"On December 27, 2024, the Ministry of Health, Labor and Welfare of Japan issued Announcements No. 419 and 420 on Food Safety, amending two regulations on the management of tablets and capsules, aiming to improve the regulatory measures for similar products after the Kobayashi Pharmaceutical red yeast rice product damage incident. They are: (1) Revised the ""Guidelines for the Production Management and Quality Control of Tablets and Capsules"", mainly stipulating the inspection methods for the quality and safety of microbial raw materials (including algae) added to tablets and capsules, and adding new regulations for the preparation of specifications and product information display requirements for tablets and capsules containing microbial raw materials; (2) Introduce the revised content in point 1 into the ""Guidelines for Self-inspection of Raw Material Safety and Product Formula Design for Tablets and Capsules"", requiring the production and processing enterprises of such foods to implement the relevant requirements in self-inspection. The above revisions will take effect from the date of publication."
Consumer News Region