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

Japan ISHL: Industrial Safety and Health Law

Industrial Safety and Health Law ("Japan ISHL") was firstly enacted in 1972 to ensure the safety and health of workers in workplaces. IHSL designates substances that are prohibited to manufacture or import, substances requiring permission and chemical substances requiring safety data sheets and labels. ISHL also controls new substances and requires manufacturers and importers to notify them to the Ministry of Labor and Welfare (MHLW) prior to production and importation.

New Substance Notification under Japan ISHL

Any substance that is not on ISHL list requires notification prior to manufacture or importation. ISHL list 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;

ISHL is available for search via the following link:

Note: Chemical Substance Control Law(CSCL) has its own definition of new substances and its own existing substance inventory ENCS. You should also check ENCS for your substance.

Read more about new substance notification in Japan.

ISHL and GHS

ISHL is one of the main laws for implementing GHS in Japan. The Article 57-2 of ISHL states that businesses are required to provide SDSs to their clients when transferring or providing any of the notifiable chemical substances(about 644) specified by ISHL. Even for hazardous chemicals not specified by ISHL, suppliers shall make reasonable efforts to comply with GHS requirements in Japan.

Read more about GHS in Japan.

More Info about Japan ISHL

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