European Parliament 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 (D051451 — 2017/2780(RSP))
Date: 2017-09-13
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: animal feedingstuffs, food safety, foodstuff, herbicide, labelling, leguminous vegetable, market approval, marketing standard, soya bean, transgenic plant








C_2018337EN.01005401.xml










20.9.2018   


EN


Official Journal of the European Union


C 337/54






P8_TA(2017)0341
Genetically modified soybean DAS-68416-4
European Parliament 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 (D051451 — 2017/2780(RSP))
(2018/C 337/08)

The European Parliament,






—


having regard to 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 (D051451),










—


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 7(3), 9(2), 19(3) and 21(2) 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, of 12 June 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) on 26 January 2017 and published on 16 March 2017 (3),










—


having regard to the proposal of 14 February 2017 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 25 January 2011, Dow AgroSciences Europe submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified DAS-68416-4 soybean to the national competent authority of the Netherlands in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003; whereas that application also covered the placing on the market of genetically modified soybean DAS-68416-4 in products consisting of it or containing it for uses other than food and feed as any other soybean, with the exception of cultivation;










B.


whereas on 26 January 2017, 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 subsequently published on 16 March 2017 (5);










C.


whereas Regulation (EC) No 1829/2003 specifies 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;










D.


whereas numerous critical comments were submitted by Member States during the three-month consultation period (6); whereas the most worrying assessments found that, for example, ‘the current application and the presented risk assessment data do not provide sufficient information to exclude adverse effects on animal and human [health] unambiguously’, that ‘the data so far provided by the applicant are not sufficient to complete the evaluation of the application’ and ‘limited studies make it challenging to perform a complete risk assessment’;










E.


whereas Member States have criticised, inter alia: the lack of studies on the effect of genetically modified soybean on human and animal health, which is preventing the environmental risk assessment from being finalised; the choice and location of the field sites for the comparative assessment; the fact that the toxicological risk assessment cannot be completed because there was no appropriate toxicity text with plant material from DAS-68416-4 soybean; the lack of information on the complementary herbicides which may be used on the genetically modified crop and their metabolites; the fact that the nutritional assessment is supported by an industry study from which no scientific conclusions can be drawn; and the fact that the applicant’s proposal for an environmental monitoring plan does not meet the objectives defined in Annex VII to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (7);










F.


whereas the DAS-68416-4 soybean expresses the aryloxyalkanoate dioxygenase-12 (AAD-12) protein, which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides; whereas it also expresses the phosphinothricin acetyltransferase (PAT) protein, conferring tolerance to glufosinate ammonium-based herbicides;










G.


whereas independent research raises concerns about the risks of the active ingredient of 2,4-D as regards embryo development, birth defects and endocrine disruption (8); whereas although the approval of the active substance 2,4-D was renewed in 2015, information from the applicant as regards the potential endocrine properties is still outstanding (9);










H.


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 of 21 October 2009 concerning the placing of plant protection products on the market (10); whereas the approval of glufosinate expires on 31 July 2018 (11);










I.


whereas a number of experts have voiced concerns about a breakdown product of 2,4-D, 2,4-Dichlorophenol, which may be present on imported DAS-68416-4 soybeans; whereas 2,4-Dichlorophenol is a known endocrine disruptor with reproductive toxicity;










J.


whereas owing to the fact that it is highly soluble in fats and oils, 2,4-Dichlorophenol is expected to accumulate in soy oil during the processing of soybeans; whereas the major soy product used by humans is soy oil, which is incorporated into, among many other products, some infant formulas (12);










K.


whereas the amount of 2,4-Dichlorophenol in a product may be higher than the amount of 2,4-D residue; whereas there is no Union maximum residue level (MRL) for 2,4-Dichlorophenol;










L.


whereas a recent UN report shows that pesticides are responsible for an estimated 200 000 acute poisoning deaths per year, of which 99 % occur in developing countries; whereas the Union has signed up to the sustainable development goals (SDGs), which include a commitment to substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination by 2030 (SDG 3, target 3.9), for which one of the indicators is the mortality rate attributed to unintentional poisoning (13); whereas it has been shown that herbicide-tolerant genetically modified crops result in higher use of these herbicides than their conventional counterparts (14);










