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 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (D052754),

–  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 14 September 2017, where 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) 19 January 2005, and published on 3 March 2005(3),

–  having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 30 November 2016, and published on 12 January 2017(4),

–  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(5), with particular regard to its previous resolution on ‘Placing on the market for cultivation of genetically modified maize 1507 seeds’ of 6 October 2016,

–  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 27 February 2015 Pioneer Overseas Corporation and Dow AgroSciences Ltd. jointly 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 for the placing on the market of foods and feed containing, consisting of, or produced from genetically modified maize 1507; whereas the scope of the renewal also covers products other than food and feed containing or consisting of maize 1507;

B.  whereas on 30 November 2016, the European Food Safety Authority (EFSA) adopted a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003, which was published on 12 January 2017;

C.  whereas Regulation (EC) No 1829/2003 states that genetically modified food or feed must not have adverse effects on human health, animal health or the environment and requires that the Commission 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 genetically modified maize 1507 expresses the Cry1F protein, which is a Bt protein (derived from Bacillus thuringiensis subsp. Kurstaki) conferring resistance to the European corn borer (Ostrinia nubilalis) and certain other lepidopteran pests such as the pink borer (Sesamia spp.), fall armyworm (Spodoptera frugiperda), black cutworm (Agrotis ipsilon) and south-western corn borer (Diatraea grandiosella), and the Pat protein, which confers tolerance to the herbicide glufosinate-ammonium;

E.  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);

F.  whereas the authorisation for the cultivation of maize 1507 in the Union is pending; whereas Parliament objected to such an authorisation due to concerns as to, inter alia, a possible evolution of resistance to the Cry1F protein in lepidopteran target pests which may lead to altered pest control practices(8);

G.  whereas many critical comments were submitted by Member States during the three-month consultation period for EFSA’s risk assessment relating to the initial authorisation; whereas the most critical comments relate to observations that the documentation is insufficient to perform a risk assessment, that the monitoring plan is not in accordance with Annex VII to Directive 2001/18/EC, and that the data and risk assessments provided by the applicant are not adequate(9);

H.  whereas many critical comments were submitted by Member States during the three-month consultation period for EFSA’s risk assessment in relation to renewal of the authorisation(10); whereas the most critical comments relate to observations that the proposed monitoring plan is not considered appropriate to address relevant issues of post-market environmental monitoring of GM maize 1057 and cannot be regarded as sufficiently elaborated for the monitoring of potential environmental exposure by GM maize 1507, that monitoring as conducted by the notifier did not generate reliable data to confirm the risk assessment conclusion that effects on human and animal health would be negligible, and that evidence showing a history of safe use of the Pat protein, as required under Commission Implementation Regulation (EU) No 503/2013, is not duly documented by the notifier;

I.  whereas persistence of Cry proteins released into the environment due to use of GM maize 1507 in feedstuffs was not monitored, even though Cry proteins may persist in soil for months retaining their insecticidal activity, as found for Cry1Ab-toxin(11);

J.  whereas glufosinate is classified as toxic to reproduction and thus falls under the ‘cut-off criteria’ set out in 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; whereas the approval of glufosinate expires on 31 July 2018;

K.  whereas the application of the complementary herbicides is part of regular agricultural practice in the cultivation of herbicide-resistant plants and it can therefore be expected that residues from spraying will always be present in the harvest and are inevitable constituents; whereas it has been shown that herbicide-tolerant genetically modified crops result in higher use of complementary herbicides than their conventional counterparts(12);

L.  whereas the residues from spraying with glufosinate were not assessed; whereas it cannot therefore be concluded that genetically engineered maize 1507 is safe for use in food and feed;

M.  whereas maize 1507 is authorised for cultivation in Argentina, Brazil, Canada, Colombia, Honduras, Japan, Panama, Paraguay, the Philippines, South Africa, the USA and Uruguay; whereas a recent peer-reviewed study finds that targeted insects developing resistance to Cry proteins is a ‘major threat to the sustainability of the Bt technology’(13); whereas glufosinate-resistant weeds have been observed since 2009;

