On November 20, 2023, the Ministry of Health, Labour and Welfare of Japan (MHLW)  issued Proposal No. 495230249 to amend the “Guidelines for Voluntary Inspection of the Safety of Food Raw Materials such as Tablets and Capsules” (Draft for Comment) and the “Production Control and Quality Control of Food such as Tablets and Capsules” (Draft for Comment). As a result of amendments to the Food Hygiene Law in 2018, it is mandatory to contain specified ingredients in "health food" based on Good Manufacturing practice (GMP). Whether or not applicable to foods containing specified ingredients, etc., a certain degree of manufacturing and quality control is required for foods in the form of tablets, capsules and other concentrated ingredients. In addition, according to various survey results, about 3 to 6% of the population uses "health food" to maintain physical condition and health, and the importance of correctly evaluating the safety of each raw material and manufacturing products of a certain quality has further increased. The main revisions are as follows:

(1) The overall structure of the guidance is based on the importance of ensuring the safety of raw materials and proper product design and manufacturing based on GMP;

(2) Clarify the scope and definition of the draft Guide and clarify other terminology;

(3) The Guidelines for Voluntary Inspection of the Safety of Food Raw Materials such as Tablets and Capsules (Draft for Comment) clarify the concept of voluntary inspection of the safety of raw materials, and add a description of the precautions for product design. In addition, an overall review of the flow chart for voluntary inspection of raw material safety was conducted;

(4) The Production Control and Quality Control of Food Products such as tablets and Capsules (Draft for Comment) provides a more specific description of the description in a manner consistent with GMP for specified ingredients, and clarifies the whole. In addition, in addition to GMP, attention should be paid to hygiene management in accordance with the Food Hygiene Act.

The above regulations are planned to be issued and implemented in late June 2024, and the feedback period ends on December 21, 2023.