# C_2021202EN.01001101.xml

| 28.5.2021 | EN | Official Journal of the European Union | C 202/11 |
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28.5.2021

EN

Official Journal of the European Union

C 202/11

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P9_TA(2019)0028

Genetically modified maize MZHG0JG (SYN-ØØØJG-2)

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 (D061869/04 — 2019/2830(RSP))

(2021/C 202/03)

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 MZHG0JG (SYN-ØØØJG-2), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D061869/04, |
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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 MZHG0JG (SYN-ØØØJG-2), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D061869/04,

| — | 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, |
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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 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, |
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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), |
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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 17 October 2018, and published on 14 November 2018 (3), |
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having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 17 October 2018, and published on 14 November 2018 (3),

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

| — | having regard to Rule 112(2) and (3) of its Rules of Procedure, |
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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, |
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having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,

| A. | whereas, on 1 September 2016, Syngenta Crop Protection NV/SA submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified (GM) maize MZHG0JG (the application) to the national competent authority of Germany on behalf of Syngenta Crop Protection AG and 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 GM maize MZHG0JG (maize MZHG0JG) for uses other than food and feed, with the exception of cultivation; |
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A.

whereas, on 1 September 2016, Syngenta Crop Protection NV/SA submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified (GM) maize MZHG0JG (the application) to the national competent authority of Germany on behalf of Syngenta Crop Protection AG and 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 GM maize MZHG0JG (maize MZHG0JG) for uses other than food and feed, with the exception of cultivation;

| B. | whereas, on 17 October 2018, EFSA adopted a favourable opinion, which was published on 14 November 2018 (5); |
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B.

whereas, on 17 October 2018, EFSA adopted a favourable opinion, which was published on 14 November 2018 (5);

| C. | 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; |
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C.

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;

| D. | whereas maize MZHG0JG has been made tolerant to glyphosate-based herbicides, as well as glufosinate ammonium-based herbicides (6); |
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D.

whereas maize MZHG0JG has been made tolerant to glyphosate-based herbicides, as well as glufosinate ammonium-based herbicides (6);

| E. | whereas Member States submitted many critical comments to EFSA during the three-month consultation period (7); whereas the most critical comments concern the toxicology assessment, the comparative analysis and the environmental risk assessment; whereas several Member States considered the data on toxicology to be insufficient and unreliable, especially as regards residue levels of glyphosate and glufosinate; whereas one comment highlights the fact that the comparative analysis revealed a lack of equivalence for ferulic acid — an important compound of plant cell walls — between maize MZHG0JG and reference varieties, which may result in increased herbicide accumulation; |
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E.

whereas Member States submitted many critical comments to EFSA during the three-month consultation period (7); whereas the most critical comments concern the toxicology assessment, the comparative analysis and the environmental risk assessment; whereas several Member States considered the data on toxicology to be insufficient and unreliable, especially as regards residue levels of glyphosate and glufosinate; whereas one comment highlights the fact that the comparative analysis revealed a lack of equivalence for ferulic acid — an important compound of plant cell walls — between maize MZHG0JG and reference varieties, which may result in increased herbicide accumulation;

| F. | whereas an independent study (8) concludes that the risk assessment by EFSA is not acceptable in its present form since it fails to properly assess toxicity, especially as regards the possible cumulative effects of the two transgenes and the complementary herbicides and their metabolites; whereas the study questions the reliability of the data from the 90-day feeding study and furthermore concludes that EFSA’s environmental risk assessment is not acceptable since it does not consider the risk of the transgenes spreading through gene transfer between maize MZHG0JG and its wild relative teosinte in the event that viable maize MZHG0JG plant material were to enter the environment; |
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F.

whereas an independent study (8) concludes that the risk assessment by EFSA is not acceptable in its present form since it fails to properly assess toxicity, especially as regards the possible cumulative effects of the two transgenes and the complementary herbicides and their metabolites; whereas the study questions the reliability of the data from the 90-day feeding study and furthermore concludes that EFSA’s environmental risk assessment is not acceptable since it does not consider the risk of the transgenes spreading through gene transfer between maize MZHG0JG and its wild relative teosinte in the event that viable maize MZHG0JG plant material were to enter the environment;

Complementary herbicides

| G. | whereas it has been shown that the cultivation of herbicide-tolerant GM crops results in a higher use of herbicides, due in large part to the emergence of herbicide-tolerant weeds (9); whereas, as a consequence, it has to be expected that maize MZHG0JG crops will be exposed to both higher and repeated doses of glyphosate and glufosinate, which will potentially lead to a higher quantity of residues in harvests; |
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G.

whereas it has been shown that the cultivation of herbicide-tolerant GM crops results in a higher use of herbicides, due in large part to the emergence of herbicide-tolerant weeds (9); whereas, as a consequence, it has to be expected that maize MZHG0JG crops will be exposed to both higher and repeated doses of glyphosate and glufosinate, which will potentially lead to a higher quantity of residues in harvests;

| H. | whereas, under the Union’s latest coordinated multiannual control programme (for 2020, 2021 and 2022), Member States are not obliged to measure glufosinate or glyphosate residues in imports of maize (10); whereas it cannot be excluded that maize MZHG0JG or products derived from it for food and feed will exceed the Union’s Maximum Residue Levels (MRLs), which have been put in place to ensure a high level of consumer protection; |
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H.

whereas, under the Union’s latest coordinated multiannual control programme (for 2020, 2021 and 2022), Member States are not obliged to measure glufosinate or glyphosate residues in imports of maize (10); whereas it cannot be excluded that maize MZHG0JG or products derived from it for food and feed will exceed the Union’s Maximum Residue Levels (MRLs), which have been put in place to ensure a high level of consumer protection;

| I. | 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 (11); whereas the approval of glufosinate for use in the Union expired on 31 July 2018 (12); |
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I.

