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Announcement of “Regulations Governing the Application of Animals Testing for the Safety Assessment of Cosmetics or Cosmetic Ingredients 【Date:2017-09-14】 unit:醫療器材及化粧品組

For the purpose of ensuring the usage safety of cosmetic products for consumers, while taking into account both the compliance of humanity and animal protection, the Ministry of Health and Welfare (hereinafter referred to as the MOHW) has promulgated the “Regulations Governing the Application of Animals Testing for the Safety Assessment of Cosmetics or Cosmetic Ingredients” on September 14, 2017. The main contents of the Regulations are related administrative application procedures regarding animal testing for safety assessments of cosmetics or cosmetic ingredients. The full text contains a total of 8 articles that will come into force starting from November 9, 2019, to establish an environment for the people of Taiwan to use cosmetic products safely as well as balance the interests of animal protection at the same time.

The President’s administrative order issued on November 9, 2016, amended partial article contents of Statute for Control of Cosmetic Hygiene that shall be implemented on November 9, 2019. Based on the requirement of Paragraph 3 in Article 23-2 of the Statute, cosmetics manufacturers, importers or sellers shall not subject animals to testing when conducting safety evaluation of cosmetics or cosmetic ingredients, unless the ingredient is widely used and its function cannot be replaced by other ingredients, or is necessary to conduct animal testing due to having evaluation data that demonstrate the potential for harming human health. The regulations governing its application procedure and other matters to be complied with shall be prescribed by the central competent authority.

On February 2, 2017, MOHW promulgated the draft of “Regulations Governing the Application of Animals Testing for Cosmetics or Cosmetic Ingredients” for public consultation. The final version of the Regulations that is now issued has taken opinions from every sector during the consultation period as references for modifying the draft’s title and contents. The main contents that have been formulated include: documents to be submitted when applying for animal testing on safety assessments of cosmetics or cosmetic ingredients; procedures for supplement or correction and refusal of acceptance; notification to applicants by the central competent authority about review results and reasons for revoking or repealing approval documents of those who conduct animal testing; applications no longer accepted for the next two years after approval documents revoked or repealed by the central competent authority; documents to be submitted when applying for reissue or renewal of approval documents.

For more detailed information of the Regulations, please visit the website of Executive Yuan Gazette Online, or the page on “Latest Info.” of “Laws and Regulations of MOHW” at the website of MOHW, or visit the “Announcement” of “News Rooms” at the website of Taiwan Food and Drug Administration.