P8_TA(2019)0314

Genetically modified maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6)

European Parliament resolution of 27 March 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 maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D060917/01 — 2019/2604(RSP))

(2021/C 108/04)

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 maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D060917/01,

— having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 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 7 March 2019, at which no opinion was delivered,

— having regard to Articles 11 and 13 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (2),

— having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 20 June 2018 and published on 25 July 2018 (3),

— having regard to the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (COM(2017)0085, 2017/0035(COD)),

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

— having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,

— having regard to Rule 106(2) and (3) of its Rules of Procedure,

A. whereas Commission Decision 2007/703/EC (5) authorised the placing on the market of food and feed containing, consisting of, or produced from genetically modified (GM) maize 1507 × NK603; whereas the scope of that authorisation also covers the placing on the market of products, other than food and feed, containing or consisting of GM maize 1507 × NK603 for the same uses as any other maize with the exception of cultivation;

B. whereas, on 20 October 2016, Pioneer Overseas Corporation, on behalf of Pioneer Hi-Bred International, Inc., and Dow AgroSciences Europe, on behalf of Dow AgroSciences LLC, jointly 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 25 July 2018, EFSA issued a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003;

D. whereas the EFSA opinion stated that the applicants’ literature search had retrieved 120 publications, out of which, after having applied eligibility and inclusion criteria that had been defined a priori by the applicants, only one publication, an opinion by the EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel), was considered as relevant by the applicants;

E. whereas EFSA, despite the fact that it considered that the applicants’ future literature searches could be improved, did not perform a systematic literature search on its own, but simply assessed the literature search carried out by the applicants, and on that basis concluded that no new publication had been identified which would raise a safety concern;

F. whereas, likewise, for the other items assessed, such as bioinformatic data, post-market monitoring, as well as the overall assessment, EFSA simply relies on information given by the applicants, and as a consequence takes over the applicants’ assessment;

G. whereas EFSA adopted its opinion on the assumption that the DNA sequence of the two events in GM maize NK603 x MON 810 is identical to the sequence of the originally assessed events; whereas this hypothesis does not seem to have been based on any data or evidence provided by the applicants but rather purely on a statement provided by them;

H. whereas EFSA acknowledges that the annual post-market environmental monitoring reports proposed by the applicants consist mainly of general surveillance of imported GM plant material; whereas EFSA considers that further discussion with applicants and risk managers is needed on the practical implementation of the post-market environmental monitoring reports, e.g. regarding actual data gathered on exposure and/or adverse effects as implemented in existing monitoring systems;

I. whereas the GM maize 1507 × NK603 expresses the cry1F gene, which confers protection against certain lepidopteran pests, the pat gene, which confers tolerance to glufosinate-ammonium based herbicides, and the cp4 epsps gene, which confers tolerance to glyphosate-based herbicides;

J. whereas GM Bt plants express the insecticidal toxin in every cell throughout their life, including in the parts eaten by humans and animals; whereas animal feeding experiments show that GM Bt plants may have toxic effects (6); whereas it has been shown that the Bt toxin in GM plants differs significantly from that of the naturally occurring Bt toxin (7); whereas there are concerns regarding a possible evolution of resistance to Cry proteins in lepidopteran target pests, which may lead to altered pest control practices in the countries where it is cultivated;

K. whereas glufosinate is classified as toxic to reproduction and thus falls under the exclusion criteria set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council (8); whereas the approval of glufosinate expired on 31 July 2018 (9);

L. whereas questions remain concerning the carcinogenicity of glyphosate; 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 World Health Organisation’s International Agency for Research on Cancer classified glyphosate as a probable carcinogen for humans (10);

M. whereas application of the complementary herbicides, in this case glyphosate and glufosinate, is part of regular agricultural practice in the cultivation of herbicide-resistant plants and it can therefore be expected that residues from spraying will be present in the harvest and are inevitable constituents;

N. whereas it has to be expected that the GM maize will be exposed to both higher and repeated doses of glyphosate and glufosinate, which will not only lead to a higher burden of residues in the harvest, but may also influence the composition of the GM maize plant and its agronomic characteristics;

O. whereas information on residue levels of herbicides and their metabolites is essential for a thorough risk assessment of herbicide-tolerant GM plants; whereas residues from spraying with herbicides are considered outside the remit of the EFSA GMO Panel; whereas the impacts of spraying the GM maize with herbicides have not been assessed, nor has the cumulative effect of spraying with both glyphosate and glufosinate;

