| TOP |
| 6th Report of Market Access Ombudsman Council (March 16, 2000) |
1. Complainant: Tokyo Chamber of Commerce and Industry
2. Ministry concerned: Ministry of International Trade and Industry, Ministry of Health and Welfare.
3. Complaint:
When businesses import cartridges for personal computer printers, copiers or fax machines, the Law Concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances is applied to the new chemical substances in the toner or ink inside the cartridges, requiring that the minister for health and welfare and the minister for international trade and industry be notified. This procedure is complicated, requiring that detailed documentation be drawn up for notification, and the procedure should be simplified.
4. Corresponding Policy of the Ministries concerned:
(1) Simplification of the notification procedure
The Law Concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances (hereafter referred to as "the Law") is under the dual administration of the Ministry of Health and Welfare and the Ministry of International Trade and Industry. Because of this, notification of manufacture or import of new chemical substances called for by the Law must be made to both ministries; however, a uniform format has been adopted for the test reports and other documentation attached to the notification, as needed. But the contents of documentation which must be prepared for submittal to respond to questions about certain items raised by the examination councils may differ depending on the questions raised.
To simplify the procedures for notification of new chemical substances based on the Law, including notification of new chemical substances in small quantities, the ministries are currently developing an electronic-based notification system, and acceptance of notifications sent by electronic media will begin from FY2000.
(2) "Products" as defined under the Law
The regulations of the Law deal with the chemical substances constituting products, and not with so-called finished products. For this reason, as indicated in I.(4) of the "Application of the Law Concerning the Examination and Regulation on Manufacture, etc. of Chemical Substances" (notice issued jointly by the director of the Pharmaceutical Affairs Bureau, Ministry of Health and Welfare and the director of the Basic Industries Bureau, Ministry of International Trade and Industry, No. MHW 291-62/No. MITI 171, dated March 24, 1987), substances having a specific usage form or mixtures, in which only when the substances are mixed does a product result, and which in principle are used for the final use of the product in question (in other words, which are in a form that ordinary consumers use) are considered "products" and are exempt from the notification requirement based on Article 3 of the Law.
Accordingly, regarding imports of toner and ink cartridges containing new chemical substances, if these coincide with the description of "products" above, no prior notification for new chemical substances is necessary; if they do not, prior import notification for new chemical substances is required under the Law. Specifically, if the toner or ink for ordinary consumers is sealed inside a cartridge and is in a form intended to be used by ordinary consumers, it can be considered a "product" under the Law. However, since toner, ink and cartridges may come in many different form, it is difficult to judge across the board whether all of them meet the above definition of a "product."
Regarding import of "products" using Class I specified chemical substances (9 substances, including PCB) or Class II specified chemical substances (23 substances, including trichloroethylene) designated under the Law, separate regulations, in accordance with Article 13, etc. of the Law, apply.
5. Remarks
The complainant accepted this policy.