October 27, 2020
On October 16, 2020, Japan announced new amendments to the Cabinet Order and Ordinance of the Industrial Safety and Health Law (ISHL). The new amendments intend to mandate the preparation of a Safety Data Sheet (SDS) and a label for Benzyl alcohol and products containing the substance in a concentration of 1% or above. The amendments are expected to be published in early December and to take effect January 1, 2021.
The ISHL is one of the legislations in Japan implementing the Globally Harmonized System of Classification and Labelling (GHS). The law selects a set of hazardous substances subject to GHS SDS and labelling requirements. Table 9 of the Cabinet Order of the ISHL currently identifies 633 chemical substances as such, and Table 2 of the Ordinance of ISHL sets the concentration limit for each substance listed in Table 9 of the Cabinet Order.
A transitional measure of 6 months is proposed on the labelling requirement, and chemical suppliers are to have until June 30, 2021 to update the label of their existing Benzyl alcohol and Benzyl alcohol mixture products if the amendments take effect on January 1, 2021.
The proposal of regulating Benzyl alcohol was discussed and decided during the 7th meeting of the Study Group Concerning the Management of Chemical Substances in the Workplace held on July 16, 2020 by Ministry of Health, Labour and Welfare (MHLW). Some key decision points include:
- The hazards of Benzyl alcohol have been identified via the government’s GHS classification project. MHLW and Ministry of Environment (MOE) classified and published the GHS classification of Benzyl Alcohol in 2009 and subsequently revised it in 2020. Among the hazards identified are:
- Specific target organ toxicity – Single exposure (central nervous system, kidney)
- Specific target organ toxicity – Repeated exposure (central nervous system)
- There is an increase in the number of accidents involving Benzyl alcohol in the workplace. Five cases of acute poisoning have been reported to the Labour Standards Inspection Office under MHLW in the last 12 months.
- Benzyl alcohol is considered a high production volume chemical (HPV) in Japan. According to the data collected under the scheme of Japan’s Chemical Substances Control Law, the total volume of the domestic production and import of the substance in the year 2018 was 6,000 tons.
The further expansion of the Table 9 substances was also agreed upon during the Study Group meeting, and in the future, the number of substances subject to the mandatory SDS and label could potentially increase to 3,014 substances, for which the Japanese government has so far published GHS classifications.
Recommended Action Items
- Review your products to determine if updates are required for their SDS and label. The amendment will require the disclosure of Benzyl alcohol on the SDS and label when the concentration is 1% or above.
Draft of an amendment to the Cabinet Order of Industrial Safety and Health Law (Summary) – https://search.e-gov.go.jp/servlet/PcmFileDownload?seqNo=0000207775 – (Available in Japanese only)
Draft of an amendment to the Ordinance of Industrial Safety and Health Law (Summary) – https://search.e-gov.go.jp/servlet/PcmFileDownload?seqNo=0000207777 – (Available in Japanese only)
MHLW Document outlining its approach concerning the expansion of Table 9 – https://www.mhlw.go.jp/content/11201000/000667652.pdf – (Available in Japanese only)
GHS Classification Result for Benzyl alcohol by the Japanese Government, revised in 2019 and published 2020 – https://www.nite.go.jp/chem/english/ghs/19-mhlw-2005e.html