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South Korea

Applicable legislation

Cosmetics sold in Korea are regulated by the Ministry of Food and Drug Safety (MFDS), which monitors production and distribution in several sectors. Cosmetic products placed on the Korean market must comply with the Cosmetics Act, with the Cosmetic Regulation as well as with the Cosmetics notice from the Korean government.

What type of products are cosmetics?

The definition of a cosmetic is described in the Korean Cosmetics Act. Cosmetics are divided into cosmetics and functional cosmetics as below.

Cosmetics: “The term cosmetic means any item intended to be used by means of spreading, rubbing, spraying on or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or brightening the appearance, or maintaining or improving the health of skin and hair, which have light effects on the human body”.

Functional cosmetics: The term “functional cosmetics” means cosmetics prescribed by ordinance of the prime minister, falling under any of the following:

(a) Products that encourage the whitening of skin;

(b) Products that help improve or limit wrinkles;

(c) Products that gently tan or protect skin from ultraviolet rays;

(d) Products that aid in the changing or removal of colour from, or nourishment of, hair;

(e) Products that aid in the prevention of, or improvement on, problems resulting from weakened functions of skin or hair e.g., dryness, split-ends, hair- loss, cornification, etc.

Requirements

The most important requirement is that cosmetic products sold in Korea are manufactured, prepared, preserved, packed and stored under sanitary conditions and are, therefore, safe for use by consumers.

Foreign cosmetics manufacturers should designate an importer or a distributor within Korea, which has its own storage facility, to secure the quality of the product. The manufacturer or importer should also assign a quality manager to conduct quality control work according to quality control standards as well as guarantee work according to the Safety Management Standard after Manufacture and Sale of the Korean Cosmetics Act, called the pre-market registration process. The quality manager is required to participate annually in quality training at a training institution that has been designated by the minister of food and drug safety.

In the case of functional cosmetics, the manufacturer or importer are required to submit technical documents to the Ministry of Food and Drug Safety (MFDS) in order to evaluate the safety and effectiveness of the cosmetic, called the technical document review process.

Cosmetic product labels must conform to the specific requirements for labelling that can be found in the Cosmetics Act, as well as the Cosmetics notice from the Korean government. Special attention must be paid to the language, claims and price used on the labels. The label must be written in Korean. However, it may include other languages also. In the case of exporting products, the label may be written in the language of the country the product is being exported to. Only claims in line with the definition of cosmetics or functional cosmetics and supported by evidence can be used. The price should be readily identifiable on the outer package label.

Services offered

  • Product classification
  • Formula review
  • Labelling review
  • Establishment registration
  • Consultation of functional cosmetic evaluation
  • Consultation of a cosmetic GMP within Korea

Check also Flowchart for the Evaluation of Functional Cosmetics here.

Services offered

  • Product classification
  • Formula review to ensure compliance with the cosmetics legislation
  • Labelling review
  • Consultation on functional cosmetics evaluation
  • Establishment registration
  • Consultation on cosmetic GMP in Korea
  • Label translation to Korean

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