The European Parliament adopted a resolution by 465 votes to 169, with 30 abstentions, a resolution objecting to 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.

On 11 January 2013, Dow AgroSciences Europe submitted, on behalf of Dow AgroSciences LLC, an application. The application concerned the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and sub-combinations thereof. The application also covered the placing on the market of products containing or consisting of the stacked GM maize for uses other than food and feed, with the exception of cultivation.

Member State comments and an independent study

Member States submitted many critical comments to EFSA during the three-month consultation period which followed the publication of a favourable opinion from the European Food Safety Authority (EFSA) on 28 November 2018. Those critical comments include the observation that the data provided by the applicant is insufficient to ensure a correct risk assessment, that the risk assessment conducted by EFSA is not sufficient in its present form, having failed to properly assess the overall safety and potential toxicity of the stacked GM maize event for humans, animals and the environment, that EFSA did not take into account recent studies about the potential toxicity of Bt toxins, and that it is impossible to reach conclusions concerning the health risks associated with the stacked GM maize.

An independent study also concluded that the risk assessment by EFSA is not acceptable in its present form, having failed to properly assess the overall safety and potential toxicity of the stacked GM maize event.

Lack of assessment of herbicide residues, metabolites and cocktail effects

Members noted that a number of studies show that herbicide-tolerant GM crops result in a higher use of ‘complementary’ herbicides, in large part because of the emergence of herbicide-tolerant weeds. As a consequence, it has to be expected that the stacked GM maize will be exposed to both higher and repeated doses of glufosinate and glyphosate, and that therefore a higher quantity of residues may be present in the harvest. Glufosinate is classified as toxic to reproduction 1B and the approval of glufosinate for use in the Union expired on 31 July 2018. In addition, questions remain about the carcinogenicity of glyphosate.

Maximum residue levels, Bt proteins

The resolution noted that according to a 2018 EFSA review of the existing MRLs for glyphosate, available data were insufficient to derive MRLs and risk assessment values for glyphosate in relation to GM maize with an EPSPS modification. The stacked GM maize has the EPSPS modification.

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, meaning that they can increase the allergenicity of other proteins that they come into contact with.

The EFSA is called on to further develop and systematically use methods that permit the identification of unintended effects of stacked GM events, such as in relation to the adjuvant properties of Bt toxins.

Undemocratic decision-making

Members stressed that the Commission recognised 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 has become the norm for decision-making on GM food and feed authorisations, is problematic. That practice has, on several occasions, been deplored by the Commission President as not being democratic.

On the basis of these comments, Parliament called on the Commission:

- to withdraw its draft implementing decision;

- in the meantime, to stop authorising GMOs when no opinion is delivered by Member States in the Appeal Committee, whether for cultivation or for food and feed uses, in accordance with Regulation (EU) No 182/2011 (comitology);

- not to authorise herbicide-tolerant GM crops until the health risks associated with the residues have been comprehensively investigated on a case-by-case basis, which requires a full assessment of the residues from spraying the GM crops with complementary herbicides, their metabolites and any combinatorial effects;

- 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 is for import into the Union for food and feed uses;

- not to authorise the import for food or feed uses of any GM plant which has been made tolerant to a herbicide-active substance that is not authorised for use in the Union;

- not to authorise any sub-combinations of stacked GM events unless they have been thoroughly evaluated by EFSA on the basis of complete data submitted by the applicant.

Parliament reiterated its commitment to advancing work on the Commission proposal amending Regulation (EU) No 182/2011.

The Commission is urged to treat the Union’s obligations under international agreements, such as the Paris Climate Agreement, the UN Convention on Biological Diversity and the UN Sustainable Development Goals, and to give them the weight they deserve, as well as communicating on how they have been taken into account in the decision-making process.