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Gene Editing and the UK-EU SPS Area: Legal Implications of Regulatory Divergence
In May, the EU and the UK agreed to pursue a Common SPS Area, aiming to remove most border controls on agri-food products through regulatory alignment. This article examines how England’s new gene editing regime, set to take effect in November 2025, may complicate those negotiations, and assesses the legal and commercial implications for businesses navigating regulatory divergence across the UK, EU, and other major markets.
In May, the EU and the UK agreed to establish a Common Sanitary and Phytosanitary (SPS) Area, representing the most significant development in UK-EU relations since Brexit, with both governments committing to work towards eliminating border checks on the "vast majority" of plant and animal products through dynamic alignment on food safety standards. However, the regulatory divergence between England's progressive gene editing framework and the EU's more cautious approach threatens to complicate these ambitious negotiations and could serve as a litmus test for how far the UK is willing to align with Brussels on emerging biotechnologies.
The May 2025 UK-EU Summit delivered what many considered impossible just months earlier: a comprehensive agreement to negotiate a Common SPS Area that would fundamentally transform agricultural trade between the jurisdictions. Under the proposed framework, the UK has committed to "dynamically align" with EU sanitary, phytosanitary, food safety, and general consumer protection rules applicable to agri-food products, effectively creating a single rulebook across both jurisdictions. This dynamic alignment would require UK rules to change automatically when EU rules change, giving "due regard to the UK's constitutional and parliamentary procedures".
The agreement's territorial scope covers the European Union and Great Britain, with Northern Ireland continuing under the Windsor Framework arrangements. This would result in the vast majority of movements of animals, animal products, plants, and plant products between Great Britain and the EU being undertaken without the certificates or controls currently required. The UK will make a financial contribution for access to EU decision-making committees, databases, and data, though without voting rights, and disputes will ultimately be resolved by the Court of Justice of the European Union.
Crucially, the Common Understanding document allows for "a short list of limited exceptions to dynamic alignment" under specific conditions. An exception can only be agreed if it does not lead to lower standards compared to EU rules, does not negatively affect EU products being placed on the UK market, and respects the principle that only EU-compliant products move into the EU. This exception mechanism has become the focal point for UK efforts to preserve its progressive gene editing regulations whilst securing the broader benefits of SPS alignment.
England's regulatory revolution in gene editing reached full implementation with the signing of secondary legislation by Minister Daniel Zeichner MP on 13th May 2025. The Genetic Technology (Precision Breeding) Regulations 2025, laid before Parliament on 25th February 2025, will commence operation on 13th November 2025, following the mandatory six-month WTO implementation period. This framework establishes England as one of the world's most progressive jurisdictions for gene editing technology, operating through a streamlined two-tier approach that bypasses traditional GMO regulations for qualifying products.
The regulatory structure mandates all applicants conduct a "Tier 1" safety assessment evaluating three specific statutory criteria: whether the precision-bred organism belongs to a species with confirmed safe food use history before 15th May 1997, in the UK or EU; whether genetic changes adversely affect nutritional quality, toxicity, or allergenicity; and whether features affecting food or feed safety are introduced. Products passing Tier 1 assessment face no mandatory labelling requirements, representing a fundamental departure from traditional GMO regulation. The Food Standards Agency aims to provide recommendations within 60 days for Tier 1 applications, whilst Tier 2 assessments require longer evaluation periods.
The regulations apply exclusively to England, creating significant internal UK complications that mirror the broader UK-EU divergence. Neither Scotland nor Wales provided legislative consent for the original Act, with both devolved nations explicitly rejecting the Genetic Technology Act and opposing cultivation and sale of genome-edited organisms within their territories. Northern Ireland remains bound by EU regulations on gene editing under the Windsor Framework, requiring compliance with EU rules that encompass gene-edited crops.
