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The Ministry of Food and Drug Safety (MFDS) of South Korea has revised functional cosmetic technical review and dossiers submission requirements.

The requirements are:

  • 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 skin and anti-rhagades cosmetics, if all ingredients are the same except for fragrance and humectants, duplication of reports for safety, efficacy and function can be exempted.
  • Addition of 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.
  • Clarification of claims for adverse skin reaction warnings
  • For reliability, only notarized methods can be used during testing.

The new requirements were released on May 30, 2017.



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