Legislation passed in 2023 opened the door to greater flexibility for precision genetic technology in England. The Genetic Technology (Precision Breeding) Act 2023 aimed to reduce the regulatory burden and financial barriers in place for researchers and commercial breeders using advanced DNA editing methods, like CRISPR-Cas9 in the agrifood sector (read more).
Regulatory approval process
New regulations for precision bred plant varieties created using gene editing will come into effect in November 2025. There will be a two-stage process to gaining regulatory approval. First, developers must submit a marketing notice to Department for Environment, Food & Rural Affairs (Defra), demonstrating that the plant meets the criteria for precision bred status – namely, that its genetic changes could have occurred through traditional breeding methods. Once confirmed, the plant is added to the Precision Breeding Register. Separately, if the plant is intended for use in food or feed, applicants must seek a food and feed marketing authorisation from the Food Standards Agency. This can follow either a streamlined route, where the species has a history of safe use and no safety concerns are identified, or a safety assessment. The system is designed to ensure transparency, traceability, and proportionate oversight, while facilitating innovation in plant breeding.
Draft guidance to accompany the regulations explores how various technologies, such as site-directed nucleases (SDNs), cisgenesis, and base editing, are assessed for precision bred status. Technologies like SDN1 and SDN2, which create genetic changes through mechanisms that mimic natural mutation and repair processes, are generally considered to fall within the scope of “traditional breeding” as defined by the Precision Breeding Act.
Cisgenic techniques, which introduce genetic material from sexually compatible species, may also qualify, provided transgenic elements are removed. In contrast, intragenesis, which involves recombining genetic elements from the same species in novel ways, is less likely to meet the criteria unless a strong rationale is provided. For the most part, this will continue to be regulated, when used in food, under the existing GMO regime. The framework emphasises that precision bred organisms must not contain transgenic material and that all genetic changes must be stable and heritable. This nuanced approach allows regulators to distinguish between technologies based on their outcomes and alignment with traditional breeding processes, ensuring that only qualifying organisms benefit from the streamlined regulatory pathway.
The Plant Varieties and Seeds Framework
Defra has recently published the outcome of its consultation on the proposed Plant Varieties and Seeds Framework for precision bred plant varieties in England, marking a further significant step towards implementation.
The consultation, which ran from February to April 2025, sought views from stakeholders across the plant breeding and agricultural sectors on the creation of a Precision Bred Variety List (PB VL) and the mandatory labelling of precision bred status on seeds and other plant reproductive material (PRM). With over 400 responses received, the consultation revealed broad support for increased transparency and traceability, particularly among organic businesses and certification bodies.
Respondents generally welcomed the proposed PB VL, recognising its potential to support regulatory compliance and consumer confidence. However, many emphasised that publication in the Plant Varieties and Seeds Gazette alone would not be sufficient. There was strong consensus on the need for a central, searchable register, alongside clear and accessible labelling, to ensure the information is usable across the supply chain.
Mandatory labelling of precision bred status was another key theme. A majority of respondents –especially those in the organic sector –supported this measure, citing benefits for informed choice, supply chain integrity, and certification. Concerns were raised about administrative burden and cost, but most respondents felt that the absence of mandatory labelling would create greater compliance challenges and financial pressures.
Next steps
Looking ahead, Defra has confirmed its commitment to implementing the Precision Breeding Act and will use the latest consultation feedback to shape future policy decisions. This includes further work on how precision bred status is communicated, with an emphasis on multi-channel information sharing and minimising costs to businesses.
Defra is working with other government departments and industry to ensure that the final framework is both effective and proportionate. Businesses involved in plant breeding should monitor updates closely as the implementation phase progresses.
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