Sittings · Document
Follow up to the European Parliament non-legislative resolution on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 94804 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
1. Resolution tabled pursuant to Rules 115(2) and (3) of the European Parliament’s Rules of procedure
2. References: 2024/2841(RSP) / B10-0153/2024/ P10_TA(2024)0045
3. Date of adoption of the resolution: 26 November 2024
4. Competent Parliamentary Committee: Committee on the Environment, Climate and Food Safety (ENVI)
5. Brief analysis/assessment of the resolution and requests made in it:
The resolution calls on the Commission to withdraw the draft Commission implementing decision (paragraph 3) on the grounds that it exceeds the implementing powers provided for in Regulation (EC) No 1829/2003 (paragraph 1) and that it is not compatible with the aim of that Regulation and the general principles of Regulation (EC) No 178/2002, i.e. the protection of human life and health, animal health and welfare, the environment and consumer interests (paragraph 2).
The resolution raises questions on EFSA’s risk assessment of the effects of artificial miRNA (a Ribonucleic Acid molecule) (recitals E to G) and of the related effects of the decreased gibberellic acid levels (a substance regulating various physiological processes in plants; in this case reducing plant height) (recitals H to K).
The resolution welcomes that the Commission recognises the need to take sustainability into account for the authorisation of genetically modified organisms (GMOs) and expresses its disappointment that the Commission proceeds with GMO authorisations for import despite ongoing European Parliament objections and in the absence of a qualified majority of Member States voting in favour (paragraph 4).
The resolution refers to the need to reduce dependency on imported feed (recital L).
It urges the Commission to consider the European Union’s (EU) obligations under international agreements, such as the Paris Climate Agreement, the United Nations (UN) Convention on Biological Diversity and the UN Sustainable Development Goals (paragraph 5).
The resolution refers to Member State and stakeholder concerns (recitals M and N) recalls the numerous resolutions objecting to GMO authorisations adopted by the European Parliament in its eighth and ninth terms (recital O). Furthermore, the resolution recalls that the fact that authorising decisions continue to be adopted by the Commission with the lack of support of Member States and the objections of Parliament (recital P) and states that no change of law is required for the Commission not to authorise GMOs in the absence of a qualified majority of Member States in favour in the Appeal Committee (recital Q).
6. Response to the requests and overview of actions taken, or intended to be taken, by the Commission: [Please, see comments on TA(2024)0038 and 0039.]
The Commission would like to recall that the draft implementing decision concerns the authorisation for placing on the market of products containing, consisting of or produced from genetically modified (GM) maize MON 94804, but not the cultivation of this maize.
With respect to paragraphs 1 and 3 of the resolution, the Commission would like to point out that the draft decision has been prepared in line with and has undergone the procedural steps set out in Regulation (EC) No 1829/2003 on GM food and feed and in Regulation (EU) No 182/2011 on comitology, as illustrated below:
on 14 February 2023, Bayer Agriculture BV, based in Belgium, submitted on behalf of Bayer CropScience LP, based in the United States, an application to the national competent authority of the Netherlands for authorising the placing on the market of GM maize MON 94804 for food/feed and other uses, except of cultivation;
on 26 April 2024, the European Food Safety Authority (EFSA) issued a favourable scientific opinion which concluded that this GM maize is as safe as its conventional counterpart and the tested non-GM maize reference varieties with respect to the potential effects on human and animal health and the environment;
in its scientific opinion, EFSA considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003;
the public commented on the EFSA opinion, and all the scientific comments received were scrutinised by EFSA, which confirmed the conclusions of its initial scientific opinion;
the draft decision was voted in the Standing Committee on 17 September 2024 with no qualified majority in favour or against;
the draft decision was voted in the Appeal Committee on 29 October 2024 with no qualified majority in favour or against;
in accordance with the rules set out in Regulation (EC) No 182/2011 on comitology, it is for the Commission to decide on the adoption of the draft decision;
on that basis, the Commission decision was adopted on 9 April 2025.
The Commission therefore considers that by going forward with the adoption process of a decision that fully complies with the procedural steps set out by the co-legislators in the GMO legislation and is in line with EFSA’s scientific opinion, that opinion having considered all the scientific comments having been submitted by Member States, it does not exceed its implementing powers.
With respect to the other provisions of the resolution, the Commission considers that they fall outside the remit of the right of scrutiny, which is limited to the question of whether the implementing act exceeds the implementing powers provided for in the basic act. The Commission is not required to justify the implementing act as regards these points. Nevertheless, the Commission has carefully considered the position expressed by the Parliament and would like to make the following comments:
EFSA performed a comprehensive risk assessment which concluded positively, after considering Member States’ comments as well as comments from the public. Therefore, the Commission considers that its draft decision is fully in line with the objectives of EU legislation on GM food and feed and of the EU’s General Food Law to protect health and the environment after an objective, independent and transparent scientific assessment of the risks (paragraph 2).
With respect to the concerns raised in relation to the effects of artificial miRNA (recitals E to G) and of decreased gibberellic acid levels (recitals H to K), EFSA concluded in its risk assessment that miRNAs do not present a toxicity risk for humans and animals and that reduced gibberellins level in this GM maize do not pose a toxicological concern in terms of regulating physiological processes in plants.
Regarding the call expressed in paragraph 8 to take sustainability into account in the authorisation of GMOs, sustainability is central to the Commission. The Commission will shape the way forward by building on the recommendations of the Strategic Dialogue on the future of agriculture in the EU and on stakeholder engagement. A ‘Vision for Agriculture and Food’ has been adopted on 19 February 2025.
As regards the call to consider the EU’s international obligations (paragraph 5), the Commission is highly committed to respecting the EU’s international commitments in the field of the environment. However, the adoption of Commission decisions for the placing on the market of GMOs that do not present risks to health or to the environment do not run counter to such international commitments. As regards the call in paragraph 5 for draft implementing acts to be accompanied by an explanatory memorandum explaining how they uphold the principle of ‘do no harm’, the Commission would like to stress that the draft decision is based on a positive EFSA scientific opinion, as described above.
Issues related to reducing dependency on imported critical commodities (recital L) will be part of the Commission’s work in accordance with its political guidelines and the mission letters of the responsible Commissioners. However, such issues go well beyond the remit and cannot be addressed in the context of the Commission decisions regarding the placing on the market of GMOs.
Finally, with regards to the arguments concerning the decision-making process and the lack of support by the Member States for any GMO authorisation for food and feed uses (recitals Q to R), the Commission submitted a proposal to the Council and the Parliament on 14 February 2017 to amend Regulation (EU) No 182/2011, changing the voting rules at the Appeal Committee to increase transparency and accountability in the GMO decision-making process. However, this proposal has not been adopted by the co-legislators. In such circumstances, the Commission is bound to apply the procedures laid down in Regulation (EU) No 182/2011 on comitology and in Regulation (EC) No 1829/2003 on GM food and feed.