The European Parliament adopted by 402 votes to 208, with 25 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 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.

On 13 September 2013, Monsanto Europe S.A. submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified (GM) maize MON 87427 × MON 89034 × NK603 to the national competent authority of Belgium. It covers the placing on the market of products consisting of or containing genetically modified maize MON 87427 × MON 89034 × NK603 for uses other than food and feed as any other maize, with the exception of cultivation.

The application covered, for those uses, all three sub-combinations of GM maize MON 87427 × MON 89034 × NK603.

GM maize MON 87427 × MON 89034 × NK603 contains two genes for glyphosate resistance and produces Cry1A.105 and Cry2Ab2 proteins which confer resistance to specific lepidopteran pests.

Although the European Food Safety Authority (EFSA) adopted a favourable opinion to renew the authorisation, many critical comments were submitted by Member States in relation to the opinion during the three-month consultation period relating to:

• the fact that the compositional analysis does not cover residues of the complementary herbicides nor its metabolites;
• that, due to concerns over studies showing an increase in the incidence of bladder stones in mice fed on MON 89034, a conclusion about the risks associated with the use of this GM organism (‘GMO’) in human or animal food cannot be drawn;
• that further information is required before the risk assessment can be finalised.

Other areas of concern include: (i) the lack of experimental data for MON 87427 × MON 89034 and MON 87427 × NK603 sub-combinations; (ii) the post-market environmental monitoring plan submitted by the applicant for the three-event stack maize does not include any provisions for the two sub-combinations MON 87427 × MON 89034 and MON 87427 × NK603.

Members also questioned the issue concerning the carcinogenicity of glyphosate. However, one of the key purposes of the stacked event is to increase the plant’s tolerance to glyphosate (both NK603 and MON 87427 express EPSPS enzymes which confer tolerance to glyphosate). In consequence, it has to be expected that the plant will be exposed to higher and also repeated dosages of glyphosate.

On the basis of these considerations, Parliament considered that the Commission’s implementing decision is not compatible with Union law which requires the provision of the basis for ensuring a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, while ensuring the effective functioning of the internal market.

As a result, Parliament asked the Commission to withdraw its draft implementing decision.

On a procedural level, Members recalled that since the entry into force of authorisation procedure for GMOs, authorisation decisions have been adopted by the Commission without the support of the Standing Committee on the Food Chain and Animal Health.

Moreover, 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. This practice has also been deplored by Commission President Juncker as not being democratic.

Parliament also called on the Commission to suspend any implementing decision regarding applications for authorisation of GMOs until the authorisation procedure has been revised in such a way so as to address the shortcomings of the current procedure, which has proven inadequate.

It also called on the legislators responsible to advance work on the Commission proposal amending Regulation (EU) No 182/2011 on comitology as a matter of urgency and to ensure that, inter alia, if no opinion is delivered by the Food Chain and Animal Health Standing Committee with respect to GMOs approvals, either for cultivation or for food and feed, the Commission will withdraw the proposal.

Parliament also called on the Commission to:

• not to authorise any herbicide-tolerant genetically modified plants (HT GMP) without full assessment of the residues from spraying with the complementary herbicides and their commercial formulations as applied in the countries of cultivation;
• request much more detailed testing of health risks relating to stacked events such as genetically modified maize MON 87427 × MON 89034 × NK603;
• develop strategies for health risk assessment, toxicology and post-market monitoring that target the whole food and feed chain;
• fully integrate the risk assessment of the application of complementary herbicides and their residues into the risk assessment of HT GMP, regardless of whether the GM plant is for cultivation in the Union or for import for food and feed.