With regulatory gridlock in the USA, could Europe take the lead?

The momentum behind cultivated food has slowed in key markets such as the USA and Singapore, which raises the question: could Europe ultimately emerge as the next global hub for cultivated meat and seafood?

Progress in the USA has dropped off dramatically. No new ‘no questions’ letters have been issued by the Food and Drug Administration (FDA) since 2023, and with the new Trump administration in full swing and Robert F. Kennedy Jr. at the helm of the FDA, the future of cultivated meat appears uncertain. State-level bans are gaining traction, threatening to stifle the industry even in the absence of a federal-level ban.

Singapore, once the frontrunner in cultivated meat approvals, is also experiencing delays – not due to politics but as a result of the sheer volume of applications. The Singapore Food Agency (SFA) is stretched thin, and is currently processing a growing backlog of novel food dossiers.

With approvals lagging in the USA and Asia, advances in Europe could position it as the next leader in cultivated food regulation

Meanwhile, Australia and New Zealand await the long-anticipated approval of Vow’s cultured quail. Food Standards Australia New Zealand (FSANZ) issued a positive safety opinion in early 2023, yet a second public consultation wasn’t launched until late 2024. FSANZ is also considering a standards-based approach that would exempt cultivated products from being classified as novel foods, provided they meet specific requirements – potentially streamlining approvals in the future.

In South Korea, meanwhile, the newly introduced regulatory framework and requirements for cultivated meat/seafood has added another layer of complexity. The Ministry of Food and Drug Safety (MFDS) requires extensive toxicological data, creating an additional hurdle for cultivated food companies.

Although approvals in other regions have slowed, Europe is showing signs of movement. In the UK, the Food Standards Agency (FSA) is set to launch its cell-cultivated product (CCP) regulatory sandbox in early 2025, which marks an exciting step in cultivated meat/seafood regulation. The UK could see its first cultivated meat or seafood product approved as a novel food within the next two years. Meatly has already made history, securing approval to sell cultivated chicken for pet food in 2024 – marking the UK’s first commercial CCP entry point.

In Switzerland to date, four companies have submitted novel food applications for cultivated meat and seafood, with two of these applications already having passed the first phase (Part A), which is the FSVO novel food consultation confirming that these products fall in scope of the novel food regulation in Switzerland. While Swiss legislation does not specify strict timelines, approvals are expected within 1.5 to two years.

In the European Union, the European Food Safety Authority (EFSA) updated its guidance in 2024 to include specific requirements for cultivated meat/seafood, providing some clarity for applicants. Two novel food applications have already been submitted – Gourmey in 2024, followed by Mosa Meat. Gourmey’s dossier passed EC validation and EFSA’s suitability check in just four months, significantly faster than the average nine-month timeline (based on an analysis conducted by Atova).

However, EFSA’s rigorous risk assessment could extend well beyond the legal nine-month deadline. As we all know, the real challenge in the EU lies in the risk management phase, where approvals require the support of 55% of EU Member States, representing 65% of the population. Given the political landscape, this could be a tough hurdle to clear.

Although Europe is making strides, regulatory processes remain slow, and political uncertainty presents a significant challenge. Cultivated food companies must prepare for extended timelines and let’s hope they have enough runway to survive the wait! That said, with approvals lagging in the USA and Asia, advances in Europe could position it as the next leader in the cultivated food regulation. The next two years will be critical.

Dr Hannah Lester is the CEO of Atova Regulatory Consulting and also Head of Regulatory Strategy at Gourmey. This article is republished from the Q1 2025 edition of Protein Production Technology International, the industry's leading resource for alternative proteins. To subscribe to all future editions, please click here