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The Council of the EU wants to speed up the release of GMM into the environment

By Eric MEUNIER

Published on the 06/07/2026

    

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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 not

Initially, 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 deregulation

For 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 work

Now 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