South Korea Cosmetics Compliance

South Korea's Cosmetic Regulation Context

The South Korean government has established a comprehensive regulatory framework for the cosmetics industry, which is mainly regulated by the Cosmetic Act, Enforcement Decree, and Enforcement Rule of the Cosmetics Act. The regulatory framework for cosmetics in South Korea is designed to protect consumers and promote cosmetic safety and quality. The Cosmetic Act sets out the requirements for cosmetic product registration, labeling, and safety testing, as well as the responsibilities of manufacturers and importers in ensuring compliance with the regulations.

Anyone intending to import, distribute and sell cosmetics must register with the Ministry of Food and Drug Safety (MFDS) as a Market Authorization Holder (MAH). In order to sell cosmetics, MAHs must submit a notification to the Korea Pharmaceutical Traders Association (KPTA). For functional cosmetics, MAHs are required to obtain an approval letter from MFDS through a complicated registration process before proceeding with the manufacturing or import process. Additionally, importers of cosmetic products also have to obtain approval from the KPTA.

About Us

We understand the complex regulatory requirements for cosmetics in South Korea and offer comprehensive services to help companies comply with the regulations and register their products.

Our company acts as a technical provider of Cosmetic Act compliance services to domestic and foreign cosmetic manufacturers and distributors exporting cosmetics to South Korea, as well as to South Korean cosmetic importers. Our team of regulatory experts is familiar with the South Korean cosmetic legal framework and is capable of providing guidance and preparing the necessary documentation regarding the registration of general and functional cosmetics and ingredient and labeling requirements in the Cosmetic Act. Our services are designed to provide our clients with the necessary support throughout the product lifecycle, from development to post-market surveillance.

Our South Korea Cosmetics Compliance Services

We offer our clients a wide range of cosmetic compliance services including risk assessment of cosmetic products, registration of general and functional cosmetics, and regulatory consulting services. Our services include:

• Provide a determination of the product category (regular or functional)
• Provide the Korean ingredient list and INCI list, as well as usage warnings and precautions
• Provide formula review (perform toxicological and regulatory assessments of ingredients and impurities and provide a formula review report with a conclusion from the expert who carried out the tests)
• Provide label review (ingredients list, symbols, legal requirements, etc.)
• Provide claims review
• Provide strategic recommendations for updating the label
• Provide safety testing
• Assist in the registration of a Responsible Cosmetic Distribution Business
• Provide dossiers for the evaluation of functional cosmetics, including data concerning the origin and explanations of development, data concerning safety and efficacy, data concerning standards and testing methods, etc.
• Provide general and functional cosmetics registration services
• Provide "entry notice of imported products" submission services
• Provide standard custom clearing schedule report
• Post-market surveillance

If you need help or have a question, please feel free to contact us for more details.