South Korea’s cosmetic regulations are detailed, and for most teams, the difficulty is not understanding them but aligning all requirements before launch. Manufacturers must register with MFDS if they carry out activities that require cosmetics manufacturing business registration. Companies that import cosmetics for distribution or sale must register as a responsible cosmetics distribution business. This business must also register a responsible cosmetics distribution manager.
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 do assigned regulatory and inspection duties. Relevant MFDS processes apply to business registration and product evaluation.
How the System Works
- MFDS cosmetic regulations in Korea set the rules
- NIFDS evaluates certain products
- Regional offices handle approvals, audits, and checks
South Korea Cosmetics 2026 Regulatory Updates
Important changes have appeared in South Korea’s cosmetics regulations framework in 2026. The updates focus on strengthening product safety management. Improvements in regulatory oversight and support for the cosmetics industry are also part of the update. Companies planning to enter or continue operating in the South Korean market should review the changes. They should prepare for the requirements that apply to their products and business activities.
Cosmetics Safety Assessment Requirements
An amendment to South Korea’s Cosmetics Act, promulgated on December 30, 2025. It introduces a cosmetics safety assessment system. Cosmetic responsible sellers under this framework must prepare safety assessment information. They should have a qualified safety assessor review it and retain the records as required by law. However, the requirements take effect on different dates, depending on the business and product.
The effective date for this amendment is different for each business. The general commencement date ~ December 31, 2026. However, the Act sets out later dates for some businesses and products. These include the following, based on the category:
- January 1, 2028
- January 1, 2030
- January 1, 2031
Companies should check the transitional provisions before they decide when the safety assessment duty applies to them. MFDS announced a proposed amendment to the Enforcement Rule on July 8, 2026.
The proposal specifies that certain responsible sellers would be excluded from the safety assessment requirement. These are those with annual sales of KRW 1 billion or less that distribute and sell only handmade cosmetic soaps they manufacture themselves. It also proposes qualifications for safety assessors depending on relevant education or professional experience. There are also requirements for preparing and retaining safety assessment records.
New Cosmetics Management Plan and Policy Coordination
A further amendment to the Cosmetics Act was
- Put into effect ~ September 15, 2026
- Effective date ~ September 16, 2027
It sets up a framework for the MFDS. It involves preparing and implementing a basic cosmetics management plan every five years.
The amendment also establishes a Cosmetics Management Council within the MFDS. Here, they discuss and coordinate relevant policies. These changes solidify the systematic management of cosmetics safety and quality. They also wish to improve regulatory support and promote international cooperation. These measures are intended to improve policy coordination and long-term planning for South Korea’s cosmetics sector.
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 that claim or intend to be used to treat or prevent disease may fall outside the cosmetics category. Some oral care products, including some toothpastes, may be regulated as quasi-drugs instead of cosmetics.
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.
Companies must register the relevant cosmetics business category if their activities fall within the registration requirements. Manufacturers and responsible cosmetics distribution businesses have different registration obligations.
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
Functional cosmetics must undergo MFDS evaluation unless they qualify for the applicable reporting procedure.
Important: Compliance happens across multiple steps. Missing even one step can delay or block your product.
Step-by-Step Cosmetic Registration Process in South Korea
The Korea cosmetics approval process follows a fixed order, especially for imports. It’s given below:
Step 1: Register the Responsible Cosmetics Distribution Business
Companies importing cosmetics for distribution or sale must register as a responsible cosmetics distribution business and register a responsible cosmetics distribution manager.
Step 2: Classify the Product
General or functional
Step 3: Complete the Functional Cosmetics Procedure (If Required)
Functional cosmetics must undergo MFDS evaluation. That’s unless they qualify for the applicable reporting procedure. Some qualifying products can be reported instead of undergoing a full evaluation.
Step 4: Complete the Required Import Procedures
Complete them for the shipment.
Step 5: Customs Declaration and Clearance
Handled by the Korea Customs Service
Step 6: Complete Quality Checks and Korean Labeling
The responsible cosmetics distribution business must conduct the required quality checks for each manufacturing batch before distribution. The product must also meet South Korean labeling requirements before sale.