M.


whereas the Union is committed to Policy Coherence for Development, which aims to minimise contradictions and build synergies between different Union policies, including in the areas of trade, the environment and agriculture (15), in order to benefit developing countries and increase the effectiveness of development cooperation (16);










N.


whereas authorising the import of DAS-68416-4 soybean into the Union will undoubtedly lead to an increase in its cultivation in third countries, including in developing countries, and to a corresponding increase in the use of 2,4-D and glufosinate herbicides;










O.


whereas the development of genetically modified crops tolerant to several selective herbicides is mainly due to the rapid evolution of weed resistance to glyphosate in countries that have relied heavily on genetically modified crops;










P.


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 of 12 June 2017, delivered no opinion; whereas 15 Member States voted against, while only 11 Member States — representing just 36,57 % of the Union population — voted in favour, with two Member States abstaining;










Q.


whereas on several occasions the Commission has deplored the fact that since the entry into force of Regulation (EC) No 1829/2003 it has had to adopt 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 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 this practice has also been deplored by President Juncker as not being democratic (17);










R.


whereas Parliament rejected the legislative proposal of 22 April 2015 amending Regulation (EC) No 1829/2003 on 28 October 2015 at first reading (18) and called on the Commission to withdraw it and submit a new one;










S.


whereas, pursuant to recital 14 of Regulation (EU) No 182/2011, 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 goes beyond the scope of 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 (19), 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, 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 as to address the shortcomings of the current procedure, which has proven inadequate;












5.


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;












6.


Calls on the Commission not to authorise any HT GMP made resistant to a combination of herbicides, as is the case with soybean DAS-68416-4, without full assessment of the specific cumulative effects of the residues from spraying with the combination of the complementary herbicides and its commercial formulations as applied in the countries of cultivation;












7.


Calls on the Commission to request much more detailed testing of health risks relating to stacked events such as DAS-68416-4;












8.


Calls on the Commission to develop strategies for health risk assessment and toxicology, as well as for post-market monitoring, that target the whole food and feed chain and their mixtures as being present in the food and feed chain under practical conditions;












9.


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 destined for cultivation in the Union or for import for food and feed;












10.


Calls on the Commission to fulfil its obligation of Policy Coherence for Development stemming from Article 208 of the Treaty on the Functioning of the European Union;












11.


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)  https://www.efsa.europa.eu/en/efsajournal/pub/4719

(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 (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 (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 (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) (Texts adopted, P8_TA(2017)0214).





(5)  https://www.efsa.europa.eu/en/efsajournal/pub/4719

(6)  Annex G — Member States’ comments and GMO Panel responses: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2011-00052

(7)  OJ L 106, 17.4.2001, p. 1.

(8)  http://www.pan-europe.info/sites/pan-europe.info/files/public/resources/reports/pane-2014-risks-of-herbicide-2-4-d.pdf

(9)  Commission Implementing Regulation (EU) 2015/2033 of 13 November 2015 renewing the approval of the active substance 2,4-D in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 298, 14.11.2015, p. 8).

(10)  OJ L 309, 24.11.2009, p. 1.

(11)  http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32015R0404&from=EN

(12)  Member State consultation document, pp. 31-32. http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2011-00052

(13)  https://sustainabledevelopment.un.org/sdg3

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

(15)  Commission communication of 12 April 2005 entitled ‘Policy Coherence for Development: Accelerating progress towards attaining the Millennium Development Goals’ (COM(2005)0134).

(16)  https://ec.europa.eu/europeaid/policies/policy-coherence-development_en

(17)  See, for example, the opening statement at the plenary of Parliament included in the political guidelines for the next Commission (Strasbourg, 15 July 2014) and the State of the Union Address 2016 (Strasbourg, 14 September 2016).

(18)  Texts adopted, P8_TA(2015)0379.

(19)  OJ L 31, 1.2.2002, p. 1.