P9_TA(2022)0025

Genetically modified cotton GHB614 (BCS-GHØØ2-5)

European Parliament resolution of 15 February 2022 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 cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D076839/01 — 2021/3006(RSP))

(2022/C 342/04)

The European Parliament,

— 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 cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D076839/01,

— 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 (1), and in particular Article 11(3) and Article 23(3) thereof,

— having regard to the vote of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003 on 8 December 2021, at which no opinion was delivered, and to the vote of the Appeal Committee on 31 January 2022, at which again no opinion was delivered,

— having regard to Articles 11 and 13 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 (2),

— having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 28 May 2021, and published on 7 July 2021 (3),

— having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (‘GMOs’) (4),

— having regard to Rule 112(2) and (3) of its Rules of Procedure,

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

A. whereas Commission Decision 2011/354/EU (5) authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified cotton GHB614 (‘the GM cotton’); whereas the scope of this authorisation also covered the placing on the market of products other than food and feed containing or consisting of the GM cotton, for the same use as any other cotton, with the exception of cultivation;

B. whereas on 22 April 2020, BASF SE, based in Germany, on behalf of BASF Agricultural Solutions Seeds US LLC, based in the United States (‘the applicant’) submitted to the Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of that authorisation;

C. whereas, on 28 May 2021, EFSA adopted a favourable opinion in relation to the renewal of the GM cotton, which was published on 7 July 2021; whereas, on 5 March 2009, EFSA adopted a favourable opinion in relation to the initial authorisation of the GM cotton which was published on 10 March 2009 (6);

D. whereas the GM cotton express a modified 5-enopyruvyl-shikimate-3-phosphate synthase (2mEPSPS) of maize origin that is insensitive to broad-spectrum, post-emergent, foliar applied herbicides containing the active ingredient glyphosate (7); whereas, in other words, the GM cotton is tolerant to glyphosate, the ‘complementary herbicide’;

E. whereas while the human consumption of cottonseed oil may be relatively limited in Europe, it can be found in a wide variety of food products, including dressings, mayonnaise, fine bakery wares, chocolate spreads and chips; whereas cotton is fed to animals mainly in the form of cottonseed cake/meal or as full fat cottonseeds (8); whereas cotton is also consumed in the form of cotton flour by humans;

Lack of assessment of the complementary herbicide

F. whereas Commission Implementing Regulation (EU) No 503/2013 (9) 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 resistant plants;

G. 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 (10); whereas, as a consequence, it has to be expected that the GM cotton will be exposed to both higher and repeated doses of glyphosate, and that therefore a higher quantity of residues may be present in the harvest;

H. 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 (11);

I. whereas, according to EFSA, toxicological data allowing a consumer risk assessment to be performed for several breakdown products of glyphosate relevant for GM glyphosate-tolerant crops are missing (12);

J. whereas assessment of herbicide residues and their breakdown products found on GM plants is considered outside the remit of the EFSA Panel on Genetically Modified Organisms (‘EFSA GMO Panel’) and is therefore not undertaken as part of the authorisation process for GMOs; whereas this is problematic since the way in which complementary herbicides are broken down by the GM plant concerned, and the composition and thus toxicity of the breakdown products (‘metabolites’), can be impacted by the genetic modification itself (13);

Member State competent authority comments

K. whereas Member States submitted many critical comments to EFSA during the three-month consultation period (14); whereas those critical comments include that in the absence of any real surveillance system making it possible to specifically trace the consumption of GMOs or their by-products by humans or by animals, it is not possible to draw any pertinent lessons on the safety of consuming GMOs from the ten-year period, that the monitoring reports (2011 to 2019) have many deficiencies and are neither in line with Directive 2001/18/EC of the European Parliament and of the Council (15) and the corresponding guidelines nor with 2011 EFSA guidance on the post-market environmental monitoring of genetically modified plants, that the presented literature analysis (submitted by the applicant) was suboptimal and thus incomplete and that spraying the GM cotton with higher concentrations of glyphosate, which studies show to be toxic to humans and animals, is likely to result in more herbicide residues and metabolites on the crops and consequently in the food and feed chain;

Upholding the Union’s international obligations

L. 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 (UN) Sustainable Development Goals (‘SDGs’), the Paris Climate Agreement and the UN Convention on Biological Diversity (‘UN CBD’);

