European Ϸվ 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 Ϸվ and of the Council on genetically modified food and feed (D056125-02 – )
Ϸվ,
–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 GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Ϸվ and of the Council on genetically modified food and feed (D056125-02),
–having regard to Regulation (EC) No 1829/2003 of the European Ϸվ and of the Council of 22September 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 23 April 2018, at which no opinion was delivered,
–having regard to Article 11 of Regulation (EU) No182/2011 of the European Ϸվ and of the Council of 16February 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 21 September 2017 and published on 24 October 2017(3),
–having regard to the proposal for a regulation of the European Ϸվ 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 (, 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 2008/280/EC(5) authorised the placing on the market of food and feed containing, consisting of, or produced from genetically modified maize GA21 (‘maize GA21’); whereas the scope of that authorisation also covered products other than food and feed containing or consisting of maize GA21 for the same uses as any other maize, with the exception of cultivation;
B.whereas prior to Decision 2008/280/EC, on 13 September 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 2 October 2007(6) (‘EFSA 2007’);
C.whereas on 6 October 2016, Syngenta France SAS submitted to the Commission, on behalf of Syngenta Crop Protection AG, Switzerland, an application, in accordance with Articles 11 and 23 of Regulation (EC) No1829/2003, for the renewal of the above authorisation;
D.whereas on 21 September 2017, EFSA adopted a favourable opinion, in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003, which was published on 24 October 2017(7) (‘EFSA 2017’);
E.whereas maize GA21 has been developed to provide tolerance to glyphosate by expressing a modified version of the EPSPS protein;
F.whereas application of the complementary herbicide, in this case glyphosate, is part of regular agricultural practice in the cultivation of herbicide-resistant plants and it can therefore be expected that residues from spraying will be present in the harvest and are inevitable constituents; whereas it has been shown that herbicide-tolerant genetically modified crops result in a higher use of complementary herbicides than their conventional counterparts;
G.whereas, in consequence, it has to be expected that maize GA21 will be exposed to both higher and repeated doses of glyphosate, which will not only lead to a higher burden of residues in the harvest but may also influence the composition of the GM maize plant and its agronomic characteristics;
H.whereas many critical comments were submitted by Member States during the three-month consultation period, both with regard to EFSA 2007(8) and EFSA 2017(9); whereas, for example, Member States criticised the fact that further information was needed before conclusions could be drawn as regards the risk assessment of maize GA21, that data supporting a history of safe use was not provided, that the monitoring reports for maize GA21 for the authorisation period had fundamental shortcomings and that the monitoring approach implemented was not fully in line with Directive 2001/18/EC;
I.whereas the EFSA Panel on Genetically Modified Organisms (EFSA GMO panel) itself considers that further discussion with applicants and risk managers is needed on the practical implementation of the post-marketing environmental monitoring plans for genetically modified (GM) plants for import and processing;
J.whereas questions concerning the carcinogenicity of glyphosate remain; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency (ECHA) concluded in March 2017 that no classification was warranted; whereas, on the contrary, in 2015 the World Health Organisation’s International Agency for Research on Cancer classified glyphosate as a probable carcinogen for humans;
K.whereas Ϸվ has established a special committee on the Union’s authorisation procedure for pesticides, which will help to establish whether the relevant Union scientific standards were adhered to in the risk assessment procedure and whether there was any undue industry influence over the Union agencies’ conclusions on glyphosate’s carcinogenicity;
L.whereas, in general, according to EFSA’s pesticide panel, conclusions on the safety of residues from spraying GM crops with glyphosate formations cannot be drawn(10); whereas additives and their mixtures used in commercial formulations for spraying glyphosate can show a higher toxicity than the active ingredient alone(11);
M.whereas the Union has already removed a glyphosate additive known as POE tallowamine from the market owing to concerns over its toxicity; whereas problematic additives and mixtures may, however, still be permitted in the countries where maize GA21 is cultivated (Argentina, Brazil, Canada, Japan, Paraguay, the Philippines, South Africa, the USA, Uruguay and Vietnam);
N.whereas information on residue levels of herbicides and their metabolites is essential for a thorough risk assessment of herbicide-tolerant GM plants; whereas residues from spraying with herbicides are considered outside the remit of the EFSA GMO panel; whereas the impacts of spraying maize GA21 with glyphosate have not been assessed;
O.whereas Member States are not required to measure glyphosate residues on maize imports in order to ensure compliance with maximum residue levels as part of the coordinated multiannual control programme for 2018, 2019 and 2020, in accordance with Commission Implementing Regulation (EU) 2017/660(12), nor are they required to do so for the years 2019, 2020 and 2021(13); whereas it is therefore not known whether glyphosate residues on this imported maize GA21 comply with Union maximum residue limits;
P.whereas maize GA21 is cultivated in, inter alia, Argentina; whereas the devastating impact of the use of glyphosate on health has been widely documented; whereas the Union has signed up to the UN’s sustainable development goals (SDGs), which include a commitment to substantially reduce, by 2030, the number of deaths and illnesses from hazardous chemicals, and air, water and soil pollution and contamination (SDG 3, target 3.9)(14);
