Sittings · Document
Follow up to the European Parliament non-legislative resolution on the Commission implementing decision (EU) 2024/2627 authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton COT 102 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. Reference numbers: 2024/2835(RSP) / B10-0145/2024 / P10_TA(2024)0039
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 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).
The resolution raises questions on the toxicity of Bt toxins (recitals E to G) and the potential adverse effects of Bt crops on non-target organisms (recitals L and M).
The resolution also raises concerns about the use of antibiotic resistance marker genes (ARMGs) (recitals L to R) and reiterates its call on the Commission not to authorise the placing on the market of any genetically modified (GM) plants containing genes which confer antimicrobial resistance and considers that authorisation would be in violation of Article 4(2) of Directive 2001/18/EC, which calls for a phase out of antibiotic resistance marker genes which may have adverse effects on human health or on the environment (paragraph 4).
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 5).
The resolution refers to the need to reduce dependency on imported feed (recital K).
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 6).
The resolution refers to Member State and stakeholder concerns (recitals S to T) 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 GM food and feed authorisations (recitals V and X). Furthermore, the resolution recalls the numerous resolutions objecting to GMO authorisations adopted by the European Parliament in its eighth and ninth terms (recital U), 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 W).
6. Response to the requests and overview of actions taken, or intended to be taken, by the Commission:
The Commission would like to recall that the implementing decision concerns the authorisation for placing on the market of products containing, consisting of or produced from GM cotton COT102, but not the cultivation of this cotton.
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:
on 31 March 2017, Syngenta Crop Protection NV/SA, submitted an application to the national competent authority of Germany for authorisation for the placing on the market of GM cotton COT102 for food/feed and other uses, except for cultivation;
on 26 June 2023, the European Food Safety Authority (EFSA) issued a favourable scientific opinion and concluded that GM cotton COT102 is as safe as its conventional counterpart and the tested non-GM cotton reference varieties with respect to the potential effects on human and animal health and the environment;
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;
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;
the draft decision was voted in the Standing Committee on 8 July 2024 with no qualified majority in favour or against;
the draft decision was voted in the Appeal Committee on 3 September 2024 with no qualified majority in favour or against;
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;
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 authorising GM cotton COT102.
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:
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 raised in recitals E to J 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.
As regards to the objection and comments expressed on ARMGs (paragraph 4 and recitals L to R), the Commission would like to highlight that under the GMO legislation (Article 4(2) of Directive 2001/18/EC) theCommission must ensure that GMOs that contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs that may have adverse effects on human health and the environment. In this case, EFSA, in consultation with the European Medicines Agency (EMA), confirmed that this GM cotton – which contains a marker gene related to the antibiotic hygromycin B – does not fall under that category. There have never been and currently there are no authorisations at national or EU level for medicinal products for human or veterinary use containing hygromycin B. Moreover, in its risk assessment for this application EFSA concluded that there is no safety concern linked to the presence of this antibiotic resistance gene in GMO cotton COT102.
Regarding the call expressed in paragraph 5 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 to consider the EU’s international obligations (paragraph 6), 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 6 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.
Issues related to reducing dependency on imported critical commodities (recital K) 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.
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 U to X), 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.