The European Parliament adopted by 435 votes to 207, with 18 abstentions, a resolution objecting to the draft Commission implementing decision authorising 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.

The application for marketing authorisation was submitted to the competent authorities of the Netherlands on 6 February 2013 by Dow AgroSciences Europe on behalf of Dow AgroSciences LLC.

Comments from Member States

Member States made many critical comments during the three-month consultation period following the publication of the favourable opinion of the European Food Safety Authority (EFSA) adopted on 28 November 2018. In particular, they indicated that it is impossible to reach a final conclusion (in particular with regard to foodstuffs) with reference to the long-term reproductive or developmental effects of the food and/or feed in question and that further information is required to complete the risk assessment. Therefore, safety cannot be guaranteed.

Complementary herbicides

Members noted that a number of studies show that herbicide-tolerant GM crops result in a higher use of those herbicides. As a consequence, it has to be expected that the stacked GM maize will be exposed to both higher and repeated doses of glufosinate, glyphosate and 2,4-D, and therefore a higher quantity of residues may be present in the harvest.

Glufosinate is classified as toxic for reproduction (1B) and the approval of the authorisation of glufosinate in the Union expired on 31 July 2018. In addition, questions remain about the carcinogenicity of glyphosate.

In addition, questions remain about the carcinogenicity of glyphosate.

Several studies have also shown 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.

Undemocratic process

Members stressed that the Commission 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 opinion of the Member States’ committee 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 GM food and feed authorisations.

On the basis of these considerations, Parliament called on the Commission to:

- withdraw its draft implementing decision;

- suspend any implementing decision regarding applications for GMO authorisation until the authorisation procedure has been revised in such a way as to address the shortcomings of the current procedure, which has proven inadequate;

- withdraw proposals for GMO authorisations if no opinion is delivered by the Standing Committee on the Food Chain and Animal Health, whether for cultivation or for food and feed uses;

- not authorise any herbicide-tolerant GM plants without a full assessment of the residues from spraying with complementary herbicides, their metabolites and commercial formulations as applied in the countries of cultivation;

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

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

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

Parliament reiterated its commitment to advancing work on the Commission proposal amending Regulation (EU) No 182/2011 (comitology). It called on the Council to move forward with its work on that Commission proposal as a matter of urgency.