Guidance

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

Published 10 July 2026

Applies to England, Scotland and Wales

1. Purpose

This document outlines the scientific requirements for evaluating the identity, production processes and microbiological hazards of Cell Cultivated Products (CCPs) when seeking market authorisation as novel foods in Great Britain (GB).

This is supplemental guidance to the 2016 European Food Safety Authority (EFSA) technical guidance which supports applicants through assimilated regulation (EU) 2017/2469 and details administrative and scientific requirements for novel food applications under Article 10 of assimilated regulation (EU) 2015/2283 for novel foods.  

This supplemental guidance aims to help applicants understand the safety assessments required relating to identity, production and microbiological hazards of CCP production. It should be read in conjunction with Article 10 of assimilated regulation (EU) 2015/2283 and the 2016 EFSA technical guidance, which continue to apply to CCP safety assessments.

This supplemental guidance is part of a series of technical supplementary guidance as part of the CCP Sandbox programme (February 2025 to February 2027).  

2. Summary

An important aim of the CCP sandbox programme is for the Food Standards Agency (FSA) and Food Standards Scotland (FSS) to fast-track knowledge about CCPs and use this to produce supplemental guidance on a range of topics relevant to these products.

This supplemental guidance aims to better guide companies on how to make products in a safe way and how they can demonstrate this to us. The FSA and FSS are using the knowledge learnt from the CCP sandbox programme, in addition to expert elicitation and literature reviews, to publish supplemental guidance documents that provide clarity to businesses on the path to market.   

This supplemental guidance provides detailed scientific considerations for assessing the identity, production processes and microbiological hazards of CCPs, supporting the general requirements of assimilated regulation (EU) 2015/2283 and 2016 EFSA technical guidance.

It provides tailored information about these areas which CCP companies should consider when compiling a CCP dossier for regulatory review.

By following this supplemental guidance, applicants can address common issues, ensure their submissions are comprehensive, and support efficient regulatory evaluation. The goal is to support the development and authorisation of CCPs that are safe, accounting for risks associated with identity, production and microbiological hazards.

3. Scope

This supplemental guidance applies specifically to CCPs regulated as novel foods in GB. Specifically, this supplemental guidance applies to CCPs defined as food products produced by culturing animal cells, including those from meat, seafood (fish and shellfish), fat, offal, fertilised avian eggs or other animal embryonic material in a controlled environment, without the use of traditional farming or animal slaughter.

This supplemental guidance is on products derived from both invertebrate and vertebrate animal cells such as mammalian, fish, shellfish, or avian cells, particularly those intended to replicate the appearance and characteristics of conventional meat or seafood.

Applicants seeking market authorisation for CCPs must comply with assimilated regulation (EU) 2015/2283. This includes providing evidence of hazard identification, characterisation, and implementation of appropriate mitigations to ensure safety. This supplemental guidance is on safety hazards associated with identity, production processes and microbiological risk within the CCPs as novel foods.

While this supplemental guidance outlines important considerations for CCP applications, it is not exhaustive.  As scientific methods develop, alternative approaches to those referenced within this supplemental guidance may be suitable to support the safety assessment in the identity, production and microbiological risks and may be accepted by the FSA and FSS.

All approaches used should be scientifically justified, generate reliable and conclusive data, and satisfy the applicable regulations for novel foods. Further information on genetically or gnomically modified CCPs is provided in Section 4.

4. General considerations

Applicants must ensure they are using the latest version of this supplementary guidance found on the FSA webpage alongside the assimilated regulation (EU) 2015/2283 and 2016 technical guidance published by the European Food Safety Authority (EFSA) for novel food applications. 

All safety assessments should be supported by scientific evidence, with analyses conducted by accredited laboratories using nationally or internationally recognised and validated methods. Where a method has been used that is not internationally recognised, a full description of the methods should be provided within the application.

Applicants are also encouraged to adhere to the Organisation for Economic Co-operation and Development (OECD) guidelines on Good Laboratory Practice (GLP) and chemical testing where applicable. Where this is not possible, fully validated internal methods with appropriate controls may be used, provided they are scientifically justified. Copies of the certificates of analysis (CoA) should be provided.

The FSA and FSS will review applications to ensure compliance with regulatory standards. Additional information may be requested during the verification process to address any gaps or uncertainties identified in the review of the submission.

