News
As early as 2023, experts were refuting the basis for the deregulation of GMOs obtained by NGTs
By Eric MEUNIER
Published on the 03/11/2026, modify the 04/11/2026
Whilst the deregulation of GM plants produced using new techniques of genetic modification (GMO/NGT) was adopted on 17 June 2026, experts from several Member States had, as early as 2023, expressed their doubts and disagreements regarding the assumptions put forward by the European Commission. They were also disappointed for not having been consulted before the legislative proposal was drafted. Despite this, their objections fell on deaf ears.
Acording to the European Commission and the policy-makers in Brussels, GMO/NGT are, with a few exceptions, equivalent to conventional plants. The legislator has therefore concluded that these plants do not pose any greater risk than those derived from conventional breeding. The deregulation of these GMO/NGT crops, adopted in June 2026, provides in particular for the abolition of risk assessment but this would not constitute a departure from the European policy of ensuring a high level of food safety according to the legislator. The concern is that neither the assertion of equivalence nor the conclusion that there is no additional risk is supported by scientific evidence. Whilst in the United States a court rebuked the government in December 2024 for a lack of scientific literature to justify this assertion, the European Commission had, at the same time, already made its decision…
A new regulation with a pernicious wording
In the preamble to Regulation 2026/1388, published on 26 June 2026 in the Official Journal of the European Union and deregulating GMO/NGTi, the European legislator states that the new NGT techniques “can result in organisms with modifications equivalent to those which can be obtained by conventional breeding methods“. This so-called equivalenceii implies that these GMO/NGT plants “should be treated in the same way 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”.
The European Commission explained in 2023 that “Various stakeholders (biotechnology/biotech industry, plant breeding/seeds, plant protection products/fertilisers, feed, ornamental plants sector and trade sector) believe that risk assessment is not needed when these plants could have been produced through conventional plant breeding or classical mutagenesis”iii. Whilst it also pointed out that, conversely, “a majority of NGOs, and consumer organisations consider that the current legislation is fit for purpose and effective in terms of risk assessment“, it did not have to report any scientific disagreements regarding the equivalence assumptions underpinning its entire proposal, as scientists had not been kept informed prior to this publication.
Experts from the Netherlands, the Czech Republic and Belgium are sceptical
It was, in fact, on 29 May 2024, in the midst of legislative discussions between the Commission, the Parliament and the Council of the European Union, that certain scientific experts began to cast doubt on the scientific validity of the Commission’s assumptions.
At a meeting organised by the European Food Safety Authority (EFSA) with experts from the Member Statesiv, the Dutch representatives referred to “certain effects [which] may not be predicted by molecular data“, the only data required from companies. They added that agronomic and phenotypic data would make it possible to predict such effects. However, EFSA responded at the time that “certain unwanted characteristics may probably be eliminated during the development of the NGT plants (e.g. by backcrossing)”. Apart from the EFSA’s response, which does not definitively confirm the absence of unintended characteristics in the final product, this remark by the Dutch experts shows that the assumption of “equivalence between NGT and conventional” – and therefore the absence of risk – is not widely accepted, let alone scientifically established. However, it was in 2025 that certain critics began to take a more assertive stance.
“regulatory decisions are made by risk managers“
EFAS, 14 May 2025
On 14 May 2025, the same working group met again, but this time the comments were more directv. Experts from the Czech Republic thus opened the discussions by expressing their concerns “on the fact that Annex I of the proposed legislation [Editor’s note: the annex setting out the criteria defining NTG equivalence with conventional crops and thus their deregulation] was not discussed with the Network experts. This would have been important since Category 1 NGT plants would not undergo risk assessments, therefore the definition of this category becomes critical“. The EFSA responded to this comment by passing the buck back to the legislator, explaining that “regulatory decisions are made by risk managers [Editor’s note: the legislator] and that the role of the scientific group is to support the implementation of decisions […] are robust and fit-for-purpose”. The Commission, in turn, responded by confirming that “scientists were not directly involved in drafting Annex I”, but that the criteria it proposed are based on “the criteria were based on scientific literature, EFSA’s work, and [European Commission’s] Joint Research Center reports”.
