The revised enforcement ordinance of the Chemical Substances Control Law (CSCL) issued by Japan’s Ministry of Economy, Trade and Industry (METI) on October 1, 2024, officially took effect on April 1, 2025. Under the updated rules, all enterprises engaged in the manufacture or import of chemical substances must submit annual reports starting from fiscal year 2025 using four revised reporting formats, significantly tightening oversight of General Chemical Substances, Priority Assessment Substances, Monitoring Substances, and Class II Specified Chemical Substances.
Differentiated Requirements for Four Reporting Formats
1.General Chemical Substances (Format 11)
- Scope: Reporting required if total annual manufacturing/import volume ≥1 ton.
- Key Requirements: Must indicate whether the substance is a polymer.
2.Priority Assessment Chemical Substances (Format 12)
- Scope: Reporting required if total annual manufacturing/import volume ≥1 ton.
- Key Requirements: Must specify if the substance is a polymer and disclose the name and location of manufacturing facilities.
3.Monitoring/Class II Specified Chemical Substances (Format 13)
- Scope: Reporting required if total annual manufacturing/import volume ≥1 kilogram.
- Key Requirements: Must clarify the substance category (Monitoring, Class II, or products containing Class II substances), report the content of Class II specified substances in products, and disclose manufacturing facility details.
4.Forecasted Quantities or Revisions for Class II Specified Substances (Format 14)
- Scope: Reporting required for projected annual manufacturing/import volumes or revisions of Class II substances if ≥1 kilogram.
- Key Requirements: Must declare the content of Class II substances in products.
Unified Reporting Obligations
While the four formats vary in specifics, all submissions must include:
- Basic Information: Reporter’s name, address, corporate ID, and contact details (phone/email).
- Substance Identification: Full chemical name, CAS number, official gazette designation, and reference number.
- Data Transparency: Detailed reporting of manufacturing/import volumes, shipment totals, and usage categories.
- Supporting Documents: Optional attachments (e.g., substance structure, composition).
The amendments aim to enhance chemical safety governance through granular regulatory frameworks, bolstering protections for public health and the environment. Enterprises are urged to prioritize compliance with the revised requirements and streamline reporting processes accordingly.
Further Information
