Upcoming changes in European Union legislation will significantly alter how gene-edited crops are regulated. This article outlines the key trends in the new framework established by the EU for plants obtained through New Genomic Techniques (NGT), as well as critical intellectual property issues that innovators must consider.

The EU Approach to Genetically Engineered Plants

To date, Genetically Modified Organisms (GMOs) have been regulated under Directive 2001/18/EC. While plants bred through traditional breeding techniques or conventional mutagenesis have generally been exempt, a landmark ruling by the Court of Justice of the European Union (CJEU) in 2018 interpreted this strictly. The CJEU ruled that newer, targeted mutagenesis techniques fall within the scope of the GMO Directive, subjecting them to the same stringent risk assessment and labeling requirements as transgenic crops. This high regulatory threshold has historically hindered gene-edited plants from entering the European market.

New EU rules on how to handle New Genomic Techniques reached a provisional agreement during the trilogue negotiations (between the European Parliament, the Council, and the Commission) at the end of 2025. As emphasized in the European Commission's press release on December 4, 2025, these rules will "enable the EU to conduct more innovative plant breeding, helping farmers to grow plants that are more resilient to climate change and more sustainable, as producers will need fewer resources, fertilizers, and pesticides to prevent pests and diseases."

According to the provisionally agreed regulatory text, NGT plants are plants created through targeted mutagenesis, cisgenesis, or a combination of these two techniques, and do not contain any genetic material derived from outside the gene pool available for traditional breeding. Consequently, any plants created via methods such as transgenesis do not fall within the scope of the NGT regulation and will continue to be regulated under Directive 2001/18/EC.

NGT plants will be divided into "Category 1" and "Category 2."

Category 1 (NGT 1): Plants and any progeny obtained through conventional hybridization that:

• Meet the "specific criteria" set out in Annex I of the draft text, which is equivalent to conventional plants and sets limits on the type, scope, and number of modifications that can be made;

• And do not contain traits such as herbicide resistance or the production of known insecticidal substances.

Category 2 (NGT 2): Any other type of NGT plant. These plants will continue to be regulated under GMO legislation.

It is possible to apply for the verification of a plant as NGT 1. Once verified, NGT 1 plants will be considered excluded from GMO legislation and treated in the same manner as conventional plants.

In other words, the intention of the new legislation is to relax the regulation of those NGT plants that could have been produced through natural means or traditional breeding processes, even though they were actually generated through more rapid gene-editing techniques.

Intellectual Property Considerations

The issue of whether patents should be allowed for NGT plants had previously reached a stalemate in the trilogue negotiations. Some concerns were raised regarding whether small-scale farmers and breeders would be able to navigate and access germplasm resources. However, based on an assessment by a specially commissioned expert committee, it has now been agreed that NGT plants can still be patented.

To help ensure that farmers and breeders can benefit from this, the focus has been placed on transparency and measures to reduce the practical burden of Freedom to Operate (FTO). Therefore, when applying for NGT 1 verification, the applicant must state, to the best of their knowledge, any patents or published patent applications that include claims covering that NGT 1 plant. This includes not only patents and applications held by the applicant but also those held by any third party. This information does not appear to be verified during the verification process, but it will appear in a public database, and the applicant has an obligation to notify any changes.

Furthermore, applicants may choose to declare their willingness to license relevant patents or applications covering that NGT 1 plant to third parties on fair and reasonable terms in all member states, or declare their membership in any licensing platform, such as the Agricultural Crop Licensing Platform (ACLP).

The draft text of the regulation also includes a "Recital 46b," which points out to member states the importance of taking appropriate measures to implement breeders' exemptions. Consequently, one may see more countries implementing such exemptions in the coming years.

Next Steps

Once the final regulatory text is formally adopted, it will be published in the Official Journal. This is expected to be completed by the end of 2026. As a two-year transition period will apply, the NGT regulation is expected to come into effect by the end of 2028.

The economic, environmental, and social impacts of the implementation of the draft regulation will be monitored by an expert panel established by the European Commission. The expert panel will review the impact of patents and the effect of breeders' exemptions on NGT plants and innovation, seed supply, and the competitiveness of the EU plant breeding industry, with conclusions planned for publication within one year of implementation.