N.  whereas 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 14 September 2017 delivered no opinion; whereas 12 Member States voted against, 12 Member States, representing only 38,75 % of the Union population voted in favour, and four Member States abstained;

O.  whereas on several occasions the Commission has 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 Standing Committee on the Food Chain and Animal Health 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 also been deplored by Commission President Juncker as not being democratic(14);

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

Q.  whereas recital 14 of Regulation (EU) No 182/2011 states that the Commission will, 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;

R.  whereas the Commission’s proposal to amend Regulation (EU) No 182/2011 is not sufficient in terms of addressing the lack of democracy in the GMO authorisation process;

S.  whereas democratic legitimacy can only be ensured by providing, at the very least, that when no opinion is delivered by the Food Chain and Animal Health Standing Committee the Commission proposal is withdrawn; whereas this procedure already exists for some other standing committees;

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

2.  Considers that the 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, the environment 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.  Calls on the legislators responsible to advance work on the Commission proposal amending Regulation (EU) No 182/2011 as a matter of urgency and to ensure that, inter alia, if no opinion is delivered by the Food Chain and Animal Health Standing Committee with respect to GMOs approvals, either for cultivation or for food and feed, the Commission will withdraw the proposal;

6.  Calls on the Commission not to authorise any herbicide-tolerant genetically modified plants (HT GMP) without full assessment of the residues from spraying with the complementary herbicides and their commercial formulations as applied in the countries of cultivation;

7.  Calls on the Commission to develop strategies for health risk assessment and toxicology, as well as post-market monitoring, that target the whole food and feed chain;

8.  Calls on the Commission to fully integrate the risk assessment of the application of the complementary herbicides and their residues into the risk assessment of HT GMP, regardless of whether the genetically modified plant is for cultivation in the Union or for import for food and feed;

9.  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) http://www.efsa.europa.eu/en/efsajournal/pub/182 (4) https://www.efsa.europa.eu/en/efsajournal/pub/4659 (5) ––––––––––––––––– –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 (Texts adopted, P8_TA(2015)0456).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 (Texts adopted, P8_TA(2016)0040).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 (Texts adopted, P8_TA(2016)0039).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) (Texts adopted, P8_TA(2016)0038).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 (Texts adopted, P8_TA(2016)0271).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) (Texts adopted, P8_TA(2016)0272).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 (Texts adopted, P8_TA(2016)0388).Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of genetically modified maize MON 810 products (Texts adopted, P8_TA(2016)0389).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 (Texts adopted, P8_TA(2016)0386).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 (Texts adopted, P8_TA(2016)0387).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 (Texts adopted, P8_TA(2016)0390).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 (Texts adopted, P8_TA(2017)0123).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 (Texts adopted, P8_TA(2017)0215).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 (Texts adopted, P8_TA(2017)0214).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 (Texts adopted, P8_TA(2017)0341).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 (Texts adopted, P8_TA(2017)0377).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 (Texts adopted, P8_TA(2017)0378). (6) See, for example, El-Shamei ZS, Gab-Alla AA, Shatta AA, Moussa EA, Rayan AM, Histopathological Changes in Some Organs of Male Rats Fed on Genetically Modified Corn (Ajeeb YG). J Am Sci. 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 SR, Horowitz AR, 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) 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 (Texts adopted, P8_TA(2016)0387). (9) http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2004-08 (10) Annex F – Member States’ comments and GMO Panel responses, http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2015-00342 (11) Annex F – Member States’ comments and GMO Panel responses, http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2015-00342, p. 7. (12) https://link.springer.com/article/10.1007%2Fs00267-015-0589-7 (13) https://drive.google.com/file/d/0B7H5dHXeodSCc2RjYmwzaUIyZWs/view (14) 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). (15) OJ C 355, 20.10.2017, p. 165. (16) OJ L 31, 1.2.2002, p. 1.