As cultivated meat edges closer to widespread acceptance, the regulatory landscape remains a formidable hurdle. Atova Consulting’s Hannah Lester, a seasoned expert in novel food regulation, offers a unique perspective on the challenges and opportunities facing this burgeoning industry.
Speaking with Alex Crisp on the Future of Foods Interviews podcast, Lester outlined the intricacies of regulatory processes across the globe, shared her insights on working with agencies like EFSA and the FDA, and discussed how political shifts—particularly in the United States—could reshape the future of food technology.
The evolving regulatory landscape: Europe’s challenges and opportunities
For companies like those Lester represents, Europe presents a double-edged sword: rigorous scientific evaluation paired with political complexity. While the European Commission has clarified that cultivated meat falls under novel food regulation, approval is no simple task. “For a novel food to gain approval, 55% of EU member states representing 65% of the population must vote in favor,” Lester explains. With large nations like France often opposing, companies face an uphill battle.
Lester emphasized the importance of education in overcoming resistance. “Companies and trade associations must engage member states early, demystifying cultivated meat and addressing misconceptions,” she said. Such efforts, she argues, are critical to turning skeptics into supporters.
The European Food Safety Authority (EFSA), meanwhile, appears enthusiastic about cultivated meat’s potential, providing prompt feedback and guidance. However, the EFSA’s nine-month risk assessment timeline is rarely straightforward. The process can stall as regulators request additional information, prolonging approvals and frustrating innovators.
America moves from enthusiasm to uncertainty
The United States was once seen as a global leader in food technology, but shifting political priorities and regulatory ambiguities have clouded its future role. Lester highlights that cultivated meat’s regulatory pathway in the U.S.—overseen jointly by the FDA and USDA—lacks clear legislative backing. “The framework is evolving, but it’s not firmly entrenched in law,” she said.
One complicating factor is the change in administration. With elections looming, the potential for new leadership could either accelerate or hinder progress. “A new administration could bring uncertainty to the FDA and USDA’s approach,” Lester warned. In deeply conservative states like Florida and Alabama, bans on cultivated meat demonstrate the growing politicization of food innovation.
Yet, there are reasons for optimism. The FDA has shown openness to engaging with innovators, offering pre-submission meetings to refine applications. This collaborative approach has helped streamline early dossiers, though Lester anticipates new guidelines in 2025 that could further clarify expectations.
While the US grapples with political shifts, other regions are forging ahead. Singapore remains the gold standard for cultivated meat regulation, leveraging its ambitious “30 by 30” policy to produce 30% of its protein domestically by 2030. The city-state’s proactive approach, including pre-submission consultations and a clear regulatory framework, has made it the first country to approve cultivated meat products.
The Middle East is also emerging as a key player. Israel, in particular, has created a fast-track pathway for novel foods, allowing companies with approvals in two other regions to expedite their applications. Saudi Arabia and the UAE have followed suit, establishing frameworks for cultivated foods. However, as Lester notes, compliance with halal standards remains a crucial consideration for the region’s broader adoption.
Building a dossier – the art and science of approval
For any company seeking approval, a well-prepared dossier is the linchpin of success. Lester breaks down the process into three critical steps:
- Regulatory Feasibility Assessment: This initial phase determines whether the product qualifies as a novel food or falls under another category, such as a food additive. Potential red flags—like cell line traceability or microbial safety—are identified early.
- Gap Analysis and Roadmap: Companies outline the data and studies needed to support the product’s safety and identity. This phase is essential for estimating costs and timelines, providing a clear strategy for the road ahead.
- Regulator Engagement: This involves presenting a well-prepared dossier to regulators, ensuring the submission meets expectations. “You can’t simply show up and say, ‘Here’s our product—what do we do?’” Lester advises. Instead, companies must demonstrate a deep understanding of the regulatory framework and be ready to discuss their data.
Despite the meticulous planning, challenges abound. Intake and exposure assessments, for instance, require specialized expertise. Toxicology sections can also be daunting, particularly when justifying the omission of certain studies. But as Lester emphasizes, building strong relationships with regulators is equally critical. “Upset them, and you may never hear from them again,” she cautions.
Balancing safety and innovation
Looking to the future, Lester sees both promise and obstacles. Safety remains paramount, but the pace of regulatory innovation often lags behind technological advancements. “Frameworks must evolve to balance public safety with the need for progress,” she says.
Regions like Singapore and Israel offer a blueprint for success, combining robust safety protocols with clear, predictable pathways. Meanwhile, Europe and the U.S. have work to do in streamlining processes and addressing political uncertainties.
The stakes are high, but so are the rewards. As Lester aptly puts it, “It’s challenging but fascinating work, and we’re privileged to be part of such groundbreaking developments.” For cultivated meat companies, the journey to approval may be arduous, but the potential to revolutionize global food systems makes the effort worthwhile.
With the regulatory landscape in flux, one thing is clear: the future of cultivated meat depends on collaboration, innovation, and a shared commitment to sustainable food solutions.
Listen to the full interview here https://open.spotify.com/episode/2WTOg3CNTvGC8z9d4kw3g2?si=4e2e5f9f8d61473c
