This article provides an update to two earlier pieces I wrote in 2021 on UK and EU reforms to the regulation of gene-edited organisms: Reform of Regulation of Gene-Edited Organisms – An update (18 October 2021) and UK Government Consults To De-Regulate Gene Edited Organisms In England (9 March 2021).
The Genetic Technology (Precision Breeding) Act 2023 established a framework in the UK for authorisation of precision bred plants and animals.
The UK Parliament recently enacted the necessary secondary legislation, the Genetic Technology (Precision Breeding) Regulations 2025. The Regulations come into force on 13 November 2025, implementing the Act exclusively in respect of precision bred plants.
The new Regulations signal a simplified route to market for precision bred plants. However, the UK and EU have now agreed to enter into an SPS Agreement providing enhanced cooperation in the area of sanitary and phytosanitary goods and food safety, as part of a larger reset of UK-EU relations.
At first glance, the SPS Agreement appears to thwart the UK's move towards deregulation. However, alignment with current EU SPS rules might be avoided, depending on the interpretation given to the two-tiered authorisation process recently outlined by the UK's Food Standards Agency. Whether the UK can be granted an exception (to EU alignment) in respect of precision bred plants could depend on whether the plants are considered to be of a 'lower standard', compared to those authorised under current EU rules.
Precision bred
In the UK, for a plant or animal to be considered precision bred:
- feature of its genome results from the application of modern biotechnology,
- those features are stable,
- those features could have resulted from traditional processes, and
- its genome does not contain any feature that results from the application of any artificial modification technique other than modern biotechnology.
Modern technology
The techniques used to alter the organism's genome must be limited to:
- recombinant nucleic acid techniques using a virus, bacterial plasmid or other vector system;
- direct introduction into an organism, including micro-injection, macro-injection and micro-encapsulation;1
Precision bred plants and animals do not therefore include organisms that contain DNA that is not present in the non-modified organism or in a sexually-compatible species. These organisms remain classified as genetically modified organisms (GMOs) and regulated as GMOs 2.
Simplified authorisation
It is worth noting that agriculture is a policy area that is devolved to the four constituent nations of the UK. The substantive functions of the Act apply only to England and Wales. The Regulation only applies the Act to England, meaning that regulation of precision bred organisms (PBOs) will be different in the various parts of the UK, at least for the moment.
The Scottish Government has indicated that it currently has no intention of implementing its own primary legislation in respect of precision breeding and appears to be awaiting developments at the EU level. Northern Ireland is subject to alignment with EU sanitary and phytosanitary (SPS) product regulations as part of the EU Withdrawal Agreement. Accordingly, any precision bred plant will need to comply with EU law on GMOs before entering Northern Ireland.
Although the regulations only apply to England, the UK government has indicated that it considers that seed obtained from precision bred plants cultivated in England could be sold into Scotland and Wales under the UK Internal Market Act 2020 and the Windsor Framework, unless an exclusion is put in place 3.
The UK government's Advisory Committee on Releases to the Environment (ACRE) has now issued guidance for products for food or for feed: ACRE guidance: producing precision bred organisms.
This guidance sets out a two-step process for obtaining marketing authorisation. Initially, confirmation must be sought from DEFRA (Department for Environment, Food & Rural Affairs) that the procedure is a precision breeding procedure. A separate authorisation must then be obtained from the FSA (Food Standards Agency).
The Food Standards Agency has issued draft Technical Guidance for applicants, which provide two approaches to obtaining market authorisation.
Tier 1 authorisation
Under Regulation 20, if the organism for which approval is sought:
i) belongs to a species that has a history of safe food use and
ii) the genetic change is not expected to:
- negatively alter certain defined properties of the organism, such as nutritional quality, toxicity, allergenicity; or
- introduce any other feature which may affect the safety of the food or any feed produced from the organism,
The authorisation application will be processed by the FSA under a Tier 1 safety assessment.
Compositional data and continued food use in the UK or EU before 15 May 1997 will be determining factors.
Tier 2 authorisation
If the organism does not satisfy the Tier 1 conditions, authorisation will be processed under Regulation 22 with a Tier 2 safety assessment.
A Tier 2 assessment imposes additional evidence requirements to confirm the safety of the organism. During a Tier 1 assessment, an authorisation application may be transferred to Tier 2.
Tier 2 authorisation is expected to take significantly longer than Tier 1 authorisation.
UK-EU Alignment
It remains to be seen how quickly the FSA will process marketing authorisation requests, but Rothamsted Research has suggested that: 'UK consumers could see gene edited products on supermarket shelves by late 2026'4.
The EU has been following a parallel path towards deregulation, but it is some way behind finalising and implementing its proposals. The legislative process is at the stage of negotiations between the Commission and the European Parliament.
The slower pace of change at the EU level means a potential divergence between the authorisation and availability of gene-edited organisms between the UK and EU.
However, the authorisation process outlined in the UK may now have to be paused pending further progress in the EU.
