Japan - Home

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.

Update 29 October 2025:

On 29 October 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the final promulgated order on the country’s e-GOV Public Comment Portal. The delisting of entries took effect on the same day.

Original News:

On 25 July 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published draft ordinance for amending the Poisonous and Deleterious Substances List on the country’s e-Gov Public Comment Portal. Fenazaquin has been proposed to get added, whereas formulations containing sodium chlorate or sodium bicarbonate scheduled to get removed from the list. Furthermore, Japan notified the World Trade Organization (WTO) on August 1, 2025, of a draft designating fenazaquin as a deleterious substance.

Poisonous and Deleterious Substances List

The Poisonous and Deleterious Substances List under Japan's Poisonous and Deleterious Substances Control Act (PDSCA) classifies chemicals based on their toxicity and health risks, categorizing them as "poisonous" or "deleterious." These substances are regulated for safe handling, storage, and transportation to prevent accidents and ensure public safety. Updated regularly by Japan's MHLW, new substances are added based on scientific evidence. The regulations include safety procedures such as labelling, record-keeping, and reporting to minimize health and environmental risks. Currently there are 587 entries present on the list.

Key Insights from the Draft Ordinance

Draft ordinance proposes the following amendments to the list of Deleterious Substances:

• 4-[2-(4-tert-Butylphenyl)ethoxy]quinazoline (Fenazaquin) (CAS: 120928-09-8) and its preparations (except from those with a concentration ≤19.4%) have been designated as a new deleterious substance.
• Taking a formulation off the list: Made with sodium bicarbonate (27–37%) (CAS: 144-55-8) and sodium chlorate (47.5–52.5%) (CAS: 7775-09–9), except powdered versions.

It was determined that fenazaquin posed a significant risk of acute toxicity upon exposure, supporting its designation as a deleterious substance. On the other hand, it was found that the sodium chlorate/sodium bicarbonate formulation had far lower toxicity, which justified its removal from the list.

Obligations for the Stakeholders

Manufacturers, importers, and distributors of the Poisonous and Deleterious Substances must register their substances with the MHLW and comply with Safety Data Sheets (SDS) and Labelling regulations.

Comment Period and Enforcement Dates

Stakeholders are requested to comment on the draft till 24 August 2025. While as per WTO notification, members can comment on the WTO draft till 30 September 2025. Final ordinance will be published in late October 2025. Enforcement is scheduled to be from 1 November 2025 (Except for delisting of entries which will come into effect on the same day of ordinance publication).