidiaries of large agri-food groups : AB Enzymes and Kerry Bioscience.AB Enzymes (28 dossiers, including 21 for GMMs) is a member of the ABF Ingredients division, itself a subsidiary of the British Association British Food group (which owns the Twinnings, Primark, Jordan’s, La tisanière and Ovomaltine brands) [38]. This division comprises several companies that share the market for enzymes and other molecules (ABBiotek, AB Enzymes, Abitec, Fytexia, PGP International, SPI Pharma, Ohly), including yeast to produce « vegan meat » [39]). Together with Anora, AB Enzymes acquired the Finnish company Roal Oy (6 MGM files). Roal Oy had itself been set up in 1991 as a joint venture between Finland’s Alko Ltd and Germany’s Röhm GmbH, two companies heavily involved in enzyme research and production. Röhm was subsequently acquired by Evonik (1 non-GMO file).Kerry Bioscience (17 dossiers, including 7 GMMs) is a subsidiary of the Irish multinational Kerry Group. Among its many subsidiaries [40], two, purchased in 2022 for around €200 million [41], have filed dossiers for micro-organisms : c-LEcta GmbH (Germany, 2 MGM dossiers) and Enmex (Mexico, 2 dossiers) [42]. In 2011, Kerry Group had already bought Cargill’s « aroma » division for $230 million [43].In a never-ending chase, companies have little room for maneuver : if they don’t want to be absorbed, they have to get bigger and therefore absorb their competitor. Christophe NOISETTE [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [191] => Array ( [objectID] => 6745 [title] => Micro-organisms and industry : a very, very concentrated market [timestamp] => 1703116800 [date] => 21/12/2023 [annee] => 2023 [url] => https://infogm.org/en/micro-organisms-and-industry-a-very-very-concentrated-market/ [image] => https://www.infogm.org/IMG/arton7949.jpg [extrait] => In the European Union, 137 « different entities » filed 768 applications for authorisation of micro-organisms to produce different molecules. 50 of these entities filed applications using genetically modified micro-organisms (GMMs) declared as such. Four companies (and their subsidiaries) submitted 64% of these applications : Novozymes, DSM, IFF and AB Enzymes.They have bought and taken stakes in a […] [chapo] => [texte] => In the European Union, 137 « different entities » filed 768 applications for authorisation of micro-organisms to produce different molecules. 50 of these entities filed applications using genetically modified micro-organisms (GMMs) declared as such. Four companies (and their subsidiaries) submitted 64% of these applications : Novozymes, DSM, IFF and AB Enzymes.They have bought and taken stakes in a large number of companies. As a result, they have conquered every continent and are present in every industrial sector. Beyond this concentration, which resembles that seen in the seed sector, what is striking and what we are going to show, is that these companies, through alliances and partnerships, collaborate and organise a de facto monopoly.Four industrial groups dominate the market for genetically modified micro-organisms. Of the 272 applications filed that strictly concern GMMs, 173 (64%) are from :- Novozymes (54 applications + 4 via its subsidiary Chr. Hansen) ;- DSM (42 cases + 1 via Biomin GmbH + 1 via Avansya, a joint venture between DSM and Cargill) ;- Danisco/IFF (40 cases + 1 via Dupont + 1 via Amyris + 2 via Finnfeeds Int’l) ;- AB Enzymes (21 cases + 6 via Roal Oy) [1].The above list relates exclusively to GMM dossiers but, of course, these companies have also filed dossiers for non-GM micro-organisms or micro-organisms of an unspecified nature. Here again, their subsidiaries are involved in these other dossiers. Novozymes has submitted a total of 76 dossiers, and DSM 73. Genencor, a subsidiary of Danisco (now IFF), has submitted 7 dossiers, the GMO (or non-GMO) origin of which is not specified. Similarly, Dupont Nutrition Bioscience has submitted three applications in the European Union (EU), only one of which is labelled GMO. These figures could be even higher, as several dossiers have been filed by specialist firms such as Intertek Scientific & Regulatory Consultancy (18 dossiers filed, three of which are clearly GMO and two clearly non-GMO).Novozymes, the undisputed leaderThe undisputed leader in micro-organisms is the Danish company Novozymes. Created in 2000, it was spun off from the pharmaceutical company Novo Nordisk, whose flagship product is insulin derived from MGM [2]. Together under Novo Holding, they are the world’s leading enzyme producer [3].Novozymes has acquired or taken major stakes in a number of companies. Thanks to its acquisitions, alliances and partnerships, it can offer molecules derived from micro-organisms (whether genetically modified or not) for all industrial sectors : household cleaning and maintenance products, food and feed, human health, energy, waste water treatment, textile, leather, pulp and paper industries, etc. Its already hegemonic position will be strengthened by the recent takeover of Chr. Hansen (9 dossiers, including 4 GMOs), another Danish company also present on most micro-organism markets. The merger was approved by the European Commission on 12 December 2023. To obtain this green light, they agreed to « sell off part of the combined company’s worldwide lactase enzyme business, claiming that a buyer had already been found » [4]. Indeed, « the Commission’s investigation showed that the merger, as initially notified, would have reduced competition in the market for the manufacture of a specific enzyme, lactase, using genetic modification technology » [5]. Chr. Hansen develops enzymes for food and feed, « biocontrol solutions », probiotics and other molecules for human and animal health.Novozymes is present on the probiotics market following the acquisition of Synergia Life Sciences Pte. Ltd [6] or Microbiome Labs [7]. This presence increased in 2015, when it joined forces with Adisseo (9 files, including 2 GMMs) to produce probiotics for animal feed [8]. Adisseo is part of the Chinese SinoChem Group, which bought ChemChina, a company that had previously absorbed Syngenta (1 MGM file).Novozymes has invested in the biocontrol market. In 2013, it formed an alliance with Monsanto (AgBio Alliance) to develop and distribute micro-organisms for use in agriculture [9] [10]. Monsanto paid the Danish company €218 million. With the takeover of Monsanto by Bayer, this alliance continued, but was extended to other companies, such as Univar Solutions [11] or UPL [12]. Novozymes also has a partnership for « biocontrol solutions » with Syngenta.In the food sector, Novozymes and Puratos formed an alliance in 2006. Puratos has filed 7 applications for GMMs in the EU, and one of its subsidiaries, Beldem, has filed 2. Puratos is a company mainly invested in sourdoughs for bakery and snack products [13]. This alliance began with the launch of a « cake improver » called Acti-Fresh : a product designed to make cakes more « fresh, moist and soft » [14]. This product uses an enzyme (amylase) from Novozymes. In 2020, Novozymes also teamed up with Swiss company Firmenich [15]. Together, they are marketing a « natural sugar reduction solution TasteGEM® SWL with Saphera® lactase » in order, the press release points out, « to reduce the sugar content of yoghurts and other dairy products by up to 50% without using sweeteners ».Finally, in 2021, Novozymes and DSM created « The DSM-Novozymes Feed Enzymes Alliance » [16]. As part of this, in 2021 the two companies announced the marketing of ProAct 360, a protease-based « feed solution » for the poultry industry [17]. In 2022, they launched another product, a phytase, sold under the trade name HiPhorius [18]. Other enzymes followed, such as a xynalase and an amylase.DSM, the challenger ?DSM (73 dossiers, including 42 for GMMs) is the second largest company in terms of GMM dossiers filed in the EU. This company is a leader in enzyme production. Since the late 90s, it has been acquiring companies specializing in this field, and even more broadly in the agri-food and health sectors. In 1998, for example, DSM bought Gist-brocades for 8.5 billion francs (1.8 billion euros), thus entering the world of biotechnology [19]. Gist-brocades had previously developed a phytase enzyme for pig and poultry feed. In 1995, Gist-brocades sold its North American bakery enzyme activities to Lallemand Boulangerie and its industrial enzyme division to Genencor (now part of IFF).‍Buyout yearBuyout companyIndustrial sectorBuyout amount2003Vitamin division of Roche (Switzerland)Vitamin2011Martek Bioscience (United States)Nutritional products, notably derived from algae$1.1 billion [20]2011Vitane (Spain)Carotenoids from mushroom fermentation [21]2012Verenium (Cargill’s enzyme division) (United States)Enzyme so those needed for oilseed processing$37 million [22].This purchase enabled DSM to resume partnership agreements with the Bunge, Alfa Laval and Desmet Ballestra groups.2012Fortitech (United States)Nutrition (colorant, edulcorant, protein,etc.)634 million dollars [23]2012Ocean Nutrition Canada (Canada)Omega 3 and other fish-derived oils$530 million [24]2013Unitech2013Andre Pectin (China)texture ingredients [25]2013Tortuga (Brazil)Animal Nutrition$576 Million [26]2015Aland (China)Vitamin C [27]2015Jiangshan (China)Vitamin C2020Biomin et Romer Labs (Erber Group) (Allemagne)Gstion des risques liés aux mycotoxines, tests allergènes, etc.980 millions de dollars [28]2020Glycom (Danemark)Production d’une enzyme issue du lait maternel humain765 millions de dollars [29]2021Division Flavor & Fragrance de Amyris (Etats-Unis)DSM has also acquired pharmaceutical and resin companies. DSM has also set up various joint ventures, such as in 2011 with the Chinese Sinochem Group (DSM Sinochem Pharmaceuticals) or with Cargill (Avansya).In May 2023, DSM and Firmenich (which we have already crossed with Novozymes) will merge to create the DSM-Firmenich group. Together, they hold some 16,000 patents [30]. Fimenich is a market leader in flavors and fragrances. This merger is therefore also the merger of two industrial sectors. Firmenich had begun to take an interest in food additives in the 2020s [31]. This merger with DSM will bring it significant patents, skills and markets. But the same idea was to be found in the merger between Dupont and IFF...From Danisco to IFF, a series of takeoversThe third-largest company in terms of filings in the EU database, Danisco, another Danish company, no longer exists as such. Here again, the last 20 years have been marked by takeovers and mergers. In 2005, Danisco bought Genencor for $419 million [32] and FinFeeds (Finland). It invests heavily in several companies, including TMI Europe (France) [33] and Protos (Germany) [34]. In 2011, Danisco is acquired by Dupont for $6.3 billion [35]. In 2019, Swiss company IFF (International Flavors and Fragrances) and Dupont’s Nutrition & Biosciences" business will merge [36]. [37]. Danisco is now part of the multinational IFF. For a long time, IFF specialized in fragrances and food flavors. But the acceleration of the enzymes and additives market, and the strong concentration and competition in this market, prompted IFF to take an interest in this flourishing sector.Enzymes, an important sector for major food companiesTwo companies that have filed dossiers in the EU are subsidiaries of large agri-food groups : AB Enzymes and Kerry Bioscience.AB Enzymes (28 dossiers, including 21 for GMMs) is a member of the ABF Ingredients division, itself a subsidiary of the British Association British Food group (which owns the Twinnings, Primark, Jordan’s, La tisanière and Ovomaltine brands) [38]. This division comprises several companies that share the market for enzymes and other molecules (ABBiotek, AB Enzymes, Abitec, Fytexia, PGP International, SPI Pharma, Ohly), including yeast to produce « vegan meat » [39]). Together with Anora, AB Enzymes acquired the Finnish company Roal Oy (6 MGM files). Roal Oy had itself been set up in 1991 as a joint venture between Finland’s Alko Ltd and Germany’s Röhm GmbH, two companies heavily involved in enzyme research and production. Röhm was subsequently acquired by Evonik (1 non-GMO file).Kerry Bioscience (17 dossiers, including 7 GMMs) is a subsidiary of the Irish multinational Kerry Group. Among its many subsidiaries [40], two, purchased in 2022 for around €200 million [41], have filed dossiers for micro-organisms : c-LEcta GmbH (Germany, 2 MGM dossiers) and Enmex (Mexico, 2 dossiers) [42]. In 2011, Kerry Group had already bought Cargill’s « aroma » division for $230 million [43].In a never-ending chase, companies have little room for maneuver : if they don’t want to be absorbed, they have to get bigger and therefore absorb their competitor. Christophe NOISETTE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [192] => Array ( [objectID] => 6422 [title] => Welcome [timestamp] => 1701993600 [date] => 08/12/2023 [annee] => 2023 [url] => https://infogm.org/en/welcome/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => **** [chapo] => [texte] => Inf'ogm [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [193] => Array ( [objectID] => 6758 [title] => Genetically modified microorganisms to be released soon in the EU environment ? [timestamp] => 1701993600 [date] => 08/12/2023 [annee] => 2023 [url] => https://infogm.org/en/genetically-modified-microorganisms-to-be-released-soon-in-the-eu-environment/ [image] => https://www.infogm.org/IMG/arton7939.jpg [extrait] => On June 14 2022, the European Commission met with PivotBio. This US company markets genetically modified microorganisms (GMMs) to « convert atmospheric nitrogen and deliver it to crops ». During the meeting, PivotBio explained that these microorganisms are modified « by conventional mutagenesis or by genome editing ». But it does not wish to market them in Europe « since […] [chapo] => Genetically modified bacteria, yeast and, why not, viruses released in the environment without any regulatory oversight ? This is what companies are strongly suggesting to the European Commission. Documents obtained by the association Corporate Europe Observatory (CEO) show an intense lobby to ensure that the principles of deregulation proposed for GMO/NGT plants also applies in the future to genetically modified microorganisms. [texte] => On June 14 2022, the European Commission met with PivotBio. This US company markets genetically modified microorganisms (GMMs) to « convert atmospheric nitrogen and deliver it to crops ». During the meeting, PivotBio explained that these microorganisms are modified « by conventional mutagenesis or by genome editing ». But it does not wish to market them in Europe « since they would be considered GMOs subject to the GMO legislation ». On the day of the meeting, the European Commission was still working on its proposal to deregulate GMO/NGT plants only, which it will present on July 5, 2023. But it was already interested in GMMs. Indeed, it replied to the company that it had « started the process of gathering information on NGTs applied to microorganismsThis dialogue illustrates existing industrial projects to disseminate genetically modified bacteria, fungi and even viruses into the environment. An industrial sector that would like to see the deregulation of GM plants also applied to GMMs.GMMs released in the environment without oversight ?In a report published in 2023, Friends of the Earth U.S. wrote that at least « two products are currently being used by U.S. farmers — a GE bacteria from Pivot Bio called Proven® and BASF’s ‘2.0’ version of its Poncho®/VOTiVO® seed treatment » [1]. The use of microorganisms is not new in agriculture, but the use of genetically engineered microorganisms is still rare [2].According to Friends of the Earth USA, the recent entrance of the four multinationals Bayer-Monsanto, Syngenta, Corteva and BASF into this market could mark a turning point. These companies « have spent millions acquiring biologicals companies in recent years [...]. The global biologicals market is expected to nearly triple in a span of eight years [...] to 29.31 billion dollars in 2029 ». The association gives the example of Bayer, which, armed with a « collection of at least 125,000 wild microbial strains », launched a partnership in 2022 with Ginkgo Bioworks, « a startup company which has received 15 billion dollars in investment to develop a platform to automate the genetic engineering of thousands of microbes at once ».In terms of practical dissemination, Friends of the Earth USA has recorded 128 authorisations issued by the US Department of Environmental Protection for GMM experiments in the environment. The majority of these authorisations were obtained by universities. Faced with the companies’ commercial projects, Friends of the Earth USA is concerned about the risks associated with their release into the environment (very large-scale release, uncontrolled gene transfer, modification of the existing microbiome, antibiotic resistance, potential appearance of new pathogens, etc.).European Lobby in actionEuropaBio is a well-known European lobbying organisation that has historically been very active on the issue of GMO plants. But when it wrote to and met with the Commission in early 2023, the subject was GMMs, not plants. The organisation is indeed concerned, on behalf of its members, about the potential implications the legislative work being at that time prepared by the European Commission for GM/NGT plants could have on the regulation of GMMs obtained by new genomic techniques. There is obviously nothing innocent about this concern. GMMs as such are GMOs regulated by the European Union. While the legislator has exempted molecules produced by GMMs in fermenters [3], this is not the case for these GMMs if released as such into the environment.During its meeting, EuropaBio told the European Commission that the interpretation of this legislation is a challenge for companies. EuropaBio concludes that it is currently preparing a document summarising current knowledge on the safety of GMMs released into the environment, the risk assessments that have been carried out and recommendations for a regulatory framework. In other terms, EuropaBio is asking the European Commission to provide the necessary legal certainty so that these GMMs can be marketed without being subject to the requirements of current GMO legislation.A future deregulation of GMMs ?As early as July 2022, EuropaBio, together with the Association of Manufacturers and Formulators of Enzyme Products (Amfep) and the EU Association of Specialty Feed Ingredients and their Mixtures (Fefana), considered that any political action on plants obtained using new techniques would also have an impact on microorganisms. These three organisations wrote to the European Commission to argue that knowledge and experience with microorganisms could and should contribute to policy actions concerning any organism, whether plants or microorganisms.This position was reaffirmed in November 2022 at the 15th European Forum for Industrial Biotechnology & the Bioeconomy (EFIB) in Vilnius [4]. For the companies meeting in Lithuania, « Many highly advanced genetic engineering techniques [...] are already actively used in contained use applications ». This industry is therefore calling on the European legislator to adopt « a cohesive approach across sectors » and for « advanced knowledge on microorganisms [to be] recognised and considered when developing the policy action for plants developed using NGTs ».For the Commission, the door is openedAt each meeting, the European Commission reiterated that its legislative work (which will be completed the 5 July 2023) concerned only plants. Nonetheless, it has declared itself open to discussions on the regulatory issues concerning GMMs. In fact, it explained to EuropaBio at the beginning of 2023 that work was underway with the Member States on the implementation of Regulation 1829/2003 in specific areas relating to GMMs. Two European expert committees are also working on GMMs.In 2020, the European Network of GMO laboratories (ENGL) received a mandate to work on the detection of GMMs in food and feed [5]. However, this mandate only concerns GMMs used in confined environments to produce molecules. As for GMMs released in the environment, the experts who worked on the report covering the detection of plants modified by « new mutagenesis techniques » recently « modified its mandate to include microorganisms ». They are « evaluating if the report could be extended to cover them ». [6].In July 2020, the European Commission asked the European Food Safety Authority (EFSA) to draw up a table of GMMs intended for release into the environment [7]. The informations, which are still awaited, concern the GMMs themselves, the techniques and modifications used, the associated « novel potential hazards and risks » and whether the existing risk assessment guidelines need to be « updated, adapted or complemented ». A wording quite similar to the mandates received by EFSA on new techniques applied to plants...The European Commission’s proposal to deregulate GMOs therefore seems to hide a future deregulation of genetically modified microorganisms. Given the public concern that GM bacteria, fungi or even viruses could be disseminated in the environment without any controls, it can be understood that this aspect of deregulation remains voluntarily hidden, to say the least. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [194] => Array ( [objectID] => 6816 [title] => The dilemma faced by certain seed companies in relation to intellectual property rights [timestamp] => 1701820800 [date] => 06/12/2023 [annee] => 2023 [url] => https://infogm.org/en/the-dilemma-faced-by-certain-seed-companies-in-relation-to-intellectual-property-rights-2/ [image] => https://www.infogm.org/IMG/arton7936.jpg [extrait] => The wave of GMOs/NGTs (new genomic techniques) is promised by US and European multinationals, and promoted by the European Commission and agricultural lobbies. But it also raises intellectual property issues for some « intermediate » seed companies. These GMOs/NGTs are in fact protected by patents with a potentially very broad scope, which can have an impact on […] [chapo] => Des multinationales de la semence aux petits semenciers traditionnels, le rapport aux droits de propriété intellectuelle sur les végétaux varie. Le sujet des OGM/NTG brevetables exacerbe la question en Europe et fait émerger divergences et ambiguïtés chez certains acteurs de la filière semencière. [texte] => The wave of GMOs/NGTs (new genomic techniques) is promised by US and European multinationals, and promoted by the European Commission and agricultural lobbies. But it also raises intellectual property issues for some « intermediate » seed companies. These GMOs/NGTs are in fact protected by patents with a potentially very broad scope, which can have an impact on the activities of such seed companies (as well as those of farmers and peasants) [1]. What position should these seed companies therefore adopt ?Heterogeneous positions in EuropeThe pre-eminence of patents in the field of plants is perceived by some seed players as a source of tension : reconciling patent protection and access to genetic material in plant improvement. This is particularly true of the German association of plant breeders, the BDP (Bundesverband Deutscher Pflanzenzüchter e. V.). In January 2023, it called for regulations restricting the patentability of « natural biological material ». Also representing the seed multinationals, the BDP concedes that setting up licensing platforms on patents owned in large part by the said multinationals is a solution for all seed companies to gain access to GMO/NGT technologies [2]. Plantum, the representative of Dutch seed companies, is broadly adopting the same position on platforms. In September 2023, however, it expressed its « concern » about the growing number of patents arising from NGTs : « it is very important to resume the discussion on the operation of patent law in the field of plant breeding » [3]. These two organisations are still trying to find a way to satisfy all their members and their various intellectual property policies.Austrian seed companies also fear that the increase in the number of patents will make breeding more difficult for small and medium-sized breeders. They also put the respective roles of patents and PVRs (Plant variety rights) into perspective : « variety protection should be the first right of protection in plant breeding » [4]. They point out that patents protect biotechnological inventions on plants and only complement the protection of varieties. The Austrian organisation continues : « It must be guaranteed in a legally binding manner that the biological material of plants, which exists or could exist in nature (e.g. by point mutation) or which results from selection, cannot be patented ».The heterogeneity of positions in Europe on this subject is illustrated in particular by those of the Czech seed companies, the CMSSA (Czech Seed Trade Association), and Euroseeds (representing European seed companies), of which the CMSSA is a member. On 27 March 2023, the CMSSA stated that it considered that « if NGTs are no longer considered GMOs, which it agrees with, they must be clearly labeled as methods derived from nature, i.e. natural methods. And it must be clearly stated that products derived from these methods cannot be patented » [5]. For its part, in a statement dated 15 October 2023, Euroseeds echoed the European Commission’s position : « the 1991 UPOV Convention is the sui generis existing intellectual property system most appropriate for the protection of plant varieties », « other specific forms of intellectual property protection, such as patents for biotechnological inventions, as provided for in EU Directive 98/44, must co-exist with the current system of plant variety protection ». According to Euroseeds, GMOs/NGTs are therefore GMOs and patentable.Plant Variety Rights and patentsPlant Variety Rights (PVR) cover new plant varieties, offering their breeder exclusive rights to market them. This concerns the visible aspects of the variety, such as its shape or characteristics such as resistance to transport. Registration offices such as UPOV (Union for the Protection of New Varieties of Plants) also use molecular markers to characterise varieties at the level of their genes.Patents are granted for a wider range of inventions, including genetically modified varieties. They grant a temporary exploitation monopoly in exchange for public disclosure of the invention. The claimed invention - for example, a genetic modification process - cannot be exploited without the consent of the patent holder. Patents are granted for new inventions, involving an inventive step and industrial applicability.French seed companies cultivate contradictionAt a meeting on the premises of Semae (interprofessional association for seeds and seedlings) in Februray 2023, the French seed companies RAGT and Florimond Desprez took a reserved and distanced position on patents for GMOs/NGTs [6]. On 18 October 2023, during a round table discussion at the French National Assembly, the UFS (Union Française des Semenciers) confirmed this position through the voice of Laurent Guerreiro, who is also Chairman of the Board of RAGT : « the position of our association consists of saying that since we want the plant variety certificate to remain the primary form of protection, we do not want to see a prevalence of patents for NGTs » [7]. This concern on the part of the UFS perhaps points to the fact that patents on GMOs/NGTs with a very broad scope could have an impact on the variety industry and restrict innovation.At the same round table, Laurent Guerreiro added : « We are hoping for the fastest possible access to a large number of technologies, including ’new breeding techniques’ [Editor’s note : NBT, another term for GMOs/NGTs], which should enable the breeding and development world to shorten selection times even further, to accumulate resistance criteria more easily and therefore to obtain much more resilient varieties in the future ».There is a contradiction in Laurent Guerreiro’s statements, or at least a difficulty in reconciling them. Access to a large number of GMOs/NGTs is theoretically possible, provided that they are developed and that a return on investment can be envisaged by their owners. But to do this, a large number of patents will have to be filed on these NBTs. But this does not seem to be what the Union Française des Semenciers (UFS) wants.On 29 November 2023, the UFS gave us its official position, which confirms that of 15 October, albeit with a shift in emphasis. The fear of the prevalence of patents is no longer put forward. Instead, the UFS speaks of the « coexistence » of the patent and PVC systems and of the « dynamics of varietal innovation ». Among the five principles proposed by the UFS (see box), the representative of the French seed industry even calls for « respecting the scope of patents », including those relating to GMOs/NGTs insofar as they do not cover native traits, i.e. those already present in nature. The UFS refers here to the « disclaimer » principle, which the European Patent Office has introduced to artificially exclude unpatentable elements from patent claims. The UFS also calls for « supporting transparency of information on patented features and their access between companies on fair, reasonable and non-discriminatory terms ». But this reference to transparency raises the question of the risk of GMO/NGT traceability, which concerns small seed companies, farmers and peasants, and therefore the inability for them to distinguish patented plants from natural varieties or those resulting from traditional selections. This could allow a few multinationals, including Corteva, Bayer/Monsanto, BASF and Syngenta, which own the main patents on key traits in agricultural plants, to restrict the use of seeds by these « small players ». This situation could lead to these companies controlling crops and food in Europe.But, as we have just learned, the European Parliament’s Agriculture Committee has just unanimously stressed the need to resolve these patent issues. By finally proposing a system that respects « small players », or a new stratagem in fine that is benevolent to the seed multinationals ?The UFS clarifies its positionUFS’s 5 fundamental principles for « guaranteeing coexistence, and maintaining the dynamics of varietal innovation » :Support the implementation at European level of the breeder’s exemption principle with regard to patents. The UFS is committed to maintaining access to the genetic background and patented traits of a variety for breeding purposes, as permitted by the breeder’s exemption under French law. The UFS supports the legislative implementation of this principle in every member state of the European Union and in those of the European Patent Convention (39 countries).Affirm the non-patentability of conventional breeding methods. French and European patent law have long excluded conventional selection methods from the scope of patentability. These methods, referred to as « essentially biological processes », include crossing.Affirm the non-patentability of native traits and those created by random mutagenesis. The UFS has always supported the exclusion from patentability of traits derived from existing and spontaneous natural variability. This exclusion is now enshrined in European law. In addition, although patent law permits it, the UFS considers that plants obtained by random mutagenesis should be excluded from the scope of patentability.Respect the scope of patents. As NGTs enable the creation of mutations that could also exist spontaneously, it is important that patents on NGT-mutated traits should not cover equivalent native traits. In this sense, the UFS supports the decision of the European Patent Office, which imposes a « disclaimer » clause in every patent, to ensure that native characters, equivalent to the patented character, which pre-exist or could potentially appear spontaneously, are not covered by these patents. The UFS considers this exclusion clause to be an essential device for limiting the scope of a patent, enabling breeders to work with plant genetic resources.Support transparency of information on patented traits and access to them between companies on fair, reasonable and non-discriminatory terms. Patent protection must be fully transparent, so that all seed companies are aware of the presence of a patented trait in marketed varieties. The UFS encourages all initiatives aimed at improving the transparency, completeness and dissemination of information, such as, for example, the PINTO database, accompanying measures for SMEs or non-exclusive access to patented innovations (as proposed, for example, by license-sharing platforms). Denis MESHAKA Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [195] => Array ( [objectID] => 6292 [title] => The dilemma faced by certain seed companies in relation to intellectual property rights [timestamp] => 1701820800 [date] => 06/12/2023 [annee] => 2023 [url] => https://infogm.org/en/the-dilemma-faced-by-certain-seed-companies-in-relation-to-intellectual-property-rights/ [image] => https://www.infogm.org/IMG/arton7936.jpg?1701860035 [extrait] => From multinational seed companies to small traditional seed companies, the relationship with intellectual property rights on plants varies. The issue of patentable GMOs/NGTs is exacerbating the problem in Europe and is causing divergences and ambiguities to emerge among certain players in the seed industry. The wave of GMOs/NGTs (new genomic techniques) is promised by US […] [chapo] => [texte] => From multinational seed companies to small traditional seed companies, the relationship with intellectual property rights on plants varies. The issue of patentable GMOs/NGTs is exacerbating the problem in Europe and is causing divergences and ambiguities to emerge among certain players in the seed industry. The wave of GMOs/NGTs (new genomic techniques) is promised by US and European multinationals, and promoted by the European Commission and agricultural lobbies. But it also raises intellectual property issues for some “intermediate” seed companies. These GMOs/NGTs are in fact protected by patents with a potentially very broad scope, which can have an impact on the activities of such seed companies (as well as those of farmers and peasants) [1]. What position should these seed companies therefore adopt?Heterogeneous positions in EuropeThe pre-eminence of patents in the field of plants is perceived by some seed players as a source of tension: reconciling patent protection and access to genetic material in plant improvement. This is particularly true of the German association of plant breeders, the BDP (Bundesverband Deutscher Pflanzenzüchter e. V.). In January 2023, it called for regulations restricting the patentability of “natural biological material”. Also representing the seed multinationals, the BDP concedes that setting up licensing platforms on patents owned in large part by the said multinationals is a solution for all seed companies to gain access to GMO/NGT technologies [2]. Plantum, the representative of Dutch seed companies, is broadly adopting the same position on platforms. In September 2023, however, it expressed its “concern” about the growing number of patents arising from NGTs: “it is very important to resume the discussion on the operation of patent law in the field of plant breeding” [3]. These two organisations are still trying to find a way to satisfy all their members and their various intellectual property policies.Austrian seed companies also fear that the increase in the number of patents will make breeding more difficult for small and medium-sized breeders. They also put the respective roles of patents and PVRs (Plant variety rights) into perspective: “variety protection should be the first right of protection in plant breeding” [4]. On 15 October 2023, during a round table discussion at the French National Assembly, the UFS (Union française des semenciers) confirmed this position through the voice of Laurent Guerreiro, who is also Chairman of the Board of RAGT (Rouergue Auvergne Gévaudan Tarnais): “the position of our association consists of saying that since we want the plant variety certificate to remain the primary form of protection, we do not want to see a prevalence of patents for NGTs”. This concern on the part of the UFS perhaps points to the fact that patents on GMOs/NGTs with a very broad scope could have an impact on the variety industry and restrict innovation.At the same round table, Laurent Guerreiro added: “We are hoping for the fastest possible access to a large number of technologies, including ’new breeding techniques’ [Editor’s note: NBT, another term for GMOs/NGTs], which should enable the breeding and development world to shorten selection times even further, to accumulate resistance criteria more easily and therefore to obtain much more resilient varieties in the future”. There is a contradiction in Laurent Guerreiro’s statements, or at least a difficulty in reconciling them. Access to a large number of GMOs/NGTs is theoretically possible, provided that they are developed and that a return on investment can be envisaged by their owners. But to do this, a large number of patents will have to be filed on these NBTs. But this does not seem to be what the Union Française des Semenciers (UFS) wants.On 29 November 2023, the UFS gave us its official position, which confirms that of 15 October, albeit with a shift in emphasis. The fear of the prevalence of patents is no longer put forward. Instead, the UFS speaks of the “coexistence” of the patent and PVC systems and of the “dynamics of varietal innovation”. Among the five principles proposed by the UFS (see box), the representative of the French seed industry even calls for “respecting the scope of patents”, including those relating to GMOs/NGTs insofar as they do not cover native traits, i.e. those already present in nature. The UFS refers here to the “disclaimer” principle, which the European Patent Office has introduced to artificially exclude unpatentable elements from patent claims. The UFS also calls for “supporting transparency of information on patented features and their access between companies on fair, reasonable and non-discriminatory terms”. But this reference to transparency raises the question of the risk of GMO/NGT traceability, which concerns small seed companies, farmers and peasants, and therefore the inability for them to distinguish patented plants from natural varieties or those resulting from traditional selections. This could allow a few multinationals, including Corteva, Bayer/Monsanto, BASF and Syngenta, which own the main patents on key traits in agricultural plants, to restrict the use of seeds by these “small players”. This situation could lead to these companies controlling crops and food in Europe.But, as we have just learned, the European Parliament’s Agriculture Committee has just unanimously stressed the need to resolve these patent issues. By finally proposing a system that respects “small players”, or a new stratagem in fine that is benevolent to the seed multinationals?The UFS clarifies its positionUFS’s 5 fundamental principles for “guaranteeing coexistence, and maintaining the dynamics of varietal innovation”: Support the implementation at European level of the breeder’s exemption principle with regard to patents. The UFS is committed to maintaining access to the genetic background and patented traits of a variety for breeding purposes, as permitted by the breeder’s exemption under French law. The UFS supports the legislative implementation of this principle in every member state of the European Union and in those of the European Patent Convention (39 countries). Affirm the non-patentability of conventional breeding methods. French and European patent law have long excluded conventional selection methods from the scope of patentability. These methods, referred to as “essentially biological processes”, include crossing. Affirm the non-patentability of native traits and those created by random mutagenesis. The UFS has always supported the exclusion from patentability of traits derived from existing and spontaneous natural variability. This exclusion is now enshrined in European law. In addition, although patent law permits it, the UFS considers that plants obtained by random mutagenesis should be excluded from the scope of patentability. Respect the scope of patents. As NGTs enable the creation of mutations that could also exist spontaneously, it is important that patents on NGT-mutated traits should not cover equivalent native traits. In this sense, the UFS supports the decision of the European Patent Office, which imposes a “disclaimer” clause in every patent, to ensure that native characters, equivalent to the patented character, which pre-exist or could potentially appear spontaneously, are not covered by these patents. The UFS considers this exclusion clause to be an essential device for limiting the scope of a patent, enabling breeders to work with plant genetic resources. Support transparency of information on patented traits and access to them between companies on fair, reasonable and non-discriminatory terms.Patent protection must be fully transparent, so that all seed companies are aware of the presence of a patented trait in marketed varieties. The UFS encourages all initiatives aimed at improving the transparency, completeness and dissemination of information, such as, for example, the PINTO database, accompanying measures for SMEs or non-exclusive access to patented innovations (as proposed, for example, by license-sharing platforms). Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [196] => Array ( [objectID] => 6856 [title] => Deregulation of GMOs/NGTs : Unanimity is not on the agenda [timestamp] => 1700524800 [date] => 21/11/2023 [annee] => 2023 [url] => https://infogm.org/en/deregulation-of-gmos-ngts-unanimity-is-not-on-the-agenda-2/ [image] => https://www.infogm.org/IMG/arton7919.jpg [extrait] => Recently, the European Economic and Social Committee urgently adopted an opinion critical of the Commission’s plan to deregulate new GMOs/NTGs, as part of the mandatory consultation procedure. The European Committee of the Regions has also been consulted, but its opinion has not yet been published. However, in May 2023, this committee issued an opinion on […] [chapo] => [texte] => Recently, the European Economic and Social Committee urgently adopted an opinion critical of the Commission’s plan to deregulate new GMOs/NTGs, as part of the mandatory consultation procedure. The European Committee of the Regions has also been consulted, but its opinion has not yet been published. However, in May 2023, this committee issued an opinion on agri-food systems, which already critically addressed the issue of GMOs/NTGs. These two European Union bodies are insisting that a precautionary approach be genuinely implemented in the supervision of products derived from new genetic modification techniques.On October 25, 2023, the European Economic and Social Committee (EESC) published an opinion on « plants produced by new genomic techniques » [1]. This opinion is clearly critical of the European Commission’s legislative proposal. Admittedly, it begins by stating that these new techniques could « accelerate plant breeding processes and provide EU [European Union] farmers with promising and resilient plant varieties ». It also seems to accept « the principle of environmental and health risk assessment adapted to the type of modification applied ». On the other hand, the EESC disassociates itself from the European Commission and demands « monitoring [that] includes monitoring of potential systemic effects as well as a benefit-cost analysis [of these NGT plants] ». Note the use of the adjective « systemic ». It is rare for official bodies to request an assessment of systemic effects. The EESC therefore states (paragraph 37) : « Systemic, or global, monitoring differs from case-by-case assessment, as in the case of analytical evaluation. It requires the development […] of indicators relating to the dynamics of the systems to which we belong (societies, ecosystems, etc.) ».The EESC also calls for harmonized coexistence measures at European level, so that organic farming and the « GMO-free » sector can continue to « prosper ». But the EESC also points out that « GMOs are banned [in organic farming] and NTGs would also be banned, however, as no detection, identification and traceability methods are required, buyers, member states and the Commission would be unable to apply the law properly ». Finally, the EESC calls for the creation « in a public and decentralized manner, [of] a European bank of traditional seeds [...] to preserve them and make them available » and for it to be made « impossible for persons other than NTG professionals to buy on the Internet and use without supervision kits enabling the genetic modification of living beings ». The opinion is also very clear on the threat posed by patents to farmers and small and medium-sized seed companies [2]. Thus, the EESC « calls for a clarification of the rules governing intellectual property on living organisms between now and the entry into force of this legislation ».For its part, the European Committee of the Regions (CoR), in an opinion published in May 2023 and devoted to sustainable food systems, said it was « concerned about a possible reintroduction of genetically modified organisms (GMOs) into our European food supply with the future proposal for a European regulation on plants produced by new genomic techniques (NTG). This proposal should be based on a solid assessment and sound scientific evidence from the European Food Safety Authority (EFSA). In any case, every food product containing GMOs should carry a label on the front of the packaging indicating the presence of GMOs » [3]. Several Austrian regions have already taken a public stance to demand the right to ban GMOs/NTGs, as a CoR representative told us.The European Committee of the Regions has been asked by the Council of the EU to issue an opinion on the legislative proposal. This opinion will be discussed by the Commission on November 23, following contributions from Cécile Collonier (from the European Agency for Plant Variety Rights - CPVO), Guy Kastler (European Coordination of La Via Campesina) and a representative of the Spanish Presidency. When questioned by Inf’OGM, the CoR explained : « This is a mandatory consultation, but agreement on this text between the Parliament and the Council may be reached without the CoR opinion being adopted ». The Council had asked the CoR to publish its opinion before the end of the year (within three months). The Committee’s website states : « When the European Parliament, the Council or the Commission consult the Committee (on both a mandatory and an optional basis), they may set the Committee a deadline (of at least one month, in accordance with Article 307 of the TFEU (Treaty on the Functioning of the European Union)), on expiry of which they may disregard the absence of an opinion ». However, the CoR bodies considered that this was a very complex subject, requiring time for debate and information. They therefore preferred to postpone the timetable. The final opinion will then be adopted by the plenary session on April 17-18, 2024.At a conference organized on Thursday September 24 by MEP Christophe Clergeau, representatives of the two committees underlined the pressure that had been brought to bear by Spain to deliver their opinion in what was clearly record time. For the CoR representative, « the most important point today is the timetable. On a subject of such complexity, the timetable imposed by the European Parliament rapporteur is simply unacceptable ».Spain hopes to finalize the adoption of this GMO/NTG regulation before the end of its presidency, at the end of December 2023... Will the European Commission, Council and Parliament listen to these two committees ? Or will they continue to play for time to prevent a democratic and open debate ? Christophe NOISETTE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [197] => Array ( [objectID] => 6964 [title] => Who is funding us? [timestamp] => 1700438400 [date] => 20/11/2023 [annee] => 2023 [url] => https://infogm.org/en/who-we-are/who-is-funding-us/ [image] => https://infogm.org/wp-content/uploads/2026/04/virugle_bleue_70-1.jpg [extrait] => **** [chapo] => [texte] => [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [198] => Array ( [objectID] => 6843 [title] => GMOs/NGTs : consumers want a choice [timestamp] => 1700438400 [date] => 20/11/2023 [annee] => 2023 [url] => https://infogm.org/en/gmos-ngts-consumers-want-a-choice-2/ [image] => https://www.infogm.org/IMG/arton7925.jpg [extrait] => At a conference organized at the European Parliament on October 26, 2023 by Socialist MEP Christophe Clergeau, the French consumer association UFC-Que Choisir, through the voice of Olivier Andrault, was clear : GMOs, whether « classical » or renamed NGT (New Genomic Techniques), must be assessed, labeled, and present real benefits, notably for the end consumer. The position […] [chapo] => [texte] => At a conference organized at the European Parliament on October 26, 2023 by Socialist MEP Christophe Clergeau, the French consumer association UFC-Que Choisir, through the voice of Olivier Andrault, was clear : GMOs, whether « classical » or renamed NGT (New Genomic Techniques), must be assessed, labeled, and present real benefits, notably for the end consumer. The position of France’s leading consumer federation is identical to its position on transgenic GMOs.At the end of October, the French consumer association UFC-Que Choisir added its voice to the chorus of positions already expressed by its European counterparts in Germany, Austria, Norway and France [1].Introducing his speech to the European Parliament on October 26, Olivier Andrault, head of the food mission at UFC-Que Choisir, France’s largest consumer association, stressed from the outset that the scientists who had spoken at the conference had clearly shown that NGTs are GMOs. For him, the debate is not new, and is part of a historical continuity and a specific socio-economic context. For UFC-Que Choisir, the issue is not to be for or against GMOs, but rather to ensure that a certain number of conditions are met. Six conditions seem unavoidable.The conditions necessary for the acceptance of GMOsThese conditions derive from the implementation of the precautionary principle and respect for consumers’ freedom of choice. For UFC-Que Choisir, GMOs can be marketed on condition that :they carry no short- or long-term environmental or health risks ;they bring benefits to all users along the food chain, and in particular to end consumers ;it is very difficult or impossible to obtain the same benefits with conventionally bred plants ;producers have the possibility of choosing whether or not to use these GMOs/NGTs ;strict traceability throughout the production chain is mandatory ;end consumers be informed of the possible presence of a GMO/NGT in the product they are about to buy.This last condition is the spearhead of his organization. He has repeated it several times : « we demand that the consumer be in the position of having a free and informed choice to buy or not to buy products containing or produced from GMOs/NGTs ».After listing these conditions, Olivier Andrault drew up a rapid, critical assessment of current legislation and « conventional GMOs ». In his view, risk assessment as currently established is really limited : it only looks at short-term impacts. He notes that, for example, the assessment of benefits for all is not taken into account. UFC-Que Choisir is therefore calling for long-term environmental monitoring of GMOs/NGTs. Another flaw in current legislation is labeling. It recognizes that products intended for human consumption must be labelled, but regrets that this labeling does not apply to products from animals fed on GMOs. For UFC-Que Choisir, this is a major shortcoming.Finally, he refers several times to the promises made 20 or 30 years ago : to fight world hunger, improve the nutritional quality of food, use fewer pesticides... The reality is that GMOs marketed since the 90s are designed to tolerate herbicides or produce insecticides. And, as a result, the cultivation of these GMOs has led to a greater quantity of pesticides being sprayed (notably due to plants becoming resistant to herbicides). Thus, Olivier Andrault asserts : "the « pragmatic » conclusion of UFC-Que Choisir on conventional GMOs was and remains that they bring no benefit and that it is always difficult to make a choice, so we are opposed to these conventional GMOs".Lack of knowledge and precaution relegatedThe rest of his presentation takes a more detailed look at GMOs/NGTs and the Commission’s proposal to deregulate them. He noted a number of important blind spots in the scientists’ presentations, and a notorious lack of knowledge about these new genetic modification techniques. The scientists interviewed stated that categories 1 and 2 are « arbitrary », that there is nothing scientific about their definition, and that there is no link with the level of risk.As for the Commission’s proposal, the UFC-Que Choisir spokesperson notes that it contradicts the precautionary principle. In fact, for many future GMOs (category 1 NGTs), the Commission is proposing to do away with risk assessment and reduce the current regulatory framework (assessment, authorization, labeling, etc.) to a simple declaration procedure [2]. However, he adds, « what concerns us greatly is that a very large number of NGTs will be classified in category 1, for which the level of obligation will be extremely low ». This proposal, the consumer association points out, removes the possibility for Member States to oppose the cultivation of such GMO/NGT plants on their territory [3].No traceability, no labeling, no real benefitsAs a consumer protection association, the Commission’s proposal to abolish traceability and labeling of GMOs/NGTs is particularly shocking for UFC-Que Choisir. This has several implications.The first is that the absence of traceability and labeling will lead to an enormous risk of contamination of « conventional » or organic products, and de facto widespread contamination. And who will pay if organic products are contaminated ? UFC-Que Choisir regrets not having received an official answer to this question.The second implication is the impossibility for producers and consumers to make an informed choice.With such a proposal, UFC-Que Choisir criticizes, « there is no possibility of making an informed choice, of buying or not buying products containing such NGTs. Yet this is the main demand of our association ». Added to this is UFC-Que Choisir’s concern that these GMOs/NGTs should bring real benefits to consumers. On this point too, Olivier Andrault is more than skeptical. « I can’t see how the promises made previously are any different from those currently being made for NGTs », he asserts. For him, diet-related health problems are due to « industrial recipes » (sic) that involve too much sugar, saturated fat, salt, food additives... He also refers to the problems of packaging and the use of bisphenols. And the causes of overpriced food are to be found in the management of national or local production. But in both cases, he insists, « it has nothing to do with NGTs ».After such an argument, Olivier Andrault concludes : « UFC-Que Choisir, as it stands, is not in favor of these GMOs/NGTs, and demands that all NGTs go through a full authorization procedure, that member states be able to oppose such GMOs/NGTs, and that full traceability and labeling on packaging for all category 1 and category 2 NGTs be mandatory ». Christophe NOISETTE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [199] => Array ( [objectID] => 6853 [title] => EU : vitamins and additives produced by GMOs [timestamp] => 1699833600 [date] => 13/11/2023 [annee] => 2023 [url] => https://infogm.org/en/eu-vitamins-and-additives-produced-by-gmos-2/ [image] => https://www.infogm.org/IMG/arton7920.jpg [extrait] => Many additives and vitamins are now produced industrially by micro-organisms, some of them being genetically modified. The applications for authorization consulted by Inf’OGM for the latter are less numerous (122 dossiers out of 723 read) than for enzymes. But these molecules are important to know, as they are increasingly present in human and animal foodstuffs… […] [chapo] => [texte] => Many additives and vitamins are now produced industrially by micro-organisms, some of them being genetically modified. The applications for authorization consulted by Inf’OGM for the latter are less numerous (122 dossiers out of 723 read) than for enzymes. But these molecules are important to know, as they are increasingly present in human and animal foodstuffs… Especially as cases of illegal presence of GM micro-organisms in Europe have already been observed via the marketing of one of these vitamins.In a series of articles, Inf’OGM attempts to unravel the complex subject of genetically modified microorganisms (GMMs) and their industrial use [1]. We have already analyzed the use of these GMMs to produce enzymes used in agri-food chains [2]. Vitamins or additives, such as sweeteners or amino acids, can also be produced industrially via GMMs.Less applications than for enzymesFor the period going from 2005 to mid-2023, Inf’OGM was able to read 723 applications for authorizations for molecules used in the agri-food chain [3]. Of these 723 applications filed in the European Union and analyzed by the European Food Safety Authority (EFSA), a small proportion concern vitamins or other additives. The table below summarizes the share of each dossier.MoleculeNb of applications readGMO originUncertain originOrigin declared as non-GMOEnzymes601242252107Vitamins6291934Other additives60222018TOTAL723273291159As we’ll see from two examples, vitamins and other additives are important products in the food industry. These vitamins, amino acids or sweeteners are added to human or animal foodstuffs to be directly assimilated by the latter. Although they are present in a large number of products, their origin « produced from GMOs » is not indicated to the processors who use them. In 2006, the member states of the European Union decided to make such labelling non-mandatory [4]. Industries can sometimes go even further, claiming that additives are « non GMO », even though they have been produced by GMMs... [5]Two vitamins produced by GMMsBetween 2005 and mid-2023, EFSA examined 62 applications for vitamins. These 62 dossiers concern 13 vitamins [6]. While most of these are produced by chemical synthesis, five are produced by micro-organisms (vitamins B2, B12, C, D2 and D3). For these five vitamins, 20 dossiers were submitted by 15 industrial entities [7].Only one, vitamin B2, is the subject of eleven applications for industrial production using GMMs. Of these eleven applications submitted, eight - the majority of the applications for this vitamin - involve GMM production. They were submitted by six industrial entities [8]. This vitamin has a special history within the GMM file in Europe. In 2018, 20 tonnes of vitamin B2 already present in the European Union were found to be contaminated by the GMM used to produce it, namely the transgenic bacterium B. subtilis KCCM-1045. Officially, the vitamin must be DNA-free. Discovered by the German authorities, this contamination had spread to twenty member states. At the time, Inf’OGM explained that Germany, Austria and Belgium were among the countries keeping a watchful eye on these imports. They feared contamination « in the event of the use of genetically modified micro-organisms in a contained environment or of products derived from these GMOs » [9].Additives produced by GMMsThe other molecules produced by GM microorganisms are various additives, mainly amino acids (the building blocks of proteins), but also sugars, pigments or salts. 62 applications for authorization have been filed between 2005 and mid-2023, 22 of which involve the use of GMMs. GMMs are mainly used to produce amino acids, but also lactic acid and steviol glycosides (used as sweeteners). These 22 applications were filed by nine different industrial entities [10].Among the amino acids produced by GMMs, the most emblematic is lysine, or more precisely the L-Lysine. This amino acid is mainly used by the agri-food industry, but is also found in products for the pharmaceutical and cosmetics industries [11]. Of the six dossiers submitted to EFSA, five involved the production of lysine by a GMM, and all five were intended for animal feed. Lysine is essential for human and animal development. As they do not naturally produce this amino acid, they need to find it in their diet, such as leguminous plants, eggs, etc. In farms where the feed is not sufficiently varied or nutritious, this amino acid is provided as a supplement. Four companies have therefore applied for authorization to market L-Lysine produced by genetically modified bacteria [12].Steviol glycosides are another example of an additive that can be produced by GMMs, but in this case, production is more recent. Originally extracted from a plant native of South America, stevia (Stevia rebaudiana) has been used traditionally for centuries in the form of herb or honey. Today, this sweetener has become a very promising market. Authorized in France since 2010 under the name E960, stevia presents itself as a direct alternative to aspartame, itself being an alternative to sugar for diabetics in particular [13]. They are mainly produced by extraction from stevia leaves. But, in 2021, two companies have applied for authorization to market certain steviol glycoside molecules (Rebaudioside) produced by genetically modified yeasts [14]. A first, as Amyris points out in the application for approval filed in New Zealand one year earlier than in Europe, in 2020 [15]. According to the company, the main benefit of producing via GMMs is that it leads to greater amount than extracting stevia leaves. Profitability for the company would therefore be higher.It is to be detailled here that a third company, SweeGen, does not produce stevia directly from MGM, but uses enzymes produced by MGM in its manufacturing process. These enzymes are used to produce stevia from leaf extracts [16].One special additiveIn 2019, the European Union received a specific request for authorization from the US company Impossible Food Incorporation. This application, which is still under process by the EFSA, concerns a molecule called leghemoglobin, a component of « plant steak ». As Inf’OGM reported, this molecule, which claims to be « very close to hemoglobin, is obtained through the culture of transgenic yeast » and the company hopes that it will "give the red color and « ferrous » taste" from meat to veggie steak" [17]. The company has also approached the USA, Canada, Hong Kong and Singapore. Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [200] => Array ( [objectID] => 6737 [title] => GMOs : sweetened transparency [timestamp] => 1698624000 [date] => 30/10/2023 [annee] => 2023 [url] => https://infogm.org/en/gmos-sweetened-transparency-2/ [image] => https://www.infogm.org/IMG/arton7908.jpg [extrait] => Inf’OGM has studied over 600 dossiers filed in the European Union for molecules (enzymes, vitamins, additives) produced by micro-organisms, whether genetically modified or not. Among these dossiers, three concern the production of molecules, attempts at synthetic copies of chemical compounds present natively in Stevia. The aim is to produce sweeteners. The three companies, Avansya, Amyris […] [chapo] => [texte] => Inf’OGM has studied over 600 dossiers filed in the European Union for molecules (enzymes, vitamins, additives) produced by micro-organisms, whether genetically modified or not. Among these dossiers, three concern the production of molecules, attempts at synthetic copies of chemical compounds present natively in Stevia. The aim is to produce sweeteners. The three companies, Avansya, Amyris and SweetGen, use genetically modified yeast to produce these sweeteners. As we shall see, these companies’ communications are misleading.Recently, the European Food Safety Agency (EFSA) examined three applications for the authorization of sweeteners produced by genetically modified yeast. More specifically, they concern the production of molecules called Rebaudioside (or Reb), from the steviol glycoside family. These molecules will be found in food additives (E 960) [1]. Companies not only fail to mention that their sweeteners are derived from GMOs, but use misleading vocabulary.Synthetic molecules produced by GM micro-organismsAvansya, a joint venture between DSM and Cargill, is promoting a « EVERSWEET™ » sweetener on its website. It writes that, at its plant in Blair (Nebraska, USA), is produced « a stevia-based, calorie-free, non-artificial sweetener » [2]. It goes on to state that « these highly sought-after sweet-tasting molecules, such as Reb M and Reb D [are] used to make EVERSWEET™, and offers food and beverage manufacturers an even more scalable, sustainable and low-cost-to-use solution than if these molecules were extracted from stevia leaf ». And therein lies the appeal of industrial production : the artificial is cheaper than extracting the natural.Cargill’s website provides « further details » : « EverSweet®, the next generation stevia sweetener. A calorie-free sweetness inspired by nature. Our secret ? The age-old technique of fermentation - with a modern twist. Thanks to a specially designed yeast, our EverSweet® stevia sweetener delivers the same sweet taste as stevia leaf » [3].In the case of EverSweet, these molecules appear to be produced by the genetically modified yeast Yarrowia lipolytica. The company has submitted an application for authorization (dossier EFSA-Q-2021-00356) in June 2021 for the production of several Rebaudioside molecules. In addition, Avansya states on its website that it has received authorization from the US authorities. The FDA has in fact evaluated the production of this additive from this genetically modified yeast [4]. The FDA states, « Most of the genes [inserted into yeast] are from the plant Stevia rebaudiana (but have been synthetically produced and adapted with respect to codon usage for optimal expression in yeast). [...] Introduced DNA sequences are integrated into the host organism’s genome, partly at predefined loci (targeted integration), but mostly in a random fashion. As the yeast Yarrowia lipolytica is not known to harbor toxin-coding genes or other harmful sequences, random or targeted introduction of DNA sequences will not result in increased risk due to unintended pleiotropic effects ».So to speak of « an ancestral technique » (sic) of fermentation and stevia as a non-artificial sweetener is deliberately misleading. Indeed, it borders on synthetic biology, since these genes are « adapted » for optimal expression.Synthetic biology company Amyris, meanwhile, has submitted a dossier for the production of these molecules using another genetically modified yeast, Saccharomyces cerevisiae (dossier EFSA-Q-2021-00357). Their website states, « RealSweet™ Reb M : A natural, calorie-free sweetener - pure, long-lasting, diabetic-friendly and exceptionally sweet, sustainably derived from sugarcane and GMO-free » [5]. Or : « The key to our production is large-scale fermentation. We’ve programmed our yeasts to produce Reb-M, and our fermenters replicate the same enzymatic steps as the plant during the natural growth process ». If the yeasts are « programmed », they are GMO. On its website, the company confuses the consumer : it refers to non-GMO sugar cane (used as feed for these GMO yeasts) and specifies that the final sweetener is « non-GMO » [6]. Since the final product is not a living organism, it cannot logically be genetically modified. And, like Avansya, Amyris refers to traditional fermentation processes. It writes on its website : « The process of making Reb-M is similar to that of kombucha or beer. We ferment our sugar cane with special yeasts, which produces Reb-M, a new sweetener ».Another route : enzymatic conversationFinally, a third company, SweeGen, has also submitted a dossier to EFSA (EFSA-Q-2020-005208). It too mentions on its website that its sweetener, named Signature Stevia, « is GMO-free, has a pure taste, is of natural origin and is easy to label » [7]. However, to produce the various Rebaudioside molecules present in its sweetener, this company also uses a genetically modified yeast, K. phaffii. The process is a little different, however. Genetically modified yeasts produce enzymes, which act on a purified extract of Stevia leaves. The EFSA points out that « on the basis of available data, the Scientific Panel cannot exclude the possibility that a residual amount of DNA encoding the kanamycin resistance gene remains in the final product. If this gene were to spread into the microbiota due to the presence of recombinant DNA in the final product, this would be a cause for concern. Therefore, the Scientific Panel concluded that the safety of Rebaudioside D produced via this enzymatic bioconversion was not sufficiently demonstrated by the available data, given that the absence of recombinant DNA has not been demonstrated » [8].Bio-economy of promise and misleading communicationMicroorganisms to produce molecules are presented as an ecological solution, requiring no agricultural land... This obliterates the fact that these « factories » need energy, water and sugar to function. The sugar needed by these micro-organisms comes from a variety of sources, including corn, sugar beet and sugar cane. In all cases, agricultural land is diverted from its original purpose. And sugar cane is a problematic crop, both from an environmental and social point of view : deforestation, heavy pesticide use, land disputes, precarious employment, etc. In 2019, Christian Berdot wrote in our columns : "If this new bio-economy were to develop on a large scale - agrofuels, « green » chemistry, foods, etc. - the explosion in global sugar needs would therefore threaten many of the planet’s precious ecosystems and the people who live in them" [9].On the other hand, the companies insist that steviol glycoside molecules derived from the whole plant, or produced by micro-organisms, are identical. The question of the difference between natural and synthetic molecules is vast. Some argue that the difference is due to the totum effect : natural, non-isolated molecules act in conjunction with the other molecules around them. They would therefore not act in the same way as an isolated molecule. This notion has been widely defended by phytotherapy practitioners. In the Vidal, an article gives an example of this totum effect with white willow : « when taken to relieve lower back pain, the dose of salicin (transformed into salicylic acid in the body) to be ingested is much lower than the effective dose of aspirin (acetylsalicylic acid). Yet white willow has been shown to be effective in this indication, suggesting that other substances present play a role in reducing painful symptoms » [10].We’re in the same situation with stevia : steviol glycosides from stevia leaves comprise a large number of molecules, which interact with each other and with other stevia molecules. This is quite different from the isolated molecules (Reb) produced industrially by genetically modified organisms ; or from Reb-M, which is not present in stevia and is produced enzymatically... All these molecules are therefore not natural and their production is not sustainable. Christophe NOISETTE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [201] => Array ( [objectID] => 6733 [title] => European organic food processors say « no » to GMOs/NGTs [timestamp] => 1698364800 [date] => 27/10/2023 [annee] => 2023 [url] => https://infogm.org/en/european-organic-food-processors-say-no-to-gmos-ngts-2/ [image] => https://www.infogm.org/IMG/arton7907.jpg [extrait] => The organisation of European organic food processors and retailers (OPTA) rejects GMOs/NGTs, but sets out conditions for their possible adoption. At the beginning of September, a new player took a stand against the European Commission’s proposal to deregulate “new GMOs“, which it has renamed NGTs : Opta (Organic Processing and Trade Association), the European organisation that […] [chapo] => [texte] => The organisation of European organic food processors and retailers (OPTA) rejects GMOs/NGTs, but sets out conditions for their possible adoption.At the beginning of September, a new player took a stand against the European Commission’s proposal to deregulate "new GMOs", which it has renamed NGTs : Opta (Organic Processing and Trade Association), the European organisation that represents the interests of companies processing and trading organic products [1].OPTA claims that GMOs/NGTs are incompatible with the principles of organic farming and consumers’ perception of organic products. It considers that the authorisation of GMOs/NGTs threatens organic businesses in the European Union (EU) [2].The historic commitment of the "organic" sector to GMOsOrganic farming is based on strong concepts, including the use of natural fertilisers and respect for ecosystems. It also imposes strict standards and organic certification, and refuses to use GMOs. As GMOs/NGTs (or "new GMOs") are, like their predecessors, derived from genetic modification, organic farming’s defenders believe that they are not compatible with its foundations [3] [4].The seed industry takes a different view. It is even developing a discourse - and an associated novlanguage - praising the "agroecological" virtues of these "new GMO » [5]. In particular, it misleadingly puts forward the argument that GMOs/NGTs (Crispr/Cas9, TALEN,...) make it possible to produce organisms as nature would, but much more quickly than nature would. Another "agroecological" argument put forward by the industry is that these GMOs/NGTs will reduce chemical inputs and water consumption. We can legitimately question this type of promise, given that those - very similar - concerning transgenic GMOs have not been kept [6].This kind of semantic, even ideological, intrusion by agribusiness into the concept of agroecology is arrogant, to say the least. It is clearly aimed at admitting GMOs/NGTs into organic farming, in total disregard of the fundamental principles of this sector, such as the absence of chemical inputs and the priority given to biodiversity.To counter this industrial strategy, the European Union’s organic product processors and traders are calling for vigilance and action through their official representative, Opta.GMOs/NGTs, a risk for the organic supply chainIn concrete terms, Opta is calling for the application of strict rules to ensure the traceability, labelling and protection of organic operators for all GMOs/NGTs. This would guarantee that organic products remain free from NGT products and that consumers have a clear view of the origin of products. She is also calling for rules to be put in place to ensure coexistence between different types of farming. For example, it is calling for the introduction of "a mechanism to ensure that GMO/NGT manufacturers bear the additional costs associated with prevention and monitoring of the organic supply chain". Similarly, the association is calling for compensation for organic operators in the event of damage caused by the presence of GMO/NGT material. The proposal, it should be remembered, no longer provides for any rules on coexistence or compensation for damage in the event of contamination.The debate on the impact of GMOs/NGTs on organic farming is not yet over at EU level, but concerns remain within this still fragile sector, which currently occupies just 9.9% of cultivated land [7].The French industry also on alertIn a press release dated 5 July 2023, a number of organisations, includingSynabio, FNAB, Bio Consom’acteurs, La Maison de la Bio, had warned of the dangers to organic production of removing traceability and labelling for "new GMOs" derived from NGTs [8]. They call on the French public authorities to :"- Make traceability and labelling of [GMOs/]NGTs mandatory, in the same way as for other GMOs. Maintain the ban on the use of GMOs in organic farming, including [GMO/]NGT, inaccordance with the principles of the European organic regulation Eliminate "sustainable" claims for [GMOs/]NGTs, which are misleading for consumers Maintaining the risk assessment of [GMOs/]NGTs Continue to publish a method for detecting [GMOs/]NGTs Guaranteeing the availability of information at no extra cost to organic operators Introduce effective coexistence measures that are not the responsibility of the organic sector,including a compensation fund for contamination by biotech companies. Funding innovation to help develop organic farming and food". Denis MESHAKA Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [202] => Array ( [objectID] => 6725 [title] => GMOs : the Commission ignores its experts to reassure industry [timestamp] => 1698192000 [date] => 25/10/2023 [annee] => 2023 [url] => https://infogm.org/en/gmos-the-commission-ignores-its-experts-to-reassure-industry-2/ [image] => https://www.infogm.org/IMG/arton7902.jpg [extrait] => Has the European Commission based its proposal to deregulate GMOs/NTGs on « sound science » or on the demands of seed companies ? Documents obtained by Corporate Europe Observatory (CEO) show that the Commission chose to listen to the companies rather than its own experts at the European Food Safety Authority (EFSA). The EFSA had indeed asked for […] [chapo] => [texte] => Has the European Commission based its proposal to deregulate GMOs/NTGs on « sound science » or on the demands of seed companies ? Documents obtained by Corporate Europe Observatory (CEO) show that the Commission chose to listen to the companies rather than its own experts at the European Food Safety Authority (EFSA). The EFSA had indeed asked for an assessment - albeit a relatively light one - of the risks of « new GMOs ». However, the European Commission has proposed to abolish this requirement, as requested by certain companies.On July 5, 2023, the European Commission published its plan to deregulate GMOs obtained using « new genomic techniques » (GMOs/NGTs). Contrary to its usual practice, the Commission made very little reference to the notion of « sound science ». It makes no mention of it either in the press release accompanying its proposal, or in the contribution on the « Green Pact » policy which serves as the political justification for the same proposal [1]. Only the FAQ details that the Commission has relied « on EU-level scientific advisory bodies », including the EFSA [2]. An Authority which recommended, in October 2022, that plants genetically modified by new techniques be evaluated [3].Commission reassures companiesBetween 2012 and 2020, EFSA published several opinions on the risks associated with GMO/NGT plants. These concluded that a risk assessment, albeit a simplified one, is necessary. In October 2022, this body completed its work by publishing a document listing the « six main criteria to assist the risk assessment » of these GMO/NGT plants [4].This latest opinion has caused concern among companies, who want no risk assessment to be required. In fact, this opinion, like its predecessors, acknowledges the need for a risk assessment. Correspondence between the Commission and certain companies or company representatives shows that the latter mobilized against this opinion at the end of 2022 / beginning of 2023.In December 2022, Croplife explained to the European Commission that it was concerned that the EFSA opinion « might give the impression that a mandatory risk assessment strep is necessary for all plants obtained by targeted mutagenesis, cisgenesis and intragenesis ». For, Croplife argues, current GMO legislation is simply « not an appropriate basis to regulate these plants [unlike] the existing framework available for conventional breeding has shown to provide a high level of protection. ».In January 2023, Limagrain expressed the same concern to the Commission, albeit in more restrained terms. It regretted that the Commission had restricted EFSA’s mandate to the legislative framework for GMOs, whereas it should have asked EFSA « considerations of whether a risk assessment would be needed for conventional-like NGT plants ».Finally, in the same month, the French Plant Biotechnology Association (AFBV) also took up the cause. In February 2023, the European Commission replied that it had received the document in which the AFBV wrote that it does « not share EFSA’s apparent recommendation that a mandatory risk assessment step is necessary for plants obtained by directed mutagenesis, cisgenesis and intragenesis ».In its responses, the European Commission is willing to reassure. In January 2023, it replied to CropLife that EFSA’s work « on possible criteria for risk assessment also feeds into this policy work as scientific advice to the Commission for consideration. This in no way prejudges what regulatory framework could eventually be proposed for NGT plants. The framing of the Terms of Reference of the Commission’s mandate to EFSA was indeed focused on the development of criteria for risk assessment, in case such an approach were to be proposed. A decision on whether risk assessment should be performed on NGT plants or not is outside EFSA’s remit, as you correctly noted ». Of course, the Commission is right to point out that politicians are the decision-makers, not scientific experts. But in the present case, it is going against their advice by proposing, on July 5 2023, that no risk assessment be carried out for a majority of GMO/NGT plants.No risk assessment for a large number of GMOsIndeed, in its text presented to the Council of the European Union and the European Parliament, the Commission proposes that GMOs obtained by new techniques of genetic modification (GMOs/NGTs) be divided into two categories. The first would be the NTG class 1, which could eventually concern the majority of GMOs obtained by these techniques [5] [6]. For them, the Commission proposes that no health and environmental risk assessment be carried out. Because, it claims, « risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs [...] and these requirements can be disproportionate or inadequate » [7]. It adds that these NTG1 plants « should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques », in particular because « they are equivalent and that their risks are comparable » [8].In the « whereas », which refer to the legislator’s intentions, the European Commission does not mention the EFSA’s opinion on Category 1 GMO/NTG plants. However, this opinion concerns all plants obtained by « targeted mutagenesis, cisgenesis and intragenesis », including these category 1 GMO/NTG plants. But the Commission refers to this opinion only for category 2 GMO/NTG plants, defined by the European Commission as those not belonging to category 1. The Commission thus suggests that, on the basis of the EFSA opinion, « considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants » [9]. These NTG2 plants would therefore be subject to a variable risk assessment.A proposal that ignores the opinion of European expertsSurprisingly, the European Commission’s reference to EFSA’s opinion in this proposal is partial and biased as it has taken the liberty of rewriting EFSA’s opinions.On the one hand, it considers that the risk assessment requirements of current GMO legislation « can be disproportionate and inadequate ». In its October 2022 opinion, however, EFSA reminded the European Commission that it had already issued opinions on the subject [10]. It was on the basis of these opinions that the Commission concluded, in 2021, that it was only « in some cases [that the requirements] can be disproportionate or inadequate ».On the other hand, the European Commission claims that NTG1 plants « are equivalent and that their risks comparable » to conventionally obtained or naturally occurring plants. However, in 2022, the EFSA recalled that it had considered, in 2012 and 2020, « that plants produced by targeted mutagenesis, cisgenesis and intragenesis, in some cases, do not pose new hazards compared to plants produced with classical mutagenesis or conventional breeding techniques » [11]. Only in some cases, not in all cases ! To overlook these restrictions is misleading, to say the least.If followed, the EFSA criteria would have resulted in a much lighter risk assessment for these GMOs than what is legally required today. But they were clearly already too much for the European Commission, which ultimately chose to ignore the EFSA’s opinion. It therefore proposes that only « a description of the trait(s) and characteristics which have been introduced or modified » be provided for GMOs/NTG1 and that no risk assessment be conducted [12]. In this, it responds favourably to the concerns expressed by several representatives of pro-GMO companies and lobbying associations... Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [203] => Array ( [objectID] => 6707 [title] => GMO: In the USA, a decade of promises without commercialization [timestamp] => 1698105600 [date] => 24/10/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/gmo-in-the-usa-a-decade-of-promises-without-commercialization/ [image] => https://www.infogm.org/IMG/arton7911.jpg [extrait] => In the USA, in 2012, the authorities decided for the first time to exempt a GMO from regulatory requirements. It was a vine genetically modified by cisgenesis, one of the new techniques of genetic modification. Since then, nearly a hundred « new » GMOs have been the subject of a similar decision. Paradoxically, a decade after this […] [chapo] => [texte] => In the USA, in 2012, the authorities decided for the first time to exempt a GMO from regulatory requirements. It was a vine genetically modified by cisgenesis, one of the new techniques of genetic modification. Since then, nearly a hundred « new » GMOs have been the subject of a similar decision. Paradoxically, a decade after this first decision, only six of them have been commercialized.The European Commission and multinationals would have us believe that plants genetically modified using new techniques are present everywhere except in the European Union. They accuse European legislation of being too restrictive. In this article, Inf’OGM takes stock of the actual marketing of these plants in the United States. This country’s legislation is particularly open to GMO plants, and should therefore be the site of this massive commercialization [1].Few new GMOs actually reach the marketSince 2012, 95 green lights for plants modified by combinations of new techniques have been granted [2]. But very few of these new GM plants have been commercialized in the United States. In terms of plant species, while the number of 95 may seem large in absolute terms, it conceals a huge disparity. Almost half the dossiers concern just five plants, most of which have already been modified by transgenesis alone (see Table 1). The « transgenic » dossier already showed this same trend, with over 80 species experimentally tested in European fields in 30 years, for just four that have dominated the commercial market (soybean, rapeseed, maize and cotton).Table1PlantNumber of requestsPlantNumber of requestsSoya15Tobacco4Potato10Camelina3Maize9Mustard3Canola8Wheat3Tomato7Avocado2Penicress7Switchgrass2Rice6Mushroom2Apple, Barley, Lemon, Flax, Grape, Kentucky Bluegrass, Lettuce, Alfalfa, Pea, Petunia, Setaria Veridis, St. Augistinegrass, Strawberry, Teff1Inf’OGM questioned companies or laboratories that had obtained « authorization » (in fact, an exemption) to find out about their marketing results or prospects. Only eleven companies or universities (out of 23 questioned) replied as to the marketing of a product in the United States. These responses, together with knowledge of commercialization in previous years, make it possible to establish that only six plants modified by « new techniques » are or have been commercialized, eleven years after the first decision not to subject such plants to US legislation. Six plants... which are : a mustard with reduced « spiciness », by Pairwise (marketed in 2023) ; a soybean with a modified fatty acid composition, by Calyxt (its marketing began in 2019, but was gradually scaled back in the face of lower-than-anticipated yields) ; a modified herbicide-tolerant canola, by Cibus ; two potatoes with delayed browning and lower acrylamide levels when fried, by Simplot ; a herbicide-tolerant Clearfield rapeseed by BASF (marketed in France, among other countries).On the other hand, a number of responses promised commercial development in the near future. Bioheuris announces a GM rice in 2026 and a soybean between 2027 and 2029. For its part, Yield 10 replies that it is « in a position to begin to provide it to growers under contract as early as 2024 » for a spring camelina (brassica family). On its website, Cibus announces genetically modified wheat, rice, soybean and corn for the years to come, some as early as 2023.For its part, Corteva, which questioned the USDA about genetically modified corn, soybeans and canola, does not announce any dates, but states that it is currently « conducting pre-market activities ». Finally, Toolgen has no « plan to commercialize ToolGen’s seed in the USA at this moment », as the company still has to go through « further breeding practices to plant in the field as an elite variety ».Note that Syngenta has only two dossiers for rice and corn, while Bayer and BASF do not appear on the USDA website for such crops. Yet these companies are one of the spearheads of their deregulation in Europe. Their presence can nevertheless be indirect, as is the case for Bayer, which invests in CoverCress or has developed a partnership with Pairwise.Other companies among those who didn’t reply to us may already have commercialized one or more plants genetically modified using new techniques in the USA. But, if this were the case, the overall observation that the USA is not experiencing unbridled commercialization would nonetheless remain unchanged. Ultimately, the USA is proof that, despite permeable regulations, GMOs obtained using new techniques are very, very little commercialized.Some problems on the road to marketSome of the responses received reveal the reasons why no commercialization has yet taken place, or ever will. The most emblematic of these concerns the famous mushroom genetically modified for delayed browning, which the European Commission once used extensively to promote its policy. In 2016, the USDA gave the green light for the commercialization of this mushroom without any regulatory oversight. Seven years later, there’s no trace of this mushroom on American shelves. And with good reason. Penn State University explained that the researcher behind the mushroom, Prof. Yinong Yang, did not « pursue further improvement and commercialization of that gene-edited mushroom due to negative perception of GMOs by consumers and mushroom companies ». But, according to Prof. Yinong Yang, there are other reasons for this non-commercialization, « such as CRISPR/Cas9 intellectual properties, industry and public concerns, and funding ». Toolgen, meanwhile, has just suffered a setback in court in Australia by failing to have a patent application on the use of Crispr upheld [3].These blockages linked to intellectual property rights on Crispr/Cas9 are a concrete illustration of the positions defended in France by seed companies RAGT and Florimond Desprez, who have denounced the cost of royalties linked to patents on these new techniques.Many requests for free commercializationIn the United States, the Department of Agriculture may be asked to determine whether or not a genetically modified plant should be subject to formal authorization, with a risk assessment to be carried out beforehand. In legal terms, this means determining whether or not a plant should be regulated [4]. There are two approaches to this. The first aims to establish whether a modified plant can become a « parasite » depending on the nature of the plant to be modified, the origin of any potential inserted DNA or the nature of the plant ultimately modified [5]. The second, formalized in 2020, simply establishes whether the modification method has already been exempted, or whether the modified plant could have been obtained by « conventional breeding methods » [6]. Each of these two procedures, which are rather light, involves sending a request and receiving a response posted online on the USDA website [7]. In all cases, a response confirming unregulated status opens the way to faster marketing for companies.Table 2Companies or laboratories of UniversityAgriculture and Agri-Food Canada (AAFC)Mustard 21 Canada Inc.Agrivida, Inc.Nexgen Plants Pty LtdAltria Client Services LLCNorth Carolina State UniversityArista Cereal TechnologyOkanaganBenson Hill, Inc.Oregon State UnivBioheurisPairwiseCalyxt Inc.Penn State UniversityCellectis Plant SciencesPioneer Hi-Bred Canada CompanyCibus US LLCRiceTec, Inc.Cold Spring Harbor LabSanatech Seed Co., Ltd.Corteva AgriscienceScotts Miracle-Gro CompanyCoverCress Inc.SoilceaDonald Danforth Plant Science CenterTexas A&M UniversityDuPont PioneerToolGen, Inc.Evogene, Ltd.Tropic BiosciencesGreen Venus LLCUniversity of FloridaHartwick CollegeUniversity of GeorgiaIllinois State UniversityUniversity of KentuckyInari Agriculture, Inc.University of MinnesotaIntrexon CorporationUniversity of MissouriIowa State UniversityWageningen UR, Plant Research InternationalJ. R. Simplot Plant SciencesWeizmann Institute of ScienceMax Planck Institute for Chemical EcologyYield10 BioscienceMichigan State UniversitySince 2011, 28 plant species have been submitted to the US Department of Agriculture for genetic modification using combinations of different techniques. On the basis of these rather succinct dossiers, the Department has generally validated the unregulated nature of the plants obtained, thus focusing on the end product alone. Because, as we saw in a previous article, the genetic modification protocols followed to obtain these plants are highly complex, involving several poorly mastered techniques [8].Between 2011 and 2023, a total of 47 companies or universities (see Table 2) have been given the green light by the US government over the past eleven years to market a total of 95 different plants modified by new techniques (see Table 1). Of this total, six plants modified by new genetic modification techniques are currently on the market. This is a far cry from the tidal wave of new products promised by the European Commission if Europe were to deregulate these GMOs... Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [204] => Array ( [objectID] => 6712 [title] => GMO-derived enzymes used in food and feed [timestamp] => 1697500800 [date] => 17/10/2023 [annee] => 2023 [url] => https://infogm.org/en/gmo-derived-enzymes-used-in-food-and-feed-2/ [image] => https://www.infogm.org/IMG/arton7888.jpg [extrait] => Between 2005 and 2023, the European Food Safety Authority (EFSA) received and studied 601 applications for commercial authorization for enzymes produced by micro-organisms. These proteins, capable of catalyzing chemical reactions, play an important role in the food and feed industry. As part of our investigation, Inf’OGM consulted the 601 dossiers : almost half of them are […] [chapo] => [texte] => Between 2005 and 2023, the European Food Safety Authority (EFSA) received and studied 601 applications for commercial authorization for enzymes produced by micro-organisms. These proteins, capable of catalyzing chemical reactions, play an important role in the food and feed industry. As part of our investigation, Inf’OGM consulted the 601 dossiers : almost half of them are for enzymes produced by genetically modified micro-organisms (GMMs) !Bacteria, yeast, fungi, as well as animals and plants, all living organisms produce enzymes. These proteins have a fundamental role : they catalyze the chemical reactions necessary for living things to... live. Over the last few decades, a number of industrial companies have specialized in the production of these enzymes. These latter can be and are used in the "food processing, animal feed, healthcare, textiles, leather processing, detergents and cleaners, agrofuels, cosmetics..." industry [1]. To produce them, manufacturers have their favorite production factories, micro-organisms, whether genetically modified or not.An industrial production using GMOs, off the radarIn Europe, enzymes used in food or animal feed require a green light from the EFSA. This body therefore provides English-speaking citizens with highly technical dossiers that are freely accessible, but difficult to access. Of the 723 dossiers submitted between 2005 and July 2023 that Inf’OGM was able to study [2], 601 concern enzymes intended for food and feed [3]. The other files concern vitamins or additives. Of these 601 dossiers, 242 concern enzymes produced by genetically modified microorganisms (GMMs) (i.e. 40.3% of the dossiers consulted). 107 dossiers involved micro-organisms specifically declared as non-GMO (i.e. 17% of dossiers consulted). 252 other applications do not provide enough information to know whether the micro-organism used is a GMO or not.It should be remembered that the users of these enzymes (food chain processors, for example) are not kept informed of the production process. Indeed, since 2006 and a political decision taken by the Council of the European Union, enzyme producers have ahd no legal obligation to label their enzymes marketed as produced by GMOs [4]. 6-phytase and alpha-amylase are two typical examples of enzymes produced by GMMs.NameNumber of dossierGMONon GMOUnknown originNumber of petitionner6-Phytase1813 (76,5 % of the read dossier)049Alpha-amylase5424 (44,4%)121817Other (56 enzymes)529204 (38,6%)95230Total601242 (40,3%)107252137 (50 for the GMO dossier)The phytases, an important microbial production6-Phytase belongs to the phytase family, which includes other enzymes such as 3-phytase, 4-phytase... This is an important enzyme family in the agri-food sector, since phytases have taken 40% of the food enzyme market in recent years. One of their functions is to break down complex phytate molecules into phosphorus. Phosphorus is an important mineral salt for animal growth. However, in order to be metabolized by animals, this phosphorus must be available via the diet. So-called biological availability has become a key issue for the animal feed industry.In plants, most of this phosphorus is stored in a complex molecule known as phytic acid, or phytate. Any animal having a plant-based diet must therefore be capable of degrading these phytates in order to recover and utilize phosphorus. In ruminant animals, this degradation occurs naturally via enzymes produced by their microflora. But in poultry or pigs, for example, which are non-ruminant animals, this enzyme is not sufficiently present, or under inadequate conditions, for the natural degradation into phosphorus of phytates supplied by plants to be sufficient. While some plants, such as wheat or rye, naturally produce sufficient phytase, the concern is that it does not sufficiently release phosphorus from the raw materials, but also that "this natural phytase is partly destroyed by food manufacturing processes" [5]. It is therefore necessary to supplement animal feed. There are two possibilities :The first is to add phosphorus directly to the feed. The problem with this approach is that phosphorus is the dosage and release via animal excrement, making it an environmental pollutant. Between 60% and 80% of the phosphorus ingested by pigs is excreted.The second is to add phytases directly to the feed. In this way, the phosphorus present in animal feed becomes efficiently accessible and utilized by the animals. As plant phytases are "not very resistant to certain heat treatments frequently used in animal feed", the industrial production of phytases quickly turned to the use of micro-organisms [6].Several fungi have been genetically modified, mainly by transgenesis, to express this enzyme. In the 17 dossiers submitted by nine companies [7] concerning the enzyme 6-Phytase, 13 involve the use or GMM. These are five different fungi or different strains of one fungi [8].The alpha-amylase, an enzyme « designed » for the industryAlpha-amylase is one of the star enzymes produced industrially by micro-organisms. It breaks down starch (a complex sugar) into several simple sugars, such as glucose, fructose and maltose. This process occurs naturally, as in saliva, which contains amylase to break down starch into maltose. The industrial uses resulting from this reaction are numerous : food and feed, textiles, paper, even industrial detergents.The production of alpha-amylase by means of microorganisms has received industrial preference due to the financial lower cost of production as well as the greater ease of manipulating microorganisms to make them produce the desired alpha-amylase [9]. Among the characteristics sought by the processing industry are enzyme stability at various temperatures or salt concentrations. The main industrial use of alpha-amylase is therefore in the transformation of starch into glucose or fructose syrup. In the human food industry, this enzyme can be used in "bakery, beer brewing, cake, fruit juice or starch production", as well as for pre-digesting animal feed. The importance of this enzyme in industrial manufacturing processes gives it a special place in the applications processed by the EFSA. Inf’OGM was able to consult 56 applications, submitted by 17 different companies. [10]. 24 of these applications involve GMMs, 12 involve non-GM microorganisms and 18 do not allow to formally establish the GM or non-GM status of the used microorganism.A safeguarded non-GMM production ?Inf’OGM’s monitoring of applications submitted to the EFSA gives a partial picture of how enzymes are produced. While many are naturally produced by animals, plants and/or micro-organisms, the enzyme industry has nevertheless favored the latter. As we have seen, the reason is mainly economic, since working with micro-organisms is regularly described as less costly. The advent of genetic modification techniques has also strengthened the position of these micro-organisms, as they are faster to work with. The speed of multiplication of a micro-organism is indeed incomparable with that of plants or animals.This probably partial view provided by a reading of the dossiers submitted to the EFSA raises a question : is it possible that such or such an enzyme is only produced by genetically modified micro-organisms ? Apart from the uncertainties associated with dossiers that fail to provide sufficient information, some enzymes appear to have been submitted for authorization only when produced by GMMs. This is the case for 35 enzymes whose scientific name is given in a note to spare the reader who has not studied biology [11]. Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [205] => Array ( [objectID] => 214 [title] => GMO & labeling in European Union [timestamp] => 1697500800 [date] => 17/10/2023 [annee] => 2023 [url] => https://infogm.org/en/themes-en-anglais/etiquetage-3/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Following the many food scandals that have affected France and other European countries, an increasing number of consumers are concerned about the food on their plates. The possible presence of genetically modified organisms (GMOs) is one of these concerns. But it isn’t always easy for consumers to follow and understand what lies behind the labels, […] [chapo] => [texte] => Following the many food scandals that have affected France and other European countries, an increasing number of consumers are concerned about the food on their plates. The possible presence of genetically modified organisms (GMOs) is one of these concerns. But it isn’t always easy for consumers to follow and understand what lies behind the labels, if and when they exist. Although the European Union has effectively ruled on the obligation to inform consumers if the product contains GMOs, the impact of this regulation is considerably reduced by the number of exceptions that exist. Here are some explanations to help people to gain a better understanding of how GMOs are considered in food and help them to navigate between obligations and exceptions.Food containing GMOs should be labelled...Food products that contain GMOs should state so on the label. This is European legislation, and is common to all Member States.There is however a certain tolerance included in this regulation : in the case of “adventitious or technically unavoidable” presence of below 0.9% per ingredient, it is not compulsory to label the product. In other words, the minute there is a deliberate presence of a GMO in a food product, it should be labelled, irrespective of the level of GMO present. Likewise, the minute a product contains over 0.9% per ingredient, it must be labelled, even if the producer has done his/her best to avoid this contamination.Within the European Union, few products mention the presence of GMOs. The European Commission has listed only about thirty references, mainly imported from the USA and Asia. These products are not widely present in supermarkets, as there is a general fear that consumers refusal of them would lead to their being eliminated from the supermarket’s referenced products.… but there are exceptionsIn spite of the compulsory labelling, there are many exceptions that greatly reduce consumers’ possibilities of informed choice of food. Industrial kitchens (school and company canteens…) are in no way obliged to indicate whether GMOs have been used in preparing the dishes. In France there is a possibility for managers to stipulate a certain number of criteria in their procurement process, such as ‘organic produce’ or quality labels (AOC, Label Rouge…) as well as ‘GMO-free’ labelling, certified GMO-free-fed animals or short circuit procurement… It is therefore possible for parents, elected representatives and those eating in canteens to take up this question, and overcome the gaps in European legislation ! It is, however necessary to put what regulations consider as GMOs into perspective. There are several different techniques that produce genetic modification. [1], but only one of these, transgenesis, effectively falls into the regulatory field of application of European legislation on GMOs. This is therefore the only one that is covered by the obligation to label GMOs. Citizens and consumers thus have no comeback on GMOs produced by other techniques that modify the genome (such as mutagenesis), and that may nevertheless end up on our plates. Another major exception is on animal produce (eggs, milk, cheese, meat). Because even if the animals were fed on GMO feed for their entire lives, there is no obligation to label this. And agribusiness has leaped into this gap in transparency : nowadays an estimated 70% of all animal feed contains GMOs.European regulation on labelling GMOs is therefore more than incomplete and flawed, and does not enable consumers to make a real informed choice. Nevertheless there is a request for transparency on GMOS, particularly in the area of animal feed ; the ‘GMO-free’ label is an attempt to respond to this concern. The EU has left it up to Member States to enact national legislation that define what is included in the ‘GMO-free’ label. Germany, Austria, and France have legislation of this kind. But since 2011, the EU has been considering introducing European harmonisation on this subject, with a ‘GMO-free’ label common to all the Member States. They have launched a wide consultation on this subject [2]. Given the realities of the European legislative process, this labelling will not be introduced for several years. In the meanwhile, national labelling remains relevant.French ‘GMO-free’Since July 2012 [3], French producers can showcase their produce by using the ‘GMO-free’ label if their fruit and vegetables have not been genetically modified, or the animals not been fed on GMO feed. There are several different claims and appraoches. It is thus possible to find labels that state ‘GMO-free< 0.1%’ on certain products, but only where a GMO equivalent exists, such as soy or maize. A tin that has not been labelled can imply that there is no GM equivalent (for example in the case of green beans…), or that the farmer did not wish to showcase his product as being GMO-free, or again that he can not guarantee that the level of GMO is < to 0.1%. It is also worth bearing in mind that if there is a GMO presence of over 0.9%, that the product must then be labelled as containing GMOs. ‘GMO-free’ is also applicable to meat and fish : ‘raised GMO-free< 0.1%’, or ‘raised GMO-free < 0.9%’. Milk and eggs and processed food may also include ‘from animals raised GMO-free < 0.1%’, or ‘from animals raised GMO-free 0.9%’. This label only applies to animals have been raised without GMOs ‘for their entire life’, even if there some adaptation to these regulations is possible. Finally honey and apicultural produce can be labelled ‘No GMOs within a radius of 3 kilometres’.The different thresholds for ‘GMO-free’ in France should not be considered as allowing ‘a little’ GMO into a product that is otherwise labelled as GMO-free. All voluntary use of GMOs, as we have seen, effectively excludes any product from being labelled as GMO-free. On the contrary, these thresholds provide a safety margin for producers : an overly restrictive threshold would not have enabled a GMO-free chain to be created, as it is very complicated, even impossible to guarantee the total absence of GMOs.These various ‘GMO-free’ labels that we have described are included in the list of ingredients, after each ingredient in question. It may also be found on the front of packaging where the ingredient represents over 95% of the overall weight of the product (with the exceptions of water and salt). In practice, only non-processed products (such as meat or fish) or simple products (natural yoghurts) may be labelled in this way. For products that contain many different ingredients, more visible labelling is not allowed, given the high rate of 95%. So it is up to consumers to keep their eyes open and decode the lists of different ingredients, even if it is highly unlikely that the agribusiness industry will bother to include ‘GMO-free’, unless they are able to really communicate on the effort they are making and increasing their visibility...Although there are an increasing number of GMO-free products in France, they are still not very visible to consumers. German and Austrian ‘GMO-free’ products may be more demanding in terms of their specifications (such as the time-span of non-GMO animal feed), but they have been highly successful : many products are available and they very popular. This success is encouraging producers to move to GMO-free animal feed [4].Alternatives that enable ‘GMO-free’ consumptionOther labels have eliminated GMOs from their production methods, including in the case of animal feedstuff. This is the case for example of organic agriculture. The specifications that now apply at European level, forbid the use of GMOs in products and animal feed, although there is a tolerance level of 0.9% (as long as this presence is obviously “unintentional but technically unavoidable”). Some specifications have decided to go even further and to totally ban GMOs. This is the case of Bio coherence, Demeter and Nature et Progrès. Some quality labels that combine know-how and local produce have decided to exclude GMOs for animal feed, such as PAO (Protected Appelations of Origin), DPO (Designation of Protected Origin) and PGO (Protected Geographical Origin), Red Labels… But this becomes very puzzling for consumers, as not all these quality labels systematically do this. And those that do, do not systematically promote it by ‘GMO-free’ labelling, for fear of swamping consumers with too much information (that which specifically refers to DPO, ‘GMO-free’, and possibly other environmental approaches…). The National Institute of Origins and Labelling (INAO), that is responsible for ensuring implementation of French policy on official identification of origin and quality, does not facilitate transparency on the ‘GMO-free’ nature of labelling certain products for which it is responsible [5]. To get the information, you have to consult the specifications for each product, and this isn’t easy to do when you are doing your shopping…So it isn’t easy for people who want to avoid eating GMOs. Consumers need to juggle between various labels to buy the kind of food they want. Yet this information is essential because it is also through consumption that citizens can ensure their voices are heard and support the kind of agriculture that they want, both now and in the future. Patchy or lack of labelling is something that denies consumers their right to choose. [Type article] => page [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [206] => Array ( [objectID] => 4147 [title] => Biodiversity and farmers’ rights : still a long way to go [timestamp] => 1695859200 [date] => 28/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/biodiversity-and-farmers-rights-still-a-long-way-to-go/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => The agriculture/biodiversity interface is legislated by numerous texts (p.10-11). Some of these, such as the « Seeds Treaty » and the Convention on Biological Diversity, are the subject of regular meetings, during which the many debates often struggle to reach decisions. The last two major meetings were no exception to the rule… The international legal framework that […] [chapo] => [texte] => The agriculture/biodiversity interface is legislated by numerous texts (p.10-11). Some of these, such as the « Seeds Treaty » and the Convention on Biological Diversity, are the subject of regular meetings, during which the many debates often struggle to reach decisions. The last two major meetings were no exception to the rule...The international legal framework that deals with the agriculture/biodiversity interface from different angles is made up of three texts. The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), which has been in force since 2004, concerns the conditions of access to certain cultivated genetic resources, and therefore to cultivated biodiversity ; the Convention on Biological Diversity (CBD), adopted in 1992, covers all aspects of biodiversity, including those linked to genetic modifications ; and finally, the United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas (UNDROP) defines the access rights of peasants to cultivated and bred species.CDB : an ambitious but not very concrete action planWith the exception of UNDROP (see box), the ITPGRFA and CBD bodies meet every two years to evaluate and develop the implementation of these texts. All the resolutions adopted at the end of their last two meetings can be found on their respective websites : the COP15 on biological diversity, in Montreal, in December 2022 [1] ; and the Tirpaa, in New-Delhi, in September 2022 [2].UNDROP : many farmers’ rights, but non-bindingThe United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas (UNDROP [3] was adopted in 2018 [4]. This legally non-binding text incorporates and complements farmers’ rights already present in other texts (ITPGRFA , CBD and UN Declaration on the Rights of Indigenous Peoples).Some of its articles specifically concern biodiversity. They include access to and management of « resources » (article 5) ; the « fair sharing of the benefits from their use » ; and the protection of « traditional agricultural, grazing, forestry, fisheries, livestock and agroecological systems relevant to the conservation and sustainable use of biological diversity » (article 20).In short, this Declaration aims to remedy the legal and political distortions that have a negative impact on peasant seed systems and therefore on cultivated biodiversity. Revolutionary in spirit, it was adopted by the United Nations General Assembly on 17 December 2018, with 121 votes in favour, 8 against and 54 abstentions. In view of France’s behaviour in the face of the problems of land and water grabbing by a few landowners, is it surprising that our country is among those abstaining ?This text has not yet been widely used. In a declaration issued in December 2022, various United Nations experts called « to implement the Undrop by incorporating its norms and standards into national laws and policies, [as it] also serves as a roadmap for States [...] and other stakeholders to take concrete action on the ground ».The CBD COP15 adopted « the Kunming-Montreal Global Biodiversity Framework », which aims to « restore biodiversity » by 2050. Some of the decisions relate more specifically to the links between agriculture and biodiversity.In one of them, entitled « Biodiversity and Agriculture », [5], the COP adopted the « International Initiative for the Conservation and Sustainable Use of Soil Biological Diversity Action Plan 2020-2030 ». This plan lists the actions to be taken over the coming decade. They include : strengthening the study of soil biodiversity, « promoting [...] agroecological practices », « preventing the introduction and spread [...] of invasive alien species », etc. They are all laudable objectives that the CBD plans to pursue through a host of training and research partnerships at all levels (research bodies, relevant organisations and networks, as well as indigenous peoples and local communities). It also aims to « promote access to and fair sharing of benefits from the use of soil genetic resources ».This subject is linked to that of digital sequencing information on genetic resources (DSI), which was also debated at the COP [6] [7].Three other protocols, within the framework of the CBD, concern the link between biodiversity and agriculture. They were also the subject of meetings on the sidelines of COP15. The first two aim to protect biodiversity from contamination by living modified organisms (LMOs), which are alive and therefore capable of reproduction [8]. The two following protocols aim to control and limit the uncontrolled spread of LMOs in nature : The Biosafety Protocol (Cartagena Protocol), ratified by 173 countries (the United States, Canada and Argentina, three of the main GMO producing countries, are not party to it) and entered into force in 2003 ; supplemented by the Protocol on Liability and Redress for Damage Caused by GMOs (Nagoya-Kuala Lumpur Protocol), which came into force in 2018. The third protocol, the Nagoya Protocol, concerns access to genetic resources and the sharing of the benefits from their use (these are non-agricultural resources, which are covered by the TRIPs Agreement (see below)). Ratified by 138 States, it entered into force in 2014. It applies to all genetic resources, except those covered by the ITPGRFA (see below). The Nagoya Protocol endorsed « the multilateral benefit-sharing mechanism » for the DSI decided at COP15 [9]. However, it decided « to return to the question of the need for and modalities of a global multilateral benefit-sharing mechanism » at its next meeting.ITPGRFA : peasants’ rights in the hot seatThe last meeting of the ITPGRFA (New Delhi, September 2022) postponed the discussion on the status of DSI until the next CBD COP, which took place a few months later. The ITPGRFA prohibits the appropriation of the resources it manages through patents, and the fear, expressed in particular by La Via Campesina, was that the future status of DSIs would allow this (see p.13-14). This seems to have been confirmed by the multilateral mechanism on ISPs DSIs decided at COP15.Six months after the meeting of its governing body, the ITPGRFA published a list of « Options to encourage, guide and promote the realization of Farmers’ Rights as set out in Article 9 of the International Treaty » [10]. Since governments are only encouraged to promote Farmers’ Rights, the ITPGRFA has drawn up this list of 27 options, based on the experiences of member countries to provide ideas for everyone, especially governments. For example, paying funds to farmers who « conserve, develop and sustainably use [plant genetic resources] ».But here again, there is no obligation to implement it, which is what the ITPGRFA claims : « the term ’option’ confers a non-prescriptive and discretionary character » [11].Each of these international meetings leaves a bitter taste in the mouth. How is it possible that such major meetings produce so few concrete results ? How is it possible that certain debates have been postponed from meeting to meeting for so many years ? How is it possible that we are all so full of words and good intentions but that they are so devoid of obligations and concrete applications ? Could it be that, as long as no decisions are taken, the status quo remains, which suits all the plunderers of biodiversity just fine ? Fortunately, there are a number of watchdogs, such as La Via Campesina at global level, of which the Confédération paysanne in France is a member. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [207] => Array ( [objectID] => 4148 [title] => Agroecology, farming that respects the living world [timestamp] => 1695859200 [date] => 28/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/agroecology-farming-that-respects-the-living-world/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Industrial agriculture is destroying biodiversity (see p.3-5). Yet it is possible to produce without destroying (too much) biodiversity, thanks to agro-ecological practices and a farming organisation based on autonomy. But beware of distortion : agro-ecology can only be peasant-based… Agroecology has the wind in its sails : in France, agricultural research institutes (CIRAD, INRAE, IRD) […] [chapo] => [texte] => Industrial agriculture is destroying biodiversity (see p.3-5). Yet it is possible to produce without destroying (too much) biodiversity, thanks to agro-ecological practices and a farming organisation based on autonomy. But beware of distortion : agro-ecology can only be peasant-based... Agroecology has the wind in its sails : in France, agricultural research institutes (CIRAD, INRAE, IRD) have even had dedicated programmes for a number of years, programmes federated at international level by the Consultative Group on International Agricultural Research (CGIAR). In the European Union, the new Common Agricultural Policy (CAP) 2023-2027 provides for aid to develop agroecology as part of the « Farm to Table » strategy. But are we talking about the same thing every time ?Agroecology with GMOs ?The use of pesticides is one of the causes of the disappearance of biodiversity. To stop it, we need to eliminate these products. The forerunner of agro-ecology, organic farming originated in Europe in the 1930s, and gradually took shape in France in the 1960s (notably with the Nature et Progrès association). Two watchwords : no synthetic fertilisers or pesticides, and nourishing the soil to nourish the plant. These were the beginnings of agro-ecology. But let’s see why there are two types of agroecology.The economic take-off of organic farming has led to the emergence of « organic opportunists », players who have entered the sector to make a profit rather than to protect biodiversity. And this divergent objectives has led to a divergence in means and practices, made possible by technical specifications that are more or less strict. For example, it is possible for conventional farming to co-exist with organic farming on the same farm, or even with productions of different species using GMOs [AB specifications legally allow these co-existences of production, with only partial conversions] . The same differences can be seen with the concept of agroecology, which is also less regulated because there are no official specifications. But without a label everything is permitted ! This is how we find the supposedly fervent advocates of agroecology... with GMOs.Let’s be serious. This eternal choice between the devil and the deep blue sea (in this case, GMOs or pesticides) is nonsense, since 99% of GMOs are linked to pesticides. It often reflects intellectual laziness at best, and outright deception at worst. Years of developing real organic or even biodynamic farming, with strict technical specifications, have shown that it is feasible to produce without synthetic fertilisers or pesticides... or GMOs, of course. As for the so-called « developing » countries, which have very limited access to inputs, mainly due to a lack of resources, they have long been supplying the bulk of agricultural production - up to 80% of the food in non-industrialised countries [1] - with practices similar to agroecology.No, a peasant agroecology above all !Although it has no official label, agroecology has been the subject of numerous definitions [2]. The one we are interested in here, peasant agroecology, is defined and defended by those who practise it, the peasants themselves, many of whom are grouped together within La Via Campesina [3]. They defined it as « a way of life [...], in collaboration with nature in a circular production model [that strengthens] the autonomy of peasants [...] [and] respects local resources and protects the environment and biodiversity through the application of specific peasant knowledge [...] ». It transforms society : « peasant agroecology is based on collective rights [...] recognising the right [...] of communities to self-determination and autonomy. [...] [I]t means working together with nature, not against it » [4].The global, or holistic, approach includes not only techniques that respect the environment, but also the know-how of farmers and indigenous peoples, for whom humans are an integral part of Mother Earth (the famous Pacha Mama of the Andean countries, but which is of course a universal reality). The abandonment of synthetic inputs, the reduction in the use of fossil fuels and the use of renewable energy, closing as much as possible nutrient cycles, saving resources, particularly water... all these factors contribute not only to reducing the loss of biodiversity, but also to increasing it. Farm-saved seeds are the inevitable corollary to agroecology Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [208] => Array ( [objectID] => 4149 [title] => Farmers burst in international debates on cultivated biodiversity [timestamp] => 1695859200 [date] => 28/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/farmers-burst-in-international-debates-on-cultivated-biodiversity/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Farmers are organising themselves to defend the preservation and renewal of millions of local peasant seeds in their fields in the arenas of global governance. They are thereby fighting the industry’s attempts to reduce this immense diversity to a few patented gene combinations. Founded in 1993, La Via Campesina (LVC) is now the world’s leading […] [chapo] => [texte] => Farmers are organising themselves to defend the preservation and renewal of millions of local peasant seeds in their fields in the arenas of global governance. They are thereby fighting the industry’s attempts to reduce this immense diversity to a few patented gene combinations.Founded in 1993, La Via Campesina (LVC) is now the world’s leading peasant organisation, representing over 200 million farmers. It came to light at the major international demonstrations organised at the turn of the 21st century against the free trade agreements of the GATT and then the WTO. century against the free trade agreements of the Gatt and then the WTO, where it demanded that "agriculture be taken out of the WTO", which has since been extinguished in favour of numerous bilateral trade agreements [1].Farmers’ right to seeds : a long struggleHowever, LVC has not abandoned other international bodies. In 1991, a farmers’ delegation led by Yves Manguy, the first spokesman for the Confédération Paysanne, went to the meeting of the Union for the Protection of New Varieties of Plants (UPOV) to adopt a new convention. It obtained the support of the "South" countries (a semantic shortcut for countries that are not part of the so-called "North" block : North America, Europe, Japan, Australia and New Zealand) to reject the attempt by the "North" countries to abolish the right of farmers to use the seeds from their own harvests, a right then left to the discretion of each country.In 2001, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) recognised farmers’ rights to protect their knowledge and to save, use, exchange and sell their own seeds. This recognition was gained in return for access by the seed industry in rich countries to millions of seed samples collected from farmers’ fields, mainly in the "South", and stored in gene banks. But this recognition was left to the discretion of national laws, which were free to make it subject to intellectual property rights (IPR) and seed laws imposed by the WTO. A right to "share the profits" from patents was added to ensure acceptance of the introduction of the fox of seed privatisation into the henhouse of farmers’ rights. Bypassed by the industry, this sharing is reduced to a few symbolic dollars paid to researchers, NGOs or institutions linked to the seed industry, and not to autonomous farmers’ organisations. The access to seeds stored in gene banks is theoretically conditional on the commitment not to claim any IPR that could limit access to these seeds, or their genetic parts or components, for research and breeding purposes.2022 : A first light ?In 2007, LVC was invited to speak at the opening of the second meeting of the ITPGRFA Governing Body, which brings together representatives of all the countries that have ratified the Treaty every two years. Noting that the Treaty had fulfilled its first mission of facilitating access to plant genetic resources, LVC demanded the immediate fulfilment of its second mission : the effective and unrestricted application of Farmers’ Rights. Supported by the countries of the "South", the main suppliers of these resources, this demand was opposed by the rich countries. Since then, LVC has defended these rights at every meeting of the ITPGRFA within the International Planning Committee for Food Sovereignty [2], which, alongside a number of NGOs, provides a counterweight to the seed industry.After numerous meetings, in 2022 the ITPGRFA produced a list of "Options to encourage, guide and promote the achievement of Farmers’ Rights" [3]. The options proposed by farmers’ organisations are aimed at the stated objectives, but are accompanied by other options aimed at strengthening IPRs and the commercial monopoly of industrial seeds.Towards a binding Convention to ensure the respect for of the rights of peasants ?In 2008, LVC initiated negotiations with Bolivia [4], within the UN Human Rights Committee, negotiations that led, in December 2018, to the adoption of the "United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas" (UNDROP) [5]. This declaration reiterates the farmers’ rights defined by the Tirpaa by removing the reservation of national laws that may oppose them. However, it is currently optional.One might ask whether so much effort is worthwhile in order to obtain nothing but pious hopes while the industry obtains free trade treaties and binding IPRs. The answer is yes. Farmers’ presence in these international arenas makes it possible to denounce the industry’s false promises and support the adoption of national laws protecting farmers’ rights. These national laws pave the way for transforming the voluntary UNDROP into a binding Convention.But the industry’s manoeuvres know no bounds. At the end of the last century, the genetic sequencing of the first plant species required six years’ work by hundreds of researchers and millions of dollars. Today, it only takes a few dollars and a few hours to obtain the complete sequencing of a seed. In 2014, the ITPGRFA Secretary announced his decision to commit the Treaty to the DivSeek programme, which aims to sequence the millions of seed samples held in the collections under its governance [6]. LVC immediately denounced this initiative, which would facilitate the patenting of these genetic sequences. A year later, the ITPGRFA secretary was dismissed and the Treaty withdrew from the DivSeek programme.The trick of genetic sequence informationIn 2017, the industry and the rich countries started singing a new tune : genetic information (Digital Sequence Information, or DSI in English) is a product of research and not a genetic resource. It therefore dodges the article of the Treaty that prohibits "any intellectual property right or other right limiting facilitated access to plant genetic resources for food and agriculture or to their genetic parts or components, in the form received from the Multilateral System" [7]. The industry thus continues to claim patents on the genetic information offered by DivSeek and to extend their scope to all seeds containing it and expressing its function (resistance to a disease, nutritional character or industrial interest, etc.). This includes seeds derived from farmers’ or traditional selections that cannot be shown to have contained this genetic information prior to the patent being claimed.No farmer or small seed grower has access to the systematic genetic sequencing that is essential to provide proof of this anteriority. This semantic subterfuge, which transforms genetic resources into "research products", now enables five multinationals to control 60% of the world market in certified seeds. However, it is generating strong protests from countries in the "South", alerted by LVC and NGOs. The ITPGRFA Governing Body referred the issue to the Convention on Biological Diversity (CBD) before recently putting it back on its agenda. Meanwhile, patents on "genetic information" identifying the genetic sequences introduced into plants by new genetic modification techniques are piling up [8]. In the mean time, the European Commission is trying to abolish the traceability requirement for GM plants. Yet this obligation is the last legal tool preventing the scope of patents on this genetic information from being extended to farmers’ or traditional seeds that contain it naturally [9].While the conflicts generated by this new hold-up on living organisms are growing, three quarters of the food available on the planet still comes from farmers’ seed systems and not from industrial seeds. Farmers everywhere are organising to develop, exchange and protect their seeds and their knowledge. The arrogance of the rich countries is increasingly being contested. The industry’s false promises only fool those who believe them, and there are fewer and fewer of them. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [209] => Array ( [objectID] => 4150 [title] => An opulent and powerless regulatory landscape for declining biodiversity [timestamp] => 1695859200 [date] => 28/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/an-opulent-and-powerless-regulatory-landscape-for-declining-biodiversity/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Environmental standards are proliferating everywhere, yet biodiversity is declining. Over the last fifty years or so, international, European and national standards have been adopted to substantiate mankind’s responsibility towards the environment and to reconcile human activities with its protection. One fact is widely acknowledged : the loss of biodiversity is proceeding with great strides. While some […] [chapo] => [texte] => Environmental standards are proliferating everywhere, yet biodiversity is declining. Over the last fifty years or so, international, European and national standards have been adopted to substantiate mankind’s responsibility towards the environment and to reconcile human activities with its protection. One fact is widely acknowledged : the loss of biodiversity is proceeding with great strides. While some legal advances have been made, the proliferation of environmental standards does not appear to benefit either the environment or the law overall. Environmental law was born in the 1970s. Over the past fifty years or so, growing awareness of the need to protect the environment has led to a proliferation of standards, to the extent that environmental law now legislates an ever-increasing number of human activities in the fields of industry, agriculture, energy production, waste management and so on.An abundant production of standardsThe abundant production of standards affects the international, European and national levels. At international level, for example, more than 300 multilateral conventions or treaties have been adopted, one of the most recent being the treaty to protect marine biodiversity in the high seas and one of the best known being the Convention on Biological Diversity. According to the foreword to this convention, "the preservation of biological diversity is a common concern of humankind". In addition to these legally binding texts, there are a multitude of non-legally binding texts (declarations, resolutions, strategies, etc.).All these standards are essentially aimed at limiting the rights of those who use and/or appropriate natural resources, whether by protecting specific species and areas or, following a global approach, biodiversity, i.e. living organisms as a whole. Ambitious standards have been adopted to prevent international trade of endangered species, to preserve migratory species or wetlands, or to reduce the use of pesticides, etc. In France, in 2016, the law for the reconquest of biodiversity, nature and landscapes enshrined the principle of non-regression in law. According to this principle, "environmental protection, ensured by legislative and regulatory provisions relating to the environment, can only be subject to constant improvement, taking into account current scientific and technical knowledge". This principle applies only to the regulatory authority and not to the legislative authority, but it has already been applied, albeit with some nuance, by the administrative courts. Other principles characterise environmental law (see box).Omnipresence of the precautionary principleOne of the main principles of environmental law is the precautionary principle. It has been enshrined at European Union level (Maastricht Treaty), at international level (Rio Declaration and Convention on Biological Diversity, among others) and has been incorporated into French law (“Code de l’environnement”, then “Charte de l’environnement” with constitutional value). According to this principle, the absence of knowledge about the exact short- or long-term consequences of certain actions should not be used as a pretext for postponing the adoption of measures to prevent environmental degradation. The precautionary principle has become the cornerstone of GMO regulation. In France, the Conseil d’Etat referred to it for the first time in 1998 in connection with transgenic maize varieties. Recently, the Court of Justice of the European Union used this principle to rule that Member States cannot authorise the marketing of seeds treated with products (neonicotinoids) that have been banned by a regulatory act of the European Commission. The derogations granted by the French government for sugar beet cultivation in 2021 and 2022 were therefore illegal.Inefficient standards on the wholeFew human activities are now exempt from the requirements of environmental conditionality. This is one of the consequences of the principle of integration stated in the Rio Declaration, according to which environmental protection must be integrated into other policies. At European Union level, "environmental protection requirements must be integrated into the definition and implementation of the Union’s policies and activities, in particular with a view to promoting sustainable development" (Article 11 of the Treaty on the Functioning of the European Union).But despite the recognition of the principle of integration, the profusion of environmental standards, the 26,935 Natura 2000 sites in the European Union, including 1,753 in France (in December 2021), etc., human activity continues to fuel the worrying pace at which the fauna, flora and habitats are disappearing. In France, the latest report on the state of the environment, published by the Ministry of Ecological Transition and Solidarity, shows that between 1998 and 2018, the abundance of birds specialising in agricultural environments fell by 38%. On a global scale, the latest scientific report from the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES) also makes an alarming observation : 1 million plant and animal species are endangered. The loss of diversity is also affecting local varieties and breeds of domesticated plants and animals. As for micro-organisms, the evolution of their diversity remains a black hole of knowledge.Provisions that are too complex, delays in adopting national transposition measures or implementing decrees, principles that have no legal effect, non-compliance with the law, inadequate penalties for non-compliance with the rules, insufficient monitoring and control resources... these are just some of the reasons that can explain, from a legal point of view, the ineffectiveness of environmental standards. But all these reasons are above all indicative of a political will that bows to economic interests, whether defended by companies or by economically powerful states against weaker states.Biodiversity dependant on economic interestsEconomic logic is interfering in the very architecture of environmental standards. A good example of this are the various compensation mechanisms, such as the one applied to greenhouse gas emissions or the "Avoid, Reduce, Compensate" (ARC) sequence. Behind this formula lies an accounting approach : a company can destroy an ecosystem to build a factory if it contributes financially to restoring or protecting another ecosystem. The aim is therefore to define the rights of those who wish to exploit natural resources within the limits of what is acceptable... for economic activities. This type of mechanism leads to a reasoning similar to that of a criminal : will not respecting the environment cost me more or less than respecting it ? While the ARC sequence aims for no net loss or even a gain in biodiversity, in practice it is unbalanced in favour of compensation that is necessarily not equivalent to the ecosystem destroyed.Very often, environmental standards help to create a market (the carbon market, for example) or seek to create favourable regulatory conditions for the development of new pockets of growth, under the false pretext of protecting the environment. This is the case, for example, with "new GMOs". The European Commission has justified the need to adopt more flexible rules for these GMOs on the grounds of their supposed ability to reduce the amount of water and pesticides used, to adapt to climate change, and so on. The legislative proposal that the European executive plans to put forward is in line with its "Green Pact" and its "Farm to Fork" strategy.Despite their profusion, the environmental standards, which are obviously not all to be dismissed, are not succeeding in halting the loss of biodiversity. Beyond the environmental issue, this observation is also the symptom of a law that no longer succeeds in imposing itself and whose primary purpose, that of founding a social contract, has been forgotten. The dishonest logorrhoea of standards undermines the credibility of the law, while human activity, fuelled by greed and the lure of short-term gain, continues ineluctably to eat away at biodiversity. Will peoples be able to reverse these trends ? Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [210] => Array ( [objectID] => 4151 [title] => The ”Réseau Semences Paysannes”:20 years of defence of cultivated biodiversity [timestamp] => 1695859200 [date] => 28/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/the-reseau-semences-paysannes20-years-of-defence-of-cultivated-biodiversity/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Just 20 years ago, over 350 people, including representatives of farmers’ movements and unions, organic and biodynamic farming organisations and NGOs, came together for the first farmers’ seed meetings in France. These meetings marked the birth of the Réseau Semences Paysannes (RSP), a group of collectives working to promote cultivated biodiversity. Twenty years on, where […] [chapo] => [texte] => Just 20 years ago, over 350 people, including representatives of farmers’ movements and unions, organic and biodynamic farming organisations and NGOs, came together for the first farmers’ seed meetings in France. These meetings marked the birth of the Réseau Semences Paysannes (RSP), a group of collectives working to promote cultivated biodiversity. Twenty years on, where do we stand ?In 2003, the issue of farm-saved seeds was confined to a small world of insiders, and everything still had to be done : finding seeds, reinventing know-hows, experimenting, creating new organisational forms to act together, defending against prohibitive regulations and facing up to the threat of GMOs.Spreading farm-saved seeds Since then, many books, films, research programmes and, more recently, podcasts have documented the dynamic management of cultivated biodiversity and raised the profile of farmers’ seeds.These seeds are not just "seeds" : they are the fruit of colossal collective work and carry a strong political message. When certain terms (old seeds, local varieties, farmers’ selection, etc.) are used for marketing purposes, they are emptied of their substance.The seed industry and supermarkets are indeed using expressions from the ecological struggle to convince a public that is increasingly sensitive to these issues : we have seen F1 hybrid "old tomatoes", pleas in favour of new GMOs promoting sustainability and the fight against climate change...The RSP did try to play this game, to enable consumers to identify and recognise products made from farm-saved seeds, with their associated values, by experimenting with a brand... which in the end only remained at the experimental stage, in particular because of the risk of being taken over by supermarkets.Today, a "farm-saved seed" label can sometimes be attached to marketed products, but it must be accompanied by educational documentation. These rules of use and operation are defined collectively by the members of the RSP.In the final analysis, this confrontation with the world of mass distribution illustrates just how important it is, over and above raising awareness of the term, to defend the values embodied in farm-saved seeds.Swinging into action for legal recognitionSince its creation, the Réseau has been involved in the legal recognition of farmers’ seed production practices and farmers’ rights over their seeds. At the time, the Official Seed Catalogue [The Official Seed Catalogue is the restrictive list of varieties whose seed and seedlings are authorised to be marketed in the European Union. In order to be registered, varieties must meet the criteria of distinctness, uniformity and stability (DUS) and VATE (agronomic, technical and environmental value) for field crop species.]] was strong, and it was not until 2004 that the ITPGRFA, which recognises the right of farmers to use, exchange and sell their own seed, was ratified by France [1].The RSP began by working to bring this issue to the fore in the political arena and the media, by launching petitions, drafting legislative proposals and, more generally, by actively lobbying national, European and even international bodies. RSP representatives have taken part in meetings of the ITPGRFA Governing Body and ministerial cabinets, and have sat, in France, on bodies such as the Foundation for Research on Biodiversity (Fondation pour la Recherche sur la Biodiversité), the "Genetic Resources" section of the Permanent Technical Committee on Plant Breeding (Comité Technique Permanent de la Sélection ) and the High Council on Biotechnology (Haut Conseil des Biotechnologies).The RSP is also involved in the fight against varieties made tolerant to herbicides by mutagenesis, or hidden GMOs, as part of the Poitiers Appeal [an informal group comprising the Confédération Paysanne, the RSP, Vigilance OGM 33, CSFV 49, Vigilance OG2M, Nature et progrès, OGM Dangers, Friends of the Earth France and the Collectif vigilance OGM et pesticides 16]]. This trial is still ongoing, with the issue of new GMOs recently brought into the debate.At the same time, the Seed Legal Watch (Veille Juridique Semences) was set up in 2009 to pool information on seed rights (marketing regulations, industrial property rights, farmers’ rights, "new GMOs", etc.). In 2013, the VJS directed its efforts on facilitating discussion and building collective expertise. An effort was being made to popularise legal issues, with the production of thematic fact sheets and educational summaries, the organization of brainstorming groups on specific points and the running of training courses.Since then, in its new guidelines adopted at the end of 2017, the RSP has chosen to no longer carry out active advocacy. It focuses on supporting its members’ advocacy. The long time needed to develop collective proposals is hardly compatible with political time, and the diversity of the players making up the RSP makes it difficult to build adamant positions.Uniting to defend cultivated biodiversityHowever, building and participating in alliances and coalitions is, and remains, the very essence of the RSP. As early as 2005, the RSP, together with the Coordination nationale pour la défense des semences fermières (National Coordination for the Defense of Farm-saved Seeds), initiated the European meetings "Libérons la diversité"(Let’s free Diversity), which led to the creation in 2012 of the European coordination Let’s Liberate Diversity (LLD), which brings together organisations for the defence of cultivated biodiversity from all over Europe. Today, the coordination has become a genuine platform for exchange, with the organisation of annual European meetings.For two decades, sowers have been organising and taking part in meetings (international, national, by species, by themes, etc.) : it is through exchanges, migrations and blending that cultivated biodiversity lives and is enriched. These meetings have one essential thing in common : they leave room for practitioners and focus on exchanges in the fields and gardens. This need to meet and exchange has led to the concept of Maisons des Semences Paysannes (see box).Les Maisons des Semences Paysannes : a space for collective workThe story goes that the Maisons des Semences Paysannes (MSPs) were inspired by the Brazilian Casas de Sementes Criolas, places for the collective management of farmers’ seeds, introduced in France by Agrobio Périgord in the early 2000s. The formula is proving a success, and is spreading well beyond the RSP, as there are now several dozen MSPs throughout France. Giving a standard description of MSPs would be a perilous exercise. They all operate in their own way. Some have a physical existence, with a place of their own, while others do not. Some bring together farmers, others gardeners, and some combine the two. Some work on vegetables, others on wheat or maize, and others on all species. Some have dozens of members, others just a handful.The important thing to remember is that MSPs are a flexible framework, available to all those who want to manage cultivated biodiversity collectively.Further information : Réseau Semences Paysannes, Les Maisons des Semences Paysannes. Regards sur la gestion collective de la biodiversité cultivée en France, 2014.Horizontality : embodying a different model of societyBeyond the “what”, the question of how is also important. Since 2010, the RSP has been gradually "cultivating horizontality" : the association’s office is collegiate, the team staff and the Board of Directors operate under shared governance, members have plenty of opportunities to get involved beyond the Board, and collective intelligence tools are being used in meetings, training courses and other gatherings... Finally, in moments of despondency, it can seem as if nothing has changed in 20 years, and that nothing can be done against the giants of agribusiness, the privatisation of life and capitalism. But it is not because they speak louder that other voices don’t exist. Today, the RSP is investing its efforts in the construction of alternatives to build another model of society, more respectful of living beings in all their dimensions. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( [0] => Biodiversité cultivée [1] => Semence paysanne [2] => Semences ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( [0] => Associations / ONG ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [211] => Array ( [objectID] => 4152 [title] => Farmers’ seed systems, in the light of an alternative [timestamp] => 1695859200 [date] => 28/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/farmers-seed-systems-in-the-light-of-an-alternative/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => The autonomy of peasant seed systems is a founding element of the agro-ecological shift. Guy Kastler and Antonio Onorati, members of La Via Campesina, use examples to demonstrate the importance of peasant seeds in this movement. Farmers’ seed systems are not a vague aspiration of the ”custodians” of local varieties. Nor are they the aspiration […] [chapo] => [texte] => The autonomy of peasant seed systems is a founding element of the agro-ecological shift. Guy Kastler and Antonio Onorati, members of La Via Campesina, use examples to demonstrate the importance of peasant seeds in this movement. Farmers’ seed systems are not a vague aspiration of the ”custodians” of local varieties. Nor are they the aspiration of producers’ organisations looking for economic niches in which to sell agricultural products under the pretext of sophisticated, luxury marketing. It’s a dynamic reality, constantly "innovating". The data confirms this.Farm-saved seeds : living and effective systemsFarmers’ seed systems, despite the attacks they face from the seed industry and public policy, remain alive and able to function effectively. In many countries, such systems are "illegal". They nevertheless weigh on the agricultural economy, even if they are constantly asked to demonstrate this reality. Here we provide data and assessments of the effectiveness of such systems in terms of food security and sovereignty.The seed industry distinguishes between "illegal" seeds (farmers’ seeds) and "legal" seeds (certified seeds). It is possible to estimate the respective weight of the two seed systems in a country’s agricultural production. To do this, we need to highlight the counterpart of ’illegal’ seeds, i.e. the extent to which ’legal’ seeds are used. We also present data from sample surveys, many of which are part of academic research. These are obviously partial data, but they concern the most widespread crops, such as cereals, and this is precisely what makes them so important. These crops are indeed the most relevant economically, and are the ones on which the seed industry is concentrating its efforts to impose its certified seed system.Certified seeds are not always popularFrom one region to another, we can see that the use of ’legal’ certified seed is not necessarily in the majority. They are sometimes much less widely used than ’illegal’ farmers’ seed.In 2020, the use of certified seed for horticulture in Africa represented 1.1% in Mali, 1.4% in Mozambique, 2.1% in Senegal, 4.9% in Côte d’Ivoire, 11.7% in Nigeria and 14.3% in Ethiopia. With 31.2%, it is Kenya that uses certified seed the most [1]. More generally, according to the various statements made by seed companies, on average less than 20% of cultivated land in Africa is sown with certified varieties.In Europe, according to a Euroseeds report dated 19 November 2020, certified seed accounts for 54% of cultivated land for grain maize and 46% for silage maize [2]. For winter-sown wheat, certified seed accounts for 60%, and only 0.5% is hybrid seed. For all the data presented, however, the report states that, according to farmers’ responses, the reality is much lower. In other words, the use of certified seed is lower than these figures. Kazakhstan is a major wheat exporter in Central Asia. Agriculture is one of its main economic drivers [3]. An international team used data from household surveys conducted in the country’s northern region between April and June 2019 [4]. Over 74% of this area is suitable for agricultural production. It guarantees 80% of the country’s wheat production. Although several certified wheat varieties have been released by the Red Fall experimentation station since 2000, the adoption of certified varieties in the experimentation as a whole does not exceed 40% on average. In other words, in the most ecologically favourable wheat-growing zone in the country, at least 60% of farmers will continue to use their own seeds because they "judge them to be more profitable". These results are all the more convincing given that the study specifies that the process "is carried out in strict compliance with the guidelines and only the producers formally registered in the seed register can take part". In other words, those who are a priori inclined to adopt certified varieties.Farmers’ seeds : quality, adaptability and profitabilityA number of research studies report that, throughout the world, farmers’ seeds are not always perceived as being of inferior quality to certified varieties. This is shown by an Asian study on wheat. Bangladeshi farmers selected certified wheat varieties that had a theoretical yield advantage of at least 10% over farmers’ varieties [5]. The study points out that "the absence of detectable yield differences between certified and traditional varieties was considered to be the main determining factor of the non-adoption [by farmers] of improved varieties".In West Africa, the tomato industry makes a significant contribution to the nutritional status and livelihoods of farmers. A study by Ghanaian researcher Adinan Shafiwu concludes : "despite important investment in the tomato sector by successive governments through the establishment of a number of tomato processing plants, the certified varieties that should guarantee the quality and quantity of tomatoes required for commercial processing are not grown, with farmers preferring to cultivate local varieties" [6]. This study, initially devoted to proving the superior quality of certified varieties, ultimately shows the persistence of farmers in using their peasant varieties, which they consider to be superior, including for industrial processing.A report on the use of peasant seeds in Latin America was published in November 2019 by the NGO Swissaid (Swiss Foundation for Development Cooperation) [7]. It highlights the important role played by community seed banks in countries such as Nicaragua and Colombia. These banks work with open-pollinated local varieties (whose seeds can be used for reseeding), enabling ecological agriculture adapted to climate change. The report adds : "hybrid or genetically modified seeds are not accepted in community seed banks. Most Colombian and Nicaraguan farmers have always had bad experiences with certified industrial seeds (e.g. poor germination capacity). Although these are often distributed free of charge through governmental incentive programmes, they are generally unsuited to local environmental conditions".In Mexico, the use of certified maize seed is less than 60% of the area sown, and the same applies to beans. According to the Oleaginosas website : "Two of the most important crops in the Mexican diet [maize and beans] have a low rate of adoption of improved certified seed" [8]. In addition to the high quality of peasant seeds, this can be explained by the fact that indigenous peoples, who are very important to Mexico’s social and agricultural network, are historically keen on using such seeds and remain suspicious of certified, standardised varieties.According to a 2016 survey on the seed industry in France, the European Union’s leading wheat producer, "half of the acreage [is grown] with certified seed" [9]. The other half is therefore cultivated with seeds grown by farmers themselves, farm-saved seeds (i.e. certified seeds reproduced on the farm) or seeds grown by farmers.In short, a range of data on examples of crops that are very important in food or economic terms confirms not only resistance to the adoption of certified varieties, but also the ability of farmers’ seed to dominate important sectors of a country’s agricultural economy. It also proves that there is an economic reason for using seeds from the farmers’ system. