NGTs in the EU

The provisional EU agreement maintains the principle that NGT-1 plants are equivalent to conventional plants, in line with the Commission proposal. National authorities must verify that NGT plants belong to category 1, but their offspring do not need to be subsequently verified. Importantly, NGT-1 plants and products will not need to be labelled with the exception of seeds and other plant reproductive material of NGT-1 plants. The legislators believe this would not entail a disproportionate burden for plant breeders and would allow operators to ensure an NGT-free chain, if they wish to do so.

Furthermore, the agreement includes a list of intended traits that must be excluded from the NGT-1 category, including tolerance to herbicides and ‘production of a known insecticidal substance’ will be on the exclusion list and cannot be one of the intended traits for category 1 NGT plants. This change to the Commission’s original proposal will mean that such plants are classed as NGT-2 and therefore remain subject to GMO authorisation, traceability and monitoring.

Protection of intellectual property (IP)

Alongside labelling, protection of IP has been one the thorniest issues in the negation of this file. The agreement reached attempts to strike a balance between the concerns of plant breeders and farmers. Patent rules are governed by the EU's Biotech Directive, and when applying to register a category 1 NGT plant or product, companies or breeders must submit information on all existing or pending patents. The patenting information must be included in a publicly available database. Furthermore, on a voluntary basis, companies or breeders can also provide information on the patent holder's intention to licence the use of a patented NGT 1 plant or product, under equitable conditions.

The Council and the Parliament agreed on the creation of a patenting expert group, focusing on the effect of patents on NGT plants, composed of experts from all member states, the European Patent Office and the Community Plant Variety Office. One year after the entry into force of the regulation, the Commission will publish a study on the impact of patenting on innovation, on the availability of seeds to farmers and on the competitiveness of the EU plant breeding sector. The Commission will then indicate what follow-up measures are needed or publish a legislative proposal to address any issues found in the study.

Next steps:

The regulation must now be formally adopted by both the Council and the European Parliament, likely in the April Plenary. It is expected to be published in the Official Journal in 2026 and to take effect no later than two years later. Its implementation will be supported by a monitoring programme assessing economic, environmental and social impacts, including sustainability and safety considerations.

Organic: NGT plants will be prohibited in organic production. For NGT Cat-2 plants subject to authorisation, the legislative proposal maintains the traceability and labelling requirements of the GMO legislation. Today, GMOs are banned in organic production by the EU Organic Production Regulation. In addition, the proposal makes the adoption of coexistence measures at national level mandatory. Member States must adopt measures so that different types of cultivation can exist side by side, e.g., distances between the fields.

To exclude NGT plants from organic production, even those that have been verified to be comparable to conventional plants, organic and GM-free farmers can consult a public register of all NGT products and seed labelling in common catalogues of varieties.

Feature	EU NGT Regulation	England Precision Breeding Act 2023
Legal instrument	EU Regulation (directly applicable across 27 Member States)	National Act applying only in England
Current status	Political agreement reached; formal adoption pending	In force; plant regulations operational
Organisms covered	Plants only (initially)	Plants and vertebrate animals in force (secondary legislation for animals not presented))
Key concept	“New Genomic Techniques (NGTs)”	“Precision-bred organisms (PBOs)”
Core test	Whether genetic change could occur naturally or via conventional breeding	Same core principle: changes that could arise naturally or by traditional breeding
Categorisation	Two tiers: NGT-1 (lighter regime) and NGT-2 (full GMO regime)	No formal tiers; binary decision (precision-bred or GMO)
GMO treatment	NGT-1 treated like conventional plants; NGT-2 remain GMOs	Precision-bred organisms are not GMOs
Risk assessment	NGT-1: verification only NGT-2: full GMO risk assessment	Simplified, proportionate assessment for PBOs
Food labelling	NGT-2: mandatory GMO-style labelling NGT-1: generally not labelled at food level	No mandatory labelling of precision-bred food
Seed labelling	Required for NGT-1 seeds	No dedicated seed labelling regime
Traceability	Public databases; formal traceability for NGT-2	Public register of approved PBOs
Member State flexibility	States may opt out of cultivating NGT-2 plants	No internal opt-out (England only framework)
Patent transparency	Disclosure of patent status required	No special patent disclosure requirement
Regulatory philosophy	Balance innovation with precautionary oversight	Innovation-first, science-based proportionality