5. Identity

The FSA and FSS assess the food safety risks of the novel food and its production, in line with Article 11 of assimilated regulation (EU) 2015/2283 and Article 7 of assimilated Commission Implementing regulation (EU) 2017/2469. This section of the supplemental guidance specifically addresses the requirements of identity.

5.1 Identity of the novel food

The identity section of the application must define clearly what the final product is. The final product is the novel food as intended to be placed on market and consumed.  The application must include a description of the physical form of the food and should include a detailed characterisation to allow it to be fully understood and assessed.

The description of the novel food should define exactly what the food is, how it will be used, and what it is made from. This should include, where appropriate, any scaffolding or any other culture input that may remain within the novel food as placed on market for example, chicken cells cultured on an edible structural support.

The following bullet points should be used as a baseline for considering what information is required to clearly detail what the identity of the novel food is.

This list is not exhaustive, and applicants should consider what additional information may be required to characterise the identity of their novel food.

Applicants should provide a description of what the novel food is, as intended to be placed on market. This includes characteristics of the novel food under assessment (for example, isolated cells, cells combined with a scaffold).

• description and authenticity of the cell types used within the novel food as placed on market, including clarity on whether cells are differentiated in the final product.  This should include morphological and physical characteristics of the cells in the final product

• characterisation of genetic stability, including description of any genetic modification in the final product including the characteristics of intentional epigenetic modification, or epigenetic consequences of genetic modification where relevant

• characterisation of the stability of any additional genetic or genomic alterations.

• proximate analysis and form of the final food for example, wet biomass. See Allergenicity and Nutrition guidance for further information

To understand what the food is, it is important to characterise the cell line and cell line identity used to produce the CCP product. Section 3.2 describes the information required from the starting cell line.

5.2 Characterisation and identity of the cell lines

An essential component of establishing the identity of the novel food is a clear understanding of the cell lines used in its production. The safety assessment relies on evidenced authenticity and identity of the cell lines used to develop the CCP product as a novel food. The cell lines should be verified using a justified approach to analytical techniques to confirm cell species and cell type.

The process to isolate the cells from the biological source, to create the cell line, should be described in detail within the application. This should be inclusive of the steps taken to establish the cell line from the biological tissue sample, or equivalent for example, cell isolation from the cell source and processes for selection of the cell type.

Where appropriate, consider the use of tables, diagrams or flow charts within the application to aid description and provide detailed narrative.  

Characterisation of the cell type should include, but not be limited to, the following:

• biological source of the cells, including taxonomic information for the cell source, authenticity of the cell type derived from the source animal for example, the exact cell lineage and any changes to the cells through production. Include the biological function of the cell type isolated

• species testing of the cell line to confirm the cell line originates from the declared species and has not been contaminated or misidentified. Note: this is of particular importance for non-farmed animals where traceability information may not be fully available

• confirmation of the cell type authenticity using morphological, phenotypic and molecular marker analysis

• verification of cell immortalisation and effect on cellular physiology, if applicable, and how this has been achieved

• differentiation state of the cell. This should include information regarding all differentiation stages during the production processes

• stability of the cell line should be demonstrated in terms of genomic stability (See section 3.3 for genomic integrity)

• purity of the cell line, including a defined acceptance criteria and specific details of any additional cell types within the culture

• consideration for the absence of risk from adventitious agents including viruses and mycoplasma within the cell culture

• free from adventitious agents including viruses and mycoplasma within the cell culture

5.3 Source animal traceability

An important part of the identity and safety assessment process is to have full understanding and traceability of the cell source. General Food Law (GFL) regulation (EC) 178/2002 applies to all inputs used in the production of CCPs. For further information on hygiene requirements for CCPs see the FSA and FSS published guidance.

Whilst there are several different methods to source cells from the biological source, all methods should include the appropriate traceability information. All certification of animal health status should be independently confirmed by personnel qualified to assess animal health.

Where cells are sourced from animals outside of the United Kingdom (UK) or the European Union (EU), there should be demonstration that UK and EU, or demonstrably comparable, best practices have been adopted.

