From Lab to Ladle; Proposed Changes to the UK Novel Food Regime

Many people believe cultivated meat to constitute the future of the global protein market. Although potential barriers such as consumer acceptance, pricing, and scalability of production have received broad journalistic treatment, relevant authorities have not explicitly clarified the route to market in the UK.

As things stand in the UK, cultivated meat and other cellular agriculture food products will require premarket authorization as a “novel food” to access the market. Notably, in the recent policy paper titled “The Benefits of Brexit: How the UK is taking advantage of leaving the EU,” the UK government has indicated that changes to the novel food regime are inbound with the aim of making the UK “the best in the world for innovators, investors and consumers” in this sector. More specifically, the paper commits to delivering “distinct regulatory frameworks” for cultivated meats, signaling flexibility around the status of cultivated meat products within the novel foods regime itself. This is a welcome development for cultivated meat companies that have yet to obtain a novel food authorization from the UK’s Food Standards Agency (FSA).

Beyond the requirements of the novel food application, some of the regulatory and commercial hurdles that manufacturers may encounter include the following.

Labeling and packaging. Considerations around labeling and packaging are likely to play a crucial role in the success of cultivated meat, in particular when it comes to persuading consumers that the end product really is “meat.” Novel foods are subject to the general labeling requirements laid down in the European Union Food Information to Consumers Regulation as amended. Among other requirements, these regulations cover rules concerning naming the food and listing the ingredients. Further requirements may be prescribed for novel foods to inform consumers of specific compositional characteristics as well as nutritional value or effect.

Duration of application. The FSA estimates that most novel food applications in the UK will take at least one year. In the case of cultivated meat, the one-year time estimate is highly optimistic, in particular given the complexity of the product and the likelihood of unforeseen and, perhaps, unprecedented hurdles that both the regulators and manufacturers are likely to encounter.

Legislation covering genetically modified organisms. Depending on the degree to which the genetic makeup of cultivated meat products vary from naturally occurring organisms, regulations on genetically modified food may apply, which would impose an entirely separate package of regulatory standards. To be clear, most cultivated meat manufacturers are keen to distinguish their processes from genetic modification.

Food- and meat-specific legislation. Agricultural regulations may apply if cultivated meat is deemed to fall under the legal definition of meat in the UK, which captures, inter alia, skeletal muscles of mammalian species recognized as fit for human consumption with naturally included tissue. Food law requirements around quality, traceability, and origin, among others, will also apply to the finished products.

Intellectual property. A handful of companies are reaching dominant intellectual property positions in this space. They are largely seeking to protect the technical manufacturing processes central to the creation of the final food product rather than the final product itself. The ability to block competitors by holding intellectual property over the strongest manufacturing techniques will be a powerful competitive advantage.

Until the FSA publishes specific guidance detailing the framework of a route to market, the UK appears to be toward the back of the regulatory queue. Investors and manufacturers alike see the U.S., Israel, or far East as presenting more compelling regulatory offers and more viable first-market options. However, the UK government’s commitment to review the novel foods regime is a significant step forward in the process of developing a well-defined pathway for cultivated meat products to reach consumers in the UK and has been welcomed by the growing industry. Companies will justifiably be drawn to jurisdictions in which their products are most likely to be approved and where the authorities have expressed a desire to receive applications; the UK appears open to developing a competitive route to market.

Though regulatory scrutiny on cultivated meat will be intense, as will the political scrutiny on the regulators themselves, there is room for regulatory flexibility in the UK. Just as supplementary frameworks have been mooted by the Medicines and Healthcare Products Regulatory Agency for the development of artificial intelligence as a medical device, so too the FSA has an analogous opportunity, having parted from the European Food Safety Authority following Brexit, to enable innovation in food technology within the novel foods regime in the UK and, in so doing, harness the opportunities that cultivated meat might offer. Stay tuned for updates.