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 95275 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: 2024/3011(RSP) / B10-0060/2025 / P10_TA(2025)0015
3. Date of adoption of the resolution: 12 February 2025
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 and to submit a new draft to the committee (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 the European Food Safety Authority’s (EFSA’s) risk assessment of two insecticidal proteins (Mpp75Aa1.1 and Vpb4Da2) and of the double stranded RNA DvSnf7 (constituent with insecticidal properties) regarding the evaluation of their toxicity, immune responses and combinatorial effects on non-target organisms (recitals E, F, I and J). The resolution also states that the EFSA opinion provides insufficient data to assess unintended genetic effects, the biological activity of read-through sequences, and potential impacts on non-target organisms (recital C). It raises questions on potential gene flow to wild relatives (recital G), appropriateness of field trials (recital D) and adequacy of monitoring requirements (recital H).
The resolution calls on the Commission to ensure convergence of standards between the European Union (EU) and its partners in free trade agreement negotiations, in order to meet the EU’s safety standards (paragraph 4). It also states that the EU-Mercosur trade agreement will incentivise imports of genetically modified (GM) food and feed and allow the export of agricultural products to the EU from top GMO-producing countries, using pesticides that are banned in the EU due to their potential risks to health and the environment (recital N).
The resolution calls on the Commission not to authorise the GM crops due to risks to biodiversity, food safety and workers’ health in line with One Health approach (paragraph 5).
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 6).
It urges the Commission to consider the EU’s obligations under international agreements, such as the Paris Climate Agreement, the United Nations (UN) Convention on Biological Diversity and the UN Sustainable Development Goals and reiterates its call on the Commission for draft implementing acts to be accompanied by an explanatory memorandum explaining how they uphold the principle of ‘do no harm’ (paragraph 7).
The resolution refers to Member State and stakeholder concerns (recital K) and recalls that the fact that authorising decisions continue to be adopted by the Commission without the lack of support from Member States (recital M). Furthermore, the resolution recalls the numerous resolutions objections to GMO authorisations adopted by the European Parliament in its eighth, ninth, and the current tenth terms (recital L).
6. Response to the requests and overview of actions taken, or intended to be taken, by the Commission:
The Commission would like to recall that the draft implementing decision concerns the authorisation for the placing on the market of products containing, consisting of or produced from GM maize MON 95275, 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 29 April 2022, Bayer Agriculture B.V., 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 authorisation for the placing on the market of the on the market of GM maize MON 95275 for food/feed and other uses, except of cultivation;
on 1 August 2024, EFSA issued a favourable scientific opinion and concluded that GM maize MON 95275 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 22 November 2024 with no qualified majority against or in favour;
the draft decision was voted in the Appeal Committee on 17 December 2024 with no qualified majority against or in favour;
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;
on that basis, the Commission decision was adopted on 9 April.
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, 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 (recital K) as well as comments from the public. Therefore, the Commission considers that its 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 (paragraph 2).
With respect to the calls on the Commission not to authorise the GM crops due to risks to biodiversity, food safety and workers’ health (paragraph 5) and regarding the concerns raised about the risk assessment of insecticidal proteins (recitals E, F, I and J) and sufficiency of data for assessment (recital C), EFSA concluded that, based on the known biological function of these constituents, there is no evidence to suggest that these proteins or other compounds in maize would interact in a harmful way that affects its safety as food or feed. In addition, with respect to the concerns raised on environmental risk assessment (recitals D, G, H and K), EFSA confirmed that environmental effects will not differ from that of conventional maize varieties, that there is no indication of an increased likelihood of gene flow to non-target organisms, and that the field trials were appropriate to support the risk assessment and the post-market environmental monitoring.
Regarding the call expressed in paragraph 6 to take sustainability into account in the authorisation of GMOs, sustainability is central to the Commission. The Commission has presented the way forward in the ‘Vision for Agriculture and Food’, that builds on the recommendations of the Strategic Dialogue on the future of agriculture in the EU. This Vision provides predictability for the agri-food sector and aims to make it attractive, competitive, and resilient as a key part of Europe’s economy.
As regards the call to consider the EU’s international obligations (paragraph 7), 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. With respect to the call expressed in paragraph 7 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 decision is based on a positive EFSA scientific opinion, as described above.
Concerning the call on the Commission to ensure convergence of standards between the EU and its partners in free trade agreement negotiations, in order to meet the EU’s safety standards (paragraph 4) and concerns expressed about incentivizing the import of products that do not comply with EU legislation (recital N), all imported food and feed must comply with relevant EU regulations and standards relating to safety and health, which are applicable irrespective of whether the product is produced domestically or imported.
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 L and M), 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.