細胞培養食品（いわゆる「培養肉」）を取り巻く最近の情勢について―その開発状況と安全性に係る諸外国の規制動向

抄録

Cell-cultured foods, also known as "cultured meats," are novel foods produced by mass cultivation of animal-derived cells. These foods lack a history of safe use that would help ensure their safety. There are no internationally established safety assessment methods yet, perhaps because there are many unknowns regarding hazard factors. Here we provide a comprehensive overview of the current status of cell-cultured food development and safety regulatory trends in other countries based on publicly available information, with the aim of identifying potential hazard factors related to these foods.

We investigated development examples from 22 major companies and found that the animal species being developed ranged from common livestock and poultry to fish, crustaceans, and wild animals. Established cell lines are more common than primary cultured cells, and a variety of cells, not just skeletal muscle, are being developed, including ES/iPS cell lines, mesenchymal stem cell lines, myoblast cell lines, and fibroblasts.

On the other hand, regarding regulatory trends, the sale of cell-cultured foods has become possible in five regions, including Israel, Hong Kong, and Australia/New Zealand, following Singapore and the United States. The products have expanded from chicken and quail to include beef, pork, and fish (salmon). The pre-market safety confirmation process can be broadly divided into two forms: 1) review and approval as Novel Foods (the EU-style) and 2) pre-market consultation (the US-style), which does not require licensing. The Singapore Food Agency's safety assessment requirements call for detailed information on cells, inputs, and manufacturing processes, as well as safety explanations. However, only the FDA and FSANZ publish safety assessment documents.

Meanwhile, the FAO/WHO report identified a relatively large number of potential hazards at each manufacturing stage. The authors pointed out that the potential hazard factors specific to cell-cultured foods include mutant proteins, novel allergens, and physiologically active substances that are resistant to digestion and heat.