Cosmetic Hygiene and Safety Act｜第 4 條｜Food and Drug Administration｜Act｜In Force
第 二 章｜衛生福利部｜v1.0
Last Amended: 2018-05-02
本條規定化粧品的產品登錄與產品資訊檔案義務，適用對象為經中央主管機關公告之化粧品種類及一定規模之化粧品製造或輸入業者。該等業者應於化粧品供應、販賣、贈送、公開陳列或提供消費者試用前，完成產品登錄及建立產品資訊檔案，有變更者亦同。一定規模、產品登錄之項目內容程序、產品資訊檔案之建立與保存方式期限地點、安全資料簽署人員資格等，均由中央主管機關另定辦法。
Cosmetics categories and cosmetics manufacturers or importers of a certain scale that are specified by the central competent authority as per public announcement shall complete product notification and establish product information file prior to the supply, sale, giveaway, public display, or consumer trial offer of cosmetics. The same shall apply to modifications. Regulations governing the certain scale, the items, contents, procedures, modifications, validity period, revocation, and rescission of product notification, and other matters to be observed with regard to the preceding paragraph shall be prescribed by the central competent authority. Regulations governing the certain scale, the items, contents, modifications, methods for establishment and maintenance, retention period, location, qualification of signatory for the safety report of product information file, and other matters to be observed with regard to Paragraph 1 shall be prescribed by the central competent authority.
依本條第一項，經中央主管機關公告之化粧品種類及一定規模之化粧品製造或輸入業者，應於化粧品供應、販賣、贈送、公開陳列或提供消費者試用前，完成產品登錄及建立產品資訊檔案；其有變更者，亦同。
依本條第二項與第三項，一定規模、產品登錄之項目、內容、程序、變更、效期、廢止與撤銷，以及產品資訊檔案之項目、內容、變更、建立與保存方式、期限、地點、安全資料簽署人員資格等應遵行事項之辦法，均由中央主管機關定之。