Food Law | UK Regulatory Outlook January 2025

UK

Could 2025 be the year that further progress is made on authorising innovative foods?

At the end of last year, several announcements highlighted a drive in innovation which could streamline the process for bringing alternative proteins, such as cell-cultivated products to market. Key developments include the introduction of the Regulatory Innovation Office (RIO) and the Food Standards Agency's (FSA) regulatory sandbox.

One of the four initial areas of focus for the RIO is on engineering biology, which can create new products such as cultivated meats. The RIO's aim is to help regulators bring innovative products to market safely. In addition to the RIO, the FSA's regulatory sandbox will provide pre-application support to cell-cultivated products companies, addressing key questions such as labelling issues and nomenclature before market entry. By allowing businesses to test new developments under regulatory supervision, the sandbox aims to reduce the time and cost associated with regulatory approval.

Significant investment by the government is also being directed towards alternative protein research. A notable example from last year was the launch of the £38 million National Alternative Protein Innovation Centre (NAPIC), dedicated to advancing research in this field. This adds to the already growing private-sector research hubs such as the Cellular Agriculture Manufacturing Hub, Microbial Food Hub and Bezos Centre for Sustainable Protein.

Last year in the UK we saw the first lab-grown meat used for pet food receiving regulatory approval. This was a significant and welcomed milestone for cultivated meats. This development should be monitored by businesses seeking to bring similarly innovative products to market. Whilst this development was within the animal feed sector, it will be interesting to see whether this has a positive impact on the FSA's approach to alternative proteins being approved for human consumption and whether there is any impact on consumer behaviour as consumers become more familiar with the types of technologies used to manufacture these products.

These announcements suggest that 2025 could see a positive shift in the application process of alternative proteins, making it easier for these products to reach the market in the future.

Regulated Products Reform Update

The FSA ran a consultation on proposals to reform the authorisation process for regulated products. Regulated products are food and feed products which require authorisation before they can be sold and include food additives, flavourings, novel foods, genetically modified organisms (GMOs) as food and feed, food contact materials and feed additives. Currently the process is slow and burdensome on the regulator, meaning few applications have been authorised under the current regime. Two proposals to reform the regime have been put forward:

1. to remove renewal requirements (currently every ten years) for feed additives, food or feed containing, consisting of or produced from GMOs and smoke flavourings; and
2. to remove the process of laying legislation after ministerial authorisation of a regulated product, which currently slows down the approval process. Instead the authorisation would be added to an official register, following a ministerial decision, which the FSA said will speed up the process.

In September 2024, the FSA published the response to the consultation highlighting broad support from stakeholders. As such, they will continue with the above two proposals to reform the regulated products authorisation process and the responses they received will inform finalisation of the legislation which we anticipate will be published in 2025.

The progress of this consultation will likely mean changes being introduced for regulatory reform in 2025, further supporting the development and market entry of innovative food products as explored above.

Regulations under the Genetic Technology (Precision Breeding) Act 2023

As reported in our October issue, the government said it would introduce secondary legislation under the Genetic Technology (Precision Breeding) Act 2023 as soon as parliamentary time allows. The environment secretary has now confirmed the government plans to introduce it by the end of March. The regulations will aim to simplify the authorisation process for bringing new products to market, to make "things fairer for SMEs and boosting investment", and will allow precision-bred products to be rolled out across the country. Although the Act covers both plants and animals, these initial regulations will only apply to plants. Therefore, businesses should stay informed about the development of these regulations and be prepared to engage in any potential consultations.

Prepare for incoming HFSS restrictions in October 2025

From 1 October 2025, there will be a ban on advertisements for less healthy food and drink (also referred to as products high in fat, salt or sugar (HFSS))being shown on TV before 21:00 in the UK. 

Ads within Ofcom-regulated on-demand programme services will be subject to the same 21:00 watershed, and otherwise paid-for ads for in-scope food and drink products will be banned completely online. 

The government has laid the Advertising (Less Healthy Food Definitions and Exemptions) Regulations 2024 before Parliament and published guidance on them.

Businesses should promptly review the details to determine whether they are affected by the new restrictions and understand what steps they need to take to ensure compliance by October 2025. 

Additionally, for those businesses operating in England, they should also be aware that the restrictions on volume price promotions, such as buy one, get one free" and "get three for the price of two," of HFSS products are also due to come into force in October 2025.

FSA withdraw on plans for supermarkets to conduct own food safety inspections

A paper on the national level regulation (see our September issue) was discussed at the Food Standards Agency's (FSA) Board meeting on 11 December 2024. Within this the FSA revealed from discussions with stakeholders that greater transparency is needed around the trial that was conducted. The paper sets out following this engagement concerns were raised over how the process would work in detail, including how it would interact with the work of primary authorities and local authorities, how risks would be managed, and how complaints would be dealt with. 

In response to this, the FSA has developed an engagement plan on two key areas:

1. Intensive engagement on the proof-of-concept trial and immediate next steps: This involves providing delivery partners and key stakeholders with better insights into the trial, opportunities to ask questions, and share reflections. The next steps will be co-designed with stakeholders through a new Senior Steering Forum. This activity has already started and will continue into early 2025.
2. Strategic level discussions on the future of regulation: An additional forum will be created for comprehensive discussions about reform with representatives from regulatory delivery partners, businesses, and consumers. This will cover all building blocks for reform and potential legislative changes, starting in early 2025.

It will return to the Board with its proposals in June 2025 and so businesses should keep on top of progress with this initiative.

