South Korea has a unique and wholesome cosmetic regulation scheme globally, which also guides product safety and encourages product innovation. Understanding Korea's cosmetic regulation can help enterprises in developing their products and entering the market without obstacles. ChemLinked compiles the FAQs for K-beauty based on the Ministry of Food and Drug Safety (MFDS)’s Notice and Korean law center. These questions cover the ingredient, labeling, and functional cosmetic, etc.
The Appendix 1 and Appendix 2 of the Regulation on Safety Standards, etc. for Cosmetics specify the prohibited and restricted ingredients for use in cosmetics.
For other ingredients, the "cosmetic responsible distributor" has to ensure their safety before use. Please also note that Article 6 of the Regulation on Safety Standards, etc. for Cosmetics sets limits on the number of microorganisms in general cosmetics, which should be no more than 1,000/g (mL).
According to Article 13 of the Cosmetics Act, it is prohibited to make any false or misleading claims or advertisements that may deceive or mislead consumers, or to make any claims or advertisements that differ from the safety and efficacy assessment results of functional cosmetics. Violating this provision may result in penalties such as imprisonment for up to one year or fines of up to KRW 10 million.
Therefore, it is important to ensure that the usage instructions provided to consumers are consistent with the safety and efficacy assessment results of functional cosmetics.
According to Article 2 of the Cosmetics Act, cosmetics refer to products that are applied to or sprayed on the human body to clean, beautify, or change the appearance of the body, or to maintain or improve the health of the skin or hair, and that has a mild effect on the human body. However, pharmaceuticals used to diagnose, treat, alleviate, cure, or prevent human diseases are excluded from this definition.
Meanwhile, Article 13 of the Cosmetics Act prohibits any claims or advertisements that may be mistaken as pharmaceuticals, may deceive or mislead consumers, or may cause consumers to misunderstand the facts. In addition, Appendix 5 of the Enforcement Rules of the Cosmetics Act prohibits any claims or advertisements beyond the scope of cosmetics.
Furthermore, according to Article 14 of the Cosmetics Act, business entities must be able to prove any facts related to their claims or advertisements.
In addition, the Guideline for Management of Cosmetic Labelling and Advertisements (Appendix 2) specifies that the claim "temporary cellulite reduction" can be used when empirical evidence is provided. However, the Guideline prohibits using expressions of "diet," "fat decomposition," or other similar terms in cosmetics claims and advertisements.
Therefore, "weight loss" cannot be claimed on cosmetics.
According to the Cosmetics Act, “cosmetic manufacturing" refers to manufacturing the whole or a part of the cosmetics (excluding processes such as secondary packaging or labeling). In addition, Cosmetic Good Manufacturing Practice and Quality Control Standards defines "manufacturing" as a series of processes including weighing raw materials, mixing, filling (primary packaging), secondary packaging, and labeling.
If you import bulk products and repackage them in South Korea, the repacked products will be classified as domestically manufactured products and must be manufactured by a cosmetic manufacturer.
According to the Cosmetics Act, cosmetic manufacturers must establish and keep manufacturing management standards, product standards, manufacturing management records, and quality management records (including electronic documents).
According to Article 3 of the Cosmetics Act, the "cosmetic responsibility distributor" shall comply with the quality control standards and be responsible for the post-sale safety control of cosmetics. In addition, the "cosmetic responsibility distributor" shall employ a “responsible distribution manager” who is capable of managing such measures.
According to Article 8 of the Enforcement Rules of the Cosmetics Act, the "responsible distribution manager" must perform the quality management tasks based on the quality management standards in Appendix 1 in the Enforcement Rule and safety assurance tasks based on the safety management standards in Appendix 2 in the Enforcement Rule.
As per Article 12 of the Enforcement Rules of the Cosmetics Act, the "responsible distribution manager" must conduct thorough quality inspections for each batch of production based on the internal quality management standards before the product distribution.
As stated in Article 4 of the Regulation on Safety Standards, etc. for Cosmetics, salicylic acid and its salts can be used up to 2% in rinse-off human cleansing products. Therefore, salicylic acid can be used as an effective ingredient in functional cosmetics within the allowable limit.
However, functional cosmetics that help alleviate acne are subject to official review. Enterprises intending to manufacture these products shall submit the safety data, efficacy data and other dossiers to MFDS.