P. whereas the Union is party to the UN Convention on Biological Diversity, which places on its parties the responsibility to ensure that activities within their jurisdiction do not cause damage to the environment of other States (11); whereas the decision on whether or not to authorise the GM maize is within the Union’s jurisdiction;

Q. whereas comments submitted by Member States during the three-month consultation period refer to, inter alia: non-compliance with EFSA’s guidelines as regards the post-market environmental monitoring reports, several deficiencies in those reports, including the fact that the occurrence of teosinte as a wild relative of maize in Europe had been ignored and that information regarding the fate of Bt toxins in the environment is missing; concerns regarding the reliability of data to confirm the risk assessment conclusion; an insufficient proposed monitoring plan; an inadequate literature search, leading to the omission of important studies, and an improper declaration of identified literature as being irrelevant; and the failure to provide any data to demonstrate the sequence identity of a current maize variety containing the stacked event 1507 x NK603, with the originally assessed event (12);

R. whereas the vote on 7 March 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 there was no qualified majority in favour of authorisation;

S. whereas on several occasions (13) the Commission has deplored the fact that, since the entry into force of Regulation (EC) No 1829/2003, it has adopted authorisation decisions without the support of the Standing Committee on the Food Chain and Animal Health, and that the return of the dossier to the Commission for a 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 also been deplored by President Juncker as being undemocratic (14);

T. whereas, on 28 October 2015, Parliament rejected at first reading (15) the legislative proposal of 22 April 2015 amending Regulation (EC) No 1829/2003 and called on the Commission to withdraw it and submit a new one;

U. whereas recital 14 of Regulation (EU) No 182/2011 states that the Commission should, as far as possible, act in such a way as to avoid going against any predominant position which might emerge within the appeal committee against the appropriateness of an implementing act, especially on sensitive issues such as consumer health, food safety and the environment;

V. 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 that the Commission shall take into account any relevant provisions of Union law and other legitimate factors relevant to the matter under consideration when drafting its decision renewing the authorisation;

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 ( 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;

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 to suspend any implementing decision regarding applications for authorisation of genetically modified organisms (GMOs) until the authorisation procedure has been revised in such a way as to address the shortcomings of the current procedure, which has proven inadequate;

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;

7. Calls on the Commission to uphold its commitments under the UN Convention on Biological Diversity, and in particular not to authorise the import of any GM plant for food or feed uses which has been made tolerant to a herbicide which is not authorised for use in the Union;

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

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

(1) OJ L 268, 18.10.2003, p. 1.

(2) OJ L 55, 28.2.2011, p. 13.

(3) EFSA GMO Panel 2018. Scientific Opinion on the assessment of genetically modified maize 1507 x NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-008). EFSA Journal 2018; 16(7): 5347.

(4)

— Resolution of 16 January 2014 on the proposal for a Council decision concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests (OJ C 482, 23.12.2016, p. 110).

— Resolution of 16 December 2015 on Commission Implementing Decision (EU) 2015/2279 of 4 December 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603 × T25 (OJ C 399, 24.11.2017, p. 71).

— Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788 (OJ C 35, 31.1.2018, p. 19).

— Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87708 × MON 89788 (OJ C 35, 31.1.2018, p. 17).

— Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) (OJ C 35, 31.1.2018, p. 15).

— Resolution of 8 June 2016 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 × GA21, and genetically modified maizes combining two or three of those events (OJ C 86, 6.3.2018, p. 108).

— Resolution of 8 June 2016 on the draft Commission implementing decision as regards the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) (OJ C 86, 6.3.2018, p. 111).

— Resolution of 6 October 2016 on the draft Commission implementing decision renewing the authorisation for the placing on the market for cultivation of genetically modified maize MON 810 seeds (OJ C 215, 19.6.2018, p. 76).

— Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of genetically modified maize MON 810 products (OJ C 215, 19.6.2018, p. 80).

— Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize Bt11 seeds (OJ C 215, 19.6.2018, p. 70).

— Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize 1507 seeds (OJ C 215, 19.6.2018, p. 73).

— Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (OJ C 215, 19.6.2018, p. 83).

— Resolution of 5 April 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, and genetically modified maizes combining two, three or four of the events Bt11, 59122, MIR604, 1507 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 298, 23.8.2018, p. 34).

