The French food safety agency ANSES has strongly criticized the European Commission’s proposal regarding the definition of a new class of genetically modified (GM) plants, known as Category I NGT plants. This proposed class would be exempted from undergoing risk assessment, traceability, and labeling, based on the assertion that they are “equivalent” to conventional plants.
The Commission’s proposal specifically includes a criterion for equivalence, setting a limit of no more than 20 genetic modifications per plant at the target site and in locations with similar sequences. Additionally, the proposed size for insertions and substitutions is 20 nucleotides. In a statement, ANSES challenges the scientific foundation for assuming such equivalence, as highlighted in an article by GMWatch.
“The Commission’s technical document states that ‘similar genetic modifications obtained by different techniques are not assumed to present different risks’, and ‘if certain types and numbers of mutations can be introduced by conventional breeding techniques as well as by NTGs, then the type of traits associated with these mutations will not differ between these techniques’. It concludes that it is sufficient to consider only the type and number of mutations to assess equivalence between these plants, and that it is not necessary to consider the associated effects.
“The Biotechnology WG [working group] considers that there is no scientific basis for equivalence of type of trait or level of risk between two categories of plants on the basis of equivalent content of genetic variations or modifications defined solely by their type, size and number.
ANSES questions the scientific basis for such an assumption of equivalence
“The WG points out that genetic variability or genetic variations observed in nature are the product of thousands of years of evolution, drift or natural selection. Genetic variations or modifications observed in varieties produced by conventional breeding techniques have undergone selection by breeders.
“In both cases, genetic variations or modifications associated with deleterious effects are eliminated, whether in terms of the plant’s fitness or its selective value in nature, or in terms of the agronomic and qualitative characteristics sought by man in conventional breeding programmes. The elimination or selection of these variations and modifications is not based on their type, size or number, but on their potential impact on a biological function.
“The Biotechnology WG 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, or, to a lesser extent, of targeted cisgenesis without target orthology 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 adds, “The possibility or probability that a given modification or combination of modifications could be obtained by conventional techniques should be considered.”
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