What changed

Follow up to the European Parliament non-legislative resolution on the Commission decision (EU) 2024/1828 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 810, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

P10_TA(2024)0041

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

Genetically modified maize MON 810

2. References: 2024/2840(RSP) / B10-0146/2024 / P10_TA(2024)0041

PE763.280

3. Date of adoption of the resolution: 26 November 2024

European Parliament resolution of 26 November 2024 on Commission Implementing Decision (EU) 2024/1828 renewing the authorisation for the placing on the market of feed containing, consisting of and of food and feed products produced from genetically modified maize MON 810 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and repealing Commission Implementing Decision (EU) 2017/1207 (2024/2840(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 Commission Implementing Decision (EU) 2024/1828 renewing the authorisation for the placing on the market of feed containing, consisting of and of food and feed products produced from genetically modified maize MON 810 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and repealing Commission Implementing Decision (EU) 2017/1207,

The resolution calls on the Commission to repeal the 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).

– 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 11(3) and Article 23(3) thereof,

The resolution raise questions on the safety of the authorisation of the insecticidal Bt toxins (recital D) and Bt crops, with specific concerns for their potential adverse effects on non-target organisms (recitals E and F).

– 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 26 April 2024, at which no opinion was delivered, and the vote of the Appeal Committee on 29 May 2024, at which again no opinion was delivered,

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).

– 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 refers to the need to reduce dependency on imported feed (recital I).

– having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 30 November 2023, and published on 19 January 2024,

The resolution 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 and calls on the Commission to deliver on a proposal to ensure that hazardous chemicals banned in the EU are not produced for export (paragraph 5).

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

The resolution refers to Member State and stakeholder concerns (recitals G and H) and 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 genetically modified (GM) food and feed authorisations (recital J). Furthermore, the resolution recalls the numerous resolutions objecting to GMO authorisations adopted by the European Parliament in its eighth and ninth terms (recital K), 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 M).

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

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

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

The Commission would like to recall that the Commission implementing decision concerns the renewal for the placing on the market of products containing, consisting of or produced from GM maize MON 810 for food and feed and other uses, with the exception of cultivation.

A. whereas, on 6 October 2022, Bayer Agriculture BV, based in Belgium, submitted on behalf of Bayer CropScience LP, based in the United States, an application to the Commission for the renewal of Commission Implementing Decisions 2013/649/EU and (EU) 2017/1207; whereas, in accordance with Article 11(4) of Regulation (EC) No 1829/2003, the period of authorisation of genetically modified pollen produced from genetically modified maize MON 810 (the ‘GM maize’) for food uses covered by Implementing Decision 2013/649/EU has been automatically extended until a decision is taken on the renewal application;

With respect to paragraphs 1 and 3 of the resolution, the Commission would like to point out that the 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:

B. whereas, on 30 November 2023, EFSA adopted a favourable opinion, which was published on 19 January 2024;

on 6 October 2022, Bayer Agriculture 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;

C. whereas the GM maize has been modified to produce insecticides (‘Bt toxins’);

on 19 January 2024, EFSA published an opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 concluding that this 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;

Outstanding questions concerning Bt toxins

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;

D. whereas a number of studies show that side effects have been observed that may affect the human immune system following exposure to Bt toxins and that some Bt toxins may have adjuvant properties, meaning that they can increase the allergenicity of other proteins with which they come into contact;

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;

Bt crops: effects on non-target organisms

the draft decision was voted in the Standing Committee on 26 April 2024 with no qualified majority in favour or against;

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

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 29 May 2024, where no qualified majority in favour or against was obtained either;

F. whereas the assumption that Bt toxins exhibit a single target-specific mode-of-action can no longer be considered correct and effects on non-target organisms cannot be excluded; whereas an increasing number of non-target organisms are reported to be affected in many ways; whereas 39 peer-reviewed publications that report significant adverse effects of Bt toxins on many ‘out-of-range’ species are mentioned in a recent overview;

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;

Member State comments

on that basis, the Commission decision was adopted on 2 July 2024.

G. whereas Member States submitted many critical comments to EFSA during the three-month consultation period, including that the compositional data for the GM maize should be checked and re-analysed and that the analysis should fulfil the present EFSA requirements, inter alia equivalence testing, and that the literature review did not include studies on the fate of Cry1Ab in the environment or on potential effects of Bt-crop residues on non-target organisms, which is problematic because publications indicate that a carryover from GM maize feed to manure may lead to exposure of soil organisms to Cry1Ab and that this may trigger negative effects on soil organisms with consequences for biodiversity and ecosystem services;

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..

H. whereas Regulation (EC) No 1829/2003 states that GM food or feed must not have adverse effects on human health, animal health or the environment, and requires the Commission to take into account any relevant provisions of Union law and other legitimate factors relevant to the matter under consideration when drafting its decision; whereas such legitimate factors should include the Union’s obligations under the United Nations Sustainable Development Goals (UN SDGs) and the UN Convention on Biological Diversity (UN CBD);

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:

Reducing dependency on imported feed

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).

I. whereas one of the lessons from the COVID-19 crisis and the ongoing war in Ukraine is the need for the Union to end the dependencies on some critical materials; whereas in the mission letter to Commissioner-designate Christophe Hansen, Commission President Ursula von der Leyen asks him to look at ways to reduce imports of critical commodities;

With respect to the concerns raised in recitals D to F in relation to Bt toxins and Bt crops, 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.

Undemocratic decision-making

Regarding the call expressed in paragraph 4 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.

J. whereas the vote on 26 April 2024 of the Standing Committee on Plants, Animals, Food and Feed referred to in Article 35 of Regulation (EC) No 1829/2003 delivered no opinion, meaning that the authorisation was not supported by a qualified majority of Member States; whereas the vote on 29 May 2024 of the Appeal Committee again delivered no opinion;

As regards the call to consider the EU’s international obligations (paragraph 5 and recital H), 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 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.

K. 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 objections to placing GMOs on the market;

Issues related to reducing dependency of imported critical commodities (recital I) 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.

L. 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;

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 (recitals J to L), 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.

M. whereas no change of law is required for the Commission to be able not to authorise GMOs when there is no qualified majority of Member States in favour in the Appeal Committee;

N. whereas, on 2 July 2024, the Commission renewed the authorisation for the placing on the market of the GM maize;

1. Considers that Implementing Decision (EU) 2024/1828 exceeds the implementing powers provided for in Regulation (EC) No 1829/2003;

2. Considers that Implementing Decision (EU) 2024/1828 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;

3. Calls on the Commission to repeal Implementing Decision (EU) 2024/1828;

4. 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;

5. Urges the Commission, again, to take into account the Union’s obligations under international agreements, such as the Paris Climate Agreement, the UN CBD and the UN SDGs; reiterates its call for draft implementing acts to be accompanied by an explanatory memorandum explaining how they uphold the principle of ‘do no harm’;

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