The European Parliament adopted by 491 votes to 184, with 20 abstentions, a resolution objecting to the draft resolution on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

On 30 September 2014, Bayer CropScience AG submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 (‘the GM cotton’). The application also covered the placing on the market of products containing or consisting of the GM cotton for uses other than food and feed, with the exception of cultivation. On 21 June 2018, 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:

- data and data analyses provided on phenotypic evaluation, composition and toxicity is insufficient;

- the compositional analysis did not take into account residues nor metabolites of the complementary herbicides;

- the applicant’s proposal for an environmental monitoring plan does not meet the objectives defined in Directive 2001/18/EC;

- it does not relate the monitoring activities to relevant protection goals.

Lack of assessment of the complementary herbicides and outstanding questions concerning Bt toxins

Members pointed out that assessment of herbicide residues, and herbicide break-down products, found on GM plants 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.

Questions concerning the carcinogenicity of glyphosate remain. EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency concluded in March 2017 that no classification was warranted. On the contrary, in 2015, the International Agency for Research on Cancer, the specialised cancer agency of the World Health Organization, classified glyphosate as a probable carcinogen for humans.

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 full involvement of Parliament;

- 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 break-down 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.