Korea Cosmetics Regulation

  •   29 Jun 2017
  •    Jo Zhou

     Korea Cosmetics Legislation

    Overarching Regulation
    Cosmetic Act
    Competent Authority
    Ministry of Food and Drug Safety (MFDS )
    Korea Pharmaceutical Traders Association (KPTA)
    Main Supporting Rules 
    30 May 2017Enforcement Rule of Cosmetic Act
    16 Jun 2017Korea Cosmetic Safety Standard
    23 May 2017Standards for Testing Methods of Functional Cosmetics

    Korea’s most important legal foundation for regulation and administration of cosmetics is the “Cosmetic Act”. Numerous other regulations and standards expand upon this to provide a comprehensive framework to manage cosmetics in Korea. These regulations are enacted and executed by Ministry of Food and Drug Safety (MFDS), the Korean competent authority which also deals with cosmetic registration issues.

    Pursuant to “Cosmetic Act”, cosmetics in Korea are divided into two categories: general cosmetics and functional cosmetics. General cosmetics are permitted to be manufactured/imported without registration but are subject to post-market supervision. Functional cosmetics are subject to a complex evaluation and approval procedure by MFDS before marketing. Currently there are 9 types of functional cosmetics.

    Before conducting any commercial operations related to cosmetic products, an enterprise should register for the type of cosmetic business. According to “Cosmetic Act”, an enterprise intending to manufacture cosmetics shall be registered as a “manufacturer" while an enterprise that intends to import cosmetics shall be registered as a “Marketing authorization holder (MAH)".

    Contents

    Part 1 Regulatory Framework and Competent Authority

    1. Existing Main Cosmetic Regulations in Korea

    Type

    regulation

    Effective Date

    Status

    Overarching

    Cosmetic Act

    2017-05-30

    Original Sep.1999

    In force

    Enforcement Rule

    Enforcement Rule of Cosmetic Act

    2017-05-30

    Original Sep.1999

    In force

    Standard

    Korea Cosmetic Safety Standard

    2017-06-13

    Original Jul.2000

    In force

    Standards for Testing Methods of Functional Cosmetics

    2017-05-23

    Original Jul.2001

    In force

    Standards of Manufacture and Quality Management for Excellent Cosmetics

    2015-09-02

    Original Dec.2000

    In force

    Standards for Evaluation Dossiers of Functional Cosmetics

    2015-03-25

    Original Aug.2008

    In force

    2. Competent Authority of Cosmetics

    Ministry of Food and Drug Safety (MFDS) is Korea competent authority, which is responsible for formulating cosmetic regulations and registering functional cosmetics

    Korea Pharmaceutical Traders Association (KPTA) is responsible for issuing importing cosmetic approval and supervising cosmetic trading.

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