Official Journal C 208 of the European Union

Volume 64

English edition Information and Notices 1 June 2021

Contents

EUROPEAN 2019-2020 SESSION Sittings of 13 and 14 November 2019 The Minutes of this session have been published in OJ C 174, 7.5.2021. TEXTS ADOPTED

I Resolutions, recommendations and opinions

RESOLUTIONS

European Parliament

Thursday 14 November 2019

2021/C 208/01 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)) ...... 2

2021/C 208/02 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 (D061871/04 — 2019/2857(RSP)) ...... 7

2021/C 208/03 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 (D062828/04 — 2019/2859(RSP)) ...... 12 EN 2021/C 208/04 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 (D063846/02 — 2019/2860(RSP)) ...... 18

2021/C 208/05 European Parliament resolution of 14 November 2019 on the criminalisation of sexual education in (2019/2891(RSP)) ...... 24

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Parliament

Thursday 14 November 2019

2021/C 208/06 European Parliament decision of 14 November 2019 on the request for waiver of the immunity of José Manuel Fernandes (2019/2005(IMM)) ...... 29

III Preparatory acts

European Parliament

Thursday 14 November 2019

2021/C 208/07 European Parliament legislative resolution of 14 November 2019 on the proposal for a Council directive amending Council Directive 2006/112/EC of 28 November 2006 as regards provisions relating to distance sales of goods and certain domestic supplies of goods (COM(2018)0819 — C8-0017/2019 — 2018/0415(CNS)) ...... 31

2021/C 208/08 European Parliament resolution of 14 November 2019 on the proposal for a decision of the European Parliament and of the Council on the mobilisation of the European Globalisation Adjustment Fund (application from Belgium — EGF/2019/001 BE/Carrefour) (COM(2019)0442 — C9-0127/2019 — 2019/2114(BUD)) ...... 36 Key to symbols used * Consultation procedure *** Consent procedure ***I Ordinary legislative procedure: first reading ***II Ordinary legislative procedure: second reading ***III Ordinary legislative procedure: third reading (The type of procedure depends on the legal basis proposed by the draft act.) Amendments by Parliament: New text is highlighted in bold italics. Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in bold italics and by deleting or striking out the text that has been replaced.

1.6.2021 EN Official Journal of the European Union C 208/1

EUROPEAN PARLIAMENT

2019-2020 SESSION

Sittings of 13 and 14 November 2019

The Minutes of this session have been published in OJ C 174, 7.5.2021.

TEXTS ADOPTED C 208/2 EN Official Journal of the European Union 1.6.2021

Thursday 14 November 2019

I

(Resolutions, recommendations and opinions)

RESOLUTIONS

EUROPEAN PARLIAMENT

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),

(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 1.6.2021 EN Official Journal of the European Union C 208/3

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— 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

(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? C 208/4 EN Official Journal of the European Union 1.6.2021

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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;

(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). 1.6.2021 EN Official Journal of the European Union C 208/5

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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;

(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)). C 208/6 EN Official Journal of the European Union 1.6.2021

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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 of the Member States.

(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). 1.6.2021 EN Official Journal of the European Union C 208/7

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P9_TA(2019)0055 Genetically modified soybean MON 89788 (MON-89788-1) 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 (D061871/04 — 2019/2857(RSP)) (2021/C 208/02)

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 soybean MON 89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D061871/04,

— 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 2 July 2008, and published on 11 July 2008 (3),

— having regard to the opinion in relation to renewal adopted by the European Food Safety Authority on 17 October 2018, and published on 16 November 2018 (4),

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

(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 application (reference EFSA-GMO-NL-2006-36) for the placing on the market of the glyphosate tolerant genetically modified soybean MON89788, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto, The EFSA Journal (2008) 758, 1-23, https://efsa.onlinelibrary. wiley.com/doi/epdf/10.2903/j.efsa.2008.758 (4) Scientific opinion on the Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011), EFSA Journal 2018; 16(11):5468, https://efsa.onlinelibrary.wiley.com/doi/ epdf/10.2903/j.efsa.2018.5468 (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). C 208/8 EN Official Journal of the European Union 1.6.2021

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— 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 2008/933/EC (6) authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified soybean MON 89788 (‘soybean MON 89788’);

B. whereas, on 20 November 2017, the authorisation holder, Monsanto Europe S.A./N.V., on behalf of Monsanto Company, 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 (7), which was published on 16 November 2018, in relation to the renewal of that authorisation;

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 soybean MON 89788 has been made tolerant to glyphosate-based herbicides; whereas soybean MON 89788 has been developed to provide tolerance to glyphosate by expressing the CP4 EPSPS protein (8);

Lack of assessment of glyphosate residues and metabolites

F. 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 (9); whereas, as a consequence, it has to be expected that crops of soybean MON 89788 will be exposed to both higher and repeated doses of glyphosate which will potentially lead to a higher quantity of residues in the harvest;

G. whereas questions concerning the carcinogenicity of glyphosate remain; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency (ECHA) concluded in March 2017 that no classification was warranted; whereas, on the contrary, in 2015, the International Agency for Research on Cancer (IARC), the specialised cancer agency of the World Health Organization, classified glyphosate as a probable carcinogen for humans; whereas a number of recent scientific peer-reviewed studies confirm the carcinogenic potential of glyphosate (10);

(6) Commission Decision 2008/933/EC of 4 December 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 333, 11.12.2008, p. 7). (7) Scientific opinion on the Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011), EFSA Journal 2018; 16(11):5468, https://efsa.onlinelibrary.wiley.com/doi/ epdf/10.2903/j.efsa.2018.5468 (8) Initial EFSA opinion, p. 1. (9) 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 (10) 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/ 1.6.2021 EN Official Journal of the European Union C 208/9

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H. whereas in GM plants, the way that complementary herbicides are broken down by the plant, and the composition and thus toxicity of the break-down products (‘metabolites’), may be driven by the genetic modification itself (11); whereas, according to EFSA, toxicological data allowing a consumer risk assessment to be performed for several break-down products of glyphosate relevant for GM glyphosate-tolerant crops are missing (12);

Lack of maximum residue levels and related controls

I. whereas, under Regulation (EC) No 396/2005 of the European Parliament and of the Council (13), which aims to ensure a high level of consumer protection, specific maximum residue levels (MRLs) should be set for food and feed produced in third countries, when the use of pesticides results in levels of residues different from those resulting from agricultural practice within the Union (14); whereas this is indeed the case for imported herbicide-tolerant GM crops because of the increased volumes of herbicides used vis-à-vis non-GM crops;

J. whereas, however, according to a 2018 EFSA review of the existing MRLs for glyphosate, available data were insufficient to derive MRLs and risk assessment values for glyphosate in relation to a number of GM crops, including for soybeans with an EPSPS modification (15);

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;

L. whereas the lack of analysis of herbicide residues on the GM crops and associated health risks was raised by many Member State competent authorities as a concern in their comments on EFSA’s risk assessment (16);

Other remarks

M. whereas many Member States expressed concern over the quality of the post-market environmental monitoring (PMEM) plan, stating, inter alia, that it does not fully meet the objectives set out in Annex VII to Directive 2001/18/EC of the European Parliament and of the Council (17) or the relevant supplementary guidance notes; Member States also commented generally that the monitoring of soybean MON 89788 is inadequate, that it does not provide any sound data to support the conclusion that there has been no adverse health or environmental effects with the import and use of soybean MON 89788 and that it does not provide lessons pertinent to the safety of its use for animal or human consumption (18);

N. 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;

(11) 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 (12) EFSA conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, EFSA Journal 2015; 13(11):4302, p. 3, https://www.efsa.europa.eu/en/efsajournal/pub/4302 (13) 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). (14) See recital 26 of Regulation (EC) No 396/2005. (15) Reasoned Opinion on the 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. 4. https://doi.org/10.2903/j.efsa.2018.5263 (16) Member State comments on soybean MON 89788 can be accessed via EFSA’s register of questions: http://registerofquestions.efsa. europa.eu/roqFrontend/login? (17) 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). (18) Member State comments on the soybean MON 89788 can be accessed via EFSA’s register of questions: http://registerofquestions. efsa.europa.eu/roqFrontend/login? C 208/10 EN Official Journal of the European Union 1.6.2021

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O. whereas the Biotechnology working group of the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) states that, because the literature review conducted by the applicant of scientific studies published since soybean MON 89788 was first authorised has been too restrictive, it cannot come to a conclusion as to the safety of soybean MON 89788;

P. whereas GM soybean, when it is cultivated in countries such as Brazil and Argentina, is a key driver of large-scale deforestation; whereas this aspect, in addition to the Union’s obligations under the UN Sustainable Development Goals, the Paris Climate Agreement and other international biodiversity targets, has not been considered in the authorisation process;

Undemocratic decision-making

Q. 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;

R. 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 (19); whereas that practice has, on several occasions, been deplored by the Commission President as not being democratic (20);

S. 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;

T. 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 (21);

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 (22), 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;

(19) 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. (20) 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). (21) 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)). (22) 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). 1.6.2021 EN Official Journal of the European Union C 208/11

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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. Reiterates its alarm that the Union’s high dependence on imports of animal feed in the form of soybeans causes deforestation in third countries and recalls that the UN Sustainable Development Goals can only be achieved if supply chains become sustainable and synergies are created between policies (23); 9. Calls on the Commission not to authorise the import of GM soybeans unless it can be clearly demonstrated that their cultivation did not contribute, directly or indirectly, to deforestation; 10. 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; 11. Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.

