New regulation in the EU

New genomic techniques (NGT), such as targeted mutagenesis and cisgenesis, allow specific changes to be made to the genome of plants without introducing genetic material from other species. Until now, such plants have been subject to the same strict rules in the EU as conventional genetically modified organisms (GMOs). Under the Regulation on plants obtained using certain new genomic techniques, which was adopted on 17 June 2026, NGT plants are removed from the scope of general genetic engineering legislation and regulated in a more nuanced manner.

Scope

This Regulation applies to genetically modified plants obtained through targeted mutagenesis or cisgenesis (including intragenesis) (NGT plants), as well as to products derived from them: food and feed containing, consisting of or produced from NGT plants, and other products containing or consisting of NGT plants. Plant propagating material, including forest reproductive material, also falls within the scope of application. Where the regulation does not contain specific provisions, the requirements of the GMO regulations continue to apply (lex specialis principle). GMOs produced by transgenesis – that is, by the introduction of genetic material from non-interbreedable species – continue to fall exclusively under existing GMO legislation.

Definitions

‘New genomic techniques’ are defined as targeted mutagenesis and cisgenesis. Targeted mutagenesis encompasses all techniques capable of inducing one or more changes to the DNA sequence at specific sites within an organism’s genome. Cisgenesis refers to the introduction into an organism’s genome of genetic material already present in the ‘gene pool for conventional breeding purposes’. Intragenesis is a sub-type of cisgenesis and involves the introduction of a rearranged copy of DNA sequences that are already present in the gene pool for conventional breeding purposes. Intragenic plants can be produced both by intragenesis methods and by cisgenesis methods in the strict sense: new technical developments make it possible to insert even contiguous DNA sequences that do not constitute complete genes (e.g. promoters or regulatory sequences) specifically at certain locations in the genome.

The ‘gene pool for conventional breeding purposes’ comprises the entirety of the genetic information present in a species and in other taxonomic species with which it can be crossed, including through the use of advanced techniques such as embryo rescue, induced polyploidy and bridge crossing.

The plants must not contain any genetic material from outside the gene pool for conventional breeding purposes. If such material has been temporarily introduced during the development of the NGT plant, it must have been removed prior to release or placing on the market.

Categories

NGT plants are classified into two categories. Category 1 NGT plants are considered equivalent to conventionally bred plants. To be classified in Category 1, the plants must meet the equivalence criteria set out in Annex I (see below). In addition, exclusion criteria were introduced at the insistence of Parliament: plants whose intended traits include tolerance to herbicides or the production of a known insecticidal substance cannot be classified in Category 1. Such plants automatically fall under Category 2 and are therefore subject to authorisation, traceability and monitoring.

The progeny of NGT-1 plants obtained through conventional breeding methods (including crossing with conventionally bred plants or with other NGT-1 plants) are also considered to be NGT-1 plants, without the need to undergo a new assessment procedure. If, however, further targeted mutagenesis or cisgenesis is carried out on an NGT-1 plant, the resulting plant must be re-assessed to determine whether it meets the criteria for Category 1.

All NGT plants that do not meet the criteria for Category 1 fall into Category 2.

Category 1

Category 1 NGT plants are exempt from EU legislation on GMOs. This means that the authorisation procedure, the environmental risk assessment and post-market monitoring do not apply. However, they are subject to sector-specific legislation on plant reproductive material, nature conservation regulations and environmental liability.

Labelling and traceability

There is no obligation to label NGT-1 plants or products derived from them (food and feed) as GMOs.

Plant propagating material (seeds, seedlings, tubers, etc.) from NGT-1 plants must, however, be labelled as such. This is intended to enable operators to maintain an NGT-free supply chain, should they so wish. All NGT plants are also listed in a publicly accessible database. Information on NGT plant propagating material is also entered into the common EU catalogues of plant varieties.

Verification procedure

Before an NGT plant may be released or placed on the market as a Category 1 plant, it must undergo a verification procedure. The applicant must demonstrate that the plant is an NGT plant and meets the equivalence criteria set out in Annex I. Copies of relevant studies and scientific evidence demonstrating the link between the introduced genetic modifications and the intended traits must be submitted. The applicant must also declare that the intended traits do not meet any of the exclusion criteria (herbicide tolerance, production of known insecticidal substances).

In addition, the applicant must provide details of any existing or pending patents relating to the plant. This patent information is included in the public database.

