Japan Publishes Draft Safety Assessment Guideline for Cell-Cultured Foods
On May 28, 2026, Japan’s Consumer Affairs Agency (CAA) published meeting materials that include a draft safety assessment guideline for foods produced using cell culture technology [1]. The draft was discussed by the Food Sanitation Standards Council’s Subcommittee on Newly Developed Foods and reflects 13 rounds of government discussion over the past four years.
The draft builds on CAA’s earlier discussion materials [2], which outlined safety check points across three broad stages, i.e., cell sourcing, production process, and food processing. It further elaborates on these checkpoints, providing more detailed guidance on starting cells and cell characterization, manufacturing and quality controls, substances used during manufacture and cultivation, finished product specifications, as well as allergen and nutritional information.
Specifically, the draft requires submission of the information regarding the origin of starting cells and tissues, including donor animal health, collection and handling procedures, pathogen controls, veterinary drug residues, and naturally occurring toxins. In addition, it addresses manufacturing and quality control, requiring both general hygiene and HACCP-based contamination control measures, while also covering cell stability, cell banking, and cell monitoring during the culture process. Notably, the draft addresses the use of genetic modification and genome editing in cell-line development which may trigger additional review under Japan’s existing GMO or genome-edited food framework.
With the publication of this draft guideline in Japan, it demonstrates the efforts of the government to join the limited countries in the world that explicitly stipulate the requirements for cultured foods. For example, Singapore regulates such products under its novel food safety assessment regime. The United States adopted a coordinated framework by involving both the U.S. Food and Drug Administration (FDA) and United States Department of Agriculture (USDA‑FSIS) to share regulatory oversight of cell-cultured foods. Australia and New Zealand assess these products through the novel foods pathway, whereas Korea introduced guidance on dossier preparation and safety evaluation under its temporary standards and specifications system.
At this stage, Japan’s draft seems to be limited in scope, focusing on the specific items for confirmation within the safety assessment process, while broader elements, such as the overall framework of governing structure and legislative changes (e.g., whether Japan would develop a new framework of novel food), remains subject to future discussion involving multiple authorities.
For companies considering Japan as a future commercialization market, this draft offers helpful guidance regarding the safety evaluation of foods produced using cell culture technology. We will continue to monitor Japan’s development of safety guidelines and related requirements for cell-cultured foods. Please sign up for our newsletters here.
Keller and Heckman represents the food industry around the world on various regulatory matters. If you have questions about food law in Japan and other Asian countries, please contact David Ettinger (ettinger@khlaw.com), Jenny Xin Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.
[1] https://www.caa.go.jp/policies/council/fssc/meeting_materials/assets/fscc_cms105_260528_06.pdf
[2] https://www.caa.go.jp/policies/council/fssc/meeting_materials/assets/fscc_cms105_260527_07.pdf