On August 23, 2024, the Japanese Cabinet Office issued Cabinet Order No. 71, revising food labeling standards. The revision mainly relates to the functional food labeling system, with the aim of avoiding the recurrence of harmful incidents of KOBAYASHI PHARMACEUTICAL monascus-related products. The main contents include:

(1) Added items for compliance by functional food declarants. If the operator of a functional food, as a declarant, labels "specific health purposes" based on the added functional ingredients, a supplementary report is required to the Commissioner for Consumer Affairs when new scientific evidence is available; The manufacturing management and quality management process of functional foods in the form of tablets and capsules shall conform to GMP standards; If a consumer is suspected of health damage after ingestion of a functional food, even if the causal relationship with the food is not clear, the business operator is required to report the relevant information to the administrative authority urgently based on the health injury information and doctor's diagnosis; After the successful declaration of functional food, the operator shall conduct a self-evaluation every year on whether the functional ingredients can achieve the specific health purposes claimed by the label, and report the evaluation results to the Director General of the Consumer Department;

(2) Modify the labeling requirements for functional food. Because functional food is different from specific health food and pharmaceutical products in terms of functionality and safety, its label should be marked with the interaction with pharmaceutical products and other products and precautions to prevent excessive intake; In addition, the functional food label should also mark the name and contact information of food operators and other basic information related to food operators, information on safety and functional basis, manufacturing and quality management information, health hazard information collection system and other necessary matters;

(3) The review period of the newly declared functional component information will be changed from the current 60 working days to 120 working days, etc. The effective date of the amendment is September 1, 2024.

Learn more: https://www.caa.go.jp/policies/policy/food_labeling/food_labeling_act/assets/food_labeling_cms201_240823_11.pdf