Commission says it will ignore warnings of French food safety agency ANSES. Report: Claire Robinson

In a development that will challenge the mindset of those who believe the European Commission's GMO deregulation plans are based on science, the Commission has announced it stands by its decision to treat crops produced with new GM techniques as conventionally bred ones. It will not ask EU food safety authority EFSA to review its scientific assessment in light of a report by the French food safety agency ANSES. ANSES had concluded that there was no scientific basis to the Commission's determination to treat the majority of new GM plants as equivalent to conventionally bred ones.

The Commission's response to the ANSES report was given by Health and Food Safety Commissioner Stella Kyriakides in answer to a question by Christophe Clergeau MEP. Clergeau had proposed that the Commission should revisit the issue by referring it to EFSA.

Kyriakides said, "The criteria have been developed by the Commission based on a scientific literature analysis about the changes in plants’ genome obtained by conventional breeding methods. They are underpinned by the European Food Safety Authority’s (EFSA) conclusions about the safety of plants obtained by NGTs [new genomic techniques, new GM techniques]... The criteria proposed by the Commission are in line with and take into account EFSA’s scientific opinions. In this regard, the Commission does not consider there is a need to mandate EFSA to establish new equivalence criteria."

The Commission's answer related to the first of two devastating reports by ANSES on the risks of new GM plants. In the report, published in December, ANSES had concluded that the equivalence criteria that the Commission was proposing, that would exempt the majority of new GM plants from risk assessment, traceability and labelling requirements, were "insufficiently justified".

Numbers game

The Commission' criteria included the threshold of 20 genetic modifications for so-called NGT1 plants — which the Commission claims are conventional-like — as well as describing the types of modifications that would be allowed a free regulatory pass.

But ANSES's panel of experts criticised the Commission's failure to consider the unintended effects of the GM processes. ANSES warned, “The Biotechnology WG [ANSES’ working group of experts on biotechnology] emphasises that the functional or biological consequences of a given genetic variation or modification are not determined by its type or size.

“Nevertheless, when analysing the proposed equivalence approach, which focuses on the types, sizes and number of genetic modifications, the Biotechnology WG considers that the thresholds of 20 genetic modifications per plant, at the target site and at sites with similar sequences, and a size of 20 nucleotides for insertions and substitutions, are not justified. Nor is the acceptance of any deletion or inversion without conditions... Nor is the lack of consideration for potential modifications outside the targeted sites and similar sequences (with the exception of transgenic elements, due to the definition of the NGT plant) justified.”

ANSES distinguishes the risks of natural breeding from new GM techniques, saying that any harmful genetic changes brought about by conventional breeding are selected out by breeders over time, based on their impact on biological function, not on the type or number of genetic changes.

An amendment voted through by the European Parliament would restrict the number of modifications allowed in NGT1 plants to three, with certain conditions regarding their type, though according to molecular geneticist Prof Michael Antoniou, these criteria are as scientifically invalid – and just as dangerous – as the original criteria proposed by the Commission.

The second ANSES report, released this month after delays allegedly caused by French government censorship, was even more critical of the Commission's proposal than the first. ANSES called for new GM plants to be assessed for health and environmental risks on a case-by-case basis and said it was "important" to set up a monitoring plan after each market launch, both for the environmental impact of these new GMOs and their socio-economic effects. The agency warned of risks linked to unexpected changes in the composition of the plant, which could give rise to nutritional, allergenicity or toxicity problems, or medium- and long-term environmental risks.

Under the Commission's proposal and the version voted through by the Parliament, these risks would be ignored for the vast majority (around 94%) of new GM plants.

Commission goes against the view of EFSA to please industry

In reality, and contrary to the Commission's claim, EFSA never recommended abolishing all risk assessment for new GM plants. But the Commission has been selective in taking on board the advice the agency gave, in line with industry's wishes. As the French civil society group Inf'OGM explained, EFSA had indeed asked for an assessment – albeit a relatively light one – of the risks of new GMOs. However, the European Commission proposed to abolish this requirement, as requested by certain companies and GMO industry lobby groups.

For example, in December 2022, CropLife told the European Commission that it was concerned that the EFSA opinion "might give the impression that a mandatory risk assessment strep is necessary for all plants obtained by targeted mutagenesis [gene editing], cisgenesis [GM used to introduce genes from a sexually compatible plant] and intragenesis [GM used to transfer new combinations of genes and regulatory sequences belonging to the particular species being engineered]". Croplife argues that current GMO legislation is simply "not an appropriate basis to regulate these plants", whereas the existing framework for conventional breeding has been shown "to provide a high level of protection".

Similar responses came from the French seed giant Limagrain, which has invested heavily in GM crop R&D, and the lobby group, the French Plant Biotechnology Association (AFBV). The AFBV wrote that it does "not share EFSA’s apparent recommendation that a mandatory risk assessment step is necessary for plants obtained by directed mutagenesis, cisgenesis and intragenesis".

The Commission reassured the lobby groups. In January 2023, it replied to CropLife that EFSA’s work "on possible criteria for risk assessment also feeds into this policy work as scientific advice to the Commission for consideration. This in no way prejudges what regulatory framework could eventually be proposed for NGT plants. The framing of the Terms of Reference of the Commission’s mandate to EFSA was indeed focused on the development of criteria for risk assessment, in case such an approach were to be proposed. A decision on whether risk assessment should be performed on NGT plants or not is outside EFSA’s remit, as you correctly noted."

In deciding to ignore ANSES's reports and overrule EFSA's advice, the Commission has definitively turned its back on science. It has shown that it is only concerned with promoting the economic interests of a tiny sector of society – the GMO industry.

In spite of the Commission's stance, however, GMWatch understands that in response to a request from the European Parliament, EFSA will provide an opinion on ANSES’s reports by this July.