In Vitro Skin Sensitisation: Human Cell Line Activation Test（h-CLAT）

On August 28, 2023, China National Medical Products Administration (NMPA) announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). The key updates include the addition of a new prohibited ingredient, the clarification of benzene limit in cosmetics, the revision of 5 testing methods, and the introduction of 14 additional testing methods. Notably, except that the revised methods are scheduled to come into force on March 1, 2024, all other new contents will take immediate effect upon release. 

The new testing method “In Vitro Skin Sensitisation: Human Cell Line Activation Test (h-CLAT)” specifies the basic principles, requirements, and procedures for conducting an in vitro skin sensitization test known as the Human Cell Line Activation Test (h-CLAT). This method is applicable to the toxicological testing of chemical ingredients used in cosmetics, which are either soluble or can form stable dispersion systems, to assess their safety in terms of skin sensitization.