Provisional Translation
| OTO No. | 564 | Classification | MHW-244 |
|---|---|---|---|
| Date of Acceptance | February 6, 1998 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | USA UK France |
| Subject | Promotion of deregulation regarding cosmetics (hair dyes) | ||
| Details of Measures | Description of Complaint: 1. Many hair dyes generally available for use in Europe and the United States (colorants/decolorants) are not available in Japan owing to the regulations of the Pharmaceutical Affairs law. Colorants (hair coloring) and decolorants (bleaches) could not be imported, because the tar pigments and the alcohol concentration used in the respective products did not conform to domestic regulations. 2. The complainant maintains that the safety of these products has been confirmed in other countries and that since their general use is allowed, the standards for hair dyes such as levels for tar pigments or concentration of active ingredients, etc. should be made consistent with international standards by amending the relevant laws. The ministry replied as follows: 1. With respect to synthetic tar used in cosmetics and quasi-drugs, the tar pigments which can be used in these products is determined by ministerial ordinance, in order to prevent harm and ensure the safety of consumers. In cases where new tar pigments not included in the ministerial ordinance are contained in products, as in this complaint, it is necessary to judge the appropriateness of using such substances by evaluating the safety of the tar pigments based on the same data as that used in Europe and the United States, and to add the pigments to the approved list of the ministerial ordinance. 2. The Pharmaceutical Affairs Law includes no standards regarding the concentration of ethyl alcohol or degenerated alcohol contained in cosmetics or quasi-drugs. |
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| Classification of Processing | Cc | Directions | I-a |
| Remarks | |||