(23) European Parliament resolution of 11 September 2018 on transparent and accountable management of natural resources in developing countries: the case of forests (Texts adopted, P8_TA(2018)0333), paragraph 67. C 208/12 EN Official Journal of the European Union 1.6.2021

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P9_TA(2019)0056 Genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and sub-combina­ tions MON 89034 × NK603 × DAS-40278-9, 1507 × NK603 × DAS-40278-9 and NK603 × DAS-40278-9 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 (D062828/04 — 2019/2859(RSP)) (2021/C 208/03)

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 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 (D062828/04,

— 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 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 12 July 2019, at which no opinion was delivered, and to the vote of the Appeal Committee on 16 September 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 (EFSA) on 28 November 2018, and published on 16 January 2019 (3),

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

(1) OJ L 268, 18.10.2003, p. 1. (2) OJ L 55, 28.2.2011, p. 13. (3) Scientific opinion on the Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2013-112), EFSA Journal 2019; 17(1):5522, https://efsa.onlinelibrary.wiley.com/doi/ epdf/10.2903/j.efsa.2019.5522 (4) 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). 1.6.2021 EN Official Journal of the European Union C 208/13

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— 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 11 January 2013, Dow AgroSciences Europe (the ‘applicant’) submitted, on behalf of Dow AgroSciences LLC, an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 (‘the stacked GM maize’) and sub-combinations thereof; whereas the application also covered the placing on the market of products containing or consisting of the stacked GM maize for uses other than food and feed, with the exception of cultivation;

B. whereas seven sub-combinations of the stacked GM maize have already been authorised, or are in the process of being authorised under a separate application; whereas the remaining three sub-combinations (MON 89034 × NK603 × DAS-40278-9, 1507 × NK603 × DAS-40278-9 and NK603 × DAS 40278-9) are covered by the draft Commission implementing decision;

C. whereas the stacked GM maize is derived from crossing four genetically modified (‘GM’) maize events, and confers tolerance to herbicides containing glufosinate, glyphosate, quizalofop and 2,4-D as well as producing three insecticidal proteins (‘Bt’ or ‘Cry’ proteins): Cry1A.105, Cry2Ab2 and Cry1F which are toxic to certain lepidopteran larvae (5);

D. whereas, on 28 November 2018, EFSA adopted a favourable opinion, which was published on 16 January 2019 (6);

E. 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;

F. whereas no data were submitted by the applicant to EFSA for the three sub-combinations within the scope of the draft Commission implementing decision (7);

Member State comments and independent study

G. whereas Member States submitted many critical comments to EFSA during the three-month consultation period (8); whereas those critical comments include the observation that the data provided by the applicant is insufficient to ensure a correct risk assessment, that the risk assessment conducted by EFSA is not sufficient in its present form, having failed to properly assess the overall safety and potential toxicity of the stacked GM maize event for humans, animals and the environment, that EFSA did not take into account recent studies about the potential toxicity of Bt toxins, and that it is impossible to reach conclusions concerning the health risks associated with the stacked GM maize without carrying out chronic feeding studies to properly assess organ and reproductive toxicity, and immune system responses, which take into account realistic residue levels of complementary herbicides and potential combinatorial and cumulative effects;

H. whereas an independent study (9) also concludes that the risk assessment by EFSA is not acceptable in its present form, having failed to properly assess the overall safety and potential toxicity of the stacked GM maize event;

(5) EFSA opinion, p. 10, Table 4. Lepidoptera is an order of insects that includes butterflies and moths. (6) Scientific opinion on the Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2013-112), EFSA Journal 2019; 17(1):5522, https://efsa.onlinelibrary.wiley.com/doi/ epdf/10.2903/j.efsa.2019.5522 (7) EFSA opinion, p. 20. (8) Member State comments on the stacked GM maize can be accessed via EFSA’s register of questions: http://registerofquestions.efsa. europa.eu/roqFrontend/login? (9) https://www.testbiotech.org/sites/default/files/Testbiotech_Comment_MON%2089034%20x%201507%20x%20NK603%20x% 20DAS40278-9.pdf C 208/14 EN Official Journal of the European Union 1.6.2021

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I. whereas that independent study finds that EFSA should have taken the results of the comparative analysis as a starting point for more detailed investigations, since the analysis revealed many significant differences between the stacked GM maize and its conventional counterpart, especially when the stacked GM maize was treated with complementary herbicides;

J. whereas the independent study further concludes that in light of those significant differences, chronic feeding studies and/or multigenerational studies should have been requested by EFSA, in order to be able to properly assess organ and reproductive toxicity and immune system responses, while taking into account the high amount of Bt toxins and realistic residue levels of complementary herbicides and potential combinatorial and cumulative effects;

Lack of assessment of herbicide residues, metabolites and cocktail effects

K. 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 stacked GM maize will be exposed to both higher and repeated doses of glufosinate, glyphosate, quizalofop and 2,4-D, and that therefore a higher quantity of residues may be present in the harvest;

L. whereas questions concerning the carcinogenicity of glyphosate remain; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency (ECHA) concluded in March 2017 that no classification was warranted; whereas, on the contrary, in 2015, the International Agency for Research on Cancer (IARC), the specialised cancer agency of the World Health Organization, classified glyphosate as a probable carcinogen for humans;

M. whereas, according to EFSA, toxicological data allowing a consumer risk assessment to be performed for several break-down products of glyphosate relevant for GM glyphosate-tolerant crops are missing (11);

N. 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 (12); whereas the approval of glufosinate for use in the Union expired on 31 July 2018 (13);

O. whereas a recent article by an expert involved in developing GM plants questions the safety of GM crops tolerant to 2,4-D because of its degradation into cytotoxic breakdown products (14);

(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) EFSA conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, EFSA Journal 2015; 13 (11):4302, p. 3, https://www.efsa.europa.eu/en/efsajournal/pub/4302 (12) 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). (13) https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=as.details&as_id=79 (14) Lurquin, P.F., ‘Production of a toxic metabolite in 2, 4-D-resistant GM crop plants’, 3 Biotech (2016), 6(1): 1-4, https://link.springer. com/article/10.1007/s13205-016-0387-9#CR25 1.6.2021 EN Official Journal of the European Union C 208/15

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P. whereas assessment of herbicide residues and their break-down products found on GM plants is considered outside the remit of the EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel) and is therefore not undertaken as part of the authorisation process for GMOs; whereas this is problematic since the way in which complementary herbicides are broken down by the GM plant concerned, and the composition and thus toxicity of the break-down products (‘metabolites’), can be driven by the genetic modification itself (15);

Q. whereas, due to specific agricultural practices in the cultivation of herbicide-tolerant GM plants, there are also specific patterns of herbicide application and therefore plant exposure, as well as the emergence of combinatorial effects between the different herbicide residues and their metabolites, that require special attention; whereas these were not considered by EFSA;

R. whereas it therefore cannot be concluded that consumption of the stacked GM maize or its sub-combinations is safe for human and animal health;

Lack of maximum residue levels and related controls

S. 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, specific maximum residue levels (MRLs) should be set for food and feed produced in third countries, when the use of pesticides results in levels of residues different from those resulting from agricultural practice within the Union; whereas this is indeed the case for imported herbicide-tolerant GM crops because of the increased volumes of herbicides used vis-à-vis non-GM crops;

T. whereas, however, according to a 2018 EFSA review of the existing MRLs for glyphosate, available data were insufficient to derive MRLs and risk assessment values for glyphosate in relation to GM maize with an EPSPS modification (17); whereas the stacked GM maize has the EPSPS modification (18);

U. whereas, again, under Regulation (EC) No 396/2005 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 (19);

V. whereas, under the latest coordinated multiannual control programme of the Union (for 2020, 2021 and 2022), Member States are not obliged to measure glufosinate (nor any other herbicide) on maize (GM or otherwise) (20); whereas it cannot be excluded that the stacked GM maize, its sub-combinations or products derived from it for food and feed will exceed MRLs, which should be put in place and monitored to ensure a high level of consumer protection;

