Cosmetic Hygiene and Safety Act｜第 5 條｜Food and Drug Administration｜Act｜In Force
第 二 章｜衛生福利部｜v1.0
Last Amended: 2018-05-02
本條規範特定用途化粧品的查驗登記，並明定個人自用的例外與超量處理方式。製造或輸入經中央主管機關指定公告之特定用途化粧品者，應向中央主管機關申請查驗登記，經核准並發給許可證後始得製造或輸入。輸入特定用途化粧品有兩種情形得免申請查驗登記，且不得供應、販賣、公開陳列、提供消費者試用或轉供他用：一、供個人自用且數量符合中央主管機關公告；二、供申請查驗登記或研究試驗之用並經專案核准。個人自用超過公告數量者，其超量部分由海關責令限期退運或銷毀。
Manufacturers or importers of specific purpose cosmetics designated by the public announcement of central competent authority, an application for registration shall be filed with the central competent authority. No manufacturing or import shall be allowed until a license is approved and issued. Licensed cosmetics of the preceding paragraph shall not modify any of the originally registered particulars without approval of the central competent authority. However, this restriction does not apply to particulars that may be voluntarily modified per public announcement by the central competent authority. The import of specific purpose cosmetics shall be exempted from application for registration of Paragraph 1 if one of the following conditions applies. Furthermore, the supply, sale, public display, consumer trial offer, or transfer to other uses of said cosmetics shall be forbidden: 1. Import for personal use, the quantity of which complies with public announcement of the central competent authority; 2. Import for the application for registration of Paragraph 1 or for use in research and trial, through special permission of the central competent authority. For the import of specific purpose cosmetics for personal use of the preceding Subparagraph 1 that exceed the quantity specified in public announcement, their excess portion shall be ordered a return or destruction within a specified time limit by the customs. Prior to the enforcement of this Act as amended on April 10, 2018, for the manufacturing or import with a license of cosmetics containing medical or poisonous drugs whose license validity term expires within five years following the enforcement of this Act as amended on April 10, 2018, and where it is necessary to continue the manufacturing or import, an application for extension may be filed within three months before the expiration of validity term and an application for registration in accordance with Paragraph 1 may be exempted. Regulations governing the issuance, modifications, revocation, and rescission of licenses with regard to Paragraph 1 and Paragraph 2, the application procedure for special permission with regard to Subparagraph 2 of Paragraph 3, the license extension with regard to Paragraph 5, and other matters to be observed shall be prescribed by the central competent authority. The provisions of Paragraph 1 and Paragraph 2 shall cease to apply starting five years after the date of enforcement of this Act as amended on April 10, 2018.
依本條第一項，製造或輸入經中央主管機關指定公告之特定用途化粧品者，應向中央主管機關申請查驗登記，經核准並發給許可證後，始得製造或輸入。
依本條第三項第一款，供個人自用且其數量符合中央主管機關公告者，得免申請查驗登記；但依同項本文，不得供應、販賣、公開陳列、提供消費者試用或轉供他用。
依本條第四項，個人自用之特定用途化粧品超過公告數量者，其超量部分由海關責令限期退運或銷毀。