South Korea’s cosmetic regulations are detailed, and for most teams, the difficulty is not understanding them but aligning all requirements before launch. Under the MFDS framework, manufacturers must register with MFDS before entering the market. Any company that imports or sells products must operate through a registered responsible entity (MAH).
After that, compliance continues in multiple steps. This includes classification, import notification, labeling, and safety requirements. Read this guide to understand these steps in detail.
Regulatory Authority for Cosmetics in South Korea
MFDS regulates all cosmetic products in South Korea.
Key Bodies You Should Know
- MFDS (Central Authority): Sets rules, reviews compliance, and enforces regulations
- Cosmetics Policy Division: Defines standards and policies
- National Institute of Food and Drug Safety Evaluation (NIFDS)
- Evaluates functional cosmetics
- Conducts testing and risk assessments
- Regional MFDS Offices: Handle registrations, inspections, and enforcement
How the System Works
- MFDS cosmetic regulations Korea set the rules
- NIFDS evaluates certain products
- Regional offices handle approvals, audits, and checks
What is Considered a Cosmetic Under South Korea Regulations
A cosmetic is any product applied to the body to clean, beautify, or maintain skin or hair, with only a mild effect.
This includes:
- Skincare
- Makeup
- Hair care
- Fragrances
- Deodorants and shaving products
Some products fall under functional cosmetics, such as:
- Whitening products
- Anti-wrinkle products
- Sunscreens
- Hair loss relief products
Products with medical use are not cosmetics. Oral care products that are regulated separately as quasi-drugs:
- Toothpaste
- Mouthwash
Step-by-Step Cosmetic Registration Process in South Korea
The Korea cosmetics approval process follows a fixed order, especially for imports:
Step 1: Register as MAH
Must be done before any import or sale
Step 2: Classify the Product
General or functional
Step 3: Functional Evaluation (if applicable)
Required for functional cosmetics
Step 4: Submit Entry Notice of Imported Products
Filed before each customs clearance (to KPTA)
Step 5: Customs Declaration and Clearance
Handled by Korea Customs Service
Step 6: Quality Testing and Korean Labeling
Batch testing required before sale
Labels must be in Korean (before or after import)
Step 7: Release for Sale
Allowed only after all checks are complete
Correct order: Evaluation → Entry Notice → Customs → Testing → Sale
Documents Required for Korea Cosmetic Approval
You will need the following documents:
- Entry Notice of Imported Products
- Free Sale Certificate (for first import)
- Manufacturing Certificate
- Full Ingredient List
- Functional Cosmetics Dossier (if applicable)
- Quality Testing Reports (batch-level, unless exempted)
- Import and Quality Records (maintained by MAH)
Do You Need Cosmetic Registration in South Korea?
South Korea does not have one single product registration system for all cosmetics. But that does not mean products can be sold freely.
What is Required
- Manufacturers must register with MFDS
- Importers must operate through a registered MAH
- Requirements depend on product type
For General Cosmetics
- No pre-market approval
- Must follow ingredient rules
- Must meet South Korea cosmetic labeling requirements (in Korean)
- Must complete import notification
For Functional Cosmetics
- Mandatory evaluation and approval by MFDS before sale
Important: Compliance happens across multiple steps. Missing even one step can delay or block your product.
Responsible Person Requirement in South Korea (MAH / CRP)
Every cosmetic product sold in South Korea must have a registered local responsible person.
This is called a Cosmetics Responsible Person (CRP) or MAH.
This entity is responsible for:
- Product safety and quality
- Maintaining manufacturing and import records
- Batch-level quality checks
- Appointing a qualified safety officer
- Reporting ingredient and annual production/import data
Without a registered MAH, you cannot sell cosmetics in South Korea.
Regulatory and Import Requirements for Cosmetics in South Korea
Before selling, companies must meet three key requirements:
Business registration with MFDS
Product compliance (ingredients, safety, labeling)
Import clearance
Important Clarification
General cosmetics → No approval, but full compliance required before import
Functional cosmetics → Must be approved before sale
Products can only be sold when all three are complete.
Cosmetic Labeling Requirements in South Korea
Labels must be in Korean and fully ready before sale.
Required Information
- Product name
- Manufacturer and MAH details
- Batch number
- Expiry date or period after opening
- Volume or weight
- Full ingredient list
- Price
- Precautions for use
Functional cosmetics must clearly state their category.
Claims must be accurate and supported. Authorities can ask for proof at any time.
Ingredient Regulations for Cosmetics in South Korea
South Korea follows a negative list system.
This means:
- Ingredients are allowed unless restricted
- Responsibility for safety lies with the MAH
Key Rules
- Over 1,000+ ingredients are prohibited
- Some ingredients are restricted with limits
- Only MFDS-approved preservatives, UV filters, and colorants can be used
Strict Safety Limits
- Heavy metals (lead, arsenic, mercury, cadmium)
- Chemicals (formaldehyde, methanol, phthalates, dioxane)
- Microbial limits (harmful bacteria must not be present)
- Product-specific safety parameters like pH
Even small non-compliance can lead to rejection or recall. Ingredient checks should be done early.
Product Safety and Market Surveillance in South Korea
MFDS monitors products even after they are sold.
This includes:
- Regular and surprise inspections
- Market testing for safety
- Monitoring labels and advertisements (including online)
- Tracking global safety alerts
MFDS also updates ingredient limits based on risk assessments.
Timeline and Fees for Cosmetic Approval in South Korea
The timeline and fees differs based on the type of cosmetic.
Functional Cosmetics
- Approval timeline: ~60 days
- Fees:
- ~KRW 189,000 (electronic)
- ~KRW 210,000 (offline)
Changes and Updates
- Major changes: ~60 days
- Minor changes: ~15 days
- Reissue: ~7 days
General Cosmetics
- No fixed timeline
- No approval fee
Timelines depend on how quickly you complete labeling, testing, and documentation.
Conclusion
South Korea’s cosmetic regulations are structured but detailed.
To enter the market, you must align:
- Product classification
- MAH registration
- Ingredient compliance
- Labeling
- Import process
There is no single approval step. Missing even one requirement can delay your launch. The best approach is to prepare everything before import, not fix issues later.
Artixio supports companies with South Korea cosmetic compliance. This includes classification, ingredient checks, MAH setup, documentation, labeling, and import readiness. For support, contact info@artixio.com.