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( [0] => Biodiversité cultivée [1] => Semence paysanne [2] => Semences ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [212] => Array ( [objectID] => 9461 [title] => Patents on living organisms: a growing appropriation [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/patents-on-living-organisms-a-growing-appropriation/ [image] => https://infogm.org/wp-content/uploads/2026/03/couv_176_InfOGM_2024-page-001-768x1086.jpg [extrait] => In a world where biotechnologies are developing at lightning speed, it is essential to think on about the way they are regulated by law and how the legislator anticipates their impact on the ground. This dossier explores the various aspects of this issue, from the battle over patents in the agro-industry, particularly around the Crispr-Cas […] [chapo] => This issue on intellectual property rights (IPR) in the field of living organisms raises a crucial question: how far can living organisms – particularly plants – be privatised without compromising fundamental ethical principles and certain social balances, in particular the rights of farmers? [texte] => In a world where biotechnologies are developing at lightning speed, it is essential to think on about the way they are regulated by law and how the legislator anticipates their impact on the ground. This dossier explores the various aspects of this issue, from the battle over patents in the agro-industry, particularly around the Crispr-Cas system, to the potentially devastating effects of monopolies on biodiversity and food sovereignty.On the one hand, this dossier looks at IPRs on living organisms and the economic issues raised by their most powerful representative: patents. It looks in particular at the role of patents in the ‘new genomic technologies’ (NGT) industry applied to the plant sector, and their predominant tool: Crispr-Cas. While Crispr-Cas is still the subject of a legal battle between its main inventors, it is also attracting new investment and the filing of numerous patent applications. This dossier looks at these latter aspects and the legal uncertainty they create in the seed industry, particularly among breeders, highlighting the asymmetry of access to genetic resources, which threatens the very foundations of autonomous and sustainable agricultural practices.The dossier also sheds light on the way in which, at the end of 2023, the issue of patents took the European legislative scene by surprise, to the point of preventing the adoption of the NTG regulation during the Spanish term of office. In the wake of this legal event, this dossier also looks at the seed industry's new areas of interest: DSI (Digital Sequence Information) and genotypic PVCs. Finally, it offers a broad perspective on what intellectual property rights on all forms of living organisms could cover in the longer term. The aim of this dossier is to invite our readers to reflect on these issues, both as witnesses and as players in these changes, so as to consider a future in which technological innovation does not brutalise living organisms and the ethics of living organisms. We hope that this issue will also shed light on certain grey areas and stimulate a debate that is vital for the future of our societies. Denis MESHAKA et Hélène TORDJMAN [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [213] => Array ( [objectID] => 9460 [title] => Intellectual property rights on living beings will be forced to evolve [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/intellectual-property-rights-on-living-beings-will-be-forced-to-evolve/ [image] => https://infogm.org/wp-content/uploads/2026/03/49605528282_573e7bba60_o-768x1024.jpg [extrait] => Patents and plant breeders’ rights (PBRs) are the two main IPRs for living organisms, but other suis generis systems are also possible. Patents, the most powerful tool, applies to biotechnological inventions, modified plants, their cells, their genes, etc. The PVC covers plant varieties via their phenotypic (observable) characteristics, provided that they are distinct, uniform and […] [chapo] => The principle of intellectual property rights (IPR) is widely accepted in most Western societies, but it gives rise to debate when it comes to living beings. This area of law has therefore evolved over the years, and even very recently, particularly in the plant sector. [texte] => Patents and plant breeders' rights (PBRs) are the two main IPRs for living organisms, but other suis generis systems are also possible. Patents, the most powerful tool, applies to biotechnological inventions, modified plants, their cells, their genes, etc. The PVC covers plant varieties via their phenotypic (observable) characteristics, provided that they are distinct, uniform and stable (DUS criteria). Patents and PBRs therefore cover two different objects. They can offer cumulative protection, but their balance is currently being questioned. The patent shaken upUntil June 2023, patent protection in Europe was possible via national patents and the European patent issued by the European Patent Office (EPO)i . Since 1er June 2023, applicants have been able to use a third system: the European patent with "unitary" effect, which operates throughout the territory of the European Union. These two European systems coexist for the European countries they have in common.The EPO considers as patentable "biological material isolated from its natural environment or produced by means of a technical process, even when it pre-existed in its natural state"ii . Its guidelines add that "a gene which is discovered to exist in its natural state may be patentable if a technical effect is disclosed, for example its use in the manufacture of a certain polypeptide or in gene therapy", i.e. data associated with a particular industrial utility (see p.14-15). The decision G3/19 of the EPO's Enlarged Board of Appeal nevertheless excluded from patentability "essentially biological" processes (EBPs)... "if they consist entirely of natural phenomena such as crossing or selection" and the products obtained by such processesiii . This definition of EPB is now being challenged by certain players who want so-called "non-targeted" (or random) mutagenesis to also be considered a natural phenomenon.In addition, as part of the proposal for a European regulation on GMOs/NGT plants, the Parliament voted on 6 February 2024 to exclude products derived from NGTs (plants, plant material, genetic information) from patentability, while leaving open the possibility of protecting NGT processes (see pp. 9-10). This vote is not definitive and must pass the other stages of the trialogue involving the Council of the EU and the European Commission, and would also require an amendment to the legislative acts in force on patents (see p.13).Renewed interest in PBRsThe official catalogues of varieties also impose DUS criteria, which ensures a de facto monopoly for varieties that can be protected by a PVC. This DUS "standard" only applies to industrial seeds and is incompatible with farmers' seeds, which are by nature genetically diverse and not uniformiv .In recent years, small/medium seed companies and their representatives, who are supporters of PBRs, have warned of the possible hegemony of patents on NGTs and the products derived from them, which could prevent access to genetic resources. Some patent attorneys with close ties to the industry also argue that PBRs, rather than patents, should be used to protect products derived from NGTsv .The International Union for the Protection of New Varieties of Plants (UPOV), for its part, has opened up to the use of molecular criteria for PBRs using genetic techniques to identify the characteristics of certain plant varieties. In practical terms, with the help of these genetic criteria identified by molecular markers, breeders could trace varieties more effectively and strengthen seed companies' control over farmers (see p. 4-5).i This title must then be claimed in each EPO member country where the holder wishes to exploit it, which is very costly given the number of countries involved.ii European Patent Convention, rule 27.iii European Patent Office, Decision G03/19 "Essentially biological processes", 14 May 2020.iv However, a European regulation (EC no. 2018/848) which came into force on 1 January 2022 has created the concept of biologically heterogeneous material (BHM) to authorise the marketing of less homogeneous seeds.v Kim, D. Kock, M. et al. « New Genomic Techniques and Intellectual Property Law: Challenges and Solutions for the Plant Breeding Sector ‒ Position Statement of the Max Planck Institute for Innovation and Competition », GRUR, 8 January 2024. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [214] => Array ( [objectID] => 9459 [title] => Patents and evolution of the Plant Breeders’ Rights (PBRs) [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/patents-and-evolution-of-the-plant-breeders-rights-pbrs/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => The PBR is an intellectual property right granted on a plant variety according to four criteria: distinctness, uniformity and stability of its characteristics, as well as novelty compared to known plants. These criteria, as analysed by H. Tordjman in 2008, have historically been preceded by a prior artificial definition of the seed as an object […] [chapo] => Patents and Plant Variety Certificates (PBRs) are two intellectual property regimes that can be applied to the same plants. While a patent may relate to genetic information or biological material in a plant, a PBR takes into account the visible characteristics of the plant as a whole. But plans to give greater weight to certain genetic descriptors in order to obtain a PBR are bringing the latter closer to the patent, a sort of hybrid system for the well-being of seed companies, but not farmers. [texte] => The PBR is an intellectual property right granted on a plant variety according to four criteria: distinctness, uniformity and stability of its characteristics, as well as novelty compared to known plants. These criteria, as analysed by H. Tordjman in 2008, have historically been preceded by a prior artificial definition of the seed as an object in order to enable its "commercialisation"i . The authorisation to market a variety is granted via registration in the catalogue, based on the criteria of distinctness, uniformity and stability, as well as a novelty criterion based solely on other varieties already registered.Patents and PBRs: their major differencesA patent, on the other hand, is granted for a technical process or a product containing biological material or genetic information. While the scope of a PBR excludes breeding processes, that of a patent excludes varieties in their phenotypic and genotypic entirety.The PBR also differentiates by the "farm-saved seed exception", which allows farmers, for certain species, to resow seed from a protected variety for "fair remuneration" from the breeder (small farmers are exempt). The second exception is for breeders, who are free to use a variety protected by a PBR for research to create new varieties. As far as patents are concerned, exceptions may be made at a national level. In France, sectoral agreements or special arrangements may allow the re-use, under strict conditions, of certain patented seeds for certain species and within an annual production limit. The breeder's exception is also provided for in the new European unitary patent, but not the "farmer's privilege"...These differences are reflected in the ways in which these rights are granted (see p.3). For genetic modification techniques, patents are granted on the basis of a description of the genetic sequences or modified biological material. A PBR is granted on the basis of a description of visible and/or measurable characteristics on whole plants only.PBRs: a description that is above all visualA PBR is applied for by providing the information needed to characterise a variety. In France, the Geves (the organism evaluating new plant varieties & analysing seed quality) verifies this file by studying the visible and/or measurable characteristics of a variety in the field (phenotype). Genetic analyses (genotype) are not used for these verification tests. For the Geves, they would even be problematic, as a molecular description does not provide any information about the appearance of a variety when grown, especially as "two distinct genetic profiles may [...] turn out to be identical in the field, which could cause confusion at a commercial level"ii . But it uses these genetic analyses to check seed batches. By detecting the presence or absence of molecular markers, it is able to prevent the controlled batches from being sown.For its part, the International Union for the Protection of New Varieties of Plants (UPOV) accepts, for certain species, the replacement of the description of certain phenotypic characteristics by a molecular marker supposed to correspond. But these markers never replace all the phenotypic characteristics describing a variety.What is a molecular marker?Molecular markers are short genetic sequences that can be used as references. Like signposts along a road, they indicate the presence of sequences that may confer a particular trait. Some people think they can be used to obtain a presumption of identification of a plant variety, facilitating traceability from its use to the consumer's plate. A list of several of these sequences provides a more or less reliable presumption of the "genetic fingerprint" of each variety. By carrying out genetic analyses in search of such markers, it is possible to classify plants into groups if these markers are present in a uniform and stable way within several plants studied. If, in addition, these markers are found in one group of plants but not in another, they can be used to identify a number of characteristics of a variety.To characterise a variety genetically, the work would consist of drawing up a list of markers typical of that variety, like a reference matrix. When a plant is analysed, the results of the presence or absence of the various markers would then give the name of the variety to which the plant belongs. But we're not there yet.Genetic analysis for the PBR?Genetic analyses would be considered as tools for describing and verifying three of the four criteria included in the specifications for obtaining a PBR: distinctness, uniformity and stability. Within the UPOV, a "working group on biochemical and molecular techniques" aims to establish guidelines allowing to define the genetic profile of varieties. Its ambition is to build a common analysis methodology and a database of molecular markers that can be used for the genetic description and identification of a varietyiii .A recently updated UPOV document provides "guidance on the possible use of biochemical and molecular markers in the examination of distinctness, uniformity and stability (DUS)"iv . In France, the Geves held its first workshop on this approach in 2023.Will the PBR, in the future, be granted on the basis of genetic characteristics rather than visible or measurable characteristics of the whole plant? As the Geves writes, in France, the wish remains to maintain a dominant role for phenotypic description. In 2017, it was noted that "the characterisation of varieties by taking phenotypes into account must remain the fundamental point to establish the difference between two varieties"v. This need to confirm the central role of phenotypic characterisation shows that this role is being called into question. But how can small seed companies provide such genetic descriptions? Without the skills, equipment and financial resources, it seems difficult. A PBR obtained by genotypic description would then be reserved for the only players capable of producing such descriptions, foreclosing access to PBRs to small seed companies and reinforcing the concentration of the sector.Removing the descriptions of the varieties to be protected from the field distances farmers from the world of intellectual property. These players identify the seeds they buy on the basis of their phenotypic characteristics of interest to the crop, not of their genomes. Molecular markers could be used by seed companies to control farmers' seeds. In Europe, farm-saved seeds under PBR are the subject of an offensive to force those who reproduce them to pay royalties (which the majority do not do, taking advantage of the difficulty of tracing phenotypic traits). The European Commission is proposing to open up the marketing of seeds to non-organic "heterogeneous material" (not subject to DUS criteria), which could therefore contain patented elements. These include, for example, farmers' seeds. These seeds could be the subject of patent claims linked to molecular markers. This proposal would surely be the end of this material, whose value lies in its genetic diversity, which enables it to adapt easily to the various growing conditions in which it is cultivated through successive multiplications from local harvests. This is a crucial ability at a time of ecological and climate upheavals.i Hélène Tordjman, "The construction of a commodity: the case of seeds" , Annales. Histoire, Sciences Sociales, 2008/6, pp 1341-1368.ii Geves, question "Can the genome study replace the DUS study in the field?".iii UPOV, "Review of document upov/inf/17 'Guidelines for dna-profiling: molecular marker selection and database construction'", 4 September 2020.ivUPOV, "Possible use of molecular markers in the examination of the distinction between uniformity and stability", 20 October 201.v CGAAER, "Scenarios for changes in PBR in relation to the development of new techniquesd'obtention variétale et l'évolution du brevet", p.51, March 2017. Eric MEUNIER [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [215] => Array ( [objectID] => 9456 [title] => Patents on NGTs, between disputes and desire: the case of Crispr-Cas 9 [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/patents-on-ngts-between-disputes-and-desire-the-case-of-crispr-cas-9/ [image] => https://infogm.org/wp-content/uploads/2026/03/6082519875_f21a00452b_o-768x431.png [extrait] => Patents on “new genomic technologies” (NGTs) cover all areas of life, from fundamental research to its applications. The ownership of these patents is shared between the public and private sectors. For the industry, the profit potential of NGTs is considerable, and patents are the major guarantors of this. Crispr-Cas 9, the subject of the main […] [chapo] => The patent rights applying to NGTs are vast and complex. They are also precious to a few multinational companies that want to control the economy of the sector. The illustration with Crispr-Cas. [texte] => Patents on "new genomic technologies" (NGTs) cover all areas of life, from fundamental research to its applications. The ownership of these patents is shared between the public and private sectors. For the industry, the profit potential of NGTs is considerable, and patents are the major guarantors of this. Crispr-Cas 9, the subject of the main NGT patent rights in the agricultural sector, is a clear illustration of this. This essential tool for this sectori is causing legal battles and leading to a concentration of the seed sector to the detriment of its "small players" and farmers.Crispr-Cas 9, rights under pressureMajor patent rights on Crispr-Cas 9 are being claimed by the Universities of California and Vienna, on the one hand, and the Broad Institute (in partnership with MIT and Harvard) on the other. The former claim to have discovered Crispr-Cas 9 (Nobel 2020) in prokaryotes (bacteria), the latter its application in eukaryotic cells (animals, plants, fungi, etc.). These bodies are still involved in a dispute over some of these rights. Other parties are also involved in various proceedings concerning the Crispr-Cas systemii . Proceedings are under way in the United States to determine the first inventor (the old US system), and others at the European Patent Office.The Max Planck Institute explains that the Crispr-Cas patent landscape will, as a result of these litigations, be characterised by multiple overlapping patents held by several partiesiii. Several parties have filed patent applications in a very short space of time and, despite certain differences, they are largely identical for the application of Crispr-Cas 9 in the modification of eukaryotic cells.The keenness of this legal battle illustrates the importance of the economic stakes associated with Crispr-Cas. Owned mainly by the academic sector, this tool is licensed to the private sector - notably agrochemical and pharmaceutical multinational companies - for commercial exploitation. The outcome of the litigations could affect the validity of the patents involved and therefore the licensing agreements.... controlled by a few powerful playersAccess to licence rights on Crispr-Cas 9 can be very expensive, especially if they are exclusive. That’s why multinational companies such as Corteva, Bayer, BASF and Syngenta share the various licences available in the agricultural sectoriv . This strategy also allows the licensors of the rights to be reassured that they will be used to the full. Another consequence of granting such rights to a small number of powerful players is that they favour the development of their own innovations and patents, thereby increasing the concentration of capital in an already highly concentrated sector. This is to the detriment of the diversity of the seed supply, which is reduced to the elite genetically modified varieties only of these few players.This business model creates legal uncertainty for the other potential users of Crispr-Cas 9, and also affects the rights of farmers and small/medium-sized seed producers, who are competitors of these seed companies, as well as consumers. If the traceability of new GMOs, involving the publication of procedures for detecting and identifying them, were to be abolished, patents on Crispr-Cas 9 could in fact cover traits expressed by plant varieties resulting from conventional crossing/selection procedures, traits native to plant species, and so on. The appropriation of these characteristics via NGTs could therefore restrict the development of cultivated biodiversity, including that which produces food. This is one of the stumbling blocks in the discussions about the European Commission's proposal to deregulate NGTs (p.9-10).iEuropean Commission, DataM, "New genomic techniques", April 2024.Zheng et al., " The Improvement of CRISPR-Cas9 System With Ubiquitin-Associated Domain Fusion for Efficient Plant Genome Editing", Frontiers in Plant Science, May 21, 2020.iiGRUR, "New Genomic Techniques and Intellectual Property Law: Challenges and Solutions for the Plant Breeding Sector - Position Statement of the Max Planck Institute for Innovation and Competition", 8 January 2024.iiiIbid.ivCanadian Biotechnology Action Network, "Patenting genome editing in Canada", March 2022. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [216] => Array ( [objectID] => 9455 [title] => Seed patents: the industry’s great manoeuvres [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/seed-patents-the-industrys-great-manoeuvres/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Developments in biotechnology over the last twenty years have been spectacular, as have those in other high-tech areas such as information science and nanotechnology. In all these fields, intellectual property issues are crucial to the development of what is essentially a scientific and technical activity. The particularity of biotechnology is that it involves living organisms […] [chapo] => Over the last two decades, biotechnology has disrupted intellectual property issues, particularly in the field of seeds. The major agrochemical companies dominate the so-called abiotic stress-resistant varieties, accumulating a large share of patents. This monopoly is giving rise to ethical and economic concerns, at a time when new genomic techniques promise to solve food crises. [texte] => Developments in biotechnology over the last twenty years have been spectacular, as have those in other high-tech areas such as information science and nanotechnology. In all these fields, intellectual property issues are crucial to the development of what is essentially a scientific and technical activity. The particularity of biotechnology is that it involves living organisms or products derived from them: as the manipulation of living organisms becomes more complex, what is appropriated by patents also becomes more complex and extensive. For example, when scientists try to work on photosynthesis or the nitrogen-fixing mechanism, patents will cover whole areas of these processes, which are the basis of life on Earth1. Bayer as the owner of photosynthesis? We're not there yet, but it's a worrying development, with the agrochemical oligopoly extending its tentacles in several directions. Let's take a look at an example that is central to the research of today's major seed companies: varieties resistant to abiotic stresses (global warming, poor or alkaline soils, extreme climate events, etc.). It is central because this is how the industry legitimates the new genomic techniques (NGT): according to their promoters, they should solve the problem of hunger in the world in an increasingly perilous climate and ecological context. But first we need to look at the broad outlines of the economic model for this sector, which is also similar to that for other technosciences.The business model of the biotech sectorWhat is produced, the output of the activity, consists mainly of scientific knowledge and the resulting technological tools. To secure this output and to be able to value it monetarily, it must be privatised by means of an intellectual property right, in this case a patent, a highly protective form for the inventor. The patent gives the inventor a monopoly right (temporary, usually 20 years), allowing profitability on an often very costly investment in R&D (research and development). This is the main justification for this infringement to the "free competition" so praised by orthodox or standard economics. Anyone wishing to use the invention will have to pay a royalty or negotiate a licence agreement. The income generated by a patent is therefore akin to an annuity, the value of which is unknown at the time it is granted. It will depend on the success of the invention. This is why it is often referred to as the "economy of promises". This term is rather vague (financial promise? Industrial? Ecological?) and masks the similarity between a patent and a financial security. In fact, both are securities that give the right to future, and therefore uncertain, income streams. As such, they are the object of bets on the future, which partly determines the strategies of the players.Patented inventions are generally the work of university scientists, and/or those who have founded start-ups, or those working in the laboratories of major companies. Biotech research is very expensive: the equipment is increasingly sophisticated and rapidly obsolete if it has to compete. Research funding is a crucial issue here. It is mainly done through public-private partnerships (PPPs) involving universities and other government bodies (often including the military body), start-ups, major transnational corporations, foundations (Bill and Melinda Gates' foundation is very active in biotech, but it is not the only one) and venture capital companies. When inventors are employed by universities, it is the universities that own the patents. However, depending on the country, researchers have the right to set up start-ups to which the universities grant operating licences (a development that originated in the United States with the Bayh-Dole Act of 1980). When the inventors belong to the private sector, the companies obviously own the patents.For several decades public policy has been encouraging researchers to set up companies to make their inventions attractive (the "start-up nation" so dear to E. Macron). Once these companies have a portfolio of patents deemed sufficient, they can attempt to raise additional funds through an Initial Public Offering (IPO) on the so-called "growth" stock markets, such as New York's NASDAQ. Another way of raising value is to sell the start-up to a large company. This is how the Big Four in seeds and agrochemicals (Bayer-Monsanto, Corteva, Syngenta and BASF) have bought dozens of small firms, to further increase their already considerable patent portfolios.Patents on climate-ready seedsCambia, an Australian organisation, has created The Lens, an open-access database listing all the biotech patents in the world. A search in this database using the keyword "abiotic stress" comes to the following results.To date, 43,000 patents have been applied for, including more than 39,000 in the United States, corresponding to 21,000 patent families2. A good half of these patents have been granted (24,000) and around 10,000 are under examination. The remaining patents have been abandoned for one reason or another. Research about climate-ready seeds got off to a slow start in the 2000s. The growth of patent applications has been very clear since 2010, and has been continuing to this day. It's worth reminding the scientific context: the late 2000s and early 2010s saw the emergence of various genome modification tools that can be used to produce "new GMOs" from NGTs. For example, patent applications for Crispr/Cas were filed in 2012. The financial stakes involved in controlling these tools are potentially enormous (see p.3). If scientists and engineers succeed in creating climate-ready varieties, there is a real risk that they will invade the global seed market, as Roundup Ready varieties did in their day. Hence the intense pressure from the industry and the European Commission to deregulate NGTs: "we must not fall behind on international competition", the same old rhetoric. "Feeding the planet in the context of the ecological crisis" is a modest way of dressing up this race for profit.The figures from The Lens confirm the massive dominance of the Big Four: they own the bulk of inventions, either directly or through their subsidiaries. Bayer, which acquired Monsanto in 2018, holds almost 50%, Corteva around 30%, with BASF and Syngenta sharing around 10% of patent families. Of the 15 largest owners, only one, Stine Seeds Farm, does not belong to the Big Four. The concentration of intellectual property in the field of climate-ready seeds is therefore massive. The public sector is very poorly represented: the four institutions at the forefront of this type of research (the University of California, Harvard, MIT and the Broad Institute - whose public-private status is unclear) share just over 500 patent families. That being said, ownership does not always mean control, and everything depends on the characteristics of the licences granted by the owners to the patent users.The Big Four are clearly betting on the "new GMOs" resulting from NGTs. If the applications of these techniques were to be widely developed, they would be in a position to appropriate not only part of the base of the global food chain, but even more importantly, the biological processes at the basis of life on Earth...1ETC Group, Capturing "Climate genes". Gene Giants Stockpile "Climate-Ready" Patents, 2011.ETC ironically calls these genes "Climate-Ready" in reference to the "Round-up Ready" genes of the first generation of GMOs. For an example of a patent, see National Institute of Agrobiological Science, Japan, C3 Plants Expressing Photosynthetic Enzyme of C4 Plants.2A family of patents relates to the same invention, which may be applied for in several jurisdictions. Figures are rounded to simplify reading. Hélène Tordjman (Economist, Senior Lecturer at Sorbonne Paris-Nord University) [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [217] => Array ( [objectID] => 9454 [title] => Is 2024 the year when patents on life are politically challenged? [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/is-2024-the-year-when-patents-on-life-are-politically-challenged/ [image] => https://infogm.org/wp-content/uploads/2026/03/3147660433_38b2f3a573_o-768x512.jpg [extrait] => On 20 March 2024, the European Coordination Via Campesina (ECVC) celebrated a victoryi : the failure of the European Commission to push through its plan to deregulate GMOs/NGTs, in particular because the issue of patents blocked discussions between governments. The Commission justified – and still justifies – its proposal for deregulation on the grounds that […] [chapo] => Patent law in the plant sector has never been so much questioned since the adoption of the European legislation governing it in 1998 Indeed, during the debates on the European Commission’s proposal to deregulate GMOs, patentability of living organisms was called into question. The European Parliament, as well as several Member States, expressed a political will to ban patents. However, there are still gaps in the written word… [texte] => On 20 March 2024, the European Coordination Via Campesina (ECVC) celebrated a victoryi : the failure of the European Commission to push through its plan to deregulate GMOs/NGTs, in particular because the issue of patents blocked discussions between governments. The Commission justified - and still justifies - its proposal for deregulation on the grounds that GMOs/NGTs would be indistinguishable from conventional plants. For the trade union, the Commission "is now caught in its own trap: this essential issue, which it did not want to take into consideration, is blocking any agreement within the Council". By denying the possibility of traceability, the Commission has opened the door to an opposition to "the patentability of these indistinguishable plants". At the end of May 2024, the European Council had still not reached agreement on the patent issue.A historic challengeWhen the European Commission presented its proposal to deregulate GMOs and NGTs on 5 July 2023, it knew that patents were going to be discussed. It noted in its introductionii that "the issue of patents for NGTs has been raised by many stakeholders. Breeders' and farmers' organisations have expressed their concern about the need to guarantee breeders' access to patented genetic material and farmers' access to NGT plant breeding material". But the Commission chose to postpone this debate, announcing a study for 2026 on the impact of patents on breeders' rights, farmers' access to seeds and European competitivenessiii .For their part, the Member States meeting within the Council of the European Union (EU) have continued to note their disagreements, particularly on the patentability of GMO/NGT plants. At the end of December 2023, a meeting summed up the five months of negotiations that had just taken placeiv . Several countries, including Austria, Poland, France and even the Netherlands, wanted the issue of patents to be addressed and resolved. For Austria, with the patenting of NGT plants, there is "a risk of market concentration which could even lead to a monopoly and which could pose problems of availability". France and the Netherlands believe that patents are an issue on which "progress needs to be made to enable small/medium sized companies [...] to gain access to these technologies". On 26 March 2024, while the European Parliament was voting on an amended text, a meeting of the Member States showed that positions had changed little on the subject. On 23 May, Belgium proposed a text addressing the non-patentability of GMO/NGT plants, but without convincing anyone. At the end of May, therefore, patents applied to potentially deregulated GMO/NGT plants were still the subject of disagreement.Parliament includes patents in its proposalIn the European Parliament, the issue of patents has moved forward against the opinion of the MEPs coordinating the work on GMO/NGT deregulation. Back in October 2023, Jessica Polfjärd MEP (Sweden), who is chairing the work of the Parliament's Environment Committee on this text, wrote plainly in a draft report "taking note of the concerns raised by breeders and farmers about patents on NGTs" (see p.11-12). However, she added that she was "in favour of the Commission's approach, which consists of regularly assessing the situation and presenting a report on how to regulate this aspect after applying the text in practice in order to assess whether a technique can be patented"v. Four months later, the European Parliament finally took a more concrete stance by openly challenging certain aspects of patent law in the plant sector.On 7 February 2024, the European Parliament adopted its own version of less deregulation of GMOs/NGTs. In this text, it considers that "the possibility of patenting new genomic techniques and their results risks reinforcing the domination of multinational seed companies over farmers' access to seeds [...] such a situation would deprive farmers of all freedom of action by making them dependent on private companies. For this reason, it is imperative to ban patents on these products"vi . Its intention is therefore that the EU should not grant patents covering plants obtained by NGTs. To this end, the Parliament believes that "NGT plants should not be subject to patent legislation, but only, as far as intellectual property protection is concerned, to the Community plant variety rights regime" and that "NGT plants, their derived seeds, plant material, associated genetic material such as genes and gene sequences, and plant traits should therefore be excluded from patentability". If the wording is not sufficiently robust, these writings, by the European Parliament, testify to an unprecedented political will to oppose patents on potentially deregulated GMOs.An inadequate solutionHowever, the wording proposed by the Parliament does not reflect this desire in concrete terms. On the one hand, it proposes articles focusing on so-called "product" patents. As far as process patents are concerned, the wording adopted does not seem clear-cut. The Parliament certainly considers that "the protection conferred by a patent on a technical process enabling the production of a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function, but which is indistinguishable from plant material obtained or obtainable by an essentially biological process". But it did not write, as ECVC proposed, that "the protection conferred by a patent relating to a process allowing the production of a biological material endowed, as a result of the invention, with specific properties does not extend to plant materials in which that biological material is incorporated and which are indistinguishable from plant materials obtained or obtainable by an essentially biological process". This leaves patent holders with the option of asserting that their patent does not relate to genetic information but to biological material. A simple change of semantics that could have major consequences if it were to leave the door open to patents granted on processes that, by extension, could extend to plants containing biological material (and not a genetic sequence or genetic information) identical to that covered by the patent, without farmers or small seed growers being able to prove that they are not derived from the patented inventionvii.Indeed under patent law, it may be up to an alleged infringer to prove that he didn’t use a patented process. He would therefore be obliged to carry out analyses showing that these seeds do not come from a patented process. These tests are impossible to carry out today, however, because the European Commission and Parliament have not planned to require GMO/NGT producers to provide their own identification method...The final obstacle is that the legal procedure is not the right one. In the EU, patent law is governed by Directive 98/44 (see p.13). Changing the patentability of GMO/NGT plants as proposed by Parliament would therefore affect this directive. However, the Commission is the only body that can propose to do so. Will it agree to listen to the Parliament's wishes at the trilogue stage? Or will it stick to its announcement of a later report on this issue? If so, there would be a risk of blocking any adoption of new NGT regulations before the Commission proposes not only a report, but also a legislative solution.i ECVC, « ECVC celebrates a first victory against GMO/NGT deregulation », press release, 20 March 2024.ii European Commission, « REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 », 5 July 2023.iii European Commission, « Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions », 5 July 2023.v European Parliament, « Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation(EU) 2017/625 (Text with EEA relevance) », 16 October 2023.vi European Parliament, « Plants obtained by certain new genomic techniques and their food and feed », amendments adopted on 7 February 2024. Eric MEUNIER and Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [218] => Array ( [objectID] => 9452 [title] => The threat of GMO/NGT patents is growing stronger [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/the-threat-of-gmo-ngt-patents-is-growing-stronger/ [image] => https://infogm.org/wp-content/uploads/2026/03/9697776714_508a798cee_o-768x512.jpg [extrait] => The 1998 court case between the Canadian farmer Percy Schmeiser and Monsanto paved the way for other legal actions in the United States and Europe. Today, farmers, plant breeders and peasants – the “small farmers” – are more than ever at the mercy of legal action by the industry and its patents. A historic dispute […] [chapo] => Twenty-five years after the first convictions for GMO patent infringement, the threat of legal action by the agrochemical industry is hanging over farmers, plant breeders and peasants more than ever because of its patents. [texte] => The 1998 court case between the Canadian farmer Percy Schmeiser and Monsanto paved the way for other legal actions in the United States and Europe. Today, farmers, plant breeders and peasants - the "small farmers" - are more than ever at the mercy of legal action by the industry and its patents. A historic disputeIn 2004, the famous patent infringement trial involving a genetically modified rapeseed ended in Canada. The farmer Percy Schmeiser, whose field had been contaminated by Roundup Ready (glyphosate-tolerant) oilseed rape, was convicted of infringing Monsanto's patent rights. The same year, the French company Gautier Semences had a tough time with a Dutch seed company, Rijk Zwaan, holder of a patent on lettuces resistant to the Nasonovia aphid. The French seed company had been, for a long time developing such lettuces independently, incorporating the wild gene. Unable to finance its legal action to invalidate the patent, Gautier Semences was forced to negotiate a licence with Rijk Zwaan. In the United States, in 2013, Monsanto secured the conviction of Vernon Bowman, a farmer from Indiana. Bowman had purchased and replanted Roundup Ready soybeans from a grain silo. The Supreme Court ruled that the patent right also applied to the replanted seeds. In other words, the patentee's right "does not run out" once the seed has been sold, as is the case for other products that do not reproduce naturally. Today, the list of individuals or legal entities - small farms, some family-run - subject to patent-related legal action continues to grow, to the point that a majority of North American farmers prefer to buy every single patented seed to guarantee themselves against any infringement proceedings.Worrying legal developmentsInf'OGM recently reported on the case of two breeders under threat from patents, including a Dutch company, Nordic Maize Breeding (NMB), which has independently developed a cold-resistant maize. KWS holds a patent for this resistance trait, although it was filed after the NMB maize was developed. When asked about the patent risks, the response of Grietje Raaphorst-Travaille, co-founder of NMB, shows both the absurdity of the situation and the powerlessness of small breeders in the face of the issue: "I think it's really strange that we have to look at these issues [...] we can't test the seeds we sell to farmers to see if they are free of patent rights or not, or even if they are free of new GMOs [...] breeders and farmers thus run an enormous risk, which they will not be able to limit". In March 2024, the Californian company Norfolk Healthy Produce sued Baker Creek Heirloom Seed Company, a traditional Missouri seed company, over a patent covering a genetically modified purple tomato. Norfolk claims that Baker Creek's Purple Galaxy tomato, also purple but non-GMO, infringes its patent. However, Baker Creek says it imported its tomato from Europe, where this GM tomato is not authorised. Norfolk, on the other hand, claims that their patented genetic modification is the only way to obtain a purple tomato. Although laboratory tests did not clearly conclude whether or not Purple Galaxy was contaminated with GMOs, Baker Creek has decided to withdraw this tomato from its catalogue.Powerless small farmsToday's small farming businesses are faced with undeniable legal uncertainty due to patents, and are quite powerless in the face of this. One of the main reasons is the high number of patent applications for "new GMOs" or "new genomic techniques" (NGTs), and their complexity (see p.6 and p.7-8). In addition, the accelerating pace of innovation may encourage the accumulation of patented traits within the same plant. If this were the case, the development of a new variety from such a plant would require the negotiation of several licences and the payment of as many royalties.Furthermore, the interpretation of patents, their scope and their use as a legal tool remains a subject for specialists. If we are not specialists, how can we know whether products from non-GMO agriculture infringe a patent, especially if no obligation is imposed on their producers to describe the processes for obtaining, and above all detecting and identifying, GMOs/NGTs? This constant threat of patents covering NGTs, the potential impact of which is difficult, if not impossible, for a small farming business to identify, is detrimental for several reasons. When such a business is threatened by a patent right, there are few solutions open to it. It can decide to withdraw its products from the market, or wait for the patent holder to take action. It may also agree to take out a licence and pay royalties. These options have financial consequences for the businesses involved. A patent can also be challenged in court, but here too the asymmetry of the economic, legal and technical capacities of the parties generally sentences the weaker party. The Monsanto vs Percy Schmeiser trial is a case in point.Real solutions or legal deadlock? The European legislator provides little or no real protection for small farms threatened by patents. While the French law admits the "adventitious or accidental presence of patented genetic information in seeds" (Article 613-2-2 of the French Intellectual Property Code) - Germany also provides similar protection - the Directive 98/44 EC does not offer "immunity" in the event of contamination. The other European countries can therefore act as they please. The "farmer's exemption", which allows farmers to resow and reproduce seeds for their own use in return for payment of royalties, applies to a limited number of seed species and only concerns PBRs (Plant Breeders’ Rights) on varieties, not patents.The European legislation - Directive 98/44 EC and the European Patent Convention applied by the European Patent Office - provides protection for genetically modified products (containing or consisting of biological material or genetic information), regardless of the manufacturing process. In February 2024, the European Parliament voted to exclude the patentability of such products when they are derived from NGTs, by insufficiently limiting patents to processes. If this provision were finally adopted by the European authorities, the risk for small businesses would not disappear altogether.Indeed, in the case of a process patent, the European law provides that it normally also extends to the product obtained by the process. The UPCA (Agreement on a Unified Patent Court) also considers, in Article 55, that an allegedly counterfeit product has indeed been obtained by the patented process unless it can be proved otherwise. This is known as the "reversal of the burden of proof" (see pp. 9-10). In other words, the holder of a patent right is not being asked to prove that it has been infringed - which is a basic legal principle that is even recalled in Article 54 of the UPCA - but the small breeder, the farmer, the peasant is being asked to "exonerate" himself. Doesn't this situation create a kind of deadlock by imposing a lot on those who can do little or nothing at all, and little on those who can do a lot? Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [219] => Array ( [objectID] => 9450 [title] => Modifying EU and EPO patent legislation: a wasted effort ? [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/modifying-eu-and-epo-patent-legislation-a-wasted-effort/ [image] => https://infogm.org/wp-content/uploads/2026/03/2231568923_eb8595ded9_o-768x576.jpg [extrait] => In Europe, patents on living organisms are regulated by the European Patent Convention (EPC), which governs the European Patent Office (EPO), and the European Union (EU) Directive 98/44 on ‘biotechnological inventions’. In June 2023, the EU also adopted its own legislation on unitary patents, which applies to all fields of technology. The patentability of ‘new […] [chapo] => In the spring of 2024, opponents of patents on living organisms won a victory in the European Parliament, including the desire to exclude products derived from NGTs from patentability. However, several major hurdles still need to be overcome, particularly the adoption of the majority of these measures by the European Patent Office. [texte] => In Europe, patents on living organisms are regulated by the European Patent Convention (EPC), which governs the European Patent Office (EPO), and the European Union (EU) Directive 98/44 on ‘biotechnological inventions’. In June 2023, the EU also adopted its own legislation on unitary patents, which applies to all fields of technology. The patentability of ‘new genomic techniques’ (NGTs) has entered the debate about the deregulation of NGTs, to the point of blocking the outcome (see pp. 9-10). If the negotiating position on the deregulation of NGTs ultimately adopted by the European Parliament contained provisions aimed at amending EU legislation, what would be the effects on the EPC?Substantive changes to patentabilityIn the NGT deregulation procedure, the debate on patents focuses in particular on the exclusion from patentability of products derived from NGTs, the retention of patentability of processes, albeit with limits for some of them, and the inherent consequences (see p.9-10). Several proposed amendments on these issues, voted by the European Parliament at second reading, make explicit reference to articles of Directive 98/44.Some supporters of these amendments explain that excluding NGT products from patentability could, for example, prevent monopolies on genetic resources. Other supporters see it more as a way of sharing the genetic resources generated by these technologies. The opponents of these amendments fear that such exclusions will slow innovation by reducing the incentives for investments in research and development, which are essential for progress in biotechnology. Of the two opposing camps, the one in favour of excluding NGT-derived products from patentability won the first round. But even if the latter were to win the battle at EU level, there is nothing to suggest that some of these amendments could be adopted at the level of the EPO or the European unitary patent, the key bodies of the patent system in the European Union.An unlikely outcomeAny amendment to Directive 98/44 will have to be agreed by the Commission, which alone has the right of initiative on a new text. This could happen either at the positive conclusion of the trialogue with the Parliament, which has already voted on the text, and the Commission, or after the adoption by this trialogue of an initial text avoiding this subject. If a text including the exclusions from patentability mentioned above were adopted by the Commission, we would still be a long way from its implementation.The applicability of an amended Directive 98/44 in the European patent system could be achieved through two options, the first of which would involve amending the EPC. The other would leave each EU Member State to apply this new directive, with the risk of inconsistencies and challenges (to the) for uniform application of the rules on the patentability of biotechnological inventions in Europe.Amending the EPC will be difficult, however, because it is legally independent of the EU. Thus, a legal act of the European Union is not necessarily binding on the EPC. In addition, not all member states of the EPC are part of the EU, such as Switzerland, Turkey and Norway.In July 2017, the EPC had already complied with Directive 98/44 by amending Rule 28.2 of its Implementing Regulations to exclude from patentability plant and animal products obtained exclusively by means of essentially biological processes. The influence of this Directive on the EPC may not be sufficient in the more complex and sensitive subject of the exclusion from patentability of products derived from NGTs. Denis MESHAKA [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [220] => Array ( [objectID] => 9449 [title] => DSI: dematerialised biopiracy [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/dsi-dematerialised-biopiracy/ [image] => https://infogm.org/wp-content/uploads/2026/03/7096373457_eb135cfd0c_o-768x576.jpg [extrait] => Originally introduced as a new scientific concept, a semantic UFO has recently come to dominate all debates on seeds, biodiversity and intellectual property. Some call it DSI (Digital Sequence Information), while others call it GSD (Genetic Sequence Data). A flying object because it circulates freely in the cyberspace in the form of virtual signals picked […] [chapo] => Digital sequence information, a semantic UFO, is the subject of intense legal debate. It lies where NGT deregulation, patent law and the sharing of genetic resources meet. [texte] => Originally introduced as a new scientific concept, a semantic UFO has recently come to dominate all debates on seeds, biodiversity and intellectual property. Some call it DSI (Digital Sequence Information), while others call it GSD (Genetic Sequence Data). A flying object because it circulates freely in the cyberspace in the form of virtual signals picked up by computers that display them as a succession of five letters (ACG and T or U), symbols of the chemical components of the DNA or RNA. Unidentified because the more it is discussed in international political arenas (ITPGRFA1, CBD2...), the less it is possible to define it.Multifaceted legal conceptsThe absence of an internationally recognised definition of DSI/GSD means that the countries of the global South, the main suppliers of genetic resources, conclude that they are a genetic component of physical organisms, while the countries of the global North, the main users of these resources, conclude that they are a product of research. But this does not prevent the scope of a patent on genetic information from controlling any use of the physical organisms that contain it. The absence of a definition of this information is currently blocking discussions on the legal framework for new genetic modification techniques, like an elephant in the room that no one dares to mention.All these words refer to the same reality. But while DSI and GSD are dematerialised data, a component of a physical organism, even a genetic one, is material. As for genetic information, it is a priori dematerialised like all information, but it is also material because it is contained in biological matter (DNA). What are the consequences of playing on words ?3CBD and the ITPGRFA, what’s that?For the international law dictated by the industrial ‘Global North’, life and knowledge are first and foremost industrial resources. The CBD (Convention on Biological Diversity) is a convention between states that lays down the rules for access to biological resources and associated knowledge vital to industrial development. All access requires the signature of a bilateral agreement based on the prior consent of the state from which the coveted resource originates. This state may delegate this consent to the person, indigenous people or local community that manages the resource and holds the associated knowledge. This consent may relate to the conditions of their use (can they be the subject of research, or also multiplied, commercialised, transformed, genetically modified, patented, etc.) and to the sharing of the benefits arising from their exploitation. Since the CBD was adopted in 1992, these conditions have generally been circumvented, as most biological resources are freely available in many public collections, with no link to their origin. This is also the case for the description, in numerous freely accessible publications, of their chemical and genetic components, which can be roughly copied by chemistry or synthetic biology, without any direct use of the original biological resource. Benefit-sharing is thus limited to a few dollars, which fund the work of NGOs, researchers and sometimes indigenous peoples' organisations responsible for collecting and making available to everyone the biological resources that are not yet available and the associated knowledge held by the farmers and people who live with and maintain these resources.The ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) is the application of the CBD to seeds. It abolishes bilateral prior consent and replaces it with a multilateral system (MLS) of access (mainly to large national and international gene banks). This access is not free, but ‘facilitated’, as it is conditional on an obligation to share benefits and a prohibition on claiming any intellectual property rights that limit the facilitated access of other players to the resource provided, as well as its parts or its genetic components. A Benefit Sharing Fund is mainly financed by a few states, far below the sums promised, since the seed industry takes advantage of the lack of effective traceability of seed exchanges to pay only a few bits. This fund also finances institutions, NGOs and researchers responsible for helping farmers to save their seeds, collecting them for the multilateral system and publishing their associated knowledge.The smokescreen of patent benefit sharing The fact that the genetic sequences of millions of biological resources and thousands of publications on their characteristics of interest are now freely available on the Internet undermines both the prior consent of the CBD and the conditions for facilitated access under the ITPGRFA. Artificial intelligence and machine learning algorithms use millions of data to build predictive computer models that guide the genetic engineering that creates organisms, components and products of synthetic biology... patented before even existing.Thousands of patents have been granted on the genetic information incorporated (in) this way into plants, animals, micro-organisms, fungi, pharmaceutical, veterinary and biocontrol products, etc. and/or on the ‘new genomic techniques’ (NGT) used to obtain these products, even though only a small number of them have actually been developed and marketed. Since they are no longer directly linked to access to physical biological resources but only to dematerialised data (DSI/GSD) considered as research products, all these patents circumvent benefit sharing. The CBD is therefore examining the feasibility of a financial levy on the commercialisation of any product resulting from the use of DSI/GSD to be paid into a benefit-sharing fund. For its part, the ITPGRFA has been debating the same subject for 10 years. But the haggling of the industry, supported by the countries of the ‘global North’, is blocking any conclusion, while more and more patents are being granted.Could deregulation of the ‘new GMOs’ lead to widespread biopiracy?Since 1998, the European biotech directive 98/44 has stated that ‘the protection conferred by a patent on a product containing or consisting of genetic information shall extend to any material in which the product is incorporated and in which the genetic information is contained and performs its function’.However, it is forbidden to patent nature and traditional selection processes, known as ‘essentially biological’. Trans-genesis techniques capable of incorporating such genetic information into biological organisms all leave easily identifiable signatures (promoter, terminator, etc.). With these techniques, the scope of patents is limited solely to products resulting from the invention and to products contaminated by patented genes.But never mind! The new tale of the industry and the governments of the richest countries is that NGTs make it possible to obtain genetic information that is indistinguishable from that which may be contained in naturally existing organisms or derived from traditional, non-patentable breeding. The numerical description of the patented genetic information alone may be indistinguishable, but never the entire modified organism. This is because NGTs systematically generate numerous other so-called ‘unintentional’ genetic modifications which constitute indisputable ‘signatures’ of the use of the genetic engineering process justifying the patent. But the scope of the patent extends to any material that contains the patented genetic information. It therefore also extends to all organisms that contain it naturally or as a result of the use of non-patentable selection processes. That’s why a few pharmaceutical, agrochemical, seed and food companies think they can appropriate and control all the biological diversity in the sun. But more and more farmers and citizens are rising up, determined to abolish this new form of biopiracy resulting from the lack of regulation of genome digitisation.1International Treaty on Plant Genetic Resources for Food and Agriculture, commonly known as the Seed Treaty.2Convention on Biological Diversity.3The dimensions of this article do not allow us to go into all the details of the many procedures permitted by the legal texts mentioned. Guy Kastler (La Via Campesina delegate to the ITPGRFA and CBD meetings on seeds) [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [221] => Array ( [objectID] => 9448 [title] => Patents on life: medicine and “disruptive technologies” [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/patents-on-life-medicine-and-disruptive-technologies/ [image] => https://infogm.org/wp-content/uploads/2026/03/9121238998_b3eb24baeb_o-768x1152.jpg [extrait] => In a dossier entitled “Micro and nano technologies for healthcare” published by CEA-Leti2 , we can read: “the emergence of disruptive technologies is transforming the pharmaceutical industry“. These so-called “disruptive” technologies are mainly the result of NBIC convergence – nanotechnology, biotechnology, information technology and cognitive science(s) – in a cross-fertilization dynamic that has been underway […] [chapo] => In addition to patents on plants, animals and micro-organisms, there’s another vast field in which patents are being used: medicine and pharmaceuticals, which today are inextricably linked with digital technologies. Jaw-dropping ! [texte] => In a dossier entitled "Micro and nano technologies for healthcare" published by CEA-Leti2 , we can read: "the emergence of disruptive technologies is transforming the pharmaceutical industry". These so-called "disruptive" technologies are mainly the result of NBIC convergence – nanotechnology, biotechnology, information technology and cognitive science(s) - in a cross-fertilization dynamic that has been underway for at least two decades. Microelectronics is a key component of all these technologies, and is making a major breakthrough in the healthcare sector. The number of patents filed by CEA-Leti speaks for itself: out of a total of 2,800 patent families, the vast majority are in the healthcare field4 . We're talking about « general » health, but for the moment, the human species is the most concerned. What new medicines can these technologies offer? How far have we got in their achievement? In marketing them ? What about the biological structures (tissues, organs) newly constructed with these same disruptive technologies?Biomedicines...Biomedicines are drugs produced from living cells. The range of applications is immense: from molecules such as human insulin- long produced in fermenters from genetically modified bacteria- to gene therapies such as those using Crispr/Cas-modified Car-T lymphocytes or therapies targeted at tumour cells and associated with artificial intelligence. Other examples include modified RNA - or DNA - vaccines based on nano-biotechnologies and synthetic biology, and tissue-based therapies (transplants). But these are just a few examples.One out of every two drugs under development worldwide is a biomedicine7 , indicating the expected growth in the number of patents. Patents which are related to these biomedicines and their production processes. 76 patented biotherapies are already marketed in Europe8....to organoids on chipsDifferent from the organoids already presented in our articles, here come the organoids on chips. Organ stem cells are placed on "channels" bathing in a "microfluidic component" which reproduces some of the physical conditions encountered in real organs, and supplying the essential nutrients. It’s microelectronic fluidic systems that would enable vascularization (formation of blood vessels) in the10 organoid. The hybridisation between living and non living things is complete. These organoids on chips imitate the functions of organs. They hold promises for the study of diseases or their therapies, particularly cancers, regenerative medicine, drug assessment and the reduction in the number of laboratory animals...For example, clusters of pancreatic cells have been shown, with this system, to produce insulin more efficiently. By injecting them into people with diabetes (type 1), we may be able to cure them.All these processes, numerous and varied, are patented. "Patents have been filed, but the experimental results have not yet been published," says researcher Xavier Gidrol, who is involved in the PEPR (priority research equipment program) funded by the French government for this type of work11.In the healthcare field12 , the scope of patents is still very unclear. Will patents on processes lead to private ownership of cells belonging to an individual? Will we see the privatization of therapeutic protocols in Europe, like in the United States? It's a dizzying question, but the promises, especially in the sensitive field of health care, are bound to turn to gold for multinational firms, laboratories and start-ups... 1CEA-Leti, « Micro et nanotechnologies pour la santé », 2023.2CEA: French Atomic Energy Commission. Public organization. In 2010, it broadened its scope to include "alternative energies".CEA-Leti: based in Grenoble, France, CEA-Leti is a technology research institute and world leader in micro and nanotechnologies in a number of fields, including health and biology.4CEA-Leti, « CEA-Leti : 50 ans de technologies de miniaturisation novatrices ».CEA, « Le CEA et la deeptech, une évidence », 18 janvier 2024.7 CEA-Leti, "Biomedicines and biomanufacturing: innovating for tomorrow", March 3, 2022.8Ibid. 10 Le Monde Science & Médecine, March 13, 2024.11Ibid.12Not all "innovations" are mentioned in this article, but are described in the dossier in note 1. Annick BOSSU [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [222] => Array ( [objectID] => 9447 [title] => Towards the seizing of the processes that are the core of life on Earth [timestamp] => 1694822400 [date] => 16/09/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/towards-the-seizing-of-the-processes-that-are-the-core-of-life-on-earth/ [image] => https://infogm.org/wp-content/uploads/2026/03/2961565820_5a03199811_o-768x782.jpg [extrait] => The various articles have highlighted the complexity of intellectual property on plants, its instability, its contradictions, its past and potential developments, and challenges. One thing is certain, however: since 1980, the field of patents on living organisms has expanded and deepened considerably. It now covers all living organisms, including the human species (see p.16). Subject […] [chapo] => This issue shows the complexity of intellectual property on plants and the take over of the agrochemical industry on vital biological processes, raising ethical, economic and philosophical concerns. Patents on GMOs/NGTs (New Genomic Techniques) threaten farmers and impact humanity’s food supply, accentuating expropriation, the risks of biopiracy and threats to global food sovereignty. [texte] => The various articles have highlighted the complexity of intellectual property on plants, its instability, its contradictions, its past and potential developments, and challenges. One thing is certain, however: since 1980, the field of patents on living organisms has expanded and deepened considerably. It now covers all living organisms, including the human species (see p.16). Subject to this competition, plant variety rights, which were originally a little more flexible, are also becoming stricter (see p.4-5). The consequences of this fundamental trend are manifold, and potentially very dangerous. They are expressed and intertwined in different dimensions: philosophical, scientific, institutional, geopolitical, economic...1A reductionist perspective on lifeA property right, whether intellectual or not, requires first and foremost the object to which the property relates must be clearly defined, its form specified and its nature determined. Without these requirements, legal disputes pile up, as shown by the example of the patent war over Crispr/Cas (see p.6). Plant varieties and animal breeds, and more generally all living organisms, do not possess these characteristics spontaneously, quite the contrary. In the case of plants, the varieties that make up a species form a continuum. By selecting a variety, the breeder arbitrarily sets a boundary between one variety and another. What's more, in nature, plants are constantly evolving, as Lamarck and Darwin analysed in a slightly different way almost two centuries ago. So for the breeder, they need to be determined and prevented from evolving. These two characteristics make modern cultivated plant varieties eminently artificial objects. They have been sought since the beginning of the 20th century to meet the requirements of an increasingly industrial agriculture, and are codified in law, in particular by the DUS criteria (see p. 3 and p. 4-5).To carry out DUS tests, the various phenotypic traits of a variety have been observed, precisely defined and measured, to make them comparable and decide what distinguishes one variety from another. With this vision, a plant is no longer an organic whole but a discontinuous catalogue of traits, a representation of nature cut into small pieces. The advent of molecular biology and genetics in the 1960s and 1970s, followed by their spectacular and exponential development since the 1970s, has provided powerful technical tools to facilitate this work of identifying and measuring, no longer the ‘variety’, but a few genetic traits that may be found in many plants of many varieties. The underlying scientific theory, however, is highly reductionist. The living organism is reduced to a ‘code’, a set of genes viewed in linear terms (in DNA). The multiple interactions between genes are generally ignored, as are the interactions between the organism's genome and its environment (epigenetics). Scientists are only just beginning to admit this complexity, which makes it difficult to predict the traits and behaviour of an organism that has been genetically modified. Hence the dangers associated with these manipulations: contrary to what is said, not everything is ‘under control’.From a more philosophical point of view, this perspective leads us to consider nature in a mechanical way, in an engineering vision where everything can be tinkered with. As Erwin Chargaff, the great biologist involved in understanding the structure of the DNA molecule, wrote, ‘the idea that science is an experimental station for new natural phenomena or a repair shop for old ones that no longer work very well has had strange consequences. It has led to too much emphasis being placed on mechanical aspects [...]"2. The proponents of this Western reductionist vision are in an overhanging position with regard to nature, ‘as master and possessor’, as Descartes already said. As a result, they are unable to establish respectful and harmonious relations with nature. The ecological emergency calls for a fundamental review of this position.Appropriation and expropriationAppropriation is the twin of expropriation. The extension and examination of intellectual property rights over plants give rise to several types of expropriation.The rights of farmers vary in the opposite direction to those of large seed companies. As the latter increase, the former decrease. Since the beginnings of agriculture, twelve thousand years ago, farmers have been selecting their own seeds, adapting them to local soil and climate conditions, giving us a collective heritage of millions of cultivated varieties, patiently built up . Patented seeds do not have the right to be resown, nor do most of those under PVC, with the exception of a few species that can be resown subject to payment of royalties. More fundamentally, the standards that support industrial agriculture (in particular the DUS criteria) exclude farmers from the very selection of their seeds. All the knowledge and know-how accumulated over thousands of years are disappearing, and farmers are therefore expropriated from them.The DSIs extend and deepen this process of expropriation by allowing the unrestricted circulation of sequential digital information, without recognising the rights or fair compensation of the farmers and indigenous populations who have identified and selected the plants they have used for millennia in their agriculture and medicines. These populations are therefore also being expropriated from their plants and the knowledge associated with them. As a result, the digitisation of genetic sequences makes biopiracy much easier (see p.14-15). The law on this subject is a source of major conflict, but the false promises made by the countries of the North give a glimpse of the scale of the expropriation that is looming.GMO/NGT plants come under patents, which are overwhelmingly held by the agrochemical oligopoly, the Big Four seed companies (see p.7-8). The debate on the patentability of NGTs is not over (see p.9-10), but if patents on products are banned, as the European Commission would like, patents on breeding processes will remain authorised, thus rendering the so-called ban on patentability meaningless. Even if GMO/NGT plants are not yet at the stage of commercial development, it is possible that they will spread throughout the world, particularly on the American continent, in the Anglo-Saxon countries and in China. This will also be the case in Europe if the deregulation proposal is ratified. The agrochemical oligopoly will thus be able to appropriate an increasingly large share of seeds, the basis of the food chain. They are the ones who will decide what the world's population will eat, or not. In this it is the whole of humanity that is potentially expropriated from the right to choose what food to produce and consume.Patents cover products and processes, but also restrict the use of the knowledge that made possible their development, such as genetic sequences. This goes against the model of open science that developed in the 20th century, and imprisons researchers and expropriates them from a part of their freedom. In certain fields, such as NGT or geo-engineering, this may not be a bad thing...Last but not least, as ‘life sciences’ research gets more and more involved in biological processes, what is patented comes to concern processes at the basis of life on Earth, such as the contribution of a given genetic sequence to photosynthesis and the fixation of atmospheric nitrogen in leguminous plants. There are not enough words to describe the scale and seriousness of such an expropriation...1The following has been developed at length in Hélène Tordjman, La croissance verte contre la nature. Critique de l'écologie marchande, Éditions la Découverte, Paris, 2021.2Erwin Chargaff, Heraclitean Fire: Sketches from a Life Before Nature, Rockefeller University Press, 1978. Hélène Tordjman (Economist, Senior Lecturer at Sorbonne Paris-Nord University) [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [223] => Array ( [objectID] => 4144 [title] => Biodiversity withstanding agriculture [timestamp] => 1692144000 [date] => 16/08/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/biodiversity-withstanding-agriculture/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Almost seven years have passed since the publication of our issue « Saving cultivated biodiversity » (No. 141, October 2016). Since then, the degradation of biodiversity, i.e. the entire diversity of living organisms, has accelerated, as evidenced by recent reports from the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (better known by its acronym IPBES), […] [chapo] => [texte] => Almost seven years have passed since the publication of our issue « Saving cultivated biodiversity » (No. 141, October 2016). Since then, the degradation of biodiversity, i.e. the entire diversity of living organisms, has accelerated, as evidenced by recent reports from the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (better known by its acronym IPBES), which refer to the 6th extinction of species [1]. One of the causes of this collapse lies in intensive agriculture, which uses numerous inputs (fertilisers, synthetic pesticides, etc.) and harmful farming practices (deep tillage, monocultures, etc.), destroying the soil. However, in addition to its function as a support, the soil nourishes plants and a living soil is one of the conditions for sustainable agriculture. Another condition is the availability of a reservoir of varied biological resources, particularly so that crops and livestock can adapt to climate change. This diagnosis of the causes of the extinction of species is now generally shared, and reducing inputs is one of the objectives for saving biodiversity. But solutions differ. Broadly speaking, there are two visions of the world : accelerating the artificialisation of living things by relying on the triptych « genetics, robotics and digital technology », or working in liaison with eco-socio-systems by developing a peasant agro-ecology [2].The first part of this issue looks at the international legislative framework, with the Convention on Biodiversity and the Seeds Treaty (Tirpaa, see p.8-9). European and French examples are also discussed [3]. The role of intellectual property in the decline of biodiversity is also described [4].The second part is devoted to testimonies from farmers organised within La Via Campesina and the Réseau Semences Paysannes (Farmers’ Seeds Network) [5]. Their aim is to create a more favourable legislative framework to save this biodiversity, in particular through the Declaration on the Rights of Peasants [6]. The fight against the appropriation of cultivated biodiversity by agro-industrial and biotechnology giants also plays a large part in these farmers’ struggles, so that they can develop their own seed systems [7]. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [224] => Array ( [objectID] => 4145 [title] => Industrial agriculture kills biodiversity [timestamp] => 1692144000 [date] => 16/08/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/industrial-agriculture-kills-biodiversity/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => The collapse of biodiversity (both wild and cultivated) is essentially due to human activities. Among these, industrial agriculture, with its range of fertilisers, pesticides and other harmful practices, plays a key role. The collapse of biodiversity was once again highlighted at the Conference of the Parties (COP 15) at the Convention on Biological […] [chapo] => [texte] => The collapse of biodiversity (both wild and cultivated) is essentially due to human activities. Among these, industrial agriculture, with its range of fertilisers, pesticides and other harmful practices, plays a key role. The collapse of biodiversity was once again highlighted at the Conference of the Parties (COP 15) at the Convention on Biological Diversity (CBD) in Montreal in December 2022 [1] : the sixth mass extinction is underway [2], with one million living animal and plant species threatened (out of eight million - 75% of which are insects [3] [4]. Some categories are more affected than others (40% of amphibian species could disappear over the course of the century), but overall, the destruction of ecosystems by humans has been increasing over the last two centuries : down at least 40% for terrestrial species, 84% for freshwater species and 35% for marine species, not counting bacteria, which are essential to all life in the soil.Another meaningful figure : 10,000 years ago, the biomass of terrestrial vertebrates consisted of 99% wild animals. Today, it is essentially made up of domestic animals (67%) and humans (32%) (see diagram).Drawing based on article by Smil, V. (2011), « Harvesting the Biosphere : The Human Impact », Population and Development Review, 37 : 613-636.To eat, dress themselves, shelter, heat - in short, to live - humans have domesticated and exploited biodiversity. But in a few thousand years, this use has gone from simply taking things from the natural environment (hunting, small-scale fishing, gathering) to over-exploitation over the last century or so (industrial agriculture and fishing, cutting down entire forests, artificialising the soil, etc.), leading to extinction. This over-exploitation is itself due to exponential demographic growth and an ever-increasing desire for comfort.Destruction on all levelsBiodiversity is declining at every level of the planet, in the soil, on land and in the sea. Soil accounts for more than a quarter of the planet’s biodiversity. According to the IPBES, the primary cause of soil destruction is changes in land use, particularly as a result of urbanisation. For example, in mainland France, 60,000 hectares of agricultural, forest or natural land are artificialised every year, equivalent to the average surface area of one “département” every 10 years [5]. But these agricultural soils are themselves already heavily degraded by industrial agriculture, an agriculture that requires very high levels of capital investment (agricultural equipment, robotics, etc.) and fossil energy (in particular to get this equipment work, but also to produce fertilisers and pesticides, etc.). The aim is to obtain maximum yields in the short term : to produce more with less land, fewer farmers... but therefore more capital. Let’s look at a few examples of why this type of agriculture is destroying biodiversity.The development of agriculture involves a certain degree of soil artificialisation. The trend in industrial agriculture is to produce as much food as possible with as few peasants as possible (who have become known in everyday language as "farm operators") [6]. For example, between 1970 and 2020, France lost 1,200,000 farms (400,000 remained in 2020), from an average surface area of 20 hectares to 69 hectares [7].This "feat" was only made possible by, among other things, capital intensification, which is still ongoing (more mechanisation, more inputs, etc.) [8], the homogenisation of crops and the specialisation of livestock farming [9]. The same trend can be seen worldwide, although there are of course major disparities : farms of several thousand hectares in Argentina, Brazil or the United States have nothing in common with subsistence farms, particularly in the countries of the South. Of the 608 million farms in the world, 84% are smaller than 2 hectares, while 1% of farms cultivate 70% of the world’s agricultural land ("Which farms feed the world and has farmland become more concentrated ?", World development Vol. 142, June 2021).In these conditions of gigantism and the race for yields, agricultural soils, which are expanding at the expense of natural areas and represent more than a third of the world’s land [10], are being degraded, both by cultivation practices (use of farm machinery, etc.) and by the pesticides and fertilisers spread. The result is soil destruction and erosion, sometimes salinisation (nearly 9% of the world’s soils are affected by salinisation [11], as well as pollution that kills soil life. Without this life (bacteria, micro-organisms, etc.), the organic matter can no longer be transformed and fertility declines : for example, the level of organic carbon in the upper layers of the soil after 30 to 70 years of cultivation has fallen by 25% to 50% in temperate countries, which is a major cause of the greenhouse effect (which itself reduces the diversity of living organisms).Less and less diverse crops and livestockIn addition to wild biodiversity, cultivated plants and farm animals are also suffering from genetic erosion on two levels. Firstly, the number of cultivated species is declining : out of 6,000 food plant species, fewer than 200 make a significant contribution to global food production, and just nine of these account for 66% of total agricultural production [12]Global livestock production is based on around 40 animal species, of which only a few provide the vast majority of meat, milk and eggs. And 26% of the world’s livestock breeds are threatened with extinction.Secondly, intra-varietal genetic diversity is itself decreasing, which means that two individuals of the same variety are genetically very close, almost like clones [13]. This is due to the legal requirement in many countries that individuals of the same variety must reproduce identically in order to be marketed (and protected by intellectual property rights in the process [14]). This genetic homogenisation of individuals of a variety leads to adaptive fragility, both to biotic stresses (caused by living organisms) and climatic stresses, hence the vicious circle of pesticide use... and the continuing destruction of biodiversity ! In the official discourse, it is to break this vicious circle that researchers - and agro-seed and agrochemical companies - have genetically modified crops (and are beginning to do so for animals). The basic idea was to create plants that would protect themselves from all external aggressions, thanks to resistance genes, so as to be free from pesticides. With certain new modified varieties, some agri-seed companies are claiming an increase in biodiversity ! In practice, this is far from being the case : the GMO varieties created are mainly herbicide-tolerant, so that they can be spread without destroying the crop ; and they produce toxins to kill aggressors, such as Bt maize against the European corn borer. What’s more, they are patented, further privatising living things. We could do without such an "increase" in biodiversity !Wildlife also affectedA recent collective scientific assessment by INRAE (published in March 2023) on the impact of pesticides on biodiversity showed the extent of contamination in "all types of terrestrial and aquatic environments, all the compartments of which they are composed and most of the organisms found there" [15]. Among other things, this leads to a decline in populations of terrestrial and aquatic invertebrates and birds.One of the increasingly visible consequences is the decline in pollination by insects (bees, bumblebees, ants, butterflies or flies, etc.), leading to production losses. According to the IPBES, around 70-75% of cultivated plants (mainly fruit trees, vegetables, oilseeds and protein crops) depend on entomophilic pollination (by insects), representing 35% of the tonnage of the world’s agricultural production [16] Not to mention the fact that some plant species are strictly pollinated by a given insect species.Capitalism : the enemy of biodiversity !What is the common factor behind all this destruction and the failure to implement solutions ? Our arrogance in our desire to dominate nature, our feeling of being superior to it rather than a stakeholder. But also, and above all, the pursuit of short-term profit, defended by corporate lobbies, unfortunately often relayed by politicians. There are many examples of this in industrial agriculture, fishing and forestry. For example, the European Union has banned the use of neonicotinoids, bee-killing pesticides. Yet for several years, France authorised their use on certain crops (including beetroot, see p.10-11) [17]. Also in France, the Agence nationale de sécurité sanitaire (Anses) announced in February 2023 that it wanted to ban the herbicide S-metolachlor, whose residues are present in groundwater at levels well above European standards. However, the French Minister for of Agriculture, Marc Fesneau, asked the ANSES, at the congress of the majority farmers’union (FNSEA), to reconsider its position [18] [19] ! The same FNSEA is blocking any prospect of solutions to reduce nitrate levels in water [20], despite a "reasoned opinion" from the European Commission to France in February 2023 [21].Other examples : almost a third of fish stocks are overexploited and more than half have reached their endurance limit [22] The European Union proposes to ban deep-water trawling by 2030. The Secretary of State for the Sea, Hervé Berville, responded in March 2023 : "I say very clearly that France - the government - is totally opposed to implementing a ban on bottom trawling in marine protected areas. Totally, clearly and firmly" [23]. Finally, in terms of forestry, France wants to "build two biomass power stations by 2024-2025 to supply energy to the European Space Agency [...] on the north coast of French Guiana" [24], to produce 120,000 tonnes of biomass (5,300 hectares of forest would be destroyed), and this despite the stated need to protect tropical forests, reiterated by French President E. Macron at the One forest Summit in March 2023 [25] !The picture of the damaging effects of industrial agriculture on biodiversity is bleak. Industrial agriculture kills life, including farmers, who are poisoned by pesticides or commit suicide. The real economic losses associated with the collapse of biodiversity are often highlighted. But some of the ’green’ solutions suggested by multinationals are often used as an alibi for the same companies to continue exploiting the planet and reaping huge profits. This leaves behind the poorest populations, which, as the IPBES has shown, are those most dependent on biodiversity for their survival [26]. In agriculture, the only sustainable solutions are those that promote farmers’ autonomy, thanks to agroecology and farmers’ seeds [27] [28]. