Korea Expands the Scope of Functional Cosmetics

  •   10 May 2017
  •    Jo Zhou

    Take Home:

    According to the amendment of the “Cosmetic Act”, four categories of quasi-drugs have been designated as functional cosmetics.

    Categories of functional cosmetics converted from quasi-drugs

    Hair dye, Decolorant, Bleach agent

    Epilating agent

    Anti-hair loss agent

    Preparation of relieving acne in bath solvents

    Note: if bath solvents are not intended to alleviate acne, they are subject to general cosmetics.

    Starting from 30th May 2017, the above 4 categories will be deleted from list of quasi-drugs, and subsequently designated as functional cosmetics. To comply with functional cosmetic regulations these categories are subject to safety and efficacy evaluation before manufacturing/importing. If a product has already obtained a quasi-drug license, please submit the license together with other necessary documentation. MFDS will issue approval after 30th May 2017.

    Only manufacturers/importers registered as “cosmetic manufacturers” or “marketing authorization holder” can manufacture or import functional cosmetics. Once the new categorization system is implemented, manufacturers/importers should register or assign other functional cosmetics manufacturer/importer to operate.

    Exemption: Functional cosmetics which are exclusively for export purposes (not sold domestically) are exempted from evaluation pursuant to Article 30 of the Cosmetic Act. 

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    Comments

    Dear, Can I check with you if the amendment of Korean Cosmetic Act is draft or final version. Thanks!
    Dear, Can I check with you if the amendment of Korean Cosmetic Act is draft or final version. Thanks!
    Thank you for your comments. the Korean Cosmetic Act is constantly under revision, so it can't guarantee a final version, but here refers to the latest revision. As far as we can confirm, this new categorization system will be in force on 30th May 2017.