Opinion: Cultivated meat – UK regulatory position and challenges
Cultivated meat, also known as cell-cultured meat, is a product produced from the stem cells of animals. These cells are cultivated, and their tissues are engineered to produce the end product. Production processes are constantly evolving with companies across the world competing to make cultivated meat a viable commercial proposition. Singapore has already granted approval for cultivated meat though it is not currently authorised for sale in the UK or EU. The UK and EU share a similar regulatory framework for now but there is scope post-Brexit for the UK to diverge away from EU law.
The applicable UK regulatory framework
Cultivated meat must be authorised as a “novel food” under Regulation (EU) 2015/2283 (as retained in UK law) if it is to be lawfully placed on the UK market. The Food Standards Agency (FSA) deals with applications for the authorisation of novel foods in the UK. We also understand that certain methods of cultivating meat might fall within the scope of regulations governing Genetically Modified Food, though we understand this is not the industry’s preferred route to approval.
Novel foods will only be authorised by the FSA if:
The food does not pose (on the basis of the scientific evidence available) a safety risk to human health.
The food’s intended use does not mislead the customer, especially when the food is intended to replace another food and there is a significant change in the nutritional value.
Where novel food is intended to replace another food, it must not differ in a way that the consumption of the novel food would be nutritionally disadvantageous for the consumer.
The FSA states in their novel foods authorisation guidance that approval may take up to 17 months, noting that the clock can be stopped and re-started if further information is required. The quality of the application will significantly affect the time needed for assessment and authorisation.
The UK is free to diverge from the EU-derived novel foods system and it has explicitly stated in a policy paper in January 2022 that for new and exciting areas with significant innovation such as cultivated meats, the government will deliver a distinct regulatory framework that provides an economic advantage.
In June 2022, Victoria Prentis, the then Minister for Farming, Fisheries and Food said that the FSA is using the freedoms of Brexit to review the novel foods regulatory framework. That, however, as far as we are aware, is the extent of the UK government’s public commitment to regulatory reform and we await further detail in due course about how this new or revised regulatory framework might look and the timescales for its inception.
What we can say is that the UK government will be looking for urgent ways of showcasing the benefits of Brexit and we expect that any new or revised regulatory framework for the approval of cultivated meat and other new technologies is likely to offer a more streamlined approach to approval.
We predict that the main regulatory challenges facing cultivated meat are in relation to safety and labelling.
Producers of cultivated meat will need to prove to the FSA that their product does not pose a safety risk to human health. Full copies of all pertinent scientific data must be provided along with study reports and scientific opinions of national/international regulatory bodies. There may be some comfort that Singapore has granted approval for the sale of cultivated meat, however scientific data and studies may not reflect new and emerging large-scale production methods which may increase risks including those related to microbial and viral contamination. It may therefore take a significant amount of time for the FSA to assess the safety of the end product and approve it for sale.
The Food Information to Consumers Regulations, as retained in UK law, apply to cultivated meat products. Under these regulations, food information shall not be misleading in relation to characteristics such as identity, composition and method of manufacture or production. Cultivated meat producers must therefore pay specific attention to the labelling of the product to ensure the information on the label does not mislead the consumer. We can foresee issues arising where messages conveyed are inaccurate or not substantiated in relation to the foods in question. For example, should cultivated meat products be described as ‘meat’ or should additional words be used to avoid misleading the consumer? If cultivated meat is granted approval by the FSA, we expect the FSA to impose labelling conditions generic enough to reflect different production methods.
Alternatively, will those marketing cultivated meat products prefer the terms ‘animal free’ or ‘meat free’? These may technically be true, however, the very nature of the process of cultivated meat may result in these descriptions being misleading. This may be particularly challenging given the differences in production methods and the exact source of animal stem cells.
If cultivated meat becomes more cost-effective to produce than conventional meat, we are also likely to see a rise in the popularity of combined cultivated and conventional livestock meat products, which could also present labelling challenges, including the mislabelling of the proportion of cultivated to conventional meat.