Regulations Governing the Application of Animal Testing for the Safety Assessment of Cosmetics or Cosmetic Ingredients Article 2
Cosmetics manufacturers, importers or sellers shall, in accordance with the provisions of Paragraph 4 in Article 6 of the Act and when applying for testing of animals as subjects for the safety assessment of cosmetics or cosmetic ingredients (hereinafter referred to as the animal test), submit a completed application form along with the following documents and information to the central competent authority for approval before conducting the animal test:1. Photocopy of registration certificate for the company or business of the animal test applicant.2. Photocopy of registration document for the legal establishment of the company, business, college/university, juristic person, organization or institution that is a contractor to conduct animal test of the contract party.3. Photocopy of concurrence document upon review approved by deliberation of the care and use of laboratory animals committee/panel (hereinafter referred to as the animal care committee/panel) established by the one that conducts animal test in accordance with Article 16 of the Animal Protection Act.4. Explanation and related supporting documents for the necessity to conduct animal test that has the conditions in Subparagraphs 1 and 2 of Paragraph 4 in Article 6 of the Act.5. Explanation and related documents to demonstrate that there are no other non-animal alternative methods available.6. Animal test protocol reviewed and approved by the animal care committee/panel in accordance with Article 4 of Regulations for Establishing and Managing the Institutional Animal Care and Use Committee or Panel (hereinafter referred to as the Regulations for Animal Care).
中文原文 化粧品或化粧品成分安全性評估申請動物試驗辦法第2條
化粧品製造、輸入或販賣業者依本法第六條第四項規定，申請以動物作為檢測對象，進行化粧品或化粧品成分之安全性評估（以下簡稱動物試驗）時，應填具申請書，並檢附下列文件、資料，向中央主管機關申請許可，始得為之：
一、申請動物試驗者之公司或商業登記證明文件影本。
二、委託執行動物試驗者，其受託試驗者之公司、商號、大專校院、法人、團體或機構依法設立登記之文件影本。
三、執行動物試驗者依動物保護法第十六條規定設置之實驗動物照護及使用委員會或小組（以下簡稱照護委員會或小組）審議核可之審查同意書影本。
四、具有本法第六條第四項第一款、第二款之情形，須進行動物試驗之必要性說明及相關佐證資料。
五、無其他非動物性之替代試驗方法說明及相關證明資料。
六、經照護委員會或小組，依實驗動物照護及使用委員會或小組設置及管理辦法（以下簡稱照護辦法）第四條規定審議核可之動物試驗計畫。
一、申請動物試驗者之公司或商業登記證明文件影本。
二、委託執行動物試驗者，其受託試驗者之公司、商號、大專校院、法人、團體或機構依法設立登記之文件影本。
三、執行動物試驗者依動物保護法第十六條規定設置之實驗動物照護及使用委員會或小組（以下簡稱照護委員會或小組）審議核可之審查同意書影本。
四、具有本法第六條第四項第一款、第二款之情形，須進行動物試驗之必要性說明及相關佐證資料。
五、無其他非動物性之替代試驗方法說明及相關證明資料。
六、經照護委員會或小組，依實驗動物照護及使用委員會或小組設置及管理辦法（以下簡稱照護辦法）第四條規定審議核可之動物試驗計畫。