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Japan Chemical Substances Control Law

Overview

Enacted on 16 April 1974, the Japan Chemical Substances Control Law (CSCL) was the world’s first to regulate chemicals and control risks. It was amended with the advance of times, with its third amendments released on 20 May 2009 and entering into force on 1 April 2011. The Law is intended to manage risks of industrial chemicals both manufactured in Japan and imported from abroad, giving the Ministry of Health, Labor and Welfare (MHLW), Ministry of Environment (MOE) and Ministry of Economy and Trade and Industry (METI) a broad regulatory authority.

Notification Bodies

? Japanese manufacturers and importers of chemical substances.

? Foreign companies selling chemical substances to Japan.

Japan Inventory

The inventories of existing chemical substances consists of chemical substances manufactured, imported and used in Japan. The status of a substance, existing or new, can be confirmed by searching the inventories. Those included in the inventories and assigned with MITI numbers are existing substances while those not are new substances requiring notification under CSCL.

CSCL

Existing Chemical Substances Management

cscl

Exemptions:

??Waste solid and liquid (excluding those recalled and sold);

??Natural substances and alloys that do not meet the regulatory definition of “chemical substances”;

? Chemical substances used for R&D purposes or as reagents only;

??Articles and mixtures packaged for final use (such as household detergent);

??Intermediates (produced and totally consumed on site);

??Impurities (<10%, w/w), excluding practices of dilution and artificial mixing;

? Chemical substances regulated by other laws (i.e., pharmaceuticals, cosmetics, pesticides, food additives, etc.) except for industrial applications;

??Substances included in the Exemption List.

New Chemical Substances Notification

New substances notified with low hazard risks are regarded as White Substances and will be added into inventory 5 years after its notification. New substances notified with relatively high hazard risks will fall directly into the category of Priority Assessment Chemical Substances or Monitoring Chemical Substances, the result will be announced within 6-12 months.

cscl

Exemptions

??Chemical substances used for R&D purposes or as reagents only;

??Natural substances and alloys that do not meet the definition of “chemical substances”;

??Articles and mixtures packaged for final use (such as household detergent);

??Impurities (<1%, w/w), including byproducts, residual materials, indicators, and catalyst etc.

??Intermediates (produced and totally consumed on site);

??Chemical substances regulated by other laws (i.e., pharmaceuticals, cosmetics, pesticides, food additives, etc.) except for industrial applications.

Our Services

>>Inventory Search and New Chemical Substance Checking

>>Dossier Preparation and Submission of New Substance Notification

>>Formulation of Integral Registration Schemes (Data Evaluation/Gap Analysis/Exemption Analysis)

>>Study Monitoring

>>Communication with Competent Authorities and Experts

>>Training and Consultancy

>>Preparation of SDS and Label

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