(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). See recital 26. (17) Reasoned Opinion on the 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. 4. https://doi.org/10.2903/j.efsa.2018.5263 (18) EFSA opinion, p. 10, Table 4. (19) See recital 8 of Regulation (EC) No 396/2005. (20) 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). C 208/16 EN Official Journal of the European Union 1.6.2021

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Bt proteins

W. whereas a number of studies show that side effects have been observed that may affect the immune system following exposure to Bt proteins and that some Bt proteins may have adjuvant properties (21), meaning that they can increase the allergenicity of other proteins that they come into contact with;

X. whereas a minority opinion adopted by a member of the EFSA GMO Panel in the process of assessing another stacked GM maize and its sub-combinations found that, while unintended effects on the immune system have never been identified in any application where Bt proteins are expressed, they could ‘not be observed by the toxicological studies […] currently recommended and performed for the safety assessment of GM plants at EFSA because they do not include the appropriate tests for this purpose’ (22);

Y. whereas a recent study shows that a rapid rise in the use of neonicotinoid seed treatments in the United States coincides with increased planting of GM Bt maize (23); whereas the Union has banned the outdoor use of three neonicotinoids, including as seed coatings, because of their impact on honeybees and other pollinators (24);

Z. whereas assessment of the potential interaction of herbicide residues and their metabolites with Bt proteins is considered outside the remit of the EFSA GMO Panel and is therefore not undertaken as part of the risk assessment;

Undemocratic decision-making

AA. whereas the vote on 12 July 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 of 16 September 2019 of the Appeal Committee also delivered no opinion;

AB. 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 (25); whereas that practice has, on several occasions, been deplored by the Commission President as not being democratic (26);

AC. 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;

(21) 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. http://onlinelibrary.wiley.com/doi/10.1002/jat.3252/full (22) Application EFSA-GMO-DE-2010-86 (Bt11 × MIR162 × 1507 × GA21 maize and three sub combinations independently of their origin) Minority Opinion Wal, J.M., Member of the EFSA GMO Panel, EFSA Journal 2018; 16(7):5309, https://efsa.onlinelibrary. wiley.com/doi/epdf/10.2903/j.efsa.2018.5309, p. 34. (23) ‘Large-Scale Deployment of Seed Treatments Has Driven Rapid Increase in Use of Neonicotinoid Insecticides and Preemptive Pest Management in U.S. Field Crops’ Douglas, M.R., and Tooker, J.F., Environmental Science & Technology 2015, 49, 8, 5088-5097, Publication Date (Web): 20 March 2015, https://pubs.acs.org/doi/10.1021/es506141 g (24) https://ec.europa.eu/food/plant/pesticides/ approval_active_substances/approval_renewal/neonicotinoids_en (25) 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. (26) 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). 1.6.2021 EN Official Journal of the European Union C 208/17

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AD. 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 (27); 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 (28), 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. Calls 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 data submitted by the applicant; 10. Considers, more specifically, that to approve varieties for which no safety data have been provided, which have not even been tested, or which have not even been created yet, runs contrary to the principles of the general food law, as laid down in Regulation (EC) No 178/2002; 11. Calls on EFSA to further develop and systematically use methods that permit the identification of unintended effects of stacked GM events, such as in relation to the adjuvant properties of Bt toxins; 12. 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; 13. Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.

(27) 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)). (28) 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). C 208/18 EN Official Journal of the European Union 1.6.2021

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P9_TA(2019)0057 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 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 (D063846/02 — 2019/2860(RSP)) (2021/C 208/04)

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 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 (D063846/02,

— 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 16 September 2019, at which no opinion was delivered, and to the vote of the Appeal Committee on 11 October 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 (EFSA) on 27 February 2019, and published on 5 April 2019 (3),

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

(1) OJ L 268, 18.10.2003, p. 1. (2) OJ L 55, 28.2.2011, p. 13. (3) Scientific opinion on the Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2011-103), EFSA Journal 2019; 17(4):5635, https://www.efsa.europa.eu/en/efsajournal/pub/5635 (4) 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). 1.6.2021 EN Official Journal of the European Union C 208/19

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— 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 16 December 2011, Syngenta Crop Protection AG (the ‘applicant’) submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (‘the stacked GM maize’) and certain sub-combinations, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003; whereas the application also covered the placing on the market of products containing or consisting of the stacked GM maize for uses other than food and feed, with the exception of cultivation;

B. whereas the stacked GM maize is derived from crossing six genetically modified (‘GM’) maize events, and confers tolerance to herbicides containing glufosinate, and glyphosate as well as producing five insecticidal proteins (‘Bt’ or ‘Cry’ proteins): Cry1Ab, Vip3Aa20, mCry3A, Cry1F and eCry3.1Ab which are toxic to certain lepidopteran or coleopteran larvae (5);

C. whereas 22 sub-combinations of the stacked GM maize have already been authorised; whereas the draft Commission implementing decision covers the remaining 34 sub-combinations (6);

D. whereas, on 27 February 2019, EFSA adopted a favourable opinion, which was published on 5 April 2019 (7);

E. 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;

Member State comments and additional points

F. whereas Member States submitted many critical comments to EFSA during the three-month consultation period (8); whereas those critical comments include that neither whole plant toxicity studies with the stacked GM maize were undertaken, nor specific tests for potential combinatory effects of all transgenes contained in the stacked GM maize, that uncertainties about the effects of Cry toxins on mammals and humans persist, that the comparative assessment does not provide any evidence for safety, that the monitoring plan does not ensure that relevant information is gathered, nor does it comply with Directive 2001/18/EC of the European Parliament and of the Council (9) and that the possibility of interaction between the herbicide residues and their metabolites has not been studied, nor their levels measures;

G. whereas an independent study (10) finds that, inter alia, the toxicological assessment carried out by EFSA is not acceptable since the safety of the crop for import has not been demonstrated, that the assessment cannot be said to fulfil the requirements for assessing risks to the immune system and that the environmental risk assessment is not conclusive;

(5) EFSA opinion, p. 11, Table 4. (6) Six sub-combinations of five events (Bt11 × MIR162 × MIR604 × 1507 × 5307, Bt11 × MIR162 × MIR604 × 1507 × GA21, Bt11 × MIR162 × MIR604 × 5307 × GA21, Bt11 × MIR162 × 1507 × 5307 × GA21, Bt11 × MIR604 × 1507 × 5307 × GA21 and MIR162 × MIR604 × 1507 × 5307 × GA21); 12 sub-combinations of four events (Bt11 × MIR162 × MIR604 × 1507, Bt11 × MIR162 × MIR604 × 5307, Bt11 × MIR162 × 1507 × 5307, Bt11 × MIR162 × 5307 × GA21, Bt11 × MIR604 × 1507 × 5307, Bt11 × MIR604 × 5307 × GA21, Bt11 × 1507 × 5307 × GA21, MIR162 × MIR604 × 1507 × 5307, MIR162 × MIR604 × 1507 × GA21, MIR162 × MIR604 × 5307 × GA21, MIR162 × 1507 × 5307 × GA21 and MIR604 × 1507 × 5307 × GA21); 11 sub-combinations of three events (Bt11 × MIR162 × 5307, Bt11 × MIR604 × 5307, Bt11 × 1507 × 5307, Bt11 × 5307 × GA21, MIR162 × MIR604 × 1507, MIR162 × MIR604 × 5307, MIR162 × 1507 × 5307, MIR162 × 5307 × GA21, MIR604 × 1507 × 5307, MIR604 × 5307 × GA21 and 1507 × 5307 × GA21); and five subcombinations of two events (Bt11 × 5307, MIR162 × 5307, MIR604 × 5307, 1507 × 5307 and 5307 × GA21). (7) Scientific opinion on the Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2011-103), EFSA Journal 2019; 17(4):5635, https://www.efsa.europa.eu/en/efsajournal/pub/5635 (8) Member State comments on the stacked GM maize can be accessed via EFSA’s register of questions: http://registerofquestions.efsa. europa.eu/roqFrontend/login? (9) 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). (10) https://www.testbiotech.org/content/testbiotech-comment-bt11-mir162-mir604-1507-5307-GA21 C 208/20 EN Official Journal of the European Union 1.6.2021

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H. whereas, of the 34 sub-combinations assessed by EFSA, the applicant only provided studies relating to three of them (11); data was not provided by the applicant for the remaining 31 sub-combinations;

