Related Laws

• Japan Chemical Control Substances Law (CSCL)
• New Substance Notification in China (China REACH)
• Korea Toxic Chemicals Control Act (TCCA)
• Chemical Notification in Malaysia (EHSNR)

Industrial Safety and Health Law (ISHL)

Japanese Industrial Safety and Health Law (ISHL) was initially implemented on 1 Oct 1972. It regulates chemicals used in workplace with the purpose of preventing workers from exposure to carcinogens. The law was administered by the Ministry of Health, Labor and Welfare (MHLW).

Chemicals Regulated under Japan ISHL

The following categories of chemicals are regulated by Japan CSCL:

• New chemical substances (see next paragraph);
• Harmful substances to be prohibited(~10 substances);
• Harmful substances to be permitted(~7 substances);
• Harmful substances to be indicated(~99 substances);
• Notified substances to be delivered MSDS(~640 substances);

New Chemical Substance Notification in Japan

New chemical notifications are required by both CSCL and ISHL. Under CSCL a new chemical substance is defined as a chemical substance other than those listed as follows:

• Existing chemical substances (Approx. 20,600 substances): Chemical substances that were already manufactured/imported at the time of the promulgation of the Chemical Substance Control Law (CSCL) in 1973;
• Notified chemicals by public notice from the three ministries (Approx. 6,100 substances);
• Class I and II specified chemical substances;
• Priority assessment chemical substances;

 

All existing chemical substances and notified substances are given MITI numbers which are important for custom clearance. All lists of chemicals mentioned above can be found at:

http://www.safe.nite.go.jp/english/db.html

ISHL has its own chemical inventory called ISHL List. By default, existing chemical substances under CSCL are also existing chemical substances under ISHL. However, ISHL has its own list of notified chemicals and regulated chemicals. Any substance that is not an existing substance and not a substance on ISHL List will be regarded as a new chemical substance and thus shall be notified.

ISHL list is available for search from:

http://anzeninfo.mhlw.go.jp/anzen_pg/KAG_FND.aspx

More info about new chemical notification under CSCL can be found here:

New Chemical Substance Notification under CSCL

Data Requirement and Exemptions

The main required data for new chemical notification under ISHL are Ames-test and other company and substance specific information. This is much easier and less complex than new chemical notification under CSCL.

There are also exemptions for notification obligations (from JETOC) and they are listed as follows:

Category	Description
Full Exemption	Substances for testing and research purposes, reagent, sample for business, subs. sealed in machine, and substances in consumer’s good, existing chemical substances for the ISHL.
Exposure Exemption	Measures have been taken to prevent workplace exposure or if the substance is not well known as not carcinogen in foreign country. Pior verification is required.
Small Volume Exemption	≦ 100 kg per year per applicant; Prior verification is required.
Polymer Exemption	Polymer met criteria in notification by the MHLW; Prior reporting is required;

 

Note 1: Intermediates are exempt from new chemical notification under CSCL. Those intermediates need to be notified under ISHL if the intermediates are transformed to other chemical substances in only own site.

GHS Implementation and ISHL

The main law introducing GHS to Japan is the Industrial Safety and Health Law (ISHL). The main law introducing GHS to Japan is the Industrial Safety and Health Law (ISHL). ISHL requires GHS classification data on labeling in MSDS for the following substances from 1 Dec 2006：

1. 99 designated chemicals for which labels are required according to Article 57 of ISHL;
2. 640 designated chemicals for which SDSs are required according to Article 57-2 of ISHL;

 

Besides ISHL, the law concerning reporting, etc. of the release to the environment of specific chemical substances and promoting improvement in their management (PRTR law) has required MSDS for over 400 designated chemicals.

For other chemicals, GHS SDS and labels are strongly recommended. Japan has published three industrial standards to facilitate GHS implementation: GHS classification (JISZ7252), MSDS (JISZ7250) and label (JISZ7251). In those standards, acute toxicity category 5, skin corrosion/irritation category 3 and aspiration hazard category 2 are not adopted.

More info about GHS in China, Korea and Japan can be found here.

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