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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 MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D069147/02,

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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,

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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 26 October 2020, at which no opinion was delivered,

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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),

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having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 2 July 2009, and published on 21 July 2009 (3),

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having regard to the opinion adopted by EFSA on 25 September 2019, and published on 7 November 2019 (4),

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having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (‘GMOs’) (5),

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having regard to Rule 112(2) and (3) of its Rules of Procedure,

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having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,

A.

whereas Commission Decision 2009/866/EC (6) authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified (‘GM’) maize MIR604; whereas the scope of that authorisation also covers the placing on the market of products containing or consisting of GM maize MIR604 for uses other than food and feed, with the exception of cultivation;

B.

whereas, on 26 July 2018, the authorisation holder, Syngenta Crop Protection NV/SA, on behalf of Syngenta Crop Protection AG, submitted to the Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of that authorisation;

C.

whereas, on 2 July 2009, EFSA adopted a favourable opinion, which was published on 21 July 2009, in relation to the initial authorisation application;

D.

whereas, on 25 September 2019, EFSA adopted a favourable opinion, which was published on 7 November 2019, in relation to the renewal application;

E.

whereas the possible uses of GM maize MIR604 include the production of animal feed and food products, such as starch, syrups and oils (7);

F.

whereas GM maize MIR604 has been engineered to produce mCry3A, a synthetic insecticidal protein (also known as a ‘Bt toxin’) with enhanced toxicity (compared to the natural bacteria it is derived from) for targeting Western Corn rootworm and other related coleopteran maize pests, such as Northern Corn rootworm; whereas, in addition, GM maize MIR604 was engineered with the phosphomannose isomerase (PMI) gene from Escherichia coli (E. coli), which encodes the enzyme PMI as a selectable marker;

G.

whereas the combination of the two gene constructs was derived from stacking, but no assessment was made of the single parental plants, in contravention of Commission Implementing Regulation (EU) No 503/2013 (8);

H.

whereas Regulation (EC) No 1829/2003 states that GM food or feed must not have adverse effects on human health, animal health or the environment, and requires the Commission to take into account any relevant provisions of Union law and other legitimate factors relevant to the matter under consideration when drafting its decision;

I.

whereas, during the consultation period in relation to the initial authorisation application, Member States submitted many critical comments to EFSA’s draft opinion (9); whereas those critical comments include concerns that an increase in allergenic activity due to mCry3A protein in food and feed from GM maize MIR604 cannot be excluded, that the data from field trials cannot be regarded as sufficient for market release, that OECD testing guidelines were not followed in the toxicological studies, as recommended by EFSA, and that the rat and a poultry feeding study with the whole GM maize MIR604 plant intended to demonstrate toxicological safety did not use toxicological endpoints;

J.

whereas, during the consultation period in relation to the renewal application, Member States again submitted many critical comments to EFSA’s draft opinion (10); whereas those critical comments include concerns that the monitoring approach implemented by the applicant is not fully in line with the requirements of Annex VII to Directive 2001/18/EC of the European Parliament and of the Council (11) and with EFSA recommendations, that the claim that GM maize MIR604 is as safe as conventional maize has not been substantiated, and that the proposed general surveillance of anticipated adverse effects is not sufficiently elaborated, as well as the comment that the Union has ratified the UN Convention on Biological Diversity (CBD), which makes it clear that both exporting and importing countries have international responsibilities regarding biological diversity;

K.

whereas for the studies on acute toxicity and degradation in digestive fluids, mCry3A and PMI proteins produced in a recombinant E. coli strain were used; whereas both the mCry3A protein and the PMI protein produced in E. coli bacteria differ from the GM plant-produced proteins (12) raising doubts about the validity of these toxicity studies; whereas several Member States raised this as a concern (13);

L.

whereas, in general, little significance can be attributed to toxicological tests conducted with proteins in isolation, due to the fact that the effects of the protein in combination with the plant itself are not considered;

M.

whereas, for example, some plants, including maize, naturally produce proteinase inhibitors (PI) which have been shown to slow down the degradation of Bt toxins; whereas this results in much higher toxicity of the Bt toxin, if it is ingested together with the plant tissue, compared to the toxin in isolation; whereas a 1990 study, conducted by scientists at Monsanto, showed that even the presence of extremely low levels of PI enhanced the insecticidal activity of Bt toxins up to 20-fold (14); whereas this interaction has never been assessed, nor mentioned, by EFSA in its risk assessments of GM Bt plants;

N.

whereas it has been shown that factors which enhance the toxicity of the Bt proteins can also impact their selectivity (15): if efficacy of the Bt toxin on target organisms is increased, its selectivity may also be decreased and a wider range of non-target organisms may become susceptible; whereas, whilst no systematic research has been undertaken to date, several studies indicate the effects of PI combined with Bt toxins on non-target insects (16);

O.

whereas the risk of higher toxicity to humans and mammals, due to interaction between PI and Bt toxins in GM plants, is not known;

P.

whereas a number of studies show that side effects have been observed that may affect the immune system following exposure to Bt proteins and that some Bt proteins may have adjuvant properties (17), meaning that they can increase the allergenicity of other proteins with which they come into contact;

Q.

whereas, whilst EFSA recognises that Cry1Ac (18) has been shown to act as an adjuvant, it concludes that as maize is not a common allergenic food, the adjuvant effect of Cry proteins, observed after high dosage intragastric or intranasal administration, is unlikely to raise any concerns regarding allergenicity (19); whereas, however, EFSA does not take into account the fact that maize produces PI (20) and a much slower degradation of the Bt proteins has to be assumed if it is ingested with the plant material, compared to its isolated form; whereas this difference can also enhance its adjuvanticity and renders studies using isolated proteins invalid; whereas no empirical studies were performed to investigate the actual immunogenicity of the Bt toxin produced by the GM plant; whereas the degradation in digestive fluids was tested by using the Bt protein in isolation;