Lack of assessment of herbicide residues, metabolites and cocktail effects

I. 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 (12); whereas, as a consequence, it has to be expected that the stacked GM maize will be exposed to both higher and repeated doses of glufosinate and glyphosate, and that therefore a higher quantity of residues may be present in the harvest;

J. whereas questions concerning the carcinogenicity of glyphosate remain; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency (ECHA) concluded in March 2017 that no classification was warranted; whereas, on the contrary, in 2015, the International Agency for Research on Cancer (IARC), the specialised cancer agency of the World Health Organization, classified glyphosate as a probable carcinogen for humans;

K. whereas, according to EFSA, toxicological data allowing a consumer risk assessment to be performed for several break-down products of glyphosate relevant for GM glyphosate-tolerant crops are missing (13);

L. 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 (14); whereas the approval of glufosinate for use in the Union expired on 31 July 2018 (15);

M. whereas assessment of herbicide residues and their break-down products found on GM plants is considered outside the remit of the EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel) and is therefore not undertaken as part of the authorisation process for GMOs; whereas this is problematic since the way in which complementary herbicides are broken down by the GM plant concerned, and the composition and thus toxicity of the break-down products (‘metabolites’), can be driven by the genetic modification itself (16);

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

O. whereas it therefore cannot be concluded that consumption of the stacked GM maize or its sub-combinations is safe for human and animal health;

(11) EFSA opinion, p. 24. (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) EFSA conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, EFSA journal 2015; 13(11):4302, p. 3, https://www.efsa.europa.eu/en/efsajournal/pub/4302 (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) https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=as.details&as_id=79 (16) 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 1.6.2021 EN Official Journal of the European Union C 208/21

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Lack of maximum residue levels and related controls

P. whereas, under Regulation (EC) No 396/2005 of the European Parliament and of the Council (17), which aims to ensure a high level of consumer protection, specific maximum residue levels (MRLs) should be set for food and feed produced in third countries, when the use of pesticides results in levels of residues different from those resulting from agricultural practice within the Union; whereas this is indeed the case for imported herbicide-tolerant GM crops because of the increased volumes of herbicides used vis-à-vis non-GM crops;

Q. whereas, however, according to a 2018 EFSA review of the existing MRLs for glyphosate, available data were insufficient to derive MRLs and risk assessment values for glyphosate in relation to GM maize with an EPSPS modification (18); whereas the stacked GM maize has the EPSPS modification (19);

R. whereas, again, under Regulation (EC) No 396/2005 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 (20);

S. whereas under the latest coordinated multiannual control programme of the Union (for 2020, 2021 and 2022), Member States are not obliged to measure glufosinate (nor glyphosate) on maize (GM or otherwise) (21); whereas it cannot be excluded that the stacked GM maize, its sub-combinations or products derived from it for food and feed will exceed MRLs, which should be put in place and monitored to ensure a high level of consumer protection;

Bt proteins

T. whereas a number of studies show that side effects have been observed that may affect the immune system following exposure to Bt proteins and that some Bt proteins may have adjuvant properties (22), meaning that they can increase the allergenicity of other proteins that they come into contact with;

U. whereas a minority opinion adopted by a member of the EFSA GMO Panel in the process of assessing another stacked GM maize and its sub-combinations found that, while unintended effects on the immune system have never been identified in any application where Bt proteins are expressed, they could ‘not be observed by the toxicological studies […] currently recommended and performed for the safety assessment of GM plants at EFSA because they do not include the appropriate tests for this purpose’ (23);

(17) 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). See recital 26. (18) Reasoned Opinion on the 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. 4. https://doi.org/10.2903/j.efsa.2018.5263 (19) EFSA opinion, p. 12. (20) See recital 8 of Regulation (EC) No 396/2005. (21) 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). (22) 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. http://onlinelibrary.wiley.com/doi/10.1002/jat.3252/full (23) Application EFSA-GMO-DE-2010-86 (Bt11 x3 MIR162 x3 1507 x3 GA21 maize and three sub combinations independently of their origin), Minority Opinion, Wal, J.M., Member of the EFSA GMO Panel, EFSA Journal 2018; 16(7):5309, https://efsa. onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5309, p. 34. C 208/22 EN Official Journal of the European Union 1.6.2021

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V. whereas a recent study shows that a rapid rise in the use of neonicotinoid seed treatments in the United States coincides with increased planting of GM Bt maize (24); whereas the Union has banned the outdoor use of three neonicotinoids, including as seed coatings, because of their impact on honeybees and other pollinators (25);

W. whereas assessment of the potential interaction of herbicide residues and their metabolites with Bt proteins is considered outside the remit of the EFSA GMO Panel and is therefore not undertaken as part of the risk assessment;

Undemocratic decision-making

X. whereas the vote on 16 September 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 11 October 2019 of the Appeal Committee also delivered no opinion;

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 (26); whereas that practice has, on several occasions, been deplored by the Commission President as not being democratic (27);

Z. 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;

AA. 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 (28);

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 (29), 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;

(24) ‘Large-Scale Deployment of Seed Treatments Has Driven Rapid Increase in Use of Neonicotinoid Insecticides and Preemptive Pest Management in U.S. Field Crops’, Douglas, M.R., and Tooker, J.F., Environmental Science and Technology 2015, 49, 8, 5088-5097, Publication Date (Web): 20 March 2015, https://pubs.acs.org/doi/10.1021/es506141 g (25) https://ec.europa.eu/food/plant/pesticides/approval_active_substances/ approval_renewal/neonicotinoids_en (26) 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. (27) 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). (28) 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)). (29) 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). 1.6.2021 EN Official Journal of the European Union C 208/23

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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. Calls 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 data submitted by the applicant; 10. Considers, more specifically, that to approve varieties for which no safety data have been provided, which have not even been tested, or which have not even been created yet, runs contrary to the principles of the general food law, as laid down in Regulation (EC) No 178/2002; 11. Calls on EFSA to further develop and systematically use methods that permit the identification of unintended effects of stacked GM events, such as in relation to the adjuvant properties of Bt toxins; 12. 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; 13. Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States. C 208/24 EN Official Journal of the European Union 1.6.2021

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P9_TA(2019)0058 Criminalisation of sexual European Parliament resolution of 14 November 2019 on the criminalisation of sexual education in Poland (2019/2891(RSP)) (2021/C 208/05)

The European Parliament,

— having regard to the Universal Declaration of Human Rights of 10 December 1948,

— having regard to the United Nations Sustainable Development Goals (SDGs),

— having regard to the Council of Europe Convention on preventing and combating violence against women and domestic violence (Istanbul Convention), which opened for signature on 11 May 2011,

— having regard to the Council of Europe Convention on the Protection of Children against Sexual Exploitation and Sexual Abuse (Lanzarote Convention) of 25 October 2007,

— having regard to the Convention on the Elimination of all Forms of Discrimination against Women (CEDAW) of 18 December 1979,

— having regard to the Convention on the Rights of the Child (CRC) of 20 November 1989,

— having regard to the Charter of Fundamental Rights of the European Union (hereinafter ‘the Charter’),

— having regard to the Beijing Declaration and Platform for Action adopted by the Fourth World Conference on Women on 15 September 1995 and to the subsequent outcome documents adopted at the United Nations Beijing+5 (2005), Beijing + 15 (2010) and Beijing + 20 (2015) special sessions,

— having regard to the International Conference on Population and Development held in Cairo in 1994 and its programme of action,

— having regard to UNESCO’s 2018 International Technical Guidance on Sexuality Education,

— having regard to the 2014 Operational Guidance for Comprehensive Sexuality Education of the United Nations Population Fund (UNFPA),

— having regard to the Standards for Sexuality Education in Europe developed by the World Health Organisation (WHO) Regional Office for Europe and the German Federal Centre for Health Education,

— having regard to the Council of Europe’s Human Rights Commissioner’s report of 4 December 2017 entitled ‘Women's sexual and reproductive health and rights in Europe’,

— having regard to the judgment of the European Court of Human Rights (ECHR) of 20 June 2017 in the case Bayev and Others v. Russia, 1.6.2021 EN Official Journal of the European Union C 208/25

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— having regard to Directive 2011/93/EU of the European Parliament and of the Council of 13 December 2011 on combating the sexual abuse and sexual exploitation of children and child pornography (1), and replacing Council Framework Decision 2004/68/JHA of 22 December 2003 on combating the sexual exploitation of children and child pornography (2),

— having regard to the ‘European Union lesbian, gay, bisexual and transgender survey’ published by the European Union Agency for Fundamental Rights (FRA) in 2019,

— having regard to its previous resolutions on Poland, and, in particular, its resolution adopted on 15 November 2017 on the situation of the rule of law and democracy in Poland (3),

