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 Amends Claim Requirements for Functional Cosmetics

      Official Release   24 Nov 2017   Jo Zhou

    Takehome: MFDS require clarifications on claims of functional cosmetics This amendment was put into the Enforcement Rules of the Cosmetic Act and has been effective since 2017.11.17. MFDS require newly...
  • Korea Establishes Cosmetic Risk Ranking for Recall System

      Official Release   9 Nov 2017   Jo Zhou

    Takehome: For better implementation of its cosmetic recall scheme, Korea will classify recalled cosmetics based on risk level. MFDS will pre-decide the risk level of the cosmetic product and will assign corresponding...
  • Korea to Amend Part of Cosmetic Act Related to Manufacturer Staff Requirements

      Official Release   1 Sep 2017   Jo Zhou

    Takehome: Korea is amending Article 3 of “Cosmetic Act”, redefining the scope and penalties associated with a manufacturer’s staff found using illegal recreational drugs. In the past Korea’s overarching regulation the...
  • Korea Newly Designated Functional Cosmetics---More information on Registration

      Official Release   14 Aug 2017   Jo Zhou

    Take home: In H1 2017, Korean cosmetic authorities newly designated 4 quasi-drug categories as functional cosmetics (see news on CL). Now Korea Cosmetic Association released more instructions on how to register...
  • Korea Bans Plastic Microbeads in Cosmetics

      Official Release   4 Jul 2017   Jo Zhou

    Take home: Korea prohibits the use of microbeads with diameter less than 5mm in cosmetics (especially cleansing products) since July 1st 2017. According to the United Nations Environment Program (UNEP), 22 plastic...
  • Korea Banned 11 Ingredients Relating to Functional Cosmetics

      Official Release   22 Jun 2017   Jo Zhou

    Take home: To guarantee the safety of newly designated functional cosmetics, MFDS banned 11 ingredients and revised ‘Cosmetic Safety Standard’ again (see news about revision of Cosmetic Safety Standard last month...
  • Korea

    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...
  • 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...
  • 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...
  • Korea

    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...
  • Korea to Set Up Natural/Organic Cosmetic Certification System

      ChemLinked Exclusive   21 Aug 2017   Jo Zhou

    Takehome: To meet new market demand and reinforce management of personalized cosmetics such as natural/organic cosmetics, Korea’s MFDS is proposing to set up a Natural/Organic Cosmetic...
  • Summary of Korea Recent Ingredients Requirement Changes

      ChemLinked Exclusive   13 Jul 2017   Jo Zhou

    Take home: Because several types of quasi-drugs converted into functional cosmetics in first half year of 2017, ingredients standard for cosmetics have to revise for the integration. MFDS has revised “Cosmetic Safety...
  • Korea to Classify Solid Soaps as Cosmetics

      ChemLinked Exclusive   11 Jul 2017   Jo Zhou

    Take home: Korea will designate “solid soaps” as cosmetics. MFDS is formulating a safety standard for this product. The Safety Department of MFDS held a H1 2017 technical and administrative system reviewing conference....
  • 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...
  • Angus Zheng

    Detailing Korean functional cosmetic registration

      14 Aug 2017

    Defining a Functional cosmetic in Korea Before May 30th 2017 functional cosmetics in Korea only referred to whitening products, anti-wrinkle products and sunscreen products. However, afterwards, MFDS expanded the scope of functional cosmetics and newly designated 5...
  • 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...
  • Korea

    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...