Japan New Substance Notification

Both Chemical Substance Control Law (CSCL) and Industrial Safety and Health Law (ISHL) require a new substance to be notified prior to its production and importation. There are many differences between notifying a new substance under CSCL and notifying a new substance under ISHL


New Substance Notification under CSCL
A person who intends to manufacture or import a new chemical substance shall notify it to three ministries at least three months prior to the manufacture or importation. The three ministries are the Ministry of Economy, Trade and Industry (METI), the Ministry of Labor and Welfare (MHLW), and the Ministry of the Environment (MOE). 

The picture below shows how to determine if a new substance requires notification under CSCL.

New Substance Notification under ISHL
ISHL requires manufacturers and importers to notify a new substance to the Ministry of Labor and Welfare (MHLW) prior to its production and importation. Any substance that is not on ISHL list will be subject to new substance notification under ISHL.

ISHL List also consists of two parts:

• Existing chemical substances under CSCL(in commerce in Japan before 1973)- approximately 20,600 substances;
• New substances notified under ISHL and published on government Gazette;

New Substance Notification - Exemptions and Data Requirements

Not all new substances require notification ISHL. The picture below shows how to determine if a substance requires notification under ISHL and which type of notification is applicable.

There are two types of notification under ISHL: standard notification and small volume notification. For standard notification, the information required is AMES study and other information such as manufacturing process, reaction formula, etc. For low volume notification(<100kg/y), no test data is required.

To find out their difference, please click the link below

http://www.chemsafetypro.com/Topics/Japan/Japan_New_Substance_Notification_CSCL_ISHL.html