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Notification of New Chemical Substances in Japan

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Notification of New Chemical Substances in Japan

Cambridge Environmental Assessments, part of RSK ADAS Ltd, in conjunction with our Japanese Agent, Repre Co., Ltd., provides support for non-Japanese companies wishing to comply with the Japanese legislation for the Notification of New Chemical Substances.

There are 2 different Notifications of New Chemical Substances. The notifications are covered by

  1. Chemical Substances Control Law (CSCL), to prevent environmental pollution.

  2. Industrial Safety and Health Act (ISHA), to secure safety and health of workers.

Each has its own notification system and a list of existing substances.

For a company to manufacture or import a new chemical substance in Japan it must notify a new substance to the CSCL and ISHA separately.

 

Chemical Substances Control Law (CSCL)

1. Aim of the Law

To prevent environmental pollution caused by chemical substances that pose a risk of impairing human health and interfere with the habitation and growth of flora and fauna.

2. Differences from EU REACH:

  1. Notification required only for a new substance, i.e. not required to an existing substance.

  2. No OR (Only Representative) system.

  3. Notification required, even if manufacturing/import quantity is =<1 Tpa.

  4. Notification of polymers required.

  5. Different data set for physicochemical, toxicological and ecotoxicological information.

3. Types of Notification of New Chemical Substance

Type of notification

Data set

Applicant

Normal

Biodegradation, bioaccumulation, toxicity and ecotoxicity

Manufacturer/importer located in Japan or manufacturer/importer outside of Japan

Polymer Flow scheme

Stability, solubility and molecular weight

Low Volume (=<10Tpa)

Biodegradation, bioaccumulation

Manufacturer/importer located in Japan

Small Volume (=<1Tpa)

None

Intermediate, closed system, export only

None

Polymer of low concern

Stability, solubility and molecular weight

 

More information on procedures for new chemicals under CSCL can be found here: http://www.meti.go.jp/policy/chemical_management/english/cscl/files/about/03CSCLnewchem.pdf

 

Industrial Safety and Health Act (ISHA)

1. Aim of the Act

To secure the safety and health of workers in workplaces, as well as to facilitate the establishment of a comfortable working environment.

2. Types of Notifications on a New Chemical Substance

Type of notification

Data set

Applicant

Normal

Ames Test

Manufacturer/importer located in Japan

Small Volume (=<100Kg/annum)

None

 

Further information on procedures for new chemicals under ISHA can be found here (Japanese only): https://www.nite.go.jp/en/chem/chrip/chrip_search/sltLst#MCAT_2_003

 

Consultancy Support for compliance with Japan’s CSCL and ISHA

CEA provides support for companies, based outside of Japan, with regard to compliance under Japan’s CSCL and ISHA legislation.

The compliance is carried out through our Japanese agent, Repre, who is based in Tokyo and has many years of experience in submitting the documentation to obtain compliance. All communication between CEA, Repre and the client is conducted in English.

If you looking for support to comply with the CSCL and/or ISHA legislation, please contact Peter Godfrey (peter.godfrey@cea-res.co.uk) or Sarah Henly (sarah.henly@cea-res.co.uk).

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