Japan CSCL


Overview


The Japan Chemical Substances Control Law (CSCL) was firstly enacted on 16 October 1973 to prevent environmental pollution and control chemical risks to human health. The Law is intended to manage risks of industrial chemicals manufactured and imported in Japan. The 4th amendment of CSCL was published in June 2017 and took effect in April 2018. The competent authorities are the Ministry of Health, Labor and Welfare (MHLW), Ministry of Environment (MOE) and Ministry of Economy, Trade and Industry (METI).

Parties Covered by CSCL


•  Japanese manufacturers and importers of chemical substances.

•  Foreign companies selling chemicalsubstances to Japan.

Categorizing Chemical Substances under CSCL


The lists of Existing Chemical Substances and Newly Announced Chemical Substances include most chemical substances manufactured, imported and used in Japan. The status of a substance, existing or new, can be confirmed by searching through these lists. Those listed in the lists below are existing substances in Japan while those not are new substances subject to notification requirements under CSCL.

Note:

The figures in brackets refer to the numbersof substances as of December, 2019, cited from JCHECK and NIE-CHRIP Database.

Listed Existing Chemical Substances refers to those already manufactured/imported at the time of promulgation of the CSCL in 1973, excluding substances for R&D purposes or used as reagents.

Existing Chemical Substances Management


Exemptions:

•  Solid and liquid waste(excluding those recalled and sold);

•  Natural substances and alloys that do not meet theregulatory definition of “chemical substances”;

•  Chemical substances used for R&D purposes or asreagents only;

•  Articles and products which can be sold over thecounter with a volume of less than 20L (such as household detergent);

•  Intermediates (produced and totally consumed onsite);

•  Impurities (<10%, w/w), excluding diluting and artificialmixing practices;

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

•  Substances included in the Exemption List.

New Chemical Substances Notification


Exemptions:

•  Chemical substances used for R&D purposes or asreagents only;

•  Natural substances and alloys that do not meet thedefinition of “chemical substances”;

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

•  Impurities (<1%, w/w), including byproducts, residualmaterials, indicators, and catalyst etc.

•  Intermediates (produced and totally consumed on site);

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

Notification Process:

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

Our Services


•  Inventory Search for New Chemical Substances

•  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 andExperts

•  Training and Consultancy

•  Preparation of SDS and Label