Where the cells are sourced from:

• slaughtered farmed animals’ appropriate certification to show ante-mortem and post-mortem checks detailing the animal’s health status should be included within the application. This should include the certification to detail individual or herd/flock health status from the farm ( for example, animal health passport)

• live farmed animals application must consider what additional risks may have been introduced from cells obtained through live biopsy from a live biological source

• wild caught animals (including seafood sources)  for example, fish or other seafood species - a risk-based approach to traceability, within the requirements of GFL, must be fully detailed within the application. There should be verified documented evidence from an independent expert that the animal is of appropriate heath and quality to enter the food chain at the point of cell isolation. The application should consider potential hazards and the mitigation steps documented

• established/proprietary cell lines traceability information tracing the cell line back to the source animal and appropriate information from the source animal must be included within the application. Where cells are obtained from cell suppliers, certificates of authenticity and CoAs should be provided

Where relevant, the traceability of the source animal should also cover the traceability of any animal cells isolated from embryonic tissue or fertilised eggs.

Where cells are sourced from multiple independent sources  for example, different starting animals, the required information should be provided for each source, as the nature and variability of the risk may differ.  

Additionally, there should be consideration and appropriate justified evidence of the absence of animal disease, zoonotic diseases and Transmissible Spongiform Encephalopathies (TSEs), also known as prion disease, when selecting the biological source of CCPs.

5.4 Adventitious agents within the cell bank

This section refers to the isolated cell line that will be used to produce the CCP. Sterility testing should be performed on the cell line to confirm the cell line is sterile prior to the proliferation production stages; this may be at the working or master cell banking stage.

Cell bank sterility testing should be conducted using a risk-based approach and must consider the biological source of the animal, geographical location of the cell source and consider pathogens on a case-by-case basis. The isolation procedures have the potential to introduce pathogens, and cell safety testing should cover any contamination likely to be introduced during this phase for example, co-cultures.

A narrative and justified rationale should be provided for any testing undertaken to provide context within the application.

The application should include a justified rationale that the cell bank or starting cell material is free from any contamination that pose a safety risk.

Justifications may include details of the source animal health status or may include analytical testing to confirm. All data or rationales should be included within the application alongside an evaluation of the results, where required.

Cell bank/starting material sterility should consider the following requirements:  

• biological source of the cell line sterility testing of the isolated cells should consider the biological source/donor material. Screening should consider pathogens including species specific pathogens, viruses and zoonotic viruses where appropriate. Alternate sources of contamination should be considered, for example, animal derived sera used within the isolation/production process. Screening should consider both endogenous and adventitious agents

• mycoplasma: absence of mycoplasma should be confirmed within the cell line

• prions: the application should acknowledge and detail the risk posed by prion disease. Where risk is considered low, the application should provide a science-based rationale

Where a source animal is confirmed healthy and suitable for the food chain during post-mortem inspections, analytical confirmatory testing may not be required in the isolated cell line. A scientific justification of this approach would be required.

6. Genomic integrity

Genome modification

It is understood that in certain cases cell lines are immortalised through genetic modification. FSA and FSS agree that because the cells do not satisfy the definition of organism due to their inability to survive and replicate outside of the bioreactor environment, the immortalised cells are not a Genetically Modified Organism (GMO).

By extension, the biomass produced using such cells should not be assessed under the Genetically Modified Food and Feed regulation (regulation (EC) 1829/2003. However, where individual components used within the production process are derived from genetically modified organisms, and the resulting product contains residues of these GMOs, the application may be fall within the scope of the Genetically Modified Food and Feed regulation (regulation (EC) 1829/2003).

As this will apply to nearly all genetically modified cell lines, we anticipate most CCPs that have been produced through genetic modification will be assessed under the novel food regulations.

Similarly, CCP applications will be assessed under the novel food regulations if no genetic modification has taken place.

As the techniques used in CCP production develop, it is possible that there may be cell lines that can survive outside of the bioreactor environment.  This is why we recommend that if you have used genetic modification during your production process, you should contact us to discuss your application before submission, so we can advise on the correct regulatory regime.

You can contact us either using our Cell-cultivated products Business Support Service - GOV.UK (up until February 2027) or through contacting regulatedproducts@food.gov.uk.

Where genomic modification of the cell line has been used, a full and detailed description of the changes made to the cells during selection or the production processes (for example, differentiation or immortalisation) must be provided. Safety concerns of any downstream effects will need to be considered.  

Where appropriate, consider the use of tables, diagrams or flow charts within the application to aid description and provide narrative.  

Epigenetic modification of the cell line does not change the sequence information in the genome, but it is an important regulator of genomic function, and it may give rise to changes that require safety evaluation.  

