Cell-cultivated products: Regulatory authorisation

through the online application portal , where you can upload all the required information. Please check the guidelines on novel foods applications. We’re also publishing specific guidance for cell-cultivated products on the scientific evidence applicants must include in their application.

Every application goes through the risk analysis process. This has two parts: risk assessment and risk management. 

During risk assessment, the FSA and FSS will go over the scientific evidence in the application about the hazards involved in producing the regulated product, to determine if it’s safe.  This may involve risk assessment by one of our Joint Expert Groups or Scientific Advisory Committees. We’ll also consider other legitimate factors, such as risks to the environment.

Once we’ve completed the risk assessment, the application goes to the risk management stage. Here, the FSA and FSS set out the actions that must be taken to reduce the risks and hazards identified.

The authorisation pipeline for all regulated products looks like this:

1. We carry out initial checks on your application to make sure it contains all the information needed for a full assessment. This is known as “validation”. We may send you a Requests for Information (RFIs) as part of this process.
2. Your application then goes through risk assessment. We combine this assessment into an evidence package called a Safety Assessment (SA). This SA is the Opinion which is required by legislation.
3. Based on the SA, the FSA and FSS will consider possible risk management options.
4. During risk management, and before we make a final recommendation, we run a public consultation. This gives the public an opportunity to comment on your application.
5. The FSA and FSS make a recommendation to ministers on approving the product or process for sale in GB.
6. Ministers decide whether to authorise the product for use in England, Wales and Scotland. If they authorise it, we update the GB register. 

If we identify that any information is incomplete, incorrect or missing at any stage, we’ll send you a RFI to the applicants. This asks you to provide the required information within as specified timeframe. 

The information provided affects the speed of applications

How long the full risk analysis process takes depends on how complex the application is, the amount and type of data provided, and on the type of product.

If you’re applying for a cell-cultivated product, think about how to explain the product’s identity in your application. If it’s not clear what the product is or how you intend to use it, this will likely delay the authorisation process, as we’ll need to request more information. For example, if the biomass is not the final product, but is processed further into another form, you should explain this in your application.

You must also clearly explain the product’s intended uses. Some companies apply for a wide range of intended uses, not realising the impacts this has on the risk profile. The more foods the product is intended to be used in, the larger its risk profile. This means our risk assessors and managers need more time to assess the risks and hazards of the product’s presence in the different foods, which extends the authorisation process. Limiting the scope of your application might mean a shorter authorisation process.

The quality of the dossier, and the information provided, will significantly affect the time needed for assessment and authorisation. Missing information or incomplete evidence means we need to use RFIs, which extends both the risk analysis process and the authorisation process. 

We encourage you to follow this guidance and provide all the required information, so we can process your application as efficiently as possible. Specifically for cell-cultivated products, us at regulatedproducts@food.gov.uk, for advice to help make your application as robust as possible before you submit it.

Terms of authorisation

If a product is authorised, the authorisation sets out specific conditions. These are known as Terms of Authorisation (ToA).

Based on the scientific advice of our risk assessors, our risk managers develop specific terms the novel food must follow to be allowed on the market. These terms cover the product’s nutritional, microbiological, toxicological, allergenic profile of the product, as well as:

• identity
• intended use
• which food categories it can be added in
• the allowed level of consumption
• labelling requirements

For cell-cultivated products, ToA could look like:

• the specific types of food the biomass can be added to, and limits on the quantity used as an ingredient
• the specific labelling requirements for the name of the product containing the biomass 

Some products need to go through a risk analysis process and be authorised before they can be sold as foods on the market in the UK. These are called “regulated products”. They include food additives, flavourings, enzymes, genetically modified organisms (GMOs), novel foods, and feed additives. Follow the links for specific FSA and FSS guidance on each product type, known as a “regime”. These pages also link to the relevant guidance and regulations for each regime: 

• extraction solvents
• feed additives
• feed for particular nutritional uses (PARNUTS)
• feed detoxification processes
• flavourings
• food contact materials
• food additives
• food enzymes
• genetically modified organisms (GMOs) as food and feed
• novel foods
• smoke flavourings
• precision bred organisms (PBOs) - Please note that this only applies in England

Which regime applies to cell-cultivated products

Cell-cultivated products are regulated products. Before you can place your cell-cultivated product on the GB market, you must apply for and obtain authorisation using our regulated product application service. You are responsible for choosing the correct regulatory route for the assessing your product.

Some products may need authorisation under more than one regime, particularly if they involve genetic modification (more information on genetic modification below) or other advanced technologies. If this applies to your product, contact regulatedproducts@food.gov.uk before applying.  

