Japan Regulatory News

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, as per the scheduled timeline Japan’s MHLW published the final cabinet order to delist the two chemicals from the mandatory list of labelling and safety data sheets...

Update 2: On 19 September 2025, as per the scheduled timeline Japan’s MHLW published the final cabinet order to delist the two chemicals from the mandatory list of labelling and safety data sheets (SDS). Order was published on the Japan’s e-GOV Public Comment Portal. At the same day of publication, order comes into force. So from 19 September 2025, two chemicals i.e. sodium stearate (CAS: 822-16-2) and phosphoric acid, triphenyl ester (CAS: 115-86-6) will no longer need label or SDS obligation.

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 CAA published the revised manual of standards for substances in FCMs. The information needed for the inclusion of new additives to the PL has been updated in...

Update: On 10 September 2025, Japan’s CAA published the revised manual of standards for substances in FCMs. The information needed for the inclusion of new additives to the PL has been updated in Appendix 1. Information about the substance, physicochemical characteristics, migration to food, safety data, purpose, use, and draft standards are necessary for the addition of new additives. The previous manual which was issued on 28 May 2025 was abolished with this update.

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 17th September 2025, Japan’s MHLW, METI and MoE jointly released the promulgation date for the order on the e-GOV Public Comment Portal. As per the information from the portal, the fin...

Update: On 17th September 2025, Japan’s MHLW, METI and MoE jointly released the promulgation date for the order on the e-GOV Public Comment Portal. As per the information from the portal, the final order will be promulgated on 8 October 2025.

On 16 September 2025, Japan released draft Cabinet Order which amends parts of the Enforcement Order of the Chemical Substances Control Law (CSCL). This aligns the decision at the 10th Conference o...

On 16 September 2025, Japan released draft Cabinet Order which amends parts of the Enforcement Order of the Chemical Substances Control Law (CSCL). This aligns the decision at the 10th Conference of the Parties (COP10) to the Stockholm Convention on Persistent Organic Pollutants (June 2022) to eliminate Perfluorohexane sulfonic acid (PFHxS)-related substances. Following review by Japan’s three relevant ministries—the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of the Environment (MoE)-these substances will be designated as Class I Specified Chemical Substances under CSCL. This designation prohibits their manufacture, import, and use, as well as the import of products containing them.

Previous update in August 2024

Earlier on 1 August 2024, Japan’s MHLW, METI and MoE jointly released the draft for designating PFHxS-related substances as Class I Specified Chemicals under CSCL. Also importing the products containing PFHxS-related chemicals will be banned. More information can be found here.

Key Changes from the draft

The provisions which are proposed in the draft are:

• PFHxS-related substances designated as Class I Specified Chemicals → Manufacture, import, and use banned.
• Import bans on products containing these substances.
• Exemption removed for 8:2 Fluorotelomer Alcohol (no longer considered “difficult to substitute”).
• Technical standards & labelling rules updated accordingly.
• Transitional provisions included.

Obligations for Stakeholders

Once designated as a Class I Specified chemical, PFHxS or related chemicals will be prohibited to manufacture, import, and use, as well as the import of products containing them. Stakeholders need to search for alternatives to PFHxS or apply for specific permit to continue the activities.

Comment Period and Enforcement Dates

Stakeholders can comment on this draft proposal by 15 October 2025. Partial enforcement will begin in December 2025, the same day the final cabinet order is promulgated. But starting in June 2026, full enforcement will take place.