South Korea Cosmetics Regulation

In South Korea, the cosmetic regulatory system is founded on the Cosmetic Act which is the overarching regulation for cosmetics. Supporting this act is a series of subordinate rules, standards and guidance documents. The original Cosmetic Act was issued on September 7 1999 and came into force on July 1 2000. Since this date the Ministry of Food and Drug Safety (MFDS), formerly Korean Food and Drug Administration, has amended the act 14 times. The newest revised version came into force on July 31 2014.

In South Korea, cosmetics are divided into two categories: general cosmetics and functional cosmetics. Functional cosmetics refer to products that aid in brightening skin, improving wrinkles in skin, tanning skin gently or protecting skin from sun’s ultraviolet radiation, are subject to more stringent evaluation than general cosmetics.

To conduct commercial operations in Korean, under the cosmetic regulation, 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".

For general cosmetics, manufacturers or importers completing registration with MFDS are permitted to manufacture/import and market the cosmetic products but are subject to post-market supervision.

For functional cosmetics, both manufacturers and importers are required to undergo an evaluation on safety and efficacy of cosmetics and submit information necessary for such evaluation to MFDS. Only after getting approval are manufacturers and importers of functional cosmetics permitted to manufacture or import. Before marketing the products, manufacturers and importers need to get approval again.

Originally, all ingredients introduced to Korea for the first time that have not been designated or publicly notified as cosmetic ingredients are required to undergo an evaluation before manufacture or importation, but now (excepting sunscreen agents, preservatives and colorants) new cosmetic ingredients can be used without any approvals from MFDS. In this case, manufacturers or importers are fully responsible for the safety.

Manufacturers and importers are required to use safe containers and packaging to prevent toxic poisoning of children due to misuse. The information that shall be indicated on labels of containers or packaging includes:

  • Name of product
  • Trade name
  • Address of a manufacturer or importer
  • All ingredients used
  • Volume or weight of contents
  • Manufacturing number
  • Expiry date
  • Price
  • The words “functional cosmetics” in cases of functional cosmetics
  • Precautions labelling

All labeling or advertisements that are likely to deceive or mislead consumers are prohibited.

  • Korea to Fine Manufacturers and Importers of Animal-tested Cosmetics

      Official Release   16 Dec 2016   Angelita Hu

    Recently Korea MFDS announced that it will impose a fine of 1 million Korean won on manufacturers and importers of cosmetics that are tested on animals or contain animal-tested ingredients after...
  • Korea Recent Cosmetic Regulatory Updates

      Official Release   29 Sep 2016   Angelita Hu

    Recently Korea MFDS released a series of regulatory updates for cosmetics for public consultation which includes: Labeling of PA++++ Korea MFDS announced that from December...
  • Guidelines for 8 New Functional Cosmetics to Be Released

      ChemLinked Exclusive   23 Sep 2016   Angelita Hu

    The announcement is just a brief notice without any further enforcement rules, and fails to outline the registration, documentation, testing requirements and ingredient scope. Tiger Kim, President &...
  • Korea to Expand Functional Cosmetic Regulatory Scope

      Official Release   14 Sep 2016   Angelita Hu

    Korea MFDS recently proposed the addition of 8 kinds of products into the functional cosmetic category, including: Hair dye products Decolorizing products Depilatories Hair growth products...
  • Korea Consults on Amendments to Colorants Guidance

      Official Release   3 Aug 2016   Angelita Hu

    Korea MFDS recently consulted on the amendments to “Guidance on Category Management, Standard and Testing Methods for Cosmetic Colorants”. 
  • Korea Revises Quasi Drug Evaluation Requirements

      Official Release   5 Apr 2016   Angelita Hu

    Korea adjusted the existing evaluation requirements for quasi drugs to align with the new quasi drug reevaluation scheme implemented on December 4th 2015. Enlarge...
  • Korea to Fine Manufacturers and Importers of Animal-tested Cosmetics

      Official Release   16 Dec 2016   Angelita Hu

    Recently Korea MFDS announced that it will impose a fine of 1 million Korean won on manufacturers and importers of cosmetics that are tested on animals or contain animal-tested ingredients after...
  • Korea Recent Cosmetic Regulatory Updates

