6. Registration Processes

Cosmetics
South Korea

This section provides information on any product notification or registration and manufacturing site registration processes.

In Korea, only the responsible cosmetic distributor can import/distribute cosmetics. There are specific requirements to become the responsible cosmetic distributor and obligations are stated in Article 5 of the Cosmetic Act.

6.1 Product Registration/Certification

General cosmetics do not require pre-approval but functional cosmetics should be approved before selling.

Natural cosmetics, organic cosmetics, and kids and children products don't require approval but the responsible cosmetic person should have the required documents.

Authorities portal to do the registration

1. Drug Safety portal  by MFDS - Responsible cosmetic distributor registration, functional cosmetic application: Ministry of Food and Drug Safety>Our Works>Bio&Cosmetics>Approval Process>Cosmetics | Ministry of Food and Drug Safety (mfds.go.kr) 
2. Korean Pharmaceutical Traders Association - Cosmetic importation: https://www.kpta.or.kr/

Information required to be submitted

A. For the responsible cosmetic distributor

1. Business registration number and registration date
2. Name and birth date of the responsible cosmetic distributor manager (referring to the name and birth date of the representative where the applicant is a corporation)
3. Trade name of the responsible cosmetic distributor (referring to the name of the corporation where the applicant is a corporation)
4. Location of the business place
5. Name and birth date of the responsible cosmetic distributor manager
6. Type of manufacturing and sales

B. For functional cosmetics (for other than prescribed recipe/cosmetic types)

1. Data concerning the origin and explanations of development
2. Data concerning the safety
3. Data concerning efficacy or functions
4. Evidential data for establishing ultraviolet ray-protection factor and the protection grade of ultraviolet A (limited to those cosmetics which have efficacy in protecting skin against ultraviolet rays by screening or scattering them)
5. Data (including clinical specimens) concerning standards and testing methods

In cases of items for which the Minister of Food and Drug Safety determines and publicly notifies the ingredients and contents expressing efficacy and effects of products applying to functional cosmetics, data does not need to be submitted. There is no expiration of functional cosmetic registration unless the holder (responsible cosmetic distributor) withdraws.

A functional cosmetic application usually takes 2-3 months, if not rejected by MFDS. The cost is KRW 189,000. (UV cosmetics must go through the application process.)  

If the cosmetics can be exempted from evaluation, then it can be registered and is effective immediately. The cost is KRW51,000. An example is Niacinamide 2% lotion and every manufacturing lot should have a proof of the 2% contents. 

C. For Korean natural and organic cosmetics

Cosmetic certification can only be acquired from 3 nominated testing labs; KTR, KCL, and Union Korea. If the certification is acquired, then registration is not required [1,2].

Registration/Certification outcome as given by Authorities

• Responsible cosmetic distributor certification.
• Functional cosmetic registration.
• Natural/Organic cosmetic certification.

Mandatory dossier to be elaborated by the manufacturer (see PIF in EU) to be kept at manufacturer's site (not to be submitted to Authorities)

Responsible cosmetic distributor to keep the following:

1. Quality test results for each manufacturing lot (including functional cosmetic's active ingredient content test)
2. Manufacturing lot and sales record
3. Certificate of manufacture
4. BSE certificate (if imported)
5. Free Sales Certificate (if imported)

6.2 Ingredient Product Registration

Positive List

N/A

Negative List

N/A

Restricted ingredients 

When the restricted ingredient is used more than its limit in cosmetics, the below documents are required [3]

1. Summary of all submitted materials
2. Data on the origin of raw materials, development process, domestic and foreign usage standards and usage status, etc.
3. Data on the characteristics of raw materials
4. Data on safety and effectiveness (data on effectiveness should be submitted only when applicable)
5. Test report on raw material standards and test methods

6.3 References

1. Standard of Natural cosmetic and organic cosmetic 천연화장품 및 유기농화장품의 기준에 관한 규정 (Only available in Korean,2019 July 29)

https://www.law.go.kr/%ED%96%89%EC%A0%95%EA%B7%9C%EC%B9%99/%EC%B2%9C%EC%97%B0%ED%99%94%EC%9E%A5%ED%92%88%EB%B0%8F%EC%9C%A0%EA%B8%B0%EB%86%8D%ED%99%94%EC%9E%A5%ED%92%88%EC%9D%98%EA%B8%B0%EC%A4%80%EC%97%90%EA%B4%80%ED%95%9C%EA%B7%9C%EC%A0%95/(2019-66,20190729)

2. KTR's certification information page for reference

https://www.ktr.or.kr/certification/quality/contentsid/1838/index.do

3. Table 2 of Regulations on the Safety Standards, etc. of Cosmetics (only available in Korean version) https://www.law.go.kr/%ED%96%89%EC%A0%95%EA%B7%9C%EC%B9%99/%ED%99%94%EC%9E%A5%ED%92%88%EC%95%88%EC%A0%84%EA%B8%B0%EC%A4%80%EB%93%B1%EC%97%90%EA%B4%80%ED%95%9C%EA%B7%9C%EC%A0%95/(2023-17,20230221)