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The Amended Japanese Chemical substances Control Law

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What is CSCL


"Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture etc” is well known as “Chemical Substances Control Law (CSCL)” which has imposed strict pre-marketing evaluation of chemical substances that were introduced on the market from 1973 onward (i.e., after the enactment of the Law).CSCL was amended in 1986, 2003, 2009 respectively after its implementation. The 2009 amended version will entry into force in two steps.

First Phase of Amendment (Enacted on April 1st, 2010-the current version)


(a) Not persistent substances will be included

In addition to “chemical substances which is persistent in the environment”, which have been under control, “chemical substances which is not persistent in the environment” are regulated in the amended law.


(b) Confirmation System for Polymers of Low Concern

Polymers of Low Concern (PLCs) will be exempted from mandatory notification of manufactureand import for new chemical substances and will become subject to confirmation based on existing knowledge.


(c) Information Delivery in the Supply Chain
(d) Measures concerning Class I Specified Chemical Substances
(e) Measures concerning Class II Specified Chemical Substances
(f) Other Measures (notification for other laws and ordinances relevant)

 

Second Phase of Amendment (Enacted on April 1st, 2011)


(a) Notification of the amount of manufacturing or import for general chemical substances
(b) Priority Assessment Chemical Substances (New Category)
(c) Handling of the Monitoring Chemical Substances

Current Classification Scheme

Classification

Measures

Type I Monitoring Chemical Substance
-Existing Chemical Substance that is
-Persistent and Bioaccumulative

-Notify manufacture/import quantity, uses, etc.
-Publish name and notified quantities if quantities > 1 t/yr.
-Guidance and advice from government
-Directive for hazard investigation

Type II Monitoring Chemical Substance
-Persistent but not bioaccumulative;
-Suspected for long-term toxicity

-Notify manufacture/import quantity, uses, etc.
-Publish name and notified quantities if quantities > 100 t/yr.
-Directive for hazard investigation

Type III Monitoring Chemical Substance
-Persistent and ecotoxic

-Notify manufacture/import quantity, uses, etc.
-Publish name and notified quantities if quantities > 100 t/yr.
-Directive for hazard investigation

Class I Specified Chemical Substance
-Persistent and bioaccumulative; and
-long-term toxicity to humans or top predators

-Technical ban of manufacture/import
-Ban of uses other than those specified
-Import ban of specified products
-Compliance with handling standards for substances
-Various government orders (recall, etc.)

Class II Specified Chemical Substance
-Low bioaccumulation, Persistent and ecotoxic or has long-term toxicity to humans

-Notify planned and actual quantity, uses, etc.
-Order to change planned quantity
-Publish technical standards for substances
-Labeling obligation

New Classification Scheme (2011.04.01)

Classification

Measures

Monitoring Chemical Substance
-Existing Chemical Substance that is
-Persistent and Bioaccumulative

-Notify manufacture/import quantity, uses, etc.
-Information sharing (supply chain)
-Report Usage
-Directive for hazard investigation

Priority Assessment Chemical Substance
-From Type II and III Monitoring
-Requires prompt assessment of risk
-Detailed Use: 30 Classifications

Manufacturers/Importers
-Notify manufacture/import quantity, detailed uses, etc.
-Information sharing (supply chain)
-Toxicity Testing/Hazard Investigation
-Report usage

Class I Specified Chemical Substance
-Persistent and bioaccumulative; and
-long-term toxicity to humans or top
predators

-Technical ban of manufacture/import
-Ban of uses other than those specified (Essential Uses)
-Import ban of specified products
-Compliance with technical standards and labeling for substances and products containing them
-Various government orders (recall, etc.)

Class II Specified Chemical Substance
-Low bioaccumulation and ecotoxic or has
long-term toxicity to humans

-Notify planned and actual quantity, uses, etc.
-Order to change planned quantity
-Publish technical standards for substances and products containing them
-Labeling obligation

 

 

 

Current CSCL

 

 

Amendment CSCL (01.04.2011)

What we can offer

 

  • Regulatory Consultancy
  • Arrange testing required under CSCL. (Non-Japanese testing labs may not provide information required under CSCL)
  • Obtain existing data and evaluate the existing data
  • prepare reports and notification documents in Japanese

Last Updated on Wednesday, 16 November 2011 13:00

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