— having regard to the mission report of 10 July 2017 by the Committee on Women’s Rights and Gender Equality following its mission to Poland of 22 — 24 May 2017,

— having regard to the mission report of 3 December 2018 by the Committee on Civil Liberties, Justice and Home Affairs following the sending of an ad hoc delegation to Poland on the situation of the rule of law (19 — 21 September 2018),

— having regard to its resolution of 13 February 2019 on experiencing a backlash in women’s rights and gender equality in the EU (4),

— having regard to Rule 132(2) of its Rules of Procedure,

A. whereas on 17 July 2019, a citizens’ initiative for a law amending Article 200b of the Polish Penal Code was submitted to the by the ‘Stop Paedophilia’ initiative;

B. whereas on 15 October 2019, following the parliamentary election and resumption of a suspended parliamentary session, the Sejm debated the draft law at first reading and on 16 October 2019 voted down a motion to reject the bill; whereas legislative consideration of the draft law is expected to resume following the opening session of the newly elected Sejm on 12 November 2019;

C. whereas the purported purpose of the bill is to amend the existing laws on preventing and tackling paedophilia; whereas the equation of promoting paedophilia with providing comprehensive sexuality education for young people is alarming, misguided and detrimental;

D. whereas the new provisions of the draft law provide that anyone who publicly promotes or approves minors engaging in sexual intercourse would be subject to a penalty of up to two years in prison;

E. whereas the above provisions also apply to instances of using mass communication to promote or approve minors engaging in sexual intercourse or other sexual activity, and in the context of occupations related to the education, treatment or care or guardianship of minors, with a penalty of up to three years in prison; whereas proposals have been made to further increase this penalty to five years;

F. whereas such provisions would effectively criminalise the provision of comprehensive sexuality education to minors under the guise of preventing paedophilia, which would have an impact on, inter alia, educators, activists, healthcare providers, psychologists, publishers and journalists and even parents or legal guardians;

G. whereas the constitutional principle of proportionality implies that lawmakers do not have unfettered discretion to lay down rules of criminal law and that the criminal law should only be used as a last-resort measure, thus complying with the ultima ratio principle; whereas this draft law would violate that principle;

(1) OJ L 335, 17.12.2011, p. 1. (2) OJ L 13, 20.1.2004, p. 44. (3) OJ C 356, 4.10.2018, p. 44. (4) Texts adopted, P8_TA(2019)0111. C 208/26 EN Official Journal of the European Union 1.6.2021

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H. whereas Poland has ratified the Istanbul Convention, the Lanzarote Convention, CEDAW and the CRC, and is obliged under international human rights law to provide access to comprehensive sexuality education and information, including on the risks of sexual exploitation and abuse, and to challenge gender stereotypes in society;

I. whereas providing some form of sexuality and health education is already mandatory in 20 Member States; whereas some Member States, including Poland, have failed to comply with the Standards for Sexuality Education in Europe developed by the WHO;

J. whereas comprehensive sexuality education is a curriculum-based process of teaching and learning about the cognitive, emotional, physical and social aspects of sexuality, and aims to equip children and young people with knowledge, skills, attitudes and values that will empower them to safeguard their health, wellbeing and dignity; whereas comprehensive sexuality education would allow children and young people to develop respectful social and sexual relationships while considering how their choices affect their own wellbeing and that of others; whereas it would also allow children and young people to understand and secure the protection of their rights throughout their lives;

K. whereas providing comprehensive sexuality education is one of the main instruments for achieving the commitments of the 25th anniversary of the International Conference on Population and Development (ICPD25), namely zero unmet need for family planning, zero preventable maternal deaths, and zero gender-based violence and harmful practices against women, girls and young people;

L. whereas, according to the Charter, the ECHR and the case law of the European Court of Human Rights, women’s sexual and reproductive health is related to multiple human rights, including the right to life and dignity, freedom from inhuman and degrading treatment, the right to access healthcare, the right to privacy, the right to education and the prohibition of discrimination, as is also reflected in the Polish Constitution;

M. whereas the draft law can be seen as an additional attempt to limit sexual and reproductive rights in Poland in recent years; whereas the attempt to further limit the right to abortion was halted in 2018 as a result of mass opposition from Polish citizens as expressed in the ‘Black Friday’ marches;

N. whereas the ECHR has indicated that in sensitive matters, such as during the public discussion of sexuality education, where parental views, educational policies and the right of third parties to freedom of expression must be balanced, the authorities have no choice but to resort to the criteria of objectivity, pluralism, scientific accuracy and, ultimately, the usefulness of a particular type of information to the young audience;

O. whereas many children and teenagers are first learning about intimate relations from pornography, especially online, and from conflicting messages from their peers; whereas in this context, sexuality education becomes even more essential in order to provide the tools needed for young people to safely navigate the internet and social media and not to fall victim to online grooming, to help them make sense of the content seen, and to identify fact-based information and the presence of gender stereotypes and sexism;

P. whereas minors can face barriers to accessing contraception, such as restrictive laws and policies regarding the provision of contraceptives, in addition to a lack of knowledge; whereas even where adolescents are able to obtain contraceptives, they can be prevented from doing so due to stigma surrounding non-marital sexual activity and/or contraceptive use, fear of side-effects, or lack of knowledge as to how to correctly use contraceptives; whereas under Polish law regarding the age of consent, teenagers over the age of 15 are legally competent to consent to sexual acts; whereas they still require their guardian’s consent in order to receive a prescription for contraceptives; 1.6.2021 EN Official Journal of the European Union C 208/27

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Q. whereas sexual violence is widespread, affecting minors in particular, and should be eradicated; whereas teenage pregnancy remains a major social issue and can contribute to maternal and child mortality; whereas comprehensive sexuality education helps to deconstruct gender stereotypes and prevent gender-based violence;

1. Recalls that sexual health is fundamental to the overall health and wellbeing of individuals, couples and families, in addition to the social and economic development of communities and countries, and that access to health, including sexual and reproductive health, is a human right;

2. Expresses its deep concern over the extremely vague, broad and disproportionate provisions in the draft law, which de facto seeks to criminalise the dissemination of sexuality education to minors and whose scope potentially threatens all persons and in particular sex educators, including teachers, healthcare providers, authors, publishers, civil society organisations, journalists and parents or legal guardians, with up to three years in prison for teaching about human sexuality, health and intimate relations; remains concerned that this draft law would have a chilling effect on educators and that one of the main barriers to sexuality education is the fact that educators are not supported;

3. Strongly reiterates that access to comprehensive and age-appropriate information about sex and sexuality and access to sexual and reproductive healthcare, including sexuality education, family planning, contraceptive methods and safe and legal abortion, is essential for the creation of a positive and respectful approach to sexuality and sexual relationships, in addition to the possibility of having safe sexual experiences, free from coercion, discrimination and violence; encourages all Member States to introduce comprehensive age-appropriate sexuality and relationship education for young people in schools;

4. Recalls that such education is a necessary part of the school curriculum to meet the WHO standards for Europe to educate and protect young people; affirms that such education should include topics like sexual orientation and gender identity, sexual expression, relationships and affirmative consent, and information about negative outcomes or conditions such as sexually transmitted infections (STIs) and HIV, unintended pregnancy, sexual violence and harmful practices such as grooming and female genital mutilation;

5. Recalls that education, in addition to being a standalone fundamental right, is a precondition for the enjoyment of other fundamental rights and freedoms as guaranteed by Article 2 of the Treaty on European Union (TEU), the Polish Constitution and the Charter; stresses that rather than protecting young people, a lack of information and education about sex and sexuality puts the safety and wellbeing of young people at risk by leaving them more vulnerable and less equipped to identify sexual exploitation, abuse and violence, including domestic violence and online forms of abuse such as cyber violence, online harassment and revenge porn; believes that comprehensive sexuality education also has a positive impact on gender equality outcomes, including transforming harmful gender norms and attitudes towards gender-based violence, helping prevent intimate partner violence and sexual coercion, breaking the silence around sexual violence, sexual exploitation or abuse, and empowering young people to seek help;

6. Stresses the importance of health and sexuality education, in particular for girls and young LGBTI people, who are particularly impacted by inequitable gender norms; stresses such education must include teaching young people about relationships based on gender equality, consent and mutual respect as a way of preventing and combating gender stereotypes, homophobia, transphobia and gender-based violence; notes that sexuality education does not result in earlier sexual activity;

7. Recalls that Article 23 of Directive 2011/93/EU calls on the Member States, including Poland, to take appropriate measures with relevant civil society organisations in order to raise awareness and reduce the risk of children becoming victims of sexual abuse or exploitation;