Based on the methods used to create cell-cultivated products, we expect most applications will be assessed under the novel food regulations. Under Regulation (EU) 2015/2283, a product is a novel food if it meets both these requirements:           

• it was not consumed to a significant degree before 15 May 1997
• it meets at least one category in Article 3 of Regulation (EU) 2015/2283, such as:  
  • new molecular structures 
  • foods from microorganisms, fungi, algae 
  • cell-cultured foods 
  • foods produced using new processes 
  • nanomaterials 
  • new sources of vitamins/minerals 
  • foods previously used only in supplements (if now intended for wider use) 

You must be satisfied that your product falls under at least one of the categories set out in Article 3.

You should provide as much information as possible about the nature of your product in your application, including how you intend to use it and what characteristics it adds to the food. The more accurate your description of the identity of the product and its intended use, the fewer requests for information we will send you.

Genetically modified (GM) food authorisation 

If you use genetic modification methods in food production, companies must be aware of the two areas of legislation: 

• food regulation: the rules and requirements for the authorisation of GM food as regulated products, set out in Regulation (EC) 1829/2003
• environmental protection: the rules and requirements in the Environmental Protection Act and the Deliberate Release Regulations, that all appropriate measures are taken to avoid environmental damage from the escape or release of genetically modified organisms (GMO) from human control.

Food regulation 

Under Regulation (EC) 1829/2003 on genetically modified food and feed, the following must be authorised:

• a GMO and foods containing or consisting of that GMO, as well as foods produced from or containing ingredients produced from that GMO
• food produced from a GMO, as well as foods produced from or containing that food
• an ingredient produced from a GMO, as well as food containing that ingredient

In some cases, cell lines are immortalised through genetic modification. The FSA and FSS agree that where the cells cannot survive and replicate outside of the bioreactor environment, they do not meet the definition of “organism” under Regulation (EC) 1829/2003. This means the cells are not a GMO. As a result, the biomass produced using the cells should not be assessed under the Genetically Modified Food and Feed Regulation (Regulation (EC) 1829/2003).

However, we treat every cell-cultivated product on a case-by-case basis. We advise you to contact us at regulatedproducts@food.gov.uk to discuss whether you have used a genetic modification to manufacture your product.

Environmental protection

If you use genetic modification on the cells, the cells and biomass fit the definition of “organism” and “biological matter” in Part VI of the Environmental Protection Act 1990 respectively. This means the following rules apply: 

• Genetically Modified Organisms (Deliberate Release) Regulations 2002
• The Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002
• The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002

You must get consent before you transfer the cells or biomass from the production premises. Apply for consent to:

• Defra, for England
• The Welsh Government, for Wales
• Scottish Government GM Inspectorate, for Scotland

Many cell-cultivated product companies are scaling up production at the time of their original application. If you scale-up after your product’s been authorised, you need to think about whether you modify your authorisation. 

If you intend to introduce a change to an authorised product, contact the FSA or FSS first, as set out in our regulated products application guidance. If your changes diverge from the ToA or the information provided in the original application, you’ll need to submit a new novel food application. Depending on the nature of your proposed changes and the risks they pose, your new application may or may not require a new risk assessment. 

To make it easier to navigate the different scenarios that might lead to a new risk assessment, we’ve split them into two categories. The examples are for illustration only, to help you understand the types of changes that may require a new risk assessment. These lists are not exhaustive. We handle each request on a case-by-case basis.

Category 1: changes that might need a new risk assessment

This category could include: 

• changes, such as change in company name or other details that do not change your production process, equipment, ingredients or the product
• company scale-up, where you increase the size and output of your production; most commonly involving larger bioreactors, or changes to the media composition
• minor changes in production process, including changes in equipment. This will be dependent on if other production changes are needed and if the product can still stay within the original specification
• some minor changes in the cell growth media composition that will not change in the safety profile of the novel food
• genetic drift, which refers to random genetic changes that occur as cells divide. Genetic drift could introduce new risks to the cell culture by changing the properties of the cells in ways that may affect safety. Find more information in our identity, production and microbiology supplementary guidance.

Category 2: changes that are highly likely to need a new risk assessment

These are changes that diverge from the products’ initial authorisation and introduce new risks. These could be:

• using a new production strain or cell line
• changing how your cells differentiate, for example changing the cell types or their cellular identity
• using a different production process, such as moving from batch to continuous production, or scaling up in a way that alters the time at cultivation and some of the inputs used to manage associated issues
• using a different method of cell immortalisation
• changing your cell growth media components; either by changing the ratio of components, which could increase exposure to substances with potential adverse effects, or by replacing an ingredient with a different one, which could introduce new potential risks
• changing your product ‘type’, for example, moving from an unstructured biomass to a structured product through 3D printing, extrusion or  scaffolds
• introducing new food categories, which could mean additional exposure from related food categories not yet assessed
• increasing use levels in existing authorised categories

When you apply to modify an existing authorisation, you may not need to submit a full set of scientific information. Under Article 3(4) of Regulation 2017/2469, you can provide adequate and verifiable justification showing that your proposed changes do not affect the existing risk assessment.

