Upcoming changes to European Union (EU) legislation will significantly alter the regulation of gene-edited crops. This article outlines the main trends of the EU’s new framework for plants obtained by New Genomic Techniques (NGTs), and the critical IP considerations for innovators.
EU approach to genetically engineered plants
To date, genetically modified organisms (GMOs) have been regulated according to Directive 2001/18/EC. While plants bred by conventional breeding techniques or traditional mutagenesis are generally exempt, a landmark 2018 ruling (Case C-528/16) by the Court of Justice of the European Union (CJEU) interpreted this strictly. The CJEU held that newer, targeted mutagenesis techniques fall within the scope of the GMO Directive, subjecting them to the same rigorous risk assessments and labelling requirements as transgenic crops. This high regulatory hurdle historically stifled the introduction of gene-edited plants to the European market.
New EU rules for how to handle NGTs were provisionally agreed in trilogue negotiations at the end of 2025 (i.e. negotiations between the EU Parliament, Council, and Commission). As the European Commission highlighted in a 4 December 2025 press release, these rules will “enable more innovative plant breeding in the EU, helping farmers to grow plants that are more resilient to climate change and making them more sustainable as producers will require less resources, fertilisers and pesticides to fight pests.”
According to the provisionally agreed Regulation text, NGT plants are those that have been created by targeted mutagenesis, cisgenesis, or a combination of the two techniques, and which do not contain any genetic material which originated from outside the gene pool available for conventional breeding. Therefore, any plants created by transgenesis, for example, fall outside the NGT regulation and will continue to be regulated by Directive 2001/18/EC.
NGT plants are to be split into ‘Category 1’ and ‘Category 2’.
Category 1 (NGT1) = plants, and any conventionally crossed progeny, that:
DO fulfil specific ‘criteria of equivalence’ to conventional plants which are set out in Annex I of the draft text, and which set limits on the type, extent and number of modifications that can be made;
AND
DO NOT contain traits to herbicide-tolerance or production of a known insecticidal substance.
Category 2 (NGT2) = any other type of NGT plant. These will continue to be subject to GMO legislation.
Verification of a plant as NGT1 can be requested. Once verified, NGT1 plants will then be deemed excluded from the GMO legislation and treated in the same way as conventional plants.
In other words, the intention of the new legislation is to relax the regulations associated with NGT plants which could have occurred naturally or through conventional breeding processes (even though, in practice, they were generated through quicker gene editing techniques).
IP considerations
Trilogue negotiations had previously stalled on the question of whether to permit the patenting of NGT plants. The concern from some had been whether small farmers and breeders would be able to navigate and access germplasm. However, following assessment by a specially-commissioned expert committee, it has been agreed that NGT plants will remain patentable.
To help ensure that farmers and breeders are able to benefit, emphasis is being placed on transparency and steps for reducing the practical burden of Freedom to Operate (FTO). Therefore, when requesting NGT1 verification, the requester must declare, to the best of their knowledge, any patents or published patent applications including claims to the NGT1 plants. This includes not just patents and applications held by the requester, but also any held by third parties. It appears that these will not be checked during the verification process, but they will appear on a public database and there will be a duty to notify of any changes.
There will also be an option for a requester to declare a willingness to license relevant patents or applications covering the NGT plant to third parties under fair and reasonable conditions in all Member States or to declare membership of any licensing platforms, such as the Agricultural Crop Licensing Platform (ACLP).
The draft Regulation text also includes a Recital 46b which flags to Member States the importance of taking appropriate steps to implement breeders’ exemptions. It is possible, therefore, that we will see more countries implementing such exemptions in the coming years.
Next steps
Once formally adopted, the final Regulation text will be published in the Official Journal. This is expected by the end of 2026. A two-year transition period will apply, so it is expected that the NGT regulations will be in force by the end of 2028.
The economic, environmental and social effects of implementation of the draft Regulation are to be monitored by an expert group established by the European Commission. The expert group will review the effect of patents and the operation of breeders’ exemptions on NGT plants and innovation, seed availability and competitiveness of the EU plant breeding sector, with the view to publishing conclusions within one year of implementation.
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