— Resolution of 17 May 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize DAS-40278-9, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 307, 30.8.2018, p. 71).

— Resolution of 17 May 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ C 307, 30.8.2018, p. 67).

— Resolution of 13 September 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-68416-4, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 337, 20.9.2018, p. 54).

— Resolution of 4 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 × A5547-127 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 55).

— Resolution of 4 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-44406-6, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 60).

— Resolution of 24 October 2017 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 122).

— Resolution of 24 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 × 40-3-2 (DP-3Ø5423-1 × MON-Ø4Ø32-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 127).

— Resolution of 24 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified oilseed rapes MON 88302 × Ms8 × Rf3 (MON-883Ø2-9 × ACSBNØØ5-8 × ACS-BNØØ3-6), MON 88302 × Ms8 (MON-883Ø2-9 × ACSBNØØ5-8) and MON 88302 × Rf3 (MON-883Ø2-9 × ACS-BNØØ3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 133).

— Resolution of 1 March 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0051).

— Resolution of 1 March 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU (Texts adopted, P8_TA(2018)0052).

— Resolution of 3 May 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0197).

— Resolution of 30 May 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0221).

— Resolution of 30 May 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 × 59122 × MON 810 × NK603, and genetically modified maize combining two or three of the single events 1507, 59122, MON 810 and NK603, and repealing Decisions 2009/815/EC, 2010/428/EU and 2010/432/EU pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0222).

— Resolution of 24 October 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize NK603 × MON 810 (MON-ØØ6Ø3-6 × MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2018)0416).

— Resolution of 24 October 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122, and genetically modified maize combining two, three or four of the single events MON 87427, MON 89034, 1507, MON 88017 and 59122 and repealing Decision 2011/366/EU (Texts adopted, P8_TA(2018)0417).

— Resolution of 31 January 2019 on the draft Commission implementing decision amending Implementing Decision 2013/327/EU as regards the renewal of the authorisation to place on the market feed containing or consisting of genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0057).

— Resolution of 31 January 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 5307 (SYN-Ø53Ø7-1), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2019)0058).

— Resolution of 31 January 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 87403 (MON-874Ø3-1), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0059).

— Resolution of 31 January 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × LLCotton25 × MON 15985 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0060).

— Resolution of 13 March 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 4114 (DP-ØØ4114-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0196).

— Resolution of 13 March 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 87411 (MON-87411-9), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0197).

— Resolution of 13 March 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 × 1507 × GA21 and sub-combinations Bt11 × MIR162 × 1507, MIR162 × 1507 × GA21 and MIR162 × 1507 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0198).

(5) Commission Decision 2007/703/EC of 24 October 2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 285, 31.10.2007, p. 47).

(6) See, for example, El-Shamei, Z.S., Gab-Alla, A.A., Shatta, A.A., Moussa, E.A., Rayan, A.M., Histopathological Changes in Some Organs of Male Rats Fed on Genetically Modified Corn (Ajeeb YG). Journal of American Science 2012; 8(9):1127-1123. https://www.researchgate.net/publication/235256452_Histopathological_Changes_in_Some_Organs_of_Male_Rats_Fed_on_Genetically_Modified_Corn_Ajeeb_YG

(7) Székács, A., Darvas, B., Comparative aspects of Cry toxin usage in insect control. In: Ishaaya, I., Palli, S.R., Horowitz, A.R., eds. Advanced Technologies for Managing Insect Pests. Dordrecht, Netherlands: Springer; 2012:195-230. https://link.springer.com/chapter/10.1007/978-94-007-4497-4_10

(8) 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).

(9) https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=as.details&as_id=79

(10) IARC Monographs Volume 112: Some organophosphate insecticides and herbicides, 20 March 2015 (http://monographs.iarc.fr/ENG/Monographs/vol112/mono112.pdf).

(11) Article 3, https://www.cbd.int/convention/articles/default.shtml?a=cbd-03

(12) See EFSA Register of Questions, Annex G to Question Number EFSA-Q-2018-00509,

available online at: https://www.efsa.europa.eu/en/register-of-questions

(13) See, for example, 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 genetically modified food and feed on their territory and the explanatory memorandum of the legislative proposal presented on 14 February 2017 amending Regulation (EU) No 182/2011.

(14) 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).

(15) OJ C 355, 20.10.2017, p. 165.

(16) OJ L 31, 1.2.2002, p. 1.