Media reaction: Leaked proposal to deregulate new GMOs

Commission plan gives in to biotech seed corporations

  • European Comission proposes new GM-deregulation: more biosafety risks, and more market dominance for handful of biotech seed firms will be the result

  • EU Ombudsman investigates complaint on DG SANTE’s process


A leaked version of DG SANTE’s proposal to deregulate products of ‘new genomic techniques’ (NGTs, or new GMOs) confirms the early warnings by environmental, sustainable farming groups, consumer-groups and scientists.

The European Court of Justice ruled on 25 July 2018 NGTs are GMOs and need to be regulated as such. Ever since, biotech seed corporations massively lobbied to get the EU GMO rules scrapped for NGTs.

Nina Holland researcher at  Corporate Europe Observatory (CEO) says:

“If this proposal would go through, it would mean that these GMOs will no longer be subject to a risk assessment for health and environment, traceability nor labeling. This will increase biosafety risks and abolish consumers’ freedom of choice. Since NGT seeds will be patented, this will erode farmers’ rights, and it will lead to a further monopolization of the already highly concentrated seed market.”

“The assumption the Commission makes that new GMOs would lead to more sustainability are based on industry’s  claims, instead of real evidence. A fundamental issue is that the assumptions to justify this historic deregulation are based on industry claims, not on evidence. In reality, this is a give-away to the biotech seed firms like Bayer, Corteva and BASF.”

CEO and Friends of the Earth Europe have recently submitted a complaint to the EU Ombudsman into the very biased preparation work by DG SANTE in the lead up to this proposal. The Ombudsman has started an enquiry. DG SANTE’s consultation process was highly biased and took industry’s point of view much more into account than organic farming, environmental or consumer group views.

Key elements of the DG SANTE’s deregulation proposal:

  • The proposal creates two categories of New GMO plants. The ones in ‘Category 1 NGT’  are those that according to the Commission “could also occur naturally or be produced by conventional breeding”.

    These GM plants would have:

    - no risk assessment for health and the environmental impacts

    - no detection test required

    - no traceability

    - no consumer labelling

    - no monitoring or coexistence measures

    DG SANTE only foresees a ‘notification procedure’ for these GMOs. This results in a far-reaching deregulation, a breakdown of environmental and health protection, which the EU Health Commissioner Kyriakides and DG SANTE so far always denied would happen.

  • Category 1 is defined by a set of criteria (Annex 1), evolving around a random number of ’20 genetic modifications’ such as substitutions of nucleotides. However, there is no way of knowing that these modifications do actually occur in nature. The mere number of nucleotides changed do not mean that they are safe, and unintended effects of the modification will not be checked for. Other changes, such as deletions, can even be unlimited in number, according to the leak.

  • The proposal means that consumers will have no idea whether they are eating new GMOs, that are in addition untested. The GMO-free food sector will have a hard time avoiding contamination in their food supply chain. Farmers and breeders will be able to know which varieties are Cat. 1 NGTs, through a public register.

  • New GMOs/NGTs will not be allowed in organic farming. In that sense, new GMOs are still GMOs. However, for the deregulated group of NGTs, as described above, there will be no co-existence rules. It will be impossible for organic farmers and breeders, as well as conventional farmers producing for the GMO-free food industry, to avoid contamination and keep their fields GMO-free.

  • Corporations already dominating the patent pool on these technologies, like Corteva, Bayer and BASF, will be able with this proposal to enter the EU market with unlabelled and untraceable - but patented – GMOs, which will further increase their control over farmers and food production in Europe.

  • The only exception in Cat. 1 are herbicide-tolerant GM crops, which will still need authorization, for their evident negative impact on sustainability.

  • All other NGT products (Category 2) will be regulated, but the authorization procedure will be simplified compared to the current EU GMO rules. These will still be labeled, but there will be no monitoring plan required, not a detection method under certain conditions.

  • Remarkably, the Commission wants to still monitor “potential risks to health or the environment, impact of NGT plants on environmental, economic and social sustainability as well as impacts on organic agriculture and on consumers acceptance of NGT products” – but they will not have the data on risks, nor will consumers have knowledge of what they are eating.

Nina Holland says:

“DG SANTE has been under strong lobby influence from the biotech seed multinationals who for years have called for this deregulation. They have been supported by a group of industry-linked scientists, such as those in lobby platform EU-SAGE.”

“This draft proposal means a complete undermining of the EU GMO rules. The biotech seed multinationals – who also are the main pesticide producers – will massively raise profits by gaining access to the EU market with untested, unlabeled – but patented – GM foods. In practice this also means giving up on the freedom of choice for consumers, and bringing harm to organic and GM-free farming.”

“Even Vice-President Timmermans has claimed that such deregulation can help to reduce pesticides, without any facts supporting these assumptions. The key responsible for the Green Deal sees it as a political reality that if  he wants to get the pesticide reduction law SUR passed, the deregulation of new GMOs will have to be given in return. This ‘horse-trading’ exercise would de facto mean dissolving the existing EU GMO rules, as a mere compromise to gain something else. This is a very bad idea. There is no evidence that new GMOs will reduce pesticides, and since the dominant biotech seed and pesticide corporations are one and the same (Bayer, BASF, Corteva, Syngenta) there is even less reason to believe that this would be their priority.”

Over 300 organisations, including CEO, wrote a letter to Vice-President Timmermans in May 2023 to keep the EU GMO rules in place for all GMOs and therefore stop the planned deregulation of new GMOs. Over 400K citizens signed a petition with that demand.


More information: Nina Holland, Corporate Europe Observatory, mobile + 32 466 294420, email


Notes to editor:

1. Find the leaked documents here. This is a draft proposal by DG SANTE, which is currently in Interservice Consultation. The final proposal is currently scheduled for 5 July.

2. The Ruling by the European Court of Justice (ECJ) from July 2018 can be found here: ‘Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive’.

3. The opinions of the Regulatory Scrutiny Board on the DG SANTE Impact Assessment for this proposal, are also leaked. The first opinion was negative, the second is ‘positive with reservations’ and cites “significant shortcomings”. This includes the crucial point that the Commission does not explain in detail how it will verify that a product “could also occur naturally”. Whether something “also occurs naturally” is not even relevant; the only relevant aspect is whether the change brings a risk for environment or health if grown and consumed at large scale.

4. In a recent report ‘New Genome Techniques – A risky corporate distraction from real sustainable solutions’ Foodwatch concluded that “NGTs so far only seems to be an empty promise. Genetically modified crops suitable to achieve the “Farm to Fork” objectives are not available. It seems, they won’t be available within the next 10-15 years. Contrary to what proponents claim, under the current circumstances crops created by NGTs should be considered a high-risk technology as they pose a number of risks.”

5. This letter from IFOAMEU and ENGA to Commissioners Kyriakides and Wojciechowski confirms the united rejection of deregulation of new GMOs by the organic and GM-free industry.

6. On 16 March, Environment ministers sent a clear message to the European Commission on New Genomic Techniques advocating for the implementation of the precautionary principle and keeping risk assessment for NGTs.

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