South Korea's Cosmetics Act is the core legislation regulating the manufacture, distribution, and sale of cosmetics within South Korea, aimed at ensuring the safety and functional efficacy of cosmetics. Under this Act, cosmetics are primarily classified into two categories: general cosmetics and functional cosmetics, with functional cosmetics subject to additional functional notification and review procedures. In addition, certain products with specific pharmacological effects are classified as quasi-drugs and are subject to the relevant provisions of the Pharmaceutical Affairs Act, requiring approval or filing in accordance with the corresponding procedures.
To safeguard consumer safety, enhance product transparency, and strengthen the supervision of functional and special-use products, South Korea's Ministry of Food and Drug Safety (MFDS) has established a comprehensive notification and approval system. Based on South Korea's current laws and regulations, this article systematically outlines the notification requirements and operational procedures for general cosmetics and functional cosmetics, aiming to help enterprises accurately understand regulatory requirements and ensure compliant market entry for their products.
1. Definition
Under South Korea's Cosmetics Act (화장품법 시행규칙), "cosmetics" refers to articles applied to the human body through methods such as rubbing, spreading, spraying, or similar means, for the purpose of cleaning, beautifying, enhancing attractiveness, brightening appearance, or maintaining or improving the health of skin or hair, with only mild effects on the human body. Products classified as pharmaceuticals under Article 2, Paragraph 4 of the Pharmaceutical Affairs Act are excluded.
Note: Oral care products such as toothpaste and mouthwash fall under the category of quasi-drugs in South Korea and are subject to the relevant provisions of the Pharmaceutical Affairs Act.
2. Classification and Market Entry Requirements
General Classification
| Category | Scope | Compliance Path | Typical Product Examples |
| General Cosmetics | Cosmetic products other than functional cosmetics | Notification-based filing | Basic skincare (toners, lotions, creams), non-functional color cosmetics (foundation, eyeshadow, lipstick) |
| Functional Cosmetics |
① Cosmetics that help skin whitening by preventing melanin deposition and inhibiting the formation of freckles and blemishes; ② Cosmetics that help skin whitening by lightening the color of melanin already deposited in the skin; ③ Cosmetics that help alleviate or improve skin wrinkles by imparting elasticity to the skin; ④ Cosmetics that prevent intense sun exposure and present an even tanning effect on the skin; ⑤ Cosmetics that protect the skin from UV damage by blocking or scattering ultraviolet rays; ⑥ Cosmetics that change hair color (including dyeing and decolorizing), excluding products that temporarily change hair color; ⑦ Cosmetics that remove body hair, excluding products that remove body hair by physical means; ⑧ Cosmetics that help alleviate hair loss symptoms, excluding products that make hair appear thicker through coating or other physical means; ⑨ Cosmetics that help alleviate acne-prone skin, limited to products for human cleansing purposes; ⑩ Cosmetics that repair the skin barrier (the outermost stratum corneum of the skin) and help improve symptoms such as itching; ⑪ Cosmetics that help lighten red streaks caused by stretch marks |
Submit review or report to MFDS | Whitening products, anti-wrinkle products, sunscreen products, hair dye/hair removal/hair loss prevention products, skin barrier repair products |
Functional Cosmetics Registration Types
| Eligibility Criteria | Registration Type |
| ① Product category, ingredients, efficacy, usage and dosage, standards and test methods are consistent with MFDS public notices; ② Product information is consistent with that of a product already approved by review under the same responsible seller; ③ Product information is consistent with that of a product already approved by review under the same responsible seller + consistent with MFDS public notice information. |
Report-type |
| Products that do not meet the eligibility criteria for report-type registration | Review-type |
3. Regulatory Authorities
In South Korea, the primary regulatory authority for cosmetics is the Ministry of Food and Drug Safety (MFDS), which operates under the Office for the Prime Minister. Its regulatory system comprises the headquarters, affiliated evaluation institutions, and regional branch offices.
- Ministry of Food and Drug Safety (MFDS): Responsible for the full-chain regulation of cosmetics, including ingredient management, approval and filing of functional cosmetics, label and advertising review, as well as market supervision and adverse reaction monitoring, ensuring the safety of cosmetics and the protection of consumer rights.
- National Institute of Food and Drug Safety Evaluation (NIFDS): Responsible for the review of cosmetics standards and test methods; review of cosmetics labeling and advertising supporting documentation; technical support for human application testing of cosmetics; risk assessment research for cosmetics; investigation and research related to cosmetics manufacturing and quality management; investigation and research related to cosmetics hazard management and hazardous substance standards; technical support for cosmetics safety review; designation of cosmetics testing institutions and on-site inspections, among other duties.
- Korea Pharmaceutical Traders Association (KPTA): Responsible for processing export-related documentation for South Korean enterprises and managing matters related to imported cosmetics.
4. Enterprise Roles
Any entity intending to engage in the manufacture, distribution, or sale of cosmetics shall register with the MFDS in accordance with the regulations prescribed by the Prime Minister's Office. When significant changes occur to registered business activities, a change of registration shall be filed in accordance with the regulations.
- Responsible Seller: Responsible for the quality and safety of the cosmetics handled; engages in distribution and sales, or intermediary and authorization operations for the purpose of import agency transactions. The responsible seller must designate a responsible sales manager who possesses the statutory qualifications and is actually responsible for the quality and safety management of the products.
- Manufacturer: An enterprise that produces all or part of cosmetics (excluding processes involving only secondary packaging or labeling).
5. Compliance Process
Both general cosmetics and functional cosmetics are required to submit a 'Standard Import Declaration Report' at the KPTA stage; however, functional cosmetics must first complete the review or report procedures with the MFDS before proceeding to the customs clearance stage.
6. Documentation Requirements
General Requirements
- Standard Import Declaration Report application form
- Copy of importer's business license and cosmetics responsible seller registration certificate
- Certificate of Free Sale (CFS): must be certified by the government or public institution (including cosmetics associations or chambers of commerce) of the country of manufacture
- Certificate of Manufacture: stating the product name, full ingredients and concentrations, signed by the person in charge
- BSE/TSE-related documentation: certificate of origin or certificate confirming that the product does not contain ingredients of ruminant animal origin
- Functional cosmetics: must additionally submit a copy of the MFDS review or report documentation
- Other required information: production batch number, expiration date, etc.
MFDS Review Documentation Requirements
- Product origin and development background documentation
- Safety-related documentation (reports on acute toxicity testing, skin irritation testing, eye mucosa/other mucosa irritation testing, skin sensitization testing, phototoxicity and photosensitivity testing, human skin patch testing, etc.)
- Efficacy or functionality documentation (efficacy testing data, human trial data)
- Sun protection factor-related documentation (for sunscreen products only)
- Standards and test method documentation (including samples)
Notes:
The South Korean government plans to phase in a mandatory cosmetics safety assessment system starting from 2028. Support programs are already available, and enterprises are advised to monitor this trend.
Enterprises may utilize our proprietary GlobalCosing platform to quickly search for prohibited and restricted ingredient requirements for cosmetics in South Korea, ensuring ingredient compliance.
7. Sample Standard Import Declaration Report and Inspection Report
If you have any business needs related to South Korean cosmetics compliance, please get in touch with us via service@cirs-group.com.
Our South Korea Compliance Services
- South Korea Cosmetics Compliance Services (including functional cosmetics)
- South Korea Cosmetic Ingredient Name Registration (KCID)
- South Korea RP Services (Responsible Seller)
- South Korea Cosmetic Formula Review
- South Korea Cosmetic Label Review
- Quality Inspection
