The European Parliament,

–  having regard to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean GMB151 (BCS-GM151-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D075506/01),

–  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 Articles 7(3) and 19(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 4 February 2022, at which 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 27 January 2021, and published on 19 April 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 of the Committee on the Environment, Public Health and Food Safety,

A.  whereas, on 9 October 2018, BASF SE, based in Germany, submitted, on behalf of BASF Agricultural Solutions Seed US LLC, based in the United States, (‘the applicant’), an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified soybean GMB151 (the ‘GM soybean’), in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003; whereas the application also concerned the placing on the market of products containing or consisting of the GM soybean for uses other than food and feed, with the exception of cultivation;

B.  whereas, on 27 January 2021, EFSA adopted a favourable opinion, which was published on 19 April 2021;

C.  whereas the GM soybean has been developed to confer tolerance to a group of herbicides known as HPPD-inhibitors, such as isoxaflutole, mesotrione and tembotrionine, and produces an insecticidal protein (a Bt toxin), Cry14Ab-1.b(5), which is toxic to nematodes (roundworms);

Lack of assessment of herbicide residues, metabolites and cocktail effects

D.  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(6); whereas, as a consequence, it has to be expected that the GM soybean will be exposed to both higher and repeated doses of the complementary herbicides which will potentially lead to a higher quantity of residues in the harvest;

E.  whereas isoxaflutole is, according to the harmonised classification and labelling approved by the Union, very toxic to aquatic life and suspected of damaging the unborn child(7);

F.  whereas only isoxaflutole was used on the GM soybean for the purpose of the risk assessment; whereas, however, HPPD-inhibitor herbicides encompass a range of herbicides, including mesotrione, which could also be used in large quantities on this GM soybean;

G.  whereas, according to EFSA, mesotrione ‘may be considered to have endocrine disrupting properties’, whilst the genotoxic potential of AMBA, a breakdown product of mesotrione, ‘could not be ruled out’(8);

H.  whereas assessment of herbicide residues, and their break-down products (‘metabolites’), found on GM plants is considered to be 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 the toxicity of the metabolites, can be influenced by the genetic modification itself;

I.  whereas, due to specific agricultural practices in the cultivation of herbicide-tolerant GM plants, there are specific patterns of application, exposure, occurrence of specific metabolites and emergence of combinatorial effects that require special attention; whereas those patterns were not considered by EFSA;

J.  whereas it cannot therefore be concluded that consumption of the GM soybean is safe for human and animal health;

Outstanding questions concerning Bt toxins

K.  whereas isolated Cry14Ab-1 proteins obtained from microbial recombinant systems were used for the safety studies(9); 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 thirty years ago which showed that even the presence of extremely low levels of PI enhanced the toxicity of Bt toxins up to 20-fold(10);

L.  whereas this enhanced toxicity has never been taken into account in EFSA risk assessments, even though they are 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 arising from this enhanced toxicity due to the interaction between PI and Bt toxins cannot, therefore, be ruled out;

M.  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(11), meaning that they can increase the allergenicity of other proteins with which they come into contact;

N.  whereas a scientific study found that the toxicity of Bt toxins may also be enhanced 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)(12); whereas, however, assessment of the potential interaction of herbicide residues and their metabolites with Bt toxins is considered to be outside the remit of the EFSA GMO Panel and is therefore not undertaken as part of the risk assessment;

Comments from Member State competent authorities

O.  whereas Member State competent authorities submitted comments to EFSA during the three-month consultation period(13); whereas critical comments included that data should have been provided to assess whether an accumulation of herbicide residues and metabolites occurs in the GM soybean, whether unacceptable levels of such residues and metabolites may be contained in the GM soybean imported into the Union and the consequences with regard to sub-chronic, developmental and reproductive toxicity, that the basis for the environmental risk assessment is associated with a number of shortcomings and uncertainties therefore remain regarding the environmental risk associated with the GM soybean, that present studies are not sufficient to conclude that exposure of the environment and thus effects on non-target organisms will be negligible, that the impact of the GM soybean cultivation in the producing countries should be considered, and that ‘on the basis of the evidence presented in the dossier, it is not possible to conclude on the comparative assessment of soybean GMB151, or on its safety’;

Undemocratic decision-making

P.  whereas the Commission recognises that it is problematic 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;

Q.  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 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 the granting of authorisations include 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(14);

Upholding the Union’s international obligations

T.  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(15); whereas the UN’s Sustainable Development Goal (‘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(16); whereas authorising the import of the GM soybean would increase demand for this crop which has been modified to be treated with HPPD inhibitor herbicides such as isoxaflutole and mesotrione, thereby increasing the exposure of workers 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;

