On July 12, 2024, the Japanese Ministry of Health, Labour and Welfare of Japan (MHLW) issued Proposal No. 235080075, which intends to formulate production and processing standards for functional foods containing natural extracted ingredients, in order to strengthen the management of similar foods after the damage incident of KOBAYASHI PHARMACEUTICAL health care products containing monascus ingredients.

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

The proposal is subject to a comment period ending August 16, 2024.