MFDS(South Korea) Compliance for Cosmetic
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MFDS Compliance for Cosmetic: Essential Requirements for South Korea Market
South Korea is recognized as a leading market in the global cosmetics industry; however, compliance with the Ministry of Food and Drug Safety (MFDS) regulations can present challenges for market entry.
The Korean Cosmetic Products Act (KCPA) requires all cosmetic products, both domestic and imported, to display Korean labeling and undergo lot or batch quality testing, with specific requirements based on product category. These regulations govern manufacturing, import, sale, and export to ensure public health.
KGMP's specialists at our South Korea office assist cosmetic manufacturers in navigating the complex regulatory environment. With an average of over 10 years of industry experience, our skilled professionals enable rapid and effective market entry into South Korea. KGMP ensures access to the latest information on dynamic Korean cosmetics regulations through regular monitoring and effective communication with the MFDS.
KGMP MFDS Compliance Service
MFDS Cosmetic Registration Process
Cosmetics are categorized into general cosmetics and functional cosmetics. The Ministry of Food and Drug Safety (MFDS) evaluates only functional cosmetics for pre-market approval, while the Korea Pharmaceutical Traders Association (KPTA) reviews and certifies import requests for general cosmetics.
Foreign companies must appoint a licensed Responsible Cosmetic Seller, who is required to submit the standard customs clearance report along with the necessary documentation to the KPTA. The Responsible Cosmetic Seller also files the import declaration, obtains the certificate, and ensures that the products are tested and properly labeled before market release.
South Korea's cosmetics industry has grown significantly and gained global recognition, supported by a strong regulatory framework from the MFDS. The Cosmetics Act and additional regulations ensure product safety, quality, and uphold high industry standards. This is why you need KGMP.
Cosmetics are products applied to the body to cleanse, beautify, enhance attractiveness, or improve appearance, with the goal of maintaining or promoting skin and hair health. They are generally classified into two categories, and since the required documentation and timeframes vary significantly by category, a GAP analysis is crucial as the first step.
Q) How are cosmetics classified?
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‘The MFDS classifies beauty products into 2 categories:
ㆍGeneral Cosmetics: 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.
Q) What are Functional Cosmetics?
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ㆍFor skin: Product aiding in the whitening of skin, improving wrinkles in the skin, tanning skin gently or protecting skin from ultraviolet rays, alleviating acne breakouts, alleviating dryness caused by atopic-prone skin, and thinning red lines caused by stretch marks.
ㆍFor hair: Hair-dye, Bleaching or dye-removing products, Products aiding in alleviating hair loss symptoms, Body hair removal products, Body hair removal products.
STEP 2: Ingredient & Label Review
The MFDS frequently reports that 75% of administrative actions against cosmetic companies involve labeling and advertising violations, with 37% related to misleading drug-like claims. Adhering to South Korea's ingredient and labeling regulations ensures consumer safety and transparency, preventing harmful substances and ensuring accurate claims. Compliance is essential for legal market access and sustaining brand trust in the competitive South Korean cosmetic industry.
Q) What are the requirements that must be met for cosmetic ingredients?
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‘The MFDS enforces a negative list system for prohibited ingredients. This list allows the use of any ingredients except those specifically prohibited. For preservatives, UV filters, and colorants, only MFDS-authorized ingredients are permitted.
Q) What are the requirements that must be met for cosmetic labeling?
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‘South Korea enforces strict labeling standards, with requirements differing by cosmetic category and volume. Functional cosmetics are subject to additional claim restrictions under MFDS regulations. For example, a product approved for “anti-wrinkle” benefits may promote wrinkle reduction but cannot be labeled as “anti-aging.”
STEP 3: Appoint the Responsible Person (Cosmetic seller or distributor) in South Korea
Foreign cosmetic manufacturers or distributors must appoint a Responsible Cosmetic Seller (RCS) in South Korea to comply with local regulations. Without an RCS, products cannot be legally sold, leading to potential fines, recalls, or market restrictions. Appointing an RCS ensures regulatory compliance, reduces risks, and helps maintain consumer safety, which is key to preserving brand integrity and trust in the competitive Korean market.
Q) What is the role of a Responsible Cosmetic Seller?
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‘The Responsible Cosmetic Seller ensures compliance with safety, quality, and labeling regulations, including accurate product records and adherence to ingredient and labeling standards. They are also responsible for notifying the MFDS of any product changes, such as ingredient adjustments or new claims.
STEP 4: Functional Cosmetics Registration
Functional cosmetics must have a safety and effectiveness report submitted for each product by the Responsible Cosmetic Seller intending to manufacture or import the products, and must also be evaluated by the MFDS.
If active ingredients and functional claims already approved by the MFDS are used, clinical data or efficacy evidence may be exempted, and approval can be obtained within approximately 7 days. However, if unapproved active ingredients or functional claims are used, clinical and efficacy data must be submitted, and the approval process may take 4 to 6 months to complete. Consult with KGMP cosmetic specialists for strategic product approval guidance.
Q) What documents are required for the registration of functional cosmetics?
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‘MFDS generally requires the following documents, but this is not an exhaustive list.
STEP 5: Document preparation and product testing
The documentation for submitting the Standard Customs Clearance Report requires essential documents, including cosmetic labeling information, quality certificates, test reports, and safety reports to demonstrate product safety. Depending on the product, additional documents may be required.
Additionally, since all imported cosmetics must undergo testing by LOT number during customs clearance, it is advisable to conduct product testing in advance through KGMP to ensure compliance with MFDS regulations and prevent delays.
STEP 6: Submission of Standard customs clearance report and Customs declaration
The submission of the Standard Customs Clearance Report and customs declaration service is a crucial step in ensuring that cosmetic products comply with South Korea’s stringent import regulations. These procedures are necessary for official customs clearance and distribution within the country. They help mitigate the risk of delays, rejections, or fines at customs and ensure that products meet the MFDS requirements. While this process is typically handled by the cosmetic importer in South Korea, if an importer has not been contracted, KGMP’s cosmetic specialists can assist in navigating these regulatory requirements.
Q) Who Shall Register?
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ㆍDomestic cosmetic manufacturers or distributors in South Korea
ㆍImporter or Responsible cosmetic seller (responsible cosmetic distributor) of cosmetics in South Korea
Remember that different regulations apply in each country.
Contact us today to discover how our MFDS compliance servicescan benefit your business.
KGMP simplifies compliance with complex
cosmetic regulations.
K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final cosmetics.
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The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of cosmetic products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.
For detailed information about our cosmetic regulation compliance services, please contact our expert directly.
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