The UK’s Food Standards Agency (FSA) has recently released guidance for businesses on cell-cultivated products and the authorisation process to market these products in Great Britain.
The FSA is responsible for food safety and food hygiene in England, Wales, and Northern Ireland. However, this guide is specific to England and Wales.
The FSA’s new guidance combines general food law regulations with novel food and GMO regulations and offers business advice to streamline the authorisation process. It includes definitions, status, application details, and recommendations on product safety, labelling, and tasting trials.
The UK government has been looking to streamline the approval for cultivated meat to boost food security and sustainability. Meanwhile, the first cultivated meat product on the market is still pending in the UK. To our knowledge, only the Israeli company Aleph Farms has submitted a pre-market authorization dossier to the FSA.
FSA authorisation process
The FSA explains that cell-cultivated products cover a variety of foods produced using a controlled environment to grow animal or plant cells. After harvesting these cells, companies can create final food products.
The organisation highlights that cell-cultivated products that use any animal cells, also known as lab-grown meat, cultivated, cell-cultured or cell-based meat, are not defined as meat but instead considered as products of animal origin.
Cell-cultivated products must undergo a rigorous and independent safety assessment and must be authorised under novel food regulations (the UK follows the EU’s regulatory framework for novel foods) before being placed on the market in Great Britain.
Interested businesses must apply using the FSA’s regulated product application service to begin the authorisation process. Different regulatory routes may apply depending on the specific product and production methods. In most cases, applications will be assessed under the novel food regulations, which pertain to foods with no history of consumption in the UK or EU before the 15th of May, 1997. The FSA has also published a Novel foods authorisation guidance to help businesses apply for a novel food.
For cell-cultivated products produced using genetic modification, businesses must contact the FSA to discuss the appropriate regulatory regime under the Genetically Modified Organism regulations.
Product safety and labelling
Regarding product safety, the FSA emphasizes that all regulated products, regardless of the specific regulatory route, will undergo thorough safety assessments. They include adherence to hygiene rules, food traceability, appropriate presentation and labelling, and the provision of suitable food information.
Regarding labelling, businesses must meet specific requirements to comply with regulations. Additionally, the FSA reserves the right to impose additional labelling requirements under Article 9 of the novel food regulations if deemed necessary in the consumer’s best interests. Product labels will also indicate if a product has undergone genetic modification.
Concerning the authorisation for novel food tasting trials, the FSA quotes a guide on taste testing trials issued by the Advisory Committee on Novel Foods and Processes in 2002: “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.”
According to the FSA, to support its efforts, it has conducted extensive research, including hazard identification for cultured animal cell meat products, an analysis of alternative proteins for human consumption, and a report on 3D printing technologies in the food system. The organization also references a report by FAO and the World Health Organisation that compiles and evaluates all evidence on food safety in cell-cultivated products.
“This is an incredibly exciting development, as this guideline signifies a giant step from food regulating authorities toward making cell-cultivated products available to consumers,” shared ProVeg International.