Applicants should refer to EFSA 2012 Guidance on Risk Assessment of Food and Feed from Genetically Modified Animals and Derived Products for safety testing of genomic manipulated cell lines. Deviations to the guidance will require justification within the CCP application.

It is expected that the applicant will provide the relevant assessment on safety for the genetically or genomically modified cell lines, including detailed analysis of the genetic or genomic change, reasons for the change and the effect of the change on the final CCP product. 

6.1 Genomic stability

Genomic instability could lead to unpredictable changes in cell behaviour which could affect product safety. Understanding genomic stability is essential for safety assessment.

The application should include evidence that the cell line remains consistent and phenotypically stable throughout the production processes for example, at cell banking and at harvest.

Evidence of genomic stability may include, but is not limited to:

• demonstrating chromosomal stability for example, karyotyping analysis

• monitoring cellular division for example, evidence of number of passages used to develop the cell culture for harvest, and monitoring of genetic mutation accumulations

• description and analysis of phenotypic stability

• verification of identity markers in the final harvest for example, molecular markers for differentiation

• evidence of protein expression stability

• DNA methylation and other epigenetic mechanisms regulating gene expression, genomic stability, and transposition

Harmful changes due to (epi)genetic drift

Genetic drift, including epigenetic drift, in cell culture refers to random and non-random genetic changes that occur as the cells divide. Genetic drift has the potential to introduce new risks to the cell culture by changing the properties of the cells in ways that may affect safety.

Monitoring of genetic stability may primarily be conducted through observation of phenotypic changes in the cell culture in comparison with the starting material (for example, cell morphology, molecular markers, exponential growth etc). Applicants should provide assurance demonstrating the absence of harmful products in the novel food as placed on market attributed to genetic drift or genetic modification for example, production of toxins or allergens.

Evidence should be provided covering the entire production process from end to end.

7. Production processes

The production of CCPs relies on defined processes that support consistent cell growth. These processes form the foundation for ensuring traceability, quality and safety throughout production. All production processes, including all upstream and downstream processes, are subject to safety assessment to ensure that potential hazards are identified and managed.

Under regulation (EU) 2015/2283 and Section 2.3 of the 2016 EFSA guidance for novel foods, applications should provide a description of all production processes with sufficient detail to inform evaluation of the safety. Where novel processes are used for food production, the description should consider the effect of the method on the safety of the novel food and whether new hazards are introduced.

7.1 Production process overview

To ensure that the production processes can be fully understood for safety assessment, there should be a transparent, comprehensive and detailed summary of the production and manufacturing processes used to create the novel food for placing on the market. This should include flow chart summaries and diagrams where appropriate.

Flow diagrams provided should consider the confidential production processes and include a non-confidential summary. There should be a clear narrative detailing how the CCP was developed and include all processing steps and stages from initial sourcing of the cell line to harvest and storage of the CCP as placed on market.

Information to include in applications may include but is not limited to:

• cell sourcing and sampling

• cell isolation and cell line development

• development and contamination control of the cell bank

• proliferation and expansion

• differentiation and maturation

• harvesting

• post-harvesting processing

• storage of CCP material in final formulation

Industry best practices to produce food should be used. This ensures products are consistently manufactured and controlled to standards appropriate for their intended use.

Throughout the production summary, detailed descriptions of raw material quantities, equipment such as flask and bioreactor sizes, media components, volumes of media and other relevant details and quantities for the inputs is required for understanding the current scale of the process. The assessment is based on the current scale of the production process as described within the application.

Scale up of production methods may change the risk profile and therefore any future changes to the scale may require an application to the FSA and FSS for a change in conditions. Further details on regulatory authorisation, including scale up and re-application, will be featured in future FSA and FSS guidance.

7.2 Microbiological contamination considerations throughout production

The application should include analysis of microbiological considerations that are unique to the production methods for CCPs as novel foods, as well as microbiological considerations within food production. The application should provide a comprehensive description of the measures taken to prevent and control microbiological contamination at all stages.

This should include steps to reduce cross contamination of cell lines within all stages of the production process.

Evidence should be provided showing that the potential introduction of pathogens has been considered at each stage of production. This along with the food safety management measures and Hazard Analysis and Critical Control Points (HACCP) controls in place should demonstrate how the risks are mitigated and managed.

Contamination control should include processes for decontamination of equipment and the appropriate cleaning and sanitation procedures. Evidence may include the standards for clean room conditions, description of filtration practises, environmental monitoring and controls for manual handling. Evidence of the cleaning validation should be included within the application.

