| OTO No. | 674 | Classification | MHLW-13 |
|---|---|---|---|
| Date of Acceptance | January 20, 2005 | Ministry/Agency Receiving Complaint | Cabinet Office |
| Responsible Ministries | Ministry of Health, Labour and Welfare | Related Laws | Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | Germany |
| Subject | Relaxation of cosmetic regulations for CoQ10 | ||
| Description of Complaint |
The complainant has imported and sold products containing CoQ10 (never used for mucosa) from Germany. The Ministry of Health, Labour and Welfare revised part of the Standards for Cosmetics on October 1, 2004 to designate ubidecarenone (CoQ10) as "ingredients restricted according to types of cosmetics" and stipulate that the maximum amount of CoQ10 per 100 g of "cosmetics not used for mucosa" shall be 0.03 g. Hereby, the amount of CoQ10 in products in question exceeds the maximum amount, and the complainant thus cannot sell the products any longer. Products in question are in circulation without limitation in Europe, and materials on safety are available. First of all, CoQ10 is not on either the positive list or the negative list in Europe and the United States. In addition, no upper limit has been set in terms of use of CoQ10 for food in Japan unless the effect and efficacy of CoQ10 as drugs are advocated. Consequently, the complainant wants the ministry to eliminate the maximum limit or at least to set a standard value to the same level as in Europe and the United States from the standpoint of international consistency. Moreover, the complainant wants the ministry to give a detailed explanation of the background to the inclusion of a provision for CoQ10 into the Standards for Cosmetics and prehistory before setting the maximum amount of CoQ10 per 100 g at 0.03 g. | ||
| Details of Measures |
The ministry replied as follows: Since ubidecarenone (CoQ10) is used as an ingredient of drugs, it falls into "ingredients of drugs" under the Standards for Cosmetics. In the case where one wants to use an ingredient of drugs, which has never been used for cosmetics, as an ingredient of cosmetics, it is necessary to list the ingredient in the Standards for Cosmetics. The "Handling of Ingredients of Drugs of which Use for Cosmetics Is Desired" (Yaku-Shoku-Shinsa No. 0325019 on March 25, 2004) requires those who apply for listing to submit materials on safety, etc. pursuant to the "Outline of Listing in the Positive List" (Iyaku-Shin-Hatsu No. 325 on March 29, 2001). The Standards for Cosmetics are revised in accordance with the result of the examination of applications for listing. Regarding CoQ10, a request for listing in the Standards for Cosmetics was submitted to receive a permit for using 0.03 % with materials on safety in accordance with the Notice of the Director of the Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. As a result of examination, the maximum amount was set based on the request for listing. If the complainant wants to change the maximum amount of ubidecarenone, the complainant has to submit a request for revision of the Standards for Cosmetics through the same procedure, with materials on safety, etc. attached as grounds for change. Incidentally, the four regulatory authorities of Japan, the United States, Europe and Canada are examining international harmonization of cosmetic regulations under the CHIC (Cosmetics Harmonization International Cooperation). 2. Actions taken by the ministry after the reply In April 2005, the complainant submitted a request for revision of the maximum amount of CoQ10 under the Standards for Cosmetics, and the request is now under examination. | ||
| Classification of Processing | Pending | Directions | I-a |
| Remarks | A written reply was made on January 28, 2005 | ||