Korea Revises Functional Cosmetic Technical Review and Dossiers Submission Requirements

In line with Korea's recent expansion of the scope of functional cosmetics, MFDS revised several requirements of technical review and dossiers submission. Hair dye products, cosmetics for sensitive skins etc. which are now considered functional cosmetics are subject to these new requirements since May 30, 2017. For hair dye products efficacy and function data are required. (*data should be collected from professional institutions, domestic or overseas colleges and hospital laboratories)...

Takehome:

In line with Korea's recent expansion of the scope of functional cosmetics, MFDS revised several requirements of technical review and dossiers submission.
Hair dye products, cosmetics for sensitive skins etc. which are now considered functional cosmetics are subject to these new requirements since May 30, 2017.

For hair dye products efficacy and function data are required. (*data should be collected from professional institutions, domestic or overseas colleges and hospital laboratories)

For sensitive skin cosmetics, clinical testing is required（*data for this new testing method should also be collected from appointed CROs）

For functional cosmetics for sensitive skins and anti- rahagades cosmetics, if all ingredients are the same except for fragrance and humectants, duplication of reports for safety, efficacy and function can be exempted.

To add standards for concentration limit of epilating agent and add testing methods for concentration of hair dyes. (*specifically, add concentration limit of glycolic acid (main ingredient for epilating agent) and add salt strength testing methods to test concentration of hair dyes.)

For epilating agent and hair dye products, if one product belongs to the "safety guaranteed ingredient category", it can be exempted from safety assessment.

To clarify the claims for adverse skin reaction warnings

For reliability, only notarized methods can be used during testing