It was then the turn of the Belgian experts to voice their criticisms. Whilst they agreed that the risk assessment for GMO/NGT plants cannot follow the same approach as that for transgenic GMOs, they did not appear to agree that “equivalence with NTG plants” implies the absence of risks. They noted “that the purpose of Annex I, is to set criteria to determine molecular similarity of a NGT plant with a conventionally bred or naturally occurring plant, not to express concern about risks associated with certain modifications”. In fact, the annex, as proposed by the European Commission and adopted in June 2026, sets out the criteria for equivalence between an NGT plant and a non-NGT plant and concludes that there are no risks, since no risk assessment is deemed necessary. At the meeting on 14 May 2025, it was explained that “the Annex I could be utilized to derive hazards from the criteria for NGT plants Category 1 and to define certain “risk categories“, as these criteria essentially express concern about the risks that might be associated with certain modification“. This is a link between equivalence criteria and risks that the Belgians do not make, since they consider, on the contrary, that “Annex I combines molecular criteria with safety criteria, the purpose of this Annex is confusing and unclea“.
French experts are equally critical
On 14 May 2025, the French experts also voiced criticisms echoing those previously mentioned. They, in turn, emphasised that “Annex I and its equivalence criteria were not discussed with the GMO Network experts in the Subgroup on New Genomic Techniques, even though they are central to defining Category 1 NGT plants”, they considered that such a discussion would have been useful whilst negotiations between the Commission, the Council and the European Parliament were still ongoing at that time. The French experts also stated that they shared the Belgian experts’ view regarding “the confusion in the goal of Annex I criteria: equivalence or safety”.
“Annex I and its equivalence criteria were not discussed with the GMO Network experts in the Subgroup on New Genomic Techniques, even though they are central to defining Category 1 NGT plants”
ANSES, meeting with the EFSA on 14 May 2025
According to them, another issue should have been discussed – and not a minor one at that. Annex 1 of the proposal – as well as the regulation that has since been adopted, albeit in a different wording – stipulated that “NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications” of various types. This figure of 20 modifications raised concerns for ANSES, which, from a purely scientific perspective, questioned at that meeting in May 2025 “the assumption that the number of modifications, or the size of insertions/substitutions, correlates with the level of risk, irrespective of the nature of the [genetic] modification“. Raising the question is clearly an answer in itself, as it implies that, according to these experts, specifying a number of modifications below which equivalence – and therefore the absence of risk – is assumed is not scientifically justified. However, this question was not addressed at the meeting.
ANSES had, however, already highlighted these disagreements in late 2023 in a reportvi. It was stated there, for example, that 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”. Commenting on the wording of Annex 1 to the European Commission’s proposal, they added that the criterion of “substitution or insertion of up to 20 nucleotides” is not supported by 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“.
These concerns raised by experts from several Member States appear not to have reached the European legislator or to have been ignored. In any case, the lack of a scientific basis for the assumptions made by the Commission and policy-makers is clearly stated. This is a worrying situation, as these assumptions led the legislator to deregulate GMOs/NGTs on 17 June 2026.
i « Regulation (EU) 2026/1388 of the European Parliament and of the Council of 17 June 2026 on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625 », Official Journal of the European Union, 26 June 2026.
ii Eric Meunier, « GMO/non-GMO equivalence: the Commission turns “certain cases” into a general rule », Inf’OGM, 17 December 2025.
iii « 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 », Official Journal of the European union, 5 July 2023.
iv EFSA, « EFSA GMO Network – SUBGROUP ON NGTs – Minutes of the 1st meeting », 5 July 2024.
v EFSA, « Subgroup on New Genomic Techniques (NGTs) – Minutes of the 2nd meeting », 27 June 2025.
vi Eric Meunier, « French Anses experts : GMO deregulation has « no scientific basis » », Inf’OGM, 16 January 2024.
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