Japan Regulatory News

On 5 December 2025, the application process for FY 2026 of specific new chemical substances in Japan was released by the Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour,...

On 5 December 2025, the application process for FY 2026 of specific new chemical substances in Japan was released by the Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour, and Welfare (MHLW), and the Ministry of Environment (MOE). METI has published details of the application process on its website. Specific new chemical substances are regulated under Japan’s Chemical Substances Control Law (CSCL).  

New Chemical Substances Covered by the 2026 Process

This application process covers the following categories of new chemical substances:   

Low-volume new chemical substances: Chemicals manufactured or imported in quantities of up to 10 t/y fall under this category.  The FY 2026 application process for these substances has been published.  

Small quantities of new chemical substances: Chemicals manufactured or imported in quantities of up to 1 t/y fall into this category.  The FY 2026 application process for these substances has been published.

Key Submission Details for New Chemical Substances in Japan

Publication of the Notification Schedule in October of 2026 

On 17 October 2025, Japan’s METI, MHLW and MOE jointly published the 2026 notification schedule for particular new chemical substances. 

Annual Revisions to the New Chemical Application Procedure 

Every November-December, the ministries revise the application procedure for specific new substances. On 11 November 2024, Japan’s MHLW, METI, and MoE jointly published the new chemical application procedure for 2025.

Japan’s Ministry of Health, Labour and Welfare (MHLW) has announced that it will hold a public consultation in December 2025, in order to update the list of chemicals and mixtures that require safet...

Japan’s Ministry of Health, Labour and Welfare (MHLW) has announced that it will hold a public consultation in December 2025, in order to update the list of chemicals and mixtures that require safety data sheets (SDS) and labelling. The consultation notice was released on the MHLW portal. Labelling based on the Globally Harmonized System (GHS) is required under the Industrial Safety and Health Law (ISHL).

The public consultation is scheduled for 9 December 2025 and can be attended online via Webex or Teams. Opinions can be submitted until 5 December 2025. Non-Japanese importers and manufacturers operating in Japan are invited to take part by offering feedback on the draft proposal. In order to take part in the consultation, stakeholders must register.

Previous consultation in September 2024

Earlier on September 2024, the MHLW opened consultation to add 155 chemicals to the list. At the same time, 2 chemicals would be eliminated from the list. More details can be found here.

Classification List Update

The MHLW is considering adding 36 chemicals to the list of substances that are currently classified until 31 March 2025. Previously, the list was expanded to include compounds categorized until 31 March 2024.

Enforcement Dates

The 36 chemicals are scheduled to be added to the list by April 2028. The list of chemicals can be found here.

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...