AGRITECH + IP
The draft of The Genetic Technology (Precision Breeding) Regulations 2025 reveals practical details on how to obtain a Precision Bred Organism status
March 2025
In a recent blog post we discussed the Precision Breeding Regulatory Framework developed by the Food Standards Agency (FSA). Further details on the application process for Precision Bred Organism confirmation have now been revealed, with the recent publication of the draft Regulations implementing the Genetic Technology (Precision Breeding) Act 2023. This draft legislation provides detailed procedures for applicants seeking confirmation, release, and marketing authorisation for precision bred plants in England.
Confirmation of precision bred status may be obtained by submitting a marketing notice to the Department for Environment, Food & Rural Affairs (DEFRA). The marketing notice must provide a general description of the precision bred plant and list its intended use, and include the purpose of the genetic modifications and a comprehensive description of these. Specifically, the applicant must provide the details, location and stability of the intended and unintended genetic changes and include, if relevant, a description of any genetic elements and information relating to their origin. While the legislation does not specifically mention the need to submit sequence data, it is not clear whether such data may be needed to support the description of genetic modifications. In addition, scientific evidence must be provided to demonstrate that the modifications meet the legal definition of precision breeding (i.e. the genetic modifications have been performed using modern biotechnology and could have occurred naturally or through traditional breeding). If the application is successful, the confirmed precision bred plant will be added to the precision breeding register, allowing it to move forward in the regulatory process. Of note, such marketing notice may be used for other precision bred plants, provided that they belong to the same species and share the same genetic modifications.
Before releasing a precision bred plant into the environment, for example for R&D trials, applicants must submit a notice of release to DEFRA, at least 20 days before the plant release. The notice must contain a description of the precision bred plant, including taxonomy and genetic modifications, and list the modification techniques used. In addition, confirmation must be provided that appropriate containment measures will be put in place to prevent the marketing of the released plant. Release notices will also be included in the register.
Specific rules apply to food and feed produced from precision bred plants, for which an additional marketing authorisation from the FSA is required. In this case, applicants must provide further evidence that the products derived from a confirmed precision bred plant are safe for consumption (for example, evidence of historical safe use) and may require assessment by the FSA before authorisation can be granted. The FSA has published draft guidance documents for applicants seeking marketing authorisation of precision plants for use in the production of food and feed (https://www.food.gov.uk/business-guidance/what-are-precision-bred-organisms).
The full draft legislation may be consulted here https://www.legislation.gov.uk/ukdsi/2025/9780348269123/contents.
This article was prepared by Trainee Patent Attorney Delphine Lauté-Caly.
