What changed

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

B100147/2024

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

European Parliament resolution on the draft Commission implementing decision 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 (D098493/04 – 2024/2834(RSP))

2. References: 2024/2834(RSP) / B10-0147/2024 / P10_TA(2024)0040

The European Parliament,

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

– having regard to the draft Commission implementing decision 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 (D098493/04),

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

– 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,

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

– 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 8 July 2024, at which no opinion was delivered, and the vote of the Appeal Committee on 3 September 2024, at which again no opinion was delivered,

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).

– 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 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).

– having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 13 March 2024, and published on 29 April 2024,

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).

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

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).

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

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).

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

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).

A. whereas, on 7 October 2022, Corteva Agriscience Belgium BV, based in Belgium, on behalf of Corteva Agriscience LLC, based in the United States, and Bayer Agriculture BV, based in Belgium, on behalf of Bayer CropScience LP, based in the United States, jointly submitted an application to the Commission for the renewal of the authorisation of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and eight of its sub-combinations (the ‘GM maize);

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).

B. whereas, on 13 March 2024, EFSA adopted a favourable opinion, which was published on 29 April 2024;

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).

C. whereas the GM maize has been modified to be tolerant to glufosinate, glyphosate and to produce insecticides (‘Bt toxins’);

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.]

Lack of assessment of the complementary herbicides

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.

D. whereas Commission Implementing Regulation (EU) No 503/2013 requires an assessment of whether the expected agricultural practices influence the outcome of the studied endpoints; whereas, according to that Implementing Regulation, this is especially relevant for herbicide-tolerant plants;

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:

E. whereas the vast majority of GM crops have been genetically modified so that they are tolerant to one or more ‘complementary’ herbicides which can be used throughout the cultivation of the GM crop, without the crop dying, as would be the case for a non-herbicide tolerant crop; whereas a number of studies show that herbicide-tolerant GM crops result in a higher use of complementary herbicides, in large part because of the emergence of herbicide-tolerant weeds;

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;

F. whereas herbicide-tolerant GM crops lock farmers into a weed management system that is largely or wholly dependent on herbicides, and does so by charging a premium for GM seeds that can be justified only if farmers purchasing such seed also spray the complementary herbicides; whereas heightened reliance on complementary herbicides on farms planting the GM crops accelerate the emergence and spread of weeds resistant to those herbicides, thereby triggering the need for even more herbicide use, a vicious circle known as ‘the herbicide treadmill’;

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;

G. whereas the adverse impacts stemming from excessive reliance on herbicides will worsen on soil health, water quality, and above and below ground biodiversity, as well as leading to increased human and animal exposure, potentially also via increased herbicide residues on food and feed;

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;

H. whereas glufosinate is classified as toxic to reproduction 1B and therefore meets the ‘cut-off criteria’ set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council; whereas the approval of glufosinate for use in the Union expired on 31 July 2018;

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;

I. whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency concluded in March 2017 that no classification was warranted; whereas, on the contrary, in 2015, the International Agency for Research on Cancer, the specialised cancer agency of the World Health Organization, classified glyphosate as a probable carcinogen for humans; whereas a number of recent scientific peer-reviewed studies confirm the carcinogenic potential of glyphosate;

the draft decision was voted in the Standing Committee on 8 July 2024 with no qualified majority in favour or against;

J. whereas assessment of herbicide residues and metabolites found on GM plants is considered outside the remit of the EFSA Panel on Genetically Modified Organisms and is therefore not undertaken as part of the authorisation process for GMOs;

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;

Outstanding questions concerning Bt toxins

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;

K. whereas a number of studies show that side effects have been observed that may affect the 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;

on that basis, the Commission decision was adopted on 8 October 2024.

L. whereas a scientific study found that the toxicity of Bt toxins may also be increased through interaction with residues from spraying with herbicides, and that further studies are needed on the combinatorial effects of ‘stacked’ events (GM crops which have been modified to be herbicide tolerant and to produce insecticides in the form of Bt toxins); whereas assessment of the potential interaction of herbicide residues and their metabolites with Bt toxins is, however, considered to be outside the remit of the EFSA GMO Panel and is, therefore, not undertaken as part of the risk assessment;

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.

Bt crops: effects on non-target organisms

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:

M. 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;

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).

N. 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;

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.

Ensuring a level playing field globally and upholding the Union’s international obligations

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.

O. whereas the conclusions of the Strategic Dialogue on the Future of EU Agriculture 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 Union and its trading partners; whereas fairer trade relations, at a global level, coherent with goals for a healthy environment were one of the main demands of farmers during the demonstrations of 2023 and 2024;

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.

P. whereas a 2017 report by the United Nations’ (UN) Special Rapporteur on the right to food found that, particularly in developing countries, hazardous pesticides have catastrophic impacts on health; whereas the UN Sustainable Development Goal (UN SDG) Target 3.9 aims by 2030 to substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination;

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.

Q. whereas the Kunming-Montreal Global Biodiversity Framework (‘Kunming-Montreal Framework’), agreed at the COP15 of the UN Convention on Biological Diversity (UN CBD) in December 2022, includes a global target to reduce the risk of pesticides by at least 50 % by 2030;

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.

R. 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 UN SDGs and the UN CBD;

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.

Reducing dependency on imported feed

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.

S. whereas one of the lessons from the COVID-19 crisis and the still 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;

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.

Undemocratic decision-making

T. 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;

U. 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;

V. 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;

W. whereas the vote on 8 July 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 3 September 2024 of the Appeal Committee again delivered no opinion;

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

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;

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

4. Calls on the Commission not to authorise herbicide-tolerant GM crops, due to the associated increased use of complementary herbicides and therefore the increased risks to biodiversity, food safety and workers’ health;

5. Highlights, in this regard, that authorising the import for food or feed uses of any GM plant which has been made tolerant to herbicides that are banned in the Union, such as glufosinate, is incoherent with the Union’s international commitments under, inter alia, the UN SDGs and the UN CBD, including the recently adopted Kunming-Montreal Framework;

6. Expects the Commission, as matter of urgency, to deliver on its commitment to come forward with a proposal to ensure that hazardous chemicals banned in the Union are not produced for export;

7. 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 no qualified majority of Member States in favour;

8. 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’;

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