Food law | UK Regulatory Outlook March 2025

Draft Genetic Technology (Precision Breeding) Regulations 2025

The draft Genetic Technology (Precision Breeding) Regulations 2025 will implement the Genetic Technology (Precision Breeding) Act 2023 for precision bred plants in England. These regulations set out the regulatory framework for precision bred plants to be used in food or feed, setting out the requirements for a food and feed marketing authorisation to allow the precision bred plants to be placed on the market.

The regulations provide for the following provisions:

• Notifying the Department for Environment, Food and Rural Affairs (Defra) of the deliberate release of precision bred plants into the environment for non-marketing purposes, such as for field trials.
• Applying, via Defra, for a precision bred assessment and confirmation to enable precision bred plants to be marketed, such as for commercial cultivation.
• Applying to the Food Standards Agency (FSA) for a food and feed marketing authorisation to allow food and feed produced from confirmed precision bred plants to be placed on the market. The assessment process will be simpler in that those food or feed which do not have any safety concerns will undergo a more streamlined route to authorisation by the secretary of state. A fuller assessment will take place for those precision bred plants for use in food or feed which need further scrutiny to ensure they are safe for consumption. For more on the process, see the FSA's draft guidance.
• Two public registers: one of prescribed information associated with Defra’s regulation of precision bred plants and one of precision bred plants authorised for food and feed use kept by the FSA.
• An inspection and enforcement regime to ensure compliance with the legislation, including civil sanctions which will include enforcement notices and monetary penalty notices.

The regulations will be voted in both the House of Lords and Commons and will come into force six months later.

These regulations mark a significant step in the government's progress towards making the route to market for PBOs simpler and quicker. Those looking to bring new products will welcome the introduction of these draft regulations and should monitor the development of these.

Draft guidance published on precision breeding

In line with the above draft regulations that set out the new regulatory framework that will apply to precision bred organisms (PBOs), the FSA has issued draft guidance for the safety assessment of PBOs. All PBOs must meet the statutory requirements in the regulations before they can be sold, and in-depth safety assessments will be conducted by the FSA, in line with those regulations, for those PBOs which require more detailed scrutiny to ensure they are safe. The guidance provides applicants with information on the two routes to authorisation for PBOs used in food and feed and how to apply to FSA for authorisation (see above).

Prior to applying for a food or feed marketing authorisation, applicants will need to determine the correct regulatory route by assessing the PBO against the following criteria:

History of Safe Food Use - whether the PBO belongs to a species that has a history of safe food use in that its safety as food has been confirmed with compositional data and from experience of continued food use in the customary diet of a significant number of people in the United Kingdom or the European Union beginning before 15 May 1997

Composition - whether the application of modern biotechnology introduces genetic changes that are expected to:

1. Significantly alter the nutritional quality of the organism as it is being consumed as food or feed at the date of the application in a way that is likely to be disadvantageous to the consumer
2. Significantly elevate the toxicity of any food or feed produced from the precision bred organism
3. Alter the allergenicity of any food or feed produced from the precision bred organism

Other safety concerns - Whether the application of modern biotechnology introduces any additional features that may affect the safety of any food or feed produced from the precision bred organism.

Following this, applicants will then be able to determine whether their PBO can be authorised using the simplified route where no safety concerns arise (Tier 1 safety assessment) or the fuller route whereby the FSA will conduct a Tier 2 safety assessment.

The FSA will be seeking feedback on the clarity of the draft guidance before finalising it ahead of the regulations being confirmed.

Businesses who will be looking to place PBOs on the market, should review this guidance and submit any feedback to the FSA.

Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 

Regulations have been introduced to amend, revoke and replace various provisions in secondary assimilated law with regard to regulated food and feed products. 

The first of the two changes removes the requirement for 10-yearly renewals of authorisations for feed additives, genetically modified organisms and smoke flavourings, aligning the regimes with those for regulated food and feed products that do not require renewal.

The second change eliminates the need for secondary legislation to bring the initial authorisations into effect, allowing them to be enacted following a ministerial decision and publication in an official public register. This includes authorisations in relation to novel foods.

As the government explained in the House of Commons, "the changes will streamline the process, allow regulators to keep pace with innovation, and support economic growth without compromising consumer safety." The regulations come into force on 1 April 2025. These improvements will no doubt be welcomed by businesses, as the changes aim to expedite the authorisation process for regulated products by removing the requirement for legislation to be made.

FSA publish updated industry guidance for food allergen information in the out-of-home sector

Following a consultation that ran last year (see this earlier Regulatory Outlook for more), the FSA has issued updated best practice industry guidance on providing allergen information to consumers with food hypersensitivities, encouraging information on food allergens to be available in writing in the out of home sector.

The updated guidance includes:  

• Written allergen information should always be available for non-prepacked food alongside a conversation between servers and customers about their allergen requirements.  
• Examples of how to provide written allergen information, this includes choosing whether to provide the information using words or symbols with accompanying words. It notes that if symbols are used then the name of the allergen should form part of it, for example being written underneath.
• Free tools to support businesses with implementation, such as allergy icons, an allergen matrix and a new allergy poster which food businesses can download and use on their own assets (for example, menus and websites).