U.  whereas deforestation is a major cause of biodiversity decline; whereas emissions from land-use and land-use change, mostly due to deforestation, are the second biggest cause of climate change after burning fossil fuels(17); whereas UN SDG 15 includes the target of halting deforestation by 2020(18); whereas forests play a multifunctional role that support the achievement of most UN SDGs(19);

V.  whereas soya production is a key driver of deforestation in the Amazon, Cerrado and Gran Chaco forests in South America; whereas 97 % and 100 % of soya cultivated respectively in Brazil and Argentina is GM soya(20); whereas the vast majority of GM soybeans authorised for cultivation in Brazil and Argentina are also authorised for import into the Union;

W.  whereas the Union is party to the UN Convention on Biological Diversity (‘UN CBD’), which makes it clear that both exporting and importing countries have international responsibilities regarding biological diversity;

X.  whereas Regulation (EC) No 1829/2003 provides 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, the Paris Climate Agreement and the UN CBD;

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(21), 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(22); 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 such authorisations;

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.  Calls on EFSA to widen its risk assessment in order to fully take into account all interactions and combinatorial effects between Bt-toxins, GM plants and their constituents as well as residues from spraying with the complementary herbicides and to assess the related impact on the environment and health and food safety;

8.  Calls on the Commission to immediately suspend the import of GM soybeans cultivated in Brazil and Argentina, using Article 53 of Regulation (EC) No 178/2002 if necessary, until effective legally binding mechanisms have been put in place to prevent the placing on the Union market of products associated with deforestation and related human rights violations;

9.  Reiterates its call for the implementation of a European vegetable protein production and supply strategy(23), which would enable the Union to become less dependent on GM soybean imports and to create shorter food chains and regional markets;

10.  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’(24);

11.  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(25), 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;

12.  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 Organisms on genetically modified soybean GMB 151 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2018.153), EFSA Journal 2021;19(4):6424, https://doi.org/10.2903/j.efsa.2021.6424. (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) EFSA opinion, p. 6 and 7. (6) 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. (7) https://echa.europa.eu/substance-information/-/substanceinfo/100.114.433 (8) EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance mesotrione, EFSA Journal 2016;14(3):4419, p. 3, https://doi.org/10.2903/j.efsa.2016.4419. (9) EFSA opinion, p. 16. (10) MacIntosh, S.C., Kishore, G.M., Perlak, F.J., Marrone, P.G., Stone, T.B., Sims, S.R., Fuchs, R.L., ‘Potentiation of Bacillus thuringiensis insecticidal activity by serine protease inhibitors’, Journal of Agricultural and Food Chemistry, 1990, 38, pp. 1145-1152, https://pubs.acs.org/doi/abs/10.1021/jf00094a051. (11) For a review, see Rubio-Infante, N., Moreno-Fierros, L., ‘An overview of the safety and biological effects of Bacillus thuringiensis Cry toxins in mammals’, Journal of Applied Toxicology, May 2016, 36(5), pp. 630 648, https://onlinelibrary.wiley.com/doi/full/10.1002/jat.3252. (12) https://www.sciencedirect.com/science/article/pii/S0278691516300722?via%3Dihub (13) Member State comments on the GM soybean can be accessed via EFSA’s register of questions: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2012-00753. (14) 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)). (15) https://www.ohchr.org/EN/Issues/Food/Pages/Pesticides.aspx (16) https://www.un.org/sustainabledevelopment/health/ (17) Commission communication of 23 July 2019 entitled ‘Stepping up EU action to Protect and Restore the World’s forests’ (COM(2019)0352), p. 1. (18) See target 15.2: https://www.un.org/sustainabledevelopment/biodiversity/. (19) Commission communication of 23 July 2019 entitled ‘Stepping up EU action to Protect and Restore the World’s forests’ (COM(2019)0352), p. 2. (20) International Service for the Acquisition of Agri-biotech Applications, ‘Global status of Commercialized Biotech/GM crops in 2017: Biotech Crop Adoption Surges as Economic Benefits Accumulate in 22 Years’, ISAAA Brief No. 53 (2017), pp. 16 and 21, https://www.isaaa.org/resources/publications/briefs/53/download/isaaa-brief-53-2017.pdf. (21) 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). (22) https://tillymetz.lu/wp-content/uploads/2020/09/Co-signed-letter-MEP-Metz.pdf (23) European Parliament resolution of 15 January 2020 on the European Green Deal (OJ C 270, 7.7.2021, p. 2), paragraph 64. (24) European Parliament resolution of 15 January 2020 on the European Green Deal (OJ C 270, 7.7.2021, p. 2), paragraph 102. (25) Texts adopted, P9_TA(2020)0364.