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 (D061870/04 — 2019/2856(RSP))
Date: 2019-11-14
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: animal feedingstuffs, cotton, food safety, foodstuff, labelling, market approval, transgenic plant








C_2021208EN.01000201.xml










1.6.2021   


EN


Official Journal of the European Union


C 208/2






P9_TA(2019)0054
Genetically modified cotton LLCotton25 (ACS-GHØØ1-3)
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 (D061870/04 — 2019/2856(RSP))
(2021/C 208/01)

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 LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D061870/04,










—


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 11(3) and 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 30 April 2019, at which no opinion was delivered, and to the vote of the Appeal Committee on 5 June 2019, 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 on 6 December 2006, and published on 14 December 2006 (3),










—


having regard to the opinion in relation to renewal adopted by the European Food Safety Authority on 17 October 2018, and published on 14 November 2018 (4),










—


having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (‘GMOs’) (5),










—


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, Commission Decision 2008/837/EC (6) authorised the placing on the market of food and feed containing, consisting of, or produced from genetically modified cotton LLCotton25 (‘LLCotton25’);










B.


whereas, on 2 October 2017, the initial authorisation holder, Bayer CropScience AG (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 17 October 2018, the European Food Safety Authority (EFSA) adopted a favourable opinion, which was published on 14 November 2018 (7);










D.


whereas Regulation (EC) No 1829/2003 states that genetically modified (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;










E.


whereas LLCotton25 has been made tolerant to glufosinate-based herbicides (8);










F.


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 (9);










G.


whereas Member States submitted many critical comments to EFSA during the three-month consultation period, both in regard to the original assessment and the one for renewal (10); whereas these include that the effects of glufosinate residues and metabolites were not considered, that it is debatable whether the results of the toxicity test can be considered correct, that neither allergenicity nor toxicology has been thoroughly assessed, that monitoring reports produced by the applicant do not provide any data to support the conclusions that there have been no adverse health or environmental effects associated with the import and use of LLCotton25 and that the general surveillance plan proposed by the applicant does not meet the requirements of Annex VII to Directive 2001/18/EC of the European Parliament and of the Council (11);










H.


whereas EFSA, in response to Member State comments, has repeatedly stated that it considers that further discussion between applicants and the Commission as risk manager is needed on the practical implementation of the PMEM for GM plants for import and processing;






Lack of assessment of glufosinate residues on LLCotton25








I.


whereas a number of studies show that herbicide-tolerant GM crops result in a higher use of those herbicides, in large part because of the emergence of herbicide-tolerant weeds (12); whereas, as a consequence, it has to be expected that crops of LLCotton25 will be exposed to both higher and repeated doses of glufosinate which will potentially lead to a higher quantity of residues in the harvest;










J.


whereas whilst LLCotton25 was initially authorised for import in 2008, the approval of glufosinate for use in the Union expired on 31 July 2018 (13); 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 (14);










K.


whereas assessment of herbicide residues and their metabolites on GM plants 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 that complementary herbicides are broken down by GM plants, and the composition and thus toxicity of the break-down products (‘metabolites’), can be driven by the genetic modification itself (15);










L.


whereas, under Regulation (EC) No 396/2005 of the European Parliament and of the Council (16), which aims to ensure a high level of consumer protection in relation to maximum residue levels (‘MRLs’), the residues on imported crops for food and feed of active substances which are not authorised for use in the Union, such as glufosinate, should be carefully controlled and monitored (17);










M.


whereas, on the contrary, under the latest coordinated multiannual control programme of the Union (for 2020, 2021 and 2022), Member States are not obliged to measure glufosinate residues on any products, including cotton (18); whereas it cannot be excluded that LLCotton25 or products derived from it for food and feed will exceed MRLs, which have been put in place to ensure a high level of consumer protection;










N.


whereas EFSA found that the estimated operator exposure to glufosinate when used for weed control in GM maize exceeded the acceptable operator exposure level (AOEL) even when personal protective equipment was used (19); whereas, operator exposure is particularly concerning given the higher volumes of herbicides used on herbicide-tolerant GM crops










O.


whereas a recent report by the UN’s Special Rapporteur on the right to food found that, hazardous pesticides have catastrophic impacts on health, with pesticides responsible for an estimated 200,000 acute poisoning deaths each year, 99 per cent of which occur in developing countries (20); whereas Target 3.9 of the UN’s Sustainable Development Goals, which the Union has signed up to, aims to, by 2030, substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination (21);






Undemocratic decision-making








P.


whereas the vote on 30 April 2019 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 5 June 2019 of the Appeal Committee also delivered no opinion;










Q.


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 (22); whereas that practice has, on several occasions, been deplored by the Commission President as not being democratic (23);










R.


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 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;










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 (24);












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 (25), 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 commitment to advancing work on the Commission proposal amending Regulation (EU) No 182/2011; calls on the Council to move forward with its work in relation to that Commission proposal as a matter of urgency;












5.


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












6.


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 the GM crops with complementary herbicides, their metabolites and any combinatorial effects;












7.


Calls 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;












8.


Calls 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;












9.


Urges the Commission to treat the Union’s obligations under international agreements, such as the Paris Climate Agreement, the UN Convention on Biological Diversity and the UN Sustainable Development Goals, as ‘relevant provisions of Union law’ and/or ‘legitimate factors’ under Regulation (EC) No 1829/2003, and to give them the weight they deserve, as well as communicating on how they have been taken into account in the decision-making process;












10.


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)  Opinion of the Scientific Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-NL-2005-13) for the placing on the market of glufosinate-tolerant genetically modified LLCotton25, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience, The EFSA Journal (2006) 429, 1-19, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2006.429

(4)  Scientific opinion on the Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-010), EFSA Journal 2018; 16(11):5473, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5473

(5)  In its eighth term, the European Parliament adopted 36 resolutions objecting to the authorisation of GMOs.
Furthermore, in its ninth term the 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).





(6)  Commission Decision 2008/837/EC of 29 October 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 299, 8.11.2008, p. 36).

(7)  Scientific opinion on the Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-010), EFSA Journal 2018; 16(11):5473, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5473

(8)  Initial EFSA opinion, p. 1.

(9)  Scientific opinion on the Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2011-94), EFSA Journal 2018; 16(4):5213, https://www.efsa.europa.eu/en/efsajournal/pub/5213, pp. 17-18.

(10)  Member State comments on LLCotton25 can be accessed via EFSA’s register of questions: http://registerofquestions.efsa.europa.eu/roqFrontend/login?

(11)  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 (OJ L 106, 17.4.2001, p. 1).

(12)  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

(13)  https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.detail&language=EN&selectedID=1436

(14)  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)

(15)  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

(16)  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).

(17)  See recital 8 of Regulation (EC) No 396/2005.

(18)  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).

(19)  EFSA Conclusion regarding the peer review of the pesticide risk assessment of the active substance glufosinate. https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2005.27r, p. 3.

(20)  https://www.ohchr.org/EN/Issues/Environment/ToxicWastes/Pages/ Pesticidesrighttofood.aspx

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

(22)  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.

(23)  See, for example, the Opening Statement at the European Parliament plenary session included in the political guidelines for the next European Commission (Strasbourg, 15 July 2014) or in the State of the Union Address 2016 (Strasbourg, 14 September 2016).

(24)  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)).

(25)  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).