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [225] => Array ( [objectID] => 4146 [title] => Intellectual property rights are detrimental to biodiversity [timestamp] => 1692144000 [date] => 16/08/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/intellectual-property-rights-are-detrimental-to-biodiversity/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Patents and plant breeders’ rights (PBR) are two types of intellectual property right. Both have a major impact on both cultivated and wild biodiversity. Certain intellectual property rights (IPRs) affect cultivated biodiversity, agriculture, but also wild biodiversity, which provides genetic resources [1] such as stevia or the neem tree [2]. These are patents and, for plant crops, […] [chapo] => [texte] => Patents and plant breeders’ rights (PBR) are two types of intellectual property right. Both have a major impact on both cultivated and wild biodiversity. Certain intellectual property rights (IPRs) affect cultivated biodiversity, agriculture, but also wild biodiversity, which provides genetic resources [1] such as stevia or the neem tree [2]. These are patents and, for plant crops, plant breeders’ rights (PBR)). The latter is linked to another tool, distinct from IPRs, the “official catalogue of varieties” [3].Legislative frameworks with their own logicIn Europe, patents are granted by the European Patent Office (EPO). The patentability of biotechnological inventions, including plants and animals, is defined by Rule 27 of the European Patent Convention. In particular, "biological material isolated from its natural environment or produced by means of a technical process, even if it existed in a natural state" is patentable. For example, the EPO guidelines state that "a gene which is discovered to exist in its natural state may be patentable if a technical effect is disclosed, for example its use in the manufacture of a certain polypeptide or in gene therapy". However, decision G 3/19 of the EPO’s Enlarged Board of Appeal in May 2020 excluded from patentability processes that are "essentially biological", for example if they consist entirely of biological material. - for example if they consist entirely of natural phenomena such as crossing or selection - and products obtained by such processes [4]. Even if this remains somewhat theoretical [5].A plant can also be protected as a variety by a PBR provided that it meets the criteria of distinctness, uniformity and stability (DUS) examined by authorised bodies. While a patent relates to a characteristic linked to the plant’s genotype, i.e. genetic characteristics, a PVC has until now covered a set of phenotypic characteristics, i.e. the external appearance and measurable behaviour of the entire plant. Patents and PBR are therefore different and cumulative [6]. However, it is likely that PBR criteria will soon be called upon to integrate or replace the description of a set of phenotypic characteristics with a description of a set of genetic characteristics. With the help of molecular markers, breeders would be able to trace protected varieties more effectively and strengthen the control of farmers by seed companies.The official catalogues of varieties impose the same DUS criteria as the PBR, which ensures a de facto monopoly for varieties that can be protected by a PBR. This "standard" DUS only concerns industrial varieties and is incompatible with farmers’ seeds, which are by nature diverse and variable. A European regulation [7], which came into force on 1er January 2022, created the concept of biological heterogeneous material (BHM) to authorise the marketing of less homogeneous seed [8].Intellectual property rights undermine biodiversity...The official catalogue of varieties, PBR and patents have an impact on biodiversity. Patents obtained on products created by certain new genetic modification techniques exacerbate this impact. A study commissioned by the European Commission from the ICF consulting firm in 2021 [9] concludes : "Their development has a likely impact on plant biodiversity [...]. Paradoxically, the intensification of plant breeding activity can reduce biodiversity, and therefore resilience. The genetic diversity of plants is threatened by the loss of local varieties [which have adapted over time to their ecological and cultural environment] and the dominance of genetically uniform modern varieties in many agricultural production systems".The catalogue restricts biodiversity by prohibiting the marketing and, in many countries, the exchange of non-homogeneous and unstable farmers’ seeds. The system of the International Union for the Protection of New Varieties of Plants (UPOV) also restricts biodiversity [10]. Imposed on States through bilateral agreements, it prohibits farmers from saving, exchanging or modifying the seeds of protected varieties, even though they are historically the originators. What’s more, there is nothing to prevent a breeder from homogenising and stabilising farmers’ seed populations and then appropriating them via a PVC. The pre-eminence of such an agricultural development model, currently limited to 78 countries (out of 198), would inevitably lead to an impoverishment of cultivated genetic diversity and weaken global food security.Today, the major agro-industrial firms have large patent portfolios [11]. They may cover traits expressed by plant varieties resulting from conventional crossing-selection processes, traits native to plant species present in nature, or even in several different varieties. The appropriation of these traits can restrict the development of cultivated biodiversity, particularly that which produces food [12]....and penalise its protectorsBiopiracy" is the abusive use of biodiversity and associated traditional indigenous knowledge, particularly by companies in "northern" countries (Europe, North America, Japan, Australia, New Zealand and China). Today, it can do without access to physical genetic resources from ’the South’ and directly exploit the large amount of digital sequence information (DSI) available and generated from such resources. It is generally accepted that this term encompasses nucleic acid sequence data, but also other types of data derived from or linked to dematerialised genetic resources, including, for example, protein sequence data. The industry’s Information Technology resources enable it to apply for patents on the basis of this dematerialised information and move from a model of inventions made in vitro to one of inventions made in silico. When questioned by Inf’OGM in September 2022, the EPO stated that "the use of DSIs has no influence on the patent, and we cannot oppose the granting of patents on this ground". The EPO claims to base itself on European Directive 98/44, which contains a recital on the origin of resources and the obligation to declare their origin. This obligation is easily circumvented by the countries "of the North", which claim that an DSI is not a genetic resource, but a product of research, which renders totally futile the few "databases of traditional knowledge" intended to "identify the origin of plants or substances" [13] .This DSI issue would nullify de facto the obligation of prior consent [14] and would put the multilateral benefit-sharing system (Nagoya Protocol) to the test with a vague promise to create a global fund arising from the use of these DSI, as decided in December 2022 at the biodiversity COP15 [15]. But will this financial compensation prevent, in the long term, the possible siphoning of genetic resources from the "South" by the "North" and the granting of patents prohibiting the original holders of such resources from continuing to use them ?Patents can also restrict cultivated biodiversity. A single gene or mutated sequence can limit access to the entire biodiversity comprising the patented element. While the European PVC system authorises the use of the protected variety to breed another one and prohibits the resowing of the harvested grain (or, for 34 species, requires the payment of royalties to resow it), the patent system remains totally exclusive. Breeders who would need to use a variety with a patented element to create new varieties would be prevented from doing so without the authorisation of the patent holder. What’s more, while a variety is generally only protected by a single plant breeder’s right, it may be protected by several patents. It should be noted that, in the European Union, a variety as such cannot be patented. However, its genes can, which means that a variety can be protected by several patents.These instruments for appropriating biodiversity operate at different levels of the living world : from the organism, whether plant or animal (excluding the human body and its components in their natural environment (European Directive 98/44, Articles 5 and 6)), through nucleotide sequences that make up its genome. Are political and institutional leaders really aware that this ’funnel’ privatisation also reduces biodiversity ? Inf'ogm [Type article] => actualité [Enjeux] => Array ( [0] => Environnement ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( [0] => Biodiversité cultivée [1] => Brevets ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [226] => Array ( [objectID] => 4101 [title] => GMOs : when mammoths are Trojan horses [timestamp] => 1679443200 [date] => 22/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/gmos-when-mammoths-are-trojan-horses/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => The rampant industrialisation of our environment over the past century has led to the disappearance of many living species. This sixth mass extinction is the first one specifically attributed to human action. In the face of this observation, several political and scientific approaches have been proposed, which do not tackle the causes but try […] [chapo] => [texte] => The rampant industrialisation of our environment over the past century has led to the disappearance of many living species. This sixth mass extinction is the first one specifically attributed to human action. In the face of this observation, several political and scientific approaches have been proposed, which do not tackle the causes but try to repair the damage, such as « de-extinction ». The demiurgic idea of reviving extinct species is not new. As early as the 1920s, biologists tried to revive the aurochs, the ancestor of our bovine cattle, by crossing domestic "rustic" breeds. More recently, cloning has been attempted. A Pyrenean ibex was born (the last specimen of which disappeared in 2000) [1], which survived for only a few minutes [2] The new strategy involves genetic modification and synthetic biology. The most popular project is the resurrection of the woolly mammoth by the company Colossal Biosciences.From a technical and ethical point of view, this project raises many questions. But above all, as Teri Herridge, a biologist and researcher, in particular at the Natural History Museum in London, points out to Inf’OGM, "it is not about « de-extinction » of the woolly mammoth. It’s about creating a chimeric species from the gene pool of the Asian elephant and the woolly mammoth. If Asian elephant stem cells are used, there will also be Asian elephant mitochondria. And if African elephant mothers are used for gestation, African elephant epigenetics will also play a role" [3]. All the biological phenomena other than those concerning genomes or epigenomes that make up life at all its scales are forgotten . Colossal Biosciences is also interested in the Tasmanian tiger. This marsupial wolf was heavily hunted by the Europeans after the colonisation of the island of Tasmania, and the last of them died in Hobart Zoo, Tasmania, 86 years ago.Reviving or preventing species extinctions ?Colossal Biosciences argues that the method currently being developed for the woolly mammoth could be applied to other endangered species today, to help prevent their extinction. But the scientists involved in the fight against species extinction fear that funding such high-profile operations will undermine more traditional conservation efforts. They argue that with the same amount of money, traditional efforts could save up to eight times as many species.The current work on the woolly mammoth or the Tasmanian tiger may also hide less laudable interests. For example, the CIA, through its venture capital company In-Q-Tel, has decided to invest heavily in the company Colossal Biosciences. On 20 September 2022, two In-Q-Tel officials stated : "From a strategic point of view, it’s less about mammoths than it is about capabilities" [4]. The mammoth is therefore just a Trojan horse to facilitate social acceptance, claim the idea that biotechnology can do anything, and reap dividends to advance research that will be used for other purposes, such as agriculture, bioweapons, transhumanism, etc. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [227] => Array ( [objectID] => 4102 [title] => Are precision cattle farming and animal welfare can be reconcilable ? [timestamp] => 1679443200 [date] => 22/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/are-precision-cattle-farming-and-animal-welfare-can-be-reconcilable/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Precision agriculture, the new avatar of agribusiness, invests in robotics, digital technology and genetics [1]. This technological overkill is presented as a solution to many of the failures of industrial agriculture. In the livestock sector, will it allow, as it is often put forward, to improve the living conditions of animals ? hors note that the effectiveness […] [chapo] => [texte] => Precision agriculture, the new avatar of agribusiness, invests in robotics, digital technology and genetics [1]. This technological overkill is presented as a solution to many of the failures of industrial agriculture. In the livestock sector, will it allow, as it is often put forward, to improve the living conditions of animals ? hors note that the effectiveness of these systems also depends on the trust that the farmer places in them, which is paradoxical. They point out, for example, that only 21% of disease alerts would be successful in prompting dairy farmers to visually check the cow [2]. If the farmer can « save time » with Precision Livestock Farming (PLF), he might not be getting closer to his animals. The authors underline that this can change the human-animal relationship quite fundamentally, reducing the farmer’s knowledge of the individuals in the herd, and his ability to detect problems and abnormalities.If these systems become widespread, farmers may, over time, recruit people with technological backgrounds at the expense of those with veterinary knowledge. The authors also point out that the farms that are most favourable to animal welfare (small scale, extensiveness, etc.) are also those least adapted to these technological tools.Precision breeding can also encourage intensification, in particular to reduce the cost per animal. Indeed, it has been observed that herd size is a major determinant of the adoption of these new tools. However, when a relationship is established between herd density or size and animal welfare, it is often negative. In particular, it has been reported that mortality [3] and the prevalence of infectious diseases [4] generally increase with herd size.A springboard to speciesism and instrumentalisation ?Applying precision breeding to a selected number of species would be tantamount to assigning them a special moral status. The risk exists, especially as implementation may be easier for some species (dairy cattle) than others (chickens, fish, rabbits). Making such differences between animal species could lead to speciesism.The facilitation of the intensive systems mentioned above may also degrade their image in society. Animals raised and kept in this way would then be perceived more as exploitable commodities for human interests than as animals with a personality in their own right.Precision breeding systems are focused on increasing production efficiency, to limit costs and feed the world’s population more easily. However, this is far from being true, as the issue of world hunger is not strictly agricultural and agronomic, but firmly political. The first cause of hunger is still wars and other extreme political situations ; the second is waste. Precision breeding systems do not change breeding practices and their negative impact on the environment, such as diverse pollutions or excessive water consumption. By bounce-back effect, won’t these systems then tend to accentuate such impacts ?Another recent article concludes : « no, improving animal welfare in intensive systems is not possible », as these systems aim at « maximum productivity per unit area », exactly the same goal as precision breeding and genetic modification. The authors further argue that « reducing farm size is necessary to create animal welfare- friendly systems » : « if these systems have to be viable, the level of specialisation of farms and animals must be reduced », and « reducing this specialisation implies the use of genetically different animals, less productive, but more resistant and better able to use low-quality feeds » [5]. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [228] => Array ( [objectID] => 4103 [title] => GMOs : a further step in the loss of autonomy for farmers [timestamp] => 1679443200 [date] => 22/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/gmos-a-further-step-in-the-loss-of-autonomy-for-farmers/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => For several decades we have been witnessing a drastic reduction in the autonomy of farmers, who have become mere labourers. Farmers may soon have to deal with the arrival of GMO animals, which will certainly reinforce this phenomenon. The stranglehold of a few companies on the animal production chain has become the norm, at least […] [chapo] => [texte] => For several decades we have been witnessing a drastic reduction in the autonomy of farmers, who have become mere labourers. Farmers may soon have to deal with the arrival of GMO animals, which will certainly reinforce this phenomenon. The stranglehold of a few companies on the animal production chain has become the norm, at least in the OECD (Organisation for Economic Co-operation and Development) countries. The Encyclopedia Universalis points out : "In the United States [and Europe], it is increasingly common for a single agribusiness to control both upstream (feed production), livestock operations, and downstream (slaughter, cutting, and marketing of animals). The battery-farm breeder is thus placed in a situation of dependence on private companies or cooperatives [...] with which he has signed contracts and for which he has become a sort of contract worker" [1].This loss of autonomy will be accentuated with genetically modified animals. They go hand in hand with patents and a particular legal, social, technical and economic context. Biotechnology involves a high degree of techno-economic and capital concentration, which has never been seen before. One of the consequences of patents is the accentuation of the separation of two functions, production and reproduction, which were previously closely linked in the work of the peasant. This separation had certainly begun with elite breeding farms and insemination centres. Patents legally impose this duality, which contributes to the loss of meaning in the work of breeders.GMOs and patents thus prevent farmers from adapting their herds to local conditions and their evolution through appropriate farmer selection. The long tradition of on-farm selection and exchange between breeders has become increasingly difficult, if not impossible for certain species such as poultry. This also creates a monopolistic situation for a few companies on genetic resources.Patents accentuate the erosion of traditional knowledgeThis monopoly is one of the main factors in the reduction of cultivated biodiversity. Thus, the IAASTD (International Assessment of Agricultural Science and Technology for Development) [2] [3], an intergovernmental and interdisciplinary panel of experts, a sort of IPCC (Intergovernmental Panel on Climate Change) for agriculture, wrote in 2009 : "instruments such as patents may increase costs and reduce experimentation by farmers or public sector researchers, while at the same time risking discouraging local practices that improve food security and economic viability". Patents, they insist, lead to an erosion of traditional knowledge and farmer innovation, threatening the balance of communities.The other side of this privatisation is the accentuation of the homogeneity of the "breeds" [4] around the descendants of an ever smaller number of individuals [5]. This implies a greater fragility of the breedings, more sensitive to changes and diseases [6]. Resilience and adaptability, on the other hand, require a high degree of genetic and epigenetic diversity, which existed in the many local animal ’breeds’. However, this uniformity is criticized by both researchers and farmers, such as Guy Kastler. He points out that "no two « terroirs » are identical, so local adaptation is essential. But if, locally, everyone is the same and a new pathogen arrives, if one individual is sensitive to it, then all individuals will be equally sensitive to it, so everyone will be affected and there will be nothing left. Whereas if there is diversity, some individuals will be susceptible, others not. The latter will guarantee the harvest and a future seed resistant to the pathogen, which is called resilience..." [7]. One can of course transpose this discourse to animals. G. Kastler thus clearly contrasts genetic selection, decided from above, which allows the creation of homogeneous but fragile elite breeds, with the coevolution allowed by peasant systems. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [229] => Array ( [objectID] => 4104 [title] => GMOs : making animals sick to hope to cure us [timestamp] => 1679443200 [date] => 22/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/gmos-making-animals-sick-to-hope-to-cure-us/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => In 2019, in France, 1,865,403 animals were used for experimental purposes [1]. This number of animals was fairly stable between 2015 (414,164 of which 89,708 with a damaging phenotype) and 2017 (428,606 of which 53,076 with a damaging phenotype), but a peak was observed in 2018 : 484,463 animals of which 56,412 with a damaging phenotype ; of […] [chapo] => [texte] => In 2019, in France, 1,865,403 animals were used for experimental purposes [1]. This number of animals was fairly stable between 2015 (414,164 of which 89,708 with a damaging phenotype) and 2017 (428,606 of which 53,076 with a damaging phenotype), but a peak was observed in 2018 : 484,463 animals of which 56,412 with a damaging phenotype ; of these, 61,357 carry a phenotype that is damaging for the animal. This subgroup includes mainly mice, rats and zebrafish, but also 45 dogs (in particular from dog lines carrying a gene that induces a form of myopathy, on which treatment options are being tested). In the European Union, in 2019, 2.66 million uses of AGMs were registered, 17% of which had a damaging phenotype [2]. There are few truly significant « animal models » for human disease, but it is considered that it is sufficient for the animal to develop some features of the disease to improve knowledge of the pathophysiology. The techniques used developed in the 1980s. They may involve insertion, inactivation or mutation of genes, via additive or subtractive transgenesis techniques. The advent of new genetic modification techniques (such as that using CRISPR/Cas9) has led to the development of Clustered Regularly Interspaced Short Palindromic Repeats, known as CRISPR, which are families of repeated sequences in DNA. The CRISPR/Cas9 system is used as a molecular scissors to introduce local modifications to the genome of many organisms]) has further facilitated and multiplied these manipulations. The objectives of these experiments are primarily fundamental or applied research, covering a very broad spectrum of diseases.To these data, we must add the animals killed on farms without having been included in experiments [3] : animals produced, bred and killed from the creation of a new genetically modified line but not showing the desired characteristics : 61 205 ; animals bred and killed during the maintenance of a genetically modified line (supernumerary, sick...) : 609,996.The result is that, in total, this activity leads to the killing of around 1.1 million animals each year, more than half of which are « for nothing » ; it is far from respecting the animal, « sensitive creature », according to the terms of the 2010 European directive on the use of animals for scientific purposes.In China and Japan, these genome modifications also concern non-human primates. The aim is to create lines of animals carrying a pathogenic gene in order to have an animal model that is physiologically, anatomically and genetically similar to us, with certain characteristics of a human disease, usually a neurological disease, which monkeys do not develop spontaneously. To save time, researchers are also using the cloning method. For example, in June 2019, a gene involved in autism (SHANK3), which has already led to many mice having difficult social behaviours (without having made much progress on the subject), was introduced into the genome of macaques [4]. They showed sleep and motor disorders and increased repetitive behaviour, as well as social and learning disorders.These experiments were seen as both technical feats and dangerous experiments in terms of their ethical consequences. Some people are concerned that Europe is lagging behind China, which is less cautious about the conduct of animal experiments, although it is not certain that « the lead » is real [5]. An article weighed up the burden of neurodegenerative diseases, the promise of these genetic technologies in primates and the ethical questions raised by organizations in Europe and the United States [6]. But this article forgets to discuss the possibilities of alternative methodologies (organs on a chip, computer simulation, etc.) because the animal model with an invasive act is so deeply rooted in people’s minds. As a result the conclusion is that Western countries risk losing ground to China and Japan in terms of knowledge production.Users recognise that there is an ethical problem, but it seems that raising the issue is enough to eliminate it, conveniently, in a fine exercise in cognitive dissonance.Some procedures go further by manipulating embryos or pluripotent stem cells from different species to create chimeras, animals with different genetic heritages. One of the objectives is to better understand embryonic development. Another objective is the development of ’humanised’ organs in animals, which could then be transplanted into patients awaiting transplants. This represents the worst that can be imagined in terms of exploitation and reification of the animal. For example, human stem cells have been implanted into a sheep embryo, which is then has been reimplanted into the uterus of a sheep ; the portion of the genome that controls the formation of the pancreas has been previously deleted in the embryo, and human genes are supposed to take its place [7]. At this stage, the embryos are destroyed prematurely, but the authors promise that one day it will be possible to have human pancreases developed in sheep.The history of xenografts is a long history of failure [8]. In the recent period, genetically modified pig organs (kidney, heart) have been transplanted into primates [9]. And in January 2022, in the United States, a genetically modified pig heart [10] was transplanted into a heart failure patient, who survived for two months. The medical obstacles are still considerable if we want to avoid making the recipient completely immunocompromised, with the risk of developing infections transmitted by the animal tissue ; by the way, the graft of this American patient was precisely infected by a pig virus ! However, there are other research directions for producing tissues and organs that could possibly be transplanted to humans, in addition to the development of organ donation : bioprinting, artificial organs (heart, kidney, pancreas, etc.), with greater reliability and safety.In line with this work, some teams have created monkey-human chimeras from macaque embryos, Yet, the 2011 bioethics law stated that « the creation of transgenic or chimeric embryos is prohibited » [11]. But the revision of this law in 2021 lifts this ban, provided that it is animal embryos into which human stem cells are implanted, and not vice versa. At the beginning of 2021, without waiting, and without respecting the 2011 law, a team from Lyon published a study in which induced human pluripotent stem cells were inserted into macaque embryos [12]. The chimeric embryos lived for a few days, but the goal was to continue development for longer, until chimeric animals were born [13].In 2015, the NIH (National Institute of Health), in the United States, indicated that it would stop funding this type of studies before going back to ethical reflection [14]. This moratorium was partly lifted in 2016, with certain conditions, especially to avoid the brain of these new beings being contaminated by human cells. The debates on this topic are threefold : the impact on the well-being and interests of these living beings, the use of human embryonic materials, and safety (risk of zoonosis) [15].Researchers argue that they know the limits and will never, ever cross the red line represented by central nervous system chimeras. But we have seen above that Chinese teams are already « having fun » modifying genes involved in the functioning of the central nervous system in the macaque. The insertion of neurons from the human cortex into the brain of a mouse has also been tested. In fact, the red line has already been crossed. The risk is to get used to it and conclude that we can push back the ethical « constraint » even further. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [230] => Array ( [objectID] => 4105 [title] => GMOs : ambiguity of the animal breeding industry [timestamp] => 1679443200 [date] => 22/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/gmos-ambiguity-of-the-animal-breeding-industry/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => For some European animal breeding industries, new genetic modification techniques can contribute to a sustainable food system. But, they say, their use must be done with great care, so as not to jeopardise food safety and animal health and welfare. This precaution is coupled with a call for « a legal framework on imports to ensure […] [chapo] => [texte] => For some European animal breeding industries, new genetic modification techniques can contribute to a sustainable food system. But, they say, their use must be done with great care, so as not to jeopardise food safety and animal health and welfare. This precaution is coupled with a call for « a legal framework on imports to ensure transparency on the introduction of GM animals and products into Europe », a transparency already provided for in the current GMO regulation. Since 2020, the European Commission has been consulting on a possible proposal to deregulate GMOs obtained by "directed mutagenesis and cisgenesis" [1]. Among the actors in the GMO dossier who responded, there are some who have not been heard from publicly during the two decades of debate on transgenic GMOs, those actors are in the animal sector.No commercialisation "for the moment"Whether or not to use new genetic modification techniques is a different question for animals than for plants, according to an animal industry organisation. In 2021, in response to the consultation organised by the European Commission, the European Forum of Farm Animal Breeders (EFFAB), representing the animal breeding industries, explained that "some of EFFAB’s members are using this technology as a research tool, with, for the time being, no intention of commercialising any product" [2] It also stated that it had doubts about the acceptability of such genetically modified products by the public, surreptitiously adding that "they are legally GMOs".Furthermore, obtaining a new characteristic in an animal using a genetic modification method is difficult. As the EFFAB points out, "single gene traits are good targets [...] but many traits are polygenic". Beyond this complexity of having to modify several gene sequences for a new trait, companies using these techniques must also take into account unintended effects which, for their part, plant biotechnology promoters dismiss as "plant « suffering » is not taken into consideration whereas animal suffering is. Thus, "extensive scientific research must be conducted. The identification of long-term and off-target effects as well as residues in the genome [...] need to be further studied".Traceability and transparency demanded... and possibleThe industries represented by EFFAB want to be protected from imports of GM animals into Europe. At a seminar in March 2021 [3], the European organisation FABRE-TP (Farm Animal Breeding and Reproduction Technology Platform), also representing animal breeding industries, called for "a regulatory framework on imports to ensure transparency on the introduction of animals [genetically modified by new techniques] or their products into Europe. Otherwise, ’European producers and breeders will be unfairly put in competition with these [...] imported products’. These industries explain that they have the tools to ensure transparency and traceability. In 2021, EFFAB explained that companies and breeders’ organizations have ’a long experience in traceability of animal semen, pedigrees and performance records [...] All data are recorded in global / national / private databases’ [4]. Not to mention the need for transparency to ensure that the European industry is not left alone in the face of external competition. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [231] => Array ( [objectID] => 4106 [title] => GMO : animals authorised… without formalities [timestamp] => 1679443200 [date] => 22/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/gmo-animals-authorised-without-formalities/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Argentina and Japan have authorised three genetically modified fish using the Crispr/Cas9 molecular tool. For these two countries, these are not GMOs. In December 2018, in Argentina, a genetically modified (GM) tilapia produced by AquaBounty was exempted from the marketing authorisation requirement [1]. A victory for the same company, which had taken almost twenty years to […] [chapo] => [texte] => Argentina and Japan have authorised three genetically modified fish using the Crispr/Cas9 molecular tool. For these two countries, these are not GMOs.In December 2018, in Argentina, a genetically modified (GM) tilapia produced by AquaBounty was exempted from the marketing authorisation requirement [1]. A victory for the same company, which had taken almost twenty years to obtain permission to market a transgenic salmon. And a boon to circumvent international opposition to GM animals. In 2021, in Japan, a sea bream and a tiger puffer fish, genetically modified by Crispr/Cas9, were approved for marketing [2].Argentina and Japan decided that these GMOs were not GMOs because, in their view, they would not contain foreign DNA, unlike GMOs derived from transgenesis. These countries have adopted a new definition of GMOs, which allows GMOs to be limited to transgenic organisms only, without having fully verified the absence of foreign DNA [3]. These countries deliberately misread the definition of a GMO, which has never referred to the specific insertion of foreign DNA. In the Cartagena Protocol, a widely adopted international text (but not ratified by Argentina) [4], a GMO is defined as « any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology » [5] . In the same Protocol, « modern biotechnology » is defined as « the application of in vitro techniques to nucleic acids, including recombinant [DNA] and direct introduction of nucleic acids into cells or organelles ».Lazy legislations on new GMOsTo achieve this trick, Japan had to change its legislation. On October 1er, 2019, a decision went into effect that defines the minimalist framework for products obtained through « genome editing ». A term introduced by the companies and taken up by the authorities, to differentiate new GMOs from transgenic GMOs. The new Japanese procedure involves pre-consultation. The Health Policy Bureau for Novel Foods will decide, on the basis of a relatively light dossier drafted by the company, whether a simple marketing notification is sufficient or whether, on the contrary, a prior risk assessment is necessary due to the presence of foreign DNA. Japan does not provide for technical verification of the content. For example, if a company files a dossier claiming that no foreign DNA sequences are present in the genome, no verification by sequencing is foreseen. Yet recent news shows that such an absolute absence of foreign DNA is technically difficult, as seen with the Recombinetics bulls [6] . The situation in Argentina is broadly the same. And above all, no genetic modification technique is currently perfectly mastered. Many scientists have shown that these new genetic modifications have unintended and off-target changes that are far from trivial [7], such as the integration of pieces of DNA from the various reagents.In the EU, these fish require prior authorisation to be imported and marketed [8] [9], and must be labelled « GMO ». The regulatory gap could quickly become a major headache for customs.However, the European Commission has recently proposed to change the legislative framework for non-transgenic plant GMOs, so that they would no longer be subject to the current regulatory framework [10]. This initiative excludes animals and micro-organisms for the moment : until when ? Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [232] => Array ( [objectID] => 4092 [title] => GMO animals : the logical continuation of intensive farming [timestamp] => 1679356800 [date] => 21/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/gmo-animals-the-logical-continuation-of-intensive-farming/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => The current trend is for livestock farms to obey the « triptych » : digital, robotic, genetic technologies. This is in the name of innovation, profitability and, curiously, in the name of “animal welfare” [1]. Currently, very few GM animals are marketed and sales remain very low. As with plants, genetic engineering aims to accelerate the selection of certain […] [chapo] => [texte] => The current trend is for livestock farms to obey the « triptych » : digital, robotic, genetic technologies. This is in the name of innovation, profitability and, curiously, in the name of "animal welfare" [1].Currently, very few GM animals are marketed and sales remain very low. As with plants, genetic engineering aims to accelerate the selection of certain traits considered interesting by humans : it is a quantitative and qualitative leap in animal domestication. However, at the same time, for livestock, undesirable effects are accumulating. Indeed, sold as ethical improvements [2] or to produce more meat with fewer resources [3], these modifications are imposed to the detriment of animal welfare, its physical integrity, its health and the ancestral relationships it has with humans. Some authors from INRAE [4] believe that genetic modifications "renew [the ethical questions linked to the "use" [of animals for the benefit of humans] and exacerbate them" [5].The ethical question arises as well the question of reification of animals to the service of human health. Some animals are genetically modified to test treatments, others are used as drug or organ factories [6]. And the transgenic mosquito [7], sold to fight dengue fever or malaria, is an excellent Trojan horse to promote the social acceptability of this technology. Behind this « friendly » mosquito are an array of projects to sterilise insects that parasitise crops. These insects make up for the failures of intensive agriculture. The extinct animals are also factors of acceptability. Called « de-extinction », this phenomenon gathers a huge amount of money, and poorly conceals economic and political issues [8].Beyond ethics and animal welfare, this dossier will show how genetic modifications accelerate the privatisation of living organisms, capitalistic concentration, and the loss of autonomy of breeders [9].In the end, these GMO animals are at best band-aids on wooden legs, at worst attempts to perpetuate a agro-industrial system on its way out. They are part of the paradigmatic continuity of industrial livestock farming, of a reductive medicine and ecology, as practised for at least 50 years. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [233] => Array ( [objectID] => 4094 [title] => Hornless GM cattle : a false solution [timestamp] => 1679356800 [date] => 21/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/hornless-gm-cattle-a-false-solution/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => So far, few genetically modified livestock have been approved for marketing. But new mutagenesis techniques could change this. One modification that has already been authorised concerns hornless beef cattle : is this really a good idea ? The US company Recombinetics [Recombinetics] is a US biotechnology company founded in 2008, specialising in genetic modification of […] [chapo] => [texte] => So far, few genetically modified livestock have been approved for marketing. But new mutagenesis techniques could change this. One modification that has already been authorised concerns hornless beef cattle : is this really a good idea ? The US company Recombinetics [Recombinetics] is a US biotechnology company founded in 2008, specialising in genetic modification of animals for both agriculture and human medicine (xenotransplantation)].It has developed cows genetically modified to be hornless [1]. Indeed, the horn of cattle is considered problematic [2], especially since the generalisation in certain countries of « feedlots » (industrial feedlots that can bring together tens of thousands of cattle). In these small spaces, cows can injure each other as well as workers. Dehorning developed in the 1970s in several forms, including mechanical removal, which is costly and controversial in terms of animal welfare. It is for example forbidden in the organic specifications.Problematic crossbreedingThere are a few rare breeds of naturally hornless cows, such as the Aberdeen Angus breed [3]. But transferring this trait ("polled" or « hornless ») into other breeds is proving to be very difficult, particularly for dairy breeds. The main problem with the transfer of the polled gene is the concomitant decrease in production traits of the resulting animals compared to the target breed (reduced milk production, less muscle mass, etc.). The « polled » gene is in fact associated with other genes, which contradicts the purely mechanistic discourse. This complexity of the heritability of polled variants has increased breeders’ interest in genetic modification techniques [4].To ’create’ its hornless cattle, Recombinetics introduced two molecules into isolated and multiplied in vitro bovine cells. The first, the protein Talen [5] [6], allows the « horn » gene to be turned off ; the second, a circular DNA, inserts, under certain conditions, at the cutting site, the « not horn » gene. In 2016, Recombinetics announced the birth of two healthy, hornless animals, named Spotigy and Buri, for which analyses « revealed that [these] animals are free of off-target events, again confirming the high specificity of TALENs » [7].However, a paper published in Nature Biotechnology reported in February 2020 that the genome of Recombinetics’ bulls contained unwanted genetic sequences [8]. USDA researchers reported the presence of two copies of the « hornless » genetic sequence - and not just one as desired and reported by the company - and various other sequences from circular plasmid DNA. This study demonstrates that nuclease-based genetic modifications are far from the claimed precision, and are sources by themselves and via the related techniques inherent to these in vitro methods [9], of unintended modifications with unpredictable effects generating more or less consequential impacts.Modifying breeding conditions... or genetically modifying animals ?High-density livestock farmers often consider horns dangerous [10] and fight against any animal welfare regulations [11]. Other farmers, on the other hand, believe that horns are an essential organ of cow physiology and represent a manageable potential hazard, as do the fangs of a pet dog. But this appreciation requires knowing and living in harmony with one’s herd, a requirement that is opposed to excessive herd size as much as it is to the replacement of the farmer by robots and « digital surveillance ». Indeed, these farmers indicate that in the presence of horned cows, one must have more consideration and attention for the animal, more intuition and concentration. Thus, they state pragmatically : « If trust between a human and an animal is established from an early age, the animal will never intentionally injure a human with its horns. However, accidents can happen, for example by walking absent-mindedly near the animal’s head without anticipating its movements and intentions, or if the animal is frightened and reacts in an unusual way. Mutual trust between humans and animals is the best guarantee for a good cohabitation without problems and injuries » [12].A number of farmers’ observations compiled by Fibl [13] and scientific articles [14] remind us that horns have many interests.The horns of a bovine stand out from its massive silhouette and allow others to recognise it. Fibl states that ’each individual knows the size and shape of its horns and where the tip is, which also allows to know its place in the herd’. Other studies point out that physical interactions are less frequent in horned herds than in hornless herds, with more stable social relationships between animals.Horns are also used to diagnose nutritional deficiencies and thus to assess the health of the cow : deformed horns are a sign of health problems, massive horns at the base and thin or frayed horns at the tip are a sign of mineral deficiency during the animal’s youth [15]. One study found that the horn size of the African buffalo (Syncerus caffer) reflects the animal’s rate of parasitic infection [16] .Horns are also useful to cows in specific welfare functions. They scratch their backs with them, rub and clean their eyes with the tip of another cow’s horn, or use them for self-grooming of areas of the body that would otherwise be out of reach.Another important function in the current context of climate change, horns also regulate temperature [17] « In cattle, the extreme is the Ankole Watusi, a breed of cattle native to Africa whose horns can be up to 1.80 m long and are riddled with blood vessels. [...] [W]hen [the] blood passes close to the outside of the horn, heat can be lost into the atmosphere and the cooler blood returns to the animal’s body » [18].Biodynamists also see a digestive role of the horns [19].These bovine chimeras are « sold » to breeders and the general public as an ethical advance (reduction of nuisances in intensive breeding and of suffering linked to mechanical and thermal dehorning). Presented as progress, genetic modification is nevertheless part of a continuum with previous industrial practices, insofar as it does not propose a different way of raising animals nor a different way of living with them. It is only a question of simplifying the work of breeders to the point of eliminating it and replacing it with robots and electronic sensors, and thus increasing the size of what can no longer be called a herd. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [234] => Array ( [objectID] => 4096 [title] => Hornless GM cattle : a false solution [timestamp] => 1679356800 [date] => 21/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/hornless-gm-cattle-a-false-solution-2/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => So far, few genetically modified livestock have been approved for marketing. But new mutagenesis techniques could change this. One modification that has already been authorised concerns hornless beef cattle : is this really a good idea ? The US company Recombinetics [Recombinetics] is a US biotechnology company founded in 2008, specialising in genetic modification of […] [chapo] => [texte] => So far, few genetically modified livestock have been approved for marketing. But new mutagenesis techniques could change this. One modification that has already been authorised concerns hornless beef cattle : is this really a good idea ? The US company Recombinetics [Recombinetics] is a US biotechnology company founded in 2008, specialising in genetic modification of animals for both agriculture and human medicine (xenotransplantation)].It has developed cows genetically modified to be hornless [1]. Indeed, the horn of cattle is considered problematic [2], especially since the generalisation in certain countries of « feedlots » (industrial feedlots that can bring together tens of thousands of cattle). In these small spaces, cows can injure each other as well as workers. Dehorning developed in the 1970s in several forms, including mechanical removal, which is costly and controversial in terms of animal welfare. It is for example forbidden in the organic specifications.Problematic crossbreedingThere are a few rare breeds of naturally hornless cows, such as the Aberdeen Angus breed [3]. But transferring this trait ("polled" or « hornless ») into other breeds is proving to be very difficult, particularly for dairy breeds. The main problem with the transfer of the polled gene is the concomitant decrease in production traits of the resulting animals compared to the target breed (reduced milk production, less muscle mass, etc.). The « polled » gene is in fact associated with other genes, which contradicts the purely mechanistic discourse. This complexity of the heritability of polled variants has increased breeders’ interest in genetic modification techniques [4].To ’create’ its hornless cattle, Recombinetics introduced two molecules into isolated and multiplied in vitro bovine cells. The first, the protein Talen [5] [6], allows the « horn » gene to be turned off ; the second, a circular DNA, inserts, under certain conditions, at the cutting site, the « not horn » gene. In 2016, Recombinetics announced the birth of two healthy, hornless animals, named Spotigy and Buri, for which analyses « revealed that [these] animals are free of off-target events, again confirming the high specificity of TALENs » [7].However, a paper published in Nature Biotechnology reported in February 2020 that the genome of Recombinetics’ bulls contained unwanted genetic sequences [8]. USDA researchers reported the presence of two copies of the « hornless » genetic sequence - and not just one as desired and reported by the company - and various other sequences from circular plasmid DNA. This study demonstrates that nuclease-based genetic modifications are far from the claimed precision, and are sources by themselves and via the related techniques inherent to these in vitro methods [9], of unintended modifications with unpredictable effects generating more or less consequential impacts.Modifying breeding conditions... or genetically modifying animals ?High-density livestock farmers often consider horns dangerous [10] and fight against any animal welfare regulations [11]. Other farmers, on the other hand, believe that horns are an essential organ of cow physiology and represent a manageable potential hazard, as do the fangs of a pet dog. But this appreciation requires knowing and living in harmony with one’s herd, a requirement that is opposed to excessive herd size as much as it is to the replacement of the farmer by robots and « digital surveillance ». Indeed, these farmers indicate that in the presence of horned cows, one must have more consideration and attention for the animal, more intuition and concentration. Thus, they state pragmatically : « If trust between a human and an animal is established from an early age, the animal will never intentionally injure a human with its horns. However, accidents can happen, for example by walking absent-mindedly near the animal’s head without anticipating its movements and intentions, or if the animal is frightened and reacts in an unusual way. Mutual trust between humans and animals is the best guarantee for a good cohabitation without problems and injuries » [12].A number of farmers’ observations compiled by Fibl [13] and scientific articles [14] remind us that horns have many interests.The horns of a bovine stand out from its massive silhouette and allow others to recognise it. Fibl states that ’each individual knows the size and shape of its horns and where the tip is, which also allows to know its place in the herd’. Other studies point out that physical interactions are less frequent in horned herds than in hornless herds, with more stable social relationships between animals.Horns are also used to diagnose nutritional deficiencies and thus to assess the health of the cow : deformed horns are a sign of health problems, massive horns at the base and thin or frayed horns at the tip are a sign of mineral deficiency during the animal’s youth [15]. One study found that the horn size of the African buffalo (Syncerus caffer) reflects the animal’s rate of parasitic infection [16] .Horns are also useful to cows in specific welfare functions. They scratch their backs with them, rub and clean their eyes with the tip of another cow’s horn, or use them for self-grooming of areas of the body that would otherwise be out of reach.Another important function in the current context of climate change, horns also regulate temperature [17] « In cattle, the extreme is the Ankole Watusi, a breed of cattle native to Africa whose horns can be up to 1.80 m long and are riddled with blood vessels. [...] [W]hen [the] blood passes close to the outside of the horn, heat can be lost into the atmosphere and the cooler blood returns to the animal’s body » [18].Biodynamists also see a digestive role of the horns [19].These bovine chimeras are « sold » to breeders and the general public as an ethical advance (reduction of nuisances in intensive breeding and of suffering linked to mechanical and thermal dehorning). Presented as progress, genetic modification is nevertheless part of a continuum with previous industrial practices, insofar as it does not propose a different way of raising animals nor a different way of living with them. It is only a question of simplifying the work of breeders to the point of eliminating it and replacing it with robots and electronic sensors, and thus increasing the size of what can no longer be called a herd. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [235] => Array ( [objectID] => 4098 [title] => Hornless GM cattle : a false solution [timestamp] => 1679356800 [date] => 21/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/hornless-gm-cattle-a-false-solution-3/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => So far, few genetically modified livestock have been approved for marketing. But new mutagenesis techniques could change this. One modification that has already been authorised concerns hornless beef cattle : is this really a good idea ? The US company Recombinetics [Recombinetics] is a US biotechnology company founded in 2008, specialising in genetic modification of animals […] [chapo] => [texte] => So far, few genetically modified livestock have been approved for marketing. But new mutagenesis techniques could change this. One modification that has already been authorised concerns hornless beef cattle : is this really a good idea ? The US company Recombinetics [Recombinetics] is a US biotechnology company founded in 2008, specialising in genetic modification of animals for both agriculture and human medicine (xenotransplantation)].It has developed cows genetically modified to be hornless [1]. Indeed, the horn of cattle is considered problematic [2], especially since the generalisation in certain countries of « feedlots » (industrial feedlots that can bring together tens of thousands of cattle). In these small spaces, cows can injure each other as well as workers. Dehorning developed in the 1970s in several forms, including mechanical removal, which is costly and controversial in terms of animal welfare. It is for example forbidden in the organic specifications.Problematic crossbreedingThere are a few rare breeds of naturally hornless cows, such as the Aberdeen Angus breed [3]. But transferring this trait ("polled" or « hornless ») into other breeds is proving to be very difficult, particularly for dairy breeds. The main problem with the transfer of the polled gene is the concomitant decrease in production traits of the resulting animals compared to the target breed (reduced milk production, less muscle mass, etc.). The « polled » gene is in fact associated with other genes, which contradicts the purely mechanistic discourse. This complexity of the heritability of polled variants has increased breeders’ interest in genetic modification techniques [4].To ’create’ its hornless cattle, Recombinetics introduced two molecules into isolated and multiplied in vitro bovine cells. The first, the protein Talen [5] [6], allows the « horn » gene to be turned off ; the second, a circular DNA, inserts, under certain conditions, at the cutting site, the « not horn » gene. In 2016, Recombinetics announced the birth of two healthy, hornless animals, named Spotigy and Buri, for which analyses « revealed that [these] animals are free of off-target events, again confirming the high specificity of TALENs » [7].However, a paper published in Nature Biotechnology reported in February 2020 that the genome of Recombinetics’ bulls contained unwanted genetic sequences [8]. USDA researchers reported the presence of two copies of the « hornless » genetic sequence - and not just one as desired and reported by the company - and various other sequences from circular plasmid DNA. This study demonstrates that nuclease-based genetic modifications are far from the claimed precision, and are sources by themselves and via the related techniques inherent to these in vitro methods [9], of unintended modifications with unpredictable effects generating more or less consequential impacts.Modifying breeding conditions... or genetically modifying animals ?High-density livestock farmers often consider horns dangerous [10] and fight against any animal welfare regulations [11]. Other farmers, on the other hand, believe that horns are an essential organ of cow physiology and represent a manageable potential hazard, as do the fangs of a pet dog. But this appreciation requires knowing and living in harmony with one’s herd, a requirement that is opposed to excessive herd size as much as it is to the replacement of the farmer by robots and « digital surveillance ». Indeed, these farmers indicate that in the presence of horned cows, one must have more consideration and attention for the animal, more intuition and concentration. Thus, they state pragmatically : « If trust between a human and an animal is established from an early age, the animal will never intentionally injure a human with its horns. However, accidents can happen, for example by walking absent-mindedly near the animal’s head without anticipating its movements and intentions, or if the animal is frightened and reacts in an unusual way. Mutual trust between humans and animals is the best guarantee for a good cohabitation without problems and injuries » [12].A number of farmers’ observations compiled by Fibl [13] and scientific articles [14] remind us that horns have many interests.The horns of a bovine stand out from its massive silhouette and allow others to recognise it. Fibl states that ’each individual knows the size and shape of its horns and where the tip is, which also allows to know its place in the herd’. Other studies point out that physical interactions are less frequent in horned herds than in hornless herds, with more stable social relationships between animals.Horns are also used to diagnose nutritional deficiencies and thus to assess the health of the cow : deformed horns are a sign of health problems, massive horns at the base and thin or frayed horns at the tip are a sign of mineral deficiency during the animal’s youth [15]. One study found that the horn size of the African buffalo (Syncerus caffer) reflects the animal’s rate of parasitic infection [16] .Horns are also useful to cows in specific welfare functions. They scratch their backs with them, rub and clean their eyes with the tip of another cow’s horn, or use them for self-grooming of areas of the body that would otherwise be out of reach.Another important function in the current context of climate change, horns also regulate temperature [17] « In cattle, the extreme is the Ankole Watusi, a breed of cattle native to Africa whose horns can be up to 1.80 m long and are riddled with blood vessels. [...] [W]hen [the] blood passes close to the outside of the horn, heat can be lost into the atmosphere and the cooler blood returns to the animal’s body » [18].Biodynamists also see a digestive role of the horns [19].These bovine chimeras are « sold » to breeders and the general public as an ethical advance (reduction of nuisances in intensive breeding and of suffering linked to mechanical and thermal dehorning). Presented as progress, genetic modification is nevertheless part of a continuum with previous industrial practices, insofar as it does not propose a different way of raising animals nor a different way of living with them. It is only a question of simplifying the work of breeders to the point of eliminating it and replacing it with robots and electronic sensors, and thus increasing the size of what can no longer be called a herd. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [236] => Array ( [objectID] => 4099 [title] => GMO animals : accelerated growth with deleterious effects [timestamp] => 1679356800 [date] => 21/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/gmo-animals-accelerated-growth-with-deleterious-effects/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => More meat, milk, wool, etc. have always been some of the objectives of animal selection. For meat, two genetic modification strategies have been implemented : influencing the level of growth hormone, or blocking the gene responsible for the production of myostatin, a hormone that inhibits muscle growth. Research that is far from improving animal welfare… […] [chapo] => [texte] => More meat, milk, wool, etc. have always been some of the objectives of animal selection. For meat, two genetic modification strategies have been implemented : influencing the level of growth hormone, or blocking the gene responsible for the production of myostatin, a hormone that inhibits muscle growth. Research that is far from improving animal welfare… In 1982, researchers inserted the rat growth hormone expression gene into a mouse genome and obtained giant mice [1]. In 1989, a company called AquaBounty [2], a subsidiary of Third Security, LLC, is a company specialising in the genetic modification of fish (salmon, tilapia)], began to genetically modify salmon to produce larger animals more quickly. The company inserted into the genome of farmed Atlantic salmon a double transgene consisting of a genetic sequence from Chinook salmon (the largest of the five salmon species), which increases hormone production, and a sequence from the American Ocean pout, a species that lives in colder waters than salmon. The combination is intended to produce growth hormone continuously, stimulating the appetite of the salmon, which then grows about twice as fast as conventionally farmed salmon.Increasing the production of growth hormoneCurrently, this transgenic salmon, named AquAdvantage, has been approved for commercialization in the United States (2015) and Canada (2016) [3], but its production remains very low (91 tons in 2021) [4]. Most attempts at transgenic salmon have been abandoned [5], and plans for other species with increased levels of growth hormone never came to commercial fruition [6].Apart from a fairly widespread refusal by the major chain stores to market transgenic salmon, the primary cause of these failures is that altering the hormone level in the animals’ bodies can have many other effects : this hormone acts on several other traits (pleiotropic effect) [7]. For example, pigs with more muscle were also more sensitive to certain diseases, such as pneumonia and arthritis [8]. Research has also shown the relationship of genetic transformations with the age, breed or sex of the animal, thereby negating any claim to generalise these techniques to any breed and species, and de facto condemning breeders to revert to the many previous cross breedings.A report by the Royal Society of Canada (2001) [9] also refers to these pleiotropic effects : « pleiotropy [...] associated with the introduction of new genetic constructs is the rule rather than the exception in fish. This pleiotropy has manifested itself in changes in enzyme activity, gross anatomy, behaviour and, most likely, hormonal activity » [10]. Other studies document morphological abnormalities in transgenic coho salmon and damage on fish welfare, behaviour and ultimately survival capacity.Similar physical consequences have been observed in transgenic carp [11] and in non-transgenic catfish injected with growth hormone [12]. Transgenesis can also affect the overall shape of transgenic fish, resulting in swimming problems. The Royal Society report explains that growth hormone production can alter the sensitivity of cells to other hormones, and can reduce the size of the pituitary gland in transgenic coho salmon by 50% to 83% [13]Blocking myostatin productionMyostatin is a protein that limits muscle growth in animals. Since the beginning of the 2000s, experiments to modify the genetic sequence responsible for the expression of this protein by transgenesis have been carried out on cattle, sheep [14], salmon, mice. But none of these animals have been commercialised.Research into animal modification therefore now involves the use of new tools, such as Talen [15] or Crispr/Cas9 [16], which does not address the problems associated with embryo transfers, and animal welfare issues. But again, the proposed genetic modification technique is proving complex to implement. Marc Vandeputte (Inrae)[M. Vandeputte] works at Inrae. He specialises in aquaculture and explains that "the number of fish modified by Crispr is currently very low, due to a real problem of technical skill for the injection of the Crispr/Cas9 complex [17]. This is also true for other nuclease-based genetic modification techniques as observed in the plant domain" [18]. However, he stresses that « the system is vastly simpler and more efficient to implement and than conventional transgenesis, and the investment is significant in many countries. It therefore seems likely [...] that important innovations may emerge in the medium term through these techniques ».A large number of animal species (pigs [19], sheep [20], etc.) are currently being genetically modified worldwide, via various new genetic modification techniques to inactivate myostatin. In China, farm animals are being genetically modified for meat production, but also dogs are being genetically modified to improve their running in support of the police or the army [21]. Conversely, myostatin expression can be increased to produce dwarf animals, such as small pigs sold as pets. At present, failure rates are still quite high and there are many technical problems.Fish were still the first animals modified by Crispr/Cas9, due to the costs of processing and development. In Argentina, in 2018, AquaBounty (again) was exempted from authorisation for a genetically modified tilapia, a farmed fish consumed worldwide. In Japan, at the end of 2021, the Regional Fish Institute (RFI) [22] was able to market a genetically modified red sea bream and tiger globe fish [23]. According to figures provided by AquaBounty, figures not published in a scientific journal, its tilapia « shows a significant improvement in fillet yield by 70%, an improvement in growth rate by 16% as well as an improvement in feed conversion rate by 14% ». And the sea bream would provide « 20% more meat » according to the Japanese startup’s claims. How reliable is this data ? It has long been known that results obtained on a ’station’ are very difficult to extrapolate to larger scales : the same is true under real farming conditions [24].Less myostatin leads to perverse effectsSheep and cattle have been engineered to inhibit the myostatin gene using the Talen tool [25] A calf resulting from such manipulation turned out to be « mosaic/chimeric » : some of its tissues carrying one of the mutations, other tissues carrying the wild-type allele or another mutation, a relatively common problem with genome « editing » techniques [26]. In practical terms, this means that the modified animal may have hypertrophied hind leg muscles while other muscles will remain normal. Furthermore, modification by the Talen system implies the presence of unintended « collateral » mutations and epimutations, which could predispose the line to diseases, for example [27]. They result both from the presence of other more or less homologous sequences in the genome, which the Talen system will also cut, and from modifications due to the related techniques required by the Talen system (cell cultures in vitro, selection of modified cells...).For example, with the « zinc finger nucleases » (ZFN) technique on pigs, Chinese researchers point out that « 20% of the mutant pigs had an extra thoracic vertebra ». For Yves Bertheau, "the effect of stress on isolated cells or multicellular clusters (i.e. in vitro vs. natural environments), on their subsequent development into an organism and on genetic reprogramming [...] are currently well documented in animals. In vitro culture methods with injections are similar, if only in size, to the injections of « packages » of nucleic acids, proteins and/or ribonucleoprotein complexes of new genetic modification techniques. They induce profound disorders in the genomes and epigenomes, transcriptome perturbations... of the targeted cells and organisms, all transmissible disorders" [28].As with the variants of the « polled » dehorning gene [29], it was already possible to « play » with the myostatin gene without genetically modifying the animals, as evidenced by the « Bleu Blanc Belge » (BBB) breed of cow [30] The cows and bulls of this breed, which is very common in Belgium, appear to be deformed because of their prominent and protruding muscles. Some specimens produce 70% more meat than a « classic » bovine. In these so-called « double-muscled » (DM) cattle, muscle hypertrophy is a problem [31], even before any genetic modification : higher frequency of calving difficulties, reduced fertility, and ultimately calves with lower survival compared to other cattle [32].The altered regulation of myostatin results in significant and accelerated muscle degeneration. « The extremely high carcass yield of DM animals coincides with a reduction in the size of most vital organs. As a result, DM animals may be more susceptible to respiratory diseases, lameness, nutritional stress, heat stress in addition to [the calving problems] already reported, resulting in reduced robustness ». Another study [33] reports, on the contrary, a problematic increase in the size of some internal organs, especially the tongue. The tongue of the modified piglets was longer and heavier than that of the control piglets. This phenomenon is also known in cattle of the BBB breed.The inactivation of myostatin is also thought to result in faster and more intense fatigue. Myostatin gives skeletal muscle a high oxidative capacity. The modified animals are therefore likely to suffer more, to have more difficulty breathing and to have their well-being further degraded. Other adverse consequences have been shown : delayed puberty [34], reduced sperm count or motility [35], decreased testicular size [36], increased chances of tendon rupture [37], heart problems, etc. The economic objective of increasing meat production will therefore clearly be at the expense of the health and integrity of the animal. It could even be that, in the end, the numerous problems of discomfort of the animals will greatly reduce their economic interest, because of veterinary care and the necessary adjustments of the installations.Eric Marois, a researcher at the French National Centre for Scientific Research (CNRS) [38], interviewed by Inf’OGM [39], recommends for ethical reasons and scientific rigour, and therefore to exclude the risk of unintentional collateral modifications, « the complete sequencing of the genome of the animal obtained and to compare its genome with that of the non-genetically modified parents ». Will the legislator take into account the scientific uncertainties by making compulsory this complete sequencing a posteriori of the animals obtained ? It should be noted, however, that no sequencing, however complete, will replace controlled trials over several generations in a confined environment, the only way to reveal other possible « problems » that have gone unnoticed by genetic tools alone. