South Korea Cosmetic Regulation QA

Email: sel4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of China (GMT+8)
The Engaging Manager from Headquarter
Ms. Judy Wang, CPA(Taiwan) Speaks in both English and Chinese.
WeChat: Judