Precision breeding and the law: what England’s new framework actually says

England’s new precision-breeding regime was intended to clear the ground for plant innovation. Instead, three legal developments in three years have left developers facing something of a regulatory thicket.

The Genetic Technology (Precision Breeding) Act 2023 created the framework. The 2025 Regulations put much of it into practice. Then, in 2026, the High Court held in Beyond GM that the decision to make those Regulations was unlawful.

The result is not quite the straightforward route many breeders expected. The Act, the Regulations and the Beyond GM judgment do not yet form a neat regulatory system. They form a legal patchwork that developers must navigate with care.

The regime is nevertheless being used in practice. The Department for Environment, Food and Rural Affairs (Defra) has now issued precision bred confirmations for eight gene-edited strawberry lines with an extended harvest period. It has also issued a confirmation for a tomato that accumulates increased levels of pro-vitamin D3.

These decisions move the plants closer to commercialisation in England. But they do not authorise the resulting fruit for sale as food.

A separate food-and-feed marketing authorisation is required. At the time of writing, the Food Standards Agency’s register records no precision-bred organism food or feed authorisations.

Regulatory classification, food approval and commercial launch are therefore separate stages. No supermarket launch has yet been confirmed.

Important questions also remain about labelling, traceability and how the regime fits with existing seed laws.

This matters to anyone developing, protecting or commercialising new plant varieties in England. It also matters to overseas breeders deciding whether the English market offers a viable route for their products.

So, which plants take root within the new regime? Which remain outside it? And what further approvals are needed before a variety can reach the market?

An English framework, not a UK one

The Genetic Technology (Precision Breeding) Act 2023 creates a new statutory classification of certain plants and animals: “precision bred”. The main rules governing precision-bred plants apply only in England. These include their release and marketing, and food and feed derived from them. An English precision bred confirmation does not authorise release or marketing in Wales, Scotland or Northern Ireland. That geographical distinction is commercially important and is often overlooked.

The policy aim was to create a simpler regulatory route for genetic changes that could also have arisen through traditional processes.

Three plants, three possible routes

The distinction is easier to understand through three hypothetical examples.

First, a conventionally bred broccoli. A breeder crosses existing broccoli lines and selects progeny with improved heat tolerance. No modern biotechnology is used. The result may be a new variety, but it is not a precision-bred organism under the Act.

Second, a gene-edited potato. A developer uses targeted gene editing to switch off a native gene and produce a shorter plant. The potato might qualify as precision bred if the resulting genomic feature is stable and could have arisen through a traditional process. The precise edit, the method used and any unintended changes would all matter when assessing whether the potato falls within this category.

Third, an engineered C4 rice plant. A developer introduces several genetic changes designed to alter the plant’s photosynthetic pathway and associated leaf anatomy. If the finished plant contains genomic features that could not have arisen through traditional processes, it would not qualify as precision bred. It would remain within the GMO regime.

These examples are simplified. The statutory classification turns on the plant’s genomic features and how they were produced. It does not turn on the crop, the commercial value of the trait or whether the developer describes the technique as gene editing.

What counts as precision bred?

Precision bred is not a synonym for gene-edited or non-GM. Under the 2023 Act, a plant qualifies if one or more features of its genome result from “modern biotechnology”. Each feature must be stable. This means that it must be capable of passing to later generations. Each feature must also be capable of arising through a traditional process. The plant must not contain genomic features resulting from other artificial modification techniques, subject to limited statutory exceptions.

The test focuses on each genomic feature resulting from the use of modern biotechnology. It does not simply ask whether the finished plant looks or behaves like a conventionally bred plant. Copy number, epigenetic status and genomic location are disregarded when assessing whether a feature could have arisen through a traditional process. Whether any particular feature qualifies is sensitive to the specific facts of the plant concerned.

Release and marketing: two different stages

The Act distinguishes between release and marketing. Getting this distinction wrong can be costly.

A release occurs when a person deliberately allows a contained plant to cease being under anyone’s control and enter the environment. An experimental field trial will normally involve a release. Under the Genetic Technology (Precision Breeding) Regulations 2025, a release notice must normally be submitted at least 20 days in advance. The notice must identify the persons responsible. It must also give a general description of the plant, the intended alterations, the types of genetic change and the techniques used. The notifier must confirm that appropriate measures will prevent the material from being marketed before a precision bred confirmation is issued.

Marketing is defined broadly. It covers making a product available to another person for delivery in England, whether or not money changes hands. A precision-bred plant may generally be marketed only once a precision bred confirmation is in force. The Act also makes provision for qualifying progeny of a confirmed plant.

Confirmed for marketing, but not necessarily cleared for sale

A precision bred confirmation is not a general safety approval. Nor does it clear a new variety for immediate commercial sale.

For many agricultural and vegetable species, seed of a named variety must also be approved under statutory variety-listing rules. The existing GB Variety List covers England, Wales and Scotland. Variety listing is separate from plant breeders’ rights, which protect the intellectual property in a new variety.

This creates a territorial complication. The GB Variety List covers three nations, but the precision-breeding regime applies only to England. Defra therefore consulted on a separate Precision Bred Plant Variety List for England. At the time of writing, that proposed list does not appear to have been brought into operation.

The proposed list should not be confused with the existing precision breeding register. The register records notices, confirmations and other information under the 2023 Act. It does not approve named varieties for seed marketing or grant plant breeders’ rights.

Depending on the plant and its intended use, other rules may also apply. These include seed certification, plant-health requirements and food-and-feed authorisation.

Obtaining a precision bred confirmation

To obtain confirmation, a notifier submits a marketing notice to the Secretary of State. The 2025 Regulations require details of the plant and its intended use.

The notice must describe intended and unintended genetic changes, the techniques used and the analyses performed. It must also explain the analyses used to confirm that the plant contains only genetic sequences that could arise through traditional processes.

The Advisory Committee on Releases to the Environment (ACRE) then reports, normally within 90 days, on whether the plant satisfies the statutory definition. If satisfied, the Secretary of State issues a confirmation.

Much of the underlying information may then be published on the precision breeding register. The notifier’s identity and a general description of the plant cannot be withheld as commercially confidential.

The Beyond GM judgment

In June 2026, the High Court held that the decision to make the 2025 Regulations was unlawful. The Minister had been incorrectly advised that the 2023 Act did not give him power to require broader mandatory labelling. In fact, the parties agreed that sections 26(1) and 26(2)(b), which permit regulations securing traceability of food and feed produced from precision-bred organisms, did confer that power.

The Court found that this error materially constrained the range of options the Minister considered. There was at least a real possibility that, correctly advised, he might have considered a materially different range of options, particularly on mandatory labelling. The decision to make the 2025 Regulations was held irrational, and the judicial review claim succeeded on that ground.

The Court invited further submissions on the relief that should follow. At the time of publication, Defra was still administering the regime and maintaining the precision breeding register. We had not identified a later published judgment or order quashing the Regulations.

Conclusion

The framework gives developers a working route to “precision bred” status. But it is not yet a settled route.

The Act, the Regulations and Beyond GM have created a legal patchwork. Questions remain about labelling, traceability and the interaction with seed law. Further change looks likely.

For breeders, the key is to identify the correct regulatory route early. Precision bred confirmation may be an important step. It is not the whole path to market.

So what does all of this mean if you are trying to protect and commercialise a precision-bred variety? We explore that in our companion piece.