Resolution on the draft Commission implementing decision renewing the authorisation for placing on the market of products containing, consisting of or produced from genetically modified maize MIR162 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Implementing Decisions (EU) 2016/1685, 2019/1305 and 2019/2087 as regards the reference material

The European Parliament adopted by 412 votes to 175, with 28 abstentions, a resolution objecting to the draft Commission implementing decision renewing the authorisation for placing on the market of products containing, consisting of or produced from genetically modified maize MIR162 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Implementing Decisions (EU) 2016/1685, 2019/1305 and 2019/2087 as regards the reference material.

On 12 February 2021, Syngenta Crop Protection NV/SA, based in Belgium, submitted, on behalf of Syngenta Crop Protection AG, based in Switzerland, an application to the Commission, for renewal of the authorisation. On 1 September 2022, EFSA adopted a favourable opinion in relation to the renewal of the authorisation of the GM maize, which was published on 22 September 2022.

The GM maize has been engineered to produce the protein VIP3a20 (a ‘Bt toxin’), which is toxic to certain lepidopteran pests.

Outstanding questions concerning Bt toxins

The toxicity of the Bt toxin was assessed on the basis of feeding studies, using only the isolated Bt protein produced by bacteria. Little significance can be attributed to toxicological tests conducted with proteins in isolation, due to the fact that Bt toxins in GM crops, such as maize, cotton and soybeans, are inherently more toxic than isolated Bt toxins. This enhanced toxicity is not taken into account in EFSA risk assessments, even though it is relevant for Bt plants approved for import into the Union.

A number of studies show that side effects have been observed that may affect the immune system following exposure to Bt toxins and that some Bt toxins may have adjuvant properties, meaning that they can increase the allergenicity of other proteins with which they come into contact.

Undemocratic decision-making

The Commission recognises 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 has become the norm for decision-making on GM food and feed authorisations, is problematic. Despite its own acknowledgement of the democratic shortcomings, the lack of support from Member States and the objections of Parliament, the Commission continues to authorise imports of GMO crops for food and feed.

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 and to submit a new draft to the committee.

Parliament called on EFSA to:

- investigate 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, the environment as well as impacts on health and food safety;

- no longer accept toxicity studies based on isolated proteins which are likely to be different in structure and biological effects compared to those produced by the plant itself, and to require that all tests are carried out with tissue from the GM plant.