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Plants produced by certain new genomic techniques

In “A European Green Deal”

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The term 'new genomic techniques' (NGTs) 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), including cisgenesis (a modification of the genetic material of an organism with a sequence from the same species or one closely related). 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 Commission 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 European Parliament's Environment, Public health and Food safety committee (ENVI) adopted the report drafted by Jessica Polfjärd (EPP, Sweden) on 24 January 2024.

The European Parliament followed by and large its ENVI committee in adopting its negotiating position on 7 February 2024, by 307 votes in favour, 263 against and 41 abstentions.

MEPs maintain the general structure of the proposal: NGT plants considered equivalent to conventional plants (Category 1), would be exempt from the requirements of GMO legislation, while other NGT plants (Category 2) would have to comply with the rules of Directive 2001/18 on the deliberate release into the environment of GMOs. All NGT plants would remain banned in organic farming.

For NGT 1 plants, MEPs amended the rules on the size and number of modifications required for an NGT plant to be considered equivalent to conventional plants. To ensure transparency, MEPs decided to set up a public online list of all NTG 1 plants, as well as a mandatory labeling for all NGT products (including those in Category 1). MEPs also want the Commission to present a report on how consumers and producers perceive the new techniques, seven years after they came into force.

For category 2 NGTs, MEPs chose to maintain most of the requirements of the legislation on GMOs, including the authorisation procedure and compulsory labelling of products. To encourage their dissemination, MEPs agreed to speed up the risk assessment procedure, but stressed the need to respect the precautionary principle.

MEPs are also in favour of a total ban on patents for all NGT plants, plant material, parts thereof, genetic information and process characteristics contained therein, in order to avoid legal uncertainty, increased costs and new dependencies for farmers and breeders. They are also calling for a report to be drawn up by June 2025 on the impact of patents on farmers' and breeders' access to plant reproductive material, and for a legislative proposal to be presented to update EU rules on intellectual property rights accordingly.

Since inter-institutional negotiations failed to begin, Parliament closed the first reading and confirmed its position with 336 votes in favour, 238 against and 41 abstentions in a vote of 24 April 2024.

In the Council, the EU agriculture ministers have so far failed to reach a common position. The various compromise texts put forward by the Spanish and Belgian presidencies could not break the deadlock. While only the issue of the patentability of NGT plants seemed to stand in the way during the last debates, Hungary - which is currently holding the rotating presidency - has suggested that discussions be started up on a number of additional issues, such as labelling, controls and equivalence criteria. 

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Further reading:

Author: Ivana Katsarova, Members' Research Service, legislative-train@europarl.europa.eu

As of 20/11/2024.