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 SYHT0H2 (SYN-ØØØH2-5), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D068779/01),

–  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 15 September 2020, 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 28 November 2019, and published on 20 January 2020(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 8 August 2012, Syngenta Crop Protection AG submitted, through its affiliated company Syngenta Crop Protection NV/SA, an application to the national competent authority of Germany (‘the application’) in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003; whereas the application covered the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified soybean (Glycine max (L.) Merr.) SYHT0H2; whereas the application also covered the placing on the market of products containing or consisting of genetically modified (‘GM’) soybean SYHT0H2 for uses other than food and feed, with the exception of cultivation;

B.  whereas, on 28 November 2019, EFSA adopted a favourable opinion, which was published on 20 January 2020, in relation to that application;

C.  whereas GM soybean SYHT0H2 has been developed to confer tolerance to glufosinate ammonium and to the herbicidal active substances mesotrione and other p-hydroxyphenylpyruvate dioxygenase (HPPD)-inhibiting herbicides(5);

Lack of assessment of complementary herbicide residues

D.  whereas it has been shown that the cultivation of herbicide-tolerant GM crops results in a higher use of herbicides, due in large part to the emergence of herbicide-tolerant weeds(6); whereas, as a consequence, it is to be expected that crops of GM soybean SYHT0H2 will be exposed to both higher and repeated doses of complementary herbicides (glufosinate and HPPD-inhibiting herbicides), which will potentially lead to a higher quantity of residues in the harvest;

E.  whereas glufosinate is classified as toxic to reproduction 1B and thus meets the ‘cut-off criteria’ set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council(7); whereas the approval of glufosinate for use in the Union expired on 31 July 2018(8);

F.  whereas, according to EFSA, the HPPD-inhibiting herbicide 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’(9);

G.  whereas only glufosinate and mesotrione were considered as complementary herbicides for the purpose of the risk assessment; whereas, however, HPPD-inhibiting herbicides include a range of herbicides, including isoxaflutole, which may therefore be used in large quantities on this GM soybean; 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(10);

H.  whereas, however, assessment of herbicide residues, and herbicide break-down products, found on GM plants as well as possible combinatorial (‘cocktail’) effects is considered outside the remit of the EFSA Panel on Genetically Modified Organisms 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 break-down products (‘metabolites’), can be driven by the genetic modification itself;

I.  whereas, under Regulation (EC) No 396/2005 of the European Parliament and of the Council(11), the residues on imported crops for food and feed of herbicides which are not authorised for use in the Union should be carefully controlled and monitored;

J.  whereas, however, under the coordinated multiannual control programme of the Union for 2020, 2021 and 2022, Member States are not obliged to measure glufosinate on soybean imports (12); whereas it cannot be excluded that GM soybean SYHT0H2 or products derived from it for food and feed will exceed maximum residue limits, which are put in place to ensure a high level of consumer protection;

K.  whereas it, therefore, cannot be concluded that consumption of GM soybean SYHT0H2 is safe for human and animal health;

L.  whereas the conclusions of an international research project entitled ‘Risk Assessment of genetically engineered organisms in the EU and Switzerland’, presented in January 2020, found that the Union risk assessment of GMOs fails to deal in a satisfactory way with risks to public health and the environment, including in relation to the health risks associated with the consumption of products derived from herbicide-tolerant GM plants(13);

Comments from Member State competent authorities

M.  whereas Member State competent authorities submitted comments to EFSA during the three-month consultation period(14); whereas critical comments include the lack of analysis of herbicide residues on imports of GM soybean SYHT0H2 and the potential health risks for consumers, that toxicological information is insufficient and that, therefore, the potential risk associated with the consumption of food produced from GM soybean SYHT0H2 cannot be evaluated, that information necessary to conclude on the environmental health assessment is not complete, and that a detailed monitoring plan should be provided before authorisation can be given;

Undemocratic decision-making

N.  whereas the vote on 15 September 2020 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;

O.  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 which has become the norm for decision-making on GM food and feed authorisations, is problematic(15);

P.  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, to date, Parliament has adopted eight objections in its ninth term; whereas there was not a qualified majority of Member States in favour of authorising any of those GMOs; 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, under Regulation (EU) No 182/2011, the Commission may decide not to authorise a GMO when there is no qualified majority of Member States in favour in the Appeal Committee(16); whereas no change of law is required in this respect;

Upholding the Union’s international obligations

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

S.  whereas a recent 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(17); whereas 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(18);

