UK Finalizes Precision Breeding Rules for Plants: Genetic Technology (Precision Breeding) Regulations 2025 Now in Force

Implementing post-Brexit policy

On November 13, 2025, the Genetic Technology (Precision Breeding) Regulations 2025 (“2025 PB regulations”) took effect, completing the United Kingdom’s (UK’s) post-Brexit framework for gene-edited plants. The Regulations implement the Genetic Technology (Precision Breeding) Act 2023 (“2023 Act”), creating a streamlined approval pathway for precision-bred organisms (PBOs)—plants whose genetic edits could have occurred naturally or through conventional breeding. This marks a major shift from the prior European Union (EU) derived genetically modified organism (GMO) regime and is intended to accelerate innovation in crop development while maintaining food and feed safety oversight.

Regulatory Background: Legacy EU Framework

Under the legacy EU regulations retained after Brexit, all genetically edited plants continued to be regulated as GMO, regardless of the modification or the technology used to make the edit or change. All GMOs intended for human food and animal feed were subjected to strict regulations and required governmental authorization for release or sale within the UK. Among other requirements, the authorization process put a heavy burden on developers to bring a product to market even for genetic modifications that could have been achieved with traditional breeding.

New regulatory pathway for Precision-Bred Organisms (PBOs)

The 2025 PB regulations splits the regulatory pathway for genetically edited plants. Plants with edits that could have been achieved naturally or through conventional techniques are categorized as “Precision-Bred Organisms (PBO).”

Precision breeding involves introducing genetic or epigenetic alterations to a plant’s nuclear or non-nuclear genome. There are no specific limits to the number or size of genomic alterations that can be introduced into a single PBO, provided that the alterations could have arisen through traditional processes. However, genetically edited plants that contain transgenes (genes from another organism) or could not have been achieved through traditional breeding are still regulated as GMOs.

The new regulations provide a simplified pathway to obtain approval for release and marketing of a PBO and food and feed produced by PBOs in England.[1]

Release of PBOs: For release, applicants must provide a release notice to the Department for Environment, Food and Rural Affairs (Defra) with contact information and a description of the PBO. The description of the PBO should include the genus and species, the intended alterations to the characteristics, the types of genetic modifications introduced to cause the alteration, and the technique of modern technology used to make the genetic change.

Sale of PBOs: Prior to sale a PBO, a marketing notice must be submitted to Defra including information about genetic changes made to the PBO, any unintended genetic changes to the PBO, the analysis used to check for unintended changes, and how the genetic changes were made. Following the marketing notification, an advisory committee is to issue a statement confirming whether the organism is precision bred.

PBO Food and Feed Products: In order to market food and feed produced from the PBO, an applicant must apply for a food and feed marketing authorization from the Food Standards Agency. The application requires additional disclosure on how the genetic change introduced to the PBO affects the edible parts of the organism. Such information includes (a) how the genetic change may affect use of the organism in food and feed; (b) which parts of the organism are destined for use in food and feed; and (c) a description of the intended use of the PBO in food and feed. The applicant must demonstrate the genetic changes are not expected to alter the nutritional quality, elevate toxicity, alter the allergenicity, or introduce additional features that may affect safety.

Summary and Practice Tips:

• It is now considerably more streamlined to obtain regulatory approval for gene-edited plants in England than in the EU, following the UK’s decision to establish a distinct pathway for precision-bred organisms.
• In England, plants with edits that could have been achieved naturally or through conventional techniques are categorized as precision-bred organisms (PBOs).
• The 2023 Act and 2025 PB Regulations will streamline oversight for precision-bred crops, while maintaining the previous processes for other GMOs.
• The 2025 PB regulations provide a streamlined regulatory process for PBOs, with additional processes for PBOs used in food and feed:
• Release Notice: Submission of a release notice to Defra prior to releasing the PBO.
• Marketing Notice: Submission of a marketing notice and confirmation by Defra that the organism is a PBO.
• Food and Feed Authorization: Application for, and issuance of, a marketing authorization from the Food Standards Agency for PBO used in food and feed.

If you have any questions regarding this alert, please contact the authors.

[1] “These Regulations extend to England and Wales but apply in England only.” Part 1.