Modifying an authorisation takes time, so plan for this. 

Food improvement agents

The group of regulated products including food additives, flavourings and enzymes is called “food improvement agents” (FIAs). 

You may want to include FIAs when manufacturing your products. 

You should understand how we regulate FIAs at an early stage, so you can plan your regulatory strategies and timelines around legislative requirements. The definitions below will help with this.

Food additives are substances added to food to perform a specific technological function. This includes:

• making food look or taste better
• extending the storage and shelf-life of food
• maintaining the nutritional composition of food
• helping the food production process

Additives are used as:

• colours
• preservatives
• antioxidants
• sweeteners
• emulsifiers
• flour treatment agents

Flavourings are used to: 

• add a new taste or odour to a food
• improve the existing taste or odour of a food 

Enzymes are present in microorganisms, plants and animals and act as catalysts in various chemical reactions, increasing the rate of these reactions. This makes them useful in producing food or certain food ingredients, such as flavourings, helping to increase yields or make production processes more efficient. 

You should understand what type of food improvement agent you’re using, as each type has a different regulatory status. Unlike other FIAs, processing aids do not require authorisation to be used in food production.

Processing aids

To understand how to deal with other regulated products, first check if the materials used are classified as additives, flavouring, enzymes or processing aids.

Regulation 1333/2008 defines a processing aid as any substance which:  

1. is not consumed as a food by itself
2. is intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a specific technological purpose during treatment or processing
3. may leave unintentional but technically unavoidable residues of the substance or its derivatives in the final product, provided they do not present any health risk and or have any technological effect on the final product

If your material does not meet all three of these characteristics, it’s not a processing aid. It might be an additive, flavouring or enzyme. See the next section for more details.

If your material meets all three characteristics, it’s a processing aid and does not require authorisation before use.

Extension of use application required

If you intend to use an ingredient in a cell-cultivated product that is not a processing aid, you must ensure it has been authorised for use in cell-cultivated products. 

If your ingredient is a food additive, flavouring or enzyme, check which food categories it can be added to. Do this by consulting the registry of authorised regulated products and the 5th version of the EFSA guidance to Regulation 1333/2008.

Cell cultivation is a novel technology for producing food, so it’s unlikely any FIAs have been approved for use in cell-cultivated products at the time of publication. If the FIA you intend to use is not authorised for use in cell-cultivated products, you must submit an extension of use application and get it approved before you can use it this way. 

The extension of use application for the additive, flavouring or enzyme is separate from your application to authorise your cell-cultivated product. The manufacturer of the regulated product must submit this additional application. The extension of use must be authorised first, before the cell-cultivated product application continues through the authorisation process.

Growth factors and scaffolds will be of particular interest to the cell-cultivated products sector, so we’ve set out additional information below.

Growth factors

Growth factors play an essential role during the cell cultivation stage.

As explained above, if only traces of growth factors are left in the end product, we would consider them processing aids. However, you are responsible for determining whether your ingredient meets the processing aid characteristics, and for considering whether growth factors could fall under any of the other food improvement agent categories. 

There’s no specific legislation prohibiting the use of growth factors in food production. Therefore, General Food Law applies, and the final product must be safe for human consumption. This means your cell-cultivated product application must include evidence of the safety of using growth factors. Follow the relevant section of our Toxicology and Growth Media Components guidance for more information.

Scaffolds and microcarriers

Depending on how you use scaffolds and microcarriers, and their function in your final cell-cultivated product, we may consider them either a processing aid, or a regulated product needing authorisation. We recommend contacting us for advice if you’re planning to use scaffolds in the manufacturing of your product. Send any queries to regulatedproducts@food.gov.uk.

Regardless of categorisation, you must clearly demonstrate evidence of their safety of in your dossier. Follow the relevant section of our Toxicology and Growth Media Components guidance for more information. 

Directly applicable EU legislation no longer applies in GB. EU legislation retained when the UK exited the EU became assimilated law on 1 January 2024, published on legislation.gov.uk.  References to any legislation in FSA/FSS guidance with ‘EU’ or ‘EC’ in the title (e.g. Regulation (EC) 178/2002) should now be regarded as assimilated law where applicable to GB and as directly applicable EU law where applicable to Northern Ireland. References to ‘Retained EU Law’ or ‘REUL’ should now be regarded as references to assimilated law.  

For businesses moving goods from Great Britain to Northern Ireland, information on the Windsor Framework including the NI Retail Movement Scheme (NIRMS) is available on GOV.UK.