Taiwan Encourages the Use of Alternatives for Safety Tests

"Taiwan Ministry of Health and Welfare" has announced it will adjust the requirements for technical documents necessary for review of new compounds contained in medicated cosmetics. The motivation for this adjustment is to reduce the need for animal testing and work towards a cruelty free cosmetic regulatory framework. MOHW is attempting to align itself with the numerous scientifically substantiated viable alternatives to animal testing published by both the OECD and EU. This adjustment also meets the needs for global harmonization within the cosmetics industry and most importantly complies with article 15 of Taiwan Animal Protection Act, which is “Stakeholders should endeavor to avoid using live animals for scientific tests. If unavoidable, a reduction in the use of live animals is better; moreover, such tests must minimize animal suffering and pain”. In the announcement MOHW also encourages companies to prioritize the use of alternatives for safety tests.

Requested attached technical documents:

Items	Scope of Documents	New Ingredient	New Usage	New Limit (Improving Use Concentration)
Origin and Discovery Process, Application Situation at Abroad	Origin and Discovery Process	◇	◇	◇
	Application Situation at Abroad	◇	◇	◇
	Properties Comparison	◇	◇	◇
Physical and Chemical Properties, Testing Specification and Testing Methods	Chemical Constitutional Formula	◇	X	X
	Physical Constitutional Formula	◇	X	X
	Testing Specification and Testing Methods	◇	◇	◇
Stability Testing	Long-term Testing	◇	◇	◇
	Stress Testing	◇	◇	◇
	Accelerated Testing	◇	◇	◇
Safety Testing Reports	Acute Toxicity Study	◇	△	△
	Subacute Toxicity Study	◇	△	△
	Chronic Toxicity Study	◇	△	△
	Local Irritation Test	◇	△	△
	Antigenicity Study	◇	△	X
	*Mutagenicity Study	△	X	X
	*Carcinogenicity Study	△	X	X
	*Reproductive Toxicity Test	△	X	X
Absorption, Distribution, Metabolism and Excretion Tests Reports	Absorption Test	△	△	△
	Distribution Test	△	△	△
	Metabolism Test	△	△	△
	Excretion Test	◇	◇	◇
Related Usage Documentation	Function or Efficacy Certificate	◇	◇	◇
	Human Trial Reports	◇	◇	◇
	Approval Documentation from other countries	△	△	△

Note：

◇ means mandatory attached documentation; △ means to attach or not to attach depends on each individual case; X means there is no need to attach the documentation. * means test reports of preparations are exempt from attaching.