New regulations signal next step for precision bred plants in England

The Genetic Technology (Precision Breeding) Act 2023 heralds a new era for precision bred organisms (PBOs) in England, as it allows for a streamlined regulatory framework to facilitate their use in food and feed. It defines "precision bred organisms" as plants or animals developed using modern biotechnology (such as gene editing) that contain genetic features and could have been produced by traditional breeding processes.

Currently, PBOs undergo a complex and lengthy authorisation process under the EU's genetically modified organisms (GMO) legislation. The Genetic Technology Act removes precision bred plants and animals from the GMO regulatory system, creating a new and separate regulatory framework.

The recently published draft Genetic Technology (Precision Breeding) Regulations 2025, along with draft guidance from both the Food Standards Agency (FSA) and the Department for Environment Food and Rural Affairs (Defra), outline the requirements for obtaining food and feed marketing authorisation for PBOs. Only precision bred plants are covered by these regulations.

Simplified route to market

The newly proposed authorisation process for PBOs is based on a two-tier approach, with a lighter-touch regime for PBOs where the safety risks are understood and are not of concern. In the first instance, businesses would need to apply to Defra for a "marketing notice", which would enable them to market the PBO.

Following this, an application to the FSA for a food and feed marketing authorisation would need to be made to allow food and feed produced from the PBO to be placed on the market. All applicants would have to conduct a "Tier 1" safety assessment of their PBO to determine the appropriate regulatory route. The assessment would need to set out the following criteria:

• History of safe food use. Whether the PBO does not belong to a species with a history of safe food use confirmed by compositional data and continued food use in the UK or EU before 15 May 1997.
• Composition. Whether the PBO introduces genetic changes that significantly alter the nutritional quality disadvantageously, elevate toxicity and alter allergenicity.
• Other safety concerns. Whether the PBO introduces features affecting food or feed safety.

If any of these are met, then applicants would have to follow the "Tier 2" safety assessment, which would require further scrutiny from the FSA to ensure the PBO is safe for consumption.

Alternatively, if the applicant can evidence that the PBO is from a species that has a history of safe food use in the UK or EU and does not change the nutrient quality in a detrimental way, elevate toxicity, alter allergenicity or otherwise affect the safety of the PBO as a food, then the Tier 1 assessment – the light-touch approach – could be followed.

For this, the application would need to be submitted to the FSA along with supporting evidence. The FSA expects to submit recommendations to Defra for approval of a PBO for use in food and feed up to 60 days from receipt of this application. Applications made under the Tier 2 safety assessment will take longer.

The FSA's draft guidance to applicants for PBO authorisation provides details on these two routes for PBOs used in food and feed. It guides on how to apply to the FSA for authorisation. The FSA is seeking feedback on the clarity of the guidance before finalising it.

The draft regulations will need to be voted on in both the House of Commons and the House of Lords and will come into force six months later.

Osborne Clarke comment

If approved, the new two-tier regulatory system for PBOs will be welcomed by businesses, as the streamlined process will allow for quicker market entry.

The UK's proactive approach contrasts with the EU's. Precision breeding legislation is making slow progress through the EU's legislative procedure, particularly due to a controversial proposal by the European Parliament to ban patents for gene edited plants. This will be hotly negotiated between the Parliament and the Council. In contrast, the Genetic Technology Act and the newly proposed regulations do not address the intellectual property position in the UK.

By advancing ahead of the EU, the UK positions itself as a leader in genetic technology, offering a favourable regulatory environment for businesses and investors. However, businesses will be looking to stay informed about potential divergence between the UK and EU regimes.

These new regulations apply only in England. However, under the United Kingdom Internal Market Act 2020 (UKIMA), food and feed from authorised PBOs in England can be sold in Wales and Scotland. UKIMA principles do not cover further processing of these goods in Wales and Scotland, where they would still be subject to assimilated GMO regulations. Additionally, as GMO regulation is devolved, legislative divergence across UK nations is possible.

Businesses will want to monitor the progress of the regulations and guidance to ensure compliance and leverage the opportunities presented by this new framework.