European Parliament 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 (D054772-02 — 2018/2568(RSP))
Date: 2018-03-01
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: animal feedingstuffs, food safety, foodstuff, labelling, maize, market approval, transgenic plant








C_2019129EN.01000201.xml










5.4.2019   


EN


Official Journal of the European Union


C 129/2






P8_TA(2018)0051
Genetically modified maize DAS-59122-7
European Parliament 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 (D054772-02 — 2018/2568(RSP))
(2019/C 129/01)

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 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 (D054772-02),










—


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 16 January 2018, 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 on 18 May 2017, and published on 29 June 2017 (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 Commission Decision 2007/702/EC authorised the placing on the market of food and feed containing, consisting or produced from genetically modified maize 59122 (‘GM maize 59122’); whereas, prior to that Commission decision, on 23 March 2007, 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 3 April 2007 (5) (the ‘first EFSA opinion’);










B.


whereas on 19 July 2016, Pioneer Overseas Corporation and Dow AgroSciences Ltd. (the ‘applicant’) jointly submitted an application for the renewal of the authorisation for the placing on the market of foods and feed containing, consisting of, or produced from GM maize 59122 in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003; whereas that application also covered the placing on the market of genetically modified maize 59122 in products consisting of it or containing it for uses other than food and feed as any other maize, with the exception of cultivation;










C.


whereas, on 18 May 2017, EFSA adopted a favourable opinion, in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003, which was published on 29 June 2017 (6) (the ‘second EFSA opinion’);










D.


whereas GM maize 59122 expresses CRY34Ab1 and CRY35Ab1 proteins conferring resistance to coleopteran insect pests belonging to the genus Diabrotica such as larvae of western corn rootworm and the PAT protein which confers tolerance to glufosinate-containing herbicides;










E.


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 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;










F.


whereas many critical comments were submitted by Member States in relation to the first EFSA opinion during the three-month consultation period (7) relating to, inter alia, the insufficient surveillance plan, the risk of exposure to BT toxins of non-target organisms, the lack of basis for the conclusion that ‘feed products from GM maize 59122 are substantially equivalent to, nutritionally equivalent to and as safe as feed products from commercial maize’ and, with regard to the 90-day rat study, the fact that GM maize 59122 was administered at only one dose level for the whole study, in breach of the recommendation in the OECD guidelines concerned;










G.


whereas, following the submission from the applicant for re-authorisation, EFSA was asked to assess data submitted by the applicant, including post-market environmental monitoring reports and 11 primary research studies published between 2007 and 2016; whereas, on the basis of its assessment of the submitted data, EFSA adopted a favourable opinion (the second EFSA opinion, as referred to above), concluding that ‘no new hazards or modified exposure and no new scientific uncertainties were identified that would change the conclusions of the original risk assessment on maize 59122’;










H.


whereas many critical comments were submitted by Member States in relation to the second EFSA opinion during the three-month consultation period (8) including, inter alia, ‘that the monitoring conducted for GM maize 59122 is unable to provide meaningful results for the current assessment and to resolve uncertainties associated with the risk assessment conducted prior to authorisation, e.g. as regards exposure of the environment’ and that ‘the monitoring approach implemented for GM maize 59122 is not in line with requirements of Annex VII of Directive 2001/18/EC’;










I.


whereas one Member State questioned why several public studies demonstrating the immunogenicity of Cry proteins in mice had not been submitted by the applicant, and therefore assessed by EFSA, and advised that concerns relating to immunogenicity and adjuvanticity of the Cry proteins expressed in GM maize 59122 should be resolved before renewal of authorisation is granted;










J.


whereas one Member State noted that the Union has approved the Convention on Biological Diversity, which places international responsibilities on both exporting and importing countries regarding biological diversity and that therefore it is important to take into account the impacts of importing the GM maize 59122 into the Union, both on Union biodiversity as well as biodiversity in the countries of cultivation;










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 (9); whereas the approval of glufosinate expires on 31 July 2018 (10);










L.


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 (11);










M.


whereas the residues from spraying with glufosinate were not assessed in either EFSA opinion; whereas residues of glufosinate will be present on GM maize 59122 crop imported into the Union for food and feed uses;










N.


whereas it would be unacceptable from a food safety perspective, as well as highly inconsistent, to authorise the import of a glufosinate tolerant GM maize given that the authorisation for the use of glufosinate in the Union expires on 31 July 2018 due to its reproductive toxicity (12);










O.


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 16 January 2018 delivered no opinion; whereas 12 Member States voted against, while 12 Member States, representing only 38,83 % of the Union population, voted in favour, and four Member States abstained;










P.


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 (13);










Q.


whereas Parliament rejected the legislative proposal of 22 April 2015 amending Regulation (EC) No 1829/2003 on 28 October 2015 at first reading (14) and called on the Commission to withdraw it and submit a new one;










R.


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;












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 (15), to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modified food and feed, whilst 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, in particular, for the Commission not to authorise the import of any genetically modified plant for food or feed uses which has been made tolerant to a complementary herbicide which is banned, or which will be banned in the near future, in the Union;












7.


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)  http://www.efsa.europa.eu/en/efsajournal/pub/4861

(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 (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).










—


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 (Texts adopted, P8_TA(2017)0396).










—


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 (Texts adopted, P8_TA(2017)0397).










—


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 (Texts adopted, P8_TA(2017)0398).





(5)  https://www.efsa.europa.eu/en/efsajournal/pub/470

(6)  http://www.efsa.europa.eu/en/efsajournal/pub/4861

(7)  Annex G — Member States’ comments and GMO Panel responses: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2016-00526

(8)  Annex G — Member States’ comments and GMO Panel responses: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2016-00526

(9)  OJ L 309, 24.11.2009, p. 1.

(10)  Point 7 of the Annex to Commission Implementing Regulation (EU) 2015/404 (OJ L 67, 12.3.2015, p. 6).

(11)  https://link.springer.com/article/10.1007%2Fs00267-015-0589-7

(12)  Annex G — Member States’ comments and GMO Panel responses: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2013-01002

(13)  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).

(14)  OJ C 355, 20.10.2017, p. 165.

(15)  OJ L 31, 1.2.2002, p. 1.