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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 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.