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
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
(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
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:
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
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 http://www.meti.go.jp/policy/chemical_management/english/guidance_eng.pdf.
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 http://www.meti.go.jp/policy/chemical_management/english/samplenote_eng.pdf.
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 http://www.meti.go.jp/policy/chemical_management/english/sampleform_eng.pdf.
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 http://www.meti.go.jp/policy/chemical_management/english/cscl.html.
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