Blog post

Gene-editing: a barrier to proposed free flow of plant and animal products between the UK and EU?

Published 10 June 2025

Introduction

In May, the EU and the UK agreed to work towards a common Sanitary and Phytosanitary (SPS) area which would harmonise regulation and in return allow the ‘vast majority’ of animal and plant products to avoid border checks and controls. While the announcement was politically significant, the details are yet to be worked out. Gene-editing regulations stand out as a potential sticking point.

How to regulate this emerging technology remains unsettled. The EU’s precautionary approach to genetically modified organisms (GMO) regulation has long been contested, drawing criticism for being restrictive and unscientific in the dispute at the WTO. However, the EU has defended its approach as a commitment to protecting public health and environmental safety in case of scientific uncertainty. Gene-editing is the new(er) kid on the block: an emerging technology that allows changes within an organism that could be made more slowly through conventional breeding without introducing foreign DNA.

This blog sets out the differing EU and UK regulatory approaches to gene-editing and their potential implications for negotiating a common SPS area.

The UK’s decoupling from the EU’s GMO regime

Since Brexit, the UK has shifted away from the EU’s approach to GMOs, which requires a high burden of proof for approving new GMOs. The EU places the responsibility on developers to demonstrate safety through a comprehensive risk assessment and authorisation process to prevent potential harm, until proven otherwise. Following Boris Johnson’s pledge to scrap these ‘anti-genetic modification rules’, the UK Government passed the Genetic Technology Act not long after. Crucially, this sets out that gene-edited products should not be regulated the same as GMO products. Under the Genetic Technology Act, gene-edited organisms substantially equivalent to conventional ones may be approved through a simplified Tier 1 assessment, while those raising potential safety concerns undergo a more complicated Tier 2 assessment. The UK regulator considers factors such as novelty, nutritional changes, toxicity, and allergenicity. This marks a departure from the precautionary principle and process-based GMO regulation, where the use of genetic modification techniques mattered regardless of risk.

In parallel, the EU has been trying to depart from its current approach to the GE crops. In 2023, the European Commission adopted a proposal for a regulation to treat certain gene-edited plants less strictly, similar to the UK’s approach. The EU also proposes a two-tiered approach in its gene-editing regulations, called New Genomic Technology (NGT) regulations, which will depend on the number and size of modifications of organisms. Category NGT 1 will be considered equivalent to traditional plants and exempt from GMO regulations, whereas category NGT 2 will be applied to the same GMO legislation, including labelling and traceability requirements.

However, the EU is experiencing slow progress due to disagreements over the patentability of gene-edited crops. The proposal is now at the trilogue stage, where the European Parliament, the Council, and the Commission are negotiating their mandates to agree on the final text of the legislation.

Lack of complete convergence

Even if the NGT regulation is passed, the two-tiered approach to gene-edited crops in the EU and the UK will create key divergences in definitions and labelling. Firstly, while the UK Genetic Technology Act covers both animals and plants, the EU’s NGT regulation applies solely to plants.

Secondly, the UK’s regulation allows certain gene-edited crops to bypass GMO-level scrutiny and safety assessment without mandatory labelling or traceability, whereas the EU’s NGT 1 category mandates seed labelling and imposes strict criteria on the number of edits.

Finally, the EU’s category NGT 2 and the UK Tier 2 Assessment operate differently. Category NGT 2 plants in the EU are regulated under the existing GMO regulatory framework, requiring full risk assessments, traceability, and labelling. In contrast, the UK’s Tier 2 applies only to those that raise specific safety concerns but are assessed outside GMO law under a separate and proportionate regime led by the UK Food Standards Agency. In other words, some UK gene-edited crops would go through a less complex level of safety assessment compared to NGT2 plants in the EU without labelling requirements.

Implications for common SPS area negotiations

Importantly, few traded agri-food products are currently gene-edited. If the current proposal for EU NGT regulation is unsuccessful, or undergoes significant changes, there will be divergence in the UK and EU approach, which would likely grow in importance as the technology becomes more established. Even if it passes, and the two approaches become more similar, some differences, as outlined above, will still exist.

The EU and UK have promised that a common SPS area will cover ‘sanitary, phytosanitary, food safety and general consumer protection rules’, which appears to include gene editing regulation. This implies that the UK would be required to align with the EU.

There are political and economic arguments for England to converge with forthcoming EU NGT regulation.

Gene editing regulation is a devolved competence, and Scotland and Wales have kept the EU’s current approach. If England feels strongly about preserving its current pro-innovation approach, it could argue that gene editing rules should be included on the ‘short list of limited exceptions to dynamic alignment’. However, these can only be agreed if England does not have lower standards and if it agrees not to export these products to the EU. It remains unclear whether the EU would agree to this.

Aligning with the EU would eliminate a current source of tension in the UK’s intergovernmental relations. Indeed, three out of four UK nations remain aligned with the EU in this area, Northern Ireland pursuant to its special trade arrangements.

Also, the benefits of diverging are undercut by the costs of divergence. DEFRA’s impact assessment estimated that the UK’s embrace of gene editing would result in non-tariff barriers with the EU for imports valued at around £8.56 billion/year, ‘potentially outweighing the scale of direct benefits to business.’

UK secondary legislation enacted just before the UK-EU Summit is limited to gene-edited plants, which might indicate that the UK is already preparing to move toward the EU approach. The EU could ease the transition by allowing the UK a time-limited exemption and by being willing to consult the UK on changes to its regulation.