CBD Novel Food Applications

A paper on CBD novel food applications was also discussed at the FSA's December Board meeting. The paper outlines that the FSA and Food Standards Scotland have published the first safety assessments for CBD novel food applications, which have now entered the risk management phase. Recommendations to ministers across Great Britain will follow an eight-week public consultation starting in early 2025, with the first recommendations on the CBD applications expected in Spring/Summer 2025.

To guide the FSA’s approach to the risk management of CBD applications with positive safety assessments, the Board was asked to consider and agree on the following principles:

1. Consumer Safety: Protect public health by providing clear advice on the safe consumption of CBD.
2. Proportionality: Ensure decisions protect public safety without disproportionately limiting consumer choice or the CBD industry.
3. Ensuring Compliance: Only authorised CBD novel foods will remain on the market after assessments are complete, despite a pragmatic approach allowing certain products to stay temporarily.
4. Supporting Enforcement: Ensure decisions and recommendations support retailers and enforcement in preventing non-compliant products from remaining on the market.
5. Maintaining Trust: Maintain consumer trust in food safety and the FSA by managing legal and reputational risks.

These principles will guide the FSA’s risk management approach in making recommendations to ministers, particularly concerning THC levels and protecting vulnerable groups, including under 18s.

The Board broadly agreed with the principles and approach for risk management of CBD as set out in the paper and asked them to consider how the potential presence of a controlled substance in CBD products will be managed.

With further progress being made with these applications, it marks an exciting time for those looking to place CBD products on the UK market.

Ending the sale of high caffeine energy drinks to under 16s

The government set out in the King's Speech 2024 that it plans to end the sale of high caffeine energy drinks to under 16s. We have not yet seen any further details of this proposal from the government and so further details could be provided in 2025.

National Food Strategy to be published this year

The government is due to publish its National Food Strategy in 2025 which is expected to include details on tackling obesity levels, reduce environmental impact and help with food security whilst boosting investment. The report is anticipated to touch on issues set out in Lord Darzi's recent report on the NHS which focused on the issue of obesity, as well as building on Henry Dimbleby's National Food Strategy from 2021 which also covered measures to help reduce obesity such as introducing a sugar tax. Once published, businesses should review the report to see what measures the government has proposed and engage with any stakeholder initiatives where relevant.

EU

Updates to EU novel good guidance

The European Food Safety Authority (EFSA) has updated the guidelines for applications for novel foods in the EU. This includes both scientific and administrative guidance that will apply to all new novel food applications from February 2025. These updates aim to keep the safety assessment processes current with the evolving novel food industry, incorporating further detail where gaps were identified since the regime entered into force.

The guidance was updated to reflect changes in the EU legal framework for novel foods and recent advances in food research and innovation. The updates aim to keep the safety assessment processes current with the evolving novel food industry, incorporating further detail where gaps were identified. The new guidance clarifies definitions and data requirements, helping applicants submit higher-quality applications for a more efficient risk assessment process. Applicants must provide detailed information on the novel food, including its production, composition, expected consumption, safety data, and potential allergens. The updates will apply to all new novel food application submitted from February 2025 so businesses must ensure they are following these new guidelines when making applications from this date.

EU genomic techniques regulation

In February last year, the European Parliament adopted its position on new genomic techniques (NGT) and agreed with the European Commission's proposal to have two different categories and two sets of rules for NGT plants. Currently all plants obtained by NGTs are subject to the same rules as genetically modified organism (GMO). Under the 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 Parliament's adopted position mandates labelling for all NGT plant products, unlike the Commission's proposal, which only required it for NGT 1 plants. For NGT 2 plants, which support a sustainable agri-food system, the Parliament agreed to expedite the risk assessment but insisted on adhering to the precautionary principle.

Additionally, the Parliament's proposal bans patents on NGT plants, plant material, genetic information, and process features to "avoid legal uncertainties, increased costs, and new dependencies for farmers and breeders".

The Council of the EU has yet to adopt its negotiating position, and we await further details. Once adopted, negotiations between the two bodies are expected to begin in 2025. Businesses should stay informed about these developments.

PFAS restrictions in food contact materials in the PPWR

The Packaging and Packaging Waste Regulation (PPWR) is due to come into force in the EU in early 2025. The regulation restricts the use of Per- and polyfluoroalkyl substances (PFAS) in food contact packaging. Packaging which contains PFAS above certain thresholds will be banned from being placed on the market. The ban would come into force 18 months after the PPWR enters into force, meaning this will come into force approximately mid-2026.

This provision will have a huge impact on food businesses who will need to ensure any food contact materials they are placing on the market will need to not contain PFAS over the thresholds as set out in the PPWR. In 2025, businesses should conduct an audit of their packaging to understand which packaging will need to be changed in order to comply with this new restriction.

For more on the PPWR, please see the Products section.

Ban of Bisphenol A in food contact materials to come into effect in 2026

In June 2024, Member States endorsed a proposal from the Commission to ban Bisphenol A (BPA) in food contact materials. The European Commission adopted the this proposal on 19 December 2024, following the European Parliament and the Council agreeing to pass it into EU law, and it was then published in the Official Journal of the EU.

BPA is a chemical substance used in the manufacture of certain plastics and resins. This ban will mean that food contact materials, such as reusable plastic drink bottles and coatings used on metal cans, will not be allowed to contain BPA. This ban will come into effect on 20 July 2026, with some limited exceptions where no alternatives exist, to allow industry time to adapt and avoid disruption in the food chain.

In 2025, businesses will need to identify a safe alternative to replace BPA in food contact materials and articles in order to ensure it is in compliance with these changes.

Preparing for the implementation of the EU Deforestation Regulation

Please see ESG.