New Industrial Chemicals Notification and Assessment in Japan

  • Name of the scheme: Law Concerning the Examination and Regulation of Manufacture etc. of Chemical Substances
  • Language(s) which can be used for notification/registration: Japanese
  • Year when the scheme was established: 1973
  • Year when the scheme was last modified: 1986
  • Name of the scheme: Industrial Safety and Health Law
  • Language(s) which can be used for notification/registration: Japanese
  • Year when the scheme was established: 1977
  • Year when the scheme was last modified: 2000

2-1 Contacts in the government
2-1-1 Law Concerning the Examination and Regulation of Manufacture etc. of Chemical Substances

  • Name: Mr. Takashi YAMAGUCHI, Mr Kanji IWATA
  • Division: Chemical Management Policy Division, Manufacturing Industries Bureau
  • Organisation: Ministry of Economy, Trade and Industry
  • 1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8901 Japan
    Telephone: 81 3 3501 0080
    Fax: 81 3 3580 6347
    E-mail: Yamaguchi-takashi@meti.go.jp (for Mr. Yamaguchi), iwata-kanji@meti.go.jp (for Mr.Iwata)
  • Name: Mr. Shigeki TSUDA, Mr.Naoyuki YASUDA
    Division: Office of Chemical Safety, Pharmaceutical and Food Safety Bureau
    Organisation: Ministry of Health, Labour and Welfare
    1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916 Japan
    Telephone: 81 3 3595 2298
    Fax: 81 3 3593 8913
    E-mail: Tsuda-shigeki@mhlw.go.jp, yasuda-naoyuki@mhlw.go.jp
  • Name: Mr.Akira NITTA,
    Division: Chemicals Evaluation Office
    Organisation: Ministry of the Environment
    1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8975 Japan
    Telephone: 81 3 5521 8253
    Fax: 81 3 3581 3370
    E-mail: AKIRA_NITTA@env.go.jp

2-1-2 Industrial Safety and Health Law

  • Name: Mr. Yasuhiro Kishi
    Division: Chemical Substance Investigation Division, Labour Standards Bureau
    Organisation: Ministry of Health,Labour and Welfare
    1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916 Japan
    Telephone: 81 3 3502 6756
    Fax: 81 3 3502 1598
    E-mail: Kishi-yasuhiroky@mhlw.go.jp
    Type of enquiry that can be handled: The test form which the information equilvalent to or more than that obtainable from the mutagenicity test or any one of the carcinogenicity tests shall be conducted for the toxicity investigation

2-2 Contact in chemical industry association

  • Name: Mr.Yoshihiro Ikeda
    Division: Chemical Safety Management Center
    Organisation: Japan Chemical Industry Association
    3-2-4, Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
    Telephone: 81 3 3580 1381
    Fax: 81 3 3580 1383
    E-mail: Yikeda@jcia-net.or.jp


3-1 Legislation, its explanatory note and guidance for putting together a notification


3-1-1 Law Concerning the Examination and Regulation of Manufacture etc. of Chemical Substances

  • The Guidebook on the Law concerning the Examination and Regulation of Manufacture etc. of Chemical Substances
  • Purpose: to explain the law on each article basis referring to related Orders,etc. as well
  • Intended audience: Possible manufacturers and importers
  • Content: Explanation of each article of the law, (2)the Order and the Ministerial Order etc.; (3) Administrative provision about GLP and testing methods
  • Language(s): Japanese
  • Publication: Published by Daiichi-Houki Press Co.
  • Date of publication: 1990
  • Charge for the information: N.A.(Out of Print)
  • Contact for obtaining copy of information:
    Mr. Kanji IWATA
    Chemical Safety Office, Manufacturing Industries Bureau
    Ministry of Economy, Trade and Industry
    1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8901 Japan
    Telephone: 81 3 3501 0605
    Fax: 81 3 3501 2084
    E-mail: iwata-kanji@meti.go.jp
  • Name: The Guidebook on the Notification of New Chemicals under the Law concerning the Examination and Regulation of Manufacture etc. of Chemical Substances
  • Purpose: to answer the practical questions about the notification
  • Intended audience: Possible manufacturers and importers
  • Content: (1)Explanation of practical procedures required on Q&A basis. (2)Appendix(related legislature etc.); (3) Administrative provision about GLP and testing methods
  • Language(s): Japanese
  • Publication: Published by Japan Chemical Industry Daily Press Co.
  • Date of publication: 1999
  • Charge for the information: 5,000 yen
  • Contact for obtaining copy of information:
    Mr. Kanji IWATA/Chemical Safety Office, Manufacturing Industries Bureau
    Ministry of Economy, Trade and Industry
    1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8901 Japan
    Telephone: 81 3 3501 0605
    Fax: 81 3 3501 2084
    E-mail: iwata-kanji@meti.go.jp

