The European Parliament adopted by 398 votes to 173, with 24 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 DP4114 × MON 810 × MIR604 × NK603 and genetically modified maize combining two or three of the single events DP4114, MON 810, MIR604 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

On 2 May 2018, Pioneer Overseas Corporation, based in Belgium, submitted, on behalf of Pioneer Hi-Bred International, Inc., based in the United States, an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize DP4114 × MON 810 × MIR604 × NK603 (the GM maize).

On 26 January 2022, the European Food Safety Authority (EFSA) adopted a favourable opinion on this application.

Lack of assessment of the complementary herbicide

Members pointed out that 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. GM maize rape may therefore be exposed to both higher and repeated doses of glyphosate, which may lead to an increase in the (‘metabolites’) in the harvest.

The resolution stated that the 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. A number of recent scientific peer-reviewed studies confirm the carcinogenic potential of glyphosate.

Outstanding questions concerning Bt toxins

The toxicity of the Bt toxins was assessed on the basis of feeding studies, using only isolated Bt proteins 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 is because protease inhibitors (PI), present in the plant tissue, can increase the toxicity of the Bt toxins by delaying their degradation. This enhanced toxicity is not taken into account in EFSA risk assessments, even though it is relevant for all Bt plants approved for import or cultivation in the Union. Risks to humans and animals that consume food and feed containing Bt toxins and which arise from this enhanced toxicity due to the interaction between PI and Bt toxins cannot, therefore, be ruled out.

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.

Moreover, a scientific study found that the toxicity of Bt toxins may also be increased through interaction with residues from spraying with herbicides, and that further studies are needed on the combinatorial effects of ‘stacked’ events (GM crops which have been modified to be herbicide tolerant and to produce insecticides in the form of Bt toxins).

Undemocratic decision-making

Parliament welcomed that 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.

In its ninth term, Parliament has already adopted 27 objections to placing GMOs on the market. There was not a qualified majority of Member States in favour of authorising any of those GMOs. The reasons for Member States not supporting authorisations include lack of respect for the precautionary principle in the authorisation process and scientific concerns relating to the risk assessment.

Parliament highlighted that the amendments adopted by the European Parliament on 17 December 2020 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011, which were adopted in Parliament as a basis for negotiations with the Council, state that the Commission shall not authorise GMOs when there is not a qualified majority of Member States in favour. It insisted that the Commission respect this position and called on the Council to proceed with its work and adopt a general approach on this file as a matter of urgency.

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 GMOs.

Upholding international obligations

Members recalled the UN’s Sustainable Development Goal (SDG) Target 3.9, which aims to significantly reduce the number of deaths and illnesses caused by hazardous chemicals, pollution and contamination of air, water and soil by 2030. They considered that authorising the import of the GM maize would increase demand for this crop which is treated with glyphosate, thereby increasing the exposure of workers and the environment in third countries. The risk of increased worker and environmental exposure is of particular concern in relation to herbicide-tolerant GM crops, given the higher volumes of herbicides used.

According to a peer-reviewed study published in 2020, Roundup, one of the world’s most widely used glyphosate-based herbicides, can trigger a loss of biodiversity, making ecosystems more vulnerable to pollution and climate change.

In addition, the EU, as a party to the UN Convention on Biological Diversity (UN CBD), has the responsibility to ensure that activities within its jurisdiction or control do not cause damage to the environment of other States.

Recommendations

On the basis of these considerations, Parliament considered that the Commission's draft implementing decision was not consistent with Union law and asked the Commission to withdraw its draft implementing decision.

The Commission is also asked to:

- not to authorise herbicide-tolerant GM crops until the health risks related to residues have been thoroughly investigated on a case-by-case basis;

- take account of the EU's obligations under international agreements, such as the Paris Climate Agreement, the UN Convention on Biological Diversity (CBD) and the UN's SDGs, and ensure that draft implementing acts explain how they uphold with the principle of ‘do no harm’.