Taiwan Consults on Measures for Application for Animal Testing on Cosmetics/Cosmetic Ingredients

Taiwan MOHW released a draft named Measures for Application for Animal Testing on Cosmetics/Cosmetic Ingredients for public consultation. The draft stipulates the application procedures and detailed requirements for safety assessment of cosmetics/cosmetic ingredients conducted within the region, using animals as test subjects.

Documents Needed to Compile FDA Review Dossier:

1. A copy of business registration certificate of the applicant

2. A copy of business registration certificate or other related documents of entrusted testing company (if no entrusted testing company, the document is not required)

3. Explanations outlining the necessity of animal testing and related supporting documentation

4. Statement that there is no alternative and related supporting documentation

5. Animal testing plan, including:

• Plan name
• Responsible person
• Purpose
• Name of tested cosmetics/cosmetic ingredient, and chemical and physical property description
• Testing items and methods
• Testing duration and site
• Other necessary documents acknowledged by competent authority

FDA will inform the applicant to supplement documents if it finds the dossiers are incompliant after a review. If the applicant doesn't supplement within 30 days as of the receipt of the notice of supplementation, the application will be rejected. If there is a justified reason for not supplementing, the applicant can apply for extension of supplementation period (not exceeding 30 days).

Animal testing shall comply with Animal Protection Act and related laws.

The draft is proposed to be implemented from Nov 9 2019.