8. Recognises the important role of civil society in providing sexuality education; calls for adequate funding to be available for the organisations concerned through different funding instruments at EU level, such as the Multiannual Financial Framework 2021 — 2027 Rights and Values programme and other EU pilot projects that could have an impact on this field; C 208/28 EN Official Journal of the European Union 1.6.2021

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9. Condemns the recent developments in Poland that set out to misinform, stigmatise and ban sexuality education, and in particular the harsh, inappropriate and erroneous content of the justification provided for by the draft law; calls on the Polish Parliament to refrain from adopting the proposed draft law and to ensure that young people have access to comprehensive sexuality education and that those who provide such education and information are supported in so doing in a factual and objective manner; 10. Calls on the Council to address this matter and other allegations of violations of fundamental rights in Poland in the context of its current hearings on the situation in Poland, in accordance with Article 7(1) TEU; 11. Instructs its President to forward this resolution to the Commission and the Council, the President, Government and Parliament of Poland and the governments and parliaments of the Member States. 1.6.2021 EN Official Journal of the European Union C 208/29

Thursday 14 November 2019

II

(Information)

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

EUROPEAN PARLIAMENT

P9_TA(2019)0051 Request for waiver of the immunity of José Manuel Fernandes European Parliament decision of 14 November 2019 on the request for waiver of the immunity of José Manuel Fernandes (2019/2005(IMM)) (2021/C 208/06)

The European Parliament,

— having regard to the request for waiver of the immunity of José Manuel Fernandes, forwarded on 26 November 2018 by the Porto Department of Criminal Investigation and Prosecution, in connection with procedure No 1406/14.3TDPRT and announced in plenary on 31 January 2019,

— having heard José Manuel Fernandes in accordance with Rule 9(6) of its Rules of Procedure,

— having regard to Articles 8 and 9 of Protocol No 7 on the Privileges and Immunities of the European Union, and to Article 6(2) of the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage,

— having regard to the judgments of the Court of Justice of the European Union of 12 May 1964, 10 July 1986, 15 and 21 October 2008, 19 March 2010, 6 September 2011 and 17 January 2013 (1),

— having regard to Article 157 of the Constitution of the Portuguese Republic,

— having regard to Rule 5(2), Rule 6(1) and Rule 9 of its Rules of Procedure,

— having regard to the report of the Committee on Legal Affairs (A9-0023/2019),

A. whereas the Porto Department of Criminal Investigation and Prosecution has requested the waiver of the immunity of José Manuel Fernandes, Member of the European Parliament, in connection with a possible legal action concerning an alleged crime of malfeasance, provided for in and punishable under Article 11 of Portuguese Law 34/87 of 16 July, which carries a prison sentence of two to eight years;

(1) Judgment of the Court of Justice of 12 May 1964, Wagner v Fohrmann and Krier, 101/63, ECLI:EU:C:1964:28; judgment of the Court of Justice of 10 July 1986, Wybot v Faure and others, 149/85, ECLI:EU:C:1986:310; judgment of the General Court of 15 October 2008, Mote v Parliament, T-345/05, ECLI:EU:T:2008:440; judgment of the Court of Justice of 21 October 2008, Marra v De Gregorio and Clemente, C 200/07 and C-201/07, ECLI:EU:C:2008:579; judgment of the General Court of 19 March 2010, Gollnisch v Parliament, T-42/06, ECLI:EU:T:2010:102; judgment of the Court of Justice of 6 September 2011, Patriciello, C 163/10, ECLI:EU:C:2011:543; judgment of the General Court of 17 January 2013, Gollnisch v Parliament, T-346/11 and T-347/11, ECLI:EU:T:2013:23. C 208/30 EN Official Journal of the European Union 1.6.2021

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B. whereas the legal proceeding does not concern opinions expressed or votes cast in the performance of the duties of the Member of the European Parliament for the purposes of Article 8 of Protocol No 7 on the Privileges and Immunities of the European Union; C. whereas Article 9 of Protocol No 7 on the Privileges and Immunities of the European Union states that Members of the European Parliament enjoy, in the territory of their own state, the immunities accorded to members of the parliament of that state; D. whereas Article 157(2) and (3) of the Constitution of the Portuguese Republic provides that: ‘2. Members of the Assembly of the Republic may not appear as makers of declarations or accused persons without the Assembly’s authorisation. In the latter case, the Assembly shall obligatorily decide in favour of authorisation when there are strong indications of the commission of a wilful crime punishable by imprisonment for a maximum term of more than three years. 3. No Member of the Assembly of the Republic may be detained, arrested or imprisoned without the Assembly’s authorisation, save for a wilful crime punishable by the type of prison term referred to by the previous paragraph and in flagrante delicto.’; E. whereas José Manuel Fernandes — in his capacity as Mayor of Vila Verde and in the performance of his tasks in that role and in collusion with others — is under investigation for allegedly violating the general principles of public procurement rules, and specifically, the principles of impartiality, neutrality, competition and transparency, by putting a company in a more favourable position than its competitors, and allegedly participating in the prior preparation and completion of documents required for the tender procedure; whereas that company was awarded the tender on 22 December 2008; F. whereas, pursuant to Rule 9(8) of the Rules of Procedure, the Committee on Legal Affairs shall not, under any circumstances, pronounce itself on the guilt or otherwise of the Member, nor on whether or not the opinions or acts attributed to him justify prosecution, even if, in considering the request, the Committee acquires detailed knowledge of the facts of the case; G. whereas in accordance with Rule 5(2) of the Rules of Procedure, parliamentary immunity is not a Member’s personal privilege but a guarantee of the independence of Parliament as a whole and of its Members; H. whereas José Manuel Fernandes asked for his immunity to be waived; whereas it is for Parliament alone to decide, in a given case, whether or not to waive immunity; whereas Parliament may reasonably take account of the position of the Member in order to decide whether or not to waive his or her immunity (2); I. whereas the purpose of parliamentary immunity is to protect Parliament and its Members from legal proceedings in relation to activities carried out in the performance of parliamentary duties and which cannot be separated from those duties; J. whereas in this case, Parliament has found no evidence of fumus persecutionis, i.e. factual elements which indicate that the intention underlying the legal proceeding may be to damage a Member’s political activity and thus the European Parliament; 1. Decides to waive the immunity of José Manuel Fernandes; 2. Instructs its President to forward this decision and the report of its committee responsible immediately to the Portuguese authorities and to José Manuel Fernandes.

(2) Judgment of the General Court of 15 October 2008, Mote v Parliament, T-345/05, ECLI:EU:T:2008:440, paragraph 28. 1.6.2021 EN Official Journal of the European Union C 208/31

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III

(Preparatory acts)

EUROPEAN PARLIAMENT

P9_TA(2019)0052 Distance sales of goods and certain domestic supplies of goods * European Parliament legislative resolution of 14 November 2019 on the proposal for a Council directive amending Council Directive 2006/112/EC of 28 November 2006 as regards provisions relating to distance sales of goods and certain domestic supplies of goods (COM(2018)0819 — C8-0017/2019 — 2018/0415(CNS)) (Special legislative procedure — consultation) (2021/C 208/07)

The European Parliament, — having regard to the Commission proposal to the Council (COM(2018)0819), — having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0017/2019), — having regard to Rule 82 of its Rules of Procedure, — having regard to the report of the Committee on Economic and Monetary Affairs (A9-0019/2019), 1. Approves the Commission proposal as amended; 2. Calls on the Commission to alter its proposal accordingly, in accordance with Article 293(2) of the Treaty on the Functioning of the European Union; 3. Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament; 4. Asks the Council to consult Parliament again if it intends to substantially amend the Commission proposal; 5. Instructs its President to forward its position to the Council, the Commission and the national parliaments. C 208/32 EN Official Journal of the European Union 1.6.2021

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Amendment 1 Proposal for a directive Recital 1

Text proposed by the Commission Amendment

(1) Council Directive 2006/112/EC (3) as amended by (1) Council Directive 2006/112/EC (3) as amended by Council Directive (EU) 2017/2455 (4) provides that where Council Directive (EU) 2017/2455 (4) provides that where a taxable person facilitates, through the use of an a taxable person facilitates, through the use of an electronic interface such as a marketplace, platform, electronic interface such as a marketplace, platform, portal or other similar means, distance sales of goods portal or other similar means, distance sales of goods imported from third territories or third countries in imported from third territories or third countries in consignments of an intrinsic value not exceeding EUR 150 consignments of an intrinsic value not exceeding EUR 150 or the supply of goods within the Community by or the supply of goods within the Community by a taxable person not established within the Community a taxable person not established within the Community to a non-taxable person, the taxable person who to a non-taxable person, the taxable person who facilitates the supply shall be deemed to have received facilitates the supply shall be deemed to have received and supplied the goods himself. As this provision splits and supplied the goods himself. As this provision splits a single supply into two supplies, it is necessary to a single supply into two supplies, it is necessary to determine to which of these supplies the dispatch or determine to which of these supplies the dispatch or transport of the goods should be ascribed in order to transport of the goods should be ascribed in order to properly determine their place of supply. properly determine their place of supply. It is also necessary to ensure that the chargeable event of those (3) Council Directive 2006/112/EC of 28 November 2006 on the two supplies occurs at the same time. common system of value added tax (OJ L 347, 11.12.2006, p. 1). 4 ( ) Council Directive (EU) 2017/2455 of 5 December 2017 (3) Council Directive 2006/112/EC of 28 November 2006 on the amending Directive 2006/112/EC and Directive 2009/132/EC common system of value added tax (OJ L 347, 11.12.2006, p. 1). as regards certain value added tax obligations for supplies of (4) Council Directive (EU) 2017/2455 of 5 December 2017 services and distance sales of goods (OJ L 348, 29.12.2017, p. 7). amending Directive 2006/112/EC and Directive 2009/132/EC as regards certain value added tax obligations for supplies of services and distance sales of goods (OJ L 348, 29.12.2017, p. 7).

