Japan Proposes Expanding ISHA Regulated Chemical List: SDS and Labeling Rules to Update by April 2029

Japan’s Ministry of Health, Labour and Welfare (MHLW) is proposing amendments to the Industrial Safety and Health Act (ISHA) that will expand the list of regulated chemical substances requiring safety data sheets (SDSs) and hazard labeling.

As part of the rulemaking process, the MHLW scheduled an opinion-hearing session for overseas stakeholders on October 21, 2026, following a written submission deadline on October 19, 2026. The proposed ministerial ordinance is expected to take full effect in April 2029.

Regulatory Background

Article 57 and Article 57-2 of the ISHA oblige business operators who transfer or provide the chemical substances specified in Article 18 and Article 18-2 of the Order for Enforcement of the Act (Cabinet Order No. 318 of 1972) — namely "substances subject to labeling and SDS delivery obligations" (hereinafter "covered substances") — to give notification through labels indicating the substance names and through documents (SDSs, etc.) describing the hazards or harmful properties of the substances.

Under the current Articles 18 and 18-2 of the Order for Enforcement, covered substances are those designated by MHLW ordinance among the substances that have been classified as hazardous or harmful in the national chemical classification results as of March 31, 2025. The amendment is to extend this cut-off to March 31, 2026 (the end of Japanese fiscal year 2025), thereby bringing the classification results newly completed in FY2025 within the scope of the obligations, and to make corresponding additions, deletions, and name changes to Annexed Table 2 of the Industrial Safety and Health Regulations (Ordinance of the Ministry of Labour No. 32 of 1972).

Substances Proposed for Adjustment

According to the attached Outline of the Draft Partial Amendment to the Industrial Safety and Health Regulations, 35 covered substances are to be added, 1 deleted, and 4 existing entries renamed or otherwise adjusted. The additions cover solvents such as triethylene glycol, isothiazolinone preservatives, azo pigments, fluorinated compounds, natural rubber, and other types. The substance names and reference CAS numbers listed in each table are given below; the tables keep the Japanese substance names together with English reference names (whether a substance falls within the covered substances is determined by its Japanese name, and CAS numbers are for reference only):

Annexed Table 1 Substances Subject to Labeling and SDS Delivery Obligations (Additions, 35)

Note: *1 CAS numbers are not specified in the draft ordinance and are given for reference only; where structural isomers or similar cases exist, the same substance may be assigned different CAS numbers. In addition, some entries consolidate multiple substances under a single name as part of the reorganization of statutory names.

Annexed Table 2 Substances Subject to Labeling and SDS Delivery Obligations (Deletion, 1)

Annexed Table 3 Substances Subject to Labeling and SDS Delivery Obligations (Name Changes, etc., 4 Entries)

Note: *2 The monohydrate of lithium hydroxide is newly added this time; *3 non-fibrous silicon carbide is deleted this time, so the amended entry covers only fibrous silicon carbide; *4 the zinc salts of 2-mercaptobenzothiazole are newly added this time.

These obligations apply not only to the listed substances themselves but also to preparations and other substances containing them — business operators who transfer or provide preparations or other substances containing the listed substances are likewise required to comply with the labeling and SDS obligations. The draft partial amendment to the Industrial Safety and Health Regulations is scheduled to take effect in April 2029 (Reiwa 11).

Arrangements for the Overseas Stakeholder Hearing

This hearing is conducted under Japan’s Handling of the Creation of Standards and Certification Systems, etc. (decision of the Committee for the Promotion of Action Plan Implementation, September 30, 1985) as a statement mechanism set up specifically for overseas stakeholders. According to the notice, the arrangements are as follows:

1. Time: October 21, 2026 (Wednesday), 17:00–18:00.
2. Venue: Dedicated Meeting Room 12, 15th floor, Central Government Building No. 5, 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo; online participation is also available (via Webex or Teams only).
3. Eligible speakers: foreign stakeholders involved in the manufacture, import, etc. of covered substances, including foreign nationals and Japanese nationals working for foreign-affiliated companies.
4. Format: statements are to be made in Japanese to the officials in charge at MHLW.
5. Procedure: those wishing to make statements must prepare a written statement in Japanese stating their address, name, telephone number, affiliation, and a summary of their comments, and submit it to the reception desk by e-mail or post by October 19, 2026 (Monday) (must arrive by the deadline); this reception has now closed. Those wishing to participate online must state their intention to do so and the online tool available to them (Webex or Teams) in the body of the e-mail.
6. Reception desk: Chemical Substance Measures Office, Industrial Safety and Health Department, Labour Standards Bureau, MHLW (100-8916, 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo; tel: 03-5253-1111, ext. 5608; e-mail: risk-shourei@mhlw.go.jp).
7. Others: all expenses involved in making statements shall be borne by the speakers themselves.

CIRS Insights

In view of this list adjustment, chemical manufacturers and exporters to Japan are advised to note the following:

1. Screening affected substances: Check the three annexed tables to determine whether any ingredients of products exported to Japan fall within the 35 additions, the 1 deletion, or the 4 name changes. As covered substances also include preparations and other substances containing the listed substances, enterprises exporting downstream formulations should carry out the same screening.
2. Planning compliance updates in advance: The draft ordinance is scheduled to take effect in April 2029. Although enterprises dealing in newly added substances have a long transition period, they are advised to incorporate substance screening and label and SDS updates into their compliance plans ahead of time; enterprises involving the deleted substance (diethyl phthalate) or the renamed entries (such as silicon carbide, 2-mercaptobenzothiazole and its zinc salts, and lithium hydroxide) should pay attention to the changes in the obligation status of these substances.
3. Following up on developments: The reception of comments from overseas stakeholders closed on October 19, 2026, and the hearing is scheduled for October 21, 2026. Enterprises are advised to keep following MHLW’s subsequent deliberations and the official release of the draft ordinance.

What Can CIRS Do for You

CIRS Group is a leading provider of comprehensive regulatory compliance services and solutions for chemicals, cosmetics, food and food-related products, agrochemicals, and medical devices. Its chemical team consists of experts with extensive knowledge in chemistry, toxicology, environmental science, and related fields. They are well-versed in various international regulations, including but not limited to CSCL, EU REACH, CLP, GHS, TSCA, and K-REACH. 

CIRS operates a fully owned subsidiary in Japan. By leveraging the expertise of CIRS Japan and the international team, CIRS can provide enterprises with various Japanese chemical services, including but not limited to:

• Japan New Chemical Substance Search Service
• Japan New Chemical Substance Notification Service
• Overall Registration Strategy Development (Data Assessment / Gap Analysis / Exemption Analysis)
• Laboratory Testing Supervision Service
• Communication and Consultation with Competent Authorities and Experts
• Regulatory Training Service
• SDS (Safety Data Sheet) and Label Preparation

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further information

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