On 19 May 2025, the UK and EU agreed to enter into an SPS Agreement providing enhanced cooperation in the area of sanitary and phytosanitary goods and food safety as part of a larger reset of UK-EU relations. Under the proposed SPS Agreement, Great Britain will dynamically align its SPS rules with those of the EU. Northern Ireland is already subject to alignment with EU SPS product regulations as part of the EU Withdrawal Agreement.
Nevertheless, the agreement envisages certain exceptions to the UK's dynamic alignment obligations, provided that the exception 'does not lead to lower standards as compared to EU rules' 5. We will have to wait to see whether the term 'standards' is given a flexible meaning in the formal SPS Agreement.
For example, it could be argued that a fundamental characteristic of the UK precision breeding regime is that gene-edited organisms given marketing authorisation under the UK legislation conform to the same standards of food safety as conventional crops. In other words, if Tier 1 authorisation requires a history of safe food use, and Tier 2 requires evidence of food safety, authorised gene-edited organisms would not be of a lower 'standard' as compared with EU rules. On the other hand, the EU could require additional evidence that the genetic change does not alter nutritional quality, toxicity, or allergenicity.
Even if the UK is permitted an exception for gene-edited organisms, the SPS Agreement would still require that the exception respects the principle that only animals and goods compliant with European Union rules move into the European Union.
The UK's Secretary of State for Environment, Food and Rural Affairs, Steve Reed, gave oral evidence to the Commons Environment, Food and Rural Affairs Select Committee on the day after the UK-EU summit. His comments appeared to suggest that a mechanism was envisaged that would permit the UK to press ahead with marketing authorisations for gene-edited organisms within the framework of the proposed SPS Agreement 6.
It seems likely that if a formal SPS Agreement has not been concluded by 13 November 2025, then the granting of marketing authorisations in the UK may need to be postponed.
It remains to be seen whether the UK's two-tiered approach might be subject to additional evidential requirements in order for compatibility with the EU.
What about patent rights?
The UK's approach to deregulation has been silent on the intellectual property position, meaning that the current criteria for patentability continue to apply. However, there is ongoing uncertainty within the EU as to whether deregulation of gene-edited plants might be coupled to restrictions on patent protection for gene-edited plants.
Although an outright EU ban on patents for gene-edited plants appears increasingly unlikely, the European Council has proposed patent transparency measures.
Any additional requirements for evidencing the patent position as part of the authorisation process would, of course, increase the regulatory burden beyond the Tier 1 and Tier 2 processes set out by the UK in the Genetic Technology (Precision Breeding) Regulations 2025.
There might also be an impact on any exception to the SPS Agreement, if the UK and EU diverge on the patentability of gene-edited plants or patent transparency requirements.
National Listing still required
In order for any new plant variety to be marketed in the UK, the grower must apply to add the new variety to the UK's 'national lists', maintained by the Animal and Plant Health Agency (APHA). DEFRA consulted on a proposed Precision Bred Plant Variety List for England earlier in the year, with the consultation closing in April 2025. 7 The results of the consultation have not yet been published.
As with the application for approval by the FSA, it is proposed that the first step in the procedure will be an application to DEFRA for confirmation of precision bred status.
An application will then be made for UK listing to the APHA following existing procedures, such as providing samples of the variety for DUS (distinct, uniform and stable) testing and, for agricultural varieties, VCU (value for cultivation and use) testing.
Currently, no changes to the UK scheme of plant breeders' rights are considered to be necessary. Breeders of precision bred plants will be able to apply for plant breeders' rights in the same way that they currently do for non-precision bred varieties.
Progress paused?
The implementation the two-tiered process for authorisation signals a significant milestone for deregulation of precision bred plants in England.
The UK government's position appears to be that the EU reset will not impact this progress, but a delay beyond the 13 November 2025 seems to be a likely scenario, given the ongoing work required to finalise the SPS Agreement, and the current uncertainties around the EU's ultimate position on deregulation and patent transparency. It remains to be seen whether additional requirements may be introduced to the Tier 1 and/or Tier 2 system in order to fully or partially align with the evolving position in the EU.
Next Steps
As the regulatory landscape for precision breeding continues to evolve, businesses, breeders, and innovators will need to monitor developments closely - both in the UK and EU. At Murgitroyd, we help clients navigate these complexities, from regulatory updates to patent strategy, ensuring ideas and innovations are protected and aligned with market opportunities.
Footnotes
1. Section 5(1)(a) and (b) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002
2. Food Standards Agency guidance - What are precision bred organisms?
3. Plant Varieties and Seeds Framework at page 13 'Impact on business of the proposed Precision Bred Plant Variety List for England
4. Rothamsted Research article - Precision Breeding Regulations Signed Into Law by UK Government
5. Common Understanding Policy Paper from the UK-EU Summit - point 28
6. Question 184 from the Environment, Food and Rural Affairs Committee Oral Evidence
7. Plant Varieties and Seeds Framework
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