UK Publishes Guidance for Cell-Based Food Producers on Regulatory Authorization, Growth Media Safety
The UK Food Standards Agency (FSA) and Food Standards Scotland (FSS) have published the third package of guidance for businesses developing cell-cultivated food products, produced by the ongoing Cell-Cultivated Products Sandbox Program. The latest set of guidances covers regulatory authorization and the assessment of growth media components and toxicology.
Earlier published guidances resulting from the Sandbox Program cover:
- Hazards Analysis and Critical Control Points (HACCP) principles for animal-derived cell-based products and allergenicity and nutrition information requirements for novel food applications. Read more here.
- Navigating the regulatory requirements for novel food products to market, including hygiene requirements; identity, production, and microbiology; product applications; and novel food taste trials. Read more here.
New Guidance: Regulatory Authorization and Growth Media
The regulatory authorization guidance sets out how the regulated products framework applies to cell-cultivated products, including how to handle changes to an authorized product.
The growth media and toxicology guidance gives detailed scientific direction on assessing safety hazards linked to growth media components, supporting businesses preparing dossiers for regulatory review.
These guidances align with assimilated EU regulations on novel food authorization.
The UK Cell-Cultivated Products Sandbox Program
The guidances were produced through the Cell-Cultivated Products Sandbox Program, which is funded by the UK Government’s Department of Science and Technology and runs until February 2027. The sandbox complements the market authorization process by bringing together the regulators and industry to develop a shared understanding of how food regulations apply to cell-cultivated products. The sandbox program focuses on foods cultivated from animal cells only.
The sandbox program also offers a Business Support Service, available to companies developing cell-cultivated products until February 2027, providing direct engagement with FSA and FSS regulatory experts.
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