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 94804 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

B100153/2024

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 authorising the placing on the market of products containing, consisting of or produced from genetically modified MON 94804 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D099729/02 – 2024/2841(RSP))

2. References: 2024/2841(RSP) / B10-0153/2024/ P10_TA(2024)0045

The European Parliament,

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

– having regard to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified MON 94804 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D099729/02),

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 7(3) and Article 19(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 17 September 2024, at which no opinion was delivered,

The resolution calls on the Commission to withdraw the draft 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 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 raises questions on EFSA’s risk assessment of the effects of artificial miRNA (a Ribonucleic Acid molecule) (recitals E to G) and of the related effects of the decreased gibberellic acid levels (a substance regulating various physiological processes in plants; in this case reducing plant height) (recitals H to K).

– having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 13 March 2024, and published on 26 April 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 4).

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

The resolution refers to the need to reduce dependency on imported feed (recital L).

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

It 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 (paragraph 5).

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

The resolution refers to Member State and stakeholder concerns (recitals M and N) recalls the numerous resolutions objecting to GMO authorisations adopted by the European Parliament in its eighth and ninth terms (recital O). Furthermore, the resolution recalls that the fact that authorising decisions continue to be adopted by the Commission with the lack of support of Member States and the objections of Parliament (recital P) 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 Q).

A. whereas on 14 February 2023, Bayer Agriculture BV, 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 the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize MON 94804 (the ‘GM maize’), in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’);

6. Response to the requests and overview of actions taken, or intended to be taken, by the Commission: [Please, see comments on TA(2024)0038 and 0039.]

B. whereas the application also covered the placing on the market of products containing or consisting of genetically modified maize MON 94804 for uses other than food and feed, with the exception of cultivation;

The Commission would like to recall that the draft implementing decision concerns the authorisation for placing on the market of products containing, consisting of or produced from genetically modified (GM) maize MON 94804, but not the cultivation of this maize.

C. whereas, on 13 March 2024, EFSA adopted a favourable opinion, which was published on 26 April 2024, concluding that the GM maize is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment;

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:

D. whereas the GM maize was genetically engineered to produce an artificial miRNA intended to selectively suppress two genes within a larger gene family involved in the biosynthetic pathway of gibberellic acid (GA), thus reducing the plant’s height;

on 14 February 2023, Bayer Agriculture BV, 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 authorising the placing on the market of GM maize MON 94804 for food/feed and other uses, except of cultivation;

Outstanding questions concerning the effects of artificial miRNA

on 26 April 2024, the European Food Safety Authority (EFSA) issued a favourable scientific opinion which concluded 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;

E. whereas, the introduction of the artificial miRNA not only interferes with the targeted genes, but also involves other regulatory functions; whereas miRNA undergoes further processing in the plant, and thereby interacts with specific plant enzymes; whereas its effects in many cases are not restricted to the target gene, but often involve metabolic cascades of several hundred other gene functions;

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 applicant presents insufficient and incomplete data on interactions between the artificial miRNA, the products emerging from further processes in the cells, the persistence of these molecules in the cells and their interference in other regulatory networks;

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 to conclude miRNAs do not present a risk of toxicity for humans and animals, EFSA assumes that the artificial miRNA would be rapidly degraded; whereas however, several studies, including the one they quote to support that assertion, report that, supported by specific mechanisms, miRNA can be taken from the gut;

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

Outstanding questions concerning the effects of reduced gibberellins level

the draft decision was voted in the Appeal Committee on 29 October 2024 with no qualified majority in favour or against;

H. whereas, as highlighted by the experts from Member States, gibberellins are major regulators of various physiological processes in plants;

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;

I. whereas apart from plant stature, gibberellins also regulate germination and flowering, play a role in the regulation of stress tolerance and are part of complex regulatory crosstalk with other plant hormones in various signalling pathways, e. g. physiological processes affecting plant composition; whereas gibberellins are also involved in the immune response of plants to pathogens;

on that basis, the Commission decision was adopted on 9 April 2025.

J. whereas most impacts on these different processes have not been explored by the applicant, apart from the potential effects on germination, flowering and grain weight;

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.

K. whereas gene expression and its impact on bioactive gibberellins production and metabolic impact was only investigated in field conditions with no particular stress factors, while GA is known to be involved in many biotic and abiotic stress responses;

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:

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 draft 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).

L. 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;

With respect to the concerns raised in relation to the effects of artificial miRNA (recitals E to G) and of decreased gibberellic acid levels (recitals H to K), EFSA concluded in its risk assessment that miRNAs do not present a toxicity risk for humans and animals and that reduced gibberellins level in this GM maize do not pose a toxicological concern in terms of regulating physiological processes in plants.

Member State competent authority and stakeholder comments

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.

M. whereas Member States submitted many critical comments to EFSA during the three-month consultation period including that gibberellins are major regulators of various physiological processes in plants, in particular related to biotic and abiotic stressors, and that the data provided by the applicant are incomplete in assessing the potential impact of reduced gibberellins levels on all these processes, and that the variety in field trials is insufficient; whereas Member States also criticised the lack of data on the risks posed by a possible long term stability of the artificial miRNA in the plant, or by the fact that a non-negligible part of the modified DNA is susceptible to be taken from the gut of animals or human beings as well as the fact that the data provided do not prove that gene transfer from plant to bacteria is unlikely;

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

N. 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;

Issues related to reducing dependency on imported critical commodities (recital L) 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.

Undemocratic decision-making

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 Q to R), 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.

O. 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 the placing GMOs on the market;

P. 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;

Q. 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;

R. whereas the vote on 17 September 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;

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. 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 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’;

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