What changed

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

B100145/2024

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 cotton COT102 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D098499/04 – 2024/2835(RSP))

2. Reference numbers: 2024/2835(RSP) / B10-0145/2024 / P10_TA(2024)0039

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 cotton COT102 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D098499/04),

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 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 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 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 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).

– having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 10 May 2023, and published on 26 June 2023,

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).

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

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).

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

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

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

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).

A. whereas, on 31 March 2017, Syngenta Crop Protection NV/SA, based in Belgium, submitted, on behalf of Syngenta Crop Protection AG, based in Switzerland, an application to the national competent authority of Germany for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified cotton COT102 (the ‘GM cotton’), in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’); whereas the application also covered the placing on the market of products containing or consisting of the GM cotton for uses other than food and feed, with the exception of cultivation;

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).

B. whereas, on 10 May 2023, EFSA adopted a favourable opinion, which was published on 26 June 2023, concluding that the GM cotton is as safe as its non-GM comparator and the tested non-GM cotton varieties with respect to potential effects on human and animal health and the environment;

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

C. whereas the GM cotton contains genes producing insecticidal proteins (‘Bt toxins’) and an antibiotic resistance marker gene (‘ARMG’);

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.

D. whereas cottonseed oil may be used in the production of a wide variety of food products such as dressings, mayonnaise, fine bakery wares, chocolate spreads and chips; whereas consumption of cottonseed flour is the most likely way in which humans could be exposed to the two proteins resulting from the genetic modification; whereas cotton is commonly used in animal feed in the form of undelinted seeds and meal;

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:

Outstanding questions concerning Bt toxins

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;

E. whereas the toxicity of the Bt toxins was assessed on the basis of feeding studies using only isolated Bt proteins produced by bacteria; whereas little significance can be attributed to toxicological tests conducted with proteins in isolation, due to the fact that Bt toxins in GM crops, such as maize, cotton and soybeans, are inherently more toxic than isolated Bt toxins; whereas this is because protease inhibitors (PI), present in the plant tissue, can increase the toxicity of the Bt toxins by delaying their degradation; whereas this phenomenon has been demonstrated in a number of scientific studies, including one conducted for Monsanto which showed that even the presence of extremely low levels of PI enhanced the toxicity of Bt toxins up to 20-fold;

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;

F. whereas this enhanced toxicity is not taken into account in EFSA risk assessments, even though it is relevant for all Bt plants approved for import or cultivation in the Union; whereas risks to humans and animals that consume food and feed containing Bt toxins and which arise from this enhanced toxicity due to the interaction between PI and Bt toxins cannot, therefore, be ruled out;

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;

G. 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;

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;

Bt crops: effects on non-target organisms

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

H. 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;

the draft decision was voted in the Appeal Committee on 3 September 2024 with no qualified majority in favour or against;

I. 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;

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;

J. 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;

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

Reducing dependency on imported feed

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.

K. 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 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:

Inclusion of ARMG

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).

L. whereas the GM cotton produces the APH4 protein, which is used as an ARMG and which deactivates the activity of the antibiotic hygromycin B;

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.

M. whereas Article 4(2) of Directive 2001/18/EC of the European Parliament and of the Council requires that ‘GMOs which 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 which may have adverse effects on human health and the environment’ and sets a deadline of 2004, beyond which they should not be placed on the Union market;

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.

N. whereas Commission Implementing Regulation (EU) No 503/2013 states that it is now possible to develop GMOs without the use of ARMGs [...] the applicant should therefore aim to develop GMOs without the use of ARMGs;

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.

O. whereas several Member States raised critical comments regarding the use of ARMGs, including that, in the face of the current crisis concerning antibiotic resistance, it would be wise to implement the precautionary principle, especially in the present case where the application of the ARMG is completely unnecessary and the removal of the ARMG from the plant genome possible; whereas one Member State’s competent authority gave the authorisation an unfavourable opinion based on the presence of the ARMG in the genome of the GM cotton;

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.

P. whereas the European Medicine Agency has confirmed there are no products containing hygromycin B authorised for therapeutic, prophylactic or any other medical uses in humans or animals in the Member States and there are no central authorisations for human or veterinary use for medicinal products that contain hygromycin B11; whereas the EFSA opinion states that ‘the GMO Panel considers that the risk assessment may need to be updated in case products containing hygromycin B or other substrates of the APH4 enzyme obtain future market approval in the EU’; whereas, however, hygromycin B is used in veterinary products which are sold outside the Union;

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.

Q. whereas the Parliament has, on at least one previous occasion, objected to the import of GM crops which contained ARMGs;

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.

R. whereas antimicrobial resistance poses a threat to global health, food security, and achieving the 2030 Sustainable Development Goals, and drug-resistant infections know no borders;

Member State competent authority and stakeholder comments

S. whereas Member States submitted many critical comments to EFSA during the three-month consultation period including that cultivation of the GM cotton on agricultural fields is to be considered as deliberate contamination of natural environments with antibiotic resistance genes, as well as that the information provided on molecular characterisation, composition and toxicology is insufficient and therefore EFSA’s conclusions of equivalence of the GM cotton with conventional cotton in terms of food and feed safety is premature;

T. 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 commitments to tackle antimicrobial resistance;

Undemocratic decision-making

U. 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;

V. 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;

W. 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;

X. 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. Reiterates its call on the Commission not to authorise the placing on the market of any GM plants containing genes which confer antimicrobial resistance; notes that authorisation would be in violation of Article 4(2) of Directive 2001/18/EC which calls for a phase out of ARMGs which may have adverse effects on human health or on the environment;

5. 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;

6. 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’;

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