EFSA ignores main issues in opinion on ANSES's report on new GMO deregulation

On 10 July, EFSA published its opinion on the French health agency ANSES's opinion of December 22, 2023, concerning Annex 1 of the European Commission's proposal on the deregulation of plants obtained from new genomic techniques (NGTs). The European health authority concludes that the new GMOs can be considered equivalent to conventional plants if they correspond to the criteria retained by the Commission, omitting the issues raised by the highly critical opinion of the French health agency.

"In its opinion, EFSA completely ignores the arguments put forward by ANSES – which call into question the foundations of this proposed regulation – and totally ignores the risks of the new GMOs, which will not be assessed if the draft regulation is adopted. With this 4-page response, the agency is endorsing the European Commission's arguments, without providing a critical eye or scientific analysis," said Charlotte Labauge, campaigner at the environmental NGO Pollinis.

The Commission proposes to consider as equivalent to a conventional plant a plant that has undergone up to 20 modifications, among 5 possible types of modification, including, among others, a substitution or insertion of up to 20 nucleotides (i.e. 400 possible mutations) and deletions of unlimited size. This categorisation would concern 94% of NGT-derived plants under development and potentially marketable,[1] allowing them to enter the market without any risk assessment.

ANSES issued a clear statement against these equivalence criteria: "There is no scientific basis for equivalence of trait type between two categories of plants on the basis of equivalent content of genetic variations or modifications that would be defined solely by their type, size and number."

The national health agency added that the risks of NGTs could not be determined by a number of genetic modifications: "The proposal of a maximum threshold of acceptable genetic modifications is not scientifically founded in terms of risk: the associated risk is not directly proportional to any number of modifications."

Despite having been mandated by the European Parliament to respond to ANSES, EFSA does not comment on the relevance of the criteria chosen by the Commission to determine equivalence (number, size and type of modifications) and the importance of adopting a more comprehensive approach. It builds its opinion on the idea that such modifications can also "be the result of spontaneous mutations or random mutagenesis". This argument had already been set out in the European Commission's technical document, and was the subject of criticism from ANSES.

The European Food Safety Authority also sidesteps the question of risk, stating that "these equivalence criteria are not intended to determine a level of risk, but to allow certain NGT plants to be classified as equivalent to conventionally bred plants". However, classifying NGT plants in category 1 exempts them from any risk assessment, since this leads to them being considered equivalent to conventional plants. There is therefore a direct link between equivalence criteria and risk, which EFSA refuses to acknowledge.

EFSA's opinion has been published several months after the second ANSES opinion, which highlighted the risks of the new GMOs - on which EFSA did not express an opinion, as it had not been mandated to do so – and after the European Parliament had already adopted the European Commission's draft regulations. While this text is still being negotiated between member states at the Council of the European Union, Pollinis calls on France to reject it.

Notes

[1] Bohle F, Schneider R, Mundorf J, Zühl L, Simon S and Engelhard M (2024) Where does the EU-path on new genomic techniques lead us? Front. Genome Ed. 6:1377117. https://doi.org/10.3389/fgeed.2024.1377117

Source: Pollinis

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