      Official Release   29 Sep 2016   Angelita Hu

    Recently Korea MFDS released a series of regulatory updates for cosmetics for public consultation which includes: Labeling of PA++++ Korea MFDS announced that from December...
  • Korea to Expand Functional Cosmetic Regulatory Scope

      Official Release   14 Sep 2016   Angelita Hu

    Korea MFDS recently proposed the addition of 8 kinds of products into the functional cosmetic category, including: Hair dye products Decolorizing products Depilatories Hair growth products...
  • Korea Consults on Amendments to Colorants Guidance

      Official Release   3 Aug 2016   Angelita Hu

    Korea MFDS recently consulted on the amendments to “Guidance on Category Management, Standard and Testing Methods for Cosmetic Colorants”. 
  • Korea Revises Quasi Drug Evaluation Requirements

      Official Release   5 Apr 2016   Angelita Hu

    Korea adjusted the existing evaluation requirements for quasi drugs to align with the new quasi drug reevaluation scheme implemented on December 4th 2015. Enlarge...
  • Korea to Revise Manufacturing Standards for Quasi-Drug

      Official Release   29 Mar 2016   Albert Lee

    Recently the Korean MFDS released a notice on the revision of the manufacturing standards for quasi-drug. The main contents of this upcoming revision are: 1....
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    The provisions are formulated pursuant to Article 5 of the Cosmetics Law and Article 11 of the Ministry Regulation on The Cosmetics Law for the purpose of stipulating necessary...
    $200
  • Korea

    This regulation formulates the labeling method and exceptional items on the container, packaging, or other attachments of quasi-drugs are formulated according to Article 65 (2) of...
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  • Korea

    This is the newest version of Korea Cosmetic Act which entered into force on July 29 2015.  The Cosmetic Act is the overarching regulation for cosmetics in South Korea. Supporting...
    $230
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    This regulation, pursuant to Article 8 of the Cosmetics Law, is to ensure the management of manufacture (import) and safety management by defining standards of negative...
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  • Guidelines for 8 New Functional Cosmetics to Be Released

      ChemLinked Exclusive   23 Sep 2016   Angelita Hu

    The announcement is just a brief notice without any further enforcement rules, and fails to outline the registration, documentation, testing requirements and ingredient scope. Tiger Kim, President &...
  • Korean National Assembly Passes Cosmetics Act Amendments

      ChemLinked Exclusive   8 Jan 2016   Albert Lee

    According to Korea Cosmetic Association’s report, the National Assembly of the Republic of Korea has just passed the revised parts of the Cosmetics Act.
  • Korea Takes First Step Towards Ending Cosmetics Animal Testing

      ChemLinked Exclusive   12 Mar 2015   Angelita Hu

    On March 11 2015, the revision of Korea’s cosmetic act was proposed by congresswoman Jung-Lim Moon at the National Assembly with the goal of ending animal testing of cosmetics. The announcement marks...
  • South Korea to End Animal Testing on Finished Cosmetics

      ChemLinked Exclusive   12 Jan 2015   Angelita Hu

    KFDA announced its intent to eliminate animal testing for finished products and in the coming months will make provisions about the permitted alternatives to animal testing along with more...
  • Angelita Hu

    Korea Functional Cosmetics Regulations

      21 Sep 2016

    Korea defines functional cosmetics as products that aid in brightening skin, improving wrinkles in skin, tanning skin gently or protecting skin from sun’s ultraviolet radiation. Functional cosmetics are subject to more stringent evaluation than general cosmetics. Based...
  • Tiger Kim

    Interpretation of Custom-blending Cosmetics Sales in Korea

      1 Apr 2016

    What is custom-blending cosmetics sales?  ❍   Definition of 'custom-blending cosmetics sales'         - Custom-blending cosmetics sales is the act of selling cosmetics after mixing colorant, fragrance, and other ingredients to the existing cosmetics  by the needs of...
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    Compared to China’s policy of sweeping reforms to its cosmetic regulatory framework, Korea adopts a more gradual approach through the implementation of smaller changes over an...
    $120