European Parliament resolution of 23 June 2022 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and genetically modified maize combining two or three of the single events DP4114, MON 810, MIR604 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D081155/01 — 2022/2694(RSP))
Date: 2022-06-23
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: animal feedingstuffs, food safety, foodstuff, labelling, maize, market approval, transgenic plant








C_2023032EN.01000601.xml










27.1.2023   


EN


Official Journal of the European Union


C 32/6






P9_TA(2022)0257
Genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and genetically modified maize combining two or three of the single events DP4114, MON 810, MIR604 and NK603
European Parliament resolution of 23 June 2022 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP4114 × MON 810 × MIR604 × NK603 and genetically modified maize combining two or three of the single events DP4114, MON 810, MIR604 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D081155/01 — 2022/2694(RSP))
(2023/C 32/02)

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 maize DP4114 × MON 810 × MIR604 × NK603 and genetically modified maize combining two or three of the single events DP4114, MON 810, MIR604 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D081155/01,










—


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 7(3) and Article 19(3) thereof,










—


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 16 May 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 26 January 2022, and published on 7 March 2022 (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 on 2 May 2018, Pioneer Overseas Corporation, based in Belgium, submitted, on behalf of Pioneer Hi-Bred International, Inc., based in the United States, an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize DP4114 × MON 810 × MIR604 × NK603 (‘the GM maize’), 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 maize for uses other than food and feed, with the exception of cultivation;










B.


whereas, in addition, the application covered the placing on the market of products containing, consisting of or produced from 10 sub-combinations of the single transformation events constituting the GM maize;










C.


whereas the sub-combination MON 810 × NK603, has already been authorised by Commission Implementing Decision (EU) 2018/2045 (5); whereas the draft implementing decision therefore covers the GM maize and the 9 remaining sub-combinations in the application (6);










D.


whereas, on 26 January 2022, EFSA adopted a favourable opinion in relation to the authorisation of the GM maize, which was published on 7 March 2022;










E.


whereas the GM maize was produced by conventional crossing to combine four single GM maize events: DP4114, MON 810, MIR604 and NK603; whereas the GM maize confers tolerance to two herbicides (glufosinate and glyphosate) and produces five insecticidal proteins (7) (‘Bt toxins’);










F.


whereas no experimental data were submitted by the applicant for the 9 sub-combinations, which have not previously been assessed by EFSA (8); whereas despite that lack of experimental data, EFSA concluded that those sub-combinations would not raise safety concerns;






Lack of assessment of the complementary herbicide








G.


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-tolerant plants;










H.


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 maize will be exposed to both higher and repeated doses of glyphosate and glufosinate herbicides and that therefore a higher quantity of residues and their breakdown products (‘metabolites’) may be present in the harvest;










I.


whereas glufosinate is classified as toxic to reproduction 1B and therefore meets the ‘cut-off criteria’ set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council (11); whereas the approval of glufosinate for use in the Union expired on 31 July 2018 (12);










J.


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 other recent scientific peer-reviewed studies confirm the carcinogenic potential of glyphosate (13);










K.


whereas assessment of herbicide residues and metabolites 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 metabolites, can be impacted by the genetic modification itself (14);






Outstanding questions concerning Bt toxins








L.


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 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 (15);










M.


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;










N.


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










O.


whereas a scientific study found that the toxicity of Bt toxins may also be increased 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) (17); whereas assessment of the potential interaction of herbicide residues and their metabolites with Bt toxins is, however, considered to be outside the remit of the EFSA GMO Panel and is, therefore, not undertaken as part of the risk assessment;






Bt crops: effects on non-target organisms








P.


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;










Q.


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 (18); 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 (19);






Member State competent authority and stakeholder comments








R.


whereas Member States submitted many critical comments to EFSA during the three-month consultation period (20);










S.


whereas detailed analysis by an independent research organisation states, inter alia, that the EFSA opinion on the application for authorisation of the GM maize cannot be said to fulfil the requirements for assessment of potential synergistic or antagonistic effects resulting from the combination of the transformation events, with regard to toxicology and that, therefore, the toxicological assessment carried out by EFSA is not acceptable (21);






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 (22); whereas the UN 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 (23); whereas authorising the import of the GM maize would increase demand for this crop, which is designed to be treated with glufosinate and glyphosate based herbicides, 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;










U.


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 (24);










V.


whereas the Union, as a party to the UN Convention on Biological Diversity (‘UN CBD’), has the responsibility of ensuring that activities within its jurisdiction or control do not cause damage to the environment of other States (25);










W.


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 UN SDGs, the Paris Climate Agreement and the UN CBD;






Undemocratic decision-making








X.


whereas the vote on 16 May 2022 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;










Y.


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;










Z.


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 27 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;










AA.


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;










AB.


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 (26);












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 (27), 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.


