FAQ for precision breeding application guidance
Frequently asked questions for those making precision breeding applications.
Applies to England
Documents
Details
This resource should be read in conjunction with the FSA’s regulated products application guidance and the FSA’s technical guidance for Precision Bred Organisms
The “Precision Breeding Act 2023 and the Genetic Technology (Precision Breeding) Regulations 2025” (‘the Regulations’) are designed to provide a proportionate, science-based regulatory system for the authorisation of precision bred food and feed.
The FSA’s framework ensures that precision bred food and feed is as safe as traditionally bred food and feed. The FSA’s tiered approach to precision bred food and feed ensures that those organisms, where the risk is well understood, can move through the regulatory process swiftly through an applicant led Tier 1 safety assessment. For more significant changes to the organism or how it will be used, a bespoke safety assessment through Tier 2 provides assurance that food and feed is safe for consumption.
Applications via the Regulation 20 (Tier 1) route consist of statements using clear descriptive text that justify how the precision bred organism meets the applicant’s conclusions to the Tier 1 safety assessment. Where appropriate these statements should include quantitative values to support the conclusions. Submission of detailed quantitative data studies or dossiers is not required but applicants should hold any supporting evidence relevant to their Tier 1 safety assessment.