The cosmetics sector in South Korea has witnessed impressive expansion and gained global acclaim. The Ministry of Food and Drug Safety (MFDS) has implemented a strong regulatory system, primarily overseen by the Cosmetics Act, to guarantee the safety and quality of cosmetic items. The Cosmetics Regulatory Framework, in conjunction with additional regulations, plays a crucial role in upholding elevated industry standards.
The South Korean Cosmetics Act encompasses comprehensive regulations governing the manufacturing, importation, and commercialization of cosmetics, along with requirements for advertising and product labelling. The MFDS defines a cosmetic product as “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 mild effect on the human body”.
General vs. Functional Cosmetics
South Korea classifies cosmetics into two categories: general cosmetics and functional cosmetics. General cosmetics undergo post-market surveillance and do not require registration for manufacturing or importing. Whereas, functional cosmetics, which include products like whitening, anti-wrinkle, sunscreens, hair dyes must undergo a meticulous registration process, obtaining approval from the MFDS before manufacturing or importing can commence. Importers of cosmetic products must also seek approval from the South Korean Pharmaceuticals Traders Association (KPTA).
Registration Requirements for Businesses
Companies looking to engage in cosmetic-related business activities in South Korea must register under a specific category depending on their intended operations: companies wanting to manufacture cosmetics must register as “manufacturers.”
For companies involved in the importation of cosmetic products, they must register as marketing authorization holders (MAHs). This registration is also required for companies wishing to engage in activities associated with functional cosmetics in south korea. The MAH bears several responsibilities, including product registration, ensuring safety and quality, adhering to labelling and advertising requirements, and overseeing customs clearances, among other regulatory activities. Additionally, a cosmetic supervisor with specific qualifications and training must be designated by the MAH and registered with the MFDS.
Labelling, Claims, and Testing
Labelling standards are stringent in South Korea, with specific requirements varying according to the cosmetic category and volume. Essential information like the product’s name, MAH’s name, expiration date, and lot number must be displayed on all cosmetic product labels.
Functional cosmetics face even stricter regulations when it comes to claims. The MFDS sets specific guidelines for the types of claims that can be made. For instance, a product approved as “anti-wrinkle” can make claims related to wrinkles, but it cannot claim to be “anti-aging.” The approval process for functional cosmetics depends on whether the ingredients used are approved by the MFDS or not. If they are, the approval process is quicker, typically taking about 7 days. However, for products containing unapproved ingredients, a more thorough approval process can take 4-6 months.
Following approval from MFDS (and KPTA for imported products), cosmetic products must undergo lab testing within South Korea.
Ingredients Approval Process: Certain ingredients used in functional cosmetics have already been approved by the MFDS for specific purposes. If a manufacturer or importer plans to use these pre-approved ingredients exclusively, they do not need to provide clinical and efficacy data, and the approval process is relatively quick. However, for products containing unapproved ingredients, an extensive approval process, involving clinical and efficacy data submission, can take several months to complete.
Prohibited Ingredients: The MFDS maintains a list of “prohibited ingredients” based on a negative list system. This list serves as a reference, allowing the use of all ingredients except those on the prohibited list. For preservatives, UV filters, and colorants, only ingredients authorized by the MFDS can be used.
In April 2022, the MFDS introduced revised cosmetics safety regulations, including guidelines for Tetrahydrocannabinol (THC) and Cannabidiol (CBD) in cosmetics. These rules uphold the THC and CBD concentration limitations while guaranteeing the safe use of these ingredients in cosmetics.
Pigment Quality Control: South Korea’s regulatory landscape is continually evolving. In a recent development, the Ministry of Food and Drug Safety has revised the “Cosmetic Pigment Types, Standards, and Test Methods” document. This revision allows companies to establish their test methods, tailored to their product characteristics, while still adhering to types and quality standards for pigments used in cosmetics. This flexibility in test methods is expected to increase the industry’s competitiveness by allowing the latest techniques for pigment quality control in cosmetics.
Conclusion
South Korea’s cosmetics regulatory environment, primarily overseen by the MFDS, is comprehensive and evolving to meet the changing needs of the industry and the demands of consumers. The country’s commitment to safety, quality, and sustainability ensures that South Korean cosmetics continue to be globally admired and trusted.
DDReg is a globally reputed regulatory services provider that has supported its customers for cosmetic product registration for their desired markets. Read our blog on the Modernization of the Cosmetics Act Regulation.