JP CSCL — Pre-Market Review of New Chemical Substances
ENFORCEMENT TIMELINE
Latest guidance in effect from April 2024
Overview
The Chemical Substances Control Law (CSCL) is a Japanese law designed to prevent environmental contamination caused by chemical substances before it occurs. Businesses manufacturing or importing a new chemical substance are required to file a prior notification and undergo a pre-market review based on the substance's degradability, bioaccumulation potential, and toxicity. The law applies to substances not listed on the Existing Chemical Substances inventory, and classifies them according to their intended use and volume. The CSCL places significant weight on supply chain-wide risk assessment, and manufacturers and importers are expected to comply with its requirements rigorously.
Enforcement Timeline
Preparation stage: Businesses collect and evaluate test data on the substance's physicochemical properties, degradability, bioaccumulation potential, and toxicity.
New chemical substance notification: A prior notification is filed with the Ministry of Economy, Trade and Industry, the Ministry of Health, Labour and Welfare, and the Ministry of the Environment, in principle at least three months before manufacturing or import is set to begin.
Review period: Following acceptance of the notification, an expert panel such as the Central Pharmaceutical Affairs Council conducts a safety assessment and classification.
Notification of results: The business is notified of the substance's classification as a General Chemical Substance, Monitoring Chemical Substance, Priority Assessment Chemical Substance, or another category.
Official gazette notice: Following the review, the name of the new chemical substance is published in the official gazette, formally establishing the legal right to manufacture or import it.
Business Impact
Businesses handling new substances must prepare and submit prior notifications, along with any required toxicity test data.