On May 11 and 12, 2023, the European Food Safety Authority (EFSA) is hosting a scientific colloquium on cell culture–derived foods and food ingredients, including cell-based meat, putting the future of this innovative technology in the spotlight. With the regulatory landscape in Europe still taking shape, it is important for cellular agriculture companies and investors alike to monitor developments at the EU level, to take part in relevant consultations, and to engage with decision makers.
In response to environmental goals and global food security concerns, European agribusinesses and startups have focused their efforts on developing alternative food options. These have included insect-based, plant-based, or algae-based protein alternatives, cell-based meat, and other cellular agriculture products. Taking into account these important developments, EFSA is gathering relevant stakeholders together to discuss ongoing trends and research at a scientific colloquium in Brussels titled “Cell culture-derived foods and food ingredients.”
One of the colloquium’s objectives is to ensure that EFSA’s risk assessment is appropriate for cell culture-derived foods and ingredients. The colloquium will further seek to identify new sectors in the agrifood system and review relevant concepts, technologies, and derived products as well as the emerging safety and methodological aspects that might affect EFSA’s approach to the risk assessment of the products in question. The colloquium is open to all stakeholders interested or involved in the risk assessment of these products. Registration is open until March 30, and interested individuals can sign up here at no cost.
U.S. Leading by Example
The United States has made substantial headway in regulating food products derived from cell culture. There, cell-based meat is regulated collaboratively between the Food and Drug Administration (FDA) and Department of Agriculture (USDA). Under a March 2019 memorandum of understanding, both agencies agreed to a joint regulatory framework wherein the FDA oversees cell collection, cell banks, cell growth, and differentiation. At the harvest stage, regulatory oversight then transfers to the USDA, which oversees the processing and labeling of human food products derived from cell culture. Both the FDA and USDA are expected to provide guidance for future potential cell-based meat and poultry products.
While the U.S. system is still in its infancy, the FDA has already completed review of two potential cell-based poultry products, in November 2022 and March 2023 respectively. While not a formal approval, the FDA’s completion of the voluntary premarket consultation process means FDA has “no further questions” about either company’s conclusions that its production process is safe and that its products are as safe as conventional chicken. The two completed consultations provide significant insight into the FDA’s overall approach to the premarket review of such products, including the safety considerations future producers should be prepared to account for.
Industry Must Get Involved to Highlight the Need for an Appropriate Regulatory Pathway in the EU
As one of the categories of cell culture–derived foods likely to be discussed at EFSA’s colloquium, the regulation of cell-based meat in the EU requires a defined regulatory pathway. To date, we are not aware that any applications for approval of cell-based meat have been submitted to EFSA (application summaries are available here). Compared with that in the U.S. — which has developed a specific framework as described above — the novel food process in the EU appears less attractive to prospective applicants.
The lack of a clear pathway is frustrating an industry that is making innovations at a rapid pace and under more substantial environmental requirements than ever before. Indeed, the recently formed industry body, Cellular Agriculture Europe, has called on regulators and policy makers to “prioritize support of innovative food production technologies like cultivated foods as part of the agricultural reforms that are critical to reduce global emissions of greenhouse gases.”
It is now increasingly possible for cell-based meat manufacturers to manufacture their products without the use of fetal bovine serum — the liquid derived from the blood drawn from a bovine fetus — enhancing the ethical claims of the industry. In addition, companies are working to develop the (edible) scaffolding needed to support cells on which cell cultures can grow and maintain structural integrity. There are examples of this scaffolding being produced via three-dimensional printing techniques, which presents investors with possible exposure to disruptive technologies that are increasingly prevalent in other industries.
With one cell-based meat product already on the market in Singapore (since December 2020), and the two products already cleared by the FDA in the U.S., it is only a matter of time before regulatory authorities in the EU will be processing applications for cell-based meat products. Though overdue, the scientific colloquium is a welcome opportunity for industry to get involved in shaping a workable EU legal framework for cell culture–derived foods.