M. whereas a 2017 report by the UN’s Special Rapporteur on the right to food found that, particularly in developing countries, hazardous pesticides have catastrophic impacts on health (16); whereas 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 (17); whereas authorising the import of the GM cotton would increase demand for this crop which is treated with glyphosate, thereby increasing the exposure of workers and the environment in third countries; whereas the risk of increased worker and environmental exposure is of particular concern in relation to herbicide-tolerant GM crops, given the higher volumes of herbicides used;

N. whereas, according to a peer-reviewed study published in 2020, Roundup, one of the world’s most widely used glyphosate-based herbicides, can trigger a loss of biodiversity, making ecosystems more vulnerable to pollution and climate change (18);

Undemocratic decision-making

O. whereas the vote on 8 December 2021 of the Standing Committee on the Food Chain and Animal Health, 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 31 January 2022 of the Appeal Committee also delivered no opinion;

P. whereas the Commission recognises that the fact that GMO authorisation decisions continue to be adopted by the Commission without a qualified majority of Member States in favour, which is very much the exception for product authorisations as a whole but has become the norm for decision-making on GM food and feed authorisations, is problematic;

Q. whereas, in its eighth term, the European 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, the European Parliament has already adopted 21 objections to placing GMOs on the market; whereas there was not a qualified majority of Member States in favour of authorising any of those GMOs; whereas the reasons for Member States not supporting authorisations include lack of respect for the precautionary principle in the authorisation process and scientific concerns relating to the risk assessment;

R. 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;

S. 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 (19);

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 ( 20 ) , 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;

4. Reiterates its call on the Commission not to authorise herbicide-tolerant GM crops until the health risks associated with the residues have been comprehensively investigated on a case-by-case basis, which requires a full assessment of the residues from spraying such GM crops with complementary herbicides, an assessment of the herbicide breakdown products and any combinatorial effects, including with the GM plant itself;

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 ( 21 ) ; 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. Calls on EFSA to request data on the impact of the consumption of food and feed derived from GM plants on the intestinal microbiome;

7. 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’ ( 22 )

8. Highlights that the amendments adopted by the European Parliament on 17 December 2020 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 ( 23 ) , which were adopted in Parliament as a basis for negotiations with the Council, state that the Commission shall not authorise GMOs when there is not a qualified majority of Member States in favour; insists that the Commission respect this position and calls on the Council to proceed with its work and adopt a general approach on this file as a matter of urgency;

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

(1) OJ L 268, 18.10.2003, p. 1.

(2) OJ L 55, 28.2.2011, p. 13.

(3) Scientific Opinion of the EFSA Panel on genetically modified cotton GHB614 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-018), EFSA Journal 2021; 19(7):6671, https://www.efsa.europa.eu/en/efsajournal/pub/6671

(4) In its eighth term, Parliament adopted 36 resolutions objecting to the authorisation of GMOs. Furthermore, in its ninth term Parliament has adopted the following resolutions:

— European Parliament resolution of 10 October 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MZHG0JG (SYN-ØØØJG-2), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0028).

— European Parliament resolution of 10 October 2019 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 soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0029).

— European Parliament resolution of 10 October 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9 and genetically modified maize combining two, three or four of the single events MON 89034, 1507, MON 88017, 59122 and DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0030).

— European Parliament resolution of 14 November 2019 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 cotton LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0054).

— European Parliament resolution of 14 November 2019 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 soybean MON 89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0055).

— European Parliament resolution of 14 November 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and sub-combinations MON 89034 × NK603 × DAS-40278-9, 1507 × NK603 × DAS-40278-9 and NK603 × DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0056).

— European Parliament resolution of 14 November 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and genetically modified maize combining two, three, four or five of the single events Bt11, MIR162, MIR604, 1507, 5307 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0057).

— European Parliament resolution of 14 May 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87708 × MON 89788 × A5547-127, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0069).

— European Parliament resolution of 11 November 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × MIR162 × NK603 and genetically modified maize combining two or three of the single events MON 87427, MON 89034, MIR162 and NK603, and repealing Commission Implementing Decision (EU) 2018/1111 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0291).

— European Parliament resolution of 11 November 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean SYHT0H2 (SYN-ØØØH2-5), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0292).

