Guidance for businesses on cell-cultivated products and the authorisation process.
What is a cell-cultivated product?
Cell-cultivated products cover a variety of foods that can be made using a production process without slaughter or traditional farming and agricultural practices. Cells isolated from animals or plants, including cells from meat, seafood, fat and offal, or eggs, are grown in a controlled environment, and then harvested to make a final food product.
Cell-cultivated products status in Great Britain (GB)
Cell-cultivated products must be authorised before they can be placed on the market in GB. This is to ensure they have been through a rigorous and independent safety assessment. Because of the variety of products and complex production techniques involved, different regulations may apply to the process of their authorisation. They will also need to comply with all the regulations applicable to all food on the market, such as hygiene rules or general food law.
Applying for authorisation
To place your cell-cultivated product on the GB market you must apply for authorisation using our regulated product application service. You must ensure that you choose the correct regulatory route for the assessment of your product.
Considering the methods that are used to create cell-cultivated products , we anticipate that most applications will be assessed under the novel food regulations. Novel food regulations apply to foods with no history of consumption in the United Kingdom (UK) or the European Union (EU) before 15 May 1997.
In some cases, applications may be assessed under the Genetically Modified Organism (GMO) regulations. If genetic modification has taken place during the process, please contact us to discuss your application. Further information on making an application under the GMO regulations can be found below.
Applying for authorisation under the novel food regulations
Applications for authorisation of cell-cultivated products are required for products considered a novel food under novel food regulations (retained EU Regulation 2015/2283).
Read our Novel foods authorisation guidance to find out how to apply for authorisation of your product as a novel food.
You can check the products already authorised for the use in Great Britain in our register of novel food authorisations.
Applying for authorisation under the genetic modification regulations
GMO regulations specifically apply to the modification of an organism's genetic material (DNA) in a way that does not occur naturally by mating and/or natural recombination. Both of these regulations are designed to ensure the food is safe for human consumption.
If a cell-cultivated product is produced using genetic modification, please contact us to discuss which regulatory regime it should fall under.
Read our Genetically modified organisms authorisation guidance to find out how to apply for authorisation of your product as a GM food.
You can check the list of GMOs authorised for import and use in food and feed in GB in our register of authorised GMOs.
You may request that any confidential data supporting your application is not used without your permission by other businesses for five years from the date of authorisation.
All regulated products, regardless of regime, undergo rigorous safety assessments.
All food businesses must comply with food safety law. With some exceptions, it applies to all stages of production, processing, and distribution of food and feed.
To place safe food on the market you must:
- ensure traceability of food
- present food appropriately
- provide suitable food information
- withdraw or recall unsafe food
- ensure food and feed imported into, and exported from, GB comply with food law
You can find more information in our Managing food safety guide.
You must provide certain information with food products placed on the market to comply with the labelling rules. This includes products’ ingredients, including allergens, and their durability (a use-by or a best-before date). You can find specific labelling requirements in our Packaging and labelling guidance.
The FSA reserves the right under Article 9 of the novel food regulations to require additional specific labelling requirements if we consider it to be in the consumers’ best interests.
If a product is assessed under the GMO regime, it will be labelled as ‘genetically modified’.
Research on cell-cultivated products
We set high standards of food safety. Our research demonstrates our commitment to identifying how best to regulate new and innovative food production methods.
- Hazard identification: Identification of hazards in meat products manufactured from cultured animal cells
In March 2023, the FSA and FSS commissioned a report to identify the hazards associated with cell-cultivated products production processes. The purpose was to inform our risk assessment process for authorising these products.
This report is a synthesis of desk research, based on thorough review of the academic and non-academic literature and of the alternative proteins start-up scene, and presents an analysis of the emerging market for alternative proteins, the potential implications and the potential policy responses that the FSA might need to consider.
FAO and WHO report
In April 2023, the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO) released a report compiling and evaluating all evidence to date on food safety in cell-cultivated products Food safety aspects of cell-based food.
Novel food tasting trials
In 2002, the Advisory Committee on Novel Foods and Processes (ACNFP) issued guidance on taste testing trials (PDF):
‘If the taste test is solely to develop the food and doesn’t involve any publicity or other marketing it is permitted as part of the research in developing the novel food. If the object is publicity, then this is regarded as marketing.’
This advice is for guidance purposes and is not definitive. If you have any questions on the application process, please contact the Regulated Products Team: firstname.lastname@example.org
This web page is intended for information purposes only. It does not guarantee your product will be assessed under a particular regulatory route. We reserve the right to make that decision. Please contact us for further advice.