UK lays out clearer regulatory route for cultivated meat companies

The UK has given cultivated meat companies its clearest indication yet of how changes made during scale-up could affect regulatory approval, including when switching cell lines, altering growth media or moving to continuous production may require a new risk assessment.

New guidance published by the Food Standards Agency (FSA) and Food Standards Scotland (FSS) on 30 September sets out how Britain's existing regulated products framework applies to cell-cultivated foods made from animal cells.

It applies to England, Scotland and Wales, but not Northern Ireland, which remains aligned with EU legislation. The guidance has emerged from the Cell-Cultivated Products Sandbox Programme being run by the two regulators from February 2025 to February 2027.

• FSA and FSS expect most cultivated meat applications to be assessed under novel food regulations
• Scale-up changes involving bioreactors, media, cell lines or production processes could require further regulatory assessment
• Genetically modified cells unable to survive and replicate outside a bioreactor may not be treated as GMOs under food regulations

Most cell-cultivated products are expected to enter the British authorization system as novel foods. Companies are responsible for choosing the correct regulatory route, however, and products involving genetic modification or other technologies may fall under more than one regime.

One of the more useful parts of the new guidance concerns a problem that is particularly relevant to cultivated meat startups: what happens when a production process changes after regulatory approval.

Companies are often still scaling production when they make their original application. The FSA and FSS say subsequent changes need to be considered against the product's existing Terms of Authorisation and the information submitted with the original application.

A straightforward increase in production, including the use of larger bioreactors, is among the changes that might require another risk assessment. Minor equipment changes and some limited changes to growth media could fall into the same category.

The regulatory implications become greater when the underlying process changes more substantially.

Using a new cell line, changing how cells differentiate, introducing a different method of cell immortalization or moving from batch to continuous production are all described as changes that are highly likely to require a new risk assessment.

The same applies to some alterations to growth media, or changing the product itself, such as taking an unstructured biomass and creating a structured product using extrusion, 3D printing or scaffolds. Expanding into additional food categories or increasing permitted use levels could also trigger further assessment.

That makes regulatory planning part of the scale-up question rather than something that ends once an initial authorization has been secured.

The regulators also provide useful clarification for companies using genetic modification to immortalize cell lines.

Where modified cells cannot survive and replicate outside the bioreactor, the FSA and FSS say they do not meet the definition of an 'organism' under the relevant genetically modified food and feed regulation. The cells would therefore not be considered a GMO and the biomass produced from them should not require assessment under that regulation.

The agencies stress that products will still be considered case by case and advise companies using genetic modification to discuss their process with regulators before applying.

The document also deals with growth factors, another area that has raised regulatory questions for cultivated meat developers.

If only traces remain in the finished product, the FSA and FSS say growth factors would be considered processing aids. There is no specific legislation preventing their use in food production, although companies must demonstrate the safety of their use as part of the cultivated product application.

Scaffolds and microcarriers will depend on how they are used. They could be considered processing aids or regulated products requiring authorization in their own right.

The regulators are also encouraging companies to think carefully about how broadly they define their first application. Applying for numerous intended uses increases the product's risk profile because assessors have to consider its presence across more food categories.

Limiting the scope could therefore shorten the authorization process, while unclear product descriptions, missing evidence and incomplete dossiers are likely to generate requests for further information and extend timelines.

The guidance comes while the UK is negotiating a Sanitary and Phytosanitary agreement with the EU, which could change the role played by the FSA and FSS in regulated product authorizations.

For now, the regulators note that the regulated products framework in Great Britain is the same as that used in the EU, making the guidance relevant to cultivated meat companies considering either market.

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