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 were to 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 List of Priority Assessment Chemical Substances (PACSs).
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 Japanese Use Category under amended CSCL.
For general chemical substances, companies must use notification Form 11. For PACSs, companies must use Form 12. Examples of these forms are available at Notification of the Manufacturing Amount, etc. of General Chemical Substances and Priority Assessment Chemical Substances (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.
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.
Foreign Suppliers Now Permitted to Submit CBI Directly to METI
Originally, only manufacturers or importers in Japan were permitted to submit the required annual notifications. If a foreign supplier possessed information about a substance that was required to be reported, such as its chemical identity, the supplier was required to provide the information to the Japanese importer or manufacturer. This presented a problem for foreign suppliers who preferred to maintain as confidential certain trade secret information.
In response to these concerns, METI recently established a new joint notification procedure designed to protect foreign suppliers' confidential information. On June 2, 2011, METI released guidance authorizing foreign exporters to report confidential information directly to the Ministry, rather than through the Japanese importer or manufacturer. The guidance document is available at The guidance of special procedure to submit the annual notification of imported quantity of the previous fiscal year under CSCL.
The notification process is relatively straightforward. First, the manufacturer or importer must notify METI that it will be taking advantage of this special notification process. It must provide METI with the foreign supplier's contact information, as well as a written explanation of why it could not provide all the required information on its chemical substance. METI has provided an example of the required explanation, available at Sample of brief note. The importer must also submit to METI a "temporary notification"-a copy of the required notification form containing as much information as the manufacturer or importer can provide. On its website, METI has provided a sample notification form, indicating which items should be filled out by the manufacturer or importer in Japan, and which items should be filled out by the foreign supplier. The form is available at Sample form of a temporary notification from notifier. This notification form must be signed or sealed, and sent to the foreign supplier. The foreign supplier must then complete the form and return it directly to METI.
Note a substantial limitation that METI highlights in its new guidance: this joint notification procedure may not be used for Specified Chemical Substances, Monitoring Chemical Substances, or Priority Assessment Chemical Substances.
For more information, please see guidance documents issued by METI, at Chemical Management.
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