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On December 26, 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a ministerial notice to clarify the definition of “carcinogenic substances” regulated under the Ordinance on Industrial Safety and Health (hereafter referred to as the Ordinance) as
Substances (excluding ethanol and the substances subject to special regulatory measures according to the Ordinance on Prevention of Hazards Due to Specified Chemical Substances), designated from the ‘Substances that are subject to risk assessment in the workplace’ if classified by the authority into carcinogenicity category 1 as per JIS Z 7252 Appendix B before March 31, 2021.
Background
The Ordinance is a subordinate regulation to the Industrial Safety and Health Act (ISHL). On May 31, 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved the amendments to the Ordinance, which heightened the requirements related to risk assessment in the workplace. For carcinogenic substances designated by the authority, employers shall keep records for 30 years of relevant exposure records.
Designation of carcinogenic substances
‘Substances that are subject to risk assessment in the workplace’ are those subject to mandatory SDSs and labelling obligations under ISHL. As of 1 January 2022, only 674 hazardous substances are subject to compulsory GHS labelling and SDS requirements. Another 234 substances were newly added in February 2022 and to implement the requirements from April 1, 2024 (CL news).
Along with the notice， the MHLW announced two batches of 200 carcinogenic substances, including:
120 substances (selected from the 674 substances), effective from April 1, 2023; and
80 substances (selected from the 234 substances), effective from April 1, 2024.
Why are ethanol and the substances subject to special regulatory measures according to the Ordinance on Prevention of Hazards Due to Specified Chemical Substances excluded?
Although ethanol is classified into carcinogenicity category 1, the most common route of ethanol ingestion is oral which is basically not possible in the workplace. So, it is excluded. The substances subject to special regulatory measures according to the Ordinance on Prevention of Hazards Due to Specified Chemical Substances are excluded because they already have a 30-year record-keeping requirement.
Employers shall keep records for 30 years of the workers’ names, outlines of work, work records, and the status of workers’ exposure to these substances. However, it does not apply to enterprises handling these substances on a temporary basis, which relates to if it is handled outside the normal process and has nothing to do with the amount or frequency of use. In other words, even if the amount or frequency of use is extremely low, as long as it is included in the normal process, it needs to meet the 30-year record-keeping requirement.
