The European Parliament adopted by 470 votes to 200, with 22 abstentions, a resolution objecting to the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize Bt 11 (SYNBTØ11-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

On 24 September 2018, Syngenta Crop Protection NV/SA, submitted to the Commission an application for the renewal of the authorisation for the placing on the market of products containing or consisting of genetically modified maize Bt11 (‘the GM maize’) for uses other than food and feed, with the exception of cultivation. On 25 November 2020, EFSA adopted a favourable opinion in relation to the renewal of the GM maize, which was published on 13 January 2021.

Main concerns from Member States

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

- criticism over the literature search performed by the applicant;

- that the monitoring reports of the GM maize for the authorisation period have severe shortcomings;

- that data on glufosinate residue levels, including relevant metabolites, in plant material from the field studies would support the assessment of food, feed, and environmental safety;

- those relating to the ethical issue of whether a commodity whose cultivation will entail operators’ exposure to glufosinate which is toxic for reproduction and no longer authorised in the Union, should be authorised for import into the Union.

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

A number of studies show that herbicide-tolerant GM crops result in a higher use of ‘complementary’ herbicides, in large part because of the emergence of herbicide-tolerant weeds. As a consequence, it has to be expected that the GM maize will be exposed to both higher and repeated doses of glufosinate, and that therefore a higher quantity of residues may be present in the harvest.

The assessment of herbicide residues and their 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. This is problematic since the way in which complementary herbicides are broken down by the GM plant concerned, and the composition and thus toxicity of the break-down products (‘metabolites’), can be driven by the genetic modification itself.

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 on 17 May 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.

It should be noted that in its ninth term, the European Parliament has already adopted 18 objections to placing GMOs on the market.

Recommendations

On the basis of these considerations, Parliament considered that the Commission's implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003 and that it 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.