T.  whereas EFSA found that the estimated operator exposure to glufosinate, classified as toxic to reproduction, when used for weed control in GM maize exceeded the acceptable operator exposure level even when personal protective equipment was used(19); whereas the risk of increased operator 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(20); whereas the Paris Climate Agreement and the Strategic Plan for Biodiversity 2011-2020 adopted under the UN CBD and the Aichi Biodiversity Targets promote sustainable forest management, protection and restoration efforts(21); whereas SDG 15 includes the target of halting deforestation by 2020(22); whereas forests play a multifunctional role that support the achievement of most SDGs(23);

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(24);

W.  whereas the vast majority of GM soybeans authorised for cultivation in Brazil and Argentina are also authorised for import into the Union(25); whereas GM soybean SYHT0H2 is already authorised for cultivation in Argentina(26);

X.  whereas an analysis by the Commission found that soya has historically been the Union’s number one contributor to global deforestation and related emissions, accounting for nearly half of the deforestation embodied in all Union imports(27);

Y.  whereas a recent peer-reviewed scientific study found that the Union is the region with the largest carbon footprint in the world associated with soya imports from Brazil, 13,8% larger than that of China, the largest soya importer, due to a larger share of emissions from embodied deforestation(28); whereas another recent study found that approximately a fifth of the soya exported to the Union from Brazil’s Amazon and Cerrado regions, mostly for animal feed, may be ‘contaminated with illegal deforestation’(29); whereas forest fires in the Amazon are driven by high levels of deforestation; whereas in a 2019 Communication, the Commission expressed its ambition to protect and restore the world’s forests(30); whereas the global protection of biodiversity, including forests, is a key objective of the Commission’s recently published EU Biodiversity Strategy(31);

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(32), 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.  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(33); expresses its deep disappointment, however, that, on 28 September 2020, the Commission authorised another GM soybean for import(34) despite objections by Parliament and a majority of Member States;

5.  Calls on the Commission to move forward with the utmost urgency concerning the development of sustainability criteria, with full involvement of the Parliament; calls on the Commission to provide information on how this process will be undertaken and in what timeframe;

6.  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;

7.  Reiterates its call on the Commission to stop authorising GMOs, whether for cultivation or for food and feed uses, when no opinion is delivered by Member States in the Appeal Committee, in accordance with Article 6(3) of Regulation (EU) No 182/2011;

8.  Reiterates its calls 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 break-down products and any combinatorial effects;

9.  Reiterates its call on the Commission to fully integrate the risk assessment of the application of complementary herbicides and their residues into the risk assessment of herbicide-tolerant GM plants, regardless of whether the GM plant concerned is to be cultivated in the Union or is for import into the Union for food and feed uses;

10.  Reiterates its call on the Commission not to authorise the import for food or feed uses of any GM plant which has been made tolerant to a herbicide-active substance that is not authorised for use in the Union;

11.  Welcomes the fact that the European Green Deal, the flagship project of the Commission, has been put forward as an integral part of the Commission’s strategy to implement the UN’s 2030 Agenda and the SDGs; recalls that SDGs can only be achieved if supply chains become sustainable and synergies are created between policies(35);

12.  Reiterates its consternation that the Union’s high dependence on imports of animal feed in the form of soybeans causes deforestation in third countries(36);

13.  Welcomes the announcement of a legislative proposal from the Commission on ‘Measures to avoid or minimise the placing of products associated with deforestation or forest degradation on the EU market’ due by June 2021; in the meantime, given the urgency of tackling deforestation in the Amazon, Cerrado and Gran Chaco forests and the fact that Union demand for GM soybeans contributes to deforestation in that region, 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;

14.  Reiterates its call for the implementation of a European vegetable protein production and supply strategy(37), which would enable the Union to become less dependent on GM soybean imports and to create shorter food chains and regional markets;

