Supplementary guidance to applicants for the assessment of cell cultivated products in food: identity, production and microbiology

Specifications provide a clear description of the final CCP as it will be intended to be consumed. Applicants are required to provide a justified specification for the product. The specification should be reflective of the product, supported by the compositional data and consider the scope of the application and any future processing. 

Compliance with the specification is critical to ensure the consistency and safety of the final product. Specifications should include, but not be limited to: 

• Verification of the cell identity and characteristics the species, cell type and genetic/genomic stability of the cells should be verified in the final CCP food as it is intended to be consumed. Molecular identification methods should be utilised.
• Homogeneity of the cell population the cell types present in the final product, as it is intended to be consumed, should be fully characterised. Acceptance criteria should be established for homogeneity. Where cell lines are not homogenous, evidence must be provided to demonstrate controlled, consistent production.
• Microbiological specification the final food product must meet all appropriate microbiological safety requirements, including detection of pathogens and spoilage contaminants. The microbiological specification should reflect risks specific to cell culture and any down-stream processing.
• Compositional specifications see Allergenicity and Nutrition supplemental guidance for compositional information.
• Residue specifications the novel food, as intended to be placed on market, must meet the applicant defined specifications for residual components within the final product including cell culture media or scaffolds.
• Allergen profile see Allergenicity and Nutritional supplemental guidance for allergenicity information
• Contaminants all novel foods must meet specifications for contaminants such as heavy metals or impurities. A future FSA/FSS publication on Toxicology and Growth Media will contain further guidance on residuals and contaminants. 

The purpose of stability testing is to demonstrate that the novel food remains safe and consistent through storage and consumption. Assessment of the stability testing data must consider how the product behaves when stored, reflecting real world use for example, stability testing of both thawed and frozen products where applicable. Stability testing should evaluate factors that could compromise the safety to the consumer and the integrity of the final product and should include the characterisation and safety assessment of chemical or physical changes and any degradation. Stability data should be included within the application, supported by an evaluation of the results. 

The stability testing should be conducted on the harvested novel food, and consider stability within food matrices, as it is intended to be consumed. The effect of cooking or any other post-harvest processing steps, such as heating or mixing, should also be evaluated.  

Stability testing should address: 

• Moisture loss
• Protein profiling
• Microbiological safety
• Nutrition changes (for nutritional stability see FSA/FSS Allergenicity & Nutrition guidance)
• Inconsistencies of storage temperature (temperature abuse) 

Real-time stability testing should be performed on the product as intended to be consumed, including any packaging and processing steps. Testing should include intermediate sampling over an appropriate period.

Members of the Advisory Committee on Novel foods and Processes (ACNFP) and its Subcommittee on Cell Cultivated Products (CCPs) who reviewed this guidance as part of ACNFP176 meeting (04/2026) and CCP subgroup meetings CCP02 (08/2025) and CCP04 (01/2026).