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	Companies (importers, manufacturers) registered in Japan Companies(exporters) not registered in Japan	5 years after judgment	Every year
	polymer		Polymer Flow Scheme
(2)Low volume exemption		≦10t/year (nation-wide)	･Biodegradation study ･Bioaccumulation study	Companies (importers, manufacturers) registered in Japan	Not published	Not required
(3)small volume exemption		≦1t/year (nation-wide)	Test data are not required	Companies (importers, manufacturers) registered in Japan	Not published	Not required
(4)Polymers of Low Concern (PLC)		Not limited	Polymer Flow Scheme	Companies (importers, manufacturers) registered in Japan	Not published	Not required

 
Only companies (importers, manufacturers) registered in Japan can apply for small and low volume exemption (2, 3) and polymers of low concern (PLC) (4). Companies(exporters) not registered in Japan 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)

• Any information about degradation product is needed. Analytical data of degradation product is essential because CSCL requires assessments on bioaccumulation potential, human toxicity, and ecotoxicity for both the notified substance and the degradation products.
• OECD TG 302C can be an alternative to the 301C in certain conditions.

○Bioconcentration test (OECD TG 305)
 

• Partition coefficient test (TG107 or TG117) can be an alternative to the　bioconcentation test (OECD TG 305), if log POW is less than 3.5.
• No test is required for a chemical with molecular weight of ≥800 (≥1000 for chemical that has 2 or more halogen elements in its structure.)

○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.
 

• Repeated dose toxicity (OECD TG 407)

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

• Physicochemical stability and acid/alkali solubility tests.
• Solubility in water and organic solvents.
• Molecular weight distribution measurement

 

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