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Document stages in plenary
| Document selected : B8-0074/2019 | ||||||
Texts tabled : B8-0074/2019 |  | Debates : |  | Votes : |  | Texts adopted : P8_TA(2019)0058 |
| Texts adopted |
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| Thursday, 31 January 2019听-听Brussels | |||||
| Genetically modified maize 5307 (SYN-脴53脴7-1) |
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 European 合法博彩网站 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-脴53脴7-1), pursuant to Regulation (EC) No 1829/2003 of the European 合法博彩网站 and of the Council on genetically modified food and feed (D059689/02 鈥� ) | |||||||||||||||||||||||||||||||
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合法博彩网站, 鈥撎齢aving regard to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 5307 (SYN-脴53脴7-1), pursuant to Regulation (EC) No 1829/2003 of the European 合法博彩网站 and of the Council on genetically modified food and feed (D059689/02), 鈥撎齢aving regard to Regulation (EC) No 1829/2003 of the European 合法博彩网站 and of the Council of 22听September 2003 on genetically modified food and feed(1), and in particular Articles 7(3) and 19(3) thereof, 鈥撎齢aving regard to the vote on 3 December 2018 of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003, at which no opinion was delivered, 鈥撎齢aving regard to Articles听11 and 13 of Regulation (EU) No听182/2011 of the European 合法博彩网站 and of the Council of 16听February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission鈥檚 exercise of implementing powers(2), 鈥撎齢aving regard to the opinion adopted by the European Food Safety Authority (EFSA) on 16 April 2015 and published on 5 May 2015(3), and to the Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-DE-2011-95) for the placing on the market of genetically modified maize 5307 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG taking into consideration an additional toxicological study, adopted by EFSA on 7 March 2018 and published on 11 April 2018(4), 鈥撎齢aving regard to the proposal for a regulation of the European 合法博彩网站 and of the Council of 14 February 2017 amending Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission鈥檚 exercise of implementing powers (, , 鈥撎齢aving regard to its previous resolutions objecting to the authorisation of genetically modified organisms(5), 鈥撎齢aving regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety, 鈥撎齢aving regard to Rule 106(2) and (3) of its Rules of Procedure, A.听听whereas, on 7 April 2011, Syngenta Crop Protection AG submitted an application, through its affiliated company Syngenta Crop Protection NV/SA, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified (GM) maize 5307 (鈥榯he application鈥�) to the national competent authority of Germany; whereas the application also covered the placing on the market of products containing or consisting of GM maize 5307 for uses other than food and feed, with the exception of cultivation; B.听听whereas GM maize 5307 produces a new insecticidal protein, eCry3.1Ab, which is toxic to certain beetles and weevils and which is derived from a fusion and rearrangement of toxins that naturally occur in soil bacteria known as Bacillus thuringiensis (Bt); whereas GM maize 5307 also expresses the protein phosphommanose isomerase (PMI), which is used as a selection marker; C.听听whereas EFSA concluded in its 2015 opinion that it was unable to complete its food/feed risk assessment owing to inadequacies in the 28-day toxicity study provided by the applicant, in particular because the datasets were from two separate experiments and because an insufficient number of animals were used(6); D.听听whereas the applicant later provided a new 28-day toxicity study; whereas, however, the second study did not meet all the requirements of the Organisation for Economic Cooperation and Development (OECD) guidelines on repeated dose 28-day oral toxicity studies in rodents(7), as requested by EFSA; E.听听whereas, in its 2018 statement, EFSA adopted a favourable opinion in relation to this application; F.听听whereas although Cry proteins (Bt toxins) have been recognised as having adjuvant properties, meaning that they may reinforce the allergenic properties of other foodstuffs, this was not analysed by EFSA; whereas that is problematic, because Bt toxins may be mixed with allergens in food and feed such as soybeans; G.听听whereas in the 28-day toxicity study accepted by EFSA, only the isolated protein was tested; whereas, however, it has been shown that the toxicity of Bt toxins can be enhanced through interactions with other compounds such as plant enzymes, other Bt toxins and residues from spraying with herbicides; whereas testing the Bt toxin alone and in isolated form does not allow, therefore, for any conclusions to be drawn on its health impact after consumption(8); H.听听whereas EFSA noted that the 鈥榓pplicant identified relevant similarities between the amino acid sequence of eCry3.1Ab and parasporins, which might act as cytotoxic proteins on mammalian cells鈥�(9); whereas EFSA did not investigate that further; I.听听whereas many critical comments were submitted by Member State competent authorities during the three-month consultation period(10); J.听听whereas, according to one competent authority(11), expression levels of eCry3.1Ab in GM maize 5307 kernels exceed the default maximum residue level permitted, which is 0,01 mg/kg as set out in Regulation (EC) No 396/2005 of the European 合法博彩网站 and of the Council(12); K.听听whereas the vote on 3 December 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, meaning that the authorisation was not supported by a qualified majority of Member States; L.听听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 opinion of the Member States鈥� 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 genetically modified food and feed authorisations; whereas that practice has, on several occasions, been deplored by President Juncker as not being democratic(13); M.听听whereas, on 28 October 2015, 合法博彩网站 rejected at first reading(14) 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.听听Considers that the draft Commission implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003; 2.听听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(15), 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.听听Calls on the Commission to withdraw its draft implementing decision; 4.听听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.听听Calls on the Commission to suspend any implementing decision regarding applications for authorisation of 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.听听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.听听Instructs its President to forward this resolution to the Council, the Commission, and the governments and parliaments of the Member States.
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