Plants derived from new genomic techniques: analysis of category 1 inclusion criteria proposed by the European Commission
Since the European regulatory framework for GMOs was established in 2001, new techniques for genetically modifying plants have emerged. In order to inform discussions on changes to the regulatory framework to take account of these new genomic techniques (NGTs), ANSES issued an internal request to analyse the criteria proposed by the European Commission to define category 1 NGT plants, which are considered comparable to conventional plants. The Agency calls for clarification of several definitions or classification procedures and the scope of the techniques covered. It also highlights certain scientific and health-related limitations in the establishment of the criteria.
On 5 July 2023, the European Commission proposed a regulation to distinguish certain NGT plants covered by European legislation on GMOs (Directive 2001/18/EC), as they could be considered equivalent to plants produced using conventional techniques. The equivalence criteria proposed for these so-called category 1 plants have been examined by ANSES with the support of its group of experts dedicated to biotechnologies, based on the proposed regulation, its Annex I and the technical document distributed by the Commission on 16 October 2023. ANSES stresses that the ongoing discussions at European level are likely to have already led to changes in the text it analysed.
What does the proposed regulation cover?
The regulation covers two categories of NGT plants. Category 1 plants, mentioned as being equivalent to natural or conventionally selected plants, are defined by the criteria for equivalence to conventional plants set out in Annex I to the proposed Regulation. Once their category 1 status is established, these plants will no longer be subject to EU legislation on GMOs. On the other hand, NGT plants that are not in category 1 are automatically in category 2 and thus largely covered by GMO legislation, subject to specific provisions and derogations.
In its opinion, ANSES observes that these techniques can lead to changes in the biological functions of plants, which are not taken into account in the Commission's category 1 proposal, and that subsequent health and environmental risks cannot be ruled out. This proposal therefore extends the choices made when the GMO framework was introduced in 2001, which did not require documentation demonstrating the control or absence of risks for plants considered to be derived from conventional techniques. In the Agency's view, the regulatory framework for designating plants that are exempt from such assessment should therefore be very clear and limit the scope for discretion.
However, the Agency notes that there is no definition of what constitutes a conventional plant, with which NGT-derived plants must nevertheless be compared. ANSES also calls for the definitions of several terms to be clarified, such as the notion of "targeted site" — the specificity of NGTs being that they manipulate the genome with great precision — or the notions of "genetic material" and "breeders' gene pool", which are the tools used by those involved in selecting new varieties. It is also recommended that the scope of the techniques concerned be clarified. The opinion explains in particular why the exclusion from category 1 of plants derived from intragenesis or non-targeted cisgenesis should be more clearly formulated.
Finally, the Agency also identifies limitations in the scientific justification for the proposed equivalence criteria. For category 1, it encourages the Commission to consider thresholds for genetic modifications that depend on the size of each plant's genome; this is particularly important for polyploid plants, which have more than one pair of chromosomes.