The European Parliament adopted by 495 votes to 181, with 19 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 MZIR098 (SYN-ØØØ98-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

On 25 April 2017, Syngenta Crop Protection NV/SA submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize MZIR098 (‘the GM maize’). The application also covered the placing on the market of products containing or consisting of the GM maize for uses other than food and feed, with the exception of cultivation.

On 28 May 2020, the European Food Safety Authority (EFSA) adopted a favourable opinion on the application.

Main concerns from Member States

Members pointed out that Member States have submitted many critical comments to the EFSA, including that:

- that the data submitted from the field trials are insufficient to establish that the trial sites are representative as regards agronomic practices or abiotic (e.g. soil moisture and fertility) and biotic factors (e.g. prevailing pest and disease pressure and weed profiles);

- the scope of the comparative analysis is too narrow as it did not take into account the use of glufosinate on the GM maize;

- the monitoring plan is insufficient to address the potential environmental effects of the GM maize;

- the studies submitted by the applicant are not sufficient to conclude that the exposure to the environment and thus effects on non-target organisms will be negligible and that no final conclusion is possible with reference to long term reproductive or developmental effects of the whole food or feed;

Lack of analysis of glufosinate residues and outstanding questions concerning Bt toxins

Members pointed out that assessment of herbicide residues, and herbicide break-down products, found on GM plants, along with their interaction with Bt toxins, is considered outside the remit of the EFSA Panel on Genetically Modified Organisms and is therefore not undertaken as part of the authorisation process for GMOs.

Members also noted that side-effects have been observed which 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 decision-making

Members recalled that the vote in January 2021 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 recognised that the fact that GMO authorisation decisions continue to be adopted by the Commission without a qualified majority of Member States in favour, which is very much the exception for product authorisations as a whole but which has become the norm for decision-making on GM food and feed authorisations, is problematic.

Recommendations

On the basis of these considerations, Parliament considered that the Commission's implementing decision is not consistent EU law. Consequently, it called on the Commission to:

- withdraw its draft implementing decision;

- move forward with the utmost urgency concerning the development of sustainability criteria, with Parliament’s full involvement;

- not to authorise herbicide-tolerant GM crops until the health risks associated with the residues have been comprehensively investigated on a case-by-case basis, which requires a full assessment of the residues from spraying such GM crops with complementary herbicides, an assessment of the herbicide breakdown products and any combinatorial effects, including with the GM plant itself;

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

The EFSA is called on to finally accept the substantial differences between native Bt toxins and those expressed by synthetic transgenes in GM crop plants, and to widen its risk assessment in order to fully take into account all interactions and combinatorial effects between Bt-toxins, GM plants and their constituents, residues from spraying with the complementary herbicides, the environment as well as impacts on health and food safety