Request a DemoIn South Korea, functional cosmetics are subject to more stringent regulatory oversight than general cosmetics under the Cosmetics Act. To ensure their safety, efficacy, and quality, the Ministry of Food and Drug Safety (MFDS) mandates that these products undergo a formal pre-market evaluation or reporting process and strictly comply with designated ingredient restrictions and labeling standards.
Chapter 1 Regulatory Framework and Competent Authority
1.1 Regulations Related to Functional Cosmetics
The regulatory framework for cosmetics in South Korea relies on core acts and detailed supporting notifications. The following are the principal regulations applicable to functional cosmetics. Unless otherwise specified, functional cosmetics are also subject to all regulations generally applicable to cosmetics.
Name | Description | Status |
|---|---|---|
The overarching legal framework comprehensively regulating all aspects of cosmetic management, manufacturing, and distribution in South Korea. | In Force | |
Provides the detailed operational rules, administrative procedures, and specific requirements for enterprises to implement the Cosmetics Act. | In Force | |
Standards and Testing Methods of Functional Cosmetics (KFCC) | Details the specifications for MFDS-notified functional ingredients, standards, test methods, and general quality control requirements for functional cosmetics. | In Force |
Specifies the scope, dossier requirements, testing guidelines, and criteria for the pre-market evaluation of functional cosmetics. | In Force | |
Outlines cosmetic safety control standards (e.g., microbial and heavy metal limits) and lists the negative inventory (prohibited and restricted ingredients). | In Force |
1.2 Competent Authority
In South Korea, the Ministry of Food and Drug Safety (MFDS) is the primary regulatory authority overseeing the cosmetic industry. For functional cosmetics specifically, the MFDS takes charge of establishing safety standards, conducting product evaluations, licensing, and designating authorized testing institutes.
Another crucial organization is the Korea Pharmaceutical Traders Association (KPTA), a quasi-governmental body delegated to manage import procedures. KPTA is responsible for pre-evaluating imported products, and granting customs clearance approvals for compliant cosmetics.
Chapter 2 Functional Cosmetics
2.1 Definition
Under the Cosmetics Act, "cosmetics" are defined as products intended to be applied to the human body by rubbing, spraying, or other similar methods, to cleanse and beautify the body, enhance attractiveness, brighten the appearance, or maintain or promote the health of the skin and hair, with mild effects on the human body.
A specific sub-category, "functional cosmetics", refers to products that go beyond general cosmetic purposes to deliver targeted, proven efficacies. These include skin whitening, wrinkle improvement, UV protection, hair color alteration, and alleviating specific skin/hair conditions.
2.2 Classification
Functional cosmetics are strictly categorized into 11 distinct types based on their claimed efficacies, as defined in the Enforcement Rule of the Cosmetics Act:
No. | Efficacy Category and Description |
|---|---|
1 | Cosmetics that help whiten the skin by preventing melanin pigment deposition, thereby inhibiting the formation of freckles, blemishes, and other discolorations. |
2 | Cosmetics that help whiten the skin by lightening existing melanin pigments deposited in the skin. |
3 | Cosmetics that provide elasticity to the skin and help alleviate or improve wrinkles. |
4 | Cosmetics that protect the skin from intense sunlight and help evenly tan the skin. |
5 | Cosmetics that block or scatter ultraviolet rays to protect the skin from sun damage. |
6 | Cosmetics that alter the color of hair (including hair dyeing and bleaching). Products that temporarily change hair color are excluded. |
7 | Cosmetics that remove body hair. Products that physically remove body hair (e.g., wax strips) are excluded. |
8 | Cosmetics that help alleviate hair loss symptoms. Products that only physically thicken the appearance of hair (e.g., hair coating products) are excluded. |
9 | Cosmetics that help alleviate acne-prone skin. This category is strictly limited to rinse-off cleansing products. |
10 | Cosmetics that help restore the function of the skin barrier (the outermost epidermal layer, or stratum corneum), thereby relieving symptoms such as itching. |
11 | Cosmetics that help fade the appearance of red lines caused by stretch marks (striae distensae). |
2.3 Pre-market Approval Pathways
Before entering the South Korean market, functional cosmetics must undergo a pre-market approval process. Depending on the formulation and the functional ingredients used, products are subject to either a comprehensive Evaluation or a simplified Reporting procedure.
Functional Cosmetic Evaluation
If a product utilizes novel functional ingredients not listed in the MFDS notifications, or if its formulation, claims, or usage deviate from established standards, it must undergo a strict pre-market Evaluation by the MFDS (specifically, the National Institute of Food and Drug Safety Evaluation - NIFDS). The authority will thoroughly review a comprehensive scientific dossier to confirm the product's safety, stability, and efficacy.
