European Parliament Approves NGT Regulation

The European Parliament has approved the proposed Regulation on plants obtained through New Genomic Techniques (NGTs), bringing the European Union significantly closer to a new regulatory framework for gene-edited crops.

The approved text confirms the political agreement reached between the Parliament, Council and Commission in late 2025. For a detailed overview of the NGT framework and its intellectual property implications, see our previous article on the proposed Regulation.

A new framework for gene-edited plants

The Regulation establishes two categories of NGT plants. Category 1 (NGT1) plants are those that satisfy defined equivalence criteria and could, in principle, have arisen through conventional breeding. Once verified, NGT1 plants will be treated in the same way as conventionally bred plants and will fall outside the scope of the EU’s GMO (genetically modified organism) regime. However, plants engineered for herbicide tolerance or to produce insecticidal substances are excluded from NGT1 status, even where they would otherwise meet the relevant criteria.

By contrast, Category 2 (NGT2) plants will remain subject to the existing GMO regulatory framework, including risk assessment and authorisation requirements.

According to the European Parliament, the new rules are intended to facilitate the development of crop varieties with improved resilience to climate change and pests, higher yields and reduced reliance on pesticides.

Patent provisions remain in place

The vote also provides important clarity regarding intellectual property rights.

During the legislative process, proposals were made to restrict the patentability of NGT plants. Those proposals were ultimately not adopted and the final text retains the compromise approach agreed during negotiations.

Accordingly, the Regulation preserves the availability of patent protection for NGT plants, while introducing the transparency measures discussed in our previous article. In particular, applicants seeking verification of NGT1 plants must disclose, to the best of their knowledge, relevant patents and published patent applications covering those plants. Information regarding relevant intellectual property rights will be made available through a public NGT database.

Transparency and monitoring measures

The Regulation also includes measures intended to improve visibility of NGT-derived plant varieties more generally. NGT1 varieties will be recorded in a publicly accessible EU database.

In addition, plant reproductive material containing or consisting of NGT1 plants that is made available to third parties must be labelled “NGT-1” and include the identification number(s) of the relevant NGT plant.

The Regulation also establishes mechanisms to monitor the effect of patents on innovation, access to germplasm and competitiveness within the European plant breeding sector.

Next steps

The NGT Regulation will enter into force 20 days after publication in the Official Journal of the European Union and will apply two years thereafter.

For plant breeders, agricultural biotechnology companies and patent owners, the parliamentary vote represents a major milestone. It provides greater certainty regarding both the future regulatory treatment of gene-edited crops within the European Union and the continued availability of patent protection for NGT-based innovations.

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