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South Korea Cosmetics Regulation

  •   29 Jun 2017
  •    Jo Zhou
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    South Korea Cosmetics Legislation

    Overarching Regulation
    Cosmetics Act
    Competent Authority
    Ministry of Food and Drug Safety (MFDS )
    Korea Pharmaceutical Traders Association (KPTA)
    Main Supporting Rules 
    14 Mar.
    2019
    Enforcement Decree of Cosmetics Act
    15 Oct. 2019Enforcement Rule of Cosmetics Act
    1 Apr. 2019Regulation on Safety Standards, etc. for Cosmetics
    26 Dec. 2018South Korean Functional Cosmetics Codex (KFCC)(Standards for Testing Methods of Functional Cosmetics

    South Korean 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), South Korean competent authority which also deals with cosmetic registration issues.

    Pursuant to “Cosmetic Act”, cosmetics in South 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 South Korea

    Type

    Regulation

    Effective Date

    Status

    Overarching

    Cosmetics Act

    2019-06-12

    Original Sep.1999

    In Force

    Enforcement DecreeEnforcement Decree of Cosmetics Act2019-03-14

    Original Mar. 2013

    In Force

    Enforcement Rule

    Enforcement Rule of Cosmetics Act

    2019-10-15

    Original Sep.1999

    In Force

    MFDS Notification

    Regulation on Safety Standards, etc. for Cosmetics

    2019-04-01

    Original Jul.2000

    In Force

    South Korean Functional Cosmetics Codex(KFCC)(Standards and Testing Methods of Functional Cosmetics)

    2018-12-26

    Original Jul.2001

    In Force

    Regulation on the Cosmetics Good Manufacturing Practice Standard

    2015-09-02

    Original Dec.2000

    In Force

    Regulation on the Examination of Functional Cosmetics

    2019-06-17

    Original Aug.2008

    In Force

    Regulation on the Substantiation of Cosmetic Labeling and Advertisements2014-02-12

    Orginal Nov. 2012

    In Force

    2. Competent Authority of Cosmetics

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

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

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