JCR-Link: Japan Chemical Regulatory Consultant for North East Asian (Japanese, Chinese, Korean etc.) chemical regulations

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Q&A

Service for answering the questions related to Japanese chemical laws and regulations


This service provides you with the information preliminary prepared for the questions related to Japanese chemical laws and regulations. Price for each question is, in principle, 2,500 JPY (including tax) (about 25 USD, 18 EURO). Volume of provided information will be less than a half of letter size. Information for each question will be provided after confirming if it is the latest information at the time supplied. How to use this service: Please open each section listed below. Click "Add to Cart" button on the right side of a question you would like to select. Should you have multiple questions, click each of the "Add to Cart" buttons on the right side of questions you would like to select. After finishing selecting all questions, please click "View Cart" button to confirm selected questions. When selected questions are confirmed, please complete the payment by following the instruction of PayPal. After JCR-Link confirms the payment, PDF file with the information related to the selected questions will be sent to designated mail address. In principle, it will be sent to you within 2 working days,however, it might delay depending on the contents. Information to be sent to JCR-Link: Please send the information of the name of belonging organization and section, name and address, telephone number, mail address, and reference number of the questions selected to Misao Shiba (Mr.) (mail address: mshiba@jcr-link.com). Other than the payment using Paypal, you can use remittance to JCR-Link's bank account. For details please contact mail address described above. Even in that case, the information will be provided to you after confirming the payment. Besides, 1,500 or 4,500 (about 15 or 45 USD, 11 or 33 EURO) will be added to the price depending on the currencies you would like to remit.



	Substances and materials, etc.
	1.	New Chemical substance
	2.	Labeling and SDS
	3.	GHS
	4.	Dangerous Good
	5.	Cosmetics, Medical devices, Drugs
	6.	Foods and food additives, containers or packages for food, Detergent, Toys
	7.	Customs clearance

	Laws
	1	Chemical Substance Control Law(CSCL)
	2.	Industrial Safety and Health Law(ISHL)
	3.	Poisonous and Deleterious Substance Control Law(PDSCL)
	4.	Fire Service Law
	5..	PRTR Law

Example of questions and provided information.

SDS

1-1

Is SDS in Japan required to be described in Japanese language under the relevant laws?

The Poisonous and Deleterious Substance Control Law, the PRTR Law and the Industrial Safety and Health Law require to prepare SDS in Japanese language. (As of Jun.27, 2014)

Legal grounds:
PRTR Law:
	Paragraph 2 of Article 4 under the "Ministerial Ordinance which sets down the methodologies of the provision of information about appearance and handling of Designated Chemical Substances etc." (Dec.22, 2000, Ministry of International Trade and Industry No.401) requires describing the required information in Japanese language.
Poisonous and Deleterious Substance Control Law:
	Article 13-11 of the Ministerial Ordinance of the Poisonous and Deleterious Substance Control Law requires providing required information in Japanese language.
Industrial Safety and Health Law
	Provisions under II, No.3, 4 of the amended notice of the Notice No. 1 (KIANKAHATSU No.1020001/Oct.20, 2006/MHLW) published on Dec. 16, 2010 requires describing Labeling and SDS in Japanese language.

1-2

Are Japanese Industrial Standards (JIS) in connection with GHS available in English?

At present, we have following two JIS in connection with GHS. However, English version is available only for JIS Z 7253 2012. According to Japanese Standards Association, which is responsible for the translation of JIS, there is no plan to compile English version for JIS Z 7252 in the future. (As of Jun.27, 2014)

JISZ 7252 2014:	Classification of chemicals based on "Globally Harmonized System of Classification and Labeling of Chemicals (GHS)"
JISZ 7253 2012:	Hazard communication of chemicals based on GHS -- Labeling and Safety Data Sheet (SDS)

Above both JIS are compiled based on the 4th edition of GHS

For purchasing JIS, please visit website of Japanese Industrial Association:

http://www.webstore.jsa.or.jp/webstore/Top/indexEn.jsp?lang=en

1-3

Is SDS required for articles under the relevant laws?

No. Except for the Industrial Safety and Health law　(As of Jun.27, 2014)

Legal grounds:
PRTR Law:
	Item 1, Article 5 and Item 1, Article 6 under the Enforcement Order of the Law excludes business entities which handle products (article) defined below from the scope of the "Business Entities which Handle Designated Chemical Substances etc." and hence the law is not applicable to them: therefore, provision of SDS is not required for such products (article). "Products which neither change its physical form to none-solid, nor, to powder or granule during the handling processes of a business entity".
Industrial Safety and Health Law:
	This law does not distinguish articles from the other forms of chemical substances when they are intended to be used in industry: therefore, in such cases, articles are also subject to SDS requirements. However, consumer products (including articles) are exempt from SDS requirements. No. I, 3, HA(は) in the section titled "Related to the ISHL" of the Notice (Mar. 24, 2000, No.162) of the former Ministry of Labor prescribes that such consumer products include products described below: "Products which neither change its physical form to none-solids, nor, to powder or granule during labor's handling process"
Poisonous and Deleterious Substance Control Law:
	This law is only applicable to the substances and preparations designated as Poisonous or Deleterious. A FAQ, which is posted on the website of the Ministry of Health and Welfare, prescribes to the effect that articles are not recognized as preparation even they contains the designated substances. Article includes such as equipment, instruments, tools, and equipment and/or instruments coated with a paint of deleterious substance. Due to the above reason, articles are not in the scope of this law, hence, SDS is not required.

Confidential Business Information

2-1

When exporting existing chemical substances (in CSCL inventory) to Japan do we need to disclose chemical information to the importers?

Yes,

For customs clearance, importers are obliged to indicate CSCL inventory number in an invoice or in an import document for existing chemical substances in a product. All the intentionaly added chemical substances regardless of their concentrations in a product and all the other chemical substances contained 1% or more shall be indicated.

Detail requirements for the other types of chemical substances such as new chemical substances, chemical substances for R&D use, and Class I Specified Chemical Substances etc. are described in the "Notice for the customs clearance procedures for chemical substances related to the Chemical Substance Control Law (Mar.31, 2014, METI)"

However, this requirement does not apply to chemical substances in articles. Because articles are not in the scope of the definition of "Chemical Substance" under the law.

Note: CSCL inventory = ENCS inventory = MITI inventory = METI inventory, CSCL stands for Chemical Substance Control Law　(As of Jun.27, 2014)