EU Adopts Regulation of New Genomic Techniques – What Plant and Seed Breeders Need to Know

We previously discussed this here and here.

NGTs is the EU’s term for describing techniques that can help breed new innovative plant varieties faster and with higher precision compared to conventional plant breeding techniques like seed selection or crossbreeding. The regulation establishes a differentiated framework under which the regulatory process for NGTs is comparable to the process for natural or conventionally bred varieties. In establishing this framework, the EU has recognized that the risk assessments required by the EU’s onerous GMO regulations are not fit for purpose for these newer NGT products, and that scientific and technological advances justified a modernized regulatory approach. The adoption of the regulation is the culmination of a lengthy legislative process first instituted in July 2023. While limited only to plants, without codifying similarly streamlined processes for non-plant technologies like genetically engineered microbes, the regulation represents a significant reform in the EU’s approach to regulating organisms modified using genetic engineering. The regulation was published in the Official Journal on June 26 and entered into force 20 days thereafter, on July 16. The regulation will apply two years after publication in 2028. Until then, NGT plants remain regulated under the EU’s existing GMO legislation (Directive 2001/18/EC).

This alert summarizes the core elements of the regulation and outlines strategic implications and immediate action points for plant and seed breeders.

Key Features of the Regulation

Exemption from GMO regulation for plants and plant products satisfying “NGT1” criteria. 

The regulation establishes two separate categories of NGT plants, each regulated differently. The first category, “NGT1,” covers plants that could be obtained naturally or using conventional breeding techniques in accordance with the European Commission’s (EC) defined “equivalence criteria.” Generally, speaking, an NGT plant is considered equivalent to conventional plants if the genetic modifications result in a combination of DNA sequences that occur within the plant’s gene pool for conventional breeding purposes. Specifically, NGT1 plants may include targeted substitutions and insertions of no more than 20 nucleotides, deletions of any size, substitutions and insertions of continuous sequences of genetic material from the gene pool for conventional breeding purposes, and inversions and translocations of continuous endogenous DNA sequences, among others.

NGT1 plants will be regulated like conventional plants and exempt from the requirements of the EU’s GMO legislation. Developers must follow a verification process to confirm NGT1 status, and the EC intends to publish a database identifying the plants that qualify for the exemption. The specific data and information that will be required to demonstrate that a plant meets the NGT1 criteria will be published in a forthcoming delegated act. Offspring do not require separate re-verification. Additionally, seeds and other plant reproductive material of NGT1 plants must be labeled, but labeling of downstream plants and plant products will not be required. 

The second category, “NGT2,” consists of NGT plans that could not occur naturally or be produced using conventional breeding techniques pursuant to the EC’s equivalence criteria, e.g., plants with more complex edits or using DNA sequences outside of the gene pool. NGT2 plants will remain subject to GMO legislation requirements with some modifications. Specifically, NGT2 plants must undergo an environmental risk assessment, follow GMO directive traceability and labeling requirements, and adhere to post-market monitoring and renewal requirements. 

Exclusions steer traits into NGT2. 

Traits linked to herbicide tolerance and known insecticidal effects are excluded from NGT1 status, regardless of whether the plants would otherwise satisfy the NGT1 criteria. These NGTs remain subject to full GMO-style oversight under the NGT2 track, including risk assessment, monitoring, labeling, and potential Member State cultivation opt-outs. 

Transparency on IP rights and access.

The regulation allows patents for NGTs, except for those traits or sequences occurring in nature or produced by solely biological means. Earlier versions of the regulation included proposals that would have significantly restricted the patentability of certain NGT-related inventions, making intellectual property (IP) rights one of the most contentious issues in the negotiations. The final regulation largely abandoned those restrictions and instead adopted transparency and monitoring measures, providing substantially greater protection for patent holders and existing IP rights. Thus, NGT1 registrations must disclose existing patents or published patent applications; the Commission will maintain a public database and develop a code of conduct to promote fair, reasonable, and non-discriminatory licensing and amicable resolution of inadvertent presence disputes. The Commission is required to publish a study one year after implementation on the impact of patenting on innovation, seed availability for farmers, and competitiveness, and to propose follow-up measures if warranted. 

Organic prohibition with limited tolerance. 

Neither category of NGT plants is permitted in organic farming. However, unavoidable presence of NGT1 material does not constitute non-compliance with this restriction, and the Commission intends to assess any administrative or economic burdens for organic operators. 

Sustainability steering and monitoring. 

To steer innovation toward climate resilience and input reduction, the Commission and Member States will offer regulatory incentives, including a shorter timeline to market, for NGT2 plants that contain a sustainability trait. Examples include yield stability, tolerance or resistance to diseases or climate change conditions, or more efficient use of natural resources.

At-a-Glance: The Two-Tier NGT Framework

Practical Implications for Plant and Seed Breeders

Developers should carefully consider how changes to the EU regulatory framework for NGTs will impact product pipelines and timelines. For traits amenable to NGT1, verification offers a materially faster, lower-burden path to market. Developers should map pipelines against the equivalence criteria and the exclusion list and consider designing editing strategies and molecular characterization to support NGT1 verification. Where traits fall outside NGT1, developers should consider accelerated procedures for sustainability-linked traits. Breeders supporting organic production should implement identity preservation and coexistence protocols. Breeders should also prepare for variation in coexistence measures, cultivation opportunities, and seed certification practices across the EU. 

ArentFox Schiff’s Agriculture & AgTech group is closely monitoring this issue and other issues of importance to the industry. If you have further questions, please reach out to the authors or the ArentFox Schiff attorney who handles your matters.