July 27, 2022
by Yuko Howell, senior regulatory specialist, UL Solutions, Supply Chain team
Japan’s Industrial Safety and Health Law (ISHL) made changes to its Safety Data Sheet (SDS) requirements by amending the Ordinance on the Industrial Health and Safety Law, issued on May 31, 2022. The new requirements in the amendment pertain to information on product use and its restriction in Section 1 and composition information in Section 3. The amendment also introduces a five year review cycle of hazard information on the SDS. These changes are aimed at reinforcing the employers’ risk assessment effort required by the law to protect the health of workers from hazardous chemicals.
Information on recommended use of the chemical and restrictions on use
Recommended use of the chemical and restrictions on use is part of the minimum information requirements for Section 1 established by the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), of which the sixth revision is the latest version Japan has implemented in its standards. The amendment considers this as a critical piece of information in the risk assessment process and makes the information mandatory on SDS. Under the subheading of recommended use, chemical suppliers must identify the intended product use. It is not necessary to include the full list of potential uses. If the recipient of the chemical intends to use the product for purposes other than those listed on the SDS, they shall conduct a risk assessment and put the necessary measures into place.
When there is a specific use that the supplier advises against, the use must be included under the subheading of restrictions on use. Otherwise, generic statements such as “Use other than those listed above is prohibited,” or “Consult chemical experts when used other than those specified,” would be sufficient, as suggested by Japan Chemical Industry Association in its guidance published in supplement to the amendment.
This requirement will take effect on April 1, 2024.
New rule on composition information
The amendment now requires the actual percentage by weight to be included on the SDS for the regulated substances in a mixture product. The ISHL currently regulates 930 hazardous chemical substances by requiring preparation of SDS. When contained in a mixture product, the identify of this chemical substance must be disclosed on the SDS. Along with the chemical name, the concentration information must appear, and the amendment now requires it to be the exact percentage by weight, and a range expression is only permitted in cases where the content of the chemical varies depending on the production method or a single SDS is prepared for multiple products with the same ingredients but in varied concentrations.
When the identity and/or concentration of a regulated substance is considered as confidential business information, this information does not need to be disclosed on SDS. However, the information must still be delivered to the recipients by other means, possibly under non-disclosure agreement. This will not be applicable to the substances, for which the government is currently developing exposure limits.
This requirement will take effect on April 1, 2024.
Five year review cycle of hazard information
The ISHL requires product’s hazard information of chemical product to now be periodically reviewed and updated as necessary. Hazard information is essential in conducting risk assessments of chemicals. The focus of the law is primarily on the effect of chemicals on human health, more specifically, the health hazard endpoints identified under the GHS; however, all other endpoints including physical and environment hazards shall be subject to the review. The review must be completed within five years, counting from the date when the classification of the product was last determined or reviewed.
This requirement will take effect on April 1, 2023. For products existing in commerce on the effective date, the first review shall be completed by March 31, 2028.
When the review requires changes to the existing SDS, the update must be completed within a year of completion of the review. Consequently, the chemical supplier must notify its customers and communicate the updated information. This is a mandatory requirement for a regulated substance and any mixture product containing regulated substance(s).
When no change is necessary, it is advisable to keep the record of the date of review so that the next review is completed timely within next five years.
Modernized SDS delivery method
Much to the relief to the industry, the amendment relaxed the requirement concerning how SDSs are delivered to the recipient. Prior to the amendment, a supplier of the chemical must get approval from its recipients for the delivery method. The amendment removed this burden, and SDSs can now be delivered using the method the supplier chooses, for example, emailing a URL to the document or the document itself as an attachment. This provision has taken effect since the date the amendment was issued.
Recommended action items
- The SDS template or format must be reviewed and updated to reflect the new and updated requirements.
- Revise and update the existing Japan SDSs using the updated template by April 1, 2024.
- Prepare and set up product hazard review process, if not already in place.
Amendment to the Ordinance on the Industrial Health and Safety Law
Notification of Labour Standards Bureau Chief of Ministry of Health, Labour and Welfare Notification No. 0531-9
Japan Chemical Industry Association’ publication on model SDS in supplement to the amendment to the Ordinance