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
Companies will need to confirm the required records before shipment. These may include product and ingredient information, functional cosmetics submission data where required, import records, and quality records.
MFDS recognizes safety and efficacy or functional data for functional cosmetics. It also covers standards and test methods as part of the evaluation information. A generic list is provided below:
- 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)
Responsible Cosmetics Distribution Business in South Korea
Companies that import cosmetics for distribution or sale must register as a responsible cosmetics distribution business. The business must also register a responsible cosmetics distribution manager. They look after product quality and safety management.
This entity is responsible for:
- Product safety and quality
- Maintaining manufacturing and import records
- Batch-level quality checks
- Registering a responsible cosmetics distribution manager
- Reporting ingredient and annual production/import data
A business that is required to register as a responsible cosmetics distribution business cannot lawfully operate without that registration.
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: They don’t track the same pre-market evaluation process as functional cosmetics. However, they must satisfy all applicable requirements.
Functional cosmetics: Must undergo MFDS evaluation. Unless they qualify for the applicable reporting procedure.
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
- Business name and address
- Batch number
- Expiry date or period after opening
- Volume or weight
- Full ingredient list
- Price
- Precautions for use
The words “functional cosmetics” must appear where required by law. Additional details may be required under the implementing rules. Small packages and samples may also have to follow specific labeling provisions. Make accurate claims and ensure they are supported. Authorities can ask for proof at any time.
Cosmetic Ingredient Regulations in South Korea
South Korea prohibits some ingredients and restricts others through specified conditions and limits. Preservatives, ultraviolet filters, and colorants are also subject to specific rules.
This means:
- Ingredients are allowed unless restricted
- Responsibility for safety lies with the MAH
Key Rules
- 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, so do your ingredient checks should be done early.
Product Safety and Market Surveillance in South Korea
MFDS monitors products even after they are sold.
This includes the following:
- Inspections and compliance checks
- Safety and quality monitoring
- Review of labeling and advertising
- Follow-up action when products do not meet legal requirements
MFDS also updates ingredient limits based on risk assessments.
Timeline and Fees for Cosmetic Approval in South Korea
The timeline and fees differ based on the type of cosmetic.
Functional Cosmetics
- Approval timeline: ~60 days
- Fees:
- ~KRW 189,000 (electronic)
- ~KRW 210,000 (offline)
Some functional cosmetics qualify for reporting instead of evaluation. MFDS states that these reports usually have no fee. They are usually processed on the same day. However, supplementary requests may cause delays.
Changes and Updates
- Some revisions to a functional cosmetics evaluation: 60 days, with fees depending on the type of revision
- Other revisions: 15 days
- Reissue of the evaluation result notice: 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 organized and comprehensive. To enter the market, you must align:
- Product classification
- Responsible cosmetics distribution business
- Ingredient compliance
- Labeling
- Import process
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 Korean cosmetic compliance. We cover classification, ingredient checks, MAH setup, documentation, labeling, and import readiness. For support, contact info@artixio.com.
FAQs
1. Is it possible for foreign companies to sell cosmetics directly to consumers in South Korea?
Confirmation is needed for foreign companies to sell cosmetics in South Korea. The confirmation should be about whether their proposed sales model needs a locally registered responsible cosmetics distribution business.
2. Is recalling a cosmetic product possible after it has been approved or imported?
Yes. Products failing to satisfy safety or regulatory requirements may have to face regulatory action. This covers recall or other measures. Companies will have to maintain the quality and safety records of their business.
3. Can companies change a cosmetic’s formula after entering the South Korean market?
Assess a formula change before implementation. The checks need to be related to the change and whether it affects
- Ingredient compliance
- Product safety
- Labeling
- Any existing functional cosmetics evaluation or report
Take action on the basis of the nature of the change.
4. Does South Korea regulate cosmetic advertising claims?
Yes. Cosmetic advertising claims need to adhere to South Korean law. Avoid claims that are misleading. They shouldn’t suggest a medical effect. Evidence needs to be retained to support claims about product performance.
