On Wednesday 18 June 2026, after years of discussion, the EU Parliament approved the New Genomic Techniques (NGT) Regulation, following the text provisionally agreed in December 2025. The regulation will enter into force 20 days after publication in the EU Official Journal and will apply two years thereafter.
As discussed in our previous articles, the regulation represents a significant shift in how gene-edited plants are regulated in Europe. Historically, all plants produced by NGTs, such as CRISPR, were regulated as genetically modified organisms (GMOs) which significantly limited commercialisation. The new regulation creates a two-tier system with differing regulations for Class 1 and Class 2 NGTs.
Class I NGTs (NGT-1 plants) which are considered equivalent to conventional plants will be subject to simplified regulation and a more straightforward path to market. On the other hand, Class 2 NGTs (NGT-2) which are significantly different from conventional plants, with more complex modifications, will continue to be bound by the existing GMO legislation requirements, including mandatory labelling of products.
There were concerns that the NGT Regulation might not pass following the submission of last-minute amendments from Members of the European Parliament in the weeks leading up to the vote. These amendments sought to reinstate the proposed 2024 changes to the Biotech Patent Directive 98/44/EC, but were ultimately rejected. These proposed amendments were particularly controversial as they proposed excluding all NGT plants – as well as plants obtained by random mutagenesis or cell fusion – from patentability. The exclusion would have extended not only to the plants themselves, but also to their parts, and plant material thereof, as well as to the associated genetic information and process features.
Whilst patenting of NGT plants will still be permitted, the adopted text introduces measures aimed at increasing transparency and addressing concerns voiced by plant breeders and farmers. These include:
- Public database disclosure: Applicants must submit and maintain up‑to‑date information on any existing or pending patents relating to an NGT‑1 plant in a publicly accessible database managed by the European Commission;
- Licensing indication: On a voluntary basis, patent holders may indicate their willingness to licence patented NGT-1 plants or related products;
- Expert group formation: An expert group, including experts from Member States, the European Patent Office (EPO) and the Community Plant Variety Office (CPVO), will assess the impact of patents on NGT plants; and.
- Study commissioned: The European Commission is required to publish, within one year of the Regulation entering into force, a study on the impact of patenting on innovation, seed availability, and the competitiveness of the EU plant breeding sector, with a particular focus on access to patented NGT plants.
On adoption of the Regulation Rapporteur Jessica Polfjärd (EEP, SE) commented:
“This is a historic victory for Europe’s farmers and Europe’s future. By approving the use of NGTs, we have chosen innovation, competitiveness, and food security. European farmers have long been calling for access to these modern breeding tools, to help them develop crops that are more resilient and less dependent on pesticides. By making these safe, science-based breeding technologies available, Parliament is delivering for European farmers, safeguarding our food security, and building a more competitive and innovative Europe.”
Overall, the approval of the NGT Regulation represents a significant step towards a more innovation‑enabling regulatory environment in the EU. By creating a simplified pathway to market for NGT‑1 plants, the framework is expected to stimulate investment in plant biotechnology and accelerate the development of improved crop varieties. At the same time, the decision to retain patent protection for NGT plants preserves key incentives for innovation, albeit accompanied by new transparency measures and ongoing scrutiny of the impact of IP in this sector. The balance struck by the Regulation reflects an attempt to support technological advancement while addressing concerns around access, market concentration, and the impact of patenting on breeders and farmers. As such, its ultimate effect will depend not only on its implementation, but also on how the evolving interplay between regulation and intellectual property rights shapes access to, and use of, NGT technologies across the sector.
At Appleyard Lees we have a significant expertise in protecting innovations in plant biotechnology and protecting plant variety rights. Please contact us if you have any questions.
