Gene-editing regulation: implications for businesses in Northern Ireland, Scotland and Wales
Guest blog by Pat Thomas, Director at Beyond GM. As with any guest blog, what follows are the views of the author and should not be taken to represent those of NetRegs.
Contents
1. England: new framework for “precision-bred organisms”
2. Scotland and Wales: existing GMO framework remains
3. Northern Ireland: continued alignment with EU GMO law
4. Ongoing areas of regulatory uncertainty
5. Practical implications for SMEs
6. Recommendations for SMEs
7. Summary - key takeaways
Recent legislative changes in England have introduced a new regulatory framework for gene-edited organisms. Devolved nations operate under different regulatory regimes and this divergence may have practical consequences for Northern Irish, Scottish and Welsh businesses involved in sourcing, processing, labelling or selling food, feed, seeds or other agri-inputs.
1. England: new framework for “precision-bred organisms”
The Genetic Technology (Precision Breeding) Act 2023 is the primary legislation that creates a new regime for gene-edited organisms in England and Wales. It received Royal Assent in March 2023.
The Act, which refers to gene-editing as “precision breeding”, is now being implemented through secondary legislation, including the Genetic Technology (Precision Breeding) Regulations 2025 which came into force in November 2025.
The England-only framework for precision breeding currently applies only to plants. Under this framework:
- Precision-bred organisms (PBOs) are defined as organisms that have been produced using a genetic modification technique called gene-editing and which, theoretically, could also have been produced through traditional breeding.
- PBOs and food/feed products derived from them can be marketed in England under a new authorisation process that is separate from the existing Genetically Modified Organisms (GMO) system.
- Products authorised as PBOs in England do not require end-to-end traceability (that is, the ability to follow – either with a paper credentials or electronic record – the movement of a food through specified stage(s) of cultivation, production, processing and distribution) or on-pack GMO labelling under the new regime.
- A public PBO register is to be maintained by government, recording release and marketing notices.
This represents a shift from the previous EU-derived GMO regime retained in UK law, where gene-editing was regulated as a GMO, with full authorisation, labelling and traceability requirements.
2. Scotland and Wales: existing GMO framework remains
The Scottish Government and the Welsh Government have not adopted the precision breeding legislative framework established in England. In Scotland and Wales:
- Gene-edited organisms continue to be regulated under the existing GMO regime that applied before the Genetic Technology Act.
- Deliberate release, cultivation of GMOs remain subject to established GMO authorisation procedures.
- Food and feed derived from GMOs, including PBOs, remain subject to GMO labelling and traceability requirements.
Interaction with the UK Internal Market Act
The United Kingdom Internal Market Act 2020 (IMA) establishes the market access principle of mutual recognition, meaning goods lawfully marketed in one part of the UK can generally be sold in others.
However, mutual recognition does not apply to requirements arising after sale, including regulatory controls triggered by processing. Official guidance on the operation of the UK Internal Market Act, and Food Standards Agency recommendations, note that goods which are lawfully sold under mutual recognition may still be subject to local regulatory controls if they undergo significant production step in the destination territory before sale.
While there is no single stand-alone "significant production step" or “significant processing” definition in the IMA this principle is embedded in how mutual recognition is applied in practice by regulators.
What the interaction with the UK Internal Market Act means in practice for gene-edited foods in Scotland and Wales
The above means that a precision-bred food ingredient, imported into Scotland or Wales from England, could be sold under mutual recognition and without a label indicating it is a precision-bred product (more on labelling below). However, if that ingredient is subject to further substantial processing in Scotland or Wales (for instance, processing a precision-bred tomato into ketchup, or milling precision-bred wheat into flour), Scottish or Welsh GMO controls could apply to the processed product, because it may then fall within the GMO regulatory scope for production or composition in Scotland or Wales.
3. Northern Ireland: continued alignment with EU GMO law
Under the Windsor Framework, Northern Ireland continues to apply EU-based GMO regulation. Movement of goods from Great Britain into Northern Ireland is managed under the Windsor Framework implementation regulations, which provide the legal basis for how certain EU requirements continue to operate there.
In practical terms this means:
- Genetically modified organisms (GMOs) – including gene-edited organisms – are treated as GMOs in Northern Ireland.
- GMOs must undergo a safety assessment and authorisation before being placed on the Northern Ireland market.
- EU labelling and traceability requirements continue to apply.
4. Ongoing areas of regulatory uncertainty
Several developments may create continued uncertainty for businesses operating across UK jurisdictions.
4.1. Labelling and traceability
Unlabelled precision-bred products in England
In England, food and feed derived from authorised precision-bred organisms are not subject to GMO labelling requirements. This means there is no statutory requirement for traceability through the supply chain and no product labelling.
In Northern Ireland, Scotland and Wales, gene-edited organisms that fall within GMO definitions continue to be subject to labelling and traceability requirements under:
Traceability – which is important to guarantee product authenticity and aid in product recall – is particularly relevant for the organic sector businesses, as organic production standards prohibit GMOs and depend on verifiable supply-chain documentation (see more below).
