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 Supplements Provision for Customized Cosmetic Authentication System

      ChemLinked Exclusive   22 Mar 2018   Jo Zhou

    Korea issued an updated provision to support the newly promulgated customized cosmetic authentication system. Recently, Korea issued a specific law to regulate the customized cosmetic authentication system which will be enacted on Feb.20th 2019 (see news on CL). To...
  • Korea Drafted Regulation of Customized Cosmetic Authentication System

      ChemLinked Exclusive   6 Mar 2018   Jo Zhou

    Korea issued specific law to regulate customized cosmetic authentication system. The law will officially be enacted on Feb.20th 2019 and effective on Feb.20th 2020. In the new regulation draft, cosmetic manufacturing/ sale business will be divided into three types in the future: 1) cosmetic...
  • Korea to Make Safety Proof of Children Cosmetic Compulsory

      ChemLinked Exclusive   27 Feb 2018   Jo Zhou

    Korea is planning to amend the Cosmetic Act to make safety proof of infant/children cosmetics compulsory. Manufacturers and sellers producing infant or children cosmetics should produce, publicize and keep the following information...
  • Korea to Align Cosmetic Regulations with ASEAN Member Countries by 2019

      ChemLinked Exclusive   29 Jan 2018   Jo Zhou

    MFDS will form a new council with ASEAN member countries to create standardized cosmetic regulations for the South Asian cosmetic market by 2019...
  • Korean Authorities to Implement QR Code Digital Administration for Cosmetic Products

      Official Release   25 Jan 2018   Jo Zhou

    Korean authorities will use QR Codes (two-dimension code) to replace the use of barcodes. The QR Code will improve the efficiency of management and delivery of the product. Barcodes can...
  • Korea to Reinforce Hygiene Management of Cosmetic Product Samples

      ChemLinked Exclusive   18 Jan 2018   Jo Zhou

    An inspection revealed that most of the product test samples in cosmetic shops are contaminated with pathogenic microorganisms. The MFDS pressed the Consumer Associations to formulate rules to regulate the cosmetic test samples. The inspection investigated 42 kinds...
  • Korean Authorities to Implement QR Code Digital Administration for Cosmetic Products

      Official Release   25 Jan 2018   Jo Zhou

    Korean authorities will use QR Codes (two-dimension code) to replace the use of barcodes. The QR Code will improve the efficiency of management and delivery of the product. Barcodes can...
  • Korea Amends Claim Requirements for Functional Cosmetics

      Official Release   24 Nov 2017   Jo Zhou

    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 designated functional cosmetics used for skin allergy, acne, striae...
  • Korea Establishes Cosmetic Risk Ranking for Recall System

      Official Release   9 Nov 2017   Jo Zhou

    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 recall and fining requirements based on this. The whole...
  • Korea to Amend Part of Cosmetic Act Related to Manufacturer Staff Requirements

      Official Release   1 Sep 2017   Jo Zhou

    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 "Cosmetic Act" stipulated that manufacturers with certain...
  • Korea Newly Designated Functional Cosmetics---More information on Registration

      Official Release   14 Aug 2017   Jo Zhou

    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 these new functional cosmetics in a Q&A format. On...
  • Korea Bans Plastic Microbeads in Cosmetics

      Official Release   4 Jul 2017   Jo Zhou

    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 components are excluded from the scope of microbead. However,...
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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...
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    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...
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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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  • Korea Supplements Provision for Customized Cosmetic Authentication System

      ChemLinked Exclusive   22 Mar 2018   Jo Zhou

    Korea issued an updated provision to support the newly promulgated customized cosmetic authentication system. Recently, Korea issued a specific law to regulate the customized cosmetic authentication system which will be enacted on Feb.20th 2019 (see news on CL). To...
  • Korea Drafted Regulation of Customized Cosmetic Authentication System

      ChemLinked Exclusive   6 Mar 2018   Jo Zhou

    Korea issued specific law to regulate customized cosmetic authentication system. The law will officially be enacted on Feb.20th 2019 and effective on Feb.20th 2020. In the new regulation draft, cosmetic manufacturing/ sale business will be divided into three types in the future: 1) cosmetic...
  • Korea to Make Safety Proof of Children Cosmetic Compulsory

      ChemLinked Exclusive   27 Feb 2018   Jo Zhou

    Korea is planning to amend the Cosmetic Act to make safety proof of infant/children cosmetics compulsory. Manufacturers and sellers producing infant or children cosmetics should produce, publicize and keep the following information...
  • Korea to Align Cosmetic Regulations with ASEAN Member Countries by 2019

      ChemLinked Exclusive   29 Jan 2018   Jo Zhou

    MFDS will form a new council with ASEAN member countries to create standardized cosmetic regulations for the South Asian cosmetic market by 2019...
  • Korea to Reinforce Hygiene Management of Cosmetic Product Samples

      ChemLinked Exclusive   18 Jan 2018   Jo Zhou

    An inspection revealed that most of the product test samples in cosmetic shops are contaminated with pathogenic microorganisms. The MFDS pressed the Consumer Associations to formulate rules to regulate the cosmetic test samples. The inspection investigated 42 kinds...
  • Korea to Revise Cosmetic Safety Information Review Method

      ChemLinked Exclusive   21 Dec 2017   Jo Zhou

    According to No.334 Executive Order, MFDS will revise the "Cosmetic Safety Information Management" which relates to review time and methods...
  • Angus Zheng

    Detailing Korean functional cosmetic registration

      14 Aug 2017  Regulation

    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 types of quasi-drug as functional cosmetics...
  • Angelita Hu

    Korea Functional Cosmetics Regulations

      21 Sep 2016  Regulation

    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...
  • Inna Fu

    Whitening products regulatory status in China, Taiwan, Korea and Japan

      2 Aug 2016  Regulation

    China Whitening products with active whitening ingredients were classified as special use cosmetics since December 2013, which require registration with CFDA. Certain categories of whitening products are defined under Chinese regulations as "products which make people...
  • Tiger Kim

    Interpretation of Custom-blending Cosmetics Sales in Korea

      1 Apr 2016  Market

    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 the consumer at...
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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...
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