Resolution 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 × 1507 × MON 88017 × 59122, and genetically modified maize combining two, three or four of the single events MON 87427, MON 89034, 1507, MON 88017 and 59122 and repealing Decision 2011/366/EU

The European Parliament adopted, by 403 votes to 179 with 28 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 × 1507 × MON 88017 × 59122, and genetically modified maize combining two, three or four of the single events MON 87427, MON 89034, 1507, MON 88017 and 59122 and repealing Decision 2011/366/EU.

The application for marketing authorisation was submitted on 26 November 2013 by Monsanto Europe S.A./N.V. to the national competent Belgian authority, in accordance with Regulation (EC) No 1829/2003.

Two of the maize varieties involved express proteins which confer tolerance to glyphosate herbicides which are classified glyphosate as probably carcinogenic to humans by the International Agency for Research on Cancer (the specialised cancer agency of the World Health Organisation).

Four of the maize varieties involved express Cry proteins conferring resistance to certain lepidopteran and coleopteran pests respectively.

While the European Food Safety Authority (EFSA) expressed a favourable opinion on the application for authorisation, Member States made many critical comments during the three-month consultation period, highlighting in particular:

• poor test designs, missing tests, e.g. as regards nutritional assessment, or the lack of any 90-day feeding study in rodents;
• missing or insufficient data, e.g. regarding unintended effects associated with the combination of the events, or regarding potential interactions of the eight proteins, which might lead to unintended effects;
• wrong assumptions by the applicant, e.g. as regards degradation of orally ingested DNA during its passage through the gastrointestinal tract;
• a partly missing environmental risk assessment, and an insufficient environmental monitoring plan.

Independent research also raises concerns about major gaps in the comparative assessment, serious gaps as regards the missing toxicology assessment, about the inconclusive assessment with regard to allergenicity.

In spite of all of these concerns, EFSA did not consider any post-market monitoring of food/feed derived from genetically modified maize MON 87427, MON 89034, 1507, MON 88017 and 59122 and its sub-combinations to be necessary.

On the basis of these considerations, Parliament considered that the draft Commission implementing decision is not consistent with Union law 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.

According to Members, the draft Commission implementing decision runs contrary to the principles of the general food law, as laid down in Regulation (EC) No 178/2002, to approve varieties for which no safety data have been provided, which have not even been tested, or which have not even been created yet.

Parliament therefore called on the Commission to withdraw its draft implementing decision.

On the procedural note, Members recalled that since the current GMO authorisation procedure entered into force, authorisation decisions have been adopted by the Commission without the support of the Member States’ committee opinion 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 genetically modified food and feed authorisations.

Parliament called on the Commission to suspend any implementing decision regarding applications for authorisation of genetically modified organisms 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.