Japan's New Chemical Reporting Requirements

Japan's New Chemical Reporting Requirements

Japan's New Chemical Reporting Requirements

First Reports Due in June 2011

On April 1, 2011, a new reporting requirement for chemicals came into effect in Japan. This new requirement originated in the 2009 amendment to Japan's chemical control law and requires that companies submit an annual report on chemical substances manufactured or imported into Japan. The first round of reports must be submitted by June 30, 2011, to the Ministry of Economy, Trade and Industry (METI).

New Reporting Requirement in Japan

The primary chemical control law in Japan is the Law Concerning the Examination and Regulation of Manufacture, etc., of Chemical Substances (Law No. 117 of October 16, 1973). The law was most recently amended in 2009 to add, among other things, an annual reporting requirement.

The new scheme imposes a reporting obligation on companies manufacturing or importing more than one metric ton of a "general chemical substance" or a substance designated as a "priority assessment chemical substance" (PACS). METI has issued a list of chemical substances designated as PACSs as of April 1, 2011, available at http://www.meti.go.jp/policy/chemical_management/english/files/PACSs-list.pdf.

When METI receives a report, or notification, it will conduct a screening evaluation designed to identify any additional chemicals that should be classified as PACSs. Any substance selected as a PACS will undergo a risk assessment by METI, and the Ministry may require its manufacturer or importer to submit information on the substance's hazardous properties. Depending on the outcome of the assessment, METI may restrict the manufacture or use of the substance.

Notification Contents and Format

The notification must state the identity of the chemical substance and, if known, its Chemical Abstract Services Registry Number (CASRN). The notification must include the amount of the substance that was manufactured or imported during the previous calendar year, rounded to one significant digit. For example, 12,499 metric tons should be rounded to 10,000 metric tons, and 1,894 metric tons should be rounded to 2,000. Finally, the notification should specify the use of the substance, selected from one of the use categories provided by METI. On February 8, 2011, METI released an updated list of use categories, which is available at http://www.meti.go.jp/policy/chemical_management/english/files/use%20category.pdf.

For general chemical substances, companies must use notification Form 11. For PACSs, companies must use Form 12. Examples of these forms are available at http://www.meti.go.jp/policy/chemical_management/english/files/CSCL-setsumei-H22-12-jizen-12eng.pdf (pages 7-8 and 11-13, respectively). The notification form may be submitted by paper, electronically, or by CD. METI is developing software that will enable companies to generate notification documents electronically, and it plans to make this software available free of charge.

Reporting Deadline

The notification must be submitted annually to METI between April 1 and June 30.

Exemptions from Reporting Requirement

As explained above, the reporting requirement applies to chemical substances that are manufactured or imported in quantities of at least one metric ton per year. Certain substances determined not to be persistent or bioaccumulative are only subject to the reporting requirement if manufactured or imported in quantities of at least 10 metric tons. Note that "existing" chemical substances are subject to the reporting requirement.

The law does exempt the following types of substances from reporting:

  • Naturally-occurring substances, including substances that degrade exclusively into ions (e.g., sodium chloride), and substances that are essential to biotic activity (e.g., citric acid).
  • Substances regulated under other laws (e.g., gasoline, which is regulated under the Act Concerning the Maintenance of Quality of Gasoline).
  • Substances that are domestically purchased and either (1) sold "as is" or (2) processed in a way that does not cause a chemical reaction.
  • Substances imported for research and development (R&D) purposes.
  • Imported "products" sold to general customers.
  • A new chemical substance that is confirmed as a polymer of low concern (PLC) by the Minister of Health, Labor, and Welfare, the Minister of Economy, Trade, and Industry, and the Minister of Environment. There are two types of polymers that are eligible for this exemption:
    • A substance whose number average molecular weight is 1,000 or more.
    • Any chemical substance composed of an aggregation of molecules that are produced by linkages of one or more types of monomeric units, in which the total weight of those molecules that are composed of three or more linkages makes up 50% or more of the weight of the whole substance, and the total weight of those molecules with identical molecular weight is less than 50% of the weight of the whole substance.
  • Additional polymers that are exempt from reporting:
  • Polymers that received a determination equivalent to a non-hazardous determination under the High Molecular Flow Scheme, between April 1987 and March 2004. This exemption is limited to polymers that have no risk of ecological impact.
  • Polymers that received a determination equivalent to a non-hazardous determination under the High Molecular Flow Scheme starting in April 2004. This exemption is limited to polymers that were specifically announced.
  • Existing chemical substances that are recognized as equivalent to non-hazardous determination under the High Molecular Flow Scheme.
  • Substances that are considered intermediates, as confirmed by the three Ministers listed above.
  • Substances that are specifically exempted by METI. METI plans to annually update the list of exempt substances.

Additional Guidance

For more information, please see guidance documents issued by METI, at http://www.meti.go.jp/policy/chemical_management/english/cscl.html.


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  • 06-11-2011

thanks for share

Tina George
  • 06-22-2011

Glad we were able to provide relevant content, emlak. If there's anything you'd like to see more (or less) of, feel free to share it in the comment section or contact us at lexisnexiscommunities@lexisnexis.com. Tina George LexisNexis Community Manager