Amendment 2 Proposal for a directive Recital 2

Text proposed by the Commission Amendment

(2) While a taxable person who facilitates through the use of (2) While a taxable person who facilitates through the use of an electronic interface the supply of goods to a non-tax­ an electronic interface the supply of goods to a non-tax­ able person in the Community may deduct, in accordance able person in the Community may deduct, in accordance with existing rules, the VAT paid to suppliers not with existing rules, the VAT paid to suppliers not established in the Community, the risk is that the latter established in the Community, the risk is that the latter may not pay the VAT to the tax authorities. To avoid that may not pay the VAT to the tax authorities. To avoid that risk, the supply from the supplier selling goods through risk, the supply from the supplier selling goods through the use of an electronic interface should be exempt from the use of an electronic interface should be exempt from VAT while that supplier should be granted the right to VAT while that supplier should be granted the right to deduct the input VAT which it paid in respect of the deduct the input VAT which it paid in respect of the purchase or import of the goods supplied. purchase or import of the goods supplied. For that purpose, the supplier should always be registered in the Member State where the supplier acquired or imported those goods. 1.6.2021 EN Official Journal of the European Union C 208/33

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Amendment 3 Proposal for a directive Article 1 — paragraph 1 — point 1 a (new) Directive 2006/112/EC Article 66 a (new)

Text proposed by the Commission Amendment

(1a) the following article is inserted: ‘Article 66a By way of derogation from Articles 63, 64 and 65, the chargeable event in respect of a supply of goods by a taxable person who is deemed to have received and supplied the goods in accordance with Article 14a and of the supply to that taxable person shall occur and VAT shall become chargeable at the time when the payment has been accepted.’

Amendment 4 Proposal for a directive Article 1 — paragraph 1 — point 4 a (new) Directive 2006/112/EC Article 272 — paragraph 1 — subparagraph 1– point b

Present text Amendment

(4a) in the first subparagraph of Article 272(1), point (b) is replaced by the following:

‘(b) taxable persons carrying out none of the transactions ‘(b) taxable persons carrying out none of the transactions referred to in Articles 20, 21, 22, 33, 36, 138 and 141;’ referred to in Articles 20, 21, 22, 33, 36, 136a, 138 and 141;’

Amendment 5 Proposal for a directive Article 1 — paragraph 1 — point 7 — point a Directive 2006/112/EC Article 369a — paragraph 1 — point 3 — point c

Text proposed by the Commission Amendment

(c) in the case of the supply of goods made by an electronic (c) in the case of the supply of goods made by a taxable person interface facilitating those supplies in accordance with facilitating those supplies in accordance with paragraph 2 of paragraph 2 of Article 14a where the dispatch or transport Article 14a where the dispatch or transport of the goods of the goods supplied begins and ends in the same Member supplied begins and ends in the same Member State, that State, that Member State.’; Member State.’; C 208/34 EN Official Journal of the European Union 1.6.2021

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Amendment 6 Proposal for a directive Article 1 — paragraph 1 — point 7 — point b Directive 2006/112/EC Article 369a — paragraph 2 a (new)

Text proposed by the Commission Amendment

(b) the following third paragraph is added: (b) the following paragraph is added:

‘Where a taxable person has not established his business in ‘Where a taxable person has not established his business in the Community and has no fixed establishment therein, the the Community and has no fixed establishment therein, the Member State of identification shall be the Member State Member State of identification shall be the Member State in from which the goods are dispatched or transported. Where which the dispatch or transport of the goods begins. Where there is more than one Member State from which goods are there is more than one Member State in which the dispatch dispatched or transported, the taxable person shall indicate or transport of the goods begins, the taxable person shall which of those Member States shall be the Member State of indicate which of those Member States shall be the Member identification. The taxable person shall be bound by this State of identification. The taxable person shall be bound by decision for the calendar year concerned and the two that decision for the calendar year concerned and the two calendar years following.’ calendar years following.’

Amendment 7 Proposal for a directive Article 1 — paragraph 1 — point 11 Directive 2006/112/EC Article 369 g — paragraph 1 — point a

Text proposed by the Commission Amendment

(a) intra-Community distance sales of goods and supplies of (a) intra-Community distance sales of goods and supplies of goods in accordance with paragraph 2 of Article 14a where goods; the dispatch or transport of those goods begins and ends in the same Member State;

(aa) supplies of goods in accordance with paragraph 2 of Article 14a where the dispatch or transport of those goods begins and ends in the same Member State; 1.6.2021 EN Official Journal of the European Union C 208/35

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Amendment 8 Proposal for a directive Article 1 — paragraph 1 — point 11 a (new) Directive 2006/112/EC Article 369 g — paragraph 2 a (new)

Text proposed by the Commission Amendment

(11a) in Article 369 g, the following paragraph is added: ‘2a. Where the taxable person supplying services covered by the special scheme has one or more fixed establishments, other than that in the Member State of identification, from which the services are supplied, the VAT return shall also include the total value exclusive of VAT, the applicable rates of VAT, the total amount per rate of the corresponding VAT and the total VAT due of such supplies, for each Member State in which the taxable person has an establishment, together with the individual VAT identification number or the tax reference number of each establishment, broken down by Member State of consumption.’.

Amendment 9 Proposal for a directive Article 1 — paragraph 1 — point 12 Directive 2006/112/EC Article 369zb — paragraph 2

Text proposed by the Commission Amendment

‘2. Member States shall require that the VAT referred to in ‘2. Member States shall require that the VAT referred to in paragraph 1 is payable monthly. The deadline for payment is paragraph 1 is payable monthly by the deadline for payment that applicable to the payment of the import duty in similar applicable to the payment of the import duty.’. situations.’. C 208/36 EN Official Journal of the European Union 1.6.2021

Thursday 14 November 2019

P9_TA(2019)0053 Mobilisation of the European Globalisation Adjustment Fund — EGF/2019/001 BE/ Carrefour — Belgium European Parliament resolution of 14 November 2019 on the proposal for a decision of the European Parliament and of the Council on the mobilisation of the European Globalisation Adjustment Fund (application from Belgium — EGF/2019/001 BE/Carrefour) (COM(2019)0442 — C9-0127/2019 — 2019/2114(BUD)) (2021/C 208/08)

The European Parliament,

— having regard to the Commission proposal to the European Parliament and the Council (COM(2019)0442 — C9-0127/2019),

— having regard to Regulation (EU) No 1309/2013 of the European Parliament and of the Council of 17 December 2013 on the European Globalisation Adjustment Fund (2014-2020) and repealing Regulation (EC) No 1927/2006 (1) (EGF Regulation),

— having regard to Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (2), and in particular Article 12 thereof,

— having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (3) (IIA of 2 December 2013), and in particular point 13 thereof,

— having regard to the trilogue procedure provided for in point 13 of the IIA of 2 December 2013,

— having regard to the letter of the Committee on Employment and Social Affairs,

— having regard to the report of the Committee on Budgets (A9-0021/2019),

A. whereas the Union has set up legislative and budgetary instruments to provide additional support to workers who are suffering from the consequences of major structural changes in world trade patterns or of the global financial and economic crisis, and to assist their reintegration into the labour market; whereas this assistance is made through a financial support given to workers and the companies for which they worked;

B. whereas the Union’s financial assistance to workers made redundant should be dynamic and made available as quickly and efficiently as possible; whereas this case involves a particularly vulnerable age group, in which more than 81 % of workers are between 55 and 64 years old;

