The Council of the European Union and the European Parliament announced a provisional agreement on December 4, establishing a legal framework for new genomic techniques (NGTs) in agriculture. The deal aims to boost the competitiveness of the EU’s agri-food sector, foster a fair market environment for operators, strengthen food security, and reduce external dependencies—all while upholding robust protections for human and animal health, as well as the environment, and supporting the bloc’s sustainable development goals.
Core Regulatory Framework
At the heart of the provisional agreement is a streamlined approval process for NGT-1 plants, which are deemed substantially equivalent to conventionally bred plants. This aligns with the Council’s negotiation mandate and the spirit of the European Commission’s original proposal. National authorities will be responsible for verifying that plants qualify as NGT-1, with no requirement for repeated validation of their subsequent propagation materials.
Under the substantial equivalence principle, NGT-1 plants and their derived products will generally not require additional labeling, except for seeds and other propagation materials, which must be clearly identified. This approach avoids imposing undue burdens on breeders while allowing operators to establish separate “non-NGT” product chains if desired.
A key provision is the creation of an “excluded traits list,” jointly developed by the Parliament and the Council. Two specific traits—herbicide tolerance and the production of known insecticidal substances—have been explicitly excluded from the NGT-1 category. Plants with these traits will be classified as NGT-2 and remain subject to the full scope of existing EU regulations on genetically modified organisms (GMOs), including mandatory approval, traceability, and monitoring requirements.
NGT-2 plants, defined as those with complex genomic modifications or significant deviations from the “natural equivalence” concept, will retain all current GMO regulatory obligations, including compulsory product labeling. If manufacturers choose to disclose modified traits on labels, all relevant characteristics must be fully specified—a requirement advocated by the Council to ensure consumers receive accurate and comprehensive information.
Member states will have the autonomy to ban the cultivation of NGT-2 plants within their territories. The agreement also includes optional coexistence measures, enabling countries to take action to prevent unintended contamination of product chains by NGT-2 plants.
Intellectual Property Provisions
Patent matters related to NGTs will continue to be governed by the EU’s Biotechnology Directive, but the new regulations introduce targeted measures to address longstanding concerns of breeders and farmers. Companies or breeders applying to register NGT-1 plants or products must submit details of all existing or pending patents, which will be entered into a public database.
Stakeholders may also voluntarily provide information on whether patent holders are willing to license NGT-1 plants or products under fair and reasonable terms. A dedicated expert group on patents will be established, comprising representatives from member states, the European Patent Office, and the Community Plant Variety Office, to examine the impact of the patent system on NGT plant development.
Within one year of the regulation’s formal entry into force, the European Commission will publish a special study assessing how the patent system affects innovation in the sector, farmers’ access to seeds, and the competitiveness of the EU’s plant breeding industry. Based on the study’s findings, the Commission will propose necessary follow-up measures or draft legislative initiatives to address identified issues.
Background and Next Steps
The provisional agreement marks a significant update to EU biotechnology regulation, addressing advances in genomic technologies that have emerged since the bloc’s current GMO rules were adopted in 2001. Previously, plants developed through NGTs were subject to the same regulatory framework as traditional GMOs, despite their distinct characteristics.
The new rules cover plants produced through precise, minor edits to an organism’s own genetic material (targeted mutagenesis) or the introduction of genetic material from the same species or crossable species (cisgenesis/intragenesis). Traditional GMOs will continue to be regulated by the existing, unmodified EU GMO framework, ensuring consistent safety standards across different biotechnological approaches.
Before formally taking effect, the provisional agreement must be approved by both the Council of the European Union and the European Parliament. Jacob Jensen, Denmark’s Minister for Food, Agriculture and Fisheries, emphasized the potential of the new regulations: “New genomic technologies allow us to achieve higher yields with fewer resources. This framework will drive the development of new plant varieties that are more climate-resilient and require less fertilizer or pesticides, enabling our farmers and agri-food sector to innovate more effectively and continue supplying healthy, safe food to the public.”
NGTs encompass a range of technologies that modify seeds in ways that could occur naturally or through traditional breeding methods, but with greater speed and precision. These tools enable the development of improved plant varieties with specific traits to address pressing challenges in the agri-food sector, such as enhanced resistance to climate impacts like droughts and floods, and reduced reliance on chemical inputs.
