Can newly enacted UK rules simplifying approval for precision bred plants survive the EU reset?

The Genetic Technology (Precision Breeding) Act 2023 has established a new regulatory framework to facilitate the use of precision bred organisms (PBOs) in England.

The UK Parliament has now enacted secondary legislation, the Genetic Technology (Precision Breeding) Regulations 2025, which applies exclusively to precision bred plants and comes into force on 13 November.

PBO milestone?

This development marks a significant milestone for PBOs in England by introducing a streamlined two-tiered authorisation process, simplifying the pathway for businesses to bring these products to market.

Under the current process, obtaining authorisation of a PBO requires a lengthy process that was derived from the EU's genetically modified organisms legislation. To combat this, the new authorisation process for PBOs will revolve around a two-tier approach.

However, after the UK and EU summit on 19 May, where dynamic alignment for agrifood products was agreed upon, the implementation of these new rules now seems uncertain.

Tier 1 authorisation

Initially, businesses must apply to Defra for a "marketing notice" to market the PBO. Subsequently, an application to the Food Standards Agency (FSA) is required for food and feed marketing authorisation.

Applicants must conduct a "Tier 1" safety assessment to determine the regulatory route, considering:

• 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 (that is, it would be classified as a novel food and be required to meet existing Novel Food regulations).
• Composition: whether the PBO introduces genetic changes that disadvantageously alter nutritional quality, elevate toxicity, or alter allergenicity.
• Other safety concerns: whether the PBO introduces features affecting food or feed safety.

For PBOs with a safe food use history and no detrimental changes, the "Tier 1" light-touch approach can be followed, with applications submitted to the FSA along with supporting evidence.

Tier 2 authorisation

If any of the above criteria are met, a "Tier 2" safety assessment with further FSA scrutiny is required. Tier 2 applications will take longer due to this increased scrutiny.

The FSA is currently developing guidance on this new process, which will be published in advance of the regulations coming into force.

UK-EU alignment

Although the enactment of these regulations was being welcomed by businesses looking to bring innovative products to market, there has been a subsequent development in the UK's approach to resetting its relationship with the EU, which may slow down progress in this area.

At the UK-EU summit, an agreement was announced that work will begin for a sanitary and phytosanitary (SPS) agreement. This will cover sanitary, phytosanitary, food safety and general consumer protection rules applicable to the production, distribution and consumption of agrifood products. For this agreement, the EU has said dynamic alignment will be required by the UK, meaning that all relevant EU rules will apply to UK goods.

Pause in progress?

For gene editing, this will likely mean a pause on the UK's progress, in a bid to align it with EU standards once they have been agreed. While the EU is also seeking to adopt a more flexible approach to regulating gene-edited plants, its progress has been slow, partly due to a controversial proposal by the European Parliament to ban patent rights for gene-edited plants.

This has faced substantial resistance and is a source of difference in the negotiating positions of the European Commission, Parliament and Council in the trilogue process. It remains to be seen how quick progress might be moving forward.

Therefore dynamic alignment with the EU does not mean that gene editing in the UK will never happen, but it seems like the pace will be slower than anticipated and the deregulatory approach is likely to be subject to change.

Patent rights

There is also a lingering question mark relating to patent rights for gene-edited plants. The UK's deregulatory approach was silent on the intellectual property position, meaning that the current criteria for patentability were expected to continue to apply.

However, it remains to be seen what might be agreed in the EU and how the UK might respond to it. While it is unlikely that the final EU approach will include a ban on patents for gene-edited plants, it may include patent transparency measures that have been proposed by the European Council, which would increase the regulatory burden beyond what the UK had envisaged with its deregulatory approach.

Osborne Clarke comment

It seems likely that the UK will have to slow down its plans for regulatory reform in the gene-editing space, and while this could somewhat undermine its position as a leader in genetic technology, it could also be short-lived if the EU progresses quicker with its own regulations as a result of this new agreement.

For businesses operating in both the UK and EU, an agreement between the two jurisdictions could actually be beneficial in the longer term. Harmonising the regulatory frameworks would simplify the process of placing gene-edited products on the market, as businesses would only need to navigate the one framework.