On November 21, 2024, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued Proposal No. 235110008, proposing to revise two food management regulations for tablets, capsules, etc., in order to improve the regulatory measures for similar products after the damage incident of KOBAYASHI PHARMACEUTICAL's health care products containing monascus ingredients. The details are as follows:

(1) Revise the "Guide for the Production Management and Quality Control of Tablets, Capsules and Other Foods", the main content of which is to stipulate the inspection and inspection methods for the quality and safety of microbial raw materials (including algae) added to tablets and capsules of food products, and added the production regulations and product information display requirements of the specifications of tablets and capsules containing microbial raw materials;

(2) Introduce the above revised content into the "Guidelines for Voluntary Inspection of Raw Material Safety of Tablets, Capsules and Other Foods", requiring such food production and processing enterprises to implement relevant requirements in independent inspection. The proposal has a comment period until December 23, 2024.