April 30, 2021
by Yuko Howell, senior regulatory specialist
As we alerted in our previous article “Japan to Require SDS and Labelling for Benzyl Alcohol,” Japan’s Minister of Health, Labour, and Welfare (MHLW) is making progress with its plan to expand the number of hazardous chemical substances subject to mandatory Safety Data Sheets (SDSs) and labels under its Industrial Health and Safety Law (ISHL).
An interim plan and timeline of implementation were presented at the 13th meeting, held on April 27, 2021, of the Study Group under the MHLW Concerning the Management of Chemical Substances in the Workplace.
The plan aims to add several hundred chemical substances to Table 9 of the Cabinet Order of the ISHL per year for the next three years. Table 9 of the Cabinet Order currently identifies 633 chemical substances. The ISHL requires chemical suppliers to prepare an SDS and label for substances listed in Table 9.
Chemical suppliers also must prepare an SDS and label for mixtures containing substances in Table 9 above the cut-off value found in Table 2 of the Ordinance of ISHL. The additional substances to be added to Table 9 are to be selected from the 3,018 substances the Japanese government has classified and published according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Substances will be prioritized and added according to presence of hazards corresponding to the GHS hazard categories as follows:
|Timeline||Number of substances with existing GHS classification to be added to Table 9 (approximate)||GHS hazard category|
|2021||256||Germ cell mutagenicity - Category 1
Carcinogenicity - Category 1
Reproductive toxicity - Category 1
|2022||681||Category 1 of other GHS health hazards|
|2023||843||Category 2 or below of other GHS health hazards or having GHS physical hazards|
There will be a transitional period of two to three years prior to enforcement.
The government has committed to classifying 50 to 100 additional chemical substances per year according to the GHS. Substances classified with physical and health hazards will likely be added to Table 9 in 2024 and subsequent years.
While an SDS and label is required for substances with published classifications, the government does not require the use of the published classifications.
UL will update you on the selection of chemicals by MHLW as the announcement is expected in the near future.
The report containing the interim plan and schedule https://www.mhlw.go.jp/content/11303000/000771816.pdf (Japanese)
The results of the existing GHS classification carried out by the government are available from National Institute of Technology and Evaluation (NITE) website