— European Parliament resolution of 11 November 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and genetically modified maize combining two, three or four of the single events MON 87427, MON 87460, MON 89034, MIR162 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0293).

— European Parliament resolution of 17 December 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0365).

— European Parliament resolution of 17 December 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and genetically modified maize combining two or three of the single events MON 87427, MON 89034, MIR162 and MON 87411 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0366).

— European Parliament resolution of 17 December 2020 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 MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0367).

— European Parliament resolution of 17 December 2020 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 88017 (MON-88Ø17-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0368).

— European Parliament resolution of 17 December 2020 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 (MON-89Ø34-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0369).

— European Parliament resolution of 11 March 2021 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2021)0080).

— European Parliament resolution of 11 March 2021 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MZIR098 (SYN-ØØØ98-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2021)0081).

— European Parliament resolution of 7 July 2021 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean DAS-81419-2 × DAS–44406–6, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2021)0334).

— European Parliament resolution of 7 July 2021 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 1507 × MIR162 × MON810 × NK603 and genetically modified maize combining two or three of the single events 1507, MIR162, MON810 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2021)0335).

— European Parliament resolution of 7 July 2021 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 Bt 11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2021)0336).

(5) Commission Decision 2011/354/EU of 17 June 2011 authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 160, 18.6.2011, p. 90).

(6) Scientific Opinion of the Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-NL-2008-51) for the placing on the market of glyphosate tolerant genetically modified cotton GHB614, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience, EFSA Journal 2009; 7(3):985, https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2009.985.

(7) EFSA 2009 opinion, p. 7.

(8) Scientific Opinion of the EFSA Panel on Genetically Modified Organisms on assessment of genetically modified cotton GHB614× T304-40 × GHB119 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-122), EFSA Journal 2018; 16(7):5349, https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5349, p. 22.

(9) Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (OJ L 157, 8.6.2013, p. 1).

(10) See, for example, Bonny, S., ‘Genetically Modified Herbicide-Tolerant Crops, Weeds, and Herbicides: Overview and Impact’, Environmental Management, January 2016; 57(1), pp. 31-48, https://www.ncbi.nlm.nih.gov/pubmed/26296738 and Benbrook, C.M., ‘Impacts of genetically engineered crops on pesticide use in the U.S. — the first sixteen years’, Environmental Sciences Europe, 28 September 2012, Vol. 24(1), https://enveurope.springeropen.com/articles/10.1186/2190-4715-24-24

(11) See, for example: https://www.sciencedirect.com/science/article/pii/S1383574218300887,

https://academic.oup.com/ije/advance-article/doi/10.1093/ije/dyz017/5382278,

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0219610, and

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612199/

(12) EFSA conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, EFSA journal 2015; 13(11):4302, p. 3, https://www.efsa.europa.eu/en/efsajournal/pub/4302

(13) This is indeed the case for glyphosate, as stated in the reasoned opinion of EFSA ‘Review of the existing maximum residue levels for glyphosate according to Article 12 of Regulation (EC) No 396/2005’, EFSA Journal 2018; 16(5):5263, p. 12, https://www.efsa.europa.eu/fr/efsajournal/pub/5263

(14) Member States comments, accessible via the EFSA register of questions (Reference: EFSA-Q-2014-00721): https://www.efsa.europa.eu/en/register-of-questions

(15) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC — Commission Declaration (OJ L 106, 17.4.2001, p. 1).

(16) https://www.ohchr.org/EN/Issues/Food/Pages/Pesticides.aspx

(17) https://www.un.org/sustainabledevelopment/health/

(18) https://www.mcgill.ca/newsroom/channels/news/widely-used-weed-killer-harming-biodiversity-320906

(19) The Commission ‘may’, and not ‘shall’, go ahead with authorisation if there is no qualified majority of Member States in favour at the Appeal Committee, according to Regulation (EU) No 182/2011 (Article 6(3)).

(20) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

(21) https://tillymetz.lu/wp-content/uploads/2020/09/Co-signed-letter-MEP-Metz.pdf

(22) European Parliament resolution of 15 January 2020 on the European Green Deal (OJ C 270, 7.7.2021, p. 2), paragraph 102.

(23) Texts adopted, P9_TA(2020)0364.