7.3 Batch to batch variability

The production method must demonstrate a consistent and controlled production process with capability of reproducing repeatable batches.

The definition and justification of what constitutes an independent representative batch and how this relates to the definition of a batch in assimilated regulation (EU) 2073/2005 must be included within the application and allow for batch-to-batch comparisons to be made effectively to assess consistency. Further supplemental guidance on independent batches can be found in FSA and FSS Allergenicity and Nutrition Supplemental guidance. 

7.4 Process controls

The process controls used within the production process must show how hazards are managed and mitigated. They are steps in which a hazard can be prevented, eliminated or reduced to an acceptable level as defined in the HACCP plan.

The HACCP plan must be constructed in line with best practices, in accordance with the Codex Alimentarius Commissions HACCP principles.  The application should include explanations of the hazard, description of the process control points and justified measures taken to mitigate the risk and corrective measures identified under HACCP principles.

All hazards throughout the production process should be identified and mitigated, this should cover all the production steps up to and including the storage of the novel food as it is intended to be placed on market.

Post-processing methods such as texturisation should be considered if applicable. Critical control points should be labelled on the production flow diagrams.

Applications should include clear information on how and why microbiological contamination could occur during each processing stage, including potential sources. Each control measure should be justified in how it is sufficient to manage microbiological risk and include supporting evidence.

The food safety management plan or HACCP must be applicable to the production methods described within the application and be suited to the current scale of production. Any scale up considerations should also be addressed.

7.5 Raw materials and inputs

Details should be provided in the application about all raw materials (including but not limited to source animal, cell line, scaffolds or cell culture media) and equipment used within all stages of production, from the cell isolation stages through to the post-harvesting processes.

Applications should include CoAs or relevant data sheets to demonstrate specification compliance, such as purity. Water quality should be considered when providing raw material details.  Consideration should be given to formulations and concentration of cell culture media components (including components within the media such as sera, supplement hormones, growth factors and antibiotics), cryopreservation media, scaffolds and additives etc.  

Raw materials and inputs into the manufacturing of CCPs may have allergenic risk, see FSA and FSS published Allergenicity and Nutrition guidance. 

Any materials that contact the food during production must be appropriate for use with the food material under the proposed conditions and this evidenced within the application, including datasheets for the materials and where relevant, supporting data and an evaluation of the results.

A list of contact materials must also be provided, for example, plastic tubing, bioreactor, flasks etc. Applicants should read EFSA guidance on Food Contact Materials 2017) for further information.  It is the responsibility of the applicant to ensure that the materials used are approved food contact materials.

Where any scaffolding, beading or other structural devices are used, the sterility, raw materials and composition of the materials should be verified prior to inclusion in the production process. Where non-edible scaffolds are used, the application should clearly describe and provide evidence of how the scaffolding will be removed from the culture and detail the effect of any residuals.

Where the scaffold material is edible and is intended to remain in the final product this should be addressed as part of the CCP as a novel food.  Further supplemental guidance for raw material residue in the final product will be addressed in a future FSA and FSS supplemental guidance on growth media components and toxicology assessment.

7.6 Further processing

Following harvest, the CCP material may be modified using post-production processing steps such as washing, drying or purification. Where post-production steps are applied or will be applied, they must be described within the application to further detail how the novel food will be consumed under its intended use.

It must be clear why each post-production processing step is carried out and any safety implications considered. If any materials are used, details of these must be included.

Where the CCP is intended to be used as an ingredient within food, there must be some consideration given to any further processing steps required to incorporate it into the final food (for example, blending, heating). An outline of these steps should be provided and include how the steps may affect the safety or stability of the novel food.

Where further processing steps will be completed by a third party, within the scope of the authorisation, details of a representative example under those conditions should be used within the application.

Refer to [FSA and FSS guidance for good practice in hygiene requirements.](Cell-cultivated products: food business hygiene requirements - GOV.UK](https://www.gov.uk/government/publications/cell-cultivated-products-food-business-hygiene-requirements?cachebust=1783585656)

Storage conditions of the CCP at all stages post-harvest should also be described. This should incorporate details of storage duration, temperature and packaging. Details should include the controls taken to prevent contamination or degradation of the CCP.

7.7 Specification

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 Nutritionsupplemental 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

7.8 Stability

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 and 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.