C. whereas Belgium submitted application EGF/2019/001 BE/Carrefour for a financial contribution from the EGF, following 751 redundancies during the reference period in the economic sector classified under the NACE Revision 2 Division 47 (Retail trade, except motor vehicles and motorcycles), between 30 November 2018 and 30 March 2019; whereas an additional 268 workers were made redundant before or after the reference period; whereas, according to Commission, a clear causal link can be established with the event that triggered the redundancies during the reference period; whereas no other funds or programmes were deployed in relation to the facts described in the application submitted by Belgium;

(1) OJ L 347, 20.12.2013, p. 855. (2) OJ L 347, 20.12.2013, p. 884. (3) OJ C 373, 20.12.2013, p. 1. 1.6.2021 EN Official Journal of the European Union C 208/37

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D. whereas the application is based on the intervention criteria of point (a) of Article 4(1) of the EGF Regulation, which requires at least 500 workers being made redundant over a reference period of four months in an enterprise in a Member State, including workers made redundant by suppliers and downstream producers and / or self-employed persons whose activity has ceased;

E. whereas in accordance with Article 6(2) of Regulation (EU) No 1309/2013, Belgium has decided to also provide personalised services, co-financed by the EGF, to 330 young persons who are not in employment, education or training (NEETs);

1. Agrees with the Commission that the conditions set out in Article 4(1) of the EGF Regulation are met and that Belgium is entitled to a financial contribution of EUR 1 632 028 under that Regulation, which represents 60 % of the total cost of EUR 2 720 047, comprising expenditure for personalised services of EUR 2 665 047 and expenditure for preparatory, management, information and publicity, control and reporting activities of EUR 55 000;

2. Notes that the Belgian authorities submitted the application on 20 June 2019, and that, following the provision of additional information by Belgium, the Commission finalised its assessment on 4 October 2019 and notified it to Parliament on the same day;

3. Notes that Belgium started providing personalised services to the targeted beneficiaries on 1 December 2018 and that the period of eligibility for a financial contribution from the EGF will therefore be from 1 December 2018 to 20 June 2021;

4. Notes that Belgium started incurring administrative expenditure to implement the EGF on 25 January 2018 and that expenditure on preparatory, management, information and publicity, control and reporting activities between 25 January 2018 and 20 December 2021 will therefore be eligible for a financial contribution from the EGF;

5. Recalls that the design of the coordinated package of personalised services should also anticipate emerging labour market developments, with a special focus on the shift towards a source-efficient and sustainable economy;

6. Recalls that this is the 14th EGF application from Belgium, and that those applications have covered a variety of sectors: automotive, manufacture of basic metals, textiles, machinery and equipment, glass and, with this case, the retail sector is covered in Belgium for the first time; recalls that this is the 10th EGF application so far to cover the retail sector;

7. Acknowledges that retail trade is going through a period of major change, due to globalisation (e-commerce, online shopping), resulting in redundancies and that changing patterns in consumers' habits and digitalisation also have an impact on retail trade; underlines that the redundancies in Carrefour Belgique SA do not directly concern the food industry, but mostly pertain to the e-commerce of goods such as books and electronic devices; notes that these kind of redundancies may further increase in the future due to digitalisation, which should be considered during the discussions on the future EGF in the next multiannual financial framework for the years 2021 to 2027;

8. Believes that globalisation represents a challenge for the Union; considers, moreover, that tackling youth and other unemployment involves the creation of opportunities of re-skilling and up-skilling in the European companies; expects that Carrefour Belgique SA will ensure the necessary high-quality social dialogue with its workers during this process;

9. Notes that the application relates in total to 1 019 workers made redundant in Carrefour Belgique SA, and that the redundancies concern the whole of Belgium; notes furthermore that Belgium expects that only 400 out of the total eligible beneficiaries will participate in the measures (targeted beneficiaries), namely workers made redundant in Wallonia as those redundancies have a particularly significant adverse impact on the employment situation and thus on the regional economy of Wallonia due to scarcity of jobs in the region, the relatively high unemployment rate and, as a consequence, the expected difficulties of redeployment for the redundant workers, in particular those aged 50+; recalls, in that regard, that the unemployment rate of 8,6 % in Wallonia is considerably higher than the average unemployment rate of 6,9 % in the Union, being more than twice as high as the unemployment rate of 3,5 % in region of Flanders; C 208/38 EN Official Journal of the European Union 1.6.2021

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10. Notes furthermore that Belgium proposes personalised services co-financed by the EGF to up to 330 young people not in employment, education or training (NEETs) under the age of 25 on the date of submission of the application, given that 240 of the redundancies occur in the NUTS level 2 regions of Province Hainaut and Province Liège, that had youth unemployment rates for young persons aged 15 to 24 of at least 20 %, based on the annual data available for 2018; 11. Notes that Belgium is planning five types of actions for the redundant workers covered by this application: (i) Support/Guidance/Integration, (ii) Training, retraining and vocational training, (iii) Support towards business creation, (iv) Contribution to business start-up, (v) Allowances; underlines that, in this case, the relevance of support, guidance and integration, as well as training, retraining and vocational training is evidenced by the number of estimated participants (730 estimated participants in the first action, 460 in the second); 12. Underlines that NEETs will be particularly trained for job search and application, and will be better informed on labour law, social rights and support in administrative procedures. Moreover, a monthly allowance of EUR 350 will be granted to workers and NEETs who undertake full-time studies of at least one year; 13. Welcomes that the co-ordinated package of personalised services was drawn up by Belgium in consultation with the social partners, in particular with trade unions, vocational counsellors and social workers, in order to reconsider various redeployment solutions adapted to the needs of the redundant workers; 14. Stresses that the Belgian authorities have confirmed that the eligible actions do not receive assistance from other Union funds or financial instruments; 15. Reiterates that assistance from the EGF must not replace actions which are the responsibility of companies, by virtue of national law or collective agreements, or measures for restructuring companies or sectors; 16. Approves the decision annexed to this resolution; 17. Instructs its President to sign the decision with the President of the Council and arrange for its publication in the Official Journal of the European Union; 18. Instructs its President to forward this resolution, including its Annex, to the Council and the Commission. 1.6.2021 EN Official Journal of the European Union C 208/39

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ANNEX

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the mobilisation of the European Globalisation Adjustment Fund following an application from Belgium — EGF/2019/001 BE/Carrefour

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1309/2013 of the European Parliament and of the Council of 17 December 2013 on the European Globalisation Adjustment Fund (2014-2020) and repealing Regulation (EC) No 1927/2006 (1), and in particular Article 15(4) thereof,

Having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (2), and in particular point 13 thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) The European Globalisation Adjustment Fund (EGF) aims to provide support for workers made redundant and self-employed persons whose activity has ceased as a result of major structural changes in world trade patterns due to globalisation, as a result of a continuation of the global financial and economic crisis, or as a result of a new global financial and economic crisis, and to assist them with their reintegration into the labour market.

(2) The EGF is not to exceed a maximum annual amount of EUR 150 million (2011 prices), as laid down in Article 12 of Council Regulation (EU, Euratom) No 1311/2013 (3).

(3) On 20 June 2019, Belgium submitted an application to mobilise the EGF, in respect of redundancies in Carrefour Belgique SA. It was supplemented by additional information provided in accordance with Article 8(3) of Regulation (EU) No 1309/2013. That application complies with the requirements for determining a financial contribution from the EGF as laid down in Article 13 of Regulation (EU) No 1309/2013.

(4) In accordance with Article 6(2) of Regulation (EU) No 1309/2013, Belgium has decided to provide personalised services co-financed by the EGF also to 330 young persons not in employment, education or training (NEETs).

(5) The EGF should, therefore, be mobilised in order to provide a financial contribution of EUR 1 632 028 in respect of the application submitted by Belgium.

(6) In order to minimise the time taken to mobilise the EGF, this decision should apply from the date of its adoption,

HAVE ADOPTED THIS DECISION:

Article 1 For the general budget of the Union for the financial year 2019, the European Globalisation Adjustment Fund shall be mobilised to provide the amount of EUR 1 632 028 in commitment and payment appropriations.

(1) OJ L 347, 20.12.2013, p. 855. (2) OJ C 373, 20.12.2013, p. 1. (3) Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (OJ L 347, 20.12.2013, p. 884). C 208/40 EN Official Journal of the European Union 1.6.2021

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Article 2 This Decision shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from [the date of its adoption] (*).

Done at …,

For the European Parliament For the Council The President The President

(*) Date to be inserted by the Parliament before the publication in OJ.

ISSN 1977-091X (electronic edition) ISSN 1725-2423 (paper edition)

EN