The European Parliament adopted by 470 votes to 199, with 23 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 soybean DAS-81419-2 × DAS–44406–6, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

On 2 March 2016, Dow AgroSciences Ltd submitted an application to the national competent authority of the Netherlands. The application covered the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified soybean DAS-81419-2 x DAS-44406-6 (‘the GM soybean’). It also covered the placing on the market of products containing or consisting of the GM soybean for uses other than food and feed, with the exception of cultivation. On 15 October 2020, EFSA adopted a favourable opinion in relation to that application.

Main concerns from Member States

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

- the currently available tools for monitoring horizontal gene transfers in natural environments are inadequate to capture rare events;

- the applicant is ignoring the potential for creating genetic variability by the transfer of mutated pat, epsps and cry gene variants or fragments thereof, that the data provided to show the human and animal safety of the GM soybean on the basis of its substantial equivalence to conventional soybean are not conclusive;

- the combined environmental effects of cry toxins need further research in order to rule out any risk to the environment.

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

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.

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 risk assessment. This is problematic since residues from spraying with glufosinate are known to disturb the microbiome which, for example, may enhance immune reactions in combination with Bt toxins.

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 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;

- fully integrate the risk assessment of the application of complementary herbicides and their residues into the risk assessment of herbicide-tolerant GM plants, regardless of whether the GM plant concerned is to be cultivated in the Union or is for import into the Union for food and feed uses;

- 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.

- immediately suspend the import of GM soybeans cultivated in Brazil and Argentina until effective legally binding mechanisms have been put in place to prevent the placing on the Union market of products associated with deforestation and related human rights violations.

Lastly, Parliament reiterated its call for the implementation of a European vegetable protein production and supply strategy, which would enable the Union to become less dependent on GM soybean imports and to create shorter food chains and regional markets.