What changed

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

P10_TA(2025)0015

1. Resolution tabled pursuant to Rules 115(2) and (3) of the European Parliament’s Rules of procedure

Genetically modified maize MON 95275

2. References: 2024/3011(RSP) / B10-0060/2025 / P10_TA(2025)0015

PE766.933

3. Date of adoption of the resolution: 12 February 2025

European Parliament resolution of 12 February 2025 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 (D102172/03 – 2024/3011(RSP))

4. Competent Parliamentary Committee: Committee on the Environment, Climate and Food Safety (ENVI)

The European Parliament,

5. Brief analysis/assessment of the resolution and requests made in it:

– having regard to 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 (D102172/03),

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).

– having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, and in particular Article 7(3) and Article 19(3) thereof,

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).

– having regard to the vote of the Standing Committee on Plants, Animals, Food and Feed referred to in Article 35 of Regulation (EC) No 1829/2003, on 22 November 2024, at which no opinion was delivered, and the vote of the Appeal Committee on 17 December 2024, at which again no opinion was delivered,

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).

– having regard to Article 11 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers,

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).

– having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 19 June 2024, and published on 1 August 2024,

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).

– having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (‘GMOs’),

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).

– having regard to Rule 115(2) and (3) of its Rules of Procedure,

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).

– having regard to the motion for a resolution of the Committee on the Environment, Climate and Food Safety,

6. Response to the requests and overview of actions taken, or intended to be taken, by the Commission:

A. whereas on 29 April 2022, Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP, based in the United States, submitted an application to the national competent authority of the Netherlands for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize MON 95275 (the ‘GM maize’);

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.

B. whereas the GM maize produces two insecticidal proteins (Mpp75Aa1 and Vpb4Da2) and expresses a DvSnf7 dsRNA targeting western corn rootworm; whereas the genetic modification involves a two-step process incorporating an Agrobacterium tumefaciens-mediated transformation and a Cre/lox recombination system to remove selectable markers;

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:

C. whereas on 19 June 2024, EFSA adopted a favourable opinion, published on 1 August 2024, on MON 95275; whereas EFSA’s opinion provides insufficient data to assess unintended genetic effects, the biological activity of read-through sequences, and potential off-target impacts on non-target organisms;

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;

D. whereas the field trials conducted by the applicant failed to account for diverse environmental stress conditions or varying agricultural practices, limiting the relevance of the results to European cultivation environments;

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;

E. whereas the RNAi construct DvSnf7 dsRNA raises concerns about effects in non-target organisms;

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;

F. whereas the insecticidal proteins Mpp75Aa1 and Vpb4Da2 share structural similarities with known toxins and lack sufficient evaluation of their specificity, immune responses, and combinatorial effects;

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;

G. whereas the potential for gene flow to wild relatives, including European teosinte populations, poses risks of transgene persistence and ecological imbalance;

the draft decision was voted in the Standing Committee on 22 November 2024 with no qualified majority against or in favour;

H. whereas the monitoring requirements under Commission Implementing Regulation (EU) No 503/2013 are inadequately addressed, particularly regarding independent data verification and long-term environmental effects;

the draft decision was voted in the Appeal Committee on 17 December 2024 with no qualified majority against or in favour;

I. whereas EFSA’s assessment did not sufficiently address the role of microbiome interactions or cumulative toxicity impacts on non-target organisms;

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;

J. whereas, unlike the use of insecticides, where exposure is at the time of spraying and for a limited period afterwards, the use of insecticidal GM crops leads to continuous exposure of the target and non-target organisms to the toxins;

on that basis, the Commission decision was adopted on 9 April.

Member State and stakeholder comments

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.

K. whereas Member States submitted many critical comments to EFSA during the three-month consultation period, including that the list of relevant studies identified in the literature review of the applicant, did not include studies on the fate of insecticidal proteins in the environment or on potential effects of crop residues on non-target organisms;

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:

L. whereas, in its eighth term, Parliament adopted a total of 36 resolutions objecting to the placing on the market of GMOs for food and feed (33 resolutions) and to the cultivation of GMOs in the Union (three resolutions); whereas, in its ninth term, Parliament adopted 38 resolutions objecting to placing GMOs on the market and has adopted another 8 resolutions objecting to placing GMOs on the market already in the current tenth term;

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).

M. whereas despite its own acknowledgement of the democratic shortcomings, the lack of support from Member States and the objections of Parliament, the Commission continues to authorise GMOs;

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.

N. whereas the trade agreement between the EU and Mercosur will incentivise imports to the Union of food and animal feed containing, consisting of or produced from genetically modified organisms; whereas Brazil and Argentina are among the world’s top GMO producers and pesticide users, including GMOs and pesticides banned in the Union for health or environmental reasons;

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.

1. Considers that the draft Commission implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003;

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.

2. Considers that the draft Commission implementing decision is not consistent with Union law, in that it is not compatible with the aim of Regulation (EC) No 1829/2003, which is, in accordance with the general principles laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council, to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, and environmental and consumer interests, in relation to GM food and feed, while ensuring the effective functioning of the internal market;

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.

3. Calls on the Commission to withdraw its draft implementing decision and to submit a new draft to the committee;

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.

4. Calls on the Commission to ensure convergence of standards between the Union and its partners in free trade agreement negotiations, in order to meet Union safety standards;

5. Calls on the Commission not to authorise the GM crops due to risks to biodiversity, food safety and workers’ health in line with the One Health approach;

6. Welcomes the fact that the Commission finally recognised, in a letter of 11 September 2020 to Members, the need to take sustainability into account when it comes to authorisation decisions on GMOs; expresses its deep disappointment, however, that, since then the Commission has continued to authorise GMOs for import into the Union, despite ongoing objections by Parliament and a majority of Member States voting against;

7. Urges the Commission, again, to take into account the Union’s obligations under international agreements, such as the Paris Climate Agreement, the United Nations Convention on Biological Diversity and the United Nations Sustainable Development Goals; reiterates its call for draft implementing acts to be accompanied by an explanatory memorandum explaining how they uphold the principle of ‘do no harm’;

8. Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.