The competent national authority of the Member State is responsible for field trials. Only if other Member States raise substantiated objections to the assessment report is the decision taken at EU level. For the placing on the market, the procedure is carried out at EU level. Once a plant has been classified as an NGT-1 plant, no further assessment is required for its offspring resulting from conventional breeding.

Criteria for the equivalence of NGT plants with conventional plants (Annex I)

An NGT plant is considered equivalent to conventional plants if the genetic modifications

introduced by the new genomic techniques meet the following conditions:

(1) In the case of plants obtained by targeted mutagenesis, the genetic modifications are the following:

(a) substitution or insertion of no more than 20 nucleotides;

(b) deletion of any number of nucleotides.

The number of those genetic modifications does not exceed a limit of three for each protein-coding sequence, taking into account that genetic modifications in introns and regulatory sequences are not subject to that limit.

(2) In the case of plants obtained by cisgenesis, the genetic modifications:

(a) consist of one or more of the following types:

(i) insertion of continuous DNA sequences existing in the gene pool for conventional breeding purposes;

(ii) substitution of endogenous DNA sequences with continuous DNA sequences existing in the gene pool for conventional breeding purposes;

(iii) inversion or translocation of continuous endogenous DNA sequences; and

(b) fulfil one or both of the following conditions:

(i) they result in a combination of DNA sequences that occurs in the gene pool for conventional breeding purposes;

(ii) they do not lead to interruptions of endogenous genes, including interruptions that create chimeric proteins.

(3) The number of genetic modifications referred to in points 1 and 2 in any combination does not exceed 20 per monoploid genome.

Organic farming

NGT-1 plants are not permitted in organic production. They are treated as GMOs for the purposes of organic production. However, the accidental or technically unavoidable presence of NGT-1 plant material in organic products does not constitute a breach of the Organic Regulation. The Commission will assess whether the Regulation imposes administrative, economic or practical burdens on the organic sector, including in terms of how it is perceived by producers and consumers.

Category 2

Category 2 covers all NGT plants that do not meet the criteria for Category 1, as well as plants whose intended traits include herbicide tolerance or the production of known insecticidal substances (regardless of whether they would meet the equivalence criteria). These plants are subject to the Union’s GMO regulations.

Labelling and traceability

These plants are subject to the existing traceability and labelling requirements under GMO legislation, including the mandatory labelling of products. If the labelling includes information on the traits resulting from the genetic modification, all relevant traits must be listed.

Authorisation

The requirements of the GMO legislation also apply to the authorisation of NGT-2 plants, including risk assessment and pre-market authorisation. However, the type and amount of data required for the risk assessment, as well as post-market monitoring, may be adapted on a case-by-case basis, as the genetic modifications in NGT-2 plants can vary widely. In justified circumstances, the competent authority may waive the requirement for post-market monitoring.

Coexistence measures and opt-out

Member States may restrict or prohibit the cultivation of NGT-2 plants within their territory (opt-out).

They may also adopt optional coexistence measures to prevent the unintended presence of NGT-2 plants in other products.

Patenting

When applying for NGT-1 status, companies or breeders must provide details of all existing or pending patents. This information is entered into a publicly accessible database. On a voluntary basis, companies may also provide information on the patent holder’s willingness to license the use of the patented NGT-1 plant under fair and reasonable terms.

An expert group on patent issues relating to NGT plants will be established, comprising experts from all Member States, the European Patent Office and the Community Plant Variety Office. Within one year of the Regulation entering into force, the Commission must publish a study on the impact of patenting on innovation, the availability of seed for farmers and the competitiveness of the EU plant breeding sector. Within 18 months, the Commission may propose an EU code of conduct on licensing, setting out fair terms and dispute resolution mechanisms. The Commission will, where appropriate, indicate what follow-up measures are required or submit a legislative proposal.

Farmers retain the right to save and re-sow seed for their own use. Safeguards have been introduced to prevent market concentration and to ensure fair access and affordable prices.

Sustainability

In order to focus the use of NGTs on plants with sustainability traits (e.g. climate and pest resistance), legislators have tasked the Commission and the Member States with monitoring the sustainability impacts of NGT plants, including on the basis of data from official controls. The incentives for NGT-2 plants with sustainability traits set out in the Commission’s proposal (accelerated risk assessment procedure, pre-application advice) were further developed during the trilogue negotiations.

Entry into force and timetable

Following formal adoption by the Council and the Parliament, the Regulation will be published in the Official Journal of the EU and will enter into force 20 days later. It will become applicable after a transitional period of 24 months, expected to begin in mid-2028. In the meantime, NGT plants in the EU will continue to be regulated under the existing GMO legal framework.