Exclusion and Exemption from Pre-Manufacturing Notification

Chemical substances regulated under higher level of restrictions (e.g., pharmaceutical laws, etc.) are not subject to Chemical Substance Control Law (CSCL). However, raw materials and intermediates for those specific chemical substances are still covered by CSCL. In contrast, the Industrial Safety and Health Law applies to any chemical substance that has the possibility of exposure in the workplace.


Chemical substances described below are exempt from notification. Some exemptions are common to both laws, while some are unique due to different purpose of the laws.


1) Chemical substances in articles and products packaged for final use (in common)
2) Impurities and R&D Chemicals (in common)
3) Small volume chemical substance (in common)
4) Low volume chemical substances (CSCL only)
5) Polymers (ISHL only). CSCL applies 99% rule for polymers
6) Intermediates etc. (CSCL only)