Japan - Inventory

Japan’s chemical regulatory system operates under three major inventories: the Existing and New Chemical Substances (ENCS) Inventory under the Chemical Substances Control Law (CSCL), the Industrial Safety and Health Law (ISHL) Inventory, and the Poisonous and Deleterious Substance Inventory under the Poisonous and Deleterious Substances Control Law (PDSCL).  Together, these inventories cover approximately 30,000 unique chemicals. The ENCS itself contains 70,059 substances. 

The ENCS Inventory covers substances that were in commerce before 1973. Chemicals in the inventory are categorized as General Existing, Monitoring, PACs, Class I or Class II substances, with specific regulatory obligations linked to their classification. Listed substances require compliance with periodic hazard assessments and reporting obligations (see Articles 8 to 37 of the CSCL), while new substances require pre-notification and extensive testing for environmental persistence, toxicity, and bioaccumulation (see Articles 3 to 5 of the CSCL). The ENCS primarily regulates general substances and evaluates their environmental persistence and toxicity.  

The ISHL inventory emphasizes worker safety by addressing occupational exposure risks, while the PDSCL inventory covers business licensing and standards for the manufacture, storage, transfer and labelling.  Japan ensures that new chemicals undergo rigorous pre-market assessments, focusing on toxicity, bioaccumulation, and environmental impact.  

Japan’s chemical management system emphasizes the categorization of substances: 

• General existing substances: Do not fall under certain high-risk categories. 

• Monitoring substances: Potential to fall under Class I Substances. 

• Priority Assessment Chemical (PAC) substances: Potential to fall under Class II Substances. 

• Class I Substances: Highly hazardous, restricted chemicals. 

• Class II Substances: Subject to controlled use with mandatory safety measures. 

• Unlisted Substances: Require pre-market notification and extensive safety evaluations for persistence and toxicity. 

In Japan, confidentiality is maintained in the Existing and New Chemical Substances (ENCS) Inventory, as well as under the Industrial Safety and Health Law (ISHL). Proprietary information, such as detailed formulations or chemical uses, can be withheld upon request. Companies must justify these claims during pre-market notification, and they are reviewed to ensure consistency with public safety and regulatory transparency.