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [237] => Array ( [objectID] => 4100 [title] => GMO and sterile insects : not very efficient [timestamp] => 1679356800 [date] => 21/03/2023 [annee] => 2023 [url] => https://infogm.org/en/article_journal/gmo-and-sterile-insects-not-very-efficient/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => A certain number of insects are considered as pests, because they carry diseases or are parasites on crops. There are many ways to combat them : chemical insecticides, pheromone traps, induced sterility, etc. Several techniques are being developed to induce sterility in an insect. These techniques – radiation mutagenesis, transgenesis, inoculation with the bacterium Wolbachia [1] […] [chapo] => [texte] => A certain number of insects are considered as pests, because they carry diseases or are parasites on crops. There are many ways to combat them : chemical insecticides, pheromone traps, induced sterility, etc. Several techniques are being developed to induce sterility in an insect. These techniques - radiation mutagenesis, transgenesis, inoculation with the bacterium Wolbachia [1] and gene drive - give genetically modified insects. There are many sterile insect projects. It is difficult to really know how effective they are, given the lack of transparency of the companies, and the complexity and diversity of the ecosystems.Regarding sterility achieved through irradiation, the best known ’success story’ is the eradication of the pink cotton bollworm (Pectinophora gossypiella) in Arizona (USA) [2]. Bruce Tabashnik, an entomologist at the University of Arizona and one of the leaders of this programme, tells us that « this insect was declared eradicated from the cotton-growing regions of the American continental in 2018 by the U.S. Department of Agriculture » [3]. More than two billion of them were counted in Arizona in 2005, before the programme was set up. To eradicate them, eleven billion sterile butterflies were released from 2006 to 2015 in Arizona alone. Yves Carrière, co-responsible for this programme, tells us that ’sterile insects would not have been enough to eradicate this pest : they had to be combined with Bt cotton and other practices’ [Personal interview]. Bruce Tabashnik confirms this : « Sterile butterfly releases alone have been tried before and could not suppress the established populations because there were not enough sterile butterflies compared to wild butterflies ». Another point made by Yves Carrière is that this insect is almost exclusively associated with cotton. This is an advantage because « the problem with sterile insects is that it is difficult to ’cover’ all the populations of insects to be eradicated, if these insects use several types of habitat ». The researchers also point out that « in India, pink cotton bollworm populations have exploded after developing resistance to Bt cotton. [...] [W]e are not aware of any previous examples where pest eradication has been achieved by a transgenic crop alone or in combination with other tactics. In at least 22 documented cases worldwide, nine major pests have developed practical resistance to Bt crops.Oxitec conducted a behavioural trial with such a genetically modified butterfly (for fluorescence) but irradiated (for sterility) between 2006 and 2008 in Arizona [4]. After releasing several dozens of millions of butterflies, Oxitec estimates that »the attributes critical to [the sterile insect technique] in the field - ability to find a mate and initiate copulation, as well as dispersal and persistence in the release area - were comparable between the genetically engineered strain and a standard strain". In 2012, Oxitec tested a new, genetically sterile version of this butterfly (OX3402C) [5] in a confined environment. No information was given on any other field trials. Bruce Tabaschnik tells us that this transgenic version is intended for countries such as India [6], where the parasite proliferates and has developed strong resistance to Bt. Oxitec says its transgenic butterfly will also be useful where the irradiated version is not possible because of the prohibitive costs and safety issues associated with establishing irradiation facilities.But the most widely used GM insect is the mosquito. Transgenic mosquitoes, irradiated or inoculated with Wolbachia, have been widely disseminated internationally.Oxitec has successively developed two strains of transgenic Aedes aegypti mosquitoes. In theory, only the transgenic males are released and mate with wild females. In both cases, the offspring need tetracycline to survive. In the first case, OX513, the entire offspring dies quickly (3/4 days according to Oxitec) [7], while in the second case, OX5034, only the females die early. Thus, this second mosquito allows additional mating cycles, thus reducing the number of releases. Oxitec acknowledges that a small proportion of transgenic females are nevertheless released (unintentionally) and that hybrids (transgenic x wild) may reach adulthood (between 3 and 5%).All these releases were nevertheless accompanied by other measures. In Brazil, the municipalities involved continued to spray insecticides and reduce the number of stagnant water points, where mosquitoes breed, as evidenced by the agreement between Oxitec and the municipality of Piracicaba [8], or the testimony, in May 2022, of Ulisses Bernardinetti, coordinator of the dengue control programme in Indaiatuba [9]. In this city and in Jardim Morada do Sol, where releases began at least in 2018 and will be maintained until mid-2023 [10], transgenic mosquitoes appear to be of little use. Indeed, several hundred cases of dengue were still detected in 2022.Without being able to put an exact figure on it, dozens or even hundreds of billions of mosquitoes have been released in Brazilian cities. But the impact on dengue is, in the end, quite small. In 2022, the WHO counts 929 deaths and 2,182,229 cases... about the same as in 2016 (707 deaths and 2,220,482 cases) [11].Oxitec has plenty of other transgenic insect projects in the pipeline : other species of mosquitoes, vectors of malaria, of course but as well agricultural insect pests[18 million to try to modify two subspecies of Anopheles. Oxitec press release, « Oxitec’s Malaria Program Receives New Investment to Expand to Pilot Phases in Two Malaria-Affected Regions », 13 April 2022]]. They are designed to compensate for the failure of chemicals or Bt plants. Oxitex has developed a transgenic, sterile version of pests that attack fruit trees (Ceratitis capitata), soybeans (Chrysodeixis includens), maize (Spodoptera frugiperda), plants of the cabbage family (Plutella xylostella) or livestock (Rhipicephalus (Boophilus) microplus). GM Plutella xylostella was field tested in New York State in 2017 on 2.6 hectares. Five years later, no further trials have been conducted [12]. When asked by Inf’OGM, one of the researchers, now retired, tells us that it is only a matter of time and resources. Ceratitis capitata has been « tested » in a minimalist way in a contained environment (Australia [13], Brazil [14], Morocco [15], etc.), but without moving to commercial stage. In 2021, Brazil allowed Oxitec to commercialise transgenic Spodoptera frugiperda. It is impossible to know whether experimental or commercial releases have taken place. Curiously, the transgenic olive fly (OX3097D), which Oxitec wanted to experiment in Spain, is no longer mentioned in the company’s current projects.New techniques to get around the lawsTransgenesis is a regulated technique. Under pressure from the industry, many countries have decided not to consider organisms modified with other techniques as GMOs. In Brazil, for example, three insects modified via a new genetic modification technique are not considered GMOs. These are Spodoptera frugiperda and Helicoverpa armigera, developed by the company Evolutta Agro Biotecnologia Ltda. It is impossible to know whether these insects have been disseminated. And, on the other hand, the mosquito Aedes, « sterilised » by the company Forrest by « turning off » a gene [16]. Hundreds of millions of individuals of the Aedes mosquito have been released, especially in Ortigueira (State of Parana), since the end of 2020 [17]. In Ortigueira, the dengue epidemic has not disappeared [18]. It is possible that the number of mosquitoes is decreasing momentarily, but over the long term the situation does not change fundamentally. This would probably explain why neighbouring towns, which seem to suffer more from dengue, have not adopted this sterile mosquito... unless it is because of the cost of these mosquitoes... It is impossible to know...The fourth strategy, gene drive, has not yet been implemented. A consortium, Target Malaria [19], hopes to conduct a first full-scale experiment in Burkina Faso soon. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [238] => Array ( [objectID] => 6329 [title] => Jabal: a non-GMO wheat more resistant to drought [timestamp] => 1676246400 [date] => 13/02/2023 [annee] => 2023 [url] => https://infogm.org/en/jabal-a-non-gmo-wheat-more-resistant-to-drought/ [image] => https://www.infogm.org/IMG/arton7662.jpg?1676280037 [extrait] => Jabal, a non-GMO drought-resistant wheat variety, will soon be grown commercially in Morocco. At a time when it is mentioned to adapt new plant varieties to climate change, particularly through genetic modification, we thought it would be interesting to show that other ways are possible, even if they are not farmers’ seeds and even if […] [chapo] => [texte] => Jabal, a non-GMO drought-resistant wheat variety, will soon be grown commercially in Morocco. At a time when it is mentioned to adapt new plant varieties to climate change, particularly through genetic modification, we thought it would be interesting to show that other ways are possible, even if they are not farmers’ seeds and even if the risks of appropriating genetic sequences of interest have not been completely ruled out... The Jabal durum wheat variety is the result of a programme by Icarda, the International Center for Agricultural Research in the Dry Areas (based in Lebanon) [1]. This international centre (with public and private funding) is itself part of a network of international agricultural research centres, the CGIAR [2], a public-private partnership funded, among others, by the Bill and Melinda Gates Foundation. This Foundation is known for pushing technological solutions that often involve GMOs [3]. This is why the announcement in many media [4] of the development of this new “non-GMO” variety merited an investigation by Inf’OGM, in order to verify this claim of “non-GMO” character, whether it is transgenic or derived from other methods. To this end, we interviewed one of its designers, Filippo Bassi, a researcher at Icarda (see below). In an interview in 2019, he declared himself “a great supported of GMO and especially Crispr/Cas”, and regretted the European blockages: “It is a shame because as scientists we have been crippled by this. But we are not politicians, so we need simply to accept and work on “legal” technologies” [5]. Which probably explains why, for the time being, he says he is working without GMOs...Dissemination of elite varieties through participatory researchBut first, let us zoom in on the institutional framework of this research. This wheat variety was developed within the framework of the DIIVA-PR programme [6], itself developed within the CWR (Crop wild relatives) project. The CWR project ran from 2011 to 2021 with support from the Norwegian government. It aimed to use the potential of crop wild relatives for the development of new climate change resistant varieties. The Norwegian government? Yes, the same one that co-funds and hosts the Svalbard Global Seed Vault [7]. And this is no coincidence, since all international breeding research programmes today involve firstly, banks of “genetic resources” (physical, in the form of seeds), then genome sequencing and the identification of genes of interest, all of which is then stored in computers in the form of genetic sequencing information (DSI, digital sequence information).The general idea of the DIIVA-PR programme is that researchers identify interesting characteristics of ’wild’ cousins (or local varieties) of cultivated varieties [8] and, by crossing, integrate them into elite varieties... All this under the eye of observant farmers who select the varieties that, in the end, appear to be the best. This programme has been applied to three species in particular: wheat, barley and lentil. In this interview, we will look at the details and results obtained with durum wheat.This programme has been extended into a new three-year project, BOLD-DIVA-PR II (Dissemination of ICARDA Varieties through Participatory Research), with funding of more than one million dollars, in Morocco, Tunisia, Ethiopia, Senegal, Nigeria and Sudan [9]. The aim is to evaluate local barley and durum wheat varieties in the field for various traits of interest in these countries, crossbreed them and evaluate their performance and farmers’ preferences through participatory actions... Then make them accessible to everyone (farmers, breeders...), in particular by making all the data freely available online.The interview therefore also focused on intellectual property, which the researcher assures us is totally regulated by the material transfer agreement that each recipient must sign before using the variety (see below). However, the fact that the genetic information on this wheat has been made freely available online opens up the possibility of appropriating part of this heritage, if a seed company claims to modify one of the genes slightly and assigns it a function.Here is the interview with Filippo Bassi, a researcher at Icarda and one of the breeders of this wheat, who explains to Inf’OGM the genesis of the wheat and part of its future.Inf’OGM: Jabal, the drought-resistant wheat, is the result of crossing a durum wheat Triticum durum with the wild wheat Aegilops speltoides. How was this cross achieved?Filippo Bassi (FB): The cross is made in a greenhouse by first emasculating (removing), with small forceps, the immature anthers [10] of the flower of a modern line of wheat so that it becomes ’female’. Wheat is a monoecious plant, which means that the male and female organs are inside the same flower to promote self-pollination. So when the male part is removed, the flower becomes female and needs exogenous pollen, i.e. from another plant. So we took the pollen from the speltoides and sprinkled it on the female flower to generate a “hybrid” that combines the genetic information of both species: durum + speltoides. The resulting offspring were then used as ’females’ [again] by emasculation and a second modern durum wheat was used as a pollen donor. This three-way cross generated genetically stable offspring that were then further developed and selected to become “Jabal” [11].Where do the wild and cultivated species of these crosses come from? PB: The cross was [first] made in 2004 in Aleppo, Syria, and then in Terbol, Lebanon, for further selection. In 2012 it arrived in Morocco where I tested it in many places and finally used it in the Crop Trust-supported DIIVA-PR project [12]. The durum wheat species [...], Triticum durum, is the species that is grown on more than 18 million hectares worldwide.As for Jabal, its full pedigree is: Korifla/AegSpeltoidesSyr/Omrabi5. This means that the first cross was made between a Speltoides historically collected in Syria and an elite Cimmyt line [13] called Korifla, originally developed in Mexico and brought to Syria in the 1970s. Indeed, although susceptible to heat, Korifla was also considered a line with high yield potential, early flowering and good grain colour. Therefore, it was included in the development of Jabal. Then a second cross was made between their descendants and a line from Icarda, called Om Rabi, which has been registered under different names in more than 20 countries as a drought-tolerant variety [14]. Thus, the wild species was an accession held in the Icarda genebank, while the modern durums were provided by the Icarda breeding programme. This programme, which has existed since the early 1970s, involves conventionally bred varieties. It has resulted in the release of more than 150 varieties in 22 countries.What were the technical stages of these crosses? In particular, were there any laboratory steps to integrate certain genes? Were specific genes linked to this drought resistance identified?PB: Jabal is the result of classical cross-pollination selection, so no laboratory steps were taken. However, the genes controlling this drought tolerance have been studied, in particular via a method called “Genome-wide association study” [15]. The result is a set of markers associated with the genomic region and through marker-assisted selection we have now defined with acceptable accuracy the genomic regions contributing to drought tolerance, especially with regard to roots and grain size.Have any intellectual property rights (patents, plant breeders’ rights) been registered on these genes or varieties? Or is there free and full access to this Jabal variety? PB: The Jabal variety has not yet been grown commercially in Morocco. Yields in test plots are similar to those of commercial varieties in normal years, but can be up to 20% higher in cold mountain regions in terminal drought.Jabal will be distributed by the seed company Benchaib Semences, which has the exclusive right to market it in Morocco [16]. The sale of ’good seeds’ (certified seeds) is allowed in Morocco. This means that any farmer can buy seed from Benchaib, sow it in his own field and then sell the harvest to his neighbours. However, only farmers who sow “officially certified” seed can benefit from a government subsidy, and only Benchaib is allowed to market “officially certified seed”.Icarda retains all rights for its use in breeding.In addition, there is no patent on Jabal or its genes, so anyone is free to use it as they wish. Icarda has already provided it to more than 55 partners around the world under a Standard Material Transfer Agreement (SMTA) [17], which essentially protects its form by creating intellectual property that would prevent others from using it. We only allow commercial protection for companies that distribute and use it in their own country. ATTM is registered in the multilateral system of the International Seed Treaty (Tirpaa [18]). As such, it applies to anyone using this material. Thus, any company attempting to patent Jabal without the express consent of Icarda would be in breach of this ATTM. The Plant Treaty could then take legal action on behalf of Icarda in such cases, but normally, once the company is aware of the infringement, it tends to back off on its patenting activities.Jabal can therefore be said to be ’fully open access’ with some limitations. On the other hand, it has also been available to French breeders for some years, and has for example been sent to the company Florimond-Desprez [19]. Frédéric PRAT Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [239] => Array ( [objectID] => 6330 [title] => Rapeseed: The Anses asks to reinforce the monitoring of GMOs [timestamp] => 1675728000 [date] => 07/02/2023 [annee] => 2023 [url] => https://infogm.org/en/rapeseed-the-anses-asks-to-reinforce-the-monitoring-of-gmos/ [image] => https://www.infogm.org/IMG/arton7651.png?1675702016 [extrait] => In February 2022, Inf’OGM discovered transgenic rapeseed growing illegally in the port area of Grand-Couronne (near Rouen, Seine-Maritime, France). In July 2022, despite measures taken by the Ministry of Agriculture, new GMO rapeseed plants were found in the same area. The association also discovered transgenic rapeseed in Sète (Hérault, France). In both cases, the Saipol […] [chapo] => [texte] => In February 2022, Inf’OGM discovered transgenic rapeseed growing illegally in the port area of Grand-Couronne (near Rouen, Seine-Maritime, France). In July 2022, despite measures taken by the Ministry of Agriculture, new GMO rapeseed plants were found in the same area. The association also discovered transgenic rapeseed in Sète (Hérault, France). In both cases, the Saipol factory, which imports rapeseed to make agrofuels, seems to be responsible for this contamination. The Anses has just published an opinion and asks to reinforce the monitoring of GMOs in the environment. Will the ministry implement these recommendations? After discovering transgenic rapeseed plants in February 2022 [1], Inf’OGM alerted the Ministry of Agriculture, which then asked the Anses (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail) to conduct an expertise [2] [3]. On Friday 20 January 2023, the Anses published its opinion [4].First of all, the Anses opinion tells us that “the control services of the Ministry of Agriculture and Food Sovereignty took samples on 19 and 29 April 2022, which were analysed by the BioGEVES laboratory [...]. These analyses have confirmed the presence of genetically modified rapeseed in the environment mentioned above”. Indeed, out of 16 samples taken in the port area of Rouen, 14 were found to be positive. The opinion also states that “as a result, at the beginning of May 2022, a destruction of rapeseed plants by mechanical means (mowing, brush cutting) was requested by the DGAl from the public establishment HAROPA Port, in charge of the maintenance of the industrial port area (excluding industrial sites). It was planned to repeat this operation every month, to avoid that the possible regrowths flower and so that they do not produce pollen or seeds which could germinate in the long term”. We note from this opinion that the Ministry of Agriculture and the Anses were only interested in the port area of Rouen, whereas Inf’OGM had stated that it had discovered transgenic rapeseed in Sète.The Anses opinion underlines that “the internal procedures implemented by the operator [Saipol, editor’s note] do not allow to respect the monitoring plan foreseen in the framework of the authorisation of these GM oilseed rapes, and to avoid the dissemination of seeds and the presence of GM oilseed rape plants”.The Anses concludes that it is necessary to reinforce “the monitoring plans for environmental effects in order to make them more precise and demanding” and to have a better mapping of the areas at risk. Indeed, the Anses specifies that ports are not the only hotspots and that it is therefore also necessary to monitor “industrial sites storing or processing GM seeds [and] railroads, waterways and roads allowing the transport of goods between the aforementioned places”. As the Anses states on its website [5], “it is the authorisation holder and the operators handling these products who are responsible [for implementing the monitoring plan] to prevent any environmental risk linked to its release. In the case of the particularly volatile GM oilseed rape, the monitoring plan consists in particular of the implementation of procedures to limit losses and spills of seeds and the systematic eradication of plants present at the unloading and processing sites. Following its expertise, the Agency underlines that these monitoring plans contain gaps, in particular on the monitoring of the environment outside the sites of the operators concerned”.Return on a predictable contaminationIn February 2022, with the film crew of the program “On the Front” (France 5), we were in Rouen, near the Saipol factory (Groupe Avril), which imports rapeseed (partly transgenic) to produce agrofuels. On the side of the road, we had seen some feral rapeseed and, after analysis by an accredited laboratory, this rapeseed turned out to be transgenic. We reported on this discovery in the program and in an article on our website. We were not surprised by this result. Of course, we had only harvested a few plants, but rapeseed is known to spread very easily and to be able to grow back for ten years (dormancy). Scientists, French or British, as early as the end of the 90s, had warned about the extreme difficulty of managing a coexistence between two GMO and non-GMO rapeseed sectors [6] [7] [8]. Thus, limiting or even preventing contamination is a real challenge, yet there must be a clear will to limit it...Transgenic rapeseed: a plant that is impossible to containThe main problem with transgenic rapeseed is that its segregation is completely impossible, and it is for this reason that European governments banned its cultivation in the late 1990s. Rapeseed can remain in the ground (dormancy) for many years before waking up and growing. Thus, Anses explains in its report: “the observation of GM rapeseed plants in the spring of 2022 which may not only be 1era generation plants resulting from the germination of seeds dispersed by chance but also plants of later generations after reproduction”. In addition, rapeseed can cross with wild plants such as root, mustard, etc. Rapeseed is part of a botanical family very present on European soil. These data are confirmed again in this AAnses opinion. However, it should be noted that this transgenic rapeseed detected (but also the other GMO rapeseed resulting from mutagenesis, see box below) had been genetically modified to tolerate herbicides. However, a broad scientific consensus has shown that the use of varieties modified to be tolerant to a herbicide leads to an increase in the quantity of herbicide sprayed. Making agrofuels with rapeseed from the other side of the world, the cultivation of which leads to an increase in the quantity of herbicides, is to say the least curious… Herbicides, like maritime transport, have very significant impacts in terms of climate change.This positive result gave us a hint. If these few plants are transgenic, it could be a sign of a significant presence of transgenic rapeseed in the environment, in Rouen but also in the vicinity of other Saipol plants. Inf’OGM then launched a call for donations in order to be able to carry out a wider survey. We had collected enough money to do some sampling and analysis, but not enough to be exhaustive and to take as many samples as we would have liked. However, the little we could do shows that transgenic rapeseed is indeed growing on the French territory and that the authorities seem to have a hard time to solve this problem.We have harvested feral rapeseed in Bassens (Gironde), in Sète (Hérault), in the region of Mulhouse (Haut Rhin), in Dieppe and in Rouen (Seine-Maritime) in the vicinity of the Saipol plants.The first important piece of information is therefore that everywhere around rapeseed crushing plants, feral rapeseed is growing. As we have already noted on several occasions, rapeseed is a plant species that spreads easily, that establishes itself easily.In Mulhouse, Dieppe and Bassens, our samples were not positive. Let us specify right away that, due to a lack of sufficient means, we were not able to carry out the detection campaign that we wanted to. Mulhouse was of particular interest to us. Indeed, on several occasions, a few kilometers from this port on the Rhine, in Basel (Switzerland), transgenic rapeseed had been identified by researchers [9].In contrast, in Sète, a port city on the Mediterranean, we identified several transgenic rapeseed plants. As in Rouen, part of its production is dedicated to agrofuels. Agrofuels of transgenic origin are not labeled because GMO labeling only concerns food products. Did the Ministry of Agriculture take the time to check with other Saipol plants to see if transgenic rapeseed was growing near the plant? It is impossible to know. The ministry never answered our questions about the precise action it took.Despite the action of the ministry, transgenic rapeseed found 5 months laterThe most worrying thing is the discovery, in July 2022, of new transgenic rapeseed plants in Rouen. Indeed, Saipol officials had told us that our”discovery" was anecdotal and Saipol’s communication director, Fabien Kay, had told us on April 13, 2022 that “the procedures put in place provide for daily cleaning of the seeds on the ground in the unloading area and for the destruction of rapeseed regrowth in the area in order to prevent any potential dissemination. The samples you took certainly took place before this cleaning phase”. Alas, as early as July we found some!As for the Ministry of Agriculture, it replied on April 20, 2022: “Samples have already been taken by the ministry’s control services on rapeseed plants in the area where the detection of GMOs has been reported. The samples have been sent to a national reference laboratory for the detection of GMOs. If the analyses confirm the presence of GMO plants, the destruction of all rapeseed plants present in the area will be carried out and a follow-up of the regrowth will be set up over several years. The local services are in the process of organising this destruction”.In theory, these two entities had done everything possible to avoid the presence of transgenic rapeseed. We seriously question their actions, which proved to be ineffective. This questioning was more than legitimate. Indeed, the Anses “concludes that eradication of the plants by mowing or mechanical clearing is not appropriate. [It] calls for the implementation of manual removal, or any other method allowing a complete destruction of the plants and their roots, at a regular interval allowing to anticipate the flowering of these plants”.Rape seed: a relocated production? The decline in domestic rapeseed production really started in 2018. Imports were therefore quite low, around 17% (872,000 tons in the 2017-2018 campaign for a production of 5.1 million tons)... [10]. Gradually the quantities imported have increased. Hémeline Macret, from the agro-economic research firm Tallage, informs us that “France imported, between July 2020 and June 2021, 1.7 million tons of rapeseed”, from Canada, Australia and Ukraine. In its opinion, Anses notes that “the volumes of GM rapeseed imported by the Saipol plant have increased since 2016,” but that Saipol has refused to make the information public, asking that it be “covered by business secrecy.” However Saipol states on its website that in 2021, 53% of the rapeseed that this company processed came from French fields, 47% from imports [11]. Other information concerning these imports of transgenic rapeseed: “According to the data transmitted by the DGAl, between January 2021 and July 2022, 4 vessels of GM rapeseed were unloaded at the second port terminal: 2 in March 2021, 1 in February 2022 and 1 in July 2022”. Again, this data only concerns the port of Rouen... Partial information therefore.The presence of transgenic oilseed rape is probably too low to worry the public authorities. The Anses, itself, considers “that a possible flow of gene by pollen could only lead to an extremely low rate of contamination given the differences in terms of number of plants between the source of pollen (GM plants at the level of the industrial-port area of Rouen - Grand-Couronne) and the plots cultivated with rapeseed”. However, the various recommendations of the Anses, such as a ten-year or ten-kilometer monitoring, show that this contamination could become problematic. The closest rapeseed fields to the Saipol plant are located between one and five kilometers away, which is “compatible with gene flow through pollen”.The opinion of the Anses is a step in the right direction to avoid the dissemination of a transgenic plant on the territory. However, will the ministry of Agriculture take these recommendations seriously and actually implement them? This pleads for Inf’OGM to conduct new campaigns to ensure the concrete application of these measures...Non-transgenic GMO rapeseed illegally grown in FranceThe transgenic rapeseed discovered in France by Inf’OGM should not mask the important illegal cultivation of non-transgenic GMO rapeseed. France does not respect the judgments of the Court of Justice of the European Union (2018) and the Council of State (2020). These two courts have clearly stated that plants obtained by a mutagenesis technique with no history of safe use should be regulated as GMOs. The Council of State is relatively clear: the so-called “directed” mutagenesis technique and the so-called “random” mutagenesis technique - applied to cell cultures in vitro - are subject to GMO regulations. However, in France, rapeseed made tolerant to a herbicide by a recent mutagenesis technique (random mutagenesis in vitro) is grown illegally.In May 2020, the French government notified the European Commission of two decrees. The first one lists 96 varieties registered in the European catalog by countries other than France and “derived from random mutagenesis in vitro subjecting cultivated plant cells in vitro to chemical or physical mutagenic agents”. For these varieties, the government states that they “will be prohibited from being marketed and cultivated in France, as they have not been evaluated and authorised under GMO regulations”. The second cancels the registration of seven of them on a list in the French catalog of varieties whose seeds intended for marketing outside the European Union can be multiplied on French territory. Unfortunately, these two decrees were never formally adopted. The government is hiding behind the inaction of the European Commission and thus becomes its accomplice. Christophe NOISETTE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [240] => Array ( [objectID] => 6331 [title] => Germany: no government support for GMO deregulation [timestamp] => 1675641600 [date] => 06/02/2023 [annee] => 2023 [url] => https://infogm.org/en/germany-no-government-support-for-gmo-deregulation/ [image] => https://www.infogm.org/IMG/arton7649.jpg?1675679857 [extrait] => In 2023, the governments of the European Union member states will have to vote on the European Commission’s legislative proposal on new GMOs, which will be published in late spring. In a voting system where the weight of a state depends on the percentage of the population it represents, the position of the German government […] [chapo] => [texte] => In 2023, the governments of the European Union member states will have to vote on the European Commission’s legislative proposal on new GMOs, which will be published in late spring. In a voting system where the weight of a state depends on the percentage of the population it represents, the position of the German government could prove decisive in the outcome of the vote. Since the change of government in December 2021, this position is not clearly decided... A little more than thirty years after the first legislation on GMOs, the European Commission is planning to publish a legislative proposal on June 7, 2023, which could radically change the definition and legislative framework of GMOs in the EU. The proposal could lead to the complete exclusion of many GMOs from regulation [1]. Climate change, droughts and loss of biodiversity are some of the reasons put forward to justify the reform of the current policy framework, which is based on the precautionary principle and which ensures traceability and transparency for consumers.At the various meetings of EU Environment and Agriculture Ministers held in recent months, it has become apparent that a majority of Member States support the development and use of new genetic modification techniques. Many have also stressed the need to maintain the precautionary principle and to provide adequate information to the public. Germany’s position on the issue has changed since the parliamentary elections in December 2021. Its vote could prove decisive in the outcome of the Member States’ vote on the European Commission’s proposal.When the federal government supported the European CommissionIn May 2021, at the meeting of the Agriculture ministers of the EU member states, Germany took an unambiguous position: while bearing in mind the precautionary principle, the regulatory framework for GMOs must be adapted in order to take advantage of the new techniques of genetic modification, which are to be considered as part of green technologies and which will make it possible to have “climate-resilient” plants [2].This position reflected that of the majority party in power at the time: Angela Merkel’s CDU. The then Federal Minister of Agriculture, Julia Klöckner, called for “getting rid of ideological blinders” and “being open-minded” about “new breeding technologies that save us an incredible amount of time and which, moreover, are completely indistinguishable from spontaneous random mutations”. In an article published in the Tagesspiegel newspaper, she stated that “(f)or me, the precautionary principle is a valuable asset. However, we must also take into account the current state of science when applying it. Many scientists advocate a differentiated view of new breeding techniques. For the risk assessment of a modified plant, it is not the tool used that is important, but the specific properties worked on - in other words, the product, not the process” [3].At the time, the European Commission seemed to be able to count on Germany’s strong influence to push forward its legislative proposal. But this is not the case anymore since the parliamentary elections in December 2021 following which a coalition government of the Social Democrats (SPD), the Greens (Bündnis 90 / Die Grünen) and the Liberals (FDP) was formed.Government majority against deregulation of new technologiesThe three parties are divided on the issue of GMOs and how to regulate those resulting from new genetic modification techniques. A telling sign is that the coalition agreement does not explicitly mention GMOs and new genetic modification techniques. Nevertheless, the coalition partners commit themselves to “support the breeding of climate-resistant plant varieties” and “to create transparency in breeding methods and and strengthen risk and detection research” [4].In the coalition government, new genetic modification techniques are viewed with skepticism in the Ministry of Agriculture and the Ministry of the Environment, both led by the Greens. The Minister of the Environment, Steffi Lemke, takes the strongest position. At a conference in Brussels in June 2022, the Minister stated that she “does not see the need for new regulation [editor’s note: for GMOs from new genetic modification techniques]” [5]. For the Minister, the Court of Justice of the European Union was very clear in its 2018 ruling: GMOs from new techniques fall under the GMO regulation and their risks for human health and the environment must assessed before being authorised for any use. More recently, on January 17, at the Agricultural Congress organized by the Ministry of the Environment, which was held together with Federal Minister of Agriculture Cem Özdemir and the Executive Secretary of the UN Convention on Biological Diversity, Elisabeth Mrema, the Minister stated that “the efforts of the European Commission to remove the risk assessment for plants produced using new genetic techniques do not put us on the right path. If we work with this technology, the precautionary principle and risk assessment must be maintained” [6]. According to the Minister, genetic modification techniques, whether they be old or new, support the industrial agricultural model from which we must move away.The Ministry of Agriculture is also opposed to the deregulation of new GMOs. A spokeswoman for the Ministry of Agriculture, interviewed by Infodienst Gentechnik, states that the approval procedure for GMOs from new genetic modification techniques must remain as strict as for other GMOs [7]. The Ministry wants “the safety level and transparency to remain unchanged in the future. This means, in particular, that we will adhere to an autorisation process with a case-by-case risk assessment, a strict labeling requirement and traceability”, the spokesperson told Infodienst. She added: “(i)t must be ensured that the freedom of choice of consumers, farmers and the food industry, and thus coexistence, remains guaranteed”. Silvia Bender, State Secretary in the Ministry of Agriculture [8], said that “deregulation [of GMOs from new genetic modification techniques] at the European level would run counter to consumer desires [of transparency and freedom of choice of food, referring to different opinion polls] and I believe we should not do that” [9].A coalition still searching for a common positionThis position is important as the Ministry of Agriculture is the lead ministry for new genetic modification techniques in Germany. It is responsible for reaching a compromise within the federal government ahead of the vote on the Commission’s proposal in the Council of Ministers of the European Union.The Social Democrats of the SPD, who have been entrusted with the chancellery and who have a majority in the Bundestag (lower house of parliament), stand alongside the Greens. As reported by Inf’OGM at the end of 2022, the Social Democrats defend a strict regulatory framework [10]. Indeed, the SPD believes that GMO regulation should apply to all GMOs without exception, including those from new genetic modification techniques, in line with the 2018 CJEU ruling [11]. In 2019, the party already declared that it “does not want the cultivation of genetically modified plants in Europe. For us, the precautionary principle applies, especially to new methods of genetic modification like CRISP/Cas. We reject any weakening of European regulations in this regard” [12]. Recently, during question time with the Government, the Minister of Development, Svenja Schulze (SPD), said that “there are no genetically modified crops that really fight hunger in the world” [13].The Greens and Social Democrats’ position is in line with the arguments of major european food retailers, ranging from discount to organic. In a letter to the European Commission, they asked for new genetic modification techniques to be subject to the same rules as other GMOs [14].Within the coalition, the FDP (Liberals), who are in charge of the Ministry of Research, are the exception and are calling for a relaxation of the rules. Research Minister Bettina Stark-Watzinger says that her party will work within the government for a revision of the European regulation on GMOs “adapted to the risks and the state of science”. In an interview with the Tagesspiegel, she said that “the so-called New Breeding Techniques offer many advantages, opportunities and potentials. If we are to meet challenges such as climate change, food security and sustainable agriculture, we must rely on these advanced technologies” [15].Uncertainty on future discussionsThe European Commission’s proposal not having been published yet, it is difficult to predict the possible majority in the Council. But the Member States will have to vote on the European Commission’s proposal by qualified majority. And, according to this voting system, a proposal must, in order to be adopted, recieve the favourable votes of 55% of the Member States, representing at least 65% of the EU population. Germany alone represents 18.59% of the EU population, which is the largest demographic weight of the 27 Member States.Although a number of Member States have called for a relaxation of the rules for new GMOs (notably France, Spain and Italy, three countries that together represent 39.08% of the European population), the lack of unanimity within the German government coalition adds to the uncertainty regarding the outcome of future discussions on the European Commission’s legislative proposal. Charlotte KRINKE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [241] => Array ( [objectID] => 6334 [title] => For EFSA, risk analysis of GMOs must become the exception [timestamp] => 1673222400 [date] => 09/01/2023 [annee] => 2023 [url] => https://infogm.org/en/for-efsa-risk-analysis-of-gmos-must-become-the-exception/ [image] => https://www.infogm.org/IMG/arton7625.jpg?1673258884 [extrait] => At the end of October 2022, European experts from the European Food Safety Authority (EFSA) published an opinion on the criteria to be followed to assess the risks associated with “plants produced by targeted mutagenesis, cisgenesis and intragenesis”. While they confirm the absence of a history of safe use of these GMOs, they nevertheless recommend […] [chapo] => [texte] => At the end of October 2022, European experts from the European Food Safety Authority (EFSA) published an opinion on the criteria to be followed to assess the risks associated with “plants produced by targeted mutagenesis, cisgenesis and intragenesis”. While they confirm the absence of a history of safe use of these GMOs, they nevertheless recommend that risk assessment be reduced to a minimum. This opinion, which curiously never uses the term GMO, looks like a political order from the European Commission, which should propose, in 2023, a deregulation of these GMOs. Since the 90s, the European Union has made it mandatory to assess the health and environmental risks associated with GMOs prior to their possible marketing. This assessment, which was largely weakened in 2013 [1], concerns theoretically the molecular characteristics of the genetically modified plant, its comparison with the same non-genetically modified plant, its allergic and toxicological potential, etc. Already partially implemented by European experts, as noted by the French committee (Anses) in May 2022 [2], this risk analysis could come to an end in the coming years for a large number of GMOs. Indeed, in 2023, the European Commission could submit a project to deregulate GMOs obtained by “directed mutagenesis and cisgenesis”. In order to carry out this project, it has asked the EFSA what criteria could be followed to continue to ensure a high level of health and environmental safety as it promised [3]. The conclusion represents a real shift in risk analysis.EFSA focuses on the molecule and leaves it to the companiesIt is necessary to highlight that the opinion provided by the EFSA is somewhat original [4]. The mandate received from the European Commission concerned plants modified by “directed mutagenesis, cisgenesis and intragenesis” [5]. These techniques result in regulated GMOs, as the Court of Justice of the European Union (CJEU) recalled in July 2018 [6]. Despite that, neither the European Commission nor, consequently, European experts use this term to designate the plants concerned. Similarly, the current European legislation (Directive 2001/18 in particular) is not cited by the Commission in the mandate given and the experts only refer to it in a particular case, as we will see.Thus, the opinion provided is not subject to any legal framework, which nevertheless does exist. However, the experts take the usual precaution of announcing that their report can help establish guidelines but that “an exhaustive list [of all the cases to be considered] cannot be provided in this statement considering the vast array of products thatcan be generated by targeted mutagenesis, cisgenesis and intragenesis”. And the EFSA specifies that this exhaustive list will focus on the characteristics of the modified genetic sequence only. The plant, as a whole organism, will no longer be analysed, contrary to what the legislation provides for GMOs.The European experts centre their argument on a single question concerning the risks: is a “foreign” genetic sequence present in the genetically modified plant? That this question has no legal basis in the current legislation does not seem to be a concern for the experts. However, the answer to this question is the basis for the requirements that the experts have imagined.In concrete terms, two cases would arise according to them, namely whether the modified plant has a genetic sequence inserted or not. If no genetic sequence is inserted, the only question would be whether it has a history of safe use. In cases it does not have such a history, then a possible analysis of the structure and function of the modified sequence will have to be conducted “carefully”.If a genetic sequence is inserted (only in the case of cisgenesis and intragenesis, according to the European experts), informations will have to be provided on the origin of this sequence, its place and method of insertion in the genome. Only in this case may information be requested, for example, on “the potential [of the modified sequence] to generate a product that may be toxic or allergenic”.And this is where the experts’ recommendations for assessing the risks associated with these GMOs end. The consequence of this approach is to drastically reduce the risk analysis as foreseen by the legislator in the 90’s to the only cases of GMOs with an inserted genetic sequence and to the only description of this sequence. Except in very special cases, no toxicological or feeding analyses, for example, are planned. As shown in a figure in the report, schematizing the experts’ proposal, risk assessment would in fact become the exception.The history of safe use, a response to a political orderFrom a scientific point of view, the European experts are thus proposing to reduce to a minimum the analysis of the risks of plants modified by techniques without a history of safe use. This approach is diametrically opposed to that of the precautionary principle, which was the backdrop to the legislative debate at the end of the 90s, when Directive 2001/18 was being discussed in the European Parliament with the European Commission and the Council of the European Union.Why did EFSA take care to address in detail the issue of history of safe use as a criterion guiding the risk assessment of these GMOs obtained by directed mutagenesis and cisgenesis? The reason is not scientific, but legal. In 2018, the CJEU recalled that techniques without a history of safe use result in regulated GMOs. The European Commission being considering deregulating many GMOs, it needed an “expertise”. The European experts have fulfilled this mission, but in a very paradoxical way.First, they recall that the “demonstration of a history of safe use is based on evidence that some or all of a plant has been consumed in the diet (food and/or feed and derived products) for a considerable time with no evidence of adverse effects being produced”. As an example, they refer to a period of at least 25 years of consumption.Under these conditions, plants obtained by directed mutagenesis or cisgenesis could not be concerned. But the European experts add a consideration. This history does not have to be studied or required only for the genetically modified plant as such. The history of the organism providing the sequence to be inserted (in the case of cisgenesis and intragenesis) or that of the modified sequence itself can be taken into account. They thus detail that if the modified sequence, the new characteristic obtained or the plant that provided the sequence to be inserted (donor plant) have a history of safe use, the new genetically modified plant will benefit from this history by trickling down. For the”donor plant", they even specify that its history could simply come from being used as an intermediate variety in a breeding process.While the European Commission and companies keep claiming that new techniques can reproduce identically what can take place in a conventional or natural way, the European experts provide here an intellectual approach that they have adapted to the deregulation of these GMOs.Off-target effects? Not a problem...A stone remains in the shoe of the experts, that of the unintended effects. It is fundamental because, for a long time now, these unintended effects are put forward by scientists to remind the necessary risk assessment to be conducted, but also to argue the traceability of all GMOs (which is denied by the European Commission and the companies). However, the European experts recall in their report that they had already pronounced themselves on this issue in 2020 [7]. At that time, they indicated that, according to scientific publications, the potential “off-target mutations [...] are of the same type as those mutations used in conventional breeding, including spontaneous mutations and those produced by physical and chemical mutagenesis”. Stating that these off-target mutations are even fewer than in conventional breeding, the experts concluded that”the analysis of potential off-targets would be of very limited value for the risk assessment”.A possible proposal from the European Commission for a new regulatory framework for many GMOs is still expected in 2023. While in 2021 it announced that it wanted the risk assessment and authorization requirements to be proportionate to the potential risks presented by these GMOs, the European experts have now fulfilled this task. This is in spite of its promise in 2021 to maintain “the objectives of the current legislation on GMOs as regards a high level of protection of human and animal health and the environment”... [8] Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [242] => Array ( [objectID] => 6335 [title] => New GMOs: a deleterious link between regulation and patents [timestamp] => 1672963200 [date] => 06/01/2023 [annee] => 2023 [url] => https://infogm.org/en/new-gmos-a-deleterious-link-between-regulation-and-patents/ [image] => https://www.infogm.org/IMG/arton7623.jpg?1673012233 [extrait] => The possible absence of a traceability obligation for “new GMOs” by the European Commission would give patents an unjustified and deleterious scope for farmers and small seed companies, but also for biodiversity and food. In November 2019, the European Council invites the European Commission (EC) to “submit a study in the light of the judgment […] [chapo] => [texte] => The possible absence of a traceability obligation for “new GMOs” by the European Commission would give patents an unjustified and deleterious scope for farmers and small seed companies, but also for biodiversity and food. In November 2019, the European Council invites the European Commission (EC) to “submit a study in the light of the judgment of the Court of Justice in Case C-528/16 concerning the status of new genomic techniques in Union law, and a proposal, if appropriate to take account of the results of the study” [1] [2]. This request is addressed to all legal directorates of the Commission concerned with GMOs, including those dealing with intellectual property rights, including patents.Only the European Commission’s DG Health published a document in response, on 29 April 2021, limited to regulatory aspects [3]. This proposal to amend the current EU GMO regulation is clear: to partially or fully exempt directed mutagenesis and cisgenesis, producing “new GMOs”, from the risk assessment, labeling and traceability requirements that currently apply to GMOs.Regulation impacts the patent sphereThis lack of requirement of traceability of “new GMOs” would have several consequences, not very well highlighted by the experts and the media. In particular, it would affect the application of patent rights. The European Coordination Via Campesina (ECVC) published in early November 2022 a report denouncing this causal link between GMO regulation and patent rights [4]. It stresses that “the disappearance of the traceability requirement [for new GMOs] would lead to an abusive extension of the scope of patents, to the detriment of the guaranteed GMO-free agricultural sector and the rights of farmers and breeders with regard to seeds”. The seed industry fears the rejection of the “new GMOs” by the citizens, as the latter had rejected, in the European Union, the transgenic GMOs at the beginning of the 2000s. It therefore deploys many means to obtain a deregulation that would exempt it from labeling [5]. But it also wants to free itself from another constraint: having to trace the “new GMOs” it produces. This is where the subject of patents comes into play. Not requiring the seed industry to trace the “new GMOs” is equivalent to not having to distinguish them from plants expressing native traits comparable to those expressed by these same “new GMOs”. This would extend - in an artificial way - the scope of the patents covering these “new GMOs” to plants carrying such native traits which could however be distinguished from them if a traceability was provided. It may be noted, in passing, that the seed industry maintains a contradictory position: on the one hand, it asserts that the modifications brought about by “new genomic techniques” generate products similar to natural products (and that they are not distinguishable, dissociable) and, on the other hand, it defends the patentability of these products since they constitute technical products or products obtained by patentable technical means.A deleterious effect at different levelsThe farmers, as well as the small breeders, would be the first victims of this new approach. The means available to the seed industry in terms of “innovation” and valorization - by filing patent applications in particular - are indeed not comparable to those of small entities. Their approaches are also different: while the latter seek to identify new traits by cross-breeding without aiming at patent protection, the seed industry discovers and digitizes genetic sequences that it associates with pre-existing so-called “native” traits [6]. Its computer potential allows it to quickly process thousands of data, identify new patentable genetic information, and program genetic manipulations intended to obtain new seeds without having to work on a physical plant or seed. In this respect, one may question the patentability of this last approach, in particular the validity of the criterion of inventive step. The position of the European Patent Office on this point is itself open to question (see box below).As ECVC points out, the abolition of traceability, and its effect on the application of patent law, would also affect biodiversity: “Six transnational corporations now control more than 60% of the world seed market, reducing most of the cultivated biodiversity to the very limited gene pool they exploit. Any small or medium-sized enterprise that innovates necessarily uses at least one of these genes and thus automatically falls under their dependence: with the amount of licensing fees, the only choice left to these companies is between eliminating themselves from the market or accepting an ‘unbalanced partnership’ followed by absorption”. Imposing traceability is an evidenceIn order to avoid the risk of patent infringement for farmers and small structures, and to avoid restricting biodiversity, the requirement of traceability of GMOs is justified and unavoidable. This would also offer a guarantee for the whole of civil society that the issues of environmental risk (dissemination and contamination) and transparency (informing consumers of the presence of GMOs) are taken into account by the legislator. And the technical means are not lacking [7].Yves Bertheau, an expert on “new GMOs” traceability issues and co-founder of ENGL [8], the European Union Reference Laboratory, states: “All steps of genetic and epigenetic modification, from random mutagenesis in vitro to primary editing and transgenesis, leave detectable traces in varieties and cultivars. [... ] There is no technical bottleneck to trace all types of GMOs and to prove that the intended modifications are or are not artifactual” [9]. The researcher also points to the need for democratic debate on the issue and “a lack of clear political will to respond to consumer demands” [10].Patentability and “native features” The European Patent Office grants patents claiming characteristics of plants that already exist in nature or are already known. It justifies this position as follows: "...mere discoveries are, in general, not patentable, which also applies in the field of plants. Nevertheless, the legislator has decided that a plant obtained by means of a technical process is patentable even when the characteristic concerned (such as color, pest resistance, yield, vigorous growth, etc.) was already present in nature. The purpose is to encourage or reward inventions that involve inserting the characteristic into a plant by means of a technical process and making the related technical teaching available to the public, which is usually much faster and more targeted than with a natural process and thus has many advantages for obtaining plants" [11]. Denis MESHAKA Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [243] => Array ( [objectID] => 6336 [title] => New GMOs – Greenpeace raises awareness among consumers [timestamp] => 1672099200 [date] => 27/12/2022 [annee] => 2022 [url] => https://infogm.org/en/new-gmos-greenpeace-raises-awareness-among-consumers/ [image] => https://www.infogm.org/IMG/arton7610.jpg?1672141686 [extrait] => On Saturday, November 19, Greenpeace activists decided to raise awareness among consumers on the issue of “new GMOs” and invited supermarket chains to demand that the French and European authorities label all GMOs, whether they are derived from transgenesis or another genetic modification technique. This action complements those carried out by the Faucheurs volontaires d’OGM […] [chapo] => [texte] => On Saturday, November 19, Greenpeace activists decided to raise awareness among consumers on the issue of “new GMOs” and invited supermarket chains to demand that the French and European authorities label all GMOs, whether they are derived from transgenesis or another genetic modification technique. This action complements those carried out by the Faucheurs volontaires d’OGM for several years [1]. Greenpeace wanted to raise awareness among consumers and urge supermarkets to act in order that all GMOs, old or new, are clearly labeled. Thus, on Saturday, November 19, the activists of the environmentalist association visited about thirty supermarkets, of different brands, in France (23 cities) [2]. They proposed a “Grand Jeu OGM Surprise”. Participants in this game had to guess which food products might contain “new GMOs”. The “new GMOs” are GMOs produced by new techniques of genetic modification, which the industry tries to trivialize by talking about “genome editing”. The Greenpeace activists therefore proposed that customers write to the supermarket managers “in order to ask them to deman the government the mandatory labeling of new GMOs”. Indeed, these GMOs must be assessed, labeled, monitored, as the European Court of Justice reminded it in 2018 [3]. But a massive offensive by the European Commission, supported by the agri-seed industry, aims to exclude these GMOs from EU legislation [4] “Greenpeace believes that deregulation would go against the freedom of choice of consumers, and that the precautionary principle must be respected: new GMOs must be strictly regulated,” says the association’s press release.Interviewed by Inf’OGM, Suzanne Dalle, in charge of the “Agriculture” campaign at Greenpeace France, tells us that “the managers who were met with were very much in favour of listening and open (there were nevertheless two supermarkets where the activists could not stay). And the consumers reacted globally very well. Most of them were not aware of the issue. This allowed us to get several hundred cards signed, which will then be progressively given to the supermarket managers”.She also specifies that “91% of French people believe that supermarkets should be transparent and clearly display the presence of new GMOs on their products. Thanks to the mobilization of our activists throughout France, we have succeeded in bringing this demand to the attention of supermarkets. We now invite them to also demand that the government implements the mandatory labeling of all GMOs, including new ones” [5].In Germany, the German Federation of Consumer Associations asked the European Commission to enforce the precautionary principle to “new GMOs” [6]. Christophe NOISETTE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [244] => Array ( [objectID] => 6339 [title] => « GMO-herbicides » duo: long-term industrial prospects [timestamp] => 1668988800 [date] => 21/11/2022 [annee] => 2022 [url] => https://infogm.org/en/gmo-herbicides-duo-long-term-industrial-prospects/ [image] => https://www.infogm.org/IMG/arton7571.jpg?1668590575 [extrait] => The vast majority of genetically modified plants (GM plants) grown in the world have been modified to be herbicide tolerant. The use of these plants poses many problems, including environmental ones, and the emergence of many weeds that are also tolerant. A South Korean study of the agrochemical industry’s patent applications suggests that the industry […] [chapo] => [texte] => The vast majority of genetically modified plants (GM plants) grown in the world have been modified to be herbicide tolerant. The use of these plants poses many problems, including environmental ones, and the emergence of many weeds that are also tolerant. A South Korean study of the agrochemical industry’s patent applications suggests that the industry intends to continue developing “GMO-herbicide” duos. In 2019, 88% of transgenic plants grown worldwide are tolerant to one or more herbicides, the vast majority of which are glyphosate [2] (see box below). Examples include soybeans, maize, oilseed rape, cotton and rice. The herbicides that transgenic plants ’tolerate’, such as glyphosate or glufosinate ammonium, are non-specific. As a result, their use has become widespread, and herbicide doses have increased. Many weeds have themselves become tolerant to these molecules. In addition, many varieties of rapeseed, sunflower, rice, beet and wheat derived from mutagenesis have been made tolerant to various other herbicides (VrTH). Some of these are not labelled as GMOs, such as the Triazine-resistant OAC Triton oilseed rape [3].Some companies hold the majority of rightsTwo companies in the Corteva group, Pionneer Hi Bred Int. and Dow Agrosiences, have a combined total of 889 patent applications, two-thirds of which are in the US alone. Monsanto and its parent company Bayer have 706 patent applications in a portfolio that is more internationally oriented, as are Syngenta (389) and BASF (339), ranked third and fourth respectively. The South Korean study also provides filing statistics for the top 20 patent filers. Trends in the number of filings and applicants are also detailed for different sub-periods of the study period.Since 1985, over 90% of herbicide tolerance patent applications have been filed in the USA (2066; 55.3%), China (389; 18.8%), Europe/CBE [4] (296; 9.2%), Japan (163; 5.%) and South Korea (102; 3.1%).The South Korean study identifies “standard stages of technology development” reflected by the content of patent applications for herbicide tolerance genes. Since 2010, the number of patent applications for herbicide tolerance genes globally has been declining by about 17% and, for the first time, a downturn in the number of applicants is observed in the period 2015-2019. The study describes this as a “reflux stage” and offers an explanation: "many patent applications were filed in the early development of herbicide resistance genes (Editor’s note: "introduction stage" according to the study), but as competition intensified, only two or three companies filed applications and the number of applications declined [...] this period of decline may be due to a reduction in technology development due to standardisation of technology". Analysis of the progression of these stages leads the South Korean researchers to conclude that there would be no choice but to move towards a “stabilisation of the system [of conquering the herbicide resistance gene market] in a monopolistic position”.The results of this study seem to reveal a strategic move by the oligopoly of multinational seed companies (Corteva, Bayer, BASF...): in view of the drying up of possibilities for the development of new chemical herbicides, to choose to concentrate in their hands as many patent rights as possible on the main industrially exploitable herbicide tolerance traits.Glyphosate on its way out?Soybeans are the crop with the highest number of patent applications in the US (1067), as well as in the countries surveyed as a whole. However, as with wheat, oilseed rape, cotton and carnation, the number of patent applications is declining. In the Asian countries, China, Japan and South Korea, rice is the subject of the majority of patent applications (271).Of all the herbicide tolerance genes analysed by the study, and described in the diagram and table below, four are covered by about 75% of patent applications: ALS, EPSPS, AHAS and HPPD. However, this number of applications is gradually declining over the last period studied, from 2015 to 2019. The presence of the PAT and ALS genes tends to increase in patent applications, which could be interpreted as long-term choices in favour of glufosinate and sulphonylureas as alternatives to glyphosate. Is this because of the tolerance to glyphosate developed by weeds and the proven toxicity of this herbicide for humans and the environment? [5]. For these reasons, one can worry about the future of our food, in particular the preservation of its diversity.Herbicide tolerance, how (...)Herbicide tolerance, how does it work?GM plants become tolerant to a herbicide through genetic modification or conventional crosses making them less sensitive to these compounds. In general, either the plant produces a new protein that degrades the toxic molecule, or the protein normally targeted by the herbicide is replaced by a new protein that is not sensitive to that herbicide.The herbicides classically used on herbicide-tolerant GMOs (glyphosate, glufosinate, imidazoline, etc.) are said to be “broad-spectrum” because they are toxic to most plant families. Weeds, also called “weeds”, which nevertheless appear at the end of the crop are generally eliminated mechanically.In addition to the pollution resulting from their use, the techniques for developing herbicide-tolerant GMPs pose a problem, particularly in terms of effectiveness. To the point of having to add new tolerance genes to other herbicides but also to genetically modify GMOs to eliminate herbicide residues in their tissues [6]. Denis MESHAKA Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [245] => Array ( [objectID] => 6340 [title] => GMOs: will the CJEU uphold its 2018 ruling? [timestamp] => 1668556800 [date] => 16/11/2022 [annee] => 2022 [url] => https://infogm.org/en/gmos-will-the-cjeu-uphold-its-2018-ruling/ [image] => https://www.infogm.org/IMG/arton7568.jpg?1668432476 [extrait] => On October 27, 2022, Maciej Szpunar, Advocate General of the Court of Justice of the European Union, delivered his opinion in a case initiated in November 2021 by the French Council of State. For him, the Court should simply ignore the questions posed by the Council of State and rule that GMOs obtained by “in […] [chapo] => [texte] => On October 27, 2022, Maciej Szpunar, Advocate General of the Court of Justice of the European Union, delivered his opinion in a case initiated in November 2021 by the French Council of State. For him, the Court should simply ignore the questions posed by the Council of State and rule that GMOs obtained by “in vitro random mutagenesis” are not subject to the requirements of European legislation. This approach is based on a confusion between the history of safe-free use in the laboratory and the same history in the open environment! On October 27, 2022, the Advocate General of the Court of Justice of the European Union (CJEU) proposes to exempt products derived from “in vitro random mutagenesis” from the requirements of European GMO legislation. As the organizations behind this legal drama point out, they fear that if the Court follows this opinion “a major loophole would be opened up allowing a large number of new GMOs to invade the market, fields and plates without any assessment, labelling or monitoring”. In order to understand what is at stake in the Advocate General’s opinion, it is necessary to briefly retrace the major recent legal steps in the GMO dossier.Since 2010, the question of which techniques should benefit from the exemption provided for in Directive 2001/18 has been raised in Europe. A ruling by the Court of Justice of the European Union recalled in 2018 that any GMO obtained by a technique of mutagenesis that does not have a history of use without risk linked to traditional use must be regulated as a GMO. This implies an obligation of risk assessment, specific authorization, labelling, traceability and post-marketing monitoring... It clarified that this concerns all “new techniques/methods of mutagenesis which have appeared or have been mostly developed since Directive 2001/18 was adopted”. This ruling strongly displeased the industries and the European Commission who hoped to be able to make invisible GMOs produced from these famous new techniques of genetic modification. Following the CJEU ruling in 2018, the European Commission therefore sought to rewrite history and the law...Yet the story is simple, obvious because, to implement the 2018 CJEU ruling, it is therefore sufficient to inform whether a technique of genetic modification has a well-established history of safe use, or not. This issue was decided in 1992 by the European Commission itself. In a document dated 1992, it clarified the concept of traditional breeding [1]. This document states that “techniques applied at cellular or molecular level” do not fall within the scope of traditional techniques, unlike “undirected mutagenesis techniques” in vivo. This document is curiously ignored today by everyone, including the Commission itself and the Advocate General.Following this ruling of the CJEU, the french Council of State, in February 2020, noted on the basis of the “documents in the file” that “both the techniques or methods known as ’directed’ or of ’genome editing’ and the techniques of in vitro random mutagenesis subjecting plant cells to chemical or physical mutagenic agents (...) appeared after the date of adoption of Directive 2001/18/EC or have been mainly developed since that date”. It therefore enjoined the French government to withdraw from the catalog and from the market the varieties carrying a GMO trait obtained by such techniques and which it had registered without having first required a European authorization as GMOs.A political controversySince then, in France, the government has drafted three regulatory texts aimed at transposing this ruling into French legislation on GMOs and excluding undeclared GM varieties from the list of varieties authorized for marketing. Although these texts remained at the draft stage, they provided the European Commission with the opportunity to create a controversy as to the scope of the CJEU ruling by stating in 2020 to the French government that it would not be legal to establish a distinction “between in vitro and in vivo mutagenesis” [2]. This position is therefore contrary to that of the French Council of State, as well as to that of the European Commission, which was stated in 1992.As the government has done nothing since the notification of its draft regulatory texts, the french Council of State returned to the CJEU in November 2021 to make it clarify its 2018 ruling with two general questions. The CJEU’s answers would allow for the implementation of Directive 2001/18, regardless of the GMOs showing up at the EU’s doors. The Council of State wishes to know whether, in order to identify techniques of mutagenesis that have traditionally been used for various applications and whose safety has long been proven, one should “consider only the ways in which the mutagenic agent modifies the genetic material of the organism” or, on the contrary, “take into account all of the variations in the organism induced by the process used, including somaclonal variations, which may affect human health and the environment”. It also asks how to establish the history of safe use of a technique. Concerning in vitro random mutagenesis on plant cell culture with mutagenic agent, it notes that “there is very little evidence of agricultural use of these varieties during this period [1980s and 1990s], whereas only field use seems relevant to ensure the safety of the release of genetically modified organisms into the environment”. Should therefore only be considered field crops of plants obtained by these techniques or should be established the history by integrating the research work prior to these crops? In the end, the Advocate General proposes that the CJEU should not answer these two questions.The Advocate General validates the finding that there is no history of use but...The Advocate General simply proposes “that the Court should answer the questions for a preliminary ruling referred by the Conseil d’État (Council of State, France) [stating that] (...) random mutagenesis applied in vitro comes under point 1 of Annex I B to that directive”. It relies on an information provided by the French government and the European Commission in particular, stating that “plant varieties resulting from in vitro mutagenesis (...) have been marketed since the beginning of the 1990s, that is to say, well before Directive 2001/18 was adopted”. This statement is in line with the observation made in 1992 by the European Commission itself, as we have seen. Thus, by specifying that such varieties “have been marketed since the beginning of the 1990s”, the Advocate General, the European Commission and the French government confirm that these GMOs were not developed before that date. They were therefore developed at the same time as transgenic GMOs marketed on a much larger scale during the same period. These GMOs should therefore be subject to the 2018 ruling of the CJEU by regulating such varieties as GMOs in the same way as transgenic varieties. However, since the intention is rather to deregulate these GMOs, the Advocate General has opted for a circumvention strategy that results in asking the CJEU to overrule itself.Thus, in order to conclude as he will that these GMOs should be excluded from the scope of the legislation, he explains that in 2018, the CJEU “did not rule expressly on the method of random mutagenesis applied in vitro”. A surprising statement because, in 2018, the CJEU had taken the general view that organisms obtained by means of new techniques/methods of mutagenesis that have emerged or have mainly been developed since the adoption of Directive 2001/18 cannot be excluded from the scope of the latter.To justify his wish to exclude these GMOs from regulation, Maciej Szpunar has set out general principles to try to make people believe in a long history of proven safety by confusing development in a confined environment (the laboratory) with dissemination in the environment (field trials and marketing). He writes that “In the course of the 20th century man mastered the technique that enables mutations to be caused, with the help of chemical or physical factors” or that “random mutagenesis” is also called “traditional mutagenesis”.This convoluted approach reaches its climax when the Advocate General quotes the french Scientific Committee of the High Council for Biotechnology, which states that “mutagenesis induced in vitro was developed in the 1960s-1970s, including on isolated cells from 1974 onwards, in particular on rapeseed varieties marketed on a large scale since 1992”. However, this date of 1974 refers to laboratory work and not to various applications in an open environment, which are the only ones capable of demonstrating proven safety, provided that they have been developed for a long time. And the only precise date, which the Advocate General himself has taken up as we have seen above, of a first development in an open environment, is 1992. That is to say, at a time when GMOs without a history of safe use were already regulated by a directive that deals with release into the environment, as its title, Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms, clearly indicates. A title which will be taken again clearly in 2001 to name the directive 2001/18 replacing the directive 90/220: Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.The Advocate General proposes not to respond to the Council of State!Maciej Szpunar also tries to change the debate on the desk of the CJEU. He explains, on the basis of an opinion of the european experts of the European Food Safety Authority (EFSA), considering that “in vivo random mutagenesis and in vitro random mutagenesis are not two distinct techniques of genetic modification but the same technique, namely induced random mutagenesis, which may be applied to various types of materials, such as entire organisms or parts of organisms, tissues, calluses, cells or protoplasts”. He also recalls that the same EFSA report concludes that “the distinction between varieties resulting from in vivo and in vitro random mutagenesis is not justified” because the nature of the genetic modifications obtained would be the same according to the European experts. For him, a distinction between “in vivo random mutagenesis and in vitro random mutagenesis” would therefore be “without scientific basis”. Subtly, the Advocate General questions the ruling that the CJEU issued in July 2018.Since, in his view, it is “the same technique”, he considers that resolving the disagreement between the parties depends “on the answer to be given to the question whether the method of random mutagenesis applied in vitro must be excluded from the scope of Directive 2001/18”. He therefore proposes to ignore the questions of the french Conseil d’Etat, which would allow the CJEU to formulate a general answer of correct reading of the law. According to his opinion, the CJEU should therefore replace the European Commission in dealing with the specific case of GMOs obtained by “random mutagenesis applied in vitro” by stating abruptly that they are excluded from the requirements of the directive.A reformulation by the CJEU of the questions raised by the french Council of State is certainly legally possible. On the basis of the questions raised and the submissions received from the parties involved in the case, the judges of the Court may consider that the questions formulated are not relevant to allow a constructive response from them. And if they reformulate these questions, the stakeholders are not necessarily invited to re-file a brief on these new questions. But whether such rephrasing is warranted in this case remains to be seen.The ruling of the Court of Justice of the European Union is now expected, possibly at the beginning of 2023, just before or at the same time as the proposal announced by the European Commission on a new regulatory framework for GMOs obtained by “directed mutagenesis and cisgenesis”. In the meantime, while the seed companies have not yet communicated on this opinion of the Advocate General, the French organizations that initiated the procedure at the Council of State and thus at the Court of Justice of the European Union have reacted to his conclusions [3]. They believe that the Advocate General’s argument is based in part on studies that “do not take into account the plants that are actually grown and consumed, nor the definition of GMOs established by the legislator, which concerns entire plants”. Faced with this desire to go against European law and to deregulate GMOs obtained by random mutagenesis implemented on plant cell culture with a mutagenic agent, they hope that “the CJEU will return to the strict application of the intention of the legislator, who never wanted to exempt from GMO regulation plants obtained by new genetic modification techniques that appeared and were developed in the 1990s”. Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [246] => Array ( [objectID] => 6341 [title] => GMOs: the corporate communication department to the rescue [timestamp] => 1668384000 [date] => 14/11/2022 [annee] => 2022 [url] => https://infogm.org/en/gmos-the-corporate-communication-department-to-the-rescue/ [image] => https://www.infogm.org/IMG/arton7565.png?1668416298 [extrait] => Between December 2021 and July 2022, the European Commission met with the seed and biotech industries to discuss the proposed deregulation of many GMOs. Documents from the European Commission obtained by the European Corporate Observatory (CEO), which Inf’OGM was able to read, shed light on the legislative intentions of this body. They also show that […] [chapo] => [texte] => Between December 2021 and July 2022, the European Commission met with the seed and biotech industries to discuss the proposed deregulation of many GMOs. Documents from the European Commission obtained by the European Corporate Observatory (CEO), which Inf’OGM was able to read, shed light on the legislative intentions of this body. They also show that the Commission has advised companies to communicate in order to get support for a new framework for GMOs and the “new GMOs” themselves. This [european] Commission is in favour of innovation and the development and use of New genomic breeding technologies as a means to support the shift to a more sustainable agricultural production". This is how the European Commission’s Directorate General for Agriculture (DG Agri) planned to start a meeting on July 27, 2022 with Euroseeds, an organization representing the seed industry.A framework for a “sustainable” food systemThe Green deal and the Farm to fork strategy [1] underline the European Commission’s intention to legislate for a “sustainable” agriculture. The Commission explained to Euroseeds its intention to propose a European framework directive for a sustainable food system. Such a framework directive would aim to lay down the general principles of sustainability with the objective of integrating this sustainability into policies related to food and agriculture. For example, an ongoing legal initiative on plant and tree breeding material will specify “sustainable” characteristics of varieties that allow “more efficient use of water or resistance to plant pests”.The link between “future legislation on new genomic techniques” (NTG) and seed legislation is not yet defined according to DG Agri, but could exist. DG Agri explained to Euroseeds that, regarding commercial authorizations or registrations of varieties, a two-step approach is likely. Thus, “once [genetically modified] traits have been authorised by the possible new legislation, the [seed] legislation will examine and register varieties in which such traits are incorporated”. The European Commission’s DG Health has already communicated its intention to add a sustainability criterion both to the assessment for deciding whether or not a new GMO should be regulated and to the assessment for the registration of new varieties in the Official Catalogue. This concept has already been included in the European legislation on the “sustainable use of pesticides” since 2009, which has not led to any reduction in their use. Moreover, DG Agri received Corteva in April 2022 [2] and invited it to “engage with Commission’s services (DG SANTE mostly) and the EU legislator on the revision of the sustainable pesticides directive and the revision of the GMO legal framework”. We therefore learn that the Commission has also in its plans for 2023 to modify this legislation on the use of pesticides, in package with seeds and GMOs.In short, the European Commission’s objective is clearly aligned with the demands of the industry. In another interview with Bayer, she summarized that “our legal framework must make sure that suitable NGT varieties - which are not GMOs - once available will be grown in Europe”.Promises as criteria for sustainability?Very few of these “new GMOs” are present on the global market today, and few are in the final stages of development, ready to be commercialized. However, they are the subject of numerous patents. Why should these new GMOs be “sustainable”? For the European Commission, the promises made by the companies are being taken up. The new plants announced would be “more resistant to diseases, environmental conditions and the effects of climate change”. But the sustainability of these GMOs is also linked to the fact that they “may also require less agricultural inputs like pesticides”. This is an old promise, already made with transgenic GMOs, which has never been confirmed in the reality of the fields, but which opens the way to assume that insecticide or herbicide-tolerant GMOs could be considered as “sustainable”.Corporate communication departments mobilizedAnnounced for the second quarter of 2023, the European Commission’s legislative proposal for GMOs obtained through directed mutagenesis or cisgenesis will be discussed. Acknowledging that this is “a very sensitive issue”, the European Commission believes that “communication will be key to make any possible proposal acceptable”. DG Agri has therefore told Euroseeds that “Industry has a key role to play in communicating that the two technologies of focus (targeted mutagenesis and cisgenesis) bring benefits for the society”. For DG Agri, the role that Euroseeds can play in educating the public about the new techniques is also important. It believes that some themes should be highlighted: the accessibility of these techniques to all companies, large or small; their usefulness for many crops and not only corn, soybeans, rapeseed ...; the acceptability of modified seeds that should not be hindered by industrial property ... DG Agri also tells Euroseeds that “Linking [new techniques] to food security is not helpful. This was done with GMOs in the past and ultimately the promises made were counterproductive”. For DG Agri, “it is important not to promise more than what the technology can deliver”.BASF received the same request as Euroseeds. DG Agri explained to the company that “the Commission today would be much more open to NBTs than in earlier times, provided some conditions related to human and environmental health are met. Social acceptability is very important. Big companies as BASF [...] need to explain advantages to the public”.Same companies, same promises, same “threatsThe documents analyzed by Inf’OGM show that the communication departments of these companies and the organizations that represent them are ready to help the Commission to try to obtain the acceptability of the new GMOs by the public through communication and advertising. Among their arguments, there are the same promises as in the 90s and 2000s for transgenic GMOs, adapted to the current international context. But also the same threats.In May 2022, Bayer explained to the European Commission that the global food system is currently under”unprecedented and incommensurable pressures". But, Bayer insists, the war in Ukraine and its consequences should not overshadow “efforts for climate protection and biodiversity”. As a supplier of corn, soybean and wheat seeds, Bayer believes it bears “a great responsibility that goes beyond the business world”. Bayer therefore explained to DG Agri that it is “making every effort to live up to our responsibility to help produce greater yields with fewer inputs [and] secure food supplies in a world with a population growing towards 10 billion people affected by conflict, climate change, COVID-19, and rising costs”. But Bayer, in order to fulfill this role as savior of humanity, stresses that this “will not be achievable without innovations such as genome editing, digitalisation, and bio-fertilisers”.A month earlier, during a meeting with DG Agri in April 2022, Corteva was just as subtle in calling for the deregulation of GMOs. It stated that the use of new genetic modification techniques “is currently blocked by the European Union” and that the industries are “looking for a positive signal from the EU (as well as guidance) on the future legislation in order to start investing”. These new techniques, according to Corteva, “could benefit the organic sector as well” (see box). They “could have a role to play in food security” since they are needed to “unlock genetic progress, they are useable on large arable crops as well as smaller crops such as flax, potatoes, sugar beet, etc.”. In terms of communication, the company finally explained to DG Agri that it was "trying to reach out the sceptics ("yes but" people) to address the concerns".In the end, Euroseeds and BASF were the most forthright about the negative consequences that they believe a regulatory framework for products obtained by these new techniques as GMOs could have. Euroseeds imagines that “companies may leave Europe if the direction taken in Europe for NGT is not the same as in other parts of the world”. BASF, for its part, explains that “a regulation as GMOs would severely increase development and authorisation costs in comparison with a non-regulation. [... and] may provoke a drop of investment”. BASF’s demand is simple: “products that are identical but have been developed with different breeding methods (NGTs or conventional) should be regulated the same way”. This demand is reflected in the European Commission’s scenarios published this fall [3].Focusing on organic farmingCorteva claims that new genetic modification techniques “could benefit the organic sector as well”. The specifications for organic farming currently exclude the use of GMOs, but this does not seem to be a problem for the company. Or perhaps the future proposal for legislation from the European Commission will resolve this contradiction? This remains a possible hypothesis since, in July 2022, DG Agri addressed the problem of coexistence between NTG crops and organic crops by recalling that “The current organic legislation is very clear. GMOs are not authorised in organic production”, but “concerning the future framework [...], this is still open”. For DG Agri, the problem of coexistence between organic farming and farming using new GMOs will “will largely depend on the new legal framework (will we have specific labelling rules? Etc.) but also on the acceptance of NGT seeds by society”. Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [247] => Array ( [objectID] => 6343 [title] => FSC label: towards acceptance of GMO trees? [timestamp] => 1664236800 [date] => 27/09/2022 [annee] => 2022 [url] => https://infogm.org/en/fsc-label-towards-acceptance-of-gmo-trees/ [image] => https://www.infogm.org/IMG/arton7530.jpg?1664291815 [extrait] => The Forest Stewardship Council (FSC) is one of the world’s largest certifiers of ’sustainably harvested timber’. Since 1995, it has banned genetically modified trees, which limits de facto their development and marketing. Indeed, this label covers very large areas of forest and involves the main companies in the timber industry. However, the FSC has been […] [chapo] => [texte] => The Forest Stewardship Council (FSC) is one of the world’s largest certifiers of ’sustainably harvested timber’. Since 1995, it has banned genetically modified trees, which limits de facto their development and marketing. Indeed, this label covers very large areas of forest and involves the main companies in the timber industry. However, the FSC has been trying for some years, under pressure from paper companies, to limit this ban. Recently, it proposed a new definition of GMOs that excludes those resulting from new genetic modification techniques. The FSC General Assembly in 2025 will be decisive in confirming this proposal or not. The Forest Stewardship Council (FSC) has been opposed to genetically modified trees for more than two decades. However, from the outset, the label has left open the possibility of adapting or even restricting the ban. Thus, in June 1999, “the [FSC] General Assembly reaffirms its support for the current ban on the use of GMOs by certified forest operations but, recognising the increasing intensity and complexity of the debate, mandates the Board of Directors to a) clarify the existing definition of GMOs and b) complete the drafting of the FSC GMO policy” [1].Historically, no crops but some trials of GM treesA few months later, in 2000, the FSC interpretation of the definition of a GMO was published [2]. This non-binding document recalls the ban on GMOs... Inspired by the European directive 90/220, it takes up the definition and exclusions but mixes the two types of exemptions provided for by the directive. The FSC refers only to “techniques (...) [which] are not considered to result in genetic modification” (Annex IA), namely: in vitro fertilisation, conjugation, transduction, transformation or any other natural process, induction of polyploidy, mutagenesis, cell fusion (including protoplast fusion) of plant cells where the resulting organisms can also be produced by traditional breeding methods". However, Directive 90/220 considers mutagenesis and cell fusion to be techniques of genetic modification but excludes them from its scope (Annex IB). The difference is significant. The document goes on to state that “certification bodies will impose preconditions or conditions on applicants for certification, where applicant forest management units use or contain GMOs in their management, production or research programmes. They will impose similar corrective action requirements on certified forest management units that use GMOs”. The document, which balances the two, states that GM trees have great potential and risks and that “many of the potential negative effects may result from field research, even research designed to test for such effects”. It therefore proposes that “GMO research cannot be included in certified forests”, even though “guarantees and restrictions on such research, to enable confident prediction, assessment and avoidance of risks, are not yet formulated or agreed”. The document therefore recommends that because of “the difficulties of avoiding the spread of transgenes” "such research should be conducted in the laboratory or in extreme isolation". Furthermore, the same document argues that “FSC guidelines, strictly interpreted, do not preclude GMO research as such, but only FSC approval of forests containing such research”. The document concludes by pointing out that “some stakeholders have suggested that FSC should allow greater flexibility towards certain genetic modifications under research, which may offer environmental, social or economic benefits, without risk to FSC objectives”.With whom can the CSP associate?The FSC does not certify companies but forests. However, the FSC has gradually sought to clarify which companies it wishes to work with. This has led FSC to produce a document entitled ’policy for association’. In July 2009, the FSC Board of Directors, at its 51st meeting, stated that “FSC will only allow association with organizations that are not directly or indirectly involved in the following unacceptable activities: (...) e) Introduction of genetically modified organisms into forest operations” [3] and in 2021 [4]). Beforehand, this company and its subsidiary FuturaGene have been conducting field trials since 2012, in particular with a view to preparing their application for authorisation. The FSC should logically have excluded this company. The FSC wrote in 2015: “The authorisation to commercially deploy the GMO clone does not put Suzano in conflict with the FSC rules as long as it does not use it. However, if Suzano proceeds to plant GMO trees commercially, FSC would initiate a formal process under our association policy, leading to a disassociation from the company” [5]. The ’regulatory’ field trials are for commercial purposes. Suzano needs to conduct such trials to support its application for commercial approval. These are not trials conducted by independent scientists, but by the company itself. In other words, it is a necessary step in the commercial authorisation process. In 2021, the FSC is organising a public consultation on proposals for the evolution of its document “policy for association”. This consultation is mobilising social movements, particularly those opposed to GMOs. Thus, the Global Forest Coalition is asking for a massive response. On its website [6], which was supposed to have taken into account the comments from the public consultation. The ambiguity that was raised from the beginning has been removed. This document explicitly allows field trials: “FSC aims to partner with individuals and organisations aligned with FSC’s mission and values and will not allow a partnership if the individual, organisation or its business group is or has been engaged in the following unacceptable activities: (...) - Introduction or use of genetically modified trees for purposes other than research (which may include field trials), e.g. for commercial purposes”.FSC pro-GMO experts?In 2022, FSC also published a paper on “a learning process” in relation to GMOs [7] “FSC intends to use this knowledge to determine whether it can develop a governance model that ensures rigorous safeguarding, risk management and shared value creation for genetic engineering in forestry in non-FSC certified areas. The knowledge gained will also be used to update existing policies and enable informed decision-making for FSC and its members on issues related to future developments in genetic engineering in forestry”. In other words, the FSC wants to develop its own “governance model” of “guarantees” that it will require companies to follow when conducting field trials of GMO trees. However, if the FSC oversees GM tree field trials, it will be involved in any direct or indirect negative environmental impacts of these field trials, as well as any social, economic and cultural impacts. This can undermine its neutrality and independence. More concretely, this FSC ’learning process’ is a first step towards the acceptance of genetically modified trees. FSC claims that the learning process will help it to discuss whether or not FSC should allow member companies to commercially plant GM trees (in non-certified areas). The FSC is therefore very interested in engaging in a dialogue with biotech companies to obtain information from them and then to establish its own specifications. It says that “in phase two of the learning process (multi-year learning project), companies approved to participate will plant trees outside the FSC certified area. This planting would be for learning purposes and this phase of the process would be practical and field-based, under the control and evaluation of the expert panel and annual compliance decisions by the FSC Board, based on the expert panel reports”. The FSC is therefore clearly encouraging the establishment of field trials. Will it also consult with organisations that are reluctant or critical of GMOs or will it limit its learning to companies already involved in field trials? This learning process mobilises a panel of experts, appointed by the FSC, with a very relative neutrality. Thus Jason A. Delborne works on the social acceptability of GMOs for conservation such as the famous genetically modified chestnut tree, and as such was a member of the IUCN expert panel [8]. In 2021, he was appointed [9] a member of the American Association for the Advancement of Science (AAAS), which is very supportive of biotechnology [10] [11] [12]. Steve H. Strauss “directed the [Oregon State University] Biotechnology Outreach Program between 2004 and 2013, which aimed to promote public understanding and facilitate science-based public discussion of biotechnology” [13] and, in this capacity, he has “helped large companies in the oil and gas, mining and manufacturing sectors prepare their energy transition and circular economy strategies”. In concrete terms, he is actively involved in the social acceptability and greenwashing of polluting industries. Andrew Blackwell, also an expert on this panel, also works for 3sustainibility, and is a consultant for Arcadis, a huge consultancy firm that, among other things, has worked with Syngenta [14]. Finally, Keith Robert Hayes is a researcher at CSIRO in Australia, a relatively biotech-friendly scientific organisation. He has recently studied the spread of sterile male mosquitoes [15]. His work was used by Target Malaria to support their biosafety application and was funded by, among others, the Bill and Melinda Gates Foundation [16] [17]. In the page on this “learning process”, the FSC has taken care to differentiate between genetic engineering, “a process that changes the genetic structure of an organism by removing or introducing DNA” and gene editing, “a different process in which genetic material is removed or altered at certain points in the genome of a plant”. It is thus clearly stated that “genetic engineering takes the gene directly from one organism and transmits it to the other. The result of genetic engineering is called a genetically modified organism”... So, for the FSC, gene editing does not result in GMOs. From this “process”, as the FSC specifically states, it “will update its policy on the interpretation of GMOs to reflect the current state of research as the policy (developed in 2000) is outdated”. In some 20 years, the FSC has moved from strict opposition to an undisguised openness to field trials which it will “monitor” itself... The “process” and the modification of the GMO policy should be completed by the 2025 FSC General Assembly... Christophe NOISETTE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [248] => Array ( [objectID] => 6344 [title] => Objective 2030: deregulate most GMOs in Europe? [timestamp] => 1663286400 [date] => 16/09/2022 [annee] => 2022 [url] => https://infogm.org/en/objective-2030-deregulate-most-gmos-in-europe/ [image] => https://www.infogm.org/IMG/arton7512.jpg?1663316493 [extrait] => On 22 July 2022, the public consultation conducted by the European Commission on a potential future differentiated framework for GMOs obtained by “directed mutagenesis and cisgenesis” ended. At the same time, a targeted consultation of various European stakeholders was held by a consultancy firm mandated by the European Commission. According to the questionnaire sent out […] [chapo] => [texte] => On 22 July 2022, the public consultation conducted by the European Commission on a potential future differentiated framework for GMOs obtained by “directed mutagenesis and cisgenesis” ended. At the same time, a targeted consultation of various European stakeholders was held by a consultancy firm mandated by the European Commission. According to the questionnaire sent out by this consultancy, the European Commission envisages a complete deregulation of many GMOs by 2030. In September 2021, the European Commission has launched a legislative procedure that could lead to a major change in the regulatory framework of GMOs in the European Union. As part of this procedure, a public consultation was organized from April 22 to July 22, 2022. The highly biased questions in this consultation [1] suggested that the European Commission had a preference for adopting a more flexible regulation for GMOs obtained by “directed mutagenesis and cisgenesis”, which are covered by this legislative procedure. Only 2300 participants responded to the consultation [2]. In a previous consultation on the same subject at the end of 2021, 70,000 responses were collected and published online. They were highly against a change in the regulatory framework [3]. Recent revelations confirm the impression that this new public consultation was purely procedural. In parallel, the European Commission is conducting a confidential survey of selected stakeholders. A survey that is even more precise on some of the regulatory options it is considering...A confidential targeted surveyAn open letter from the European Greens/EFA parliament group has informed the public that a survey of selected stakeholders is being organized by the European Commission regarding the future regulatory framework of GMOs. It is a parallel investigation, conducted while the public consultation was still ongoing. In this letter dated 20 July 2022 [4], the Green MEPs informed the European Commission of "views on the European Commission’s plan to introduce a separate legislation for genetically modified (GM) plants produced by certain “new genomic techniques”, as set out in the (then) ongoing public consultation and targeted survey for the impact assessment”. However, the content of this “targeted survey” had no public existence until then. This survey was not announced by the European Commission on the portal dedicated to public consultations and even less on the page reserved for the public consultation on the legislative initiative on GMOs obtained by directed mutagenesis and cisgenesis. However, an article published on 21 July 2022 by the English-language news website GM Watch reveals the different scenarios that the European Commission is considering and that it has never publicly mentioned to date [5]. It is easy to understand why, since, as we shall see, these scenarios reveal what is behind the reassuring discourse that the European Commission has always maintained publicly.The scenarios envisaged by the CommissionThe questionnaire begins with general questions on the impacts of GMOs obtained by directed mutagenesis and cisgenesis, and then asks the respondents about the three scenarios that have been developed. This is an opportunity to understand how far the European Commission envisages possible legislative developments between now and 2030 - 2035. In broad terms, it appears that the Commission wishes to formalize two notions that have been present in its discourse for several months, if not years.The first is to establish a special treatment for GMOs that, according to her, “are also obtainable naturally or by conventional breeding”. First of all, such organisms are not identical to those that would be obtained by crossing because of all the off-target effects present at each stage of a genetic modification method. But, more fundamentally, it shows that the will is to restrict the nature of a GMO to the genetic description of the claimed new trait. To the product and not to its history. So it doesn’t matter what method is used and what other genetic and epigenetic changes it may cause.The second is to create a special treatment for GMOs that would contribute to sustainability goals.These are the two scenarios summarized by us in the two columns, the third one, which we do not present, being no change to the current legislation.GMOs that can “also be obtained naturally or by conventional breeding”Risk assessmentDetectionTraceabilityLabelingNot necessaryNot necessaryNot necessaryNot necessaryGMOs that may have an effect on “sustainable development”LabellingAuthorisationLabelling “GMO” + “Sustainable”Lighten procedure as an incentiveNo labelling but record in a registerUnsustainable GMO => not authorisedAnnounced in broad terms during a first (public) consultation in the fall of 2021, the scenarios devised by the Commission are now more detailed. This detail goes further than the demands made by many Member States.For example, the risk assessment would simply be deleted if the GMO modified by “directed mutagenesis or cisgenesis” were to be defined as being able to be “obtained naturally or by conventional breeding”. This proposal goes against what the Commission itself announced in May 2021 to the Ministers of Agriculture of the Member States when it declared that it was not going to propose any deregulation or lowering of safety standards [6] and that it repeated in the autumn of 2021 to the citizens of Europe that its objective is to “maintain a high level of protection for human and animal health and the environment” [7].But it is the issue of labelling and therefore of consumer information that represents the most important revelation in these scenarios. In December 2021, the European Ministers of the Environment had been clear about their will that the labelling of marketed products be maintained [8]. A request that did not seem to run counter to the Commission’s plans, since the latter had already indicated in May 2021 that it wanted to ensure that consumers receive the information they need to exercise genuine freedom of choice [9]. In order not to contradict itself, the Commission is still considering, in the questions asked, the possibility of information on a public register and not by labeling: double talk? Or deception, since such a register can provide information on the existence of a “GMO event” but not necessarily on all the products that contain it or are derived from it, and since it is likely that very few people will consult it before shopping.A survey conducted by a stakeholder in the debate?The survey is presented in the form of a questionnaire with multiple-choice answers but with a very ambivalent wording. Those who want to answer all the questions must first accept the precondition of a strong increase in the supply of GMOs resulting from these new techniques, and then choose one of the proposed deregulation options. The choice of maintaining the current regulations is in fact no longer proposed beyond the third question.The stated purpose of the survey is “to gather (...) input on the various impacts of elements for future policy optionsfor the legislation on plants produced using genomic techniques (NGT)” [10]. The questionnaire presents “various changes that could be envisaged regulating specifically plants developed through targeted mutagenesis and cisgenesis”. But only a selected group of experts and stakeholders are invited to respond. Who, how, why? No information at this stage, nor is it possible to know whether non-European citizens or stakeholders were also consulted. However, we do know that the structure conducting this survey, a Brussels-based consultancy, is called Technopolis. If this actor is not known as a stakeholder in the GMO debate, the same cannot be said for one of Technopolis’ subcontractors, namely the Wageningen Research University (Netherlands) [11]. This choice is quite surprising because this university is active in the GMO debate. It is involved in projects to develop cisgenic GMOs, including an apple [12], and it has initiated a database of GMOs that blurs the legal definitions of what a GMO is [13]. Above all, this university has regularly taken a position in favour of the deregulation of these GMOs. As such, in a 2022 report on the impacts of the Green Deal, it concludes that to “reduce/overcome the negative impacts of reduction of pesticides and nutrients, [...] there is an increased need for innovations in crop protection techniques, such as biocontrol, breeding, precision agriculture, biostimulants and other techniques that contribute to the resilience of crop production against pests, weeds and diseases. Removing legislative barriers to new breeding techniques, in order to shorten the breeding process significantly could help” [14]. Corporate Europe Observatory reported in March 2022 that this report had been financed by the seed industry [15].Which GMOs are we talking about?But the problem also comes from the fact that the terms “mutagenesis and cisgenesis” are not precisely defined, either legally or scientifically. These terms include multiple techniques that can follow very different protocols, especially that of mutagenesis. They could thus cover the great majority of GMOs produced tomorrow with the new techniques of genetic modification [16]. Indeed, the three types of modifications that can be carried out in a genome are the insertion of genetic sequence (transgenesis and cisgenesis), mutations and deletion of genetic sequence. By adopting the reading framework of the European Commission and the companies that wish to take into account only the claimed modifications and not the unintended effects, the very expression “directed mutagenesis” is an expression that could, according to a partisan reading, cover all mutagenesis techniques. Deregulating products obtained by directed mutagenesis and cisgenesis would therefore mean that only transgenic GMOs would remain covered by the current legislation.The precise intentions of the European Commission were thus finally revealed by a targeted stakeholder survey, not a public one. European citizens were consulted twice, but did not have the chance to hear the Commission’s true intentions. While this targeted survey is still ongoing, its results will be used to prepare the impact assessment that will accompany the European Commission’s proposal to amend the GMO regulation, scheduled for spring 2023 [17]. The precision of the scenarios presented underlines the importance that the Commission attaches to this closed consultation. It is therefore to be feared that the public consultation to which citizens have responded will carry little weight in the future legislation of the European Union and that the 2018 ruling of the European Court of Justice concerning these new GMOs will be flouted… Charlotte KRINKE,Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [249] => Array ( [objectID] => 6347 [title] => Public consultations ahead of deregulation of new GMOs? [timestamp] => 1661126400 [date] => 22/08/2022 [annee] => 2022 [url] => https://infogm.org/en/public-consultations-ahead-of-deregulation-of-new-gmos/ [image] => https://www.infogm.org/IMG/arton7490.jpg?1661161039 [extrait] => In the Western world, conducting pseudo-public consultations before decisions are made seems to become more and more the regular mode of public action and of building social acceptance. The field of GMOs is no exception. In the European Union (EU), a public consultation on the legislation applicable to certain GMOs has just ended. But the […] [chapo] => [texte] => In the Western world, conducting pseudo-public consultations before decisions are made seems to become more and more the regular mode of public action and of building social acceptance. The field of GMOs is no exception. In the European Union (EU), a public consultation on the legislation applicable to certain GMOs has just ended. But the questions asked were denounced for their biased nature. Outside the EU, several countries that have recently adopted more flexible rules for new GMOs have previously organized public consultations... without taking into account the results of the consultation. Canada [1], the United States [2] and the United Kingdom [3] have recently relaxed the rules for new GMOs. These reforms were all preceded by public consultations over several weeks and open to all stakeholders. They all have in common that the results of the public consultations were not taken into account. The final rules even go against the comments and fears expressed by the majority. In the United Kingdom, for example, the public consultation organized prior to the adoption of less restrictive rules for field trials of new GMOs showed that, among the participants, 88% of individuals and even 64% of companies wanted these GMOs to be subject to the same rules as other GMOs [4]. In the United States, the Department of Agriculture itself admits that most of the 6,150 comments made during the public consultation it held from June 6 to August 6, 2019 expressed generalised opposition to GM products. Of the comments that specifically addressed the proposed regulatory changes, only 25 expressed “some” support [5].A new public management toolPublic consultations are often presented as a means of responding to a legitimate request from citizens to be able to actively participate in the decision-making process and to strengthen citizens’ confidence in their government. But these lofty goals mask the theoretical origin of public consultations and therefore their limitations.Citizen participation in environmental decision-making is a principle enshrined in the 1992 Rio Declaration (principle 10). As for the 1998 Aarhus Convention, it requires its parties to promote “effective public participation at an appropriate stage, and while options are still open, during the preparation by public authorities of executive regulations and other generally applicable legally binding rules that may have a significant effect on the environment” [6] [7].But, beyond the environmental issue alone, public consultations tend to become a normal mode of public action in Western states as part of decision-making processes. And the origin of this evolution is to be found in the doctrine of New Public Management. Based on a neo-liberal rationale, New Public Management consists of extending to public administration the rules and methods of the private sector in the name of effectiveness and efficiency [8]. Over the past 40 years, the New Public Management principles have been gradually introduced into public administration. This has manifested itself, in particular, in the multiplication of agencies (the European Food Safety Authority for the European Union, among others) but also in the adoption of “better regulation” programs, starting in the 1980s, with the aim of simplifying them and generating time and cost savings through the reduction of the regulatory burden. Better regulation tools include impact assessments prior to the adoption of new regulations and public consultations.The link between better regulation and public consultation is very clearly established by the European Commission, which adopted the New Public Management approach in the 2000s. In 2002, its Communication entitled “Better Lawmaking” was the first step towards “simplifying” European Union legislation. It introduced the obligation to carry out impact assessments and stakeholder consultations for new initiatives proposed by the Commission [9].According to the New Public Management doctrine, the State must, to solve a given problem, stop relying on its administration alone and rely more broadly on public agencies, economic players, organisations, and on citizens considered as consumers. Public consultations perfectly reflect this idea. The rule adopted at the end of the procedure will thus reflect the concerns and values of these different stakeholders. A rule that is as close as possible to the interests of these parties, following a a client-oriented approach, is supposed to be a guarantee of its effectiveness.Goals already set, illusory participationIt is clear, however, that the ultimate objective of simplifying legislation which is to reduce the regulatory burden, as well as the imperative of competitiveness, require that certain concerns or values be given priority over others. In other words and more prosaically, since it is indeed a client-based approach that we are talking about, some clients have more weight than others.In the field of GMOs, the reduction of the regulatory burden is synonymous with less restrictive rules or even deregulation. This aim is sometimes explicitly stated before the public consultation preceding the adoption of new rules. This was the case in the United States, where a presidential executive order instructed the Department of Agriculture to review its regulations in order to « avoid undue regulatory burdens ». Taking into account the desire for existing regulations to be maintained or even strengthened is therefore excluded from the outset.Sometimes the objective of deregulation is more implicit and takes the form of a bias in the way the objectives and context of the consultation are presented and the questions are asked. In the United Kingdom, for example, the public consultation organised in January 2021 ahead of the adoption of the rules relaxing the conditions for field trials of new GMOs was introduced by a biased text. It starts by claiming that “gene editing” « has the potential to make producing abundant, healthy food part of reducing the environmental impact of a growing global population » and that it « could fine tune and speed up the natural breeding process targeted towards environmental gains in England and help us reach climate and biodiversity goals » [10].The basis of the proposal is that « organisms produced by GE or by other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods ». This position, it is stated, « follows the science, which says that the safety of an organism is dependent on its characteristics and use rather than on how it was produced ». However, these statements are not supported by any factual data. From the introduction, the citizen is led to accept these so-called “scientific” assertions.In the European Union, these same biases and the biased nature of the questions led the European Coordination Via Campesina (ECVC) to refuse to take part in the public consultation on “Legislation for plants produced by certain new genomic techniques” [11] organised by the European Commission from 29 April to 22 July 2022. In an open letter addressed to the European executive, ECVC, which represents 31 organisations of European small and medium-sized farmers and peasants, denounced a “consultation (which) does not allow to refuse the possibility of abandoning the current GMO regulation” and “where the expression of divergent views is made impossible” [12]. It should be noted that in September 2021, the European Commission launched a first consultation on an initial impact assessment (inception impact assessment) on certain new GMOs (resulting from targeted mutagenesis and cisgenesis). The majority of the more than 70,000 respondents, 96.20% of which were citizens [13], expressed their opposition to the deregulation of GMOs [14]…Admittedly, the results of public consultations are not binding on the executive. When the consultation precedes the parliamentary examination of a legislative proposal, this is quite normal because it cannot compete with the legislative process itself. But when most of the concerns and comments expressed are ignored, it is inevitable that citizens and other stakeholders will question the meaning of the public consultation and the value of participating in it. Is the die already cast ? Is citizen participation only meant to provide a democratic backing for rules that satisfy private interests more than the general interest? Is the consultation a means of assessing resistance to a particular envisaged legislative reform ?In a communication of 2021, the European Commission presents public consultations as a means of sustaining trust in the European Union [15]. But this trust must be deserved and it is never definitively won.Reversing the meaning of wordsIn the early 2000s, in Europe, the social pressure exerted by citizens’ mobilizations and public debates led to the first de facto moratorium on GMOs. Today, systematized public consultations, in the wake of the New Public Management, are a purely formal step in the decision-making process. The indifference to the opinion of the citizens manifests itself in several ways: obstacles to a broad participation of the population [16], consultations introduced by a narrative based on unfounded or even deliberately erroneous information, and orienting towards the desired answer (as in the United Kingdom), pseudo-consultations based on multiple-choice questions preventing any form of debate and confining the public to choices corresponding to the application of a decision already taken and, moreover, often contrary to the opinion expressed by the majority of the public. These pseudo-consultations are more like the collection of semantic data intended to feed social engineering algorithms (manufacturing of communication tools) than genuine consultations. Charlotte KRINKE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [250] => Array ( [objectID] => 4109 [title] => A minority of states support deregulation of new GMOs [timestamp] => 1659484800 [date] => 03/08/2022 [annee] => 2022 [url] => https://infogm.org/en/article_journal/a-minority-of-states-support-deregulation-of-new-gmos/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Many States currently reflect on the legal status of GMOs resulting from new genetic modification techniques, and some have already decided. It is not easy to give an exhaustive picture of all the positions and legislation adopted : it is sometimes difficult to have access to national legislation, national positions may be unclear at this stage, […] [chapo] => [texte] => Many States currently reflect on the legal status of GMOs resulting from new genetic modification techniques, and some have already decided. It is not easy to give an exhaustive picture of all the positions and legislation adopted : it is sometimes difficult to have access to national legislation, national positions may be unclear at this stage, the scope and categories of new techniques of national legislation may vary which means that imprecise general terms have to be used... The picture we have drawn up here nevertheless shows that it is mainly a minority of economically powerful States that have decided to deregulate GMOs resulting from new techniques. When it comes to new genetic modification techniques, biotech companies want to be reassuring. These new techniques are said to be more precise and to allow a better control of genetic modifications. They are even said to make it possible to reproduce what nature does or to obtain the same result as with conventional breeding methods, such as crossing. But above all, certain new genetic modification techniques are supposed not to imply the addition of foreign DNA in the organism…Less stringent rules in the main producing countriesThis type of rhetoric aims to justify that GMOs resulting from new genetic modification techniques should not be subject to the same rules as transgenic GMOs. In other words, existing regulations should be relaxed or even be set aside for these 2.0 GMOs. The proponents of this approach are the main GMO producing countries : the United States, Canada and Latin American countries such as Argentina and Brazil. As early as 2018, at the World Trade Organization (WTO), these States claimed that « innovations in precision biotechnology, such as gene editing, have brought the promise of major improvements in terms of the ease and precision of introducing desirable traits into agricultural organisms » [1]. They added that « government policies must continue to foster innovation [...] and mitigate unintended, unnecessary barriers to the entry of agricultural products » [2].These States have in common that their regulations are based on the novel (claimed) characteristics of the final product. Depending on the State, the (non-exhaustive) criteria leading to the non-application of GMO regulations and the application of the general regulations applicable to « conventional » products are, for example, that the organism could have been produced naturally or by a conventional breeding method or that it does not contain foreign DNA. Such criteria de facto intend to reduce the notion of GMO to transgenesis and to reject it for GMOs resulting from new genetic modification techniques.The first State to set such criteria was Argentina. In its regulation adopted in 2015, the decisive criterion for deciding whether a product resulting from new techniques should be considered a GMO is the presence of a « new combination of genetic material ». A genetic modification is considered as such when one or more DNA sequences that are part of a genetic construct are permanently introduced into the plant’s genome. Argentina has been followed by other States that have adopted similar regulations, in Latin America (Brazil [3], Chile [4], Colombia [5], Honduras [6], Paraguay [7]...) and elsewhere (USA [8], Australia [9]).Under pressure from trade agreements (international or free trade agreements) and the innovation race, some States are revising or adopting regulations to facilitate the development, commercialisation or cultivation of GMOs derived from new techniques. In March 2022, India decided that these GMOs would be exempted from the main requirements of its GMO legislation, i.e prior authorization with risk assessment and labeling requirements, even though these requirements are intended to ensure environmental and health protection [10]. In early 2022, the United Kingdom, which left the European Union, did the same for field trials and announced a broader reform of GMO regulation [11]. Nigeria, for its part, adopted specific guidelines for GMOs from new techniques in 2020. And in Canada, where GMOs are currently regulated under the novel food regulations, which are already based on an « final product » approach, a review is currently underway [12].In most countries of the world, however, GMOs derived from the new techniques continue to be subject to GMO legislation. Some countries have explicitly announced this, such as China, New Zealand or South Africa, although such decisions face strong opposition from industry [13]. In others, on the African continent among others, GMO legislation applies while consideration is given to the revision of the legislation or while revision is underway.The European Union under pressureUnlike its main trading partners, the criterion that triggers the application of the GMO regulation in the European Union is both the technique used and the final product obtained. The European definition therefore includes GMOs resulting from new genetic modification techniques. The Court of Justice of the European Union clearly confirmed this in its 2018 ruling. It said that GMOs obtained from techniques without history of safe use must be regulated as GMOs and be subject to risk assessment and comply with traceability and labeling obligations [14].Since the autumn of 2021, the European Commission has been arguing that it is necessary to adapt European GMO legislation to scientific progress. Among other reasons put forward are the supposedly lower risks of the new techniques, but also their « potential to contribute [...] to a more resilient and sustainable agri-food system » [15]. The Commission plans to adopt a legislative proposal for GMOs derived from some of these new techniques (directed mutagenesis and cisgenesis) by 2023. In the meantime, it is maintaining an ambiguous position by stating that these GMOs should benefit from a more « flexible » regulatory framework. Will the future legislative proposal meet society’s demands in terms of environmental precaution ? Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [251] => Array ( [objectID] => 4107 [title] => Patents on life, a US ” invention ” [timestamp] => 1658707200 [date] => 25/07/2022 [annee] => 2022 [url] => https://infogm.org/en/article_journal/patents-on-life-a-us-invention/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Historically, the protection of living organisms through patents has been developed in the United States and Europe. Abandoning a then conservative position, the US Supreme Court validated a patent on a genetically modified (GM) bacterium in 1980 [1]. This institution defined the micro-organism as a « composition of matter », opening up the field of patentability of living […] [chapo] => [texte] => Historically, the protection of living organisms through patents has been developed in the United States and Europe. Abandoning a then conservative position, the US Supreme Court validated a patent on a genetically modified (GM) bacterium in 1980 [1]. This institution defined the micro-organism as a « composition of matter », opening up the field of patentability of living matter. What is the current state of play in Europe, particularly with regard to GMOs, as the European Patent Convention (EPC) turns 50 next year ? In the history of patents on life [3], the first patent on a genetic sequence covers part of the human growth hormone sequence and was granted to the University of California in 1982 [4]. In 1984, the US granted a patent on insulin from GM bacteria [5] and in 1985 on GM maize [6]. In 1988, the US Patent Office granted Harvard University the first patent on a mammal, a transgenic mouse [7]. Its genome was modified by the introduction of a human gene to easily develop tumours and thus be used for cancer research. In 1992, the European Patent Office (EPO) also granted protection to the rodent. The European Directive 98/44/EC on biotechnological inventions was passed in 1998 [8]. In 2007, Craig Venter filed a patent application for a process to synthesise a bacterial genome [9], which was abandoned for ethical reasons under pressure from the ETC group [10].In Europe, " essentially biological processes " are not patentable...In 1999, in the wake of Directive 98/44/EC, the EPO reframed the patentability of plants by affirming that a claim can encompass plant varieties, even if it cannot claim varieties individually [11]. The issues at stake at that time also centred on the interpretation of the term " essentially biological process " (EBP) [12]. In 2010, two EPO decisions confirm that an EBP for obtaining plants or animals, based on the sexual crossing of complete genomes and on selection, must be excluded from patentability [13] [14]. This applies even if the process includes human technical intervention.... and the products derived from them are no longer patentableFollowing a reversal of EPO case law in 2020 [15] [16], animal and plant products and/or parts thereof obtained exclusively [17] by EBPs are no longer patentable (except for applications filed before July 2017). This follows resolutions of the European Parliament reaffirming that " plant varieties and animal breeds, including their parts and characteristics, as well as products obtained by EBPs, and these processes themselves, shall not be patentable under any circumstances " [18]. Processes for obtaining transgenic plants and technically induced mutants (non-transgenic GMOs) are patentable, whether by directed or random mutagenesis, provided that they are reproducible by " a person skilled in the art ".Digitised genetic sequences as a new source of patentsToday, it is " genetic resources " (GR), in the form of digitised genetic sequences (DSI), that are exploited by the seed industry [19]. The latter has computer tools capable of identifying and testing new genetic information that could potentially be patented, such as new functional traits in plants [20].In 2014, the European Union adopted a regulation to combat biopiracy and guarantee a share of the benefits derived from the commercial exploitation of GR [21]. It is transposed into French law via the law " for the reconquest of biodiversity, nature and landscapes " [22]. This law encourages the declaration to the National Institute of Industrial Property (INPI) of any genetic resources or associated traditional knowledge used in a French patent application. This declaration is only mandatory for access to public research funds.At the international level, the World Intellectual Property Office (WIPO) has long debated the possibility of obliging applicants for international applications to disclose certain information relating to GR and/or traditional knowledge used in an invention. This " disclosure obligation " is favoured by biodiversity-rich Member States and feared by others [23]. However, it is not mentioned in the latest WIPO report of March 2022 [24].A disclaimer to delimit products not covered by the patentContrary to what some patent holders claim about non-transgenic GMOs, the latter can be distinguished from those obtained by other techniques or other natural organisms [25]. The EPO requires that the scope of such patents be limited by specifying, via a disclaimer [26], that they do not extend beyond the products obtained by the technical means mentioned in the patent description. This excludes products which do not result from the patented invention.This principle could be applied to patents based on GR. A disclaimer formulation should remove from the claims what is obtained from digital information derived from GR and limit their subject matter to products obtained by technical means. According to the EPO, if a technical feature of a claimed plant can be derived either from technical intervention or from an EBP, a disclaimer is required. This is the case even if the descriptive part of the patent only mentions a technical breeding process and is silent on the use of an EBP [27]. The processing of thousands of data sets to identify new genetic information and to program genetic manipulations to obtain new organisms, without a physical technical step, corresponds in the end to an " essentially digital process " that can be subject to the same assessment criteria.Illustrations of the articleIllustrations of the article : patent statisticsThe complexity of public data on biotechnology patents does not allow for a single global picture. We present part of this landscape corresponding to the IPC’s C12N15 classification [28], covering in particular, but not only, mutation techniques or genetic engineering. The data covers the last 10 years in the US and Europe. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [252] => Array ( [objectID] => 6349 [title] => Traceability of new GMOs: the European Commission’s blinkers [timestamp] => 1657065600 [date] => 06/07/2022 [annee] => 2022 [url] => https://infogm.org/en/traceability-of-new-gmos-the-european-commissions-blinkers/ [image] => https://www.infogm.org/IMG/arton7460.png?1657100961 [extrait] => In April 2022, MEPs (Member of the European Parliament) organised a webinar on “ Detection and traceability of new genomic techniques for GMOs ”, concerned by the European Commission’s inertia. The invited scientists reaffirmed that they have been possible for a long time. The Director of the Joint Research Centre (JRC), the European Commission’s scientific […] [chapo] => [texte] => In April 2022, MEPs (Member of the European Parliament) organised a webinar on “ Detection and traceability of new genomic techniques for GMOs ”, concerned by the European Commission’s inertia. The invited scientists reaffirmed that they have been possible for a long time. The Director of the Joint Research Centre (JRC), the European Commission’s scientific service, pointed out the complexity and cost of implementing such a system. Is this an admission of powerlessness or a new helping hand from the Commission to the agro-industrial sector? Inf’OGM reviews the main points of this meeting. The European Commission (EC) has not implemented a programme to detect and trace ’ new GMOs ’ resulting from new genomic techniques. Questioning this, MEPs from four European parliamentary groups [1], Renew Europe, S&D (Socialists and Democrats) and The Greens/EFA, organised an exchange between scientists and the Director of the Joint Research Centre (JRC). The JRC provides the European Commission with the technical basis, notably for the management of GMOs. It also hosts ENGL [2], a European network of laboratories dedicated to GMOs, in charge of traceability and detection issues [3].Legal and scientific backgroundThe 2018 ruling of the CJEU (Court of Justice of the European Union) [4] ruled that any organism derived from mutagenesis is a GMO. It also clarified the scope of the mutagenesis exemption provided for in the directive that frames GMOs. Thus, GMOs created by recent techniques must be regulated [5] [6]. The European Commission published an ‘ initial impact assessment ’ on ‘ legislation applicable to plants produced using certain new genomic techniques ’ in September 2021. This was followed by a first public consultation in late 2021. A ‘ full impact assessment ’ published in April 2022 should lead to a legislative proposal [7] at the end of 2023 to adapt the regulatory framework for certain ‘ new GMOs ’ [8].From an environmental, health, socio-economic or ethical point of view, the new techniques still raise many questions. Moreover, they do not only cause a simple genetic modification, but also numerous so-called ‘ off-target ’ effects (mutations and epi-mutations) [9]. Finally, the ’ non-transgenic ’ character, put forward by the defenders of the new GMOs, cannot be retained. Indeed, the main technique, Crispr/Cas, requires that the Cas protein and the RNA guide be inserted into the organism by transgenesis.Applying the same rules to ‘ new GMOs ’ as those governing transgenic GMOs means implementing a procedure for detecting and tracing them. And the tools exist.The JRC as a screen for the Commission Since 2016, ENGL had proposed to the European Commission to reflect on the issue of traceability of ‘ new GMOs ’. Without success. In 2017, the Commission even openly opposed it. But in 2018, it changed course following the CJEU ruling and mandated its own experts and those of ENGL to work on this subject [10]. Four years later, the European Commission has still not taken up the issue. Yet there is no lack of resources. Guy Van den Eede, Director of the JRC, stated during the April webinar that the ENGL ‘ has immense scientific capacity ’ and is ‘ a global focal point for GMO detection ’. He further states that ‘ three central issues must be addressed if New Genomic Technologies (NGT) products are to be considered regulated GMOs: detection, identification and quantification of products. (...) This is a prerequisite for market authorisation ’.The JRC representative insists: ‘ the proposed systems for detection, identification and quantification are complicated, time-consuming and costly (...) We need to be able to find the unknown products of new genetic modification techniques ’ and ‘ the global market and imports from third countries is a real challenge ’. The final argument seeking to justify the Commission’s inertia: ‘ we are talking about techniques that modify very few nucleotides, less than 15 ’. It is on all of these points, and particularly the last one, that the expert scientists present, Yves Bertheau from INRAE [11] and Sarah Agapito-Tenfen from NORCE [12], will respond.The technical tools do exist, howeverYves Bertheau’s comments show that the techniques for developing “ new GMOs ” are not very effective, unlike those for detecting them. “ Directed ” mutagenesis, a set of techniques used for the production of ‘ new GMOs ’, is in fact particularly inaccurate. These techniques, and their associated steps such as in vitro cell culture, generate unintended mutations and epi-mutations that are never described. However, there are several techniques that can detect these ’ scars ’ or ’ signatures ’ left in GMOs by these technical steps [13] [14]. Member State control laboratories mainly use real-time quantitative PCR, but other powerful techniques are also commercially available. One example is LCR (Ligase Chain Reaction), which can detect a point mutation.Yves Bertheau stresses the urgent need for the laboratories - including ENGL - to reconsider, or even change, their methods from the 2000s : ‘ this should have been undertaken a long time ago, when the Dutch COGEM [15] started talking about NBT (New Breeding Techniques) [16] in 2007 ’.The INRAE researcher also points to the lack of political will. According to him, there are ’ no technical or financial obstacles to detecting and quantifying these new GMOs. The same set of arguments, including those of cost, had already been used in the 1990s for transgenic GMOs ’. In his view, we should start by ‘ assigning GMO status to the new products, which clearly fall into this category both for the related techniques still in use and for the NBTs themselves ’. He concludes: ‘ All we need to do is apply European legislation, which will provide the methods and reference materials. (...) The accumulated technicality of the ENGL laboratories is such that even unknown GMOs can be detected if there is the political will to do so ’.Tracing and labelling GM products in the food chain is the FoodPrint project [17] launched by the Norwegian Research Council and presented in this webinar by Sarah Agapito-Tenfen, a researcher at NORCE. In support of Yves Bertheau’s point, FoodPrint is not limited to the use of real-time PCR methods. Its approach to detection can include molecules other than DNA such as proteins, metabolites or biomarkers. Sarah Agapito-Tenfen explains that the project aims to ‘ test different methods so that they can be applied on a European scale. The aim is to establish a matrix, so that the best method can be chosen to obtain the best result on a certain genetically modified organism. The ultimate goal is to create a platform where everyone can use the FoodPrint research for other species and genes ’, she adds. We contacted Sarah Agapito-Tenfen to find out more about these future tools: ‘We don’t have any published results yet, the project has just finished its first year. We have preliminary data, but unfortunately we can’t share it with the media yet. She adds that the experimental plan for some parts of the project is now defined and that she would be willing to reveal the main lines. See you then.MEPs denounce lack of political willIn conclusion, the MEPs who initiated the meeting emphasised that it is only a question of political will. Eric Andrieu, from the S&D group, supports the words of the scientific speakers : ‘ Detection, traceability and the precautionary principle must form the basis of the new framework for the new genomic techniques, which do indeed produce GMOs ’. He also denounced ‘ the instrumentalisation of the problem of hunger in the world by the agrochemical lobby ’ to justify the development of GMOs.For Martin Häusling, from The Greens/EFA: ‘ The European Commission is in breach of a decision of the EU Court of Justice (editor’s note: previously cited ruling of 25 July 2018) according to which NGTs fall under the scope of GMOs. Therefore, labelling and risk assessment are needed to protect and inform consumers but also farmers ’. He added about the Commission’s research funds : ‘ There is little funding allocated to risk assessment and detection research. Most of the funds are used for new types of plants ’. Martin Häusling concludes : ‘ It is not acceptable to invest in new products when the risks are not assessed. We have to make it very clear that the next technologies are dangerous. ’At the end of 2023, it will be known whether the European Union will decide to regulate GMOs derived from new techniques. By then, the Commission must finalise the second phase of its public consultation. Will it wait for the outcome of this consultation before possibly sparing itself the implementation of a detection and traceability programme? Isn’t Europe, which prides itself on its transparency, lacking in this area of detection and traceability of ’ new GMOs ’ ? Beyond the scientific and legal debates, it is the freedom of choice of Europeans and the future of European agriculture that are concerned. Denis MESHAKA Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [253] => Array ( [objectID] => 6350 [title] => Crispr/Cas9: access to a minefield? [timestamp] => 1657065600 [date] => 06/07/2022 [annee] => 2022 [url] => https://infogm.org/en/crispr-cas9-access-to-a-minefield/ [image] => https://www.infogm.org/IMG/arton7459.jpg?1657100112 [extrait] => To modify genomes, new techniques of genetic modification are increasingly available. The Crispr/Cas9 system, mentioned on several occasions by Inf’OGM, is today by far the most widely used. Although this technique is less expensive, the patent law means that it does not lead to a diversification of the economic actors… The global seed market is […] [chapo] => [texte] => To modify genomes, new techniques of genetic modification are increasingly available. The Crispr/Cas9 system, mentioned on several occasions by Inf’OGM, is today by far the most widely used. Although this technique is less expensive, the patent law means that it does not lead to a diversification of the economic actors... The global seed market is highly concentrated. Since 2015, market concentration has increased following several merger and acquisition operations: Dow Chemical and DuPont merged to form Corteva Agrisciences, ChemChina bought Syngenta and Bayer bought Monsanto [1] [2] [3].In the case of GMOs, the concentration of economic players is said to be due in particular to the costs of the techniques, which are prohibitive for small and medium-sized enterprises (SMEs). However, the development of new, less costly genetic modification techniques was supposed to put an end to this concentration of the sector and allow SMEs to take their place in it.The Canadian Biotechnology Action Network (CBAN) has studied the patents on the most emblematic of these techniques, Crispr/Cas9. It shows that this far from being true."Public" patent rights... The Crispr/Cas9 technique is not the only one to be covered by patents. The Talen or “zinc finger nuclease” techniques are also covered by such rights. But according to the RCAB, in 2021, the U.S. Patent Office registered about 6,000 patents and patent applications on the use of the Crispr technique, 17% of which were for plant modification.The popularity of Crispr/Cas9 and its anchoring in the technical mainstream now seem clear. This may explain the dispute of the last few years between the holders of the basic patent rights on the Crispr/Cas9 tool : the Universities of Vienna and California/Berkeley on the one hand and the Broad Institute (MIT [4] and Harvard University) on the other [5] [6]. To date, the former holds the rights to the Crispr/Cas9 system in Europe, but these are limited to the field of prokaryotes (including bacteria) in the United States. The Broad Intitute’s rights are limited to the domain of eukaryotes (including animals and plants) and to the U.S. territory. In 2017, two-thirds of the patents on the use of Crispr/Cas9 came from the public sector [7]. This latter therefore has a dominant position in this technique. The licenses it grants for “research”, non-commercial applications, in food and agriculture in particular, are free of charge. The opposite would be surprising from publicly funded structures....largely benefiting multinational biotechnology companiesTo commercially exploit these patents, the above-mentioned public structures have created intermediary companies (or surrogate companies). These companies grant rights throughout the world to companies that market applications of the Crispr/Cas9 system and pay royalties in return. They can grant different types of licenses (exclusive, semi-exclusive or non-exclusive [8]), by technical field (human, plant, non-human animal...), by territory (United States, Europe, China...), by use (clinical, research...).The CBAN report shows that, through patents and the granting of commercial licenses, the concentration of actors, particularly agribusinesses, is reproduced. Thus, among the few companies with exclusive licensing rights, we find Corteva Agrisciences and Bayer-Monsanto [9].Corteva Agrisciences, the second largest seed company in the world in 2018 after Bayer-Monsanto [10], is a major owner of patent rights around the Crispr/Cas9 system (seed creation). It is also one of the companies that benefits from a large number of licenses, including exclusive licenses, for agricultural uses and plant applications. These licenses have been obtained directly from the same public structures that own the Crispr/Cas9 patents or from the intermediary companies Caribou Sciences and ERS Genomics. Corteva Agrisciences has set up a patent pool and an associated licensing program that it presents as providing access to the Crispr tool for a maximum number of users in the agricultural world. However, this seems to be more of a strategy to control the competition and secure a dominant position in the market [11].Bayer-Monsanto, on the other hand, has signed a collaboration agreement with the intermediary company Pairwise [12] and an exclusive license for the world’s main GMO crops, namely maize, soybeans, rapeseed and cotton [13]. It should be noted that Dr. Tom Adams, co-founder of Pairwise, is a former Monsanto executive [14]... Pairwise had obtained exclusive rights to Crispr/Cas9 in the plant field from the Broad Institute, MIT and Harvard University. Bayer-Monsanto paid $100 million in “upfront fees” [15] to access and develop Pairwise’s intellectual property in the field of row crops [16]. The royalty rate claimed is, as is often the case, not public. Nevertheless, the amount of these entry fees shows the importance of exploiting the Crispr/Cas9 rights, specifically in the agricultural field. By way of comparison, the same exclusive rights to Crispr/Cas9 have been granted to Editas Medicine Inc. for use in human therapy. The upfront fee was $240,000, which is 400 times less [17]. The royalty rates were also not made public.We contacted the public entities that own the Crispr/Cas9 patents and their intermediary companies to obtain further details on the licensing terms. Those who responded redirected us to the press releases. License agreements are available on the dedicated websites but in “redacted” versions, i.e. hiding most of the sensitive information, especially financial information.Key argument for deregulation of new GMOs weakenedIs it really that easy to use the Crispr/Cas9 tool as is often claimed? Technically perhaps, but economically and legally, absolutely not. The multitude of patents and licences creates a great deal of insecurity for potential users. And this insecurity could increase further. Indeed, as CBAN points out, “if genome editing [18] [19] is faster and cheaper to use, it could result in a shorter product development cycle where several overlapping patents will be stacked together in products”. For breeders, this could transform breeding new varieties into a ’minefield’. Breeders will have to constantly check for newly granted patents and negotiate licensing rights to commercialise the variety containing patented elements. This is a far cry from the promised “liberation” of the market...As concerns SMEs, the concentration of players in the commercial use of Crispr/Cas9 suggests that they are not benefiting as much as it was said they would. And it should be noted that this market concentration exists even in States that do not subject products derived from new techniques to GMO regulation. This undermines one of the key arguments of those in the European Union who defend more flexible rules for GMOs derived from new techniques such as those using Crispr/Cas9...In 2018, MEP Paolo de Castro (Group of the Progressive Alliance of Socialists and Democrats) already considered that “if we do not act now and support this kind of innovation [editor’s note: new techniques of genetic modification], putting them under the GMO regulation we will put ourselves in the hands of a few multinational companies that already control a major part of the market” [20].The European Commission is moving in the same direction with its legislative proposal, currently under public consultation [21]. In the inception impact assessment, it explains that “(a)dapting legal requirements for plants obtained by targeted mutagenesis and cisgenesis [...] may bring new opportunities for agri-food system and biotechnology operators, as well as researchers, and SMEs, enhancing their freedom to conduct their business” [22]. The Commission bets that a lighter framework for GMOs derived from new techniques will stimulate the growth of European SMEs. According to the Commission, SMEs have not been able to develop transgenic GMOs commercially due to overly heavy regulation and therefore high market entry costs.We interviewed about ten French SMEs in the so-called agritech sector. The few that replied to us stated that they do not use the Crispr/Cas9 technology. This non-use is not due to regulatory obstacles. For these French SMEs, the Crispr/Cas9 tool is simply not relevant to their business.However, CBAN warns that if the GMOs obtained by new techniques are not subject to GMO regulation, the development and commercialisation of such products will only be encouraged, “resulting in a flood of unregulated, unidentified, patented genetically engineered seeds and foods”. This is neither desirable for breeders, farmers nor for a large part of civil society.The proliferation of patents illustrates the race for technical innovation that is supposed to lead us to progress... another assumption that needs to be questioned.Access to pioneering techniques has always been expensiveThe biotechnology sector has been discovering and inventing for more than half a century. Each time new “breakthrough” techniques are described, the question of their access and control arises. The early 1980s saw the invention of PCR (Polymerase Chain Reaction), which provided a method for the exponential amplification of DNA (deoxyribonucleic acid) and opened the way to all-out research. Never before has the economic effect of patenting on biomedical research been so visible [23].The invention of RT-PCR (Real-Time PCR), a PCR technique that allows the quantification of nucleic acids, was less resounding from a media point of view, but of major financial interest for its historical owners, Applied Biosystems. Licensing programs were in place that charged significant upfront fees and a 20% royalty on each in vitro diagnostic test performed on a patient. These technologies are now in the public domain, but many of their improvements are still patented. Denis MESHAKA,Charlotte KRINKE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [254] => Array ( [objectID] => 6351 [title] => GMO – Cell culture techniques are not traditional [timestamp] => 1656288000 [date] => 27/06/2022 [annee] => 2022 [url] => https://infogm.org/en/gmo-cell-culture-techniques-are-not-traditional/ [image] => https://www.infogm.org/IMG/arton7450.jpg?1656320387 [extrait] => Since 2020, the European Commission has been arguing that mutagenesis carried out on cells isolated and propagated in vitro is exempt from the requirements of the GMO legislation. This position offers an open door for companies to commercialize patented plants without declaring them as GMOs. However, in 1992, the European Commission did not consider this […] [chapo] => [texte] => Since 2020, the European Commission has been arguing that mutagenesis carried out on cells isolated and propagated in vitro is exempt from the requirements of the GMO legislation. This position offers an open door for companies to commercialize patented plants without declaring them as GMOs. However, in 1992, the European Commission did not consider this technique as “traditional”. In August 2020, the European Commission challenged whether random mutagenesis techniques on cells isolated and multiplied in vitro result in regulated GMOs [9]. It was responding to a draft decree issued by the French government in response to the french Council of State’s ruling [10]. The Commission wrote, among other things, that "the legislator of the Union has never established a difference between in vivo and in vitro random mutagenesis". However, in 1992, this same Commission had a list of plant breeding techniques traditionally used at the time and, for some of them, it specified whether they gave rise to GMOs or not, regulated or not. In this list, no mutagenesis technique implemented on isolated cell culture (in vitro) was present.A mandatory chronological prerequisiteSince the ruling of the Court of Justice of the European Union (CJEU) in July 2018, the GMO debate has been agitated by a central question : which genetic modification techniques were traditionally used for various applications before 2001 ? The question is an important one. According to European legislation, a history of safe use justifies an exemption from the obligations of the law (risk assessment, labeling, post-marketing monitoring...). In 1990, when the EU adopted its first directive on GMOs, transgenesis was not a traditional technique. It is even a very recent technique. Hence the need for a regulatory framework. Around 2008, the European Union was questioned about the "new techniques of genetic modification" (oligonucleotide-directed mutagenesis, CRISPR, zinc finger, TALEN, agroinfiltration...). The novelty of these techniques was not in doubt : none of them had a history of safe use. However, the debate was an opportunity to discuss an exemption formulated as early as 1990, that of "mutagenesis" according to the term used in the legislation. Directive 90/220 and its successor, Directive 2001/18, state that "mutagenesis" does result in GMOs, but exempted from the requirements of the law. With the debate on new techniques, the opportunity arose to use this generic and vague term to include several "mutagenesis" techniques, and thus exempt them.However, contrary to the arguments of the European Commission and the companies, the CJEU recalled in July 2018 that "only organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are excluded from the scope of that directive" [11]. It also specifies that this concerns "techniques/methods of directed mutagenesis involving the use of genetic engineering which have appeared or have been mostly developed since Directive 2001/18 was adopted". Hence the importance of knowing which techniques are considered to have a history of safe use at the time of adoption of the European directives.French Council of State proposes a distinction, rejected by the CommissionThe CJEU, in 2018, merely recalled the European legal framework. It did not go into the details of the techniques. The french Council of State, on the basis of the CJEU ruling, has done this work for mutagenesis techniques. In February 2020, it noted that "it is clear from the documents in the file that both the techniques or methods known as ’directed’ or ’genome editing’ and the techniques of random in vitro mutagenesis subjecting plant cells to chemical or physical mutagenic agents (...) appeared after the date of adoption of Directive 2001/18/EC or have mainly developed since that date”. For the Conseil d’État, the products resulting from these mutagenesis techniques implemented in in vitro cell culture must therefore be considered as "subject to the obligations imposed on GMOS by this directive" [12].In July 2020, at the request of the French government, the European Commission gave its opinion on a proposed decree formulated in response to the Council of State. In this opinion, the Commission opposes random mutagenesis on isolated cell in vitro cultures as a regulated GMO. However, it does not provide any list or argument showing that this mutagenesis technique was traditionally used without risk before the 1990s. It only quotes a European Food Safety Authority (EFSA) report written in 2012 [13] and gives two examples, one of which is a non-eatable plant.In 1992, the EU lists "traditional" techniquesIn its 2012 report, the EFSA considers mutagenesis or selection by mutation to be a conventional technique, without further elaboration. To affirm this, EFSA relies on a 2010 report by Wageningen University on "traditional plant breeding methods" [14]. This report is all the more relevant because the authors have exhumed a 1992 document that they indicate is no longer easily accessible and that they annex to their report. They point out that "already soon after the enactment of the previous Directive, 90/220/EEC, [the traditional breeding techniques] have been tentatively listed in an EU background paper ‘Current plant breeding techniques’, DOC.XI/464/92" [15]. Two years after adopting its legislation, the European Union established a list of plant breeding techniques then considered traditional. This list is necessarily broader than the techniques of genetic modification alone, and is therefore fundamental for knowing which techniques give rise to GMOs exempt from the requirements of the law. However, the European Commission has never itself exhumed this report !Answering the question "What are traditional breeding methods ?", this 1992 report notes that the characteristics of these techniques are that they are "applied at organism level". As for "other available approaches to combine different desirable traits into plants such as techniques applied at cellular or molecular level", these are stated to be "beyond the scope of this paper", i.e. not traditionally used. Among the cellular techniques cited, the document lists "somaclonal selection, cell/tissue culture, cell fusion, mutation and selection in cell culture, isolated microspores”. Somaclonal selection, or variation, is one of the designations of in vitro cell culture techniques. The Commission therefore considered, in 1992, that it was not traditionally used. More importantly, the techniques referred to as "mutagenesis" in this document are those that involve subjecting pollen or seeds to physical or chemical mutagens. This reference document of the European Union therefore does not mention any mutagenesis technique implemented on in vitro cell culture in its list of traditional techniques, considering them "beyond the scope of this paper" !The Commission formalized this list in 1992As early as 1992, the European Commission - then called the Commission of the European Communities - took up this report in an official document entitled "Interpretation of the concept of traditional improvement in the context of the exemptions introduced by Annexes 1B and D of Directives 90/2019 and 90/220 Interpretation of the concept ’traditional breeding" in the context of the exemptions outlined in Annexes I B of Directives 90/219/EC and 90/220/EC", referenced DOC/XI/463/92-fin [16]. The context of the document is recalled by the Commission. The aim was to list the traditional breeding methods.In order to harmonize the reading of this directive by the Member States of the European Union, the European Commission provides in its document the official interpretation of the expression "traditional breeding". These are "practices which use one or more of a number of methods (e.g. physical and/or chemical means, control of physiological processes), which can lead to successful crosses between plants of the same botanical family". In addition to this interpretation, the Commission refers to the report published in the same year, which we have just analysed.Since 1992, there have been other discussions or exchanges on the European GMO legislation, whether in the proceedings before the Court of Justice of the European Union or in the possible comments on the French draft decree in 2020. At no time during these recent discussions has the European Commission produced a list of traditionally used genetic modification techniques, not even the one it produced itself in 1992. To this day, the latter is the one that continues to be used to implement a regulatory framework that, as early as 1990, considered transgenesis to be regulated. Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [255] => Array ( [objectID] => 6352 [title] => New GMO – Upsetting decisions for the industry [timestamp] => 1654128000 [date] => 02/06/2022 [annee] => 2022 [url] => https://infogm.org/en/new-gmo-upsetting-decisions-for-the-industry/ [image] => https://www.infogm.org/IMG/arton7428.jpg?1654154711 [extrait] => A minority of the world’s economically powerful states have decided to relax the rules for GMOs produced by new genetic modification techniques. Others have explicitly decided that these GMOs must be subject to GMO regulation. This is the case of New Zealand and South Africa. However, the decisions taken by these two countries are facing […] [chapo] => [texte] => A minority of the world’s economically powerful states have decided to relax the rules for GMOs produced by new genetic modification techniques. Others have explicitly decided that these GMOs must be subject to GMO regulation. This is the case of New Zealand and South Africa. However, the decisions taken by these two countries are facing pressure from the agribusiness. In South Africa and New Zealand, GMOs derived from new genetic modification techniques fall under the GMO regulation and must therefore be subject to the same obligations as any other GMO. In the European Union, the Court of Justice made the same finding. As a result and under pressure from the agro-industry, the European Commission initiated a process to revise the legislation.New Zealand : upholding the caution approach In New Zealand, the decision to subject GMOs derived from new genetic modification techniques to the GMO legislation resulted from a 2014 Wellington High Court ruling [1]. This was the first time in the world that a court had ruled on the legal classification of these new techniques. In the case before the Court, two modification techniques were specifically concerned (zinc finger nuclease (ZFN-1) and TALEN). The Environmental Protection Agency had decided a year earlier that these techniques did not produce GMOs [2]]. In the Agency’s view, these techniques do not involve the insertion of foreign genetic material and are therefore similar to chemical mutagenesis, one of the techniques exempted from New Zealand’s GMO regulations.The High Court disagrees with this interpretation and therefore overturned the Agency’s decision. It rules that the list of techniques exempted from the GMO regulation is a closed list. Since ZFN-1 and TALEN are not mentioned in the list, they cannot be exempted. It is interesting to note that these two techniques are not included under the term mutagenesis. Instead, they are considered as non-exempt techniques in their own right, even though they are associated with mutagenesis and a whole range of other non-GMO regulated techniques. The High Court ruling led the New Zealand government to revise the regulations in a manner reminiscent of the ruling a few years later, by the Court of Justice of the European Union. The new rules provide that mutagenesis techniques used before 1998 (when the New Zealand regulations were adopted) produce organisms that are not subject to regulation, whereas those developed subsequently produce GMOs that are subject to regulation [3]. All subsequently developed mutagenesis techniques, including new genetic modification techniques, regardless of their combination with originally excluded techniques, are therefore regulated as GMOs.The New Zealand government’s position is consistent with its precautionary approach to GMOs in general. Although the country allows the import of GMOs for food and feed use, no commercial cultivation of GMOs is permitted. The country thus enjoys a “GMO-free” image. With regard to GMOs resulting from new techniques of genetic modification, the government explains its cautious approach by the fact that the country is a billion dollar exporter of food products and must therefore be attentive to market insights as well as scientific data [4].South Africa: a surprising decisionIn the case of South Africa, on the other hand, the decision to subject GMOs derived from new genetic modification techniques to GMO regulation was not obvious at all. The country is one of the world’s top ten GMO producers. The area of GM maize, soybean and cotton production is estimated around 2.8 million hectares. More than 80% of the maize crops, about 95% of the soybean crops and 100% of the cotton crops are GM [5].However, in October 2021, the South African Department of Agriculture explains that “(t)he GMO Act defines a Genetically Modified Act (GMO) as an organism the genes or genetic material of which has been modified in a way that does not occur naturally through mating or natural recombination or both.” (note the similarity with the European definition...). It concludes that the risk assessment framework that exists for GMOs should also apply to GMOs resulting from new genetic modification techniques [6].The New Zealand and South African decisions are in line with the conclusions of the Court of Justice of the European Union in 2018 [7], followed by the French « Conseil d’Etat » in 2020 [8]. However, they go against the grain of the regulations adopted by a growing number of states, albeit a minority, which are reducing the constraints on these new techniques and the products derived from them [9] [10] [11] [12]. These deregulations are the legal translation of the agro-industry’s claim that the new techniques are more precise and therefore make it possible to obtain safer products. And since these techniques would consist of doing what nature does, but faster, there would be no scientific basis for making a legal distinction between the products that result from them and the so-called conventional products.It is therefore hardly surprising that the decisions of the New Zealand and South African governments do not please the industry that promotes these new techniques…Judicial attack in South AfricaIn South Africa, the industry is putting legal pressure on the government with an appeal to the Minister of Agriculture. The appeal was lodged by The Agricultural Business Chamber of South Africa (whose members include Corteva, Bayer, Syngenta, BASF, etc. [13]), the seed industry association Sansor (whose members include Bayer, BASF, Rijk Zwaan, etc. [14]) and CropLife SA [15]. They warn of the negative consequences of the decision « to regulate all products derived from NBTs (new breeding techniques) as GMOs ». The industry puts forward economic arguments (innovation, international trade, costs to access the South African market, etc.) but above all environmental arguments. In a context of climate change, “science-based regulation for products derived from NBTs” would be an imperative to guarantee food security, cope with pest pressure, etc. [16]. As if there were only one science, which obviously does not include scientific studies on the risks of new genetic modification techniques...An appeal board is due to rule on the industry’s appeal in the coming months. Civil society organisations, including the African Centre for Biodiversity [17], believe it is very likely that if the appeal board doesn’t go in favour of the industry, it will take the case to the High Court.Media attack in New ZealandAn important event in the challenge to the New Zealand government’s decision is the publication in 2021 of the report of the Productivity Commission, an independent administrative body made up of economists. This report, criticised for its lack of balance by the organisation GE Free New Zealand, advocates a review of the GMO regulation « to ensure it is fit for purpose and supports domestic innovation » [18] .In March 2022, in response to this report, the New Zealand government states that it has « long considered that the New Zealand brand and value is best met by maintaining a ‘proceed with caution’ approach […] (but that it is) timely to start informed conversations around New Zealand’s use of GM technologies » [19].This response triggered a series of reports in several media across the country, putting the 2021 report back on the front page and headlining the need for new genetic modification techniques to “save the planet”, in the context of climate change, etc. [20]. This is a way of skewing the debate on the regulation of new genetic modification techniques in favour of the recommendations of the Productivity Commission report... Moreover, when it is not presented as “recent”, the report is described as “revolutionary”. This lack of objectivity goes even further, since several media published a press release from the BiotechNZ company [21] on the same day, in extenso, which wants to see the GMO regulations reviewed, and the majority of them give a lot of space to the words of the company’s director. Very few of them are critical, such as that of GE Free New Zealand. The Productivity Commission’s report repeats the same mantra used 25 years ago for the deregulation of transgenic GMOs, a technology that has failed, the organisation points out. GE Free New Zealand insists: “New Zealand cannot afford industry to avoid necessary precaution and regulation [...] (and) (t)here is also value in Brand New Zealand being recognised by international consumers for safe, natural food, high standards of animal welfare and meeting the global demand for Non-GMO Food.” [22].For the time being, however, a review of the regulations is not on the agenda. The Environment Minister, David Parker, has indeed stated that the forthcoming discussion will be limited to GM medicines, as he believes that there is still mistrust in GM foods [23]. Charlotte KRINKE Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [256] => Array ( [objectID] => 6353 [title] => Burkina Faso – The Target Malaria project continues despite irregularities [timestamp] => 1644278400 [date] => 08/02/2022 [annee] => 2022 [url] => https://infogm.org/en/burkina-faso-the-target-malaria-project-continues-despite-irregularities/ [image] => https://www.infogm.org/IMG/arton7341.jpg?1644327528 [extrait] => In July 2021, the National Biosafety Agency (ANB) of Burkina Faso authorized Target Malaria, a project that fights against malaria, to import transgenic mosquito eggs. A first release took place in 2019, in the locality of Bana. This article intends to show the numerous regulatory irregularities of the project first phase. On October 21, 2021, […] [chapo] => [texte] => In July 2021, the National Biosafety Agency (ANB) of Burkina Faso authorized Target Malaria, a project that fights against malaria, to import transgenic mosquito eggs. A first release took place in 2019, in the locality of Bana. This article intends to show the numerous regulatory irregularities of the project first phase. On October 21, 2021, NEPAD (New Partnership for Africa’s Development), an African Union agency, announced the authorization given in July 2021 by the ANB (National Biosafety Agency of Burkina Faso) to import genetically modified male mosquitoes, known as “biased males”, intended for use in a confined environment. This strain importation constitutes the beginning of the second phase of the Target Malaria experiment. The first phase culmination took place in July 2019, with the release of 6,400 transgenic mosquitoes in Bana (rural village in the center west of the country) [1] [2].NEPAD defends gene drivesNEPAD is heavily involved in the activities of the ANB. However, this African Union technical agency deliberately promotes gene drives.The African Union spoke out for gene drives during its 29th ordinary session, declaring that it “commits (…) to investing in the development and regulation of the gene-drive technology” (African Union, 2017).The NEPAD also released a pro-gene drive report entitled “Gene Drives for Malaria Control in Africa”. This report states in particular that “no major risks are foreseen that cannot be mitigated in the application of gene drive technology for malaria elimination, and that the potential benefits will almost certainly outweigh any minor risks observed” (NEPAD, 2018, p.25). To support gene drive development in Africa (assessment, preparedness, regulation, dissemination, education), NEPAD received $2.35 million from the Open Philanthropy Project (Open Philanthropy Project, 2017), which is one of the sources of funding for Target Malaria (Target Malaria a).Concretely, in 2020, the African Biosafety Network of Expertise (ABNE), which depends on NEPAD, organized training for members of the Institutional Biosafety Committee (IBC) and the National Biosafety Committee (NBC) of Burkina Faso. (NEPAD 2020a, NEPAD 2020b). This network, highly favourable to gene drive, was created with funding from the Bill & Melinda Gates Foundation (Glover et al. 2018) in order, with the collaboration of the University of Michigan (United States), to " connect African biosafety regulators with advances in technology – an initiative aimed at reducing poverty through improved agricultural practices.” [3].The numerous irregularities of the project first phase.The first phase of the Target Malaria project experimentation involved sterile male transgenic mosquitoes. This phase included the following activities: importation, studies in a confined environment, release of several thousand mosquitoes in 2019 and monitoring of this release. It is characterized by a series of regulatory and ethical irregularities:• an absence of the independent risk assessment before importation and before release,• an absence of the communities informed consent,• an absence of the public involvement in the decision-making process regarding the importation and the release.A sham of risk assessment of the 2019 releaseThe genetic construct concerned by the strain of the first phase of the Target Malaria project, called Ac(DSM)2, was created in 2008 in the laboratory of Andrea Crisanti, at the Imperial College London, a member of the Target Malaria project. This genetic modification is composed of several sequences: a nuclease gene, called I-Ppo-I, which induces sterility in the male mosquitoes, two fluorescence marker genes, promoters and terminators (Windbichler et al. 2008) . This transgenic modification is transmitted according to the classic rules of heredity, to half of the descendants. It is not a gene drive that is transmitted hegemonically to all the descendants.The Ac(DSM)2 transgenic «construct was created synthetically based on sequence data, and thus the Ac(DSM)2 strain was not exposed to the living source organisms through the development process» (Target Malaria b). This means that it has never been part of a living organism and its expressions are unknown.The I-Ppo-I gene controls an endonuclease which is capable of recognizing and splitting a specific DNA sequence (recognition site). According to Target Malaria, only one specific sequence of this construction is found on the X chromosome of the Anopheles gambiae species (Windbichler et al. 2008).The genome study of the Anopheles gambiae local population, performed by Target Malaria on a sample, has shown the existence of a single recognition site specific to the endonuclease controlled by the I-Ppo gene -I, (Windbichler et al. 2008), a recognition site located in one gene of the X chromosome. This means, for Target Malaria, that the is no other gene, apart from the one on the X chromosome, that may be altered by the action of the endonuclease in question. Does the theory presented by Target Malaria withstand closer analysis? Here are some elements that question this assertion.The risk of the genetic construct transfer to local population and to other mosquito species is possible. Firstly, the population released in 2019 contained as well, unfortunately a small number of genetically modified female mosquitoes, estimated by Target Malaria at less than 0.5% (Target Malaria b, Hayes et al. 2018). Secondly, the recapture rate of genetically modified mosquitoes during the monitoring was particularly low (between 0.3% and 1.7%) (Hayes et al. 2018). The low recapture rate creates a spread of the genetically modified mosquitoes spreading out of the trial site area, this event that can be favoured by the winds (Dunphy, 2019).And, thirdly, the Target Malaria notes that there is a risk that the I-Ppo-I gene may be lost or silenced and the strain will revert to be fertile again (Target Malaria b).The Anopheles gambiae species is present in a vast area that covers most of the countries of West and Central Africa, it has a very high number of individuals, distributed in diverse ecological zones.The species may show great genetic diversity in some of these areas. Because of a statistical phenomenon called “sampling error”, some individuals in the Anopheles gambiae wide habitat area may have the specific recognition site for the I-Ppo-I gene endonuclease in the genome sites other than that identified by preliminary Target Malaria studies, or these sites may arise as a result of mutations or recombinations.In this case, the transfer of the genetic construction to the local population can cause the alteration of other genes, apart from the one on the X chromosome, by the I-Ppo-I endonuclease action.Absence of independent risk assessmentBurkina Faso’s biosafety law requires that "no decision to import, to use in a confined environment, to release or to market a genetically modified organism may be taken by the National Biosafety Agency without prior assessment of the risks to human and animal health, to biological diversity and to environment and the resulting socio-economic consequences” (Law No. 064-2012/AN, 2012, article 24).The risk assessment which enabled the ANB to deliver to Target Malaria an authorization for the release of genetically modified mosquitoes was carried out by the CSIRO (Commonwealth Science and Industrial Research Organisation, Australia) (Target Malaria v. Hayes 2018). However, Burkina Faso’s biosafety law also stipulates that “any natural or legal person having any direct interest whatsoever in the work of genetically modified organisms, should not participate in the assessment of the risks relating to these modified organisms” (Law N° 064-2012 /AN 2012, article 26).The CSIRO report is not an independent assessment, as this organization participates in the “Safe Genes” gene drive project funded by DARPA (U.S. Defence Advanced Research Projects Agency) (Godwin, 2017). Yet, DARPA also funds Target Malaria (Target Malaria a). The CSIRO also participates in the GBIRd (Genetic Biological Control of Invasive Rodents) program and promotes gene drive for rodents to various governmental agencies (Wilson, 2018).The CSIRO report lacks empirical data; its methodology is based primarily on assumptions and expert opinions. For example, the CSIRO calculates the probability of failure of the genetic construct to sterilize male individuals of the GM strain on the basis of the assumption that the effectiveness of the construct in the field will be the same as observed. under laboratory conditions (Hayes, 2018 - 64, Ex. Figure 4.8).Leach and al. point out that technological solutions frequently fail to work and create further problems because they are often modelled in labs or on computers, methodologies which do not reflect the complexity of real world situations (Leach et al. 2010, in Lebrecht et al. 2019). The CSIRO itself admits the possibility that its calculations are incorrect, saying "The possibility that the risk models and calculations are incorrect justifies the monitoring of Ac(DSM)2 strain after the ∅ field release » (Hayes, 2018 – 6).Absence of fully informed consentTarget Malaria obtained the signature of the Bana village community acceptance form from people who do not understand anything about the project, and who do not realize the issues of their signature. « The community acceptance form was a four-pages document, composed of two sections: an information sheet and a signature sheet. The information sheet included key information about the study: introduction to the project context, project steps, information about the sterile male mosquitoes, objectives of the release, compliance with regulatory requirements, ethical considerations, benefits, team in charge of the protocol, confidentiality of the information, expected results and the contact details of the team and of the institutional ethics committee » (Pare et al, 2021).The signature sheet was signed by the village and project representatives.« Four representatives - whose legitimacy had been confirmed during the process - signed on behalf of the village: the chief, a councillor and two members of the VCD bureau. A member of the project team who worked directly in the village also signed the form » (Pare et al, 2021).Target Malaria claims to have organized numerous information meetings about the project and that the 130 households of Bana were involved (Pare et al, 2021). However, one Bana resident said that “ most of the project activities took place in the centre of the village, and as she lived further away, she was not involved. (Fuhr.2018).The journalists’ Investigations show that, despite the signing of the community acceptance form, the Bana residents did not know much about the project and some of them expressed concerns about it (Fuhr, 2018).« If I am not able to understand, I cannot give my consent, because I do not know what damage will be caused by these mosquitoes. In any case, Anyway it scares me because I don’t know what is going to happen. They have gone to make sterile mosquitoes, but what will happen as a result? I really don’t understand » (Fuhr, 2018).The Bana residents said that the project representatives did not talk about risks and only explained the first stage of the experiment (the release of sterile mosquitoes), without informing "on the last stage of the project, the most controversial: gene drive” (Pujol-Mazzini, 2019).The project creates a financial interest for the village young people by giving them small jobs of "mosquito catcher » on their own bodies. They are called “volunteers”, with a payment of CFA franc 400 per hour (ACB et al., 2018), a significant sum for young people affected by poverty and unemployment, in a rural environment where the monthly peasant income is around CFA franc 30,000 (around €45).The “volunteers”, by working for several nights as “mosquito collector ”, can earn a few thousand CFA francs (Carayol, 2020). Since the release of genetically modified mosquitoes in July 2019, the “volunteers” are exposed to the risks of bites from genetically modified female mosquitoes (only female mosquitoes bite and transmit diseases) and from their descendants, but they are not informed on the risk by Target Malaria.The visual support produced by the project for the Bana inhabitants indicates that the modified mosquitoes are sterile and do not give offspring (Pare et al. 2021, fig. 3).There is very little information on the position of the Bana inhabitants regarding the experiment carried out in their village. Very few journalists were able to meet the inhabitants of the village center, the interviews being blocked by the hostility of the villagers fearing the loss of their job. (Carayol 2020One Bana resident said: " If you see that people are reluctant to do interviews, it could be because they are afraid to losing the little benefit they get from the project « (Fuhr, 2018). Only a few residents of the outlying neighborhoods were able to respond to journalists.The inhabitants of Nasso, a village located 5 km from Bana and which was not involved by Target Malaria project, told journalists that they were opposed to the project and that they fear “negative fallout” (Carayol, 2020), especially after the failure of Bt cotton (Fuhr, 2010) [4]. They said they feared being affected by the release of mosquitoes in Bana despite the reassuring words of Target Malaria, "since there is a significant movement [of people] between the two villages as they are located very close together” (Fuhr, 2018).Absence of public involvementThe authorization for the 2019 release was given by the ministerial decree based on the public consultation report as a decisive factor. But what report are we talking about? Indeed, no consultation, as defined by Burkinabe legislation, was conducted.“Public participation takes place at the first stages of the decision-making process, thus allowing public comments to be taken into account in the deliberations of the various advisory and decision-making bodies” (Decree N 2019 – 0455, article13).The mechanisms planned for public participation include public inquiry, ordinary inquiries, consultations, public hearings and the citizen forum (Decree N 2019 – 0455, article 14).The ANB must prepare, for the different forms of public participation, a summary of the risk assessment and the risk management plan, indicating "the deadline for submission of public notices and the next deadlines for the decision-making process” (Decree N 2019 – 0455, article 15).None of these mechanisms for public participation in decision-making process has been implemented by the ANB. And this absence of consultation has been documented and denounced by the Burkinabe civil society (Macé, 2018). Irina Vekcha Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [257] => Array ( [objectID] => 6360 [title] => Digitalized living in open access? The WTO enters the dance. [timestamp] => 1621900800 [date] => 25/05/2021 [annee] => 2021 [url] => https://infogm.org/en/digitalized-living-in-open-access-the-wto-enters-the-dance/ [image] => https://www.infogm.org/IMG/arton7202.jpg?1621947562 [extrait] => Since the end of 2020, the World Trade Organisation has been debating about a possible legislation on the circulation of electronic data. These talks, which are taking place within the framework of broader negotiations on e-commerce, will have a direct impact on the issue of the living’s digitalization. To understand what is at stake, Inf’OGM […] [chapo] => [texte] => Since the end of 2020, the World Trade Organisation has been debating about a possible legislation on the circulation of electronic data. These talks, which are taking place within the framework of broader negotiations on e-commerce, will have a direct impact on the issue of the living’s digitalization. To understand what is at stake, Inf’OGM has interviewed Chee Yoke Ling* who follows these talks for the Third World Network. In a recent file [1], Inf’OGM deciphered ongoing negotiations on living’s digitalization. For a few years, some countries works towards suppressing all legal framework over the use of Digital Sequence Information (DSI), the digital transcription of the sequence of molecules like genomes. The consequence of such a deregulation would simply be the legalisation of the looting of biodiversity, today regulated by the Convention on Biological Diversity (CBD) and its Nagoya Protocol.Among the initiatives implemented to this end, one is underway at the World trade Organisation (WTO) which has been negotiating the regulation of e-commerce since 2017. By the end of 2020, observing an increase of e-commerce activities due to Sars-CoV-2 epidemic, Japan, Australia and Singapore submitted a proposal for a consolidated text [2]. This text aims notably at denying States the right to regulate the flaw of electronic data. Inf’OGM interviewed Chee Yoke Ling from Third World Network to decipher what is at stake.In the World Trade Organisation (WTO), some countries opened an informal debate through a joint statment initiative on e-commerce. This JSI aims at framing e-commerce. In what way are Digital Sequence Information concerned by this initiative ? Chee Yoke Ling : This and other JSIs are illegal as they do not have a mandate based on WTO members’ consensus to start such negotiations. However, they have been moving ahead with many meetings even during the COVID-19 pandemic. The latest consolidated e-commerce text as of December 2020 that was leaked is available online [3].We are concerned about a new form of biopiracy: the transfer of DSI of biological resources (including human genetic resources) from a country or among different countries without the consent of the country of origin or source, and then intellectual property claims are made by the foreign researchers and corporations that create corporate monopolies.Let us take the example of microorganisms in the health sector. Pathogen samples are first characterized and sequenced in country A, and the DSI is with international research networks for public health purposes, meaning they are used to confirm diagnoses, to monitor genetic variations, and in other non-commercial research applications. There is little objection, if any, to the sharing and flow of DSI around the world for such purposes.However, this DSI (and often the pathogen samples, too) is shared among public health laboratories, and are subsequently used for commercial, for-profit purposes. Viruses and their genetic sequences are used by companies to develop proprietary commercial products – vaccines, medicines and diagnostics. These products are typically patented and sold back to the rest of the world on a for-profit basis. Often an extremely for- profit basis, as developing-country public health systems have learned again and again as they confront unaffordable pricing of medicines to treat diseases like AIDS, hepatitis and, most recently, COVID-19.In this connection, there are 2 worrisome proposals in the WTO e-commerce negotiation text. First is the ban on regulation of cross-border data flows which means that governments have to allow DSI and other data from being taken out of the country with no restrictions including the obligation to share the benefits from the use of the data with the country of origin or source. In addition to data privacy laws in a country there are some other exceptions in the e-commerce negotiation text, but these are insufficient, difficult to use or even “self-cancelling” (i.e. the wording of the exception creates a situation where cross-border data flow cannot be regulated).Secondly there is also a proposed ban on “data localisation” meaning that the tech companies or anyone taking data from a country cannot be required to leave a copy in the country. Although the biological resource remains in the country, the sequencing may not be done locally so having a copy of DSI is important.Considering negotiations are ongoing in CBD, WIPO, UNCLOS, WHO and FAO over DSI status and regulation, what would be the impact on those negotiations if, on its side, WTO was reaching a decision stating no rules can be adopted by WTO members to prohibit, restrict or prevent “the cross-border transfer of information” ? CYL : The main contradiction is with the Convention on Biological Diversity (CBD) and its sectoral application treaties (ITPGRFA, maritime resources...). This is the central international legal framework that recognizes the sovereignty of the State over biological resources in its territory, and also the relevant rights of indigenous peoples and local communities (IPLC). Access to biodiversity has to be with prior informed consent of the relevant state authorities and IPLC, and be accompanied by arrangements for fair and equitable sharing of the benefits from the biodiversity use. This legal system is to rectify the imbalances and injustice from centuries of biopiracy of the resources of the South and its indigenous peoples. The CBD’s Nagoya Protocol is a sub-agreement specifically directed to the subject of “access and benefit sharing” (ABS) and includes pathogens.The CBD principles and objectives have been applied in the WHO for a small set of pathogens in the Pandemic Influenza Preparedness (PIP) Framework adopted by the World Health Assembly in 2011. PIP has proven to work effectively for reliable sharing of potentially pandemic influenza viruses and, among other benefits, has generated hundreds of millions of dollars of benefit-sharing payments from vaccine and other companies. These payments have been used to support developing-country public health laboratories and to prepare future influenza pandemic response.COVID-19 has reaffirmed the crucial importance of DSI – it was the sharing of such information in international research network that led to the development of diagnostics and vaccines. Pathogen samples are also being shared. The Nagoya Protocol itself provides for expedited access for public health needs. All this shows that for public health emergencies and pandemics, countries do not hold back access and in fact do not even assert prior benefit sharing commitments from the users. However the users then lock up the resulting products in IPRs and charge as they like.If the WTO e-commerce rule on cross-border data flow gets adopted, it will undermine and even by-pass the right of a country to ensure that benefit sharing can be realized as a condition to grant access. At the domestic level, a country would be surrendering its right to regulate access and to ensure that there is fair and equitable benefit sharing from the use of DSI that is derived from its biodiversity. This means the country concerned would end up paying high prices for medicines, vaccines, diagnostics, plant and food products, etc. And as is happening with COVID-19 vaccines, the monopolies of patents and other IPRs means global shortages that cost lives too, and we can expect that the same will happen with medicines needed to treat COVID-19.If participating countries insist on going ahead, they can exclude DSI from the rule but this will face strong opposition from industry and even the Northern governments. So it is important that we have a global campaign against the proposed rule to prohibit regulation of data flow, and to expose the weaknesses and insufficiencies of the “exceptions” that are in the current e-commerce negotiation text.Can it be imagined that countries owning most of the biodiversity could step out of those negotiations, stating that they do not need to have international rules as they have (already for some of them) domestic rules to which companies must comply ? CYL : Since the e-commerce negotiations are “plurilateral” the countries that object to the JSI are not participating in the negotiations and will not be bound by the outcome. For the countries of the South that are participating there are expectations that these rules will help them to enter the digital economy world and at the moment there is not enough awareness yet of the implications for DSI and their CBD/Nagoya Protocol commitments and rights, including their domestic laws. This is because the WTO negotiators are from trade or commerce ministries and the other treaties are under different ministries. So we need to raise awareness among policy makers, negotiators, IPLC and the public generally to the serious implications of such e-commerce rules.This JSI is coordinated by Japan, Australia and Singapore. It is supported by other countries among which Australia, the US, Japan, the European Union [4], Canada, Norway, Switzerland, the United Kingdom... Opponents to the JSI are mainly India and South Africa with other countries. Those two blocks of countries are quite the same as the ones opposed in CBD over the question of DSI being or not genetic resources and in WIPO over the question of geographic origin of the material used in a patent. Do you consider those two blocks represents in the end the opposite positions in the ongoing and future discussions over a possible massive appropriation of the living ? If so, how do you see it evolving in the coming years ? CYL : Corporate forces (and the part of the scientific community that is linked to them) that oppose CBD/ABS and the inclusion of DSI in that system are using the pandemic to paint the CBD and Nagoya Protocol as obstacles to public health/pandemic response. So they are pushing for new rules in the WHO to make sharing of pathogens and DSI mandatory [5], leaving behind benefit sharing while asserting private ownership over the products from the biodiversity/DSI use.But the negative impact of IPRs shown by the COVID-19 vaccine shortages, vaccine “nationalism” and deeply inequitable access to vaccines for the low income countries (and even middle income countries) has shaken the world so civil society activists can step up efforts to push back on appropriation of nature through the use of IPRs. We need to show that proper implementation of the CBD provides all of us with a fair and equitable system, especially for the South and in particular IPLC who have suffered historical and continuing injustices over the use of our biodiversity.To reach that objective we must also not allow the WTO to be the forum to establish more rules that deepen the exploitation and injustice, handing even more rights and power to the tech, pharmaceutical and biotechnology giants. The same rules are also often pushed through bilateral and regional trade agreements or economic partnerships so we must make sure our advocacy covers those processes. Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [258] => Array ( [objectID] => 4116 [title] => The appropriation of living organisms: can we still control digitalization? [timestamp] => 1610150400 [date] => 09/01/2021 [annee] => 2021 [url] => https://infogm.org/en/article_journal/the-appropriation-of-living-organisms-can-we-still-control-digitalization/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => For the time being, digital sequence information allows certain stakeholders, including companies, to use digitalized sequences without needing the prior consent of the states and communities connected with this biodiversity. Discussions are underway in order to regulate – or not – practices which contravene the Convention on Biological Diversity. Countries allowing free access to the […] [chapo] => [texte] => For the time being, digital sequence information allows certain stakeholders, including companies, to use digitalized sequences without needing the prior consent of the states and communities connected with this biodiversity. Discussions are underway in order to regulate - or not – practices which contravene the Convention on Biological Diversity.Countries allowing free access to the digital information (DSI) on the living organisms they host are running a serious risk : companies or public entities - the only ones with the necessary equipment and technical expertise - are free to use this data and to patent what has not yet been patented. Certainly, a molecule sequence is not new and therefore should not be open to patenting. But once isolated from an organism and associated with a function - most often based on traditional knowledge - any sequence becomes a patentable "invention". All this takes place without any prior consent for access to resources, benefit sharing (ABS) or protection of the traditional knowledge behind the resources used, laid down in international treaties and texts [1]. During discussions within the Convention on Biological Diversity (CBD), some of the countries want to maintain this system, arguing that DSIs are not the equivalent of the organisms from which they have been taken. Others, on the contrary, want both the access to and use of DSIs to be duly regulated. This leads S. Aubry (collaborator of the Swiss Federal Office for Agriculture), amongst others, to say : "the follow-up at the next conference of the parties of the Convention on Biological Diversity will be very interesting : the future of these treaties is at stake" [2].Biopiracy – the scene is set…Several countries, especially those rich in biodiversity, want digital data to have the same status as the physical "resources" from which they originate. Some have even already set out this rule in their national law.For Argentina, for example, "the definition of the term "material" (...) includes the information associated with the genetic resource (...), regardless of the way it is transmitted" [3]. Malawi, on the other hand, believes that it has “commercial rights (...) in products or processes developed based on the research results or this DSI, and any use requires a contract of use with the Government of Malawi”. Malawi will therefore not accept any pillaging of its biodiversity on its territory. But does it have the means and resources to prevent a company from both accessing any digitalized genetic information related to its resources and patenting it ?For these countries, there is an urgent need to find an international agreement on the legal status of DSIs because, in the meantime, genome sequencing is still ongoing, the results of which are made generally available. It is possible to understand the motivation of companies and countries possessing this technology - but not the biodiversity - to block or delay a binding agreement in compliance with the principles of access and benefit sharing : after having sequenced the greater part of their biodiversity, the signature of this still hypothetical agreement will come too late for the beneficiaries.In order to be truly effective this agreement should, as for physical genetic resources, impose prior agreement regulating the use of the resources in question : the protection of traditional knowledge, details of the geographical origin of the organism from which the digitalized sequences originate and, of course, benefit sharing. Finally, following the example of the European Union, those countries campaigning for unrestrained access to digitalized biodiversity should not continue to issue patents that apply, in just the same way, to digital information as to all the organisms providing it.What other solutions are there ?For effective benefit sharing, some actors propose a mandatory payment [4] to a global sharing fund along with a prohibition on patenting native sequences. An even simpler option would be to prohibit all property rights on living organisms. Negotiations on DSI will continue, notably at the CBD summit in May 2021 in China. Until then, Inf’OGM will continue to provide you with all further information on this important issue. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [259] => Array ( [objectID] => 4111 [title] => Genetic resources : the wrong « label » ? [timestamp] => 1609977600 [date] => 07/01/2021 [annee] => 2021 [url] => https://infogm.org/en/article_journal/genetic-resources-the-wrong-label/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => What does the expression “genetic resource” really mean ? Of course, the word “genetic” is well-known and refers to the genome of living beings : their DNA or genetic “material”, but is this its present-day meaning ? And what about the addition of the word “resources” ? There is also the mention of the « digitalization of genetic resources” […] [chapo] => [texte] => What does the expression "genetic resource" really mean ? Of course, the word "genetic" is well-known and refers to the genome of living beings : their DNA or genetic "material", but is this its present-day meaning ? And what about the addition of the word "resources" ? There is also the mention of the « digitalization of genetic resources" or "digital sequence information". Let’s take a look at an explication based on the legal texts… When "resources" are referred to in the sphere of agriculture it makes us think of seeds and plants, as well as animals – but not only that ! It is obvious that these include the information they contain as well as the farmer knowledge that produced them. Could these resources have changed their nature with the advent of genetics and digitalization ?"Genetic resources" : a recent termThe term "genetic resources" was coined in 1967 at the International Conference on the crop Plant Exploration and Conservation organized by the FAO and used again at the Rio Earth Summit in 1992 by the Convention on Biological Diversity (CBD) [1]. A "genetic resource" is, according to this convention, "genetic material of actual or potential value", with "genetic material" being defined as of biological origin and containing hereditary functional units (genes). The CBD also expanded the notion of "genetic resources" to include "intangible components" (such as traditional knowledge), thus extending the definition beyond the simple physical characteristics of the resource in question [2].According to the Nagoya Protocol [3], entering into force in 2014, and depending on this very convention [4], it is understood that the term "genetic resources" refers to the genetic and/or biological composition of a living being. It does in fact define the "utilization of genetic resources" (Art.2c) as comprising "research and development on the genetic and/or biological composition of genetic resources including through the application of biotechnology". This definition thus differs from the one included in the CBD in 1992. In 2019, Swiss researchers stated that "the future of genetic resources for food and agriculture will be a hybrid between physical resources (seeds, gametes) and digital resources" [5] .In this way, under the term "genetic resources", we find non-genetic resources. So, with the evolution of the texts and technical advances, their difference from "biological resources" [6].Why talk about "resources" ?The word "resource" places living systems in an industrial extractivist [7] vision where natural resources represent no more than material assets. After coal, petrol and the biomass, now genes and biochemical compounds are becoming the new "minerals"to be exploited. As with the other examples of extractivist activity, this "resource" is to be found in countries rich in biodiversity - principally in the tropics or in the seas and oceans - and duly exploited by the industries of developed countries. We have come far from the etymological origin of the word "resource" which comes from to recharge, to renew…Thus, the term "genetic resource" is a way of unequivocally encompassing the whole realm of living beings, whether plants, animals or micro-organisms. Their genes are certainly elements common to life but life can in no way be reduced to genes. So, in fact, the expression "genetic resources" tends towards a utilitarian and reductionist position allowing the modification, patenting and appropriation of all forms of life. Such appropriation is not new, but nowadays it has taken on a planetary dimension due to the improved storage conditions of physical resources, as well as the possibility of rapidly obtaining genetic sequences at a lower cost and their storage in computers. In the same way, the term "material", often used in the texts, is tending to remove the primordial separation between inert matter and life. Reduced to a simple genetic sequence, life is no longer "alive", no more than an assembly of molecules. A "genetic resource" is thus life associated with a particular value ; a value in terms of biodiversity, then in terms of exploitability - which is in fact an economic value.DSI and digitalized resources"Digitalization and high-throughput sequencing techniques are bringing genetic resources into the arena of Biodata " [8] . But, what are these digitalized data ? Strictly speaking, they are the "genetic" data of living life forms, meaning nucleic acid sequences that have been digitalized and whose number is increasing rapidly and exponentially. We can take the example of the American NCB database which, in August 2018, hosted 1015 nucleotide sequences [9] [10]. Ambitious projects, such as the Earth Biogenome Project, aim at sequencing the genome of each and every eukaryotic species and bringing them into the public domain within the next decade [11].Over the past few years, another new term has appeared, resumed as DSI – Digital Sequence Information. The term itself, as well as the scope of its meaning and content, is still under discussion. It could very well include not only RNA and DNA sequences but also computerized genetic information : gene expression profiles, biodiversity assessment, genetic analysis (genotyping) as well as epigenetic data, such as DNA methylation state, metabolites or even phenotypic data [12].The dematerialization and registration of genetic resources amounts to establishing computerized databases of genetic material from which the companies hope to be able to extract sequences linked to biological functions that synthetic biology engineers will be able to draw on.All this implies reducing living beings - or at least parts of them - to virtual entities and deconnecting them from whatever integrity, resistance, adaptation or evolutionary potential they may have. Will a gene - isolated, sequenced and stored in a database - still assume the same function when it is used in another living being ?There is a real risk that digitalization will make peoples worldwide lose sovereignty over their biological wealth. The World Economic Forum justly defines digitalization as being "a technological fusion which fuses the frontiers between the physical, digital and biological spheres of existence" [13]. So if Nature is being thus ordered and oriented by Man on a huge scale, what will happen to what is not considered to be a resource ?Which data are digitalized ? Organisms whose informations, (genomes for example) are sequenced and then recorded in public or private databases, are taken from nature or from cultures, collections, breeding centers and human community preparations. The CBD believes that today, if there is less collection in the field, this could change because "individuals will be able to easily and cheaply sequence genes from physical samples anywhere in the world and send them via the Internet" [14].Once the samples have been taken, the DNA is extracted and sequenced. But the simplicity of this sentence does not reflect the difficulty of the sequencing process. Several steps interfere with the reliability of the result. After extraction, which must be contaminant-free, the DNA is cut into pieces that are sequenced using various platforms and methods with different limits and result-reliability. The sequences obtained are then assembled end-to-end to reconstitute, not without difficulty, the entire genome. These genomes are then compared with their so-called "reference" genome, and each step thus introduces biases into the results. These biases increase when the genomes are polyploid (more than two sets of chromosomes) or have numerous repeat sequences. Scientific articles summarize these difficulties, comparing methods, platforms and associated software, discussing reference and implementation standards to make the whole process reliable [15]. All these tools are complex and costly, thus limiting their use by a number of countries with few means.Moreover, DNA is more than a simple sequence of bases. In the same identical genetic sequence, the chemical state of the bases can vary from one organism to another (methylation). Finally, molecules other than DNA, such as RNA, mitochondrial DNA, proteins..., can be sequenced. Consequently, the umbrella term "digital sequence information" has today as many definitions as there are stakeholders [16].Eric Meunier Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [260] => Array ( [objectID] => 4112 [title] => What legislation for the digitilization of life and benefit sharing ? [timestamp] => 1609977600 [date] => 07/01/2021 [annee] => 2021 [url] => https://infogm.org/en/article_journal/what-legislation-for-the-digitilization-of-life-and-benefit-sharing/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => If free access to « digital sequence information » (DSI) of living organisms were to be unconditional, it would come up against the fair and equitable sharing of the benefits generated by the use of any physical genetic resource. Because this sharing of physical genetic resources is actually taking place within a framework of existing international […] [chapo] => [texte] => If free access to « digital sequence information » (DSI) of living organisms were to be unconditional, it would come up against the fair and equitable sharing of the benefits generated by the use of any physical genetic resource. Because this sharing of physical genetic resources is actually taking place within a framework of existing international texts. Despite those texts, national laws are splitting between a regulated access to data with benefit sharing on one hand and totally free access with no sharing on the other. According to the country concerned, the Digital Sequence Information (DSI) of genome would sometimes be considered as being equal to the actual physical genetic information (as with Brazil, Columbia, Ethiopia, India…) or, at other times, as totally different (as with Australia, European Union, Japan, South Korea…). Subsequently, access to and benefits relative to the use of living organisms are subject to diametrically opposite consequences.International laws are very variableIndia, for example, claims that its law on biological diversity apply equally and unequivocally and to both physical resources and digitalized data [1] [2]. Ethiopia made the same statement : "The revised draft (…) ABS proclamation incorporates DSI in its scope of application and the definition of genetic resources. A "genetic resource "(…) includes the derivatives and their digital sequence informations".Quite differently, but based on the same international texts (!), other countries draw completely opposite conclusions. Thus, the European Union [3] and its member countries "consider that DSI is not the equivalent to a genetic resource (…). PIC (Prior informed consent) cannot and should not be required for access to DSI, including from publicly available databases” [4].What do these international texts say ? Since 2016, a number of international bodies have been studying the question of DSIs with regard to benefit sharing [5]. They include the Convention on Biological Diversity (CBD) and the Nagoya Protocol (on Access and Benefit Sharing, ABS) ; the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), the WHO framework for Pandemic Influenza Preparedness (PIP) ; the United Nations Convention on the Law of the Sea (UNCLOS) [6] [7]…Benefit sharing is legally definedThe Convention on Biological Diversity, which came into force in 1993, is "the international legal instrument for the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources » [8].There are two international texts concerning this third objective of "benefit sharing ». On one hand, there is the Nagoya Protocol (effective as from 2014), under the CBD framework, enforcing "access to genetic resources and the fair and equitable sharing of benefits arising from their utilization » [9] ; on the other hand the ITPGRFA [10] under the FAO framework (already effective in 2004).The ITPGRFA concerns 64 cultivated species [11] and their food and/or agricultural use. The Nagoya Protocol applies to all other genetic resources as well as those listed in the ITPGRFA for all non-food utilization.The aim of these texts is to allow the access to and utilization of genetic resources, along with the payment of part of the derived benefits according to a Material Transfer Agreement (MTA) [12], signed between the user party and the sovereign state (holding the resources [13] for the CBD) and with the Treaty’s Benefit Sharing Fund, which mutualizes the distribution of the sums collected. Theoretically the advantage should be given to farmers in the developing countries but, in reality, it is given to the plant (phylogenetic) resource research organizations utilizing the resources they hold.It is to be noted that benefit sharing may be monetary or non-monetary. Annex 1 of the Nagoya Protocol [14] puts forward a few examples : revenue sharing from rights and licensing fees, technology transfers, capacity building, access to data-bases [15]… ITPGRFA has a multilateral system of access and benefit sharing (SLM) providing resources to beneficiaries. The latter has a commitment (but rarely respected) to pay part of the sales revenue of commercialized products that have been derived from the genetic resources [16]. However, nothing obliges the patent-holders to declare whatever resources they may have used and thus to share the subsequent benefits. A farmer, on the other hand, has to buy the seeds of a given variety whose price includes a license fee, and is thus paying royalties on the seeds coming from his own harvest ! Furthermore, if the genome of a plant has been sequenced, some argue that the very fact of making the sequences generally available is also a form of benefit sharing [17].According to the President of the French Fondation pour la Recherche sur la Biodiversité (FRB), "the exchanges relative to a fair and equitable sharing of the benefits would only concern a few thousand or tens of thousand euros on a global scale" [18]. In fact, the international texts guarantee no more than very little redistribution, and have in no way prevented cases of bio-piracy meaning the utilization of a resource with neither prior consent nor benefit sharing. Furthermore, by patenting a resource, its genes or the genetic data it contains, they forbid de facto its utilization by the original owners of the given resource (See the recent examples of the flour Eragrostis teff [19] and tisane Quassia amara [20] etc.).Two authorities, first the ITPGRFA in 2015 and then the CBD in 2016 noted discrepancies in the status of digitalized sequences and created ad hoc groups to examine the question. The last CBD meeting took place in March 2020 [21]. And the last ITPGRFA meeting occurred in 2019 [22] and had to admit failure. The CBD signatory states also contributed to this debate [23], the aim being to find agreement on benefit sharing during the COP15 in China, which has been postponed until 2021 due to the Covid19 [24].WHO and sharing the influenza virusIn its introductory statement, the Nagoya Protocol declares itself to be ""mindful of the international Health regulations (2005) of the World Health Organization (WHO) and the importance of ensuring access to human pathogens (…)". Its Article 4 establishes exceptions to the benefit sharing, "where a specialized international access and benefit-sharing instrument" can be applied in conformity with the aims of the protocol. This is the case for some pathogens like the one causing influenza.In 2011, WHO adopted a Pandemic Influenza Preparedness framework in view of the exchange of viruses and access to vaccines and other benefits, under the acronym PIP [25] [26]. A PIP review group examined the question of benefit sharing. The group deplored the fact that "genetic sequence data [27] are not included in the definition of PIP Biological Materials". It thus took care “to ensure that it is guided by the same principles as the governing the sharing of genetic material" [28]. In April 2019, its Director General proposed, amongst other things, that WHO should explore "possible (...) global multilateral mechanisms, for pathogen access and benefit sharing (…) in harmony with the Nagoya Protocol and its principles” [29]. A complete report is to be provided for the 74th World Health Assembly in May 2121 [30].Furthermore, WHO is drawing up a Code of Conduct for open and timely sharing of pathogen genetic sequence data during outbreaks of infectious disease [31], and is particularly keen that the data should be rapidly put online, even if no scientific article has yet been published. This online release is to be accompanied by a prior application for authorization to utilize the data [32].Thus, on one hand, there would be benefit sharing with the populations involved, possibly in the form of vaccines ; on the other hand, there is a concern that a researcher sharing the genetic sequence of a pathogen should not be deprived of all remuneration for his work [33].As such DSIs often lead to patent applications, it may be expected that the World Intellectual Property Organization (WIPO) should be watchful on the issue of benefit-sharing. Although there is no doubt that, in July 2019 [34], it defined new standards for recording nucleotide and amino-acid sequences requiring declaration of the living organism from which the sequences originate, nonetheless it has not yet requested their geographical origin. Thus, benefit sharing is impossible. However, discussions are in progress by the WIPO intergovernmental commission on intellectual property on genetic resources, traditional knowledge and folklore (IGC) [35] to ensure that « patent applicants (…) disclose the source or origin of genetic resources and evidence of prior informed consent and benefit-sharing » [36] [37].So what about France ?In 2016, France included the Nagoya Protocol in its Law on the recovery of biodiversity, nature and landscapes [38], but has been severely criticized by the environmental section of the Economic, Social and Environmental Council (for a virtually impossible application of the benefit-sharing modalities and the non-promulgation of the prescriptions and rulings [Bilan de la loi pour la reconquête de la biodiversité, de la nature et des paysages (Report on the law on the reconquest of biodiversity, nature and the countryside) Op. Cit.]]… and this without considering "digital sequence information". Could this be a bad omen ? Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [261] => Array ( [objectID] => 4113 [title] => Biopiracy on digitalized sequences : two examples [timestamp] => 1609977600 [date] => 07/01/2021 [annee] => 2021 [url] => https://infogm.org/en/article_journal/biopiracy-on-digitalized-sequences-two-examples/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => If cases of biopiracy of living organisms based on digital sequence information (DSI) are not frequent for the moment, Inf’OGM is aiming to show that they are not just figments of the imagination. Without a strong reaction from the international community, the two examples presented here (the Ebola virus in West Africa and a GM […] [chapo] => [texte] => If cases of biopiracy of living organisms based on digital sequence information (DSI) are not frequent for the moment, Inf’OGM is aiming to show that they are not just figments of the imagination. Without a strong reaction from the international community, the two examples presented here (the Ebola virus in West Africa and a GM potato in Rwanda) could well be the first on the scene and sign the death warrant of benefit sharing, which is however mandatory under international law.The main concern, supposing that "digital sequence information" (DSI) is not considered equivalent to physical genetic resources, is that DSI lends itself to the biopiracy of physical resources. This means their use outside any legal framework (CBD, Nagoya, ITPGRFA... [1]), and therefore with neither prior agreement for access to the resource nor any share of the benefits arising from its use... Even worse is the possibility of patents being filed on these sequences, thus preventing farmers and other operators from continuing to use the plants (and other organisms) containing them and that they have themselves provided for genetic resource collections.Such is the theory. In practice, Sylvain Aubry, a scientific associate of the Swiss Federal Office of Agriculture, interviewed by Inf’OGM, believes that "the use of (digital) resources proves to be more "subtle" than in the case of “classical” biopiracy (teff, Madagascar periwinkle, etc.). It is now up to breeders to collect as many resources/sequences as possible for their programme. This is often difficult, even if there has been "use" of a – digital - resource to identify or quantify its exact contribution to the final result (...). We are really in the domain of "Big data"”. These big data are stored in huge databases (see box below).DSI : very Big data !Below is the enthusiastic viewpoint on the databases of Chinese and European stakeholders on DSI."DSI is mostly created from physical genetic resources through scientific research. Publication in scientific journals (...) is generally through a database, of which the largest and most used are open access. The largest international database is the International Nucleotide Sequence Database Collaboration (INSDC), made up of DNA Data Bank of Japan (DDBJ), National Center for Biotechnology Information (NCBI) and the European Nucleotide Archive (EMBL-EBI). The collaboration members share data daily, and data are also shared automatically with at least 1800 other databases that provide more specialist services to user communities. (…10-15 million users from every country in the world). Data have been validated, curated, indexed for discovery and re-use, and comply with established standards, all factors that increase their value. Open access is an important consideration when considering smooth functioning of data provision for scientific research."Source : EU-China workshop on ABS and DSI, 28,29 May 2020.On the existing DSI databases, see also : Eric MEUNIER,Frédéric PRAT, « Prolifération des bases de données de séquences génétiques numérisées », Inf'OGM, 21 février 2020 ("Proliferation of Digitalized Genetic Sequence Databases").Biopiracy on a GMO potato ?Some concrete cases of "biopiracy" on DSI have however been revealed. Let us first examine the case of a potato from the International Potato Center (ICP) in Peru, documented by the African Diversity Center (ACB) [2], along with Pelum and Andes, both NGOs critical of GMO introduction. The ICP developed a cisgenic potato (with gene transfer between sexually compatible species belonging to the same genus) from the Victoria variety, itself originating from the ICP more than 25 years ago for East African countries [3]. This cisgenic potato has three genes taken from Latin American species of the genus Solanum (see table below), so that the variety is resistant to mildew. It was to be to commercialized it in Uganda and Rwanda.Table 1. GMO potato cisgenesGeneSpeciesOriginDI Gene BankRpi-vnt1.1Solanum venturiArgentine, 1973FJ423044.Sainsbury (United Kingdom)Rpi-blb2Solanum bulbocastanumMexicoDQ122125.Wageninen (Netherlands)RB (Rpi-blb1)Solanum bulbocastanumMexicoWisconsin Univ. (USA)Source : GM Potato Push in East Africa : Andean and African farmers condemn digital sequence information of potatoes from centres of origin – open doors for biopiracy, Andes, ACB, Pelum, March 2020ACB has shown that two of these three genes were not taken directly from the physical resource by the ICP but synthesized from sequences taken from the US GenBank.The first gene, Rpi-vnt1.1, was derived from Solanum venturii, collected in northern Argentina in 1973, sequenced by the Sainsbury laboratory in the UK and stored in the GenBank in 2010.The second gene, Rpi-blb2, derived from the Mexican plant Solanum bulbocastanum, was collected before 1957, sequenced and stored in GenBank in 2005 by researchers at the University of Wageningen in the Netherlands.In both cases, the researchers claimed commercial rights to these mildew-resistant genes.Subsequently, the two genes were synthesized from DSI : the synthesis of Rpi-vnt1.1 was carried out by GenScript (an American company in New Jersey) and that of Rpi-blb2, by Entelechon (a German subsidiary of the Luxembourg company Eurofins) [4].Disseminating without sharing ?In order to test its resistance, ICP provided this GM potato in partnership with the National Agricultural Research Organization in Uganda and within the framework of a jointly funded project by the United States Agency for International Development (USAID), the Centers for International Agricultural Research (CGIAR) and the Sainsbury-linked [5] English foundation, 2Blades. The Ugandan government having backed down on the adoption of a biosafety framework, it has become impossible to introduce GMOs in Uganda for the time being. So, what alternative is there but its neighbour Rwanda ? Indeed this country, initially reluctant to accept GMOs, set up a legal framework in October 2019 for their introduction. In addition, its 2016 law on seeds allows the claiming of property rights on varieties considered to be of "public knowledge", without any mention or recognition of the traditional or local varieties. The conclusion of ACB is that : “With these clauses, and without any need for the disclosure of the origin of the plant material, this law (...) encourages biopiracy and prevents the equitable sharing of benefits outlined in the Nagoya Protocol (...) to which Rwanda is a Party” [6].The financial and scientific arrangements for the development of GMO potatoes in Rwanda were described in detail in the document of the three NGOs [7]. We find a great mixture of entities : the Gates and 2Blades Foundations, USAID, CIP, CGIAR, the American company Simplot, the Dutch company Agrico, the Sainsbury laboratory, all cross-financed with capital from the United Kingdom and the United States. In addition to the destabilization of the Rwandan small-farmer market, the absence of any mention of benefit sharing is another striking feature of this project.Ebola : a treatment without benefit sharingThe second case concerns the development of a treatment against the Ebola virus, where the benefit-sharing should at least allow the affected countries to have access to this treatment. According to a paper by Edward Hammond [8], nothing as such has occurred, and this case HAS become symptomatic of the circumvention of the Nagoya Protocol.In 2014, the Ebola virus in West Africa was isolated from a Guinean patient and studied by the Pasteur Institute in Lyon (France) and the Nocht Institute in Hamburg (Germany). The Nocht Institute sequenced this sample (named C15) and shared the results in two ways : first by sending physical samples of the virus to different laboratories, accompanied by a Material Transfer Agreement (MTA) which, in accordance with the Nagoya Protocol, provides for benefits for Guinea in the event of patent filing or commercial exploitation ; and second by recording the sequence in the US GenBank, making it available to anyone without any financial counterpart.The US company Regeneron downloaded the C15 sequence and synthesized portions of it to create a monoclonal antibody-based treatment (REGN-EB3), with a subsidy of more than 400 million dollars from the US Government [9]. But each dose costs $10,000, which no African government can afford. Has there finally been an agreement between Guinea and Regeneron ? Hammond’s investigation was not able to provide evidence, but it emphasizes that the U.S. legislation did not make it mandatory. In fact, Regeneron was able to file a patent, valid for the moment, in the United States, Nigeria and South Africa… Hammond, in his article published on the deciphering of the C15 sample [10], emphasizes that the sample had been obtained without the patient’s prior consent ... and supposes without Guinea’s consent either.The sequencing of living beings is accelerating, often accompanied by the filing of patents. For marine species, 47% of patents on genetic sequences are held by a single company : BASF [11]. Is it still possible to stop this biopiracy ? We will open the discussion in the following pages of this dossier… Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [262] => Array ( [objectID] => 4114 [title] => Biodiversity : between « open source » and state sovereignty [timestamp] => 1609977600 [date] => 07/01/2021 [annee] => 2021 [url] => https://infogm.org/en/article_journal/biodiversity-between-open-source-and-state-sovereignty/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => The conditions to the access and use of information recorded in databases are the subject of fierce international debate. For some, it is a question of « protecting » their national resources and biodiversity, and for others one of « avoiding » current regulations. The ability to patent living organisms on a massive scale is a key issue that […] [chapo] => [texte] => The conditions to the access and use of information recorded in databases are the subject of fierce international debate. For some, it is a question of « protecting » their national resources and biodiversity, and for others one of « avoiding » current regulations. The ability to patent living organisms on a massive scale is a key issue that is being fought out, for the time being, without the participation of the local communities. Plants, animals and microbes are defined as genetic resources by current legislation. It is the subject of intense discussion to know precisely what is covered by the notion of "genetic resources", so far examined only on a semantic level (in a previous article [1]). The objective is to decide whether the term "genetic resource" (a corn, a cow, a virus...) refers only to the physical organism or also to its digitalized DNA sequence. What is at stake ? It is to allow or prevent access to greater biodiversity, not only without the prior agreement of those who have conserved it, but also without having to share benefits resulting from its use. Debates are therefore being launched on what is currently called "digital sequencing information" (DSI).DSI : a highly international theme…It’s on the agenda of six international bodies the Convention on Biological Diversity (CBD), ITPGRFA of FAO, as well as its Commission on Genetic Resources, PIP Framework of WHO on influenza, the Convention on the Law of the Sea (UNCLOS) and the World Intellectual Property Organization (WIPO). [2].To date, the CBD is where political positions are the most visibly exposed. Discussions have been regularly held for several years now, such as those taking place in a work group set up specifically for this purpose in 2018 [3]. In 2019, the countries that wished to do so communicated their analysis of DSI status. The documents available to the public provide a rather divided picture of the positions [4]. A first group of countries, comprising the European Union (see box below), the United States, Canada and Japan, consider that DSI should be seen as non-equivalent to genetic resources. A second group with Argentina, Brazil, India, Ethiopia, Colombia, Iran and a few countries on the African continent maintain, on the contrary, that DSI is already covered by the existing definition of genetic resources.For the former, the term DSI is inappropriate and the terms "genetic sequence data" or "genetic sequences" would be more accurate. Above all, they consider, as specified by the European Union (see box) for example, that DSIs are “not equivalent to genetic resources” [5]. Accessing and using these would therefore not be subject to the Nagoya Protocol and mandatory prior agreement within the framework of benefit sharing. Moreover, the transfer agreement signed for the use of a genetic resource may be sufficient to determine the right or not to use this resource as well as the DSI derived from it commercially. In the case of the European Union, its standpoint of making a distinction between DSI and genetic resources is paradoxical as its own legislation on patenting has, on the contrary, taken care to link the two. As Inf’OGM has already reported [6], the 1998 Directive 98/44 indeed specifies that the protection conferred by a patent on genetic information "shall extend to all material, (...) in which the genetic information is contained and performs its function" !The position of those countries refusing to make DSI subject to prior agreement and benefit-sharing figures is found in a broader notion. As set out by the United States [7] DSI would figure as a research tool. The subsequent work, if resulting in the production of freely accessible DSI, would thus be a form of "benefit sharing that creates other non-monetary benefits" !The second group has a diametrically opposite position, considering that prior consent and benefit sharing should apply to DSI. Argentina explains that it considers the expression "digital information on genetic resources sequences" to include in itself the idea that the information is a component of the "genetic resource" in question [8]. This country recalls that in 1990, as part of the preparatory work for the CBD, the states had agreed that "the reference to access to information and data on genetic resources was an important element for conservation and sustainable use (...) ensuring mutual benefit from the use of resources" [9]. India argues that the CBD and the Nagoya Protocol "recognize both the tangible and intangible elements in the genetic material, i.e. both the physical material as well as the value it contains". The value of the genetic material would be "in the genetic information it contains, whether in the actual form or a potential form" [10]. Finally, for Brazil, regardless of whether DSI is recognized as a genetic resource or not, "a systemic interpretation of the CBD and the Nagoya Protocol leaves no doubt that the use of this information is subject to benefit sharing" [11].