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

| J. | whereas questions concerning the carcinogenicity of glyphosate remain; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic; whereas, on the contrary, in 2015 the World Health Organisation’s International Agency for Research on Cancer classified glyphosate as a probable carcinogen for humans; |
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J.

whereas questions concerning the carcinogenicity of glyphosate remain; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic; whereas, on the contrary, in 2015 the World Health Organisation’s International Agency for Research on Cancer classified glyphosate as a probable carcinogen for humans;

| K. | whereas, according to EFSA, the toxicological data needed for a consumer risk assessment of several breakdown products of glyphosate relevant to GM glyphosate-tolerant crops are missing (13); |
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K.

whereas, according to EFSA, the toxicological data needed for a consumer risk assessment of several breakdown products of glyphosate relevant to GM glyphosate-tolerant crops are missing (13);

| L. | whereas in GM plants, the way that complementary herbicides are broken down by the plant, and the composition and thus toxicity of the breakdown products (metabolites), may be driven by the genetic modification itself; whereas, according to EFSA, this is indeed the case when the complementary herbicide is glyphosate (14); |
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L.

whereas in GM plants, the way that complementary herbicides are broken down by the plant, and the composition and thus toxicity of the breakdown products (metabolites), may be driven by the genetic modification itself; whereas, according to EFSA, this is indeed the case when the complementary herbicide is glyphosate (14);

| M. | whereas assessment of herbicide residues and their metabolites in GM plants is considered to be outside the remit of the EFSA Panel on Genetically Modified Organisms; |
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M.

whereas assessment of herbicide residues and their metabolites in GM plants is considered to be outside the remit of the EFSA Panel on Genetically Modified Organisms;

Undemocratic process

| N. | 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 of 5 June 2019 of the Appeal Committee also delivered no opinion; |
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N.

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 of 5 June 2019 of the Appeal Committee also delivered no opinion;

| O. | whereas, both in the explanatory memorandum of its 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 in the explanatory memorandum of the legislative proposal presented on 14 February 2017 amending Regulation (EU) No 182/2011, the Commission deplored the fact that, since the entry into force of Regulation (EC) No 1829/2003, authorisation decisions have been adopted by the Commission without the support of the opinion of the Member States’ committee and that the return of the dossier to the Commission for final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on GM food and feed authorisations; whereas that practice has, on several occasions, been deplored by the Commission President as not being democratic (15); |
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O.

whereas, both in the explanatory memorandum of its 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 in the explanatory memorandum of the legislative proposal presented on 14 February 2017 amending Regulation (EU) No 182/2011, the Commission deplored the fact that, since the entry into force of Regulation (EC) No 1829/2003, authorisation decisions have been adopted by the Commission without the support of the opinion of the Member States’ committee and that the return of the dossier to the Commission for final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on GM food and feed authorisations; whereas that practice has, on several occasions, been deplored by the Commission President as not being democratic (15);

| P. | whereas, in its eighth term, the European Parliament adopted 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 (3 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, even though it is under no legal obligation to do so; |
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P.

whereas, in its eighth term, the European Parliament adopted 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 (3 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, even though it is under no legal obligation to do so;

| 1. | Considers that the draft Commission implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003; |
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1.

| 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 (16), 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; |
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2.

| 3. | Calls on the Commission to withdraw its draft implementing decision; |
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3.

| 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 on that Commission proposal as a matter of urgency; |
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4.

| 5. | Calls on the Commission to suspend any implementing decision regarding applications for GMO authorisation until the authorisation procedure has been revised in such a way as to address the shortcomings of the current procedure, which has proven inadequate; |
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5.

| 6. | Calls on the Commission to withdraw proposals for GMO authorisations if no opinion is delivered by the Standing Committee on the Food Chain and Animal Health, whether for cultivation or for food and feed uses; |
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6.

| 7. | Calls on the Commission not to authorise any herbicide-tolerant GM plants without a full assessment of the residues from spraying with complementary herbicides, their metabolites and commercial formulations, as applied in the countries of cultivation; |
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7.

| 8. | 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 imported into the Union for food and feed uses; |
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8.

| 9. | 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 that is not authorised for use in the Union, in this case glufosinate; |
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9.

| 10. | Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States. |
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10.

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(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 MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2016-133), EFSA Journal, 14 November 2018, 16(11):5469, https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5469

(4)  In its eighth term the European Parliament adopted 36 resolutions objecting to the authorisation of GMOs.

(5)  Scientific opinion on the assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2016-133), EFSA Journal, 14 November 2018, 16(11):5469, https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5469

(6)  EFSA opinion, pp. 7-8.

(7)  Search for Maize MZHG0JG: EFSA-Q-2018-00810 on http://registerofquestions.efsa.europa.eu/roqFrontend/ListOfQuestionsNoLogin?2

(8)  Testbiotech comment on ‘Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2016-133)’ by company Syngenta, https://www.testbiotech.org/sites/default/files/Testbiotech_Comment_Maize_MZHG0JG.pdf

(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)  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.

(11)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009, p. 1.

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

(13)  EFSA conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, EFSA Journal, 12 November 2015, 13(11), p. 3, https://www.efsa.europa.eu/en/efsajournal/pub/4302

(14)  EFSA review of the existing maximum residue levels for glyphosate according to Article 12 of Regulation (EC) No 396/2005, 17 May 2018, p. 12, https://www.efsa.europa.eu/fr/efsajournal/pub/5263

(15)  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 the 2016 State of the Union Address (Strasbourg, 14 September 2016).

(16)  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.

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