Provisional Translation
| OTO No. | 451 | Classification | MHW-213 |
|---|---|---|---|
| Date of Acceptance | June 28, 1991 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | The American Chamber of Commerce in Japan (proxy complaint) | Exporting Countries | USA |
| Subject | Simplifying approval of cosmetics containing liposome | ||
| Details of Measures | Under the Pharmaceutical Affairs Law, any application for a permit (or approval) to manufacture or to import/sell cosmetics must be accompanied by the necessary data (human patch test, acute toxicity test, skin sensitivity test) supporting the product's safety. Changing to liposome could increase absorption of ingredients into the skin and even ingredients which have been safe until now could become more toxic, and no sufficient data on this has been accumulated. Therefore, the ministry replied that it would be difficult to accept only safety data on human patch tests at present. |
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| Classification of Processing | D | Directions | II-a |
| Remarks | |||