Provisional Translation
| OTO No. | 553 | Classification | MHW-238 |
|---|---|---|---|
| Date of Acceptance | March 24, 1997 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Foreign firm, domestic Firm | Exporting Countries | USA |
| Subject | Approval of new ingredients for nail polish | ||
| Description of Complaint | (1) The complainants state that when they attempted to apply for import approval for nail polish containing the new ingredient naphtopyran, it took considerable time due to inappropriate handling of the application by officers at the counter and considerable expense to obtain the safety data requested. (2) The safety of this ingredient has been verified by the U.S. organization CTFA, and the product has already been imported. (3) Given these circumstances, the complainants want the ministry to approve naphtopyran as an ingredient in cosmetics and allow the sale of nail polish containing this ingredient. |
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| Details of Measures | 1. The ministry replied as follows: (1) When a cosmetic product is imported to be sold, approval is necessary if the product is not included in the comprehensive licensing standards of cosmetics by category (CLS). (2) Since naphtopyran is not included in CLS, the importer must submit safety data (related documentation is acceptable) with the application. The application is sent in to the Ministry of Health and Welfare (MHW) through prefectural offices and examined by the MHW. (3) CTFA names ingredients for the purpose of labeling on cosmetics, but does not conduct any safety evaluation at that time. 2. In response to the above reply, the complainants filled an application for approval by category. |
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| Classification of Processing | Cc | Directions | II-a II-b |
| Remarks | |||