28 April 2025

A milestone for precision breeding in England

In this blog, Maddie Cass, Senior Policy and Public Affairs Executive at BIA, explores a major milestone for agricultural innovation in England: the implementation of a clear, science-based regulatory pathway for precision-bred plants. This landmark move promises to accelerate innovation, offering plant breeders and biotech companies a faster, more proportionate route to market, and signals the Government’s commitment to supporting the UK’s deep biotech sector.

England is the first country in Europe to create a clear, functioning regulatory pathway for the commercial marketing of precision-bred plants.

The secondary legislation underpinning the Precision Breeding Act 2023 opens a clear route for precision-bred plants for food and feed to enter the market in England. This marks a pivotal moment in the development of a science-based framework to support innovation in agriculture. In the words of Steve Reed MP, speaking at the National Farmers Union conference in February, these new rules have "huge potential to transform the plant breeding sector in England by enabling innovative products to be commercialised in years instead of in decades”.

Precision breeding has the potential to help farmers increase crop yields, reduce the burden of pests, and make the food system more resilient to climate change. For example, the fungal pathogen late blight is estimated to be responsible for the loss of 20% of potato crops worldwide. The Sainsbury Laboratory and BioPotatoes have developed a late blight-resistant potato which will be much easier to cultivate, reducing the risk for farmers and the amount of fungicide applied to fields in England.

The new Technology (Precision Breeding) Regulations 2025 provide a new route for companies like BioPotatoes to place their products on the market in England. Under the old regulatory framework, precision-bred organisms (PBOs) were subject to the burdensome Genetically Modified Organisms (GMO) (Deliberate Release) Regulations, which were inherited from EU law.

What is precision breeding?

Precision breeding refers to the use of modern biotechnology techniques, such as CRISPR gene editing, to introduce genetic changes into the DNA of an organism that could have occurred through traditional breeding methods. This technology differs from genetic modification, which involves the insertion of functional DNA from one unrelated species to another.

The new authorisation process is based on a two-tiered approach, with a proportionate level of safety assessment based on the level of risk presented by the PBO. The first approvals under the new regulatory framework are expected to take place in October 2025, six months after the regulations received royal assent.

What does this mean for the sector?

The implementation of this new framework is a significant step for the UK’s deep biotech sector. The simplified route to market means plant breeders, researchers, and biotech SMEs will be able to move from lab to field with greater confidence. This regulatory certainty provides a clearer return on investment for those developing precision-bred crops, and could encourage increased R&D activity in plant science.

Crucially, it signals the Government’s commitment to building a more supportive environment for agricultural innovation – one that is proportionate, science-led, and designed to harness the UK’s strengths in research and biotech innovation.

Implementation in England

The new framework will come into effect in October 2025, when applications for market authorisation of precision-bred plants can begin. Alongside the legislation, the Food Standards Agency (FSA) has published draft technical guidance for applicants seeking approval for PBOs intended for food and feed. This guidance will be user-tested over the coming months to ensure clarity and usability for businesses and researchers.

Defra recently consulted on proposals to introduce a Precision Bred Plant Variety List for England. This would act as a pre-market listing, supporting transparency and traceability of approved PBOs.

It is important to note that these regulations apply in England only. The Government has stated that it is engaging with devolved administrations to mitigate the impact of regulatory divergence within the UK. Continued dialogue will be needed to manage the implications for research collaboration, trade, and the internal market.

Future legislation: animals and microorganisms

While the current regulations cover plants only, the Government has indicated that animals may follow. Policy work is ongoing on the welfare declarations needed to support future legislation for precision-bred animals. However, no decision has been made to set out this next phase of regulation.

Microorganisms remain outside the scope of the 2023 Act. Separate primary legislation would be required to bring these technologies within the framework. This is an area where further clarity would be welcomed by industry, particularly given the growing role of engineered microbes in areas such as sustainable agriculture and industrial biotechnology.

Across the Channel, the European Union is beginning to reassess its approach to the regulation of engineered microorganisms. In a welcome step, the European Food Safety Authority published scientific opinion in 2024 that microorganisms derived from new genomic techniques (NGTs) are just as safe as those derived from established genomic techniques, and recommended a product over process approach to risk assessment.

International outlook

In July 2023, the European Commission introduced a proposal for new rules on plants developed using certain NGTs. These would distinguish between gene-edited plants that could have arisen naturally or through conventional breeding, and those that could not. While the EU continues to consult on its proposal, the UK has moved ahead and implemented its own regulatory system, potentially creating an early-mover advantage for companies operating here.

Key takeaways

The introduction of the secondary legislation needed to implement the Precision Breeding Act marks an important moment for the UK bioeconomy. It delivers long-awaited clarity for developers of precision-bred crops and sets a new precedent for science-based regulation in the UK. We see this as a strong example of strategic regulatory divergence – one that plays to the UK’s strengths in innovation, research, and biotech innovation. A clear, proportionate framework for precision breeding gives companies the confidence to invest and scale up new agricultural technologies. Government is already pouring funding into technologies enabled by this regulatory change with a £12.5 million competition to fund R&D using precision-bred crops to improve yield, reduce chemical inputs and enhance disease resistance.

BIA has consistently supported this regulatory reform, engaging with Government through submissions to consultations on both the primary and secondary legislation. We continue to work to improve the regulatory landscape for deep biotech companies across a range of application areas, including through ongoing engagement with the new Regulatory Innovation Office.