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Taiwan Introduces Three New Cosmetic in Vivo Testing Guidelines

On Dec 2 Taiwan FDA released three new cosmetic in-vivo testing methods.

No.English NamePurpose
1Guidelines for Human Skin Patch Testing of CosmeticsTo test if there is a possibility that cosmetics will cause an adverse reaction to human skin.
2Guidelines for Evaluating Sun Product Water Resistance of SunscreensTo evaluate the SPF of water-resistant sunscreens
3Guidelines for Human Skin Testing of CosmeticsTo evaluate the influence on the skin under the condition of proper use through directly using the tested product by subjects


In the Guidelines for Human Skin Patch Testing of Cosmetics and Guidelines for Human Skin Testing of Cosmetics, the following requirements are stipulated especially:

  • The guidelines shall be conducted by trained and experienced staff.

  • Moderators of testing take full responsibility for the testing and shall take measures to ensure the safety of test subjects. The testing can be conducted only after confirming that the tested product will not pose any risk on subjects. If there is any risk, moderators shall submit the testing plan to the Ethics Review Committees for review.

  • Prior to the testing, a safety assessment report of the tested product shall be completed. Product ingredients, toxicity, and stability shall be taken into consideration in the report. Product safety assessors need to determine if more information should be obtained, such as accurate ingredients specifications or details of recommended exposure conditions, to complete the safety assessment report.

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