3-1-2 Industrial Safety and Health Law

  • Name: The Guidebook on the Notification of New Chemicals under Industrial Safety and Health Law
  • Purpose: to explain the notification scheme under the law
  • Intended audience people who manufacture and import chemicals
  • Content: (1) Explanation of Industrial Safety and Health Law, the Enforcement Order and the Ministerial Order; (2) Notification scheme of new chemicals; (3) GLP; (4) Testing method
  • Language(s): Japanese
  • Publication: Published by Japan Industrial Safety and Health Association
  • Date of publication: 1997
  • Charge for the information: Not free
  • Contact for obtaining copy of information:
    Mr. Yasuhiro Kishi, Chemical Substance Investigation Division, Labour Standards Bureau
    Ministry of Health, Labour and Welfare
    1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916 Japan
    Telephone: 81 3 3502 6756
    Fax: 81 3 3502 1598
    E-mail: kishi-yasuhiroky@mhlw.go.jp

3-2 Guidance for putting together a notification


3-2-1 Law Concerning the Examination and Regulation of Manufacture etc. of Chemical Substances

4.1 Inventory


4.1.1 Law Concerning the Examination and Regulation of Manufacture etc. of Chemical Substances

  • Name: List of existing chemical substances
  • Purpose: To announce chemical substances other than ones on the lists in 4.2 below, for which production or import notification is not required
  • Intended audience: Possible makers and importers
  • Content: Names of chemical substances and their reference numbers
  • Type of chemicals included: All types of compounds except naturally occurring ones, ones regulated under the other legislatures etc.
  • No. of chemicals included: About 20,000
  • Language(s): Japanese
  • Publication: Official gazette issued on December 24, 1973
  • Charge for the information: Free
  • Frequency of publication or update: N.A.
  • Last year of update: N.A.
  • Contact for obtaining copy of information
    Mr. Takashi YAMAGUCHI, Mr Kanji IWATA
    Chemical Management Policy Division, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry
    1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8901 Japan
    Telephone: +81 3 3501 0080
    Fax: +81 3 3580 6347
    E-mail: yamaguchi-takashi@meti.go.jp (for Mr. Yamaguchi), iwata-kanji@meti.go.jp (for Mr.Iwata)

4.1.2 Industrial Safety and Health Law

  • Public announcement on the names of the new chemicals that are notified and assessed
  • Purpose: To open the names of the existing chemicals that are notified
  • Intended audience: Public
  • Type of chemicals included Notified and/or assessed new chemicals
    No. of chemicals included about 10,000 chemicals
  • Language(s): Japanese
  • Publication: In paper form
  • Charge for the information: Not free
  • Frequency of publication or update: regularly (ever 3 months, 4 times/year)
    Last year of update: 2001
  • Contact for obtaining copy of information:
    Mr. Yasuhiro Kishi, Chemical Substance Investigation Division, Labour Standards Bureau
    Ministry of Health,Labour and Welfare
    1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916 Japan
    Telephone: 81 3 3502 6756
    Fax: 81 3 3502 1598
    E-mail: kishi-yasuhiroky@mhlw.go.jp

4.2 Government gazette notices

  • Law Concerning the Examination and Regulation of Manufacture etc. of Chemical Substances
  • Name: List of non-designated chemical substances, List of designated chemical substances
  • Purpose: To announce the regulatory status of evaluated new and existing chemical substances
  • Intended audience: Possible makers and importers
  • Content: Names and their reference numbers under the Law
  • Type of chemicals included Class 1 specified chemical substances, Class 2 specified chemical substances, designated chemical substances and non-designated new chemical substances
    No. of chemicals included 11, 23, 422 and about 4 thousands respectively
  • Language(s): Japanese
  • Publication: As part of official gazette issued on or in advance to the date of validity
  • Charge for the information: Free
  • Frequency of publication or update: Non-periodically
  • Last year of update: 2000
  • Contact for obtaining copy of information:
    Mr. Takashi YAMAGUCHI, Mr Kanji IWATA
    Chemical Management Policy Division, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry
    Address: 1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8901 Japan
    Telephone: +81 3 3501 0080
    Fax: +81 3 3580 6347
    E-mail: yamaguchi-takashi@meti.go.jp (for Mr. Yamaguchi), iwata-kanji@meti.go.jp (for Mr.Iwata)
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