To align existing EU legislation on GMOs with new developments, on 5 July 2023, the European Commission tabled a proposal for a regulation on plants obtained by NGTs.

The initiative covers 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" – 'NGT 1 plants' – from all other plants obtained through NGTs – 'NGT 2 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, 'NGT 2 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 'NGT 1 plants') to establish equivalence with conventional products and authorisation (for 'NGT 2 plants'). 

'NGT 1 plants' are however treated as GMOs for the purposes of organic production. For ‘NGT 2 plants’ EU countries are required to adopt coexistence measures to avoid the unintended presence of such NGT plants in other products. The possibility 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 ‘NGT 1 plants’, the mandatory labelling that applies to GMOs is abandoned. The Commission proposes to maintain mandatory labelling for ‘NGT 2 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 ‘NGT 2 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 plenary followed by and large the ENVI committee in adopting its negotiating position on 24 April 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 (NGT 1 plants), would be exempt from the requirements of GMO legislation, while other NGT plants (NGT 2 plants) 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 from NGT 1 plants). 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 NGT 2 plants, 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.

On 14 March 2025, the Committee of Permanent Representatives of the Member States to the EU reached a qualified majority on an EU Council negotiating mandate. 

Under the provisions, NGT 1 plants would be exempted from the rules set out in the GMO legislation and would not be labelled, but seeds produced through those techniques would have to be labelled. For NGT 2 plants, a risk assessment and authorisation would be required before they are placed on the market and they would be labelled as such. The proposal excludes the use of NGTs in organic production. EU countries can request an opt-out from cultivation of NGT 2 plants on their territory, and they can implement optional co-existence measures. 

When applying to register NGT 1 plants or products, companies or breeders would have to submit information on all existing or pending patents, while the patenting information should be included in a publicly available database. There are also provisions for the establishment of an expert group on the effect of patents on NGT plants, with experts from all Member States and the European Patent Office. 

On the basis of the unchanged 2024 mandate, ENVI endorsed a decision to enter into interinstitutional negotiations on 8 April. Negotiations started on 6 May 2025 and are ongoing.

References:

• EP Legislative Observatory, Procedure file on Plants obtained by certain new genomic techniques and their food and feed, 2023/0226(COD) 
• Council, Mandate for negotiations with the European Parliament, 6426/25
• European Committee of the Regions, New genomic techniques and plant reproductive materials, CDR 4545, 2023
• European Economic and Social Committee, Plants produced by new genomic techniques, NAT/908, 2023
• 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
  
  

Further reading:

• European Parliament, EPRS, Plants produced by new genomic techniques, Briefing, May 2024

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