Those businesses who operate in the out of home sector should review this guidance and ensure that these measures are implemented.

FSA launch consultation on proposed changes to Food Law Code of Practice and Practice Guidance

The FSA has published a consultation on proposed changes to the Food Law Code of Practice and Practice Guidance. Key proposals include:

1. An updated risk-based approach to the prioritisation and timescales for undertaking initial food hygiene official controls of new food establishments.
2. Enabling, in certain circumstances, an establishments food hygiene intervention risk rating to be amended following a wider range of official control methods and techniques, including those undertaken remotely.
3. Extending the activities that officers, who do not hold an ‘appropriate qualification’ for food hygiene or food standards, can, if competent, undertake.
4. A clarification in approach to interventions at food business establishments that fall into risk category e for food hygiene.

The consultation closes on 19 May 2025. Consultations have also been launched in Wales and Northern Ireland.

Consultation launched on Plant Varieties and Seeds Framework for Precision Bred Plant Varieties

On 17 February, Defra launched a consultation on a framework for evaluating and registering precision bred agricultural and vegetable plant varieties in England. This new framework will be implemented under the Genetic Technology (Precision Breeding) Act 2023. Under this framework, a Precision Bred Plant Variety List is also being proposed in addition to the existing variety lists to facilitate the marketing of seed of precision bred plant varieties.

Defra is seeking views on what information on precision bred seeds and other plant reproductive material businesses and other organisations would find beneficial, and what impact the mandatory inclusion of precision bred status on labels for precision bred seeds and other plant reproductive material would have.

The consultation closes on 14 April 2025.

Government respond to House of Lords enquiry on Engineering Biology

As reported in our Insight, the House of Lords Science and Technology Committee called on the government to take immediate policy action to seize the opportunities of engineering biology and maximise its contribution to the UK economy. The government has now published its response to the enquiry, welcoming the Committee's report and agreeing with it on the opportunities engineering biology brings for the UK.

The response highlights actions already taken to support the sector including the creation of the Regulatory Innovation Office, with engineering biology one of its four early priority areas. It also highlights that the FSA is taking steps to deliver the sandbox on cell-cultivated products and that the government has also announced that the second round of the engineering sandbox fund will open in April 2025.

The government recognises that there is more to do and notes that its industrial strategy, which will be published this spring, will set out further details of how it will support growth in this sector.

Moving agri-food products via Northern Ireland Retail Movement Scheme

From 1 July 2025, additional agri-food products must be individually labelled with the words "Not for EU" under phase 3 of the Northern Ireland Retail Movement Scheme (NIRMS) which was introduced under the Windsor Framework. The NIRMS, aka the "green lane", can be used by those registered businesses moving agri-food products between Great Britain and Northern Ireland.

The guidance has been updated to include descriptions of the next phase of products that need labels in phase 3, this includes composite products that are not shelf stable or require sanitary and phytosanitary controls, such as pizza, and products that are exempt from labelling requirements. A list of commodity codes of the commodity codes of exempt products has also been published.

Businesses moving these agri-food goods via the NIRMS will need to ensure products that fall within scope of phase 3 are correctly labelled from 1 July 2025.

EU

European Council adopts position on regulation on plants obtained by new genomic techniques

The Council of the European Union has adopted its negotiating mandate on the regulation on plants obtained by new genomic techniques (NGTs) and their food and feed. Currently all plants obtained by NGTs are subject to the same rules as genetically modified organism (GMO). Under the Commission's proposal, NGT plants that could also occur naturally or by conventional breeding (NGT 1 plants) would be exempted from the requirements of the GMO legislation, and will be subject to a verification procedure set out in the proposal. For NGT 2 plants, the GMO framework still applies meaning they will be subject to the stricter requirements of GMO legislation including the authorisation procedure.

• The Council's position supports the main elements of the Commission's proposal, but suggests a number of changes, including:
• Member states can decide to prohibit the cultivation of category 2 NGT plants on their territory.
• Member states can take measures to avoid the unintended presence of category 2 NGT plants in other products and will need to take measures to prevent cross-border contamination.
• For NGT 1 plants, companies or breeders must submit information on all existing or pending patents which will need to be included in a publicly available database set up by the Commission which lists all NGT plants that have obtained a category 1 status.
• In regards to labelling the Council agrees with the Commission's proposal that NGT 2 plants must be labelled indicating them as such, but adds that in case information on modified traits appears on the label, it must cover all the relevant traits (for example, if a plant is both gluten-free and drought-tolerant owing to genomic changes, either both of those features or neither of them should be mentioned on the label).

The European Parliament adopted its position in February last year, see our January Regulatory Outlook for more.

The European Parliament and Council can now begin negotiations on the final text of the regulation. Once they have agreed a final outcome, this will then need to be formally adopted by them both before the regulation can enter into force.