Ministry of Food and Drug Safety (MFDS)
South Korea's regulatory authority for food, drugs, and cosmetics, administering the Cosmetics Act which requires product notification, GMP certification for manufacturers, and compliance with ingredient standards based on a negative-list system.
The Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), is the South Korean government agency responsible for ensuring the safety of food, pharmaceuticals, medical devices, and cosmetics.
South Korea's Cosmetics Act (revised in 2020) establishes the regulatory framework. Cosmetic manufacturers must obtain a Cosmetics Manufacturing Business Registration, and importers must obtain a Cosmetics Import Business Registration from MFDS. All products must be reported to MFDS before distribution.
Korea uses a "functional cosmetics" classification similar to Japan's quasi-drug category. Functional cosmetics — including whitening, anti-wrinkle, sunscreen, and hair-coloring products — require efficacy testing and MFDS review before marketing. General cosmetics require only post-market reporting.
MFDS maintains ingredient standards based primarily on a negative list (prohibited and restricted substances), complemented by positive lists for colorants, preservatives, UV filters, and other specific categories. Korean regulations are frequently updated and are increasingly harmonized with international standards, making Korea one of the most dynamic cosmetic regulatory markets globally.
Related Terms
Good Manufacturing Practices (GMP)
A system of guidelines ensuring cosmetic products are consistently produced and controlled according to quality standards. MoCRA requires FDA to establish cosmetic GMP regulations; in the EU, compliance with ISO 22716 is presumed to satisfy the GMP requirement of EC 1223/2009.
ProcessInternational Nomenclature of Cosmetic Ingredients (INCI)
A standardized system of ingredient naming developed by the Personal Care Products Council (formerly CTFA), used worldwide for cosmetic ingredient labeling. INCI names are required on product labels in the EU, US, Canada, and most other regulated markets.
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