Plants produced by certain new genomic techniques
In “A European Green Deal”
On 14 September 2022, in her State of the Union address, European Commission President Ursula von der Leyen announced the Commission intention to present a legislative proposal on plants produced by certain 'new genomic techniques' (NGTs). The term refers to new genetic engineering processes such as CRISPR/Cas, which are used to modify the genetic make-up of plants even more profoundly and rapidly than is possible with conventional breeding. To align existing EU legislation on GMOs with these new developments, on 5 July 2023, the European Commission tabled a proposal for a regulation on plants obtained by NGTs.
The scope of this initiative are plants produced by targeted mutagenesis (a set of techniques, allowing modifications of the genome without the insertion of foreign DNA), cisgenesis (a modification of the genetic material of an organism with a sequence from the same species or one closely related) and intragenesis (a modification of the genetic material of an organism with a combination of different sequences from the same species or one closely related) and their food and feed. The proposal does not include plants obtained by NGTs that introduce genetic material from a non-crossable species (transgenesis). Such techniques remain subject to the existing GMO legislation.
The proposal is structured around two categories of plants aiming to distinguish varieties "considered equivalent to conventional plants" – 'Category 1 NGT plants' – from all other plants obtained through NGTs – 'Category 2 NGT plants'. The proposal considers an NGT plant equivalent to conventional plants "when it differs from the parent plant by no more than 20 genetic modifications". For their part, 'Category 2 NGT plants' are defined by default: they include all other varieties obtained through NGTs.
The deliberate release and placing on the market of NGT plants would be subject to one of two procedures: verification (for 'Category 1 NGT plants') to establish equivalence with conventional products and authorisation (for 'Category 2 NGT plants').
'Category 1 NGT plants' are however treated as GMOs for the purposes of organic production. For ‘Category 2 NGT plants’ EU countries are required to adopt coexistence measures to avoid the unintended presence of such NGT plants in other products. The possibility for EU countries to restrict or prohibit cultivation of GMOs under Directive 2001/18 would not apply to such NGT plants.
Regarding the traceability of plants obtained by NGTs, the Commission opted for a hybrid solution. For ‘Category 1 NGT plants’, the mandatory labelling that applies to GMOs is abandoned. The Commission proposes to maintain mandatory labelling for ‘Category 2 NGT plants’ and leaves the possibility of specifying the characteristics brought by the genetic modification by adding a factual statement. To ensure transparency and freedom of choice for farmers, all NGT plants will be listed in a public database. In addition, their seeds and other plant reproductive material will be labelled, and information on NGT plant reproductive material will be listed in the common EU catalogues of plant varieties.
Regulatory incentives would be offered to applicants for ‘Category 2 NGT plants’ containing traits with the potential to contribute to a sustainable agri-food system, provided they do not contain herbicide-tolerant traits.
The Environment, Public health and Food safety committee (ENVI) appointed Jessica Polfjärd (EPP, Sweden) as rapporteur. In her draft report, presented on 7 November, the rapporteur seeks to relax the provisions applying to 'category 1 NGT plants' by eliminating the additional requirements that differentiate them from conventional plants. She notably proposes removing the term “genetically modified” from the definition of NGTs plants and objects to the mandatory labelling of seeds from 'category 1 NGT plants'. In addition, the rapporteur considers that “transparency” and “consumer choice” can be fully ensured by making available information about the use of NGTs in public databases. Similarly, the rapporteur suggests allowing the use of 'category 1 NGT plants' in organic farming.
Concerning the criteria set out in Annex I to determine NGT plants falling under 'category 1', the rapporteur maintains that the threshold of 20 genetic modifications must be relative to the ploidy status of the plant, that is, the number of sets of chromosomes that are found within the nucleus.
Ms Polfjärd believes that the competent authority of the EU country in which the application is submitted should be entrusted with the verification process for the marketing of NGT-derived seeds. The remaining EU countries would be able to challenge an approval decision only with a reasoned opinion. Finally, concerning patents of plants obtained through NGTs, Ms Polfjärd acknowledges the concerns of breeders and farmers but suggests that the issue should be addressed in separate piece of legislation to prevent the proposal from exceeding its scope.
A vote is tentatively scheduled in ENVI on 24 January 2024, with a vote in plenary in February.
In the Council, the EU agriculture ministers failed to reach a common position at the latest meeting of 11 December. The Belgian presidency took over the file. EU countries remain split on a number of controversial elements, namely the coexistence of organic agriculture with NGT plants, the absence of a provision allowing EU countries to ban cultivation of NGT plants on their territory and the treatment of patents (currently excluded from the text).
- EP Legislative Observatory, Procedure file on Plants obtained by certain new genomic techniques and their food and feed, 2023/0226(COD)
- European Commission, Proposal for a regulation on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625, COM(2023) 411 final
- European Council, Compromise text on a General approach, 7 December 2023
- European Council, Compromise text on Articles 1-11, 3 October 2023
- European Commission, Technical paper detailing the rationale for the equivalence criteria in Annex I, 16 October 2023
- European Economic and Social Commitee, Plants produced by new genomic techniques, NAT/908, 2023
- European Committee of the Regions, New genomic techniques and plant reproductive materials, CDR 4545, 2023
- European Parliament, EPRS, Plants produced by new genomic techniques, Briefing, October 2023
Author: Ivana Katsarova, Members' Research Service, email@example.com