R.

whereas, unlike the use of insecticides, where exposure is at the time of spraying and for a limited time afterwards, the use of Bt crops leads to continuous exposure of the target and non-target organisms to Bt toxins; whereas, with the exception of pollen, mCry3A proteins are found in all parts of GM maize MIR604 (21);

S.

whereas the mCry3A gene as expressed by GM maize MIR604 has been modified in order to enhance toxicity to target insects (22), yet no effects on non-target organisms were evaluated in the risk assessment; whereas, a Member State comments that since ‘the native Cry3A toxin is active against Chrysomelidae (23), as a minimum requirement adverse effects on non-target Chrysomelidae should be included in the risk assessment’ and that ‘[s]ince import, transport and processing of MIR604 maize may result in the presence of accidental occurrence or release of MIR604 maize in the environment, potential adverse effects of the GM maize on non-target organisms must be considered’ (24);

T.

whereas the assumption that Bt toxins exhibit a single target specific mode-of-action can no longer be considered correct and effects on non-target organisms cannot be excluded (25); whereas an increasing number of non-target organisms are reported to be affected in many ways; whereas 39 peer-reviewed publications that report significant adverse effects of Bt toxins on many ‘out-of-range’ species are mentioned in a recent overview (26);

U.

whereas combinatorial effects such as combination with PI may significantly contribute to the toxicity of Bt toxins; whereas the question of selectivity is especially relevant for synthetic Bt toxins, such as mCry3A, which may show lower selectivity in combination with higher toxicity; whereas EFSA still considers that Bt toxins only affect a narrow range of non-target organisms, not taking into account any combinatorial effects; whereas a wider range of non-target organisms might be exposed to Bt toxins via spillage, waste and manure;

V.

whereas the risk assessment did not consider the development of resistance in the target pests to the mCry3A protein, possibly resulting in the use of less environmentally safe pesticides or increased doses and number of applications to the GM crop in the country of cultivation; whereas, the US Environmental Protection Agency is proposing to phase out many current Bt corn hybrids, as well as some Bt cotton varieties, in the next three to five years, due to the growth in insect resistance to these crops (27);

W.

whereas, whilst it has been claimed that the use of Bt crops leads to a decrease in the use of insecticides, a recent study published in the United States (28) finds that ‘several analyses on the influence of Bt crops on pesticide-use patterns do not seem to have considered seed treatments and so may have overstated reductions in insecticide use (especially “area treated”) associated with Bt crops’; whereas the same study finds that neonicotinoid seed treatments are often used in conjunction with Bt maize and soybean crops, that ‘[t]his pattern of use may have unintended consequences, namely resistance in target pests, outbreaks of non-target pests, and pollution with detrimental effects cascading to wildlife’ and that ‘some of these effects have already emerged’; whereas the Union has banned the outdoor use of three neonicotinoids, including as seed coatings, because of their impact on honeybees and other pollinators (29);

X.

whereas the vote on 26 October 2020 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;

Y.

whereas the Commission recognises that the fact that GMO authorisation decisions continue to be adopted by the Commission without a qualified majority of Member States in favour, which is very much the exception for product authorisations as a whole but which has become the norm for decision-making on GM food and feed authorisations, is problematic;

Z.

whereas, in its eighth term, Parliament adopted a total of 36 resolutions objecting to the placing on the market of GMOs for food and feed (33 resolutions) and to the cultivation of GMOs in the Union (three resolutions); whereas, to date, Parliament has adopted eleven objections in its ninth term; whereas there was not a qualified majority of Member States in favour of authorising any of those GMOs; whereas despite its own acknowledgement of the democratic shortcomings, the lack of support from Member States and the objections of Parliament, the Commission continues to authorise GMOs;

AA.

whereas, under Regulation (EU) No 182/2011, the Commission may decide not to authorise a GMO when there is no qualified majority of Member States in favour in the Appeal Committee (30); whereas no change of law is required in this respect;

1.

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6.

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9.

10.

11.

12.

13.

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European Parliament resolution of 10 October 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MZHG0JG (SYN-ØØØJG-2), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0028).

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European Parliament resolution of 10 October 2019 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 soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0029).

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European Parliament resolution of 10 October 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9 and genetically modified maize combining two, three or four of the single events MON 89034, 1507, MON 88017, 59122 and DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0030).

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European Parliament resolution of 14 November 2019 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 cotton LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0054).

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European Parliament resolution of 14 November 2019 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 soybean MON 89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0055).

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European Parliament resolution of 14 November 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and sub-combinations MON 89034 × NK603 × DAS-40278-9, 1507 × NK603 × DAS-40278-9 and NK603 × DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0056).

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European Parliament resolution of 14 November 2019 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 × 1507 × 5307 × GA21 and genetically modified maize combining two, three, four or five of the single events Bt11, MIR162, MIR604, 1507, 5307 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0057).

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European Parliament resolution of 14 May 2020 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 × A5547-127, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0069).

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European Parliament resolution of 11 November 2020 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 × MIR162 × NK603 and genetically modified maize combining two or three of the single events MON 87427, MON 89034, MIR162 and NK603, and repealing Commission Implementing Decision (EU) 2018/1111 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0291).

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European Parliament resolution of 11 November 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean SYHT0H2 (SYN-ØØØH2-5), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0292).

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European Parliament resolution of 11 November 2020 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 87460 × MON 89034 × MIR162 × NK603 and genetically modified maize combining two, three or four of the single events MON 87427, MON 87460, MON 89034, MIR162 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0293).