On August 30, 2024, the Cabinet Office of Japan issued Notice No. 108 to develop production and processing standards for specific form functional foods containing natural extract ingredients, aimed at strengthening the management of similar foods after the damage incident of KOBAYASHI PHARMACEUTICAL’s health care products containing monascus ingredients.

The main contents include definition and terminology, applicable product scope (lozenges, capsules or other specific forms of functional food containing natural extracted ingredients), qualification management of production and processing enterprises, personnel and quality management system requirements, enterprise safety verification requirements for natural extracted ingredients in functional food, production process hygiene control requirements, inspection regulations for functional food, production traceability and management of sales records, verification requirements after major changes in production process and production environment, reporting procedures after adverse reactions occur, etc.

The effective date of the announcement is September 1, 2024.