Guidance

Improving your cell cultivated product application

Published 10 July 2026

Applies to England, Scotland and Wales

This guidance will help you know what you need to include in a strong application and outlines common problems with Cell Cultivated Products (CCPs) novel food applications. This advice will support the preparation of high-quality CCP applications to the Food Standards Agency/Food Standards Scotland (FSA and FSS). A strong application will be processed faster and reduces requests for further information.

1. Requirements of a market authorisation application

Applications for Great Britain (GB) market authorisation are detailed scientific submissions. You must include technical, scientific and administrative information necessary for regulators to assess the safety of the novel food.

Your application should show the necessary scientific information for the FSA to decide whether the novel food is safe under the proposed conditions of use.

The type and quality of scientific information required for each novel food application is explained in the 2016 European Food Safety Authority (EFSA) Novel Foods Guidance, supported by the FSA supplementary guidance for cell cultivated products.

If your application does not provide the necessary information expected by the FSA and FSS, the application may take longer or could be invalidated.

You should make sure your application:

• includes all required information

• is clearly structured

• contains supporting evidence

Applications to the FSA and FSS are evaluated for suitability before validation to ensure that the application is complete and contains all the information required to do the risk assessment. The FSA and FSS have identified several recommendations through the assessment of cell-cultivated product applications, which are included to help you prepare future applications.

2. How to prepare the application

Some applications are submitted to FSA and FSS in the format for non-European regulator systems. This has led to the application not including the necessary information required by the FSA and FSS novel food regulations. You should prepare your novel food application in accordance with Article 10 of assimilated Regulation (EU) 2015/2283, ensuring all sections are complete, clearly cross-referenced and supported by appropriate scientific evidence.

Those seeking market authorisation for cell-cultivated products should also use the 2016 EFSA technical guidance for the preparation of an application for authorisation of a novel food. The updated 2024 EFSA novel foods technical guidance can also be used as a guide for applicants.

As part of the cell-cultivated product regulatory sandbox programme, the FSA and FSS will publish supplementary guidance (via the FSA and FSS innovation hub) on the regulatory and scientific requirements to help you through the GB market authorisation process.

The guidance provides cell-cultivated product-specific advice on how to meet the requirements in assimilated novel food regulations and the 2016 novel food guidance. It clarifies data requirements and risk considerations to support the risk assessment.

3. Main considerations for a strong application

This list tells you what you should include to write a clear, structured, and easy to follow application. This list is not exhaustive.

3.1  Well-structured application and narrative throughout

You should use the EFSA 2016 novel foods guidance to help structure the application, and include main topics such as identity, production processes, compositional data and toxicology as examples. A well-structured application should reference raw data and include clearly labelled annexes, uploaded with names and files.

This helps risk assessors identify which data sets belong to which test, and importantly, why the testing was considered necessary and included.

A strong narrative throughout the application is important to understand the content in a logical order. It will help explain your safety evaluation strategy and helps main points on safety or risk mitigation do not get lost in the technical detail.

The data should be clear with which materials, procedures and testing techniques have been used alongside a scientific justification for their use and a clear explanation of testing results and their significance on safety. This will help the assessor to understand the reasons for the inclusion or exclusion of specific studies or information.

3.2 Supporting information for analytical methods

Safety assessments should be supported by scientific evidence to ensure that conclusions are reliable, reproducible and suitable. Testing should be conducted by accredited laboratories using validated nationally or internationally recognised methods.

The relevant methods of analysis should be described including any references, for example, limit of detection (LOD) or quantification (LOQ). Raw data and an explanation of the data should be provided within the application, and a clear explanation that justifies why testing was or was not conducted.

Where a method has been used that is not internationally recognised, a full description of the method must be provided within the application. The Organisation for economic co-operation and development (OECD) guidelines on good laboratory practice (GLP) and chemical testing are encouraged where valid.  If not, fully validated internal methods with appropriate controls may be used, provided they are scientifically justified.

These methods should be included within the application alongside validation and evidence to support skill in using these methods.

Where testing has been done, certificates of laboratory accreditation or information on laboratory expertise should be provided. This includes any appropriate lab issued certificates of analysis. Certificates must be provided to FSA and FSS in English or Welsh.

