Japan Seeks Public Feedback on Re-categorization of Substances Subject to SDS and Labelling Requirements

The Japanese Ministry of Health, Labour and Welfare (MHLW) has opened a public consultation period until July 20, 2023, seeking opinions on the revision of the Enforcement Order of the Industrial Safety and Health Law (ISHL). The purpose of the revision is to re-categorize substances that are subject to mandatory SDS and labelling requirements. It is expected to be finalized in early August 2023.

Currently, the “substances that are subject to mandatory SDS and labelling requirements” are listed in Schedule 3 and Schedule 9 of the ISHL Enforcement Order. The proposed revision will categorize these substances into four categories:

Category A. 33 elements and their compounds;
Category B. Substances officially classified with GHS classifications as of March 31, 2021, excluding:

1. Substances listed in Schedule 3, Item 1 (7 substances) of the ISHL Enforcement Order;

2. Substances in category A; and

3. Substances that only pose a hazard to respiratory organs due to dust inhalation.

Category C. Preparations containing substances in categories A and B, with thresholds set by the authority;
Category D. Preparations containing No.1~7 substances listed in Schedule 3 of the ISHL Enforcement Order.

The substances listed in Schedule 3, Item 1 of the ISHL Enforcement Order are strictly controlled under ISHL. They are:

The proposed draft lists for category A and category B substances are open for public comments. The 33 elements and their compounds in category A are already managed under the current regulation. However, for category B substances, in addition the currently managed GHS classified substances, approximately 1,550 substances will be newly added to this category. As per the plan, 1,497 category B substances will be subject to labeling and SDS obligations starting from April 1, 2025, and 779 substances starting from April 1, 2026. A one-year buffer period will be provided for these newly added substances. 

In addition, seven substances will be deleted from the current regulation, which means that they will be exempt from labeling and SDS obligations under ISHL upon the official publication of the revised ISHL Enforcement Order. The seven substances are equivalent to the third type of substances excluded from category B. They are: