JP — Designation of Class II Specified Chemical Substances under the Chemical Substances Control Law (CSCL)
ENFORCEMENT TIMELINE
Phased enforcement following designation
Overview
Under the Chemical Substances Control Law (CSCL), a "Class II Specified Chemical Substance" is a substance that, while not bioaccumulative, is poorly degradable and poses a risk of long-term harm to human health or to flora and fauna in the living environment. Designation triggers mandatory notification of planned annual manufacturing and import volumes, requirements to suppress environmental release, and compliance with technical management guidelines — strengthening risk management across the supply chain.
Enforcement Timeline
Designation is announced in the Official Gazette following deliberation and recommendation by a council under the joint authority of the Ministers of Health, Labour and Welfare; Economy, Trade and Industry; and the Environment. Following designation, businesses must submit annual notifications of planned and actual manufacturing/import volumes. Businesses must also comply with technical guidelines on facility management and emission suppression. Periodic reporting requests and on-site inspections are conducted by METI and other authorities based on the substance's distribution status.
Business Impact
Businesses handling substances designated as Class II Specified Chemical Substances are required to submit annual notifications of planned and actual manufacturing and import volumes. They must also adhere to technical management guidelines aimed at suppressing environmental releases (e.g., maintaining equipment, containment, and recovery obligations), and are subject to on-site inspections and administrative recommendations by competent ministries where necessary.