The dossier required for evaluation includes:
Dossier Category | Specific Document Requirements |
|---|---|
Safety, Efficacy, and Functionality Data | A. Origin and Development: Detailed documentation regarding the discovery, origin, and development process of the functional ingredient. |
B. Safety Data (GLP-compliant): Must include single-dose toxicity, primary skin irritation, ocular/mucosal irritation, skin sensitization, phototoxicity/photoallergenicity, human patch test data, and human cumulative patch test data. Safety must be demonstrated using validated non-animal alternative testing methods where available. | |
C. Efficacy Data:(1) Non-clinical efficacy test data supporting the mechanism of action.(2) Human application test data (clinical trials) conducted by qualified institutions (with at least 5 years of relevant experience) demonstrating the claimed effects, along with usage/dosage justification.(3) Hair dye efficacy data (if applicable). | |
D. SPF/PA Rating Justification (If applicable): Data establishing Sun Protection Factor (SPF), Water Resistance SPF, and UVA Protection Grade (PA) based on recognized methodologies (e.g., ISO 24444, ISO 24442, FDA, Cosmetics Europe, or MFDS guidelines). | |
Standards and Testing Methods Data | Documentation providing the scientific rationale for establishing quality control criteria and analytical testing methods. This includes method validation for each test item and the rationale for reference values. For the finished product, detailed information on physical appearance, pH value, identity verification, and active content measurement must be provided. |
Note: Submission of safety and efficacy data is exempted if the product is formulated with the active ingredients and within the concentration limits specified in listed in Annex 4 of the Regulation on the Examination of Functional Cosmetics.
Only products that receive an evaluation result notice from the MFDS can be legally distributed in South Korea.
Source: NIFDS
Functional Cosmetic Reporting
For certain products, a full evaluation dossier is not required. Instead, the company can follow a simplified Reporting procedure by submitting a formal "Report" to the MFDS. This pathway is available in the following cases:
Type 1: For products formulated with MFDS-notified functional ingredients at the specified concentrations and adhering to all conditions (e.g., efficacy, usage, dosage form) outlined in the "Standards and Testing Methods of Functional Cosmetics (KFCC)".
Type 2: For products that are identical in all key aspects (active ingredients, concentration, efficacy, usage, formulation type, etc.) to a functional cosmetic that has already undergone and passed a full MFDS evaluation. This is applicable if both products are from the same responsible seller or the same ODM manufacturer.
Type 3: For combination products consisting of an already evaluated functional cosmetic that is identical in active ingredients, concentrations, efficacy, testing methods, directions for use, and formulation type, together with functional cosmetic ingredients notified by the MFDS.
Upon successful submission of the report, the product is cleared for market entry.
2.4 Ingredient Requirements
The MFDS meticulously manages the functional ingredients permitted for use. The Standards and Testing Methods of Functional Cosmetics (KFCC) specifies notified functional cosmetic ingredients that can be used. These include ingredients for:
Whitening
Anti-wrinkle
UV protection (sunscreen)
Hair dyeing and bleaching
Hair removal
Alleviating acne-prone skin (for rinse-off products)
Alleviating hair loss symptoms
Furthermore, Annex 4 of the Regulation on the Examination of Functional Cosmetics specifies functional cosmetic ingredients that are exempt from the submission of safety and efficacy data when used within the prescribed concentrations and conditions.
2.5 Labeling
Cosmetic labeling in South Korea must be accurate, comprehensive, and in the Korean language. The fundamental mandatory elements for all cosmetics include the product name, the responsible seller's name and address (and manufacturer's details/country of origin for imports), full ingredient list, net volume/weight, manufacturing batch number, expiration date or period-after-opening (PAO), usage precautions, and a barcode.
Special Labeling for Functional Cosmetics
Functional cosmetics have additional mandatory labeling requirements to ensure consumers are fully informed:
Functional Cosmetic Designation: The packaging must clearly display the Korean phrase "기능성화장품" (Functional Cosmetic) or use the officially recognized functional cosmetic logo designated by the MFDS.
Efficacy and Usage: The specific approved functional efficacy and detailed usage instructions must be printed on the primary or secondary packaging.
Medical Disclaimer: For functional cosmetics targeting hair loss, acne, skin barrier restoration (itching), or stretch marks, a strict disclaimer must be prominently displayed: "This product is not a medicine for the prevention or treatment of diseases" (질병의 예방 및 치료를 위한 의약품이 아님).
