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Update:
On February 24, 2022, Japan Ministry of Health, Labor and Welfare (MHLW) officially added 234 substances to Schedule 9 of the Enforcement Order of ISHL[1], with corresponding content thresholds[2] for providing SDS and labels in Schedule 2 of Ordinance on Industrial Safety and Health. It will be implemented on April 1, 2024. A one-year buffer period will be granted until March 31, 2025.
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On December 28, 2021, Japan MHLW announced lists of candidate substances[3] for mandatory SDS and labeling requirements in 2022 and 2023, based on which the official lists will be developed.
The list of 2022 includes 675 chemicals identified in category 1 of hazard classes other than carcinogenicity, germ cell mutagenicity, reproductive toxicity, and acute toxicity. They are expected to be officially added in 2022 and implemented on April 1, 2025.
The list of 2023 includes 827 chemicals with health hazards in category 2 and below, or chemicals without health hazards but with physical-chemical hazards. They are expected to be officially added in 2023 and implemented on April 1, 2026.
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On December 16, 2021, the MHLW consulted to add 234 substances[4] to Schedule 9 of the Enforcement Order of ISHL, with corresponding content thresholds for providing SDS and labels in Schedule 2 of Ordinance on Industrial Safety and Health. The list with CAS RN for 234 substances[5] is available on the website of the National Institute of Occupational Safety and Health (JNIOSH). The deadline for comments is January 14, 2022. The revisions are expected to be released in February 2022 and implemented in April 2024. A one-year buffer period will be granted until March 31, 2025.
These 234 substances require mandatory risk assessment for chemical manufacturers and downstream users, not for importers. Previously companies have a best effort obligation to implement risk assessment for substances subject to SDS delivery, but it was changed to a mandatory obligation when ISHL was revised in 2016.
At present, 674 substances are listed in Schedule 3 and Schedule 9 of the Enforcement Order of ISHL, which are subject to mandatory SDS and labeling requirements. According to the final report of the Seminar on the Management of Chemical Substances in the Workplace published on July 19, 2021, the MHLW is planning to designate more substances for mandatory SDS and Label requirements.
So far, the authority has classified 2,900 substances with GHS classifications, of which about 1,800 hazardous substances are proposed to mandate SDS and labeling requirements under ISHL in the following three years. As planned about 250 substances will be added in 2021, 700 substances in 2022 and 850 substances in 2023. This is the third-time consultation on the first batch of substances. The number of substances was reduced compared to the last two consultations.
First time: on August 30, 2021, the MHLW consulted on the Implementation of Health Hazard Prevention Measures for 236 Substances (Chemlinked news)[6], and
Second time: on October 14, 2021, the MHLW issued a WTO-TBT prior notice to consult on 237 substances.
