Provisional Translation
| OTO No. | 116 | Classification | MHW-81 |
|---|---|---|---|
| Date of Acceptance | June 18, 1983 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | French firm | Exporting Countries | France |
| Subject | 1. Approval of use of hydrogen peroxide as a component of a permanent wave agent. 2. Approval of use of Imexines and Ionenes. |
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| Details of Measures | 1. Explanations were made that the use of hydrogen peroxide had never been approved since there were few data which could demonstrate its efficacy and safety, and that, for its use, the materials for concerning its efficacy, safety, standards and test methods were necessary in order to revise the standard for permanent wave agents. The complainant submitted a part of the materials in January 1984, but was informed that it was not enough. In June the complainant informed us that he would make a test to collect the data, and in December 1984 the complainant submitted the test program to us. In April 27, 1985, the application for approval of a permanent wave agent using hydrogen peroxide was made. After the necessary procedures including the deliberations at the central Pharmaceutical Affairs Council were taken, a revision of the standards for permanent wave agents was notified on October 14, and the agent in question was approved on December 16, 1985. 2. Explanations were made that an application for approval and license had to be made accompanied by the necessary data in order that such hair dyeing agents as Imexines and Ionenes could be used. As for Imexines, the application for its approval and the license of importer was made in September 1984 and it was approved on November 13, 1985 after the deliberations at the Central Pharmaceutical Affairs Council and other necessary procedure. |
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| Classification of Processing | 1. A 2. A |
Directions | 1. I-a 2. I-a |
| Remarks | |||