Japan Regulatory News

On 3 October 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MoE) jointly released a draft proposal to d...

On 26 September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced the addition of 149 new chemicals to the Existing and New Chemical Substances (ENCS) List. The ENCS list is regu...

Update 2: On 19 September 2025, in line with the scheduled timeline Japan’s MHLW published the final Cabinet Order delisting the two chemicals from the mandatory list requiring labelling and safety ...

Update 2: On 19 September 2025, in line with the scheduled timeline Japan’s MHLW published the final Cabinet Order delisting the two chemicals from the mandatory list requiring labelling and safety data sheets (SDS). The order was published on Japan’s e-GOV Public Comment Portal and entered into force on the same day.

As of 19 September 2025, the following substances are o longer subject to mandatory labelling or SDS requirements.

• Sodium stearate (CAS: 822-16-2)
• Phosphoric acid, triphenyl ester (CAS: 115-86-6) 

Update: On 29 July 2025, Japan's MHLW released the revised enforcement notice to remove the chemicals from the list of mandatory safety data sheets (SDS) and labelling. The notice was published on the Japanese e-GOV Public Comment Portal by MHLW. The enforcement date was rescheduled by the government from April 1, 2027, to late September 2025. This notice will take effect on the day it is promulgated, as two chemicals i.e. sodium stearate and phosphoric acid, triphenyl ester will be removed from the list. The deadline for stakeholder comments on this draft is August 28, 2025.

Original Text:

On 8 October 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified a draft to the World Trade Organization (WTO), proposing amendments to the list of chemicals and mixtures that require mandatory labelling and safety data sheets (SDS). This update, which would amend the Enforcement Order of the Industrial Safety and Health Act and is scheduled to be adopted in December 2024. Under the provisions of the Industrial Safety and Health Act (ISHA), it is mandatory to follow the Globally Harmonized System (GHS) for labelling.

Public consultation in September 2024

On 20 September 2024, the MHLW launched a consultation to not only add 155 substances to the classification list, but also to eliminate two substances from the list, which includes substances classified until 31 March 2024.

Comment Period and Enforcement Dates

Stakeholders are invited to comment on the draft proposal until 7 December 2024. The 155 chemicals are expected to be added to the list by April 2027. At the same time, sodium stearate and phosphoric acid, triphenyl ester will be eliminated from the list.

On 19 September 2025, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly released the 2026 notifica...

On 19 September 2025, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly released the 2026 notification schedule for new chemical substances (including low production volume new chemicals). The full schedule, comprehensive details, and guidance documents are available on the METI portal.

Notifications are required for  new chemicals that are manufactured or imported into Japan under the Chemical Substances Control Law (CSCL).

Annual Update of Notification Timetable

Japan revises its new chemical notification schedule each year in September. The 2025 schedule was announced on 19 September 2024 (more details can be found here), and the newly published timetable covers October 2025 through December 2026.

Notification Schedule (2026)

Submissions will be accepted in 10 rounds during the period October 2025-December 2026). The detailed schedule is given in the table below:

*Submissions  are accepted only until 3 p.m. on the designated date. Missed deadlines automatically roll over to the next round.

Documentation Required                 

Applicants must prepare the following documentation in line with CSCL requirements and the official manual:

• Preliminary review materials (detailed data on substance properties, toxicity, environmental behaviour)
• Notification form (official format under CSCL)
• Supporting data: test reports, safety evaluations, or judgment notification copy if applicable.

For substances already reviewed and notified, applicants may resubmit using a copy of the previous notification result. In such cases, no new review is required, provided the notification is submitted by any of the scheduled deadlines.

Future Outlook

Although METI has not yet disclosed the 2027 notification schedule, it is anticipated to be made public in September 2026.

Update: On 10 September 2025, Japan’s Consumer Affairs Agency (CAA) published the revised manual of standards for substances in food contact materials (FCMs.) The update includes changes to Append...

Update: On 10 September 2025, Japan’s Consumer Affairs Agency (CAA) published the revised manual of standards for substances in food contact materials (FCMs.) The update includes changes to Appendix 1, which outlines the information required for the addition of new additives to the Positive List (PL).

Applicants must now provide detailed data on the substance's identity, physicochemical properties, migration into food, safety assessment, intended purpose and use, as well as draft standards for inclusion in the PL. The previous manual which was issued on 28 May 2025 has been abolished with the publication of this revised edition.

Original Text:

On 28 May 2025, Japan’s Consumer Affairs Agency (CAA) released updated guidelines relating to Food-Contact Materials (FCMs) under the Food Sanitation Act. The CAA published the guidelines on its official portal. This time, the CAA has revised the procedures for:  

1.       Appendix 1 of the Standards for Food, Additives, etc for substances to be added or revised. 

2.       The Monomer Notification, which lists allowable monomers and processing agents in food-contact materials.  

These updates replace the 2020 guidelines and aligns with the end of the Positive List (PL) transitional period on 31 May 2025. The new guidelines are mandatory from 1 June 2025. 

Previous Update in May 2020 

The CAA previously revised the guidelines for FCMs in May 2020. 

Key Insights from the Standards: 

1. Two Types of Revisions: 

• Appendix 1: For substances expected to be widely used.
• Monomer Notification: For additions or changes to monomers and treatment agents. 

2. Procedure: 

• Advance consultation with the Consumer Affairs Agency is required.
• Submit official forms (Form 1 or 2) with supporting documents.
• Safety and migration data must follow Japan's Food Safety Commission 2019 Guidelines.
• A withdrawal form (Form 3) is provided if needed. 

3. Required Documents:  

Substance name, structure, safety data, usage scope, migration test results, and global regulatory status. 

Original Text:e-GOV Public Comment Portal    draftand are given below:    2. Changes to Electronic Notification Requirements (Articles 20–21)In addition to electronic signatures,  (e.g.,...

Update: On 17 September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MoE) jointly announced the promu...

Update: On 17 September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MoE) jointly announced the promulgation date for the order on the e-GOV Public Comment Portal. According to the information provided, the final order will be promulgated on 8 October 2025.