Calls on the Commission not to authorise the import of herbicide-tolerant GM crops, due to the associated increased use of complementary herbicides and therefore the increased risks to biodiversity, food safety and worker health;












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 (28); 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 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’ (29);












7.


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












8.


Reiterates its call on the Commission not to authorise any sub-combinations of stacked GM events unless they have been thoroughly evaluated by EFSA on the basis of complete experimental data submitted by the applicant;












9.


Considers, more specifically, that to approve varieties of GM plants for which no experimental data have been provided, which have not been tested, or which may not even have been created yet, runs contrary to the principles of general food law, as laid down in Regulation (EC) No 178/2002;












10.


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 (30), 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;












11.


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 maize DP4114 × MON 810 × MIR604 × NK603 and sub-combinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2018-150), EFSA Journal 2022,20(3):7134, https://doi.org/10.2903/j.efsa.2022.7134

(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 (OJ C 202, 28.5.2021, p. 11).










—


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 (OJ C 202, 28.5.2021, p. 15).










—


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 (OJ C 202, 28.5.2021, p. 20).










—


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 (OJ C 208, 1.6.2021, p. 2).










—


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 (OJ C 208, 1.6.2021, p. 7).










—


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 (OJ C 208, 1.6.2021, p. 12).










—


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 (OJ C 208, 1.6.2021, p. 18).










—


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 (OJ C 323, 11.8.2021, p. 7).










—


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 (OJ C 415, 13.10.2021, p. 2).










—


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 (OJ C 415, 13.10.2021, p. 8).










—


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 (OJ C 415, 13.10.2021, p. 15).










—


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 (OJ C 445, 29.10.2021, p. 36).










—


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 (OJ C 445, 29.10.2021, p. 43).










—


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 (OJ C 445, 29.10.2021, p. 49).










—


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 (OJ C 445, 29.10.2021, p. 56).










—


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 (OJ C 445, 29.10.2021, p. 63).










—


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 (OJ C 474, 24.11.2021, p. 66).










—


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 (OJ C 474, 24.11.2021, p. 74).










—


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 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ C 99, 1.3.2022, p. 45).










—


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 (OJ C 99, 1.3.2022, p. 52).










—


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 (OJ C 99, 1.3.2022, p. 59).










—


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 (OJ C 99, 1.3.2022, p. 66).










—


European Parliament resolution of 15 February 2022 on 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 (Texts adopted, P9_TA(2022)0024).










—


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 (Texts adopted, P9_TA(2022)0025).










—


European Parliament resolution of 9 March 2022 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB811 (BCS-GH811-4), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2022)0062).










—


European Parliament resolution of 9 March 2022 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified oilseed rape 73496 (DP-Ø73496-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2022)0063).










—


European Parliament resolution of 6 April 2022 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87769 × MON 89788 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2022)0115).





(5)  Commission Implementing Decision (EU) 2018/2045 of 19 December 2018 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize NK603 × MON 810 (MON-ØØ6Ø3-6 × MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 327, 21.12.2018, p. 65).

(6)  MIR604 × NK603 × DP4114, MON 810 × NK603 × DP4114, MON 810 × MIR604 × DP4114, MON 810 × MIR604 × NK603, NK603 × DP4114, MIR604 × DP4114, MIR604 × NK603, MON 810 × DP4114 and MON 810 × MIR604.

(7)  Cry1F, Cry34Ab1, Cry35Ab1, Cry1Ab and mCry3A.

(8)  EFSA opinion, p. 4.

(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)  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).

(12)  https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=search.as

(13)  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/

(14)  This is indeed the case for glyphosate, as stated in 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

(15)  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

(16)  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

(17)  https://www.sciencedirect.com/science/article/pii/S0278691516300722?via%3Dihub

(18)  See, for example, Hilbeck, A., Otto, M., ‘Specificity and combinatorial effects of Bacillus thuringiensis Cry toxins in the context of GMO environmental risk assessment’, Frontiers in Environmental Science 2015, 3:71, https://doi.org/10.3389/fenvs.2015.00071

(19)  Hilbeck, A., Defarge, N., Lebrecht, T., Bøhn, T., ‘Insecticidal Bt crops. EFSA’s risk assessment approach for GM Bt plants fails by design’, RAGES 2020, p. 4, https://www.testbiotech.org/sites/default/files/RAGES_report-Insecticidal%20Bt%20plants.pdf

(20)  Member State comments, accessible via the EFSA OpenEFSA portal: https://open.efsa.europa.eu/

(21)  Testbiotech comment on EFSA assessment of genetically engineered maize DP4114 x MON810 x MIR604 x NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2018-150) from Pioneer.

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

(23)  https://indicators.report/targets/3-9/

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

(25)  Convention on Biological Diversity, Article 3: https://www.cbd.int/convention/articles/?a=cbd-03

(26)  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)).

(27)  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).

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

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

(30)  OJ C 445, 29.10.2021, p. 257.