Regulations Governing the Application of Animal Testing for the Safety Assessment of Cosmetics or Cosmetic Ingredients

Article 1
The present regulations are prescribed pursuant to Paragraph 6 of Article 6 of the Cosmetics Hygiene and Safety Act (the “Act”).
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).
Article 3
The central competent authority shall notify the applicant to make supplement or correction within a given time limit if documents or information of the preceding Article is deficient and may be supplemented or corrected. In case supplement or correction is not made or completely made in the specified time limit, the application shall be refused.
The applicant may, with reasonable justification, apply for an extension before the deadline of the time limit in the preceding Paragraph. Such application is limited to one time only.
Article 4
The central competent authority shall issue an approval document and notify the applicant after the application has been reviewed to be in compliance with the provisions of Paragraph 4 in Article 6 of the Act.
The review in the preceding Paragraph may be conducted by experts and scholars of cosmetics, toxicology, animal protection and other relevant specialized fields invited by the central competent authority.
Article 5
The central competent authority may revoke or cancel the approval document of those who conduct animal test if there is one of the following situations:
1. The application documents or information is found to be fraudulent or untrue.
2. The animal test is conducted in violation of the animal test protocol, provisions of the Statute, the Animal Protection Act or the Regulations for Animal Care, and the circumstances are severe.
Article 6
No application shall be accepted for the next two years after the applicant’s approval document for conducting animal test is revoked or canceled by the central competent authority.
Article 7
In case of loss or damage of an approval document, a completed application form along with the following documents shall be submitted to the central competent authority to apply for reissuance or renewal:
1. Reissuance: Affidavit of Loss.
2. Renewal: Original copy of the approval document.
Article 8
These Regulations shall take effect on November 9, 2019.