Analysis of the Regulatory System for Imported Cosmetics in South Korea

As a pillar industry in South Korea, the cosmetics market is large and holds great business opportunities. The import and trade of cosmetics is managed by the Korea Pharmaceutical Traders Association (KPTA), while the Ministry of Food and Drug Safety (MFDS) is responsible for formulating cosmetics regulations and registering functional cosmetics.

The overall regulatory laws for cosmetics in South Korea are the Cosmetic Act, which includes the definition of cosmetics, cosmetics supervision, GMP, industry obligations, and general policies for advertising.

• Explanation of the overall law and detailed description of the rules for specific behaviors: Enforcement Decree of Cosmetic Act and Enforcement Rule of Cosmetic Act.
• Product and ingredient safety rules: Regulation on Safety Standards for Cosmetics.

Classification of South Korean Cosmetics

According to the Cosmetic Act, cosmetics are divided into general cosmetics and functional cosmetics. Functional cosmetics have any of the following effects:

• Skin whitening
• Reducing wrinkles
• Gently tanning the skin
• Protects the skin from ultraviolet damage
• Changing or removing the color of hair or nourishing the hair
• Preventing or improving dryness, splitting, and shedding of the skin

Marketing Authorization Holder (MAH) Regulation

Any applicant who intends to import, distribute and sell cosmetics in South Korea must register as a Marketing Authorization Holder (MAH) with the MFDS, responsible for the registration, import and sale of cosmetics on the Korean market.

Responsibilities of MAH

• Comply with quality control standards
• Comply with good safety standards
• Keep the manufacturer's quality control standards and product master files
• Prepare and keep import control records of imported cosmetics
• Sell after conducting quality control tests on batches
• Apply for import permission with KPTA for customs clearance
• Report new data and information on product safety and effectiveness, and take necessary safety measures

Requirements for Importing Cosmetics

The import application for general cosmetics is authorized by KPTA and does not require a registration process. Functional cosmetics need to undergo safety and efficacy evaluations by MFDS before entering the Korean market.

Data Requirements

• Data for verifying safety, efficacy or functionality
• Data on standards and testing methods

Requirements for Infant Cosmetic materials

• Description of the product and manufacturing method
• Cosmetic safety evaluation data
• Proof of product efficacy and effectiveness

Exempt Evaluation Situations

Products with the same active ingredients, functions, applications, forms, specifications and testing methods as those notified by MFDS (Korean Functional Cosmetics Codex, KFCC) or those approved previously.

Component Requirements

MFDS prohibits the use of germicidal substances, preservatives, ultraviolet filters and other restricted ingredients in cosmetics. The MFDS's "Cosmetic Regulatory Framework in Korea" manual provides information on prohibited and restricted ingredients for cosmetics.

Labeling Requirements

According to regulatory requirements, cosmetic product packaging must include the following information:

(1) Products with contents ≤10g

• Product name
• MAH and manufacturer name
• Lot number
• Expiry date or Period After Opening (PAO)

(2) Products with contents >10g

• Product name
• MAH and manufacturer name and address
• Full ingredient list (descending order) for products >50ml/g
• Specified ingredient names
• Net volume or weight (ml or g)
• Price
• For functional cosmetics: labeling in Korean
• Usage precautions
• Efficacy and usage instructions for MFDS-approved functional cosmetics
• Barcode
• After-sales product information

Proregulations offers compliance services for manufacturers or distributors planning to export cosmetics to South Korea. Our cosmetics technical team has extensive practical experience in areas such as product registration, formulation and label review related to South Korean cosmetics imports. If you are interested in our services, please contact us.

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