The European Parliament adopted by 435 votes to 156 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 87411 (MON-87411-9), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

The application for placing on the market was submitted on 5 February 2015 by Monsanto Europe N.V. on behalf of the Monsanto Company, United States. On 31 May 2018, the European Food Safety Authority (EFSA) adopted a favourable opinion in relation to this application.

GM maize MON 87411 was developed to confer resistance to corn rootworms by the expression of a modified version of the Bt Cry3Bb1 gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate-containing herbicides.

Main observations

Lack of assessment and controls of complementary herbicides and their residues

Members considered that the application of complementary herbicides, in this case glyphosate, is part of regular agricultural practice in the cultivation of herbicide-resistant plants. It can therefore be expected that they will be exposed to both higher and repeated doses, which will not only lead to a higher burden of residues in the harvest, and therefore in the imported product, but may also influence the composition of the genetically modified plant and its agronomic characteristics.

Questions remain concerning the carcinogenicity of glyphosate. in 2015 the World Health Organisation’s International Agency for Research on Cancer classified glyphosate as a probable carcinogen for humans, contrary to the conclusions of EFSA and the European Chemicals Agency (ECHA).

Members also stressed the following points:

-information on residue levels of herbicides and their metabolites is essential for a thorough risk assessment of herbicide-tolerant GM plants. However, the impact of spraying GM maize MON 87411 with herbicides has not been assessed;

-as part of the coordinated multiannual control programme of the Union for 2019, 2020 and 2021, Member States are not obliged to measure glyphosate residues on any maize imports in order to check compliance with maximum residue levels (MRLs). It cannot be guaranteed that glyphosate residues on GM maize MON 87411 will comply with Union MRLs.

Lack of democratic legitimacy

The vote on 14 January 2019 of the Standing Committee on the Food Chain and Animal Health delivered no opinion, meaning that the authorisation was not supported by a qualified majority of Member States.

The Commission deplored the fact that, since the entry into force of the GMO authorization procedure, the Commission has adopted authorisation decisions without the support of the opinion of the Member States’ committee. 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.

In the light of these considerations, Parliament considered that the draft Commission implementing decision is not consistent with Union law, which aims 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.

Accordingly, Parliament called on the Commission to:

- withdraw its draft implementing decision;

- not to authorise any herbicide-tolerant GM plants without a full assessment of the residues from spraying with complementary herbicides, 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;

- suspend any implementing decision regarding applications for authorisation of genetically modified organisms (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;

- 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.