Japan Proposes SDS Rule for Trade Secret Name Substitution

By Yuko Howell, Regulatory Affairs Lead, Supply Chain Team, UL Solutions

Effective April 1, 2026, Japan will introduce a new provision under the Industrial Safety and Health Law (ISHL) that permits the use of alternative chemical names in Safety Data Sheets (SDSs). This regulatory change aims to enhance protection of confidential business information (CBI) while maintaining transparency in hazard communication.

Two key draft documents outlining the proposed framework are currently open for public comment:

• Draft Ministerial Notification: Issued by the Ministry of Health, Labour and Welfare (MHLW), this document identifies eligibility criteria for alternative naming for substances with relatively low toxicity that may qualify for alternative naming.
  • Comment deadline: Nov. 22, 2025
• Draft Implementation Guidelines: This document details the procedures for providing substitute chemical names in SDSs, including rules for constructing substitute names by omitting or replacing parts of a chemical structure to protect CBI.
  • Comment deadline: Nov. 16, 2025

Under the proposed system, companies may use a substitute chemical name in SDSs if the substance meets specific criteria. According to the draft ministerial notification (to be added as Article 34-2-6-2 of the Ordinance on the ISHL), eligible substances must pose a relatively low risk to worker health or safety and meet all the following conditions:

• The substance is not:
  • Subject to special regulations (e.g., the Ordinance on Prevention of Hazards Due to Specified Chemical Substances),
  • Listed under Article 577-2(2) of the Ordinance on the ISHL (substances with concentration standards), or
  • Listed under Article 594-2(1) of the Ordinance on the ISHL(chemical substances causing skin damage).
• Based on GHS classifications as of March 31, 2025, the substance:
  • Is not classified under hazard classes for germ cell mutagenicity, carcinogenicity, or reproductive toxicity, or
  • Is present in a mixture at concentrations below the relevant GHS cut-off limits for these classes.
• The substance is not classified as Category 1 for any of the following hazard classes:
  • Respiratory sensitization
  • Skin sensitization
  • Aspiration hazard
  • Skin corrosion/irritation
  • Serious eye damage/eye irritation
  • Specific target organ toxicity (single or repeated exposure)
• The substance is not classified as Acute toxicity Categories 1 to 3.
• If part of a mixture, the substance must be present below the applicable GHS cut-off limits for any of the above hazard classes.

Rules for Constructing Substitute Names

According to the implementation guidelines, a substitute chemical name may be created by omitting or replacing part of the structural or compositional information in the original chemical name. Specifically, one of the following four elements may be replaced with a generic term or deleted:

• The structure of the base compound
• The structure and number of counter ions
• Stereoisomeric information
• The structure, number, and position of substituent groups attached to the base compound or other substituents

In principle, details such as position numbers of substituents and the number of substituents on the base compound can be deleted, and other detailed information may be replaced with generic terms.

If replacing or omitting only one element is insufficient to prevent identification of the substance—such as when the structure is simple—up to two elements may be replaced or omitted.

Furthermore, if even after replacing or omitting two elements, the number of applicable substances is very limited and there remains a risk that the composition information could be identified, companies may instead disclose the hazard classification information of the substance in place of a substitute name.

Next Steps

This new provision is intended to support both risk assessment implementation and trade secret protection. The final ministerial notification is expected to be finalized in Dec. 2025, with the provision taking effect on April 1, 2026.

References

Draft Ministerial Notification (Japanese only)
Draft Implementation Guidelines (Japanese only)