3.3 Inclusion of raw data

Raw data for all analytical methods should be provided to support conclusions within the application. Whilst there is no set way to present raw data, it must:

• be easy to navigate and understood

• data sets should be submitted in recognised accessible formats such as images or pdf

• have appendices with clear links within the main body of the application text

• a summary of the data, evaluation and a clear interpretation of results

3.4 Production process

The application should include both confidential and non-confidential summaries of the production processes used to make the novel food, including flow charts. There should be enough detail to allow these methods to be reproduced.

This is required for the risk assessor to fully understand the hazards through the production process.  The non‑confidential version of the production process is published as part of the completed risk assessment.

Information for all input materials used within the production process must be included within the application. This may include condition and quality of input materials and copies of certificates of analysis.  The applicant may set up direct communication between the FSA and a third-party supplier to enable the FSA to obtain necessary confidential information.

3.5 Food safety management

Make sure your application has a detailed food safety management plan, preferably one that follows Hazard Analysis and Critical Control Point (HACCP) principles. This is required for food businesses producing food for the GB market. You should read  guidance on the application of HACCP principles to cell-cultivated products, published by FSA and FSS.  HACCP applies to the current commercial production scale and the proposed novel food.  

The assessment should:

• include the identification of hazards at each stage of the production process.
• describe the critical control points and the corrective measures in place.
• have a justification for all measures including why the product is safe for consumers.

4. Common issues and how to avoid them

Incomplete or unclear applications cause delays and lead to requests for more information.

Some of the most common reasons for further information requests include:

4.1 Not using the available guidance

Not addressing all the areas identified in the existing guidance, either with relevant information or a scientific justification for not submitting any information.

Use the following guidance:

• EFSA Novel Food Guidance (2016)

• FSA and FSS tailored guidance on the Innovation Hub

• Cell cultivated products Business Guidance

4.2 Not clearly describing the final product

You must describe the final novel food as it will be consumed in Great Britain. Focus on what the consumer will ‘actually’ eat, as this will be used to check if the product is safe for consumption. The application needs a clear definition of the final food product and not just the inputs.  

You must describe:

• what the food is

• how it is made

• why it is safe

Describe the food

Include:

• the identity of the novel food

• the cell types present

• differentiation status

• composition and characteristics

• formulation (for example, cells alone or combined with other ingredients)

Describe how it is made

Provide:

• a full overview of the process

• all stages from cell sourcing to final product

Show that it is safe

You must:

• link product characterisation to evidence

• consider proposed uses

• consider different population groups

4.3 Not considering the current scale

The application should accurately reflect the current commercial scale of the production process and represent a final process and product. This should not significantly change during the risk assessment process. The assessment is based on the proposed scale of the production process as described within the application. 

Scale up of production methods, for example, change in the volume of bioreactors may change the risk profile and therefore any future changes to the scale may require an application to FSA and FSS for a change in conditions.

Where a product or process is still under active development, you should consider the benefits of either waiting until it has been finalised or submitting a separate, follow-up application requesting a change in conditions of use. A new application may only need to generate new data where changes introduce a difference or where new hazards are identified.

Use the Business Support Service for changes in application conditions.

4.4 Missing or incomplete data

Missing or incomplete information within the application leads to stops and delays in the risk assessment process by the FSA and FSS.

Common issues include: * missing certificates of analysis * incomplete raw data sets * unclear production descriptions * incomplete product characterisation

You must make sure your application is complete before submission.

4.5 Poor document structure and traceability

The application should be clearly structured with easy to find information. Ensure that all sections are written clearly, with annexes clearly labelled and have consistent labelling within the body of text.

When responding to requests for information, clearly explain your response and show how it links to your original submission.

4.6 Not using the business support service

You should contact the Business Support Service early to obtain further clarification and guidance.  

This service can:

• clarify requirements

• answer specific questions

• provide feedback on your application

The pilot service runs until February 2027 and provides you the opportunity to receive tailored, product specific feedback from FSA and FSS risk assessors on direct questions related to your application (pre or post submission).