Sittings · Document
Follow up to the European Parliament non-legislative resolution on the Commission decision (EU) 2024/2629 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and eight of its sub-combinations, 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: 2024/2834(RSP) / B10-0147/2024 / P10_TA(2024)0040
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 repeal the Commission implementing decision (paragraph 4) 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 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 3).
The resolution calls on the Commission not to authorise herbicide-tolerant genetically modified (GM) products due to the increased use of complementary herbicides and the associated risks and considers that authorising the import of GM food and feed from plants tolerant to herbicides that are banned in the EU is incoherent with the EU’s international commitments (paragraphs 5 and 6 and recitals D to J).
The resolution raise questions on the safety of the insecticidal Bt toxins (recitals K and L) and Bt crops, with specific concerns for their potential adverse effects on non-target organisms (recitals M and N).
The resolution also calls on the Commission to deliver on a proposal to ensure that hazardous chemicals banned in the EU are not produced for export (paragraph 7).
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 8).
The resolution recalls the conclusions of the Strategic Dialogue on the Future of EU Agriculture that call on the Commission to reassess its approach on market access for agri-food imports and exports, given the challenge of diverging standards of the EU and its trading partners (recital O) and refers to the need to reduce dependency on imported feed (recital S). 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 (paragraph 9 and recitals P to R).
The resolution recalls that the fact that authorising decisions continue to be adopted by the Commission without a qualified majority of Member States in favour has become the norm for decision-making on GM food and feed authorisations (recitals U and W). Furthermore, the resolution recalls the numerous resolutions objecting to GMO authorisations adopted by the European Parliament in its eighth and ninth terms (recital T), 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 V).
6. Responses to 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 Commission implementing decision concerns the renewal of an authorization for the placing on the market of products containing, consisting of or produced from GM maize MON 89034 × 1507 × MON 88017 × 59122 and eight of its sub-combinations for food and feed and other uses, with the exception of cultivation.
With respect to paragraphs 1and 4 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 7 October 2022, Corteva Agriscience Belgium B.V., submitted an application to the Commission for the renewal of that authorisation in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the authorisation of the placing on the market of this GM maize for food/feed and other uses, with the exception of cultivation;
on 29 April 2024, EFSA published an opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 concluding 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 opinion, EFSA considered all the specific 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, who confirmed the conclusions of its initial scientific opinion;
the draft decision was voted in the Standing Committee on 8 July 2024 with no qualified majority in favour or against;
in accordance with the rules set out in Regulation (EU) No 182/2011 on comitology, the Commission referred the draft decision to the Appeal Committee on 3 September 2024, where no qualified majority in favour or against was obtained either;
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 8 October 2024.
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. Consequently, there were no reasons not to adopt the decision for the renewal of the authorisation of GM maize MON 89034 × 1507 × MON 88017 × 59122.
With respect to the other points 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 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 about plant protection products (paragraphs 5 and 6 and recitals D to I), the Commission would like to point out that, while the authorisation of GMOs is not linked to the authorisation of herbicides, the two authorisation systems have as the common objective to ensure a high level of protection of health and the environment. The risk assessment in the context of an application for food and feed uses of an herbicide-tolerant GM crop is focused on the potential impact of the genetic modification on human and animal health and on the environment; EFSA concluded favourably as regards the GM crop concerned by this resolution. The environmental risk assessment of active substances and plant protection products is done in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. Maximum residue limits (MRLs) apply to imported food/feed, including to GM products and ensure that the health of EU consumers is fully protected. For substances no longer approved in the EU because of health concerns related to residues, the MRLs are set at the “technical zero”, the lowest level at which analytical methods allow quantification of residues, and no import tolerances will be granted.
With respect to the concerns raised in relation to Bt toxins and Bt crops (recitals K to N), the Commission would like to stress that the EFSA GMO Panel has extensively discussed the potential allergenic and adjuvant capacity of such proteins considering all available information, including literature on the topic, and has not identified safety concerns. In its risk assessment for this application, EFSA concluded on the absence of risk regarding toxicity of the Bt proteins expressed and the potential impact on non-targeted organisms.
As regards the call to consider the EU’s international obligations (paragraph 9, recitals P to R), the Commission is highly committed to respecting the EU 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 9 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.
Concerning the call in paragraph 7 to deliver on a proposal to ensure that hazardous chemicals banned in the EU are not produced for export, the Commission committed with its Chemical Strategy for Sustainability from October 2020 to work on ensuring that hazardous chemicals banned in the EU are not produced for export and to promote the EU industry as a global frontrunner in the production and use of safe and sustainable chemicals. The Commission has launched a study by an external contractor to examine various options for the possible preparation of an impact assessment. Further work on this initiative will be considered after the finalisation of the study.
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 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 3), 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 is imported. This is not something negotiable in any manner in any Free Trade Agreement.
Issues related to market access for agri-food imports and exports, diverging standards of the EU and its trading partners (recital O) and reducing dependency on imported critical commodities (recital S) will be part of the Commission’s work in accordance with its political guidelines and the mission letters to 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, regarding 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 (paragraph 8 and recitals T to W), 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.