… with so many bodies in debate Marine biological diversity is also the focus of attention. In 2017, the United Nations initiated work on a future text aimed at taking measures for the conservation and sustainable use of marine biological diversity [12]. Discussed within the framework of the United Nations Convention on the Law of the Sea (UNCLOS), the future text applies to marine diversity in international waters outside national jurisdictions. It logically addresses the DSI issue. The preparatory documents for a postponed 2020 meeting allow access to the draft of the regulatory text with the comments, article by article, from countries [13]. Thus, the articles dealing with the definition (Article 1) or the scope of application of the possible future law are commented on in order to make a reference to DSI appear or, on the contrary, disappear. Geographically, the same two blocks of countries appear : the United States, the European Union, South Korea... on one hand and Latin American countries, Indonesia, Israel, Kenya, Philippines, Senegal... on the other. For the time being, discussions are on hold. However, the matter is urgent, given the increasing number of patents filed on the genetic sequences of marine species [14].The World Intellectual Property Organization (WIPO) experiments the disagreement between these same opposing camps. Countries in Asia, Africa and South America are asking that the granting of patents on genetic resources should be better regulated at the international level. In particular, they demand that the geographical origin of the material used to develop "the invention" must be declared. Facing them, the countries opposing such mandatory declaration of the origin of the material are the same as those opposing the submission of DSI to the rules of prior agreement and benefit sharing [15].How did the European Union formulate its contribution ?On April 29, 2019, the European Union submitted a contribution to the debate on DSI to the Convention on Biological Diversity. Drafted on behalf of the European Union and its Member States, this contribution thus appears to hold a common position shared by the 27 Member States. Surprised by such a consensus, Inf’OGM put questions to the Council of the European Union in charge of producing this document. According to one European source, a contribution proposal was submitted by the Romanian Presidency of the Council on April 17, 2019. After discussion, only one amendment was proposed, and that by the Romanian Presidency itself. The contribution was then adopted according to what is known as the "silent" procedure. When a text proposal is thus considered to be stable, "the informal silent procedure is launched". If no objection is made within a given time, the text is considered to have been adopted and is duly sent to the international bodies.One of the key notions, put aside in these discussions, concerns the traditional knowledge associated with a particular plant, animal or micro-organism. While some countries such as Mexico, Brazil or South Africa point out that the international framework on genetic resources includes this traditional knowledge, it is little or not mentioned in the discussions on DSI. So much so that Mexico pinpointed the fact in its 2019 contribution to the CBD [16], underlining "a lack of work (...) that would allow indigenous peoples to be more actively involved in the discussion and decisions on digital sequence information (...) and in the processes and decisions to underpin mechanisms to ensure the fair and equitable sharing of benefits arising from the use of genetic resources"... Inf'ogm [Type article] => actualité [Enjeux] => Array ( [0] => Économie ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( [0] => Biopiraterie [1] => Numérisation [2] => Ressource génétique ) [Organisations internationales] => Array ( [0] => Convention sur la diversité biologique [1] => Protocole de Nagoya ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( [0] => Entreprise [1] => Gouvernement ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [263] => Array ( [objectID] => 4115 [title] => Life in digital form: a battle of stakeholders [timestamp] => 1609977600 [date] => 07/01/2021 [annee] => 2021 [url] => https://infogm.org/en/article_journal/life-in-digital-form-a-battle-of-stakeholders/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Companies, farmer organizations and researchers are all presently immersed in a digital society. Whether desired or not, one of the major agricultural and environmental debates stirring international bodies is that of « digital sequence information ». The stakeholders are each and all expressing their particular positions in the course of these negotiations. While the digital management of […] [chapo] => [texte] => Companies, farmer organizations and researchers are all presently immersed in a digital society. Whether desired or not, one of the major agricultural and environmental debates stirring international bodies is that of « digital sequence information ». The stakeholders are each and all expressing their particular positions in the course of these negotiations. While the digital management of trade, economy and human societies is soaring as a result of the recent series of confinements, the digitalization of life forms is not however, the ambition of all.In 2019, Sylvain Aubry and Christian Eigenmann of the Swiss Federal Office for Agriculture wrote that "the future of genetic resources for food and agriculture will be a hybrid between physical resources (seeds, gametes) and digital resources" [1]. But they specify in their own name that, "despite an open-access culture that is very prevalent in the scientific community, the modalities and consequences of the liberalization of access are diversely appreciated by numerous actors in the production chain". An overview of the positions of the stakeholders involved in the issue of digital sequence information (DSI) will clearly illustrate this [2].Industry in search of a digital Holy GrailBiotechnology companies want DSI access and use to be free of prior agreement and benefit sharing, and to achieve this, DSI must not be assimilated with the physical genetic resources from which they originate. Speaking of Genetic Resource Sequence Data (GRSD), according to EuropaBio, this term would only concern, the "order of nucleotides (DNA and RNA), as found in Nature, in the genome". The specification "as found in Nature" is heavy with meaning. Taken literally, it implies that only DSI genetic resources found "in Nature" would be concerned, but not that of genetic resources found in private seed banks, even if they are identical to the former. EuropaBio extends this first exclusion to the result of their work based on such sequences, amongst which there may be some that the companies have in fact modified [3].As for benefit sharing, EuropaBio believes that subjecting DSI to benefit sharing "will negatively affect biotech research and the societal benefits therefrom, such as the availability of innovative products improving food security and human health". This specification introduces the idea that benefit sharing should not only be monetary but also include "the resulting (non-monetary) benefits to society"....This position is shared by other representatives of industry. The International Chamber of Commerce (ICC) has thus made a contribution in line with that of EuropaBio, sometimes with paragraphs identical to the word. But it is difficult to understand on behalf of which companies the ICC is speaking. For its part, the International Fragrance Association and the International Organization of the Flavor Industry also contributed to avoid subjecting DSI to the Nagoya Protocol.Peasants defend their rightsFor several years, the international peasant movement La Via Campesina has been concerned about the ending of peasants’ rights if patents were to be obtained on DSI. Interviewed by Inf’OGM, Guy Kastler of La Via Campesina reminds us that if benefit sharing as such has not already been implemented, it is because "the Treaty is powerless to force companies to contribute to the Benefit Sharing Fund" [4]. In this context, the unregulated use of DSI is worrisome. Guy Kastler believes that "the power of computer tools available to multinational seed companies allows them to process thousands of data, identify new patentable genetic information in a very short period of time and then program genetic manipulations to obtain new seeds without having to touch any physical plant or seed". According to the unionist, it is then sufficient to tap the databases to identify plants that can be modified. The problem then arises concerning the scope of patents that may be claimed. For "if no one can prove that the genetic information thus obtained from a new plant has already been officially made public (another patent, scientific publication, commercial information...), it is patentable". This same patent could then allow its holder "to claim a property right not only on all the plants resulting from the claimed genetic manipulation, but also on all the native plants or those resulting from traditional breeding and crossing and carrying the genetic information described in the patent".La Via Campesina’s political position on DSI is part of a new paradigm. The movement believes that "ITPGRFA was built on the paradigms of the 20th century. In the 21st century, the paradigm has changed, as shown by the Covid 19 crisis. The revolution of digital capitalism must be integrated now because global governance has changed". For La Via Campesina, access to and use of DSI must be framed in such a way as to be subjected to the CBD and the ITPGRFA regulations which condition access to genetic resources, the protection of traditional knowledge and innovations of indigenous and local communities, with prior informed consent and the prohibition of their patenting. Nonetheless, this framework alone will not suffice because digitalization allows companies to circumvent them : free access to DSI is in fact as uncontrollable as is the Internet. In the field of plants and animals, Guy Kastler reminds us that these patents "forbid peasants to use their own seeds and breeding animals if one or more parts of their sequence has been patented". For La Via Campesina, it is therefore imperative that the rights of peasants be protected by national laws and international conventions, which is not the case today with patents. This is especially important since "climate change is now forcing peasants, who have lost the seeds of their parents, and small traditional seed producers to turn more and more often to national or global seed banks to enrich their new selections without using the genetically manipulated seeds available on the market. At the same time, the multinationals declare that they no longer need this reserve and sign its death warrant by patenting the genes of all the plant genetic resources it contains".Public research wants a tool, free of access and user rightsThe world of research has not yet expressed much opinion in the course of these discussions. In 2018, the (French) Fondation pour la Recherche Biologique indeed published an inventory commissioned by the Ministry of Agriculture [5]. But it does not provide a political position although public research institutes contribute to and use DSI databases. According to the information Inf’OGM was able to obtain from some researchers, one of the political tendencies in the research world would be to defend the option that free access to DSI constitutes benefit sharing per se since it appears to be less problematical and more consistent with open-science injunctions. However, some researchers question the merits of this approach. Following the opinion stated in the FRB report, open access would be a false solution since it depends on the technical and scientific ability to access and use digital resources. Indeed, how is it possible to claim that DSIs are freely accessible if this requires not only significant prior knowledge, but also equipment that is expensive and difficult to use ? On the other hand, these researchers consider that subjecting DSIs to benefit sharing in its existing form would be impossible to implement in view of its thousands if not millions of users, especially in view of only a very limited implementation of such benefit-sharing. In this context, they believe that French research needs to formulate a political position on the issue in order to make its voice heard and avoid finding itself having to deal with new standards adopted without it. Its voice should ensure that the philosophy presiding over the creation of the Nagoya and ITPGRFA protocols be respected. This philosophy aimed, on one hand, at a fair balance between the access and use of genetic resources and, on the other hand, due compensation for the countries or communities that have held - and are still holding - these resources. In accordance with this, research must now open up discussion forums for internal reflection and deliberation that would also integrate the voices of partners from research institutes, thus making them even more comprehensive. To achieve this, the researchers must nevertheless be sure to keep an eye on the agenda of the international bodies already involved in the negotiations. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [264] => Array ( [objectID] => 4110 [title] => Digitalization of living beings, for easier privatization [timestamp] => 1609891200 [date] => 06/01/2021 [annee] => 2021 [url] => https://infogm.org/en/article_journal/digitalization-of-living-beings-for-easier-privatization/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Ever since the 1992 convention on biological diversity, “genetic resources” have been under state sovereignty. On signing this convention the poorer countries of the world were able to state that “although industrially poor, we do at least have “green gold” : our biodiversity”. A variety of international texts subsequently guaranteed the exploitation of this wealth […] [chapo] => [texte] => Ever since the 1992 convention on biological diversity, “genetic resources" have been under state sovereignty. On signing this convention the poorer countries of the world were able to state that "although industrially poor, we do at least have "green gold" : our biodiversity". A variety of international texts subsequently guaranteed the exploitation of this wealth within the framework of a prior agreement with the country (or community) concerned as well as the sharing of benefits resulting from its use.In agriculture, part of such « genetic resources » [1] is stored in the form of physical samples in genetic resource banks (we may recall the vast project for worldwide seed storage on the Norwegian island of Spitzberg). However, in order to save space, facilitate and speed up exchanges, the genome (as well as other data on such resources) are digitalized and stored in data banks which are often access free. This being the case, it is tempting for researchers and seed companies to tap this data and retrieve information without necessarily having obtained the consent of the resource-owner country nor even, and more importantly, sharing whatever profit may be obtained [2].What is the aim of digitalization ? What does international legislation say about it ? What do the stakeholders think about it ? [3] Is there a real risk that, with digitalization, state sovereignty on biological wealth will lose all meaning [4] ? Is it possible to conceive the governance of digitalized data without there being any losers [5] ?Such are the questions examined in our special file on digitalized genetic, in the search for answers. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [265] => Array ( [objectID] => 4118 [title] => Biotechnologies : the power of words [timestamp] => 1605571200 [date] => 17/11/2020 [annee] => 2020 [url] => https://infogm.org/en/article_journal/biotechnologies-the-power-of-words/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Words, by guiding our thoughts, guide our actions. In the field of biotechnology, it is essential to be aware of unstated intentions. Other peoples’ language, whether accepted or used without a critical eye, may force our consent. Somewhere between self-confirming statements (tautology), false logic (sophism) and authoritative arguments (rhetoric) the following cases of discursive strategy […] [chapo] => [texte] => Words, by guiding our thoughts, guide our actions. In the field of biotechnology, it is essential to be aware of unstated intentions. Other peoples’ language, whether accepted or used without a critical eye, may force our consent. Somewhere between self-confirming statements (tautology), false logic (sophism) and authoritative arguments (rhetoric) the following cases of discursive strategy will allow you to judge when propaganda is actually being rebaptized « communication ». The 2015 INRA Genius programme published an article "Targeted gene modification : the post-GMO era ?" [1]. What was the intention behind these words ? "Targeted" modification is a qualification to make the reader think that such a technique achieves only the desired modification. The use of this adjective leads us to believe that such a modification is precise and reliable, and therefore without collateral effects, well-known as they may be [2]. In this way, the technical stages which produce unintended mutations and epimutations are masked. This is a classical case of false logic : what is not mentioned does not exist [3]. It is also understood that only minor effects are produced, which is a case of minimization [4]. Then we have the cleverly misleading interrogation, "post-GMO era ?", a suggestion which requires no response but leads the reader to believe that the product of "targeted" modification is not actually a GMO, (despite being legally defined as such since 1990). The implicit message makes us believe that these GMOs result from transgenic techniques alone. The terminal (and discreet) question mark, whether precaution or ethical garantee, disappeared from the title a year later, after validation of the initial discursive strategy.In order to have GMOs accepted by society in general, health is a domain that has been widely exploited as a means of hidden persuasion [5]. A false dilemma such as "It’s nuclear power or going back to the candle" is also often used. Faced with "numerous challenges", intensive agriculture has waved the same red flags since the first GMOs and despite evidence to the contrary : "GMOs or worldwide famine", "GMOs or global warming", "GMO vaccination or epidemics". These illustrate forced choices between two apparently incompatible options when alternatives exist.How to disguise the new GMOsSince their definition by the European Commission in 2010, these "new breeding techniques" have grouped together a set of widely differing techniques [6]. In fact, the wording "new breeding techniques" [7] involving the selection of individuals is fallacious because selection operates a postiori whereas these techniques in fact operate a priori. As with transgenesis, and relative to plant mutation for example, the category they belong to is not one of selection, but rather one of production, as sorting is carried out later according to certain criteria. By inscribing them in the continuity of the time-honored practice of selection, those promoting GMOs are in fact avoiding the mention of genetic and epigenetic manipulation. However, this persuasive rhetoric lacks coherence since these techniques are, at one and the same time, being presented to decision-makers as disruptive innovations [8].Since the 2018 ruling by the Court of Justice of the European Union stating that the new GMOs must not be excluded from current GMO legislation [9], the European Commission and biotechnology firms have been trying to divert attention towards new breeding techniques and then to "genome editing" or "gene editing" But changing a text means more than editing, which should mean correcting certain "letters" [10], that is, DNA nucleotides. It is not "innocent" to refer to writing techniques in a world dominated by word processing just as, with the idea of "retouching" [11], mutagenesis seems both simple and well-controlled. On one hand, the notion of correction implies that it is a question of rectifying a small mistake rather than the intentional modification of a gene with quite another interest at stake. On the other hand, it is a case of shelving complexity. We still have trouble correlating genotype with phenotype, as genome regulation and the production of new molecules (due to a simple shift of the reading frame) have not been and still are not duly studied. In this way, "retouching" is a misnomer capable of inducing hundreds of unexpected genetic and epigenetic effects. This misleading idea of precision is used by the communicators and is supposed to explain away such events in a reassuring way so that these techniques should be accepted [12]. It is to be noted in the case of Crispr, which necessitates prior transgenic manipulation, that there is no mention of this. Reading between the lines, it would seem that the aim is to replace legally defined GMOs by undefined EGOs, where "E" stands for "edited"."Yes, GMOs are natural !"In order to legitimatise their (epi)genetic modifications, companies, while hiding the evolutionary problems brought up by their new sophism are putting forward an argument to which people are currently sensitive : plants obtained from these new techniques could appear naturally (See argument, page 11). This argument explains why these companies are wanting politicians to focus on the end-product alone, while remaining ignorant of the process for its obtention. According to the concept that "what you don’t name doesn’t exist", it has become a question of removing the mention of in vitro cell multiplication, capable of generating genetic and epigenetic modifications. The industry is in fact hiding any techniques which do not support the concept that "Nature can do it."GMO manufacturers insist on the fact that their products would be equivalent to those resulting from the process of evolution. However, in order to demonstrate this equivalence, the context in which the comparison has been made must necessarily be determined. It so happens that the "experts" base their equivalence modelization on the molecular data of the transformed gene alone, as does the HCB scientific committee in a recent opinion published in mid-July 2020 [13]. Unintended effects are not taken into account. This denial of complexity would seem sufficient to reject the term "equivalence" when taken out of context, just as the word "similar" is used to imply "identical". Such amalgamation would lead to considering that wine, being 80% water, is the equivalent of water ! Thus, a lecturer at Agro Paris Tech (Institute of Technology for Life, Food and Environmental Sciences) has been able to state that "Yes, GMOs really are natural" [14] as it would seem that since gene transfer exists in Nature and that transgenesis is gene transfer, it follows that transgenic manipulation is naturel. QED ! The two premisses are valid of course, but the conclusion is false owing to the fact that human manipulation, being a regulation process, is involved in transgenesis.The science of biotechsIn 2016, the Inra, Infremer, Cirad ethical committee [15] wrote that "acculturation is the main stake in Life science disciplines and also brings associated ethical questions to the forefront, so that these new technologies and the innovations issuing from them should be considered a progress in society". Quite clear. The principle underlying this appraisal is that innovations, if technically possible, are to be implemented. The ethical question thus becomes a framework a postiori. Two questions are thus posed, one about the responsibility on the part of the scientists relative to the inherent risks [16], the other on the part of democracy relative to the ethical question : can it refuse certain innovations ?The most important question is to which Science - the basis of these innovations – are we referring ? Hidden under the usurped term, "Science", there are hundreds of ambiguities and stylistic devices. What GMO producers call "science" usually refers to the molecular doxa of the 1970’s, which claims that by tampering with genes or their expression we will obtain new characters. The only aim of such a mechanistic view of life - so amazing in our times of genetic regulatory networks, the circulation of genetic information between cells and the epigenetic adaptation of organisms to their environment - is to close the debate. Recurrent correlation difficulties between phenotype and genotype also prove that life can be reduced neither to its DNA nor even to an information flow. In a time when digital models are taking over from real life [17] and economic considerations are overriding precaution it is important to bring to mind the limits of our knowledge. The vision put forward by the companies also puts aside the temporality of life : laboratory time is not evolutionary time nor even the time in the field. Biotechnology lags behind biology in general but tries to prove the opposite by focussing attention on the traits considered to be of interest. A critical mind will be aware of the omnipresence of rhetorical arguments upholding this self-proclaimed "scientific expertise". A certain use of authoritative argumentation and false persuasion in the domain of biotechnology is not destined to awaken our critical mind, but rather to make us consent to an artificial world from which only a few can benefit.Yes indeed, using the power of words means being the master. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( [0] => Ethique [1] => Perception des OGM ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [266] => Array ( [objectID] => 4120 [title] => New GMOs : unwanted sequences with unknown consequences [timestamp] => 1605571200 [date] => 17/11/2020 [annee] => 2020 [url] => https://infogm.org/en/article_journal/new-gmos-unwanted-sequences-with-unknown-consequences/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Genetically modified bulls, carrying additional DNA ; cells cultivated in vitro are carrying DNA from bacteria, goats or cattle ; a famous GMO maize is not quite what was expected… These are just a few examples showing that the companies do not perfectly master the genetic modification protocols. At a time when such companies are asking the […] [chapo] => [texte] => Genetically modified bulls, carrying additional DNA ; cells cultivated in vitro are carrying DNA from bacteria, goats or cattle ; a famous GMO maize is not quite what was expected… These are just a few examples showing that the companies do not perfectly master the genetic modification protocols. At a time when such companies are asking the European and international politicians for the suppression of risk assessment and expecting blind trust in the quality of their products obtained by new techniques of genetic modification, these examples cannot but oblige those leading or legislating such experiments to adopt a position of humility. Not all the numerous steps of a protocol technique aiming at generating genetic modifications are perfectly controlled [1] and proper scientific rigour cannot ignore them. To date, the European Union has imposed risk assessment of the GMOs, prior to their marketing or their environmental spread, in order to prevent the potentially harmful effects of this lack of control. It is however limited, as it is carried out by the GMO companies themselves and does not include certain scientific advances such as epigenetics. After authorization, a surveillance plan must be carried out each year to check for the potentially harmful consequences of this lack of control. Such risk assessment and surveillance are in respect of the precautionary principle.The very nature of the potential impact on health or the environment associated with the insertion of unwanted DNA sequences for example, is an issue that must necessarily be addressed a posteriori. The existence of insertions such as those that we will examine, just like all unintended effects [2], imposes the implementation of the precautionary principle in order to avoid consumers becoming life-size testers of a supposed absence of risk. This is a precautionary principle, relative to the new GMOs, from which the companies are asking to be exonerated.The culture medium is both mutagenic and contaminantIn an 2019 article, researchers from the National Institute of Medical Science in Japan report having genetically modified mouse cells with the Crispr/Cas technique and admit to having found DNA insertions from bacteria, bovines and goats in the cell genome [3], an unexpected result for which the cause is being searched.Their protocol implied the classical multiplication of the DNA intended for insertion in a culture of the bacteria Escherichia coli. As is generally the case in such experimental protocols, this DNA (in plasmid form) contained coding sequences for a Crispr/Cas9 complex designed to cut the genome of the mouse cells at a particular site. In order to facilitate the selection of the transformed cells, an antibiotic-resisitant gene was inserted along with the transgene, a current practice (albeit criticized) since the advent of GMOs. The experiment aimed at simply cutting the DNA and observing the results. Not only did the sequencing of the sites near the cut show the insertion or deletion of one or two nucleotides of the DNA in question but also, in 4% of cases, the insertion or deletion of more than 33 nucleotides. Such sequences derived from plasmids inserted in the bacteria Escherichia coli, (including an antibiotic-resistant gene), copies of the mouse genome itself and - totally unexpectedly - DNA sequences from bovines or goats of unknown origin. After investigation, the sequences from other mammals were seen to come from the mouse cell culture medium which contained 10% of bovine or goat embryo serum ! This is general practice but the consequences, not being looked for, are therefore not brought to light. This recent example convincingly illustrates that all steps of the protocol must be taken into account when it is a question of assessing whether a new GMO may be commercialized or not.Bulls are more modified than expectedSuch unintended insertions have not only been observed within the scope of Japanese research but a similar situation recently hit the headlines ! At a 2018 OCDE conference, Alison Van Eenennaam, (currently working at the University of California Davis) contributed with information on "Genome editing in Farm animal : Cattle". She claimed that "from a risk-based perspective, it makes little sense to regulate genome edited animals differently than convention- ally-produced animals carrying the same allelic DNA" [4]. The bulls that had been genetically modified with the TALEN technique [5] so as not to have horns were about to be commercialized in Brazil by the company Recombinetics. Their birth had been announced in 2016 in a letter from Recombinetic’s research team announcing that the analyses carried out had shown "that our animals are free of off-target events and further supporting the high specificity of TALENs" [6]. However, in 2019 FDA researchers showed that, on the contrary, the bulls carried unexpected bacterial sequences resulting from previous steps carried out during genetic modification itself. Analysis of samples provided by Recombinetics proved the presence of two extra "hornless" genetic sequences rather than one, along with sequences for resistence to an antibiotic derived from a circular DNA used during the operation protocol. At the end of August, on the website Wired, Tad Sonstegard (General Director of Recombinetics), having modified the bulls, admitted that his company wasn’t "looking for plasmid integrations". He added, "We should have" [7], an admission which is in itself sufficient to totally justify the continued implementation of GMO legislation in order to anticipate potential risks associated with such imprecision. It may be partly due to this that the American Food and Drug Agency (FDA) has demanded the regulation of animals that have been genetically modified by these new techniques.Declared transgenic sequences that are admittedly not always accurateWhat if this absence of control means that a given GMO, when sold, is not exactly the one that has been assessed and authorized ? In this domaine the most famous GMO, and practically the first - Mon810 maize - is a perfect example of the use of a protein insecticide whose action is still uncertain. First authorized in the United States in 1996, this maize is still presented as being genetically modified to produce "Cry1Ab protein via the incorporation of a cry1ab coding sequence derived from Bacillus thuringiensis" (Bt) [8]. But things are not as simple or as well controlled as EuropaBio, mouthpiece of the seed industry lobby and the author of the presentation of the maize Mon810, would have us believe. In a 2009 opinion the Scientific Committee of the High Council for Biotechnology [HSB’ scientific committee on Mon810 renewal 22/12/2009]] note that "the protein expressed in Mon810 maize is shorter than the Cry/Ab protein of Bt (…) as the coding sequence actually included in the genome carries 2448 nucleotides (nt) whereas it has 3465 nt" in the construction used in vitro to genetically modify the maize. If this statement insists that this difference – "is perfectly described in the dossier", the HCB scientific committee reports that a second protein could be also be synthesized by the GM maize. To put it briefly, we do not know whether another protein (whatever its function) is produced or not, but the "insecticide" phenotype, being satisfactory the authorization is given !The conclusion of the HCB Scientific Committee makes one wonder about the technical control actually achieved. It concludes, in fact, that "one or two proteins are expressed in Mon810 maize and at least one (or both) has (have) the expected action on certain invertebrates because the plant is resistant to the European corn-borer", while admitting its ignorance of the actual mechanism behind the insecticide capacity of the corn. Science is not always able to explain what it is doing even when it is doing it. Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [267] => Array ( [objectID] => 4122 [title] => It really is possible to trace the new GMOs [timestamp] => 1605571200 [date] => 17/11/2020 [annee] => 2020 [url] => https://infogm.org/en/article_journal/it-really-is-possible-to-trace-the-new-gmos/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => Over the past few years companies have been forwarding the argument that the traceability of certain new GMOs would be impossible. However, that such traceability techniques do exist is proved by their current standardization by the international authorities in other domains as well as their routine use by the companies. In 2017, the […] [chapo] => [texte] => Over the past few years companies have been forwarding the argument that the traceability of certain new GMOs would be impossible. However, that such traceability techniques do exist is proved by their current standardization by the international authorities in other domains as well as their routine use by the companies. In 2017, the group of experts drawn up to advise the European Commission wrote about new GMOs that "it is generally impossible to distinguish the cause of [a] change as natural or resulting from the employment of any breeding technique", unless information has been given in advance [1]. Consequently, EuropaBio [2] criticises the 2018 CJEU ruling that assimilates certain products (after mutation) with GMOs : "The ruling is (...) difficult to implement and virtually impossible to enforce, given that many gene-edited products may be indistinguishable from products changed by natural processes or with conventional breeding techniques" [3]. Indistinguishable in their traceability … these new GMOs are becoming completely identifiable as soon as it is a question of patenting them ! Very crafty …Traceability is first and foremost a question of documentationThe first tool allowing to differentiate between two products is the documentary information which necessarily accompanies all commercialized GMOs, an example set by rapeseed and soybean oils in the European Union. In fact, it is only cases of illegal GMO commercialization and accidental contamination that require more sophisticated control and fraud detection techniques. If the European Commission has been slow to appoint experts on the issue of detection [4], other international authorities have already marked out the technical procedure to be followed. In order to maintain that mutations obtained via new GMO techniques are not distinguishable from natural mutations there must be voluntary ignorance of the unintended effects appearing at each step of an in vitro genetic modification protocol - scars, signatures and markers - which can very well be detected [5].Upov and Iso pave the way…The characterization of varieties in view of their registration in catalogues shows that it is possible to describe the mutations without the least ambiguity. In 2019, UPOV (International Union for the Protection of New Varieties of Plants) published its "Guidance on the use of biochemical and molecular markers in the examination of Distinctness, Uniformity and Stability (DUS)". According to this document, the molecular markers are so typical for a given variety that they represent a form of signature. Usually placed near a sequence conferring a particular phenotypic character, they are used for plant selection as well as to describe and trace a particular variety. Methods of genome analysis (sequencing etc. ) make it possible to list the markers and draw up a reference matrix. As early as 2015, the International Standardization Organization (ISO) published the standards to be followed for analysis of the corn or sunflower fingerprints and for checking the identity of the varieties. In 2019, the International Seed Testing Association presented these standards in its own name as being "DNA-based techniques (…) already used in many laboratories in many countries" [6]. Such analytical methods, with marker matrices specific to whatever modification protocol would thus allow to differentiate between new GMO and non GMO plants.…AIEA and Fao publish an instruction manualSince 2001, AIEA (International Atomic Energy Agency) and Fao have been regularly publishing a manual on the "molecular characterization of mutant germplasm", so that all countries dispose of an up-to-date description of analytical techniques for more than 20 species in order to identify the mutated plant lines. The latest version dates from 2015 [7] and "include new technologies (...) providing a contemporary tool kit for genotypic analysis and selection in plant breeding and genetics". The procedure has thus been fully outlined as unintended effects related to genetic modification protocols are actually used to establish the signatures and fingerprints such as those used in the domain of industrial property.In October 2019, the European GMO detection experts discussed "Next-Generation Sequencing applied to GMO detection" [8]. One presentation claimed that it was possible to differentiate the mutations by more globally examining the genome, and insisted that “deep analysis of mutations (...) could provide approaches for comprehensive fingerprinting. Somatic mutations (...) as a result of the transformation process might be exploited for unique fingerprinting of authorised events” ! Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [268] => Array ( [objectID] => 9128 [title] => EPO : new GMOs can be differentiated [timestamp] => 1594252800 [date] => 09/07/2020 [annee] => 2020 [url] => https://infogm.org/en/epo-new-gmos-can-be-differentiated-2/ [image] => https://www.infogm.org/IMG/arton7097.jpg?1608223499 [extrait] => According to companies, GMO products of genetic modification techniques are patentable because they are considered "inventions". But to obtain these patents, the European Patent Office (EPO) require from the applicants to be clear about the techniques used for obtaining the organisms or genetic sequences covered by their patent. This obligation shows that, for the EPO, it is possible to differentiate, e.g. between GMOs obtained by patentable mutagenesis techniques on the one hand, and GMOs obtained by other techniques or any other organisms present in nature, on the other hand. [chapo] => According to companies, GMO products of genetic modification techniques are patentable because they are considered “inventions”. But to obtain these patents, the European Patent Office (EPO) require from the applicants to be clear about the techniques used for obtaining the organisms or genetic sequences covered by their patent. This obligation shows that, for the EPO, it is possible to differentiate, e.g. between GMOs obtained by patentable mutagenesis techniques on the one hand, and GMOs obtained by other techniques or any other organisms present in nature, on the other hand. [texte] => Inf’OGM recently exposed why new GMOs are patentable1 when they are obtained by genetic modification techniques on cell cultures. But companies continue to argue that GMOs whose genetic modification is a mutation (and not a gene sequence insertion) are exempt from GMO legislation. Their reasoning is that mutagenesis techniques induce genetic modifications that are indistinguishable from what nature or other plant breeding techniques can produce and that "traditional" mutagenesis techniques are exempt from GMO regulation.Frontier between patentable and non-patentable: the disclaimerA patent application contains one or more claims which designate the invention to be protected by the rights granted by a patent2. These claims must be clear. The interest of an applicant is therefore to be as broad as possible. However, the EPO specifies in its own guidelines (see box below on guidelines) that it is sometimes necessary for patent applications to be supplemented with "negative limitations" to designate what is not covered by the patent application3. This is the case when part of the invention is partly covered by another patent or when unpatentable elements have to be excluded from the invention.Essentially biological processes and their products are part of the last case since they are explicitly excluded from patentability by an exception given by the EPO law and the European law4.Indeed, the 2019 version of the EPO Guidelines for Practical Examination states that "if a technical feature of a claimed plant or animal, e.g. a single nucleotide exchange in the genome (Editor’s note: a mutation)might be the result of either a technical intervention (e.g. directed mutagenesis) or an essentially biological process (a natural allele), a disclaimer is necessary to delimit the claimed subject-matter to the technically produced product".This quote from the EPO clarifies that a new GMO obtained by technical means, for example a mutagenesis technique implemented on cell culture, is patentable. However, the EPO considers that the patent granted can not concern organisms that have the same mutation but that have not been obtained by the process claimed in the patent application! Otherwise, the patent application will have to be rejected.To put it more simply, the EPO requires from patent applicants to limit the scope of their patent to only those organisms or genetic sequences which have actually been modified by the process claimed and which cannot be an essentially biological process or a technical process (e.g. mutagenesis) which is insufficiently detailed and not reproducible by a skilled person in the art5! Any organism or genetic sequence which is identical but not obtained by this process will not be protected by the patent granted.The disclaimer, a sometimes abstract formatThese rules now imposed by the EPO go against the discourse usually heard in the case of new GMOs. Indeed, companies are accustomed to asserting that the mutation or mutations present in their GMOs obtained by techniques of directed mutagenesis as random could not be differentiated from mutations obtained by other techniques, or even appeared spontaneously. But the EPO, which grants them patents, does not share this opinion. Or, at least, it requires companies to explicitly exclude objects not covered by the patent. It must therefore necessarily be concluded that a differentiation must be made, on the basis of documentation or analysis.With regard to plants in particular, the EPO gives a set of examples (non-exhaustive list) of formulations of technical means that are essentially biological processes or formulations of elements that are, on the contrary, patentable6.A disclaimer, what is it ? Translations difficulties.The Guidelines of the Examination in the EPO is a guide prepared by the EPO for patent applicants and examiners explaining the EPO’s approach to analysing patent applications. The term disclaimer is used in English in the French version of the Guidelines. No translation of the English term disclaimer is provided by the EPO, nor any precise definition in both version. The content of the disclaimer is not specified nor its legal scope. Globally, this term specifies what is not claimed by the patent application.Disclaimers are required at least since 2019 in the field of biotechnology. Since that year, patent applications for biological material or microbiological processes must be accompanied by a disclaimer to be valid. This means that patents on new GMOs will have to state what is patentable (what is technical or what has been technically obtained) and explicitly exclude what does not derive from it.But concretely what does that commit to? When new GMOs are concerned, the applicant must detail the techniques used, i.e. how he produced the GMO.This implies that the patent applicant is responsible for the difference between what he claims and what he does not claim. Therefore he must prove that the traits he claims (traits that could be native) were obtained with one of the techniques he has explicitly mentioned in his claims and not by a technique excluded by the disclaimer. The description provided in the patent application fulfills its role as a description, but doesn’t it have to be accompanied by a detection technique to prove it?And if a detection technique is not an obligation under EPO law, is it not an obligation for the patent applicant to use it to enforce his rights granted by the patent against third parties? Let us recall that new GMOs are indeed detectable7.Granting of patents: constantly evolving examination guidelinesOn November 19, 2020, the EPO announced that the next update of the guidelines was being finalized and would be published in March 2021. It is said that recent developments in biotechnology have been followed closely and will be reflected in this update. For the first time in the development of the guidelines, the finalization meeting was preceded by a public consultation of users.The annual revision of the guidelines is discussed and elaborated by two main actors: the Institute of Professional Representatives before the European Patent Office (epi), the Standing Advisory Committee before the EPO (Sacepo) which is composed of representatives from industry (nominated by Business Europe), professional representatives (appointed by the epi) and recognized experts in the field of intellectual property appointed ad personam by the President of the EPO. Zoé JACQUINOT [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [269] => Array ( [objectID] => 6376 [title] => Are new GMOs listed in the plant variety databases ? [timestamp] => 1580428800 [date] => 31/01/2020 [annee] => 2020 [url] => https://infogm.org/en/are-new-gmos-listed-in-the-plant-variety-databases/ [image] => https://www.infogm.org/IMG/arton6957.jpg?1580483757 [extrait] => On 25 April 2019, the Member States of the European Union claimed that no new GMOs are currently listed in any of the national plant variety databases. However, in responses provided at the same time to a questionnaire from the European Commission, the same Member States were less affirmative… A ruling of the Court of […] [chapo] => [texte] => On 25 April 2019, the Member States of the European Union claimed that no new GMOs are currently listed in any of the national plant variety databases. However, in responses provided at the same time to a questionnaire from the European Commission, the same Member States were less affirmative... A ruling of the Court of Justice of the European Union (CJEU) in July 2018 confirmed the obligation to regulate varieties obtained by new mutagenesis techniques as GMOs [1]. The first question for the Member States was therefore whether such varieties had already been registered in the national or European plant variety databases [2].No new mutated varieties in the catalogues according to Member states...The summary report of a meeting on 25 April 2019 between the European Commission and the Member States tells us that the Member States claimed that “no genome edited variety [Editor’s note: the language used to avoid talking about genetically modified varieties other than transgenic varieties] has been registered in the official plant variety catalogues” [3].However, Member States also stressed “here is no possibility to identify the technique used” to obtain the same genetic mutation with different techniques. Some of them even insisted on a current inability to control products on their territory and establish whether they are new GMOs or not, in compliance with the decision of the CJEU. Considering such a claim, how governments pretending being unable to technically distinguish between varieties that are not regulated as GMOs and varieties that are regulated as GMOs, can ensure that none of the latter are included in their plant varieties databases? A question which arises even more since, in the context of replies sent by these same Member States to a questionnaire from the European Commission and which Inf’OGM has been able to consult, several of them appear to be less affirmative.… which are not so sure!By the end of 2018, in the wake of the CJEU ruling, the European Commission sent a questionnaire to the Member States to collect the information in their possession concerning products obtained by new techniques of mutagenesis. In this questionnaire, the Commission notably questioned the Member States on the presence or absence of varieties obtained by such techniques in their national plant variety databases. Far from the claim of 25 April 2019, the Member States were relatively cautious in their replies.France, for example, replied in October 2018 that it had no “knowledge of the registration of plant varieties resulting from new techniques of directed mutagenesis in the French plant variety database”. Since information on the techniques used to obtain a variety is not requested for the registration of a variety in the database, France cannot in fact certify a real absence, but only that it does not have “knowledge” of it. In January 2019, only four months before the meeting of 25 April, France stated in an additional reply that it was taking action to develop “a typology of the modes of production and reproduction of varieties”. At that date, France therefore relied on the companies which, as it recalled in its letter, “must declare whether the variety [to be listed in the catalogue] is covered by the GMO regulations”, knowing that varieties resulting from new techniques of mutagenesis must therefore be declared as such.Spain, Belgium and Estonia appeared as cautious. Estonia, for example, replied by the end of October 2018 that “as far as we have information, there are no registered varieties with new mutagenesis techniques in Estonian national catalogue of varieties”. While some varieties such as Clearfield 7130CL, Mobil CL or Cebra CL are in its catalogue, the Estonian government states that it is “of the opinion that these varieties are not bred with new mutagenesis techniques”. In January 2019, Estonia repeated its reply, but this time stating that its “main difficulty is that when plant varieties are registered [in the database], the information how they were bred is usually not included”.Without declaration by breeders, no transparencyRequiring breeders to provide the full range of techniques used in the breeding of the varieties for which they are applying for registration in the database now seems inevitable for a government. But this declaration also has to be checkable at the very least. Because without a method of detection and traceability, States can only rely on the good faith of the breeder.This situation has been well summarized by two countries, Denmark and Slovakia. These latter have in fact replied to the European Commission that they are asking companies to include in their application the GMO status of the varieties they wish to include in the catalogue. They specify that this status needs to be provided taking into account the ruling of the CJEU. But Slovakia adds that the mutations “induced by genome editing technologies [...] are often not thoroughly documented”. This country therefore concludes that “we have to believe the applicant, when stated that the variety [...] is not GMO”!While countries such as Germany, Greece, Czech Republic, Italy, Poland or the United Kingdom had not answered the question on the national plant variety database in the European Commission’s questionnaire, others such as Bulgaria, Lithuania, Luxembourg, Romania or Sweden, for example, stated that they do not have varieties obtained by new techniques of mutagenesis registered in their database. However, these same countries also state that they do not - theoretically - have the technical means to distinguish the GMOs obtained by new techniques of mutagenesis…Finally, when the summary report of a meeting such as the one of the 25 April 2019 states that “Members States confirmed that no genome edited variety has been registered in the official plant variety catalogues”, the scope of this claim should be put into perspective. For, as it stands, either the countries do not know how the variety was obtained, since they have not asked the question until now, or they do not yet have the means to technically verify the legality of the claim made by the breeder. Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [270] => Array ( [objectID] => 6381 [title] => No labelling for additives produced from GMO micro-organisms [timestamp] => 1562284800 [date] => 05/07/2019 [annee] => 2019 [url] => https://infogm.org/en/no-labelling-for-additives-produced-from-gmo-micro-organisms/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => In November 2018, the presence of unauthorized genetically modified bacteria was detected in lots of vitamin B2. This vitamin, marketed in Europe as feed additive, had been produced in China from these GM bacteria which should not have been in the final product [1]. An unusual contamination Immediate action is taken by national and European authorities. […] [chapo] => At the end of 2018, the contamination of vitamin B2 lots used as food additive by genetically modified micro-organisms revealed that these lots were legally not labelled as produced from GMOs. A semantic nuance explains why food additives, flavours, enzymes or colours does not generally need to be assessed, authorised or labelled as produced from genetically modified micro-organisms. [texte] => In November 2018, the presence of unauthorized genetically modified bacteria was detected in lots of vitamin B2. This vitamin, marketed in Europe as feed additive, had been produced in China from these GM bacteria which should not have been in the final product [1].An unusual contaminationImmediate action is taken by national and European authorities. They decide to search for contaminated lots and remove them from the market. A research which could have been facilitated if the lots of vitamin B2 marketed had been labelled as produced from GMOs, which is not the case.However, since 2003, any marketed product that is GMO, contains GMO or is produced “from” GMO must be labelled as such. This requirement applies, for example, to genetically modified maize in cans, but also to oil produced from genetically modified rapeseed, in which it is difficult to find modified DNA or proteins. So why are the lots of vitamin B2 produced from a genetically modified bacterium, Bacillus subtilis KCCM-1045, not labelled?Three words to deprive the consumer of informationThe answer is as simple as it is confusing. Vitamin B2, unlike GM rapeseed oil, is not produced “from” GM bacteria but “with” these bacteria. A semantic meaning that this vitamin B2 is not concerned by the labelling requirements set out in the GMO European legislation, as confirmed to us by the European Commission in December 2018.Indeed, a European regulation provides that GMOs, products containing GMOs or ingredients produced from GMOs are to be labelled. A requirement that applies to both food [2]and feed [3]. But the same Regulation also provides that products produced “with GMOs” as well as “food and feed produced with genetically modified processing aids” [4] are excluded from its scope.As soon as 2004, less than one year after this Regulation was adopted, the status of food or feed obtained from GM micro-organisms appears unclear to some. In September 2004, the Standing Committee of the Food Chain and Animal Health (SCFCAH) discussed the status of these products obtained by fermentation of GM micro-organisms [5]. During this SCFCAH, 23 out of 25 Member States adopted an opinion which stated that “Food and feed (including food and feed ingredients such as additives, flavourings and vitamins) produced by fermentation using a genetically modified micro-organism (GMM) which is kept under contained conditions and is not present in the final product are not included in the scope of Regulation (EC) No 1829/2003. These food and feed have to be considered as having been produced with the GMM, rather than from the GMM” [6]. In 2006, the European Commission, in its report on the implementation of the Regulation adopted in 2003 on GMOs, pointed out that “When the GM micro-organism is used as a processing aid, the food and the feed resulting from such production process are not to be considered as falling under the scope of the Regulation” [7].With this interpretation of the European law, any additive intended for food or feed and produced in a contained environment using a genetically modified micro-organism is therefore exempt from GMO legislation and in particular from labelling. But the assimilation by the European legislator of GM microorganisms as GM processing aids raises questions. Because, doing so, the European legislator finally assimilates microorganisms to substances according to the definition of processing aids in 1989 [8]. However, in 2009, it will define these aids as “microbiological entity, cellular or not, capable of reproducing or transferring genetic material” [9]. Are microorganisms substances or microbiological entities? Answer who can.But concretely, the 2003 European GMO legislation has therefore opened the door to the trade of food additives and other enzymes produced by GMOs. Here’s why the lots of vitamin B2 marketed in Europe in 2018 were not labelled as such [10].A market to be defended...The remaining written records of the SCFCAH debates in 2004 are striking. They clearly show that the rationale pushed to exempt additives produced from genetically modified micro-organisms - sorry, produced with genetically modified processing aids - is based on commercial considerations and not on health or environmental ones. Just as the feed market (animal products obtained from animal fed with GMOs are not labelled), it seemed appropriate not to force operators using these micro-organisms to label as “GMOs” the products resulting from their use.A June 2004 report from the SCFCAH actually states that these talks are taking place at the request of Member States and “operators” [11]. Two years later, the European Commission explains that “all interested parties [editor’s note, non-governmental] are opposed to this type of product being concerned by GMO labelling” unlike some Member States supporting it and others opposing it. A few years later, in 2008, the European Association of Biotechnology Companies EuropaBio - the business lobby instrument - reacted to a legislative debate considering the possibility of a GMO labelling of these products. EuropaBio then argued that such labelling would be a commercial disadvantage for European companies, in particular because non-European competitors could be “inclined not to declare the GM origin of their products” if such labelling was required [12]. And then, as European consumers reject genetic modification technology, producers would revert to conventional production methods, “less innovative, less efficient, less environmentally friendly and more expensive”. Statements that have yet to be proven....In view of this rejection by the consumer and the possible illegal practices of competitors, it was indeed better not to introduce labelling...[1] Eric MEUNIER, « Vitamine B2 : contamination en cours par une bactérie transgénique », Inf'OGM, 7 décembre 2018[2] Regulation 1829/2003 article 3.[3] Regulation 1829/2003 article 15.[4] Regulation 1829/2003, whereas 16.[5] SCFCAH, 24 september 2004. https://food.ec.europa.eu/document/download/2f7d8432-e16c-488f-a5a0-c43702ba786e_en?filename=sc_modif-genet_20190430_sum.pdf[6] Ibid.[7] Point 10 of the report.[8] Directive 89/107 article 1.[9] Regulation 2009/41 article 2.[10] The contamination in 2018 by the GM bacteria used to produce vitamin B2 led to a search of the lots because this GM bacteria was present. However, in order to be considered a GM processing aid and be exempted from Regulation 1829/2003, the micro-organism must meet one condition: to be fully absent from the final product, with the exception of a possible “unintentional but technically unavoidable presence of residues” which must not otherwise present a “health risk”, point 10 of the report https://eur-lex.europa.eu/legal-content/FR/ALL/?uri=CELEX:52006DC0626R(01))0626_EN.pdf.[11] SCFCAH 23 june 2004. https://eur-lex.europa.eu/FR/legal-content/summary/eu-rules-on-producing-and-labelling-organic-products-from-2022.html[12] www.europabio.org/sites/default/files/europabio_comments_related_to_labelling_of_food_enzymes_additives_and.pdf Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [271] => Array ( [objectID] => 3395 [title] => Actions against GMO in United Kingdom [timestamp] => 1497916800 [date] => 20/06/2017 [annee] => 2017 [url] => https://infogm.org/en/article_journal/actions-against-gmo-in-united-kingdom/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => GM tomato paste was the first product sold in the UK, but this was soon withdrawn. Protests against Monsanto’s GM RoundUp Ready soy imports began in 1996, including some high profile direct actions against shipments. Consumer actions included voluntary labelling of supermarket products with stickers, and handing out leaflets outside stores. In 1998, Iceland became […] [chapo] => [texte] => GM tomato paste was the first product sold in the UK, but this was soon withdrawn. Protests against Monsanto’s GM RoundUp Ready soy imports began in 1996, including some high profile direct actions against shipments. Consumer actions included voluntary labelling of supermarket products with stickers, and handing out leaflets outside stores. In 1998, Iceland became the first UK supermarket to ban GM ingredients from own brand products. UK field trials of GM oilseed rape and maize attracted opposition from local people, neighbouring farmers and activists. The UK Government announced a voluntary agreement with industry not to grow GM crops commercially until a series of ’farm-scale trials’ were carried out to look at biodiversity. In 1999, major UK supermarkets and food manufacturers began removing GM food ingredients and the promised farm scale trials began. In 2002, the Government announced it would hold a public consultation exercise on GM crops, and produce reports on the science and economics. In 2003, this « GM Nation ? » consultation revealed widespread public concern. In 2004, the results of the farm scale evaluations were published, showing harm to wildlife (due to changed herbicide use) for two herbicide-tolerant GM crops (oilseed rape and sugar beet). The GM maize was compared only with a conventional crop sprayed with a harmful weedkiller, atrazine, that was later banned. Although the UK government approved this GM maize for commercial growing, the company withdrew the application. Due to public opposition, no GM crop has ever been grown commercially in the UK and products containing labelled GM ingredients rarely appear on supermarket shelves. However, GM RoundUp Ready soya continues to be imported for use in animal feed, as GM-fed meat and dairy products remain unlabelled. By 2017, Scotland, Wales and Northern Ireland had all opted out of growing GM crops commercially : however, the UK Government continues to work closely with industry to promote GM. Helen Wallace, GeneWatch Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( [0] => Europe ) [Pays] => Array ( [0] => Royaume Uni ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( [0] => Associations / ONG ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [272] => Array ( [objectID] => 3024 [title] => Citizens vs growing number of new techniques of biotechnology [timestamp] => 1390521600 [date] => 24/01/2014 [annee] => 2014 [url] => https://infogm.org/en/article_journal/citizens-vs-growing-number-of-new-techniques-of-biotechnology/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => GMOs have been under discussion in Europe since the end of the 1990s. The subject has mobilised a broad spectrum of civil society. But the GMO acronym generally refers only to transgenic organisms, whereas over the last 15 years the biotech companies have developed “new techniques” for modifying living organisms. These developments have been – […] [chapo] => [texte] => GMOs have been under discussion in Europe since the end of the 1990s. The subject has mobilised a broad spectrum of civil society. But the GMO acronym generally refers only to transgenic organisms, whereas over the last 15 years the biotech companies have developed “new techniques” for modifying living organisms. These developments have been – and are still - covert , even though companies might be close to reaching their Holy Grail, the right to modify plants’ genomes (as a first step) without falling under the constraints of the legislation that applies to GMOs and while being allowed to hold the corresponding patents. In this discussion, citizens’ and governments’ right to freedom of speech and political decision is restricted, as being socially and legally limited to purely scientific considerations. November 2013 : Pioneer announced its collaboration with Precision BioSciences aiming at modifying male maize plants with meganuclease in order to make them sterile [1]. Pioneer, as Syngenta, Monsanto, Bayer CropSciences, also signed a licence agreement with Two Blades Foundation on TALENs protein to use them to cut plant’s genome in a precise location [2]. In France, in july 2013, Euralis Semences signed a licence agreement with BASF to develop Clearfield sunflowers, resisting herbicides [3]. Those examples are given to illustrate that transgenesis has become obsolete considering the techniques developed by laboratories and industries are developing.A highly confidential discussionSince late 2008, the European Union has questioned whether the “new biotech techniques” applied to plants and/or micro-organisms give rise or not to organisms that fall under the European legislation on GMOs (Directive 2002/18, regulation 1829/2003, etc.). It was not until January 2012 that it was possible to access what is still the only existing official information provided by a decision-making body, the opinion expressed by a European group of experts mandated by the European Commission, to respond to the question that has been posed as to the status of seven techniques : oligonucleotide-directed mutagenesis, cisgenesis, zinc finger nucleases, reverse breeding, agro-infiltration, grafting, DNA methylation [4] (paper in french). C.f. also [5] ]]. Eric Poudelet, of the European Commission told Inf’OGM in May 2012 that “This is a difficult subject that the Commission finds worrying, and on which scientists do not always agree […] it is up to the States to take decisions” [6]. It was announced that discussions would be held during the summer of 2012, but in late 2013, the European Commission informed Inf’OGM that they were still in the process of analysing this “in order to establish whether the new techniques mentioned by the working group fall under the definition of GMOs as per article 2 of the 2001/18/EC Directive or not”. So can we expect a reply sometime soon or not ? It is impossible to say, as “It is impossible to provide a precise time-line or indicate the details of the publication of the Commission’s work on this subject”. Nor is it possible to know how or by whom this analysis is being carried out within the European Commission…In 2010, the Institute for Prospective Technological Studies (IPTS), a public body under the authority of the European Commission, organised a workshop on these new techniques with the European Commission, the OECD, national research and administrative institutes, companies and associations. These associations represented companies rather than civil society : Copa-Cogeca, EuropaBio, the German association of seed merchants and the French Union of Seed merchants. Although a report was published in 2011 by the IPTS [7], essentially based on this workshop, no formal report was made public, as “There is no report”, according to the IPTS. It is difficult to understand this lack of transparency, given the social stakes that biotechnology implies.The increasing lobby of private enterpriseShould the plants produced by these techniques fail to be covered by legislation pertaining to GMOs, this would imply no risk assessment prior to granting authorisation, no labelling of food products containing such plants or derived from them and no post-market environmental monitoring on the plants. These obligations are not welcomed by companies, as they imply costs, impose a time-frame, in brief, they disrupt the commercialisation of their patented products. Since January 2012 and the official publication of the report by the group of experts, the biotech lobby has increased its pressure in a more or less direct manner : scientific articles, position papers by bodies that represent the companies, scientific academic positions…Be it the European technology platform “Plants for the future” [8], or the European Seed Association (ESA) [9], the message sent to the European Commission is that it should supply companies with a solid legal framework to guarantee “their investments in innovative techniques will not be in vain and that their future products will not be subject to the uncertain outcome of politicised regulatory procedures” according to the ESA, as they are afraid of an “expensive and lengthy authorisation procedures similar to that of genetically modified organisms”. The arguments that are put forward are similar to those used for transgenesis : need to guarantee world food security, overcome the impacts of climate change on agriculture, guarantee jobs in Europe. In July 2013, the European Academies Science Advisory Council took up these arguments and requested that the European Commission declare that modified products which do not contain inserted DNA do not fall under the GMO legislation, and that the final decision is taken only by taking into account the final product, rather than the technique used. This option is the opposite of the current European position that does take the technique of modification into account. But it might become a serious one as the Commission of Agriculture of the European Parliament hdecided on january the 21st to claim this approach. Its resolution on plant breeding is based on industries arguments and underlines that “with today’s technique-based plant-breeding legislation, [...] it has also proven to be difficult, after the event, to define what technique has been used at the time of plant-breeding, which confirms the difficulties posed by technique-based laws” [10].Key questions : patents, democratic choiceThe issue of patents on plants that have been technically modified is not on the list of arguments carried, directly or not, by the industry. Companies do not wish to see most of these techniques considered as producing GMOs, and wish to see them excluded from the legal framework. The request by the European Academies Science Advisory Council to only consider the final product, and not the technique that has been used, appears in contradiction with the industrial property rights that are being claimed on these same products. For if a final product were to be classified as GMO or non-GMO without taking the technique used to produce it into consideration, (meaning only considering ‘can nature also produce such organisms ?’), industrial property rights (that are based on the concept of innovation and novelty) would still be claimed on the grounds of patents on the techniques, and hold by companies. Yet in the agricultural domain, and most especially in the area of seeds, the question of industrial property is important, for it leads to the privatisation of the first link in production, that of seeds. The most recent moves in this case demonstrate that the work in progress aims to criminalise peasant farmers’ activities even further (c.f. the analyses of Semences Paysannes network), leading to mobilisation by farmers’ unions and citizens. The new techniques enable these evolutions to take place, because they provide the companies with the tool they needed to defend what they consider to be their rights : to forbid peasants from working with seeds that industrial seed merchants wish to claim as covered by industrial property rights via patents on the genes or the techniques.Biotechnology undermines our ability to make genuinely democratic choices. It is not possible for society to follow the discussion technique by technique, as organised according to the companies’ agenda, and on the sole basis of technical and scientific criteria. The positions held by companies or the European Academies Science Advisory Council are a perfect illustration of this : the final legislative decision on whether these techniques should have the status of GMOs or not will be taken on scientific considerations alone. The WTO (World Trade Organisation) is imposing this kind of approach, and is considering all national decisions illegal should they fail to be grounded on scientific justification (c.f. the case by the WTO against national moratoriums). We also need to bear in mind that the bilateral treaty that is currently under negotiation between the United States and the European Union could provide companies with the right to claim damages if the European market were closed to their products or professional activities ; this is similar to the existing treaty between Canada and the USA [11]. This all-scientific constraint deprives governments and citizens of their right to express their opinions. For not all citizens are scientists. They are not all able to analyse 900 pages of toxicology results. But they do all have the right to an opinion based not merely on scientific considerations, but also on ethics, cultural, social and / or economic considerations that are equally legitimate in building political opinion, and they are all entitled to have their opinions taken into account by political bodies, without being rejected by these bodies on the grounds that their opinions are not scientific. This is all the more true, as this “scientific truth” is not always shared by the competent experts… The techno-scientific framework that is being imposed is therefore leading to choices being made that are not those of society in all its diversity, but rather those imposed by companies knocking on the law-making body’s door.The list of the seven techniques studied by the European group of experts between 2008 and 2012 is no longer exhaustive. These companies have since developed other techniques : meganucleases, Talens, early flowering and the new technique of Pioneer seed production… This longer list has led the European Commission to hope that their current analysis will lead to conclusions that could “also serve as a reference for other techniques that might emerge in the future” [12]. It is not just the citizens who have been left standing by the roadside, as the governments of several countries have or indeed are currently undertaking similar studies to those of the European Union, but without analysing all the techniques [13]. These different analyses will lead to different legislation being introduced, and therefore to recurrent complaints from the companies, which would prefer to have an internationally harmonised legislative framework on GMOs. Eric MEUNIER Inf'ogm [Type article] => actualité [Enjeux] => Array ( ) [Type] => Array ( ) [Continent] => Array ( ) [Pays] => Array ( ) [Thème] => Array ( ) [Organisations internationales] => Array ( ) [Sujet ponctuel] => Array ( ) [Type OGM] => Array ( ) [Acteur] => Array ( ) [Liste Entreprise] => Array ( ) [Animaux] => Array ( ) [Plantes] => Array ( ) ) [273] => Array ( [objectID] => 2787 [title] => EUROPE – Amflora : Illegal authorisation French experts say [timestamp] => 1288656000 [date] => 02/11/2010 [annee] => 2010 [url] => https://infogm.org/en/article_journal/europe-amflora-illegal-authorisation-french-experts-say/ [image] => /wp-content/themes/infogm/assets/images/defaut.png [extrait] => In January and July 2010 the French High Council of Biotechnologies (Haut conseil des biotechnologies, HCB) delivered two critical assessments concerning the application for commercial authorisations for a transgenic sugar beet (1) as well as a transgenic potato (2). The main reservation concerns the detection and quantitation methods provided by the companies and which have […] [chapo] => [texte] => In January and July 2010 the French High Council of Biotechnologies (Haut conseil des biotechnologies, HCB) delivered two critical assessments concerning the application for commercial authorisations for a transgenic sugar beet (1) as well as a transgenic potato (2). The main reservation concerns the detection and quantitation methods provided by the companies and which have been qualified as « unreliable » and « able to affect the honesty of the transactions ». For a better understanding of those assessments, Inf’OGM interviewed Yves Bertheau, specialist for the detection of GMOs at the INRA (French National Institute for Agricultural Research) and member of the Scientific Committee of the HCB. In his assessment of July 12th 2010 concerning the Amflora potato (by BASF) as well as in the one of January 7th 2010 concerning the H7-1 sugar beet (by Monsanto) the HCB stipulates that the reference gene is not appropriate. Why is that ?YB - The European system imposes that each commercialised GMP must be detectable and traceable, regarding the ingredient, in analytical terms for each cultivated species (3). That means that the methods provided by the petitioners must make it possible to measure the relative quantity of transgenic DNA present in a sample. Both the European standards and those of the Community Reference Laboratory, established at the Joint Research Center (JRC), describe the performance criteria of a reference system for each cultivated species. The aim is to clearly establish the relative quantity of transgenic DNA. The basic principle is quite simple : as for a traditional set of scales, the quantity of transgenic DNA is calculated in relation to a tare weight, which corresponds to the DNA quantity present in the cultivated species. The DNA percentage present in a sample is calculted by the following equation :% of present transgenic DNA = (number of transgenic DNA molecules / number of reference DNA molecules) *100The reference gene plays a key role. The Standards ISO 24276 and 21270 as well as the performance criteria of the European Network of GMO Laboratories (ENGL) (4) define that the chosen reference gene has to be specific of a single species, it has to be present in only one or very few copies within the genome, it has to have a sequence which doesn’t change from one variety to the other and shall not be subject to mutation. This is to assure an unambiguous and solid identification. In the case of the potato and the sugar beet, the reference genes proposed by the companies in their documents are not specific of one species. For instance, the one of the sugar beet "doesn’t allow to differenciate turnip or spring turnip [...], which are different species than the sugar beet" (5). It also doesn’t allow to make a difference between the sugar beet and the beetroot nor the fodder beet. This lack of specificity of the reference gene "could [...] affect the honesty of the transactions". For the same reasons the system proposed for the potato is simply "not reliable" (see box below).But what exactly does this mean for the quantitation ? YB - As already mentioned, those quantitation errors will be possible with over- or underestimated quantities, depending on the case. To take a concrete example, let’s imagine that a field of non transgenic sugar beet gets contaminated by transgenic sugar beet. Then, for example, by adding fodder beet it would be possible to artificially lower the quantity of transgenic DNA in a provided sample, having increased the number of the reference DNA molecules in the above mentioned equation. This is why the HCB spoke about the affected honesty of transactions. There are also cases where to the contrary, the quantity of the transgenic DNA could be overestimated as in the example of the potato, where some varieties haven’t been quantified correctly. How to assure labelling controls, measures at the borders or other customs controls under these conditions ? It is simply not possible to quantify the existing transgenic DNA correctly !Is it the same situation for the other cases ? YB - Regarding sugar beet and rapeseed, we have so called species complexes. These are plant species which comprehend many different plants. The potato family is much more complex than initially anticipated. Therefore the problem of the appropriate reference gene is particularly important for these three taxa. It is the same problem for maize, but from a different angle. Here we have some already identified reference genes which are reliable. But other reference genes which are also known, are not reliable, because some of them are subject to mutations (a change in the DNA sequence) which modifies our capacity to identify them. An article published in 2008 explaines this phenomenon. The title of this article states clearly : "A single nucleotide polymorphism (SNP839) in the adh1 reference gene affects the quantitation of genetically modified maize (Zea mays L.) » (6). For this reason the reference system is so precisely defined : the use of a specific system for each species, which is present in one single or in very few copies within the genome, in a constant amount, not subject to mutations. To be sure of the specificity, the used reference gene has to be tested with about twenty different varieties representing the genetical and geographical diversity of a plant. In some cases, it is even required that also their ancestors can be characterised by the used gene (example : Teosinte for the maize).In the case of maize it is astonishing that the Community Reference Laboratory, located at the JRC-IHCP (Institute for Health and Consumer Protection), hasn’t made use of the results of the JRC-IRMM (Institute for Reference Materials and Measurements) for this method. Since this method has been validated for purely statistical performance criteria on one single maize variety, it doesn’t fulfill anymore the regulatory requirements. Nevertheless it remains active and is used by numerous routine analysis laboratories. How can such a laboratory deal with this kind of "subtleties" if the Community Reference Laboratory doesn’t take charge of these matters ?With regard to strict regulations, the HCB’s opinion in the matter questions the legality of the authorisation issued for the Amflora potato as well as EFSA’s opinion in the context of the authorisation request for the H7-1 sugar beet.1, Assessment of the Scientific Committee of the HCB on H7-1 sugar beet by the companies Monsanto and KWS SAAT AG (Germany), glyphosate herbicide tolerant, http://ogm.gouv.fr/IMG/pdf/Avis-CS-HCB-Betterave-H7-1_cle4a4cad.pdf2, Assessment of the Scientific Committee of the HCB on the potato EH92-527-1 by the company BASF, with increased amylopectin content and resistant to certain aminoglycoside antibiotics, http://ogm.gouv.fr/IMG/pdf/Avis_CS_HCB_Amflora_100721_cle48139e.pdf3, Regulation (EC) No. 1829/2003 and No. 1830/20034, http://www.infogm.org/spip.php ?article45815, cf. note 1, page 176, "A single nucleotide polymorphism (SNP839) in the adh1 reference gene affects the quantitation of genetically modified maize (Zea mays L.)", Broothaerts, W. et al., Journal of Agricultural and Food Chemistry, 56 (19) : 8825-8831Extract of HCB’s opinion on the potato EH92-527-1 « Regarding the performance, a specific method of detection for the potato EH92-527-1 has been validated by the CRL-GMFF30. […] Regarding the relative quantitation, the reference system proposed by the petitioner is not reliable. The system based on the UDP-Glucose Pyrophosphorylase gene shows risks of cross-over reaction with other sequences of Solanaceae (Report of CRL-GMFF : Protocol EH92-527-133). The Scientific Committee of HCB reminds that according to the regulation (EC) No. 1829/2003, the petitioner needs to provide a specific identification / quantitation method for the taxon. In particular he is asked to study the existing number of copies and the allelic variation of the reference gene used on a number of potato varieties which are representative for their genetic diversity, as foreseen in the ISO standards 24276, 21569 and 21570 (ISO, 2005a, b, 2006) and recommended in the validation criteria ENGL34 35. For their publication the results have to be provided to the Community Reference Laboratory ».Extract of HCB’s opinion on H7-1 sugar beet« The respect of the coexistence principle imposes upon the member states the introduction of crop management measures, complying with the legal labelling thresholds for GMO presence. The detection and quantitation methods for the H7-1 sugar beet have been validated by the CRL-GMFF in accordance to their performance criteria. However it has to be noticed that the sugar beet reference gene, a glutamine synthase which has been provided by the petitioner, is missing specificity. It doesn’t allow to differentiate between the turnip or the spring turnip (Brassica rapa, subspecies, not further specified by the CRL- GMFF), species that are different from the sugar beet". Furthermore, unpublished results (Bertheau et al.) in collaboration with the CRL-GMFF have shown that the system proposed by the petitioner also extends to weed- and vegetable species [...]. This lack of specificity within the control systems could lead to interpretation errors for the quantitation of the GMPs and could therefore affect the honesty of transactions. According to the regulation (EC) No. 1830/2003, the Scientific Committee requests the petitioner to provide a specific identification / quantitation method, especially at the level of the taxon reference gene, before it can issue a cultivation authorisation ». 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