Q.whereas the Union is committed to policy coherence for development, which aims at minimising contradictions and building synergies between different Union policies, including in the areas of trade, environment and agriculture, to benefit developing countries and increase the effectiveness of development cooperation;
R.whereas EFSA concluded that all but one of the representative uses of glyphosate for conventional crops (i.e. non-GM crops) posed a ‘risk to wild non-target terrestrial vertebrates’, and also identified a high long-term risk to mammals for some of the main uses of glyphosate on conventional crops(15); whereas the ECHA classified glyphosate as being toxic to aquatic life with long-lasting effects; whereas the negative impacts of the use of glyphosate on biodiversity and on the environment are widely documented; whereas, for example, a 2017 US study found a negative correlation between glyphosate use and the abundance of adult monarch butterflies, particularly in areas of concentrated agriculture(16);
S.whereas re-authorisation for the placing on the market of maize GA21 will continue to create demand for its cultivation in third countries; whereas, as mentioned above, higher and repeated doses of herbicide can be expected to be used on herbicide-tolerant GM plants (in comparison to non-GM plants), as they were intentionally designed for that purpose;
T.whereas the Union is party to the UN Convention on Biological Diversity, which places on its parties the responsibility to ensure that activities within their jurisdiction do not cause damage to the environment of other States(17); whereas the decision on whether to re-authorise maize GA21 is within the Union’s jurisdiction;
U.whereas the development of GM 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 GM crops; whereas, in 2015, at least 29 glyphosate-resistant weed species were in existence globally(18);
V.whereas following a vote on 23 April 2018, the Standing Committee on the Food Chain and Animal Health, referred to in Article 35 of Regulation (EC) No 1829/2003, delivered no opinion;
W.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 a final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on GM food and feed authorisations; whereas that practice has also been deplored by President Juncker as undemocratic(19);
X.whereas on 28 October 2015 Ϸվ rejected at first reading(20) 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;
Y.whereas recital 14 of Regulation (EU) No 182/2011 affirms 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 where that act concerns sensitive issues such as consumer health, food safety and the environment;
Z.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 renewing the authorisation;
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 Ϸվ and of the Council(21), 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 decisions 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;
5.Calls, in particular, on the Commission to uphold its commitments under the UN Convention on Biological Diversity, by suspending all imports of glyphosate-tolerant GM plants;
6.Calls on the Commission not to authorise any herbicide-tolerant GM plants without full assessment of the residues from spraying with complementary herbicides and their commercial formulations as applied in the countries of cultivation;
7.Calls on the Commission to fully integrate the risk assessment of the application of complementary herbicides and their residues into the risk assessment of herbicide-tolerant GM plants, regardless of whether the GM plant concerned is to be cultivated in the Union or for import into the Union for food and feed;
8.Reiterates its commitment to advancing work on the Commission proposal amending Regulation (EU) No 182/2011 in order to ensure that, inter alia, if no opinion is delivered by the Food Chain and Animal Health Standing Committee with respect to GMO approvals, whether for cultivation or for food and feed, the Commission will withdraw the proposal; calls on the Council to move forward with its work on the same Commission proposal as a matter of urgency;
9.Instructs its President to forward this resolution to the Council, the Commission, and the governments and parliaments of the Member States.
––––––––––––––––––––––– – 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 Ϸվ 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 (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 Ϸվ 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 Ϸվ 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 Ϸվ 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 Ϸվ 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 Ϸվ 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 Ϸվ 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 Ϸվ 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 Ϸվ 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 Ϸվ and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2017)0398).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 Ϸվ 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 Ϸվ and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0197).
Commission Decision 2008/280/EC of 28 March 2008 authorising 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 Ϸվ and of the Council (OJ L 87, 29.3.2008, p.19).
EFSA conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate. EFSA journal 2015, 13(11):4302, http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4302/epdf
Commission Implementing Regulation (EU) 2017/660 of 6 April 2017 concerning a coordinated multiannual control programme of the Union for 2018, 2019 and 2020 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 94, 7.4.2017, p. 12).
Commission Implementing Regulation (EU) 2018/555 of 9 April 2018 concerning a coordinated multiannual control programme of the Union for 2019, 2020 and 2021 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 92, 10.4.2018, p. 6).
See, for example, the opening statement at the European Ϸվ plenary session included in the political guidelines for the next European Commission (Strasbourg, 15 July 2014), or the State of the Union Address 2016 (Strasbourg, 14 September 2016).