4.2. EU consideration of new genomic techniques (NGTs)
The European Commission has proposed changes to EU legislation governing gene-edited organisms, which it refers to as “new genomic techniques”, or NGTs.
These proposals are not yet finalised. If adopted, they are not expected to become operational before 2028. Until then, existing EU GMO legislation remains in force, which is relevant for Northern Ireland.
4.3. Sanitary and Phytosanitary (SPS) negotiations and regulatory divergence
The UK Government has indicated that gene-editing legislation will be excluded from ongoing UK-EU SPS negotiations (as reported in Farmers Weekly). This outcome, however, is not certain. The EU-UK Common Understanding document permits a “short list of limited exceptions”, but only if the divergence:
- Does not lower standards relative to the EU.
- Does not negatively impact EU products entering the UK market.
- Respects the principle that only EU-compliant products may enter the EU.
It is likely that SPS negotiations will be ongoing for some time before the question exclusion vs alignment is fully resolved.
5. Practical implications for SMEs
Regulatory differences between England, Northern Ireland, Scotland and Wales may have compliance implications for SMEs engaged in cross-border activity.
5.1. Supply chain transparency
Lack of end-to-end traceability and labelling means that businesses in Northern Ireland, Scotland or Wales that source ingredients or products from England may need to rely on supplier declarations or contractual assurances to understand whether gene-edited content is present.
5.2. Organic and identity-based markets
Under organic legislation PBOs are GMOs.
Organic production legislation in Scotland, as in England and Wales, is based on retained EU organic law, including older assimilated Regulations (EC) 834/2007 and 889/2008, which prohibits the use of GMOs. Given that Scotland and Wales have not adopted the Genetic Technology Act or its Regulations, where products sourced from England may include precision-bred components, businesses providing organic or identity-preserved products may need robust documentation to meet certification and customer expectations.
Northern Ireland operates under a different organic regulatory framework. Under the Windsor Framework, updated Regulation (EU) 2018/848 on organic production and labelling of organic products applies. Organic businesses in Northern Ireland must currently comply with EU rules on organic production, certification, labelling and imports, that may, in some ways, differ from those in GB.
The UK Government has signalled that alignment of organic regulations will be part of the ongoing SPS negotiations (as reported by the Soil Association) and if alignment is agreed, the rest of Britain will likely align with EU 2018/848.
6. Recommendations for SMEs
6.1. Documentation and due diligence
It is advisable for SMEs to review internal procedures around:
- supplier specifications and declarations
- risk assessments for regulatory compliance
- contractual terms addressing regulatory status and traceability
6.2. Regulatory monitoring
As devolved nations continue to evaluate their policy positions and EU proposals evolve, businesses operating across UK jurisdictions should monitor legislative changes and official guidance to stay compliant.
7. Summary – key takeaways
The regulatory landscape is still evolving
The rules governing gene-edited food in the UK are in a state of flux, and SMEs operating across more than one UK nation face uncertainty. England has a new system for gene-edited (‘precision bred’) crops and foods, but Northern Ireland, Scotland and Wales have not. Until the regulatory picture stabilises – which may not be before 2028 at the earliest – businesses need to understand where they are trading and what rules apply there.
In Northern Ireland...
Northern Ireland continues to follow EU GMO law under the Windsor Framework. This means gene-edited products – including those lawfully sold in England without a GMO label – must still undergo EU-standard safety assessment and authorisation before being placed on the Northern Ireland market. EU traceability and labelling requirements also apply. Businesses supplying Northern Ireland from England should be aware that a product that is legal and unlabelled in England may not be compliant in Northern Ireland.
In Scotland and Wales...
Gene-edited organisms are still treated as GMOs under Scottish law and Welsh law. If a business imports a gene-edited food product from England – where it has been legally sold without a GMO label – and then sells it on without further processing, it may be able to do so under UK Internal Market rules. However, if that product is then substantially processed in Scotland or Wales (for example, milling precision-bred wheat into flour, or making ketchup from a precision-bred tomato), Scottish or Welsh GMO rules are likely to apply to the resulting product, including labelling and traceability requirements. What counts as "significant production step" or "substantial processing" is not precisely defined in law, meaning there is currently a grey area that businesses will need to navigate carefully, ideally with legal advice.
For the organic sector…
Organic businesses face a particular challenge. Under both GB and EU organic law, and indeed globally, GMOs, including those produced using gene editing, are prohibited. Because England's new regime does not require end-to-end traceability or on-pack labelling for gene-edited products, organic businesses sourcing ingredients from England currently have no automatic way to verify whether gene-edited components are present in their supply chain. They will need to rely on supplier declarations and contractual guarantees – documents that are only as reliable as the supplier's own knowledge and record-keeping. Until a robust traceability system is in place, organic certification bodies and their members face a real and growing challenge in guaranteeing that their products are GMO-free.
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