EU approves lighter-touch regulation of gene editing in plants after long legislative process

After a lengthy legislative process spanning several years, the EU has adopted new rules on gene edited plants, which have now been published in the Official Journal. The new regime moves to regulating gene edited plants based on their final genetic make-up, rather than on how they were made. This marks a significant shift in EU legislation, creating a system whereby certain plants obtained by new genomic techniques (NGTs) will face lighter-touch regulation outside of the existing, more onerous rules on genetically modified organisms (GMOs).

The new rules will apply to both plants originating in the EU and those imported into the EU and therefore the new legislation will have wide reach. The regulation will enter into force on 16 July 2026, but most provisions will not apply until 17 July 2028, giving businesses looking to bring gene-edited plants, and products containing them, to market in the EU time to prepare for the regulatory change. This should enable businesses to use the lighter-touch regulatory route for NGT-1 plants immediately upon the provisions coming into force.

Two-tier system

NGT plants will be split into two categories, each with different legal obligations. NGT-1 plants will be those with a limited number of genetic changes that could have occurred through conventional breeding. Once it is verified that plants meet the NGT-1 criteria, they will be treated like conventional plants. Plants engineered to have herbicide tolerance or to produce insecticidal substances cannot be categorised as NGT-1 plants.

NGT-2 plants will have undergone extensive or complex genetic modifications. These will continue to be covered by the existing and stricter GMO rules and will be subject to risk assessment. Authorisation will need to be obtained before commercialising NGT-2 plants in the EU.

Traceability, labelling and opt-outs

Full traceability and labelling will remain mandatory for NGT-2 plants. EU Member States are also permitted to restrict or prohibit the cultivation of NGT-2 plants in their country even if the plant is authorised for cultivation in the EU.

Plant varieties containing or derived from NGT-1 plants will be listed in a public database and all seed bags and reproductive material will have to be labelled NGT-1, to allow farmers to make an informed choice whether to use them.

In an attempt to promote the development of NGT plants with sustainability features, for example climate and pest resistance, it will be mandatory for the sustainability impacts of NGT plants to be monitored.

No NGTs will be allowed in organic production, but "the technically unavoidable presence of NGT-1 plants" would not amount to non-compliance.

Patentability

In 2024, the European Parliament had voted to introduce a patent ban for NGT plants. This was subsequently dropped in favour of patent transparency measures for NGT-1 plants, voluntary licensing declarations, an expert group and an impact study.

Despite this, patentability amendments were again tabled in the lead-up to the European Parliament's vote to accept the regulation, which aimed to largely reinstate the patenting ban proposed in 2024. These amendments threatened to slow the progress of adoption of the regulation, but required an absolute majority to pass. They failed to meet this threshold.

Therefore, it will continue to be possible to patent NGT plants, except for those obtained by "essentially biological processes". The last-minute swerving of changes to the patentability rules was extremely positive for innovators in this space. 

Businesses should prepare for the patent transparency measures that the new rules introduce and consider whether they wish to make a voluntary declaration of their willingness to licence the patented subject matter under fair and reasonable conditions, or whether they are or intend to become a member of a relevant and appropriate licensing platform.

The Commission will oversee the drawing up of a code of conduct at EU level to enhance transparency of information relating to patents. It will also establish an expert group to assess the impact of the patenting of NGT plants, traits and techniques, as well as related licensing and transparency practices in the EU.

If there are significant barriers to access to patented plant biological material, undue restrictions on experimentation, negative effects on breeders and farmers, increased market concentration, reduced diversity in seed supply, insufficient transparency, or other evidence that the system is not functioning smoothly, the Commission reserves the right to submit legislative proposals to set up mandatory conditions or safeguards.

Osborne Clarke comment

The EU has finally moved closer to more relaxed rules for certain gene edited plants. This will be welcome news to those looking to commercialise gene edited plants and products containing them in the EU, whether that is done from within the EU or via importation. 

While this is positive news, businesses will still have to wait until 2028 for the new regime to take full effect. This wait, however, gives businesses the opportunity to prepare for the new regulatory system and to be able to utilise it from day one.

Businesses will also need to contend with potential UK-EU divergence on this issue. The EU has been behind England in deregulation in this area, with the UK enacting the Genetic Technology (Precision Breeding) Act 2023, and implementing secondary legislation in the form of the Genetic Technology (Precision Breeding) Regulations 2025, which introduced a different streamlined two-tier authorisation process for precision bred plants.

However, this English progress may be jeopardised by a recent High Court decision that has allowed a judicial review claim relating to the implementing regulations to proceed on the ground of irrationality, including a breach of duty by the minister to make adequate enquiries around the decision not to introduce mandatory labelling. We await the outcome of the judicial review, but it could slow down deregulatory progress in England.

Additionally, it is still unclear whether the UK will be required to introduce "dynamic alignment" with the EU on gene editing regulations as part of the ongoing negotiations of the UK-EU Sanitary and Phytosanitary (SPS) Agreement. Negotiations were to have continued at the end of this month, but have been postponed due to the prime minister's resignation. It is not clear what stance a new administration might take on the issue and how this will affect businesses operating in this area.