15.  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 the assessment of genetically modified soybean SYHT0H2 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2012-111), EFSA Journal 2020;18(1):5946, https://doi.org/10.2903/j.efsa.2020.5946 (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). (5) EFSA opinion, p. 1. (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 24, 24 (2012), https://enveurope.springeropen.com/articles/10.1186/2190-4715-24-24, and Schütte, G., Eckerstorfer, M., Rastelli, V. et al., ‘Herbicide resistance and biodiversity: agronomic and environmental aspects of genetically modified herbicide-resistant plants’, Environmental Sciences Europe 29, 5 (2017), https://link.springer.com/article/10.1186/s12302-016-0100-y (7) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). (8) https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.detail&language=EN&selectedID=1436 (9) 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 (10) https://echa.europa.eu/substance-information/-/substanceinfo/100.114.433 (11) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). (12) Commission Implementing Regulation (EU) 2019/533 of 28 March 2019 concerning a coordinated multiannual control programme of the Union for 2020, 2021 and 2022 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 88, 29.3.2019, p. 28). (13) https://www.testbiotech.org/en/content/research-project-rages (14) Member State comments on GM soybean SYHT0H2 can be accessed via EFSA’s register of questions : http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2012-00753 (15) See, for example, the explanatory memorandum of the Commission’s legislative proposal presented on 22 April 2015 amending Regulation (EC) No 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of GM food and feed on their territory and the explanatory memorandum of the Commission’s legislative proposal presented on 14 February 2017 amending Regulation (EU) No 182/2011. (16) 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 Article 6(3) of Regulation (EU) No 182/2011. (17) https://www.ohchr.org/EN/Issues/Environment/ToxicWastes/Pages/Pesticidesrighttofood.aspx (18) https://www.un.org/sustainabledevelopment/health/ (19) EFSA Conclusion regarding the peer review of the pesticide risk assessment of the active substance glufosinate, EFSA Scientific Report (2005) 27, 1-81, p. 3, https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2005.27r (20) Communication of the Commission of 23 July 2019, ‘Stepping up EU action to Protect and Restore the World’s forests’, COM(2019)0352, p. 1. (21) Idem, p. 2. (22) See target 15.2: https://www.un.org/sustainabledevelopment/biodiversity/ (23) Communication of the Commission of 23 July 2019, ‘Stepping up EU action to Protect and Restore the World’s forests’, COM(2019)0352, p. 2. (24) 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, http://www.isaaa.org/resources/publications/briefs/53/download/isaaa-brief-53-2017.pdf (25) Via a cross check of two databases in October 2020 (the Community register of GM food and feed (https://webgate.ec.europa.eu/dyna/gm_register/index_en.cfm) and ISAAA GM approval database (http://www.isaaa.org/gmapprovaldatabase/)) it can be calculated how many GM soybean crops authorised for cultivation in Brazil and Argentina are also authorised for import into the Union. For Brazil: out of 17 GM soybean crops authorised for cultivation, 12 are currently authorised for import into the Union whilst authorisation for import is pending for three of the GM soybeans. For Argentina: out of a total of 15 GM soybean crops authorised for cultivation, 10 are currently authorised for import into the Union whilst authorisation for import is pending for three of the GM soybeans. (26) http://www.isaaa.org/gmapprovaldatabase/event/default.asp?EventID=358&Event=SYHT0H2 (27) Technical Report - 2013 - 063 of the Commission, ‘The impact of EU consumption on deforestation: Comprehensive analysis of the impact of EU consumption on deforestation’, study funded by the European Commission, DG ENV, and undertaken by VITO, IIASA, HIVA and IUCN NL, http://ec.europa.eu/environment/forests/pdf/1.%20Report%20analysis%20of%20impact.pdf, pp. 23-24: Between 1990 and 2008, the Union imported crop and livestock products embodying 90 000 km2 of deforestation. Crop products accounted for 74 000 km2 (82 %) of this, with oil crops having the largest share (52 000 km2). Soybeans and soya cake accounted for 82 % of this (42 600 km2), equivalent to 47 % of the Union’s total import of embodied deforestation. (28) Escobar, N., Tizado, E. J., zu Ermgassen, E. K., Löfgren, P., Börner, J., Godar, J., ‘Spatially-explicit footprints of agricultural commodities: Mapping carbon emissions embodied in Brazil’s soy exports’, Global Environmental Change, Volume 62, May 2020, 102067 https://www.sciencedirect.com/science/article/pii/S0959378019308623 (29) Rajão, R., Soares-Filho, B., Nunes, F., Börner, J., Machado, L., Assis, D., Oliveira, A., Pinto, L., Ribeiro, V., Rausch, L., Gibbs, H., Figueira, D., ‘The rotten apples of Brazil’s agribusiness’, Science 17 July 2020, Volume 369, Issue 6501, pp. 246-248, https://science.sciencemag.org/content/369/6501/246. (30) EU Communication on Stepping up EU Action to Protect and Restore the World’s Forests, https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52019DC0352&from=EN (31) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: ‘EU Biodiversity Strategy for 2030: Bringing nature back into our lives’, May 2020, https://eur-lex.europa.eu/resource.html?uri=cellar:a3c806a6-9ab3-11ea-9d2d-01aa75ed71a1.0001.02/DOC_1&format=PDF (32) 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). (33) https://tillymetz.lu/wp-content/uploads/2020/09/Co-signed-letter-MEP-Metz.pdf (34) https://webgate.ec.europa.eu/dyna/gm_register/gm_register_auth.cfm?pr_id=100 (35) European Parliament resolution of 11 September 2018 on transparent and accountable management of natural resources in developing countries: the case of forests (OJ C 433, 23.12.2019, p. 50), para. 67. (36) Idem. (37) European Parliament resolution of 15 January 2020 on the European Green Deal (Texts adopted, P9_TA(2020)0005), para. 64.