Chemical Management

Basic Information

Basic Information

Any substance that is not on the Chemical Substances Control Law (CSCL) Inventory is classified as a new chemical, which does not have a corresponding MITI number. To determine if a substance is a "new chemical", please use CHRIP to look for the MITI number for that chemical.
Prior to manufacture (including import) of a new chemical, a notice must be submitted.
 

Types of notification

There are several types of notification depending on the production/import volume of a new chemical substance.
 

  Amount Data requirements Notifier Publication of Chemical Name Annual Report of amounts
(1)Regular
 
Non-
polymer
Not limited ・Biodegradation study
・Bioaccumulation study
・Human-toxicity study
・Eco-toxicity study
Importer
Manufacturer
Exporter(Foreigner)
5 years after judgment Every year
polymer Polymer Flow Scheme
(2)Low volume exemption ≦10t/year
(nation-wide)
・Biodegradation study
・Bioaccumulation study
Importer
Manufacturer
Not published Not required
(3)small volume exemption ≦1t/year
(nation-wide)
Test data are not required Importer
Manufacturer
Not published
 
Not required
 
(4)Polymers of Low Concern (PLC) Not limited Polymer Flow Scheme Importer
Manufacturer
Not published Not required
 
Only importer and manufacturer can apply for small and low volume exemption (2, 3) and polymers of low concern (PLC) (4) .Exporter cannot file these exemptions.
 

Data requirements

Test data should be in compliance with Good Laboratory Practice (GLP). GLP is not required for Polymer Flow Scheme(i.e., solubility and stability test) and the test for physical-chemical properties (e.g., water solubility, volatility, and melting point).
 
○Biodegradation test (OECD TG 301C or other 301-series)

○Bioconcentration test (OECD TG 305)
 

○Human-toxicity study
※OECD TG 471 and 473 are both required as genotoxicity tests. Mouse lymphoma TK test (OECD TG 476) is acceptable in place of OECD TG 473.
 

※OECD TG 408 and OECD TG 422 are also acceptable as a repeated dose toxicity test.
Polymer Flow Scheme
 

 

Exemption

The following are excluded from new chemical notification under CSCL:
○Impurities(less than 1 %)
○Substances in articles
○Naturally-occurring elements or substances
○Chemical substances regulated by other laws
・Food, food additive, package etc. (Food Sanitation Law)
・Pesticide (Agricultural Chemicals Regulations Law)
・Fertilizer (Fertilizers Regulation Law)
・Feed and feed additive (Act on Feeds)
・Medicine, cosmetic, medical device (Pharmaceutical Law)
・Radioactive material, drug
○Research & Development, Reagent

Contact us

Chemical Management Center,  National Institute of Technology and Evaluation
Phone number:+81-3-3481-1977
Fax number:+81-3-3481-2900
Address:2-49-10 Nishihara, Shibuya-ku, Tokyo, 151-0066, Japan MAP
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