However, the UK Internal Market Act 2020 creates significant complications for devolved resistance through its mutual recognition principle. Goods lawfully marketed in England, including precision-bred crops sanctioned under the Genetic Technology Act 2023, must be accepted in Scotland, Wales, and Northern Ireland, effectively meaning precision-bred products from England will be available throughout the UK despite opposition from devolved administrations.
The European Union reached agreement on 14th March 2025, establishing a common position on NGT regulation after months of political deadlock, allowing the Council president to begin trilogue negotiations with the European Parliament. The EU's proposed framework creates two distinct categories: NGT1 plants that could occur naturally or through conventional breeding, exempted from GMO rules but requiring seed labelling, and NGT2 plants subject to full GMO legislation including comprehensive risk assessments, traceability requirements, and mandatory labelling.
However, significant political obstacles remain, particularly around patent rights for gene-edited organisms. The European Parliament has proposed completely banning patents for NGT plants, whilst the Council favours increased transparency regarding intellectual property rights rather than outright prohibition. This contentious issue has slowed progress and may significantly affect innovation incentives across the EU, with implications for both research investment and commercial development.
Following the UK-EU Summit, Defra Secretary Steve Reed confirmed that the UK is actively seeking an exemption within the new SPS agreement that would safeguard Britain's ability to pursue independent regulations on precision breeding and gene-editing technologies. Speaking to the Environment, Food and Rural Affairs Committee, Reed emphasised that alignment is designed to reduce trade frictions whilst maintaining UK divergence in gene-edited crop regulation. "We are somewhat ahead of the European Union in regulations," Reed stated, "For instance, on precision breeding—gene editing, whichever terminology you want to use—I want to see our farming sector benefit from the potential higher productivity and yields that can come from using that technology".
Reed expressed optimism about achieving this exemption, stating "We are continuing with the legislation. The door remains open to an agreement around that". The UK government has explicitly committed to keeping gene-edited crops out of any broader EU alignment deal, confirming that precision breeding will proceed as planned despite broader UK-EU regulatory cooperation initiatives.
The gene editing sector has expressed significant concern about the potential impact of dynamic alignment on UK innovation leadership. Katie Vickery, regulatory and compliance lawyer at Osborne Clarke, warned that progress in gene editing "will likely be paused" as negotiations continue between the UK and EU around alignment of food standards. "Dynamic alignment with the EU does not mean that gene editing in the UK will never happen, it seems likely the pace will be slower than anticipated and the deregulatory approach is likely to be subject to change," Vickery noted.
Industry leaders have emphasised the strategic importance of maintaining the UK's progressive stance. The gene editing sector, which has attracted significant investment and positioned Britain as a potential global leader, faces uncertainty about future regulatory direction as SPS negotiations proceed. Critics argue that re-aligning with EU SPS measures may resurrect the regulatory barriers that previously stifled the UK's life sciences and biotech sector.
England has embraced a product-based, risk-proportionate approach that treats gene-edited organisms differently from traditional GMOs when they could theoretically occur through conventional breeding. This regulatory philosophy aligns with countries like the United States, Canada, and Australia that have adopted more permissive frameworks for gene editing technologies. The UK's approach permits substitution or insertion of up to 20 nucleotides, deletion of any number of nucleotides, and targeted insertion of DNA sequences existing in the breeder's gene pool, provided these modifications don't disrupt existing genes.
In contrast, the EU maintains significant elements of its process-based approach rooted in the precautionary principle, requiring more extensive oversight even for gene-edited products that could theoretically occur through natural breeding processes. The EU's criteria for NGT1 classification remain more restrictive and continue evolving through ongoing trilogue negotiations between the Parliament, Council, and Commission.
England's regulatory framework becomes operational on 13th November 2025, with marketing applications accepted for submission to DEFRA and the FSA from that date. Based on current regulatory schedules and industry preparation, UK consumers could potentially see gene-edited products on supermarket shelves by late 2026, pending successful navigation of the approval process. The Department for Environment, Food & Rural Affairs is funding the British On-Farm Innovation Network (BOFIN) to conduct a three-year £2.2 million project trialling precision-bred crops on UK farms, with trials of three precision-bred cereals available for farmers from 2026.
