European Parliament and Council provisional deal on new genomic techniques brings relaxation of gene editing a step closer

The European Commission proposed a new regulation for gene-edited plants back in 2023, with the aim of embracing a more flexible approach in the regulation of plants obtained by new genomic techniques (NGTs). These refer to a wide range of techniques that alter the genetic material of a plant but which, crucially, do not involve the insertion of genetic material from another species.

At present in the EU, all plants obtained through NGTs are subject to the same, much more stringent, rules as genetically modified organisms (GMOs). The Commission proposed a less demanding approach to certain plants produced by NGTs, and products, food and feed containing or consisting of NGT plants.

However, progress in the EU has been slow due resistance to the proposals and controversy over the interplay with intellectual property (IP) rights. Nevertheless, the European Council and Parliament have now struck a compromise agreement, which has been welcomed by the Commission. This moves the EU closer to regulatory reform – although the wheels will still turn relatively slowly. The Commission anticipates that the final regulation will be published in the Official Journal during the course of 2026 and will become applicable two years later.

Category 1 NGT plants

The Council and Parliament have provisionally maintained the principle that NGT-1 plants should be seen as equivalent to conventional plants and therefore would be subject to a simplified regulatory regime and approval process.

National authorities would need to verify NGT plants belong to category 1, but their offspring would not need to be subsequently verified. Under the agreement, due to the principle of equivalence, NGT-1 plants and products would not need to be labelled. However, seed and other plant reproductive material of NGT-1 plants would need to be labelled. The rationale behind this is that it would not cause a disproportionate burden on plant breeders and it would allow operators to ensure an NGT-free supply chain.

The Council and Parliament were aligned that there should be a list of intended traits that would be excluded from the NGT-1 category. These include a tolerance to herbicides and "production of a known insecticidal substance". This marks a change to the Commission's proposal and would ensure plants with these traits are classed as NGT-2 plants and, therefore, subject to authorisation, traceability and monitoring.

Category 2 NGT plants

The Council and Parliament agreed with the Commission that plants with "more complex" or "less 'natural-equivalent' genomic modifications" should be classed as NGT-2 plants. These would continue to be subject to the GMO legislative requirements, including mandatory labelling of products. It was agreed that, if the label contains information about the traits that were modified, it must cover all the relevant traits to ensure that consumers have access to accurate and comprehensive information.

Under the provisional agreement, Member States would be able to opt out of the cultivation of NGT-2 plants in their territory and there would be optional coexistence measures. This would mean that Member States could take measures to avoid the unintended presence of NGT-2 plants in other products.

Intellectual property

In 2024, the Parliament had proposed a controversial patent ban for all NGT plants. While the Parliament has rowed back from this position, the provisional agreement notes that the regulation should address concerns raised by plant breeders and farmers on patenting.

As such, the Council and Parliament have agreed that there should be patent transparency measures with respect to NGT-1 plants. This would mean that when applying to register an NGT-1 plant or product, companies or breeders must submit information on all existing or pending patents. This information would then be included in a publicly available database.

On a voluntary basis, companies or breeders could also provide information on the patent holder's intention to licence the use of the patented NGT-1 plant or product under equitable conditions.

The proposal agreed to create a patenting expert group, which would focus on the effect of patents on NGT plants, and would be comprised of experts from all Member States, the European Patent Office and the Community Plant Variety Office.

One year after the regulation enters into force, the Commission has committed to publishing a study on the impact of patenting on innovation, the availability of seeds to farmers and on the competitiveness of the EU plant-breeding sector. If any issues are identified, further legislative measures may be necessary to correct them.

What next?

The provisional agreement will now need to be officially endorsed by the Council and Parliament before it can be formally adopted. Once formally adopted, the Commission expects the regulation to be published in 2026, with the regulation starting to apply in 2028.

The Commission notes that the implementation of the regulation will be supported by "a robust monitoring programme of economic, environmental and social impacts of NGT products", with a particular focus on sustainability and safety.

UK-EU divergence?

The EU has been some way behind the UK (or more accurately, England) in relaxing gene-editing regulations. The Genetic Technology (Precision Breeding) Regulations 2025 came into force on 13 November. These regulations were made under the Genetic Technology (Precision Breeding) Act 2023, which established a new regulatory framework to facilitate the use of precision bred organisms (PBOs) in England.

As in the EU, the English regulations also introduce a two-tiered authorisation process, aimed at simplifying the pathway for businesses to bring PBOs and products containing them to market. Currently only precision bred plants can be released or marketed in England.

Although both jurisdictions focus on a first tier of more lightly regulated plants that are more akin to conventionally equivalent plants, the English legislation uses much looser definitions. There are also differences in labelling requirements (England does not have explicit labelling requirements for PBOs, but will rely on public registers and authorisation conditions) and approaches to IP rights (the English legislation is silent on the IP position and therefore there are no transparency requirements). All of these could lead to differences in practical application of the regulatory regimes and therefore divergence.

The developments in England come against the backdrop of concerns that there would be a pause in progress due to the UK/EU negotiations on a sanitary and phytosanitary (SPS) agreement. If the eventually negotiated SPS agreement does not require dynamic alignment by the UK, divergence can be expected.

In both the EU and UK, these products will also require pre-market novel food authorisation, currently under the jurisdiction of the European Food Safety Authority and the Food Standards Agency, respectively, which adds another regulatory hurdle in both jurisdictions.

Osborne Clarke comment

The provisional agreement between the European Council and Parliament marks a significant step towards finalising the relaxation of gene editing in plants in the EU. Although the regulation is expected to be adopted during 2026, it will not come into force for another two years.

While this may seem like slow progress for businesses seeking to bring gene-edited plants and products containing them to market in the EU, it does give them time to get ready for the regulatory change. This should enable businesses to use the lighter touch regulatory route for NGT-1 plants immediately upon implementation.

At present, it does look like there will be at least some divergence between the EU and England. Businesses operating in both markets will need to consider any divergence in their plans to bring gene-edited products to market in both jurisdictions.

Differences in labelling requirements and patent transparency provisions in the EU may add additional costs and administrative burden. We may also see certain plants and products falling within tier 1 in England that do not fall within NGT-1 in the EU. Businesses will need to ensure that they do not fall foul of any differences in practical application when operating across the jurisdictions.

That being said, there is still the possibility that a UK-EU SPS agreement might require dynamic alignment from the UK. However, the UK government has been clear on its intention to exempt gene-editing regulations from any dynamic alignment requirement during SPS negotiations.

While businesses are now able to take advantage of the relaxed regulatory requirements in the UK, those looking to operate in the EU will need to continue to follow progress there.