European Parliament 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 (D058360/01 — 2018/2872(RSP))
Date: 2018-10-24
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: animal feedingstuffs, food safety, foodstuff, herbicide, labelling, maize, market approval, pesticide residue, transgenic plant








C_2020345EN.01000801.xml










16.10.2020   


EN


Official Journal of the European Union


C 345/8






P8_TA(2018)0416
Renewing the authorisation for genetically modified maize NK603 × MON 810
European Parliament 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 (D058360/01 — 2018/2872(RSP))
(2020/C 345/02)

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 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 (D058360/01,










—


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 11 September 2018, at which no opinion was delivered,










—


having regard to Article 11 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 24 January 2018 and published on 26 February 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, COD(2017)0035),










—


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, on 20 October 2016, Monsanto Europe N.V./S.A. submitted to the Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of the authorisation of genetically modified maize NK603 × MON 810 for food and feed uses;










B.


whereas, on 24 January 2018, EFSA adopted a favourable opinion (1) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003, in which it concluded that the renewal application did not contain evidence for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on genetically modified maize NK603 × MON 810, adopted by EFSA in 2005 (2);










C.


whereas EFSA, according to its scientific opinion, did not perform a systematic literature search of its own, but simply assessed the literature search carried out by the applicant, and on that basis concluded that no new publication had been identified which would raise a safety concern;










D.


whereas EFSA adopted its opinion under the assumption that the DNA sequence of the two events in genetically modified maize NK603 x MON 810 is identical to the sequence of the originally assessed events; whereas the applicant has not provided any data supporting that hypothesis;










E.


whereas genetically modified maize NK603 × MON 810 expresses a protein that confers tolerance to glyphosate herbicides; whereas on 20 March 2015 the International Agency for Research on Cancer — the specialised cancer agency of the World Health Organisation — classified glyphosate as probably carcinogenic to humans (5);










F.


whereas authorising the import of genetically modified maize NK603 × MON 810 into the Union is supposed to lead to an increase in its cultivation elsewhere, such as in Argentina, Brazil, Canada, Colombia, Japan, the Philippines, South Africa and Uruguay, and to a corresponding increase in the use of glyphosate containing herbicides;










G.


whereas genetically modified maize NK603 x MON 810 expresses the Cry1Ab protein, which is a Bt protein (derived from Bacillus thuringiensis) conferring resistance to certain lepidopteran insect pests (Ostrinia nubilalis, Sesamia spp.);










H.


whereas genetically modified 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 genetically modified Bt plants may have toxic effects (6); whereas it has been shown that the Bt toxin in genetically modified plants differs significantly from that of the naturally occurring Bt toxin (7);










I.


whereas concerns remain regarding a possible evolution of resistance to the Cry1Ab protein in lepidopteran target pests, which may lead to altered pest control practices in the countries where it is cultivated;










J.


whereas many critical comments were submitted by Member States during the three-month consultation period; whereas those comments refer to, inter alia: lacking information with regard to lines currently used; missing data, e.g. regarding the potential for horizontal gene transfer of the events MON 810 and NK603; a deficient literature review; a partly outdated data generation; and a fragmentary environmental monitoring approach, including the fact that the persistence of Cry proteins released to the environment was not monitored, no analysis of exposure of the environment to the Cry toxin had been conducted and that the occurrence of teosinte as a wild relative of maize in Europe had been ignored (8);










K.


whereas despite those concerns, a post-market monitoring plan was not required; whereas case-specific post-market environmental monitoring was also not considered necessary;










L.


whereas the vote on 11 September 2018 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; whereas 13 Member States voted against, while only 11 voted in favour, and four abstained;










M.


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 genetically modified 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 Member States’ committee opinion 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 genetically modified food and feed authorisations; whereas that practice has, on several occasions, been deplored by Commission President Jean-Claude Juncker as not being democratic (9);










N.


whereas on 28 October 2015 Parliament rejected at first reading (10) 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;












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 (11), 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 genetically modified food and feed, while ensuring the effective functioning of the internal market;












3.


Calls on the Commission to withdraw its draft implementing decision;












4.


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












5.


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






(1)  OJ L 268, 18.10.2003, p. 1.

(2)  OJ L 55, 28.2.2011, p. 13.

(3)  Scientific opinion on an application by Monsanto (application EFSA-GMO-RX-007) — Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-007). EFSA Journal 2018; 16(2):5163: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5163

(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).





(1)  Scientific opinion on assessment of genetically modified maize NK603 × MON 810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-007). EFSA Journal 2018; 16(2):5163: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5163

(2)  Opinion of the Scientific Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-UK-2004-01) for the placing on the market of glyphosate-tolerant and insect-resistant genetically modified maize NK603 × MON 810, for food and feed uses under Regulation (EC) No 1829/2003 from Monsanto. EFSA Journal (2005) 309, 1-22: https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2005.309

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

(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 Y.G.). Journal of American Science, 2012, 8(9), pp. 1117-1123: 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, pp. 195-230: https://link.springer.com/chapter/10.1007/978-94-007-4497-4_10

(8)  See EFSA Register of Questions, Annex G to Question Number EFSA-Q-2017-00028 -
available online at: http://registerofquestions.efsa.europa.eu/roqFrontend/ListOfQuestionsNoLogin?1&panel=ALL

(9)  For example, in 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).

(10)  OJ C 355, 20.10.2017, p. 165.

(11)  OJ L 31, 1.2.2002, p. 1.