The UK-EU gene editing divergence occurs within a broader context of fragmented global regulation that affects international trade patterns and innovation flows. Current global regulatory approaches fall into four distinct models: strict regulation (New Zealand, South Africa), modified GMO frameworks (China, India, Russia), exemption-based approaches (Japan, most Central and Latin American countries), and limited supervision (United States, Australia). This fragmentation creates substantial international trade challenges, with biotechnology approvals requiring up to five years in Europe and China compared to two years or less in the United States.
The United States, as a major agricultural exporter with a permissive gene editing regulatory framework, stands to benefit significantly from England's progressive approach whilst continuing to face substantial barriers in EU markets. American companies developing gene-edited crops may find England an increasingly attractive market for early commercialisation, particularly given streamlined approval timelines and absence of mandatory labelling requirements.
China's modified GMO framework for gene editing creates additional complexity layers for international trade relationships. The country's unpredictable approval processes and lengthy regulatory timelines continue posing substantial challenges for both UK and EU exporters of gene-edited products, regardless of their domestic regulatory approaches.
Countries across Africa, Asia, and Latin America are increasingly establishing their own gene editing guidelines, with nations like Ghana, Thailand, and Malawi developing frameworks that could facilitate agricultural innovation whilst managing food security concerns. These emerging markets may become increasingly important destinations as traditional trade routes face regulatory barriers between established economies.
Gene editing regulation has emerged as a critical test case for the broader UK-EU SPS negotiations, highlighting fundamental questions about technological sovereignty, innovation policy, and the limits of dynamic alignment. The UK's ability to secure an exemption for gene editing within the SPS framework will signal how much regulatory autonomy Britain can maintain whilst accessing EU market benefits.
The resolution of gene editing within SPS negotiations will have profound implications extending beyond bilateral trade relationships to encompass broader questions about governance of emerging technologies in an interconnected world. Success in negotiating a gene editing exemption could establish important precedents for future biotechnology governance and provide a template for managing regulatory divergence in other emerging technology sectors.
Consumer acceptance varies dramatically by region, with surveys demonstrating stronger support for gene editing in the UK compared to continental Europe. Recent research by British Sugar found that 69% of UK adults strongly support gene editing to create sustainable and resilient agricultural futures. This difference in public opinion significantly influences how quickly gene-edited products gain market acceptance across different jurisdictions and may provide political cover for maintaining UK regulatory divergence.
The ongoing patent controversy in EU negotiations reflects deeper concerns about corporate control over agricultural innovation and food systems. The European Parliament's proposed patent ban stems from fears that gene editing could concentrate agricultural innovation amongst large multinational corporations, potentially limiting farmer access to improved varieties and creating technology dependency.
The gene editing divergence between England and the EU represents more than a technical regulatory difference—it embodies fundamental choices about innovation, precaution, and international competitiveness in the context of the most significant UK-EU trade negotiation since Brexit. The success or failure of securing a gene editing exemption within the SPS framework will determine whether the UK can maintain its position as a global leader in agricultural biotechnology whilst accessing the substantial trade benefits of EU market alignment.
As SPS negotiations proceed through 2025 and beyond, the gene editing issue will serve as a bellwether for broader questions about technological sovereignty and regulatory autonomy in an interconnected global economy. The stakes extend beyond agricultural trade to encompass the future of innovation policy, food security, and the governance of emerging technologies that will shape the twenty-first century agricultural landscape.
For international trade lawyers and their clients, these developments require careful attention to evolving regulatory landscapes and their implications for market access strategies in an increasingly complex patchwork of international biotechnology regulations. How England and the EU resolve their gene editing divergence within the SPS framework may well establish important precedents for future biotechnology governance and international trade relationships across multiple sectors.
