The European Parliament adopted by 526 votes to 142, with 18 abstentions, a resolution objecting to the draft Commission implementing decision authorising the placing on the market of products containing genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and genetically modified maize combining two, three or four of the single events MON 87427, MON 87460, MON 89034, MIR162 and NK603.

The application for marketing authorisation was submitted by Monsanto Europe N.V., on behalf of Monsanto Corporation, USA, to the competent authority of the Netherlands on 28 October 2016. On 3 July 2019, the European Food Safety Authority (EFSA) adopted an opinion in favour of the application.

Main comments from the Member States

Members pointed out that Member States have sent numerous critical comments to EFSA on the fact:

- that potential interactions with environmental conditions, which may affect the transgenic protein content in the plant, are not taken into account;

- that there are still unresolved questions regarding safety and possible toxicity, and that the evaluation does not take into account herbicide residues and glyphosate metabolites;

- that there are concerns regarding the use of the antimicrobial resistant gene.

In addition, the applicant has not provided experimental data for the currently unauthorised 14 sub-combinations of the stacked GM maize.

Lack of evaluation of herbicide residues and degradation products

Members pointed out that herbicide-tolerant genetically modified crops are leading to an increase in the use of ‘complementary’ herbicides, in particular due to the emergence of herbicide-tolerant weeds. It can therefore be expected that the stacked GM will be repeatedly exposed to higher rates of glyphosate, which could lead to an increase in the amount of residues in the crops.

In addition, there are still questions about the carcinogenicity of glyphosate. In 2015, the International Agency for Research on Cancer of the World Health Organization has, contrary to the EFSA and the European Chemicals Agency (ECHA), classified glyphosate as a probable carcinogen to humans.

Members also noted that:

- according to several studies, 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 could increase the allergenicity of other proteins that they come into contact with;

- stacked GM maize produces the NPTII protein that confers resistance to a range of antibiotics, including neomycin and kanamycin, which the WHO classifies as ‘critically important for human and veterinary medicine’. Austria has formally opposed the placing on the market of stacked GM maize because of the inclusion of this antibiotic resistance marker gene.

Undemocratic decision-making

Members recalled that in the vote held on 15 September 2020, 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 has repeatedly deplored the fact that decisions on the authorisation of GMOs continue to be adopted by the Commission without a qualified majority of Member States being in favour, which is very much the exception for product authorisations as a whole, but has become the norm for decisions on GM food and feed authorisations.

Recommendations

Based on these considerations, Parliament considered that the Commission's implementing decision was not compatible with EU law. Consequently, it called on the Commission to:

- withdraw its draft implementing decision;

- make progress on the development of sustainability criteria, with full involvement of the Parliament;

- take into account the EU's obligations under international agreements, such as the Paris Climate Agreement, the UN Convention on Biological Diversity and the UN sustainable development goals;

- ceases to authorise GMOs, whether for cultivation or for use as food or feed, where no opinion is given by the Member States in the Appeal Committee;

- not authorise herbicide-tolerant GM crops until the health risks from residues have been thoroughly investigated on a case-by-case basis;

- to take full account of the risk assessment of the use of complementary herbicides and their residues in the risk assessment of herbicide-tolerant GM crops, irrespective of whether the crop concerned is intended to be grown in the EU or imported into the EU as food or feed;

- allowing sub-combinations of stacked events only if they have been thoroughly evaluated by EFSA on the basis of complete data submitted by the applicant.

EFSA is called on to further develop and systematically use methods that permit the identification of unintended effects of stacked GM events.