06/11/2025 | News release | Distributed by Public on 06/12/2025 05:06
The U.K. Department for Environment, Food, and Rural Affairs (DEFRA) has announced the signing into law of the Genetic Technology (Precision Breeding) Regulations 2025, applicable only in England, making it the first European country to establish a clear, science-based regulatory pathway for precision bred plants.
DEFRA Minister Daniel Zeichner MP enacted this secondary legislation in May 2025, implementing the Genetic Technology (Precision Breeding) Act 2023 and creating a streamlined framework for regulatory approval for plant precision bred organisms (PBOs).
PBOs are gene-edited organisms that could have been achieved through traditional breeding methods or natural processes. Unlike genetically modified organisms (GMOs), they do not contain genetic material foreign to that species. They have the potential to improve food production and nutritional value, as well as climate, pest, and disease resiliency.
The regulations introduce a two-tier authorization process that replaces the lengthy procedures inherited from EU genetically modified organism legislation. Under this new system, businesses must first apply to DEFRA for a marketing notice, followed by application to the Food Standards Agency (FSA) for food and feed marketing authorization. This approach aligns England's regulatory framework with countries like Canada, Australia, Brazil, Argentina, the U.S., and Japan, positioning the U.K. as a leader in agricultural innovation outside the EU regulatory sphere.
Key takeaways related to the U.K.'s precision breeding act include the following.
The Precision Breeding Act regulations face alignment challenges both domestically and internationally. The England-only scope of the regulations creates internal market fragmentation, requiring continued dialogue with devolved administrations to manage research collaboration and trade implications.
More significantly, the May 2025 U.K.-EU summit agreement of dynamic alignment for agrifood products may require the U.K. to align with EU standards once final arrangements are established. This could potentially slow market access and create uncertainty around the deregulatory approach initially envisioned. The European Parliament's proposal to ban patent rights for gene-edited plants adds further uncertainty to intellectual property considerations.
The legislation represents a transformative shift for multiple sectors within the agrifood system. Plant breeders and biotech companies now have access to a faster, more proportionate route to market, providing greater confidence for scaling innovation and commercial implementation. The framework particularly benefits small- and medium-sized enterprises in the agribiotech sector, who previously faced prohibitive regulatory barriers. The regulations could potentially stimulate increased research and development activity in plant science as well.
Full implementation and first applications for these regulations are expected in late 2025, with authorized food products derived from PBOs potentially reaching English supermarket shelves as early as late 2026.