English High Court finds government acted unlawfully in introducing regulations on lighter-touch approach to gene editing

On 4 June 2026, in R (Beyond GM and others) v Secretary of State for Environment, Food and Rural Affairs, Mr Justice Johnson allowed a judicial review claim relating to the regulations implementing a deregulatory approach to gene editing in precision bred organisms (PBOs) in England. PBOs are organisms modified using modern biotechnology in a way that is stable and that could have arisen through traditional breeding. 

The claimants sought a judicial review of the secretary of state's decision to make regulations that treated PBOs with a lighter touch including in respect of transparency, traceability and environmental protection. They claimed that it would no longer be possible (or would be much more difficult) for the organic sector to keep genetically modified organisms out of their supply chains, and for consumers to avoid genetically modified food. 

The judge found the secretary of state's decision to be "irrational" because he had misunderstood his legal powers, which materially constrained his decision-making, and led to a lack of further enquiries about the mandatory labelling of PBOs.

The claimants had sought to rely on three further grounds relating to human rights, habitats regulations and a challenge to the scope of the minister's powers to introduce secondary legislation. These all failed. It was agreed between the parties that the court should not immediately determine the consequential remedies flowing from the decision, but that it would hear further submissions from the parties. Therefore, the fate of the regulations and the impact on England's deregulatory regime are uncertain.

Uncertainty also surrounds the effect, if any, that a UK-EU Sanitary and Phytosanitary (SPS) Agreement might have on deregulation in England. It is still unclear whether the UK will be required to introduce "dynamic alignment" with the EU on gene editing regulations. The EU has just adopted its own lighter-touch regulatory regime, which is more stringent than the English regime, but this will not take effect until 2028. The SPS agreement negotiations were postponed following the UK prime minister's resignation. It is not clear whether the new administration will take a different approach to gene editing regulation or to the negotiations, nor how either might affect businesses operating in the sector.

The regulatory framework

The Genetic Technology (Precision Breeding) Act 2023 created a regulatory pathway for PBOs in England, separate from, and lighter than, the genetically modified organism (GMO) controls that continue to apply in the rest of the UK and the EU (until the new two-tiered European approach fully enters into force).

The 2023 Act also gave the secretary of state wide powers to regulate PBO food and feed marketing by way of secondary legislation. In particular, section 26(1) confers a general marketing power and section 26(2)(b) expressly permits requirements to be imposed for the purpose of securing traceability of PBO food and feed. Before the PBO regime came into effect, food and feed containing GMOs (including PBOs) had to carry a label identifying them as such.

The secretary of state introduced the implementing regulations in the form of the Genetic Technology (Precision Breeding) Regulations 2025. These regulations established the food and feed authorisation framework administered by the Food Standards Agency (FSA). Crucially, they imposed no mandatory labelling requirements on PBO food or feed. 

Irrationality

The practical consequence of the absence of mandatory labelling is significant. Organic businesses, exporters and supply chains wishing to demonstrate PBO-free status face real difficulties in markets, including the EU and the rest of the UK, that continue to treat PBOs as GMOs and require them to be labelled accordingly. Without mandatory labelling, that assurance can come only from voluntary disclosure by suppliers.

The irrationality challenge turned on whether the minister correctly understood his legal powers when not implementing a mandatory labelling requirement and not carrying out further enquiries into the operation of such a requirement. It was common ground that compulsory labelling of PBO food and feed would assist its traceability. It therefore followed that s 26(1) and s 26(2)(b) gave the minister power to mandate such labelling. 

However, the minister had been wrongly advised that he did not have powers under the 2023 Act to mandate labelling for all PBOs placed on the market. He believed that he only had the power to mandate labelling for PBO seeds, the power for which was derived from a different piece of legislation. 

The judge found that this inevitably constrained his thinking and the range of enquiries that were appropriate. Had the minister understood the full extent of his powers under the 2023 Act, there was at least a real possibility that he would have considered materially different options for food and feed labelling. The court was not satisfied that it was highly likely that the outcome would have been substantially the same. This was sufficient to render the lack of enquiry and the decision itself irrational in the sense explained in Wednesbury (reaching a conclusion so unreasonable that no reasonable authority could ever have come to it).

Osborne Clarke comment

While the judge acknowledged that the regulations put the regulatory regime in England "out of kilter" with the rest of the UK and the EU, he did note that there were potential benefits to enacting the secondary legislation because of the "first mover competitive advantage" for innovators. This would have been capable of withstanding the irrationality challenge if the minister had correctly understood his legal powers. However, he did not and this had a material impact on his decision making.

Although the court has found the regulations to be unlawful, it is not clear what consequences will flow from this. The parties will be required to make further submissions to the court, but how long this process will take is uncertain.

The judge noted that "any prejudice to third parties, or detriment to good administration, may be considered when deciding what, if any, remedy to grant the claimants".Given that the regulations and the regime provided for in them are already in force, this may affect the remedy the court is willing to grant. It is possible that the regulations could be quashed or a declaration of unlawfulness made. Whether this would be combined with a remittal to the secretary of state to reconsider the decision lawfully and whether those orders might be stayed pending that decision remains to be seen.

Businesses operating in this space should carefully monitor the outcome of this case alongside the changing gene editing landscape in the EU and the progress of the UK-EU SPS agreement negotiations, once they resume.