Japan Regulatory News

On 27 October 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MOE), acting as a joint council, published the...

On 27 October 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MOE), acting as a joint council, published the consultation schedule for toxicity assessments of new chemical substances. The schedule was released on the National Institute of Technology and Evaluation (NITE) portal. New chemical substances are those not yet listed in the Existing and New Chemical Substances inventory (ENCS).

Purpose

The consultation schedule is intended to assist companies plan requests for expert consultation to verify the scientific validity of their non-standard methods (such as analogue methods and QSAR) used to assess degradability, accumulation, and toxicity before notifying a new chemical substance under the Chemical Substances Control Law (CSCL). 

Schedule

Obligations for the Stakeholders

Under the CSCL, manufacturers and importers must notify new chemical substances which are not yet listed on the ENCS to the MHLW, METI and MoE. Companies must apply for consultation using the analogy table template and consultation summary form available on the website of the National Institute of Technology and Evaluation (NITE) before the deadline, so that their assessment can be validated before the notification process.

On October 6, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) jointly issued a revised notice on th...

On October 6, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) jointly issued a revised notice on the handling of Class I Specified Chemical Substances contained as impurities under the Chemical Substances Control Law (CSCL). The revised notice was published on the same day on the METI Portal.

Previous Framework

The previous framework, established under the 2017 CSCL amendment, allowed exclusion of impurities when managed in accordance with the Best Available Technology (BAT) principle. However, in light of the growing focus on circular economy practices and the use of recycled plastics, the government has reviewed and updated its operational guidance to strengthen control and traceability of chemical impurities.

Key Insights from the Notice

• Impurities and by-products of Class I Specified Chemicals (e.g. hexachlorobenzene (HCB), polychlorinated biphenyls (PCB), and short-chain chlorinated paraffins (SCCP)) must now be managed under BAT to avoid environmental and health risks.
• SDSs must include information on impurity concentrations and management details.
• For recycled plastics, impurity levels must be checked and kept below international control limits, with documentation submitted to MHLW, METI, and MOE.
• Justification reports for by-products such as HCB, PCB, and SCCP are no longer required if impurity levels remain below set limits.

Obligations for Stakeholders

• Manufacturers and importers: Confirm impurity levels, apply BAT, and maintain records.
• Downstream users: Ensure proper communication of impurity-related information via SDSs.
• All operators: Continue efforts to further reduce impurity concentrations below established limits.

Enforcement Dates

The revised notice took effect on 6 October 2025, with immediate applicability to the manufacture, import, and distribution activities involving chemicals and recycled materials containing Class I specified impurities.

On 17 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 the 2026 notificatio...

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 no 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.