5th Report of Market Access Ombudsman Council (March 17, 1998)

3-(6) Approve the import of chemical products approved by TSCA and the like

1. Complainant: Tokyo Chamber of Commerce

2. Ministry concerned: Ministry of Health and Welfare, Ministry of International Trade and Industry

3. Complaint:

Diisopropenylbenzene, an intermediate chemical product, is registered with TSCA, but because it has not been registered in Japan, based on laws pertaining to regulations on the examination, manufacture, etc., of chemical substances, it cannot be imported, necessitating the use of a substitute material that is more expensive to manufacture.

The import of diisopropenylbenzene should be unconditionally or conditionally approved or inspection simplified by application of overseas inspection data.

4. Corresponding Policy of the Ministries concerned:

The U.S. TSCA, Europe's Revised Order No. 7 on the Classification, Packaging and Labeling of Dangerous Substances, and Japan's Law concerning Examination and Regulation of Manufacture, etc., of Chemical Substances all differ in terms of purpose, system structure, and the safety data, etc., necessary for advance import inspection. For the interim, even if the relevant chemical substances are registered on the TSCA inventory or EINECS, if the safety required by Japan's Law concerning Examination and Regulation of Manufacture, etc., of Chemical Substances is not ensured, in order to ensure that the objective of the law, the prevention of damage to human health through an environment in which chemical substances exist, is met, it will not be possible to do away with the confirmation of safety based on advance import inspections and the like and confirm usage.

Concerning safety-related data obtained overseas, when it is recognized that the testing facilities are in conformance with the principles of good laboratory practice (GLP) of the OECD, the attempt is being made to accept this data for the inspections under the Law concerning Examination and Regulation of Manufacture, etc., of Chemical Substances, and safety-related data obtained overseas is already being accepted.