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Companies that manufacture or import a new substance shall meet the requirements of the Industrial Safety and Health Law (ISHL) 2011, which issued by Ministry of Health, Labour and Welfare. It shall be notified prior to manufacturing or importing

In addition, for substances listed in Article 57 (107 substances) or Article 57 (2) (640 substances), the supplier of individual substance or substances contained in a mixture shall provide SDS and labels complied with JIS Z 7252 and JIS Z 7253.

Exemptions from new substance notification

R&D;
Samples;
Products which are intended primarily for ordinary use by general consumers;
Existing substances under ISHL; and
Substances that will not be exposed to workers.

Qualified notification bodies

New substance manufacturers in Japan;

New substance importers.

Regulation obligation under ISHL

Type of notification

Description

Notification

(new substances >1

t/y)

Shall be notified before manufacturing or importing. The following information needs to be submitted:

AMES study report (GLP required);

Manufacturing process;

Materials used;

Reaction formula;

Molecular weight;

Appearance, boiling point/melting point;

Volume planned to be manufactured/imported;

Uses of the substance; and

Country of origin (for imported substances only).

Low volume notification

(new substances <100kg)

Shall be notified before manufacturing or importing of a new substance. The following information needs to be submitted:

Period of import;

Volume manufactured or imported;

Uses of the substance; and

Human health hazard data if available.

SDS/labelling

The supplier of an individual substance or a substance in a mixture which contains a substance(s) listed by the Article 57 (107 substances) and which exceeds the specified concentration limit of the substance must provide labelling.

The supplier of an individual substance or a substance in a mixture which contains a substance(s) listed by the Article 57 (2) (640 substances) and which exceeds the specified concentration limit of the substance shall provide the recipient of the substance with a safety data sheet.

The supplier of an individual substance or a substance in a mixture that contains substances not listed in the ISHL but classified as hazardous shall take every effort to provide an SDS or labelling.

SDS/Labelling should be in accordance with JIS Z 7252 and JIS Z 7253.

How to check the status of a substance

Safety of Workplace website: Whether your substance is an existing substance or not can be confirmed at the following link.

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

NITE/CHRIP: To check whether your substance is an existing substance the database can be searched by entering the number or name etc. A list can be provided for each category.

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

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Summary of the Industrial Safety and Health Law (ISHL) in Japan

Exemptions from new substance notification

Qualified notification bodies

Regulation obligation under ISHL

How to check the status of a substance