Commercialising cell-cultured meat in the UK - The regulatory framework

Cell-cultured meat, also known as cultivated meat, is a hot topic in the life sciences industry. The product itself is genuine animal meat, produced by cultivating animal cells directly and involving tissue engineering techniques that are conventionally used in regenerative medicines.

In December 2020, Singapore became the first country in the world to grant regulatory approval to a cell-cultured meat product. Demand is growing for alternatives to regular meat as a result of increasing concerns about animal rights, global food security and the environment. However, no cell-cultured meat products are currently authorised for sale in the UK or the EU.

We set out below a summary of the current regulatory framework in the UK, as well as looking at possible changes to the system in the future.

Current regulatory framework

Cell-cultured meat products require authorisation before they can be sold in the UK. However, there is no distinct regulatory pathway for cell-cultured meat. For a cell-cultured meat product to be placed on the market, it would need to be authorised as a “novel food”. The novel foods regime derives from EU law that has been retained in the UK post-Brexit.

Novel foods are those that have not been widely consumed by people in the UK or EU before May 1997. Examples of novel foods authorised in the UK and EU include UV-treated bread, vitamin K2 (menaquinone) and Antarctic Krill oil. The novel foods regime does not include genetically-modified foods, flavourings, food additives and food enzymes; these are dealt with under different regulatory frameworks.

Conditions for authorisation

The purpose of the law relating to novel foods is to ensure a high level of protection of human health and consumers’ interests. Products are only authorised as novel foods if they comply with the following three conditions:

• The food does not, on the basis of the scientific evidence available, pose a safety risk to human health
• The food’s intended use does not mislead the consumer, especially when the food is intended to replace another food and there is a significant change in the nutritional value, and
• Where the food is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer

Applying for authorisation

The Food Standards Agency (FSA) deals with applications for authorisation of novel foods in the UK. Applications can be made online using the FSA’s regulated products application service. In most cases, applications will take at least a year. There is no application fee.

Applications must include information such as:

• The detailed composition of the novel food,
• The description of the production process, and
• Scientific evidence demonstrating that the novel food does not pose a safety risk to human health

Future changes to the regulatory framework

The regulations applicable to commercialising cell-cultured meat in the UK may change in the future. Now that the UK has left the EU, it is possible for the UK to diverge from the EU-derived novel foods system.

In January 2022, the UK government published a policy paper called “The Benefits of Brexit: How the UK is taking advantage of leaving the EU”. It sets out proposed reforms to regulatory systems in a number of different areas including industry, climate, health and infrastructure.

The paper describes cultivated meats as a “new and exciting area with significant innovation” and commits to creating a distinct regulatory framework for cultivated meats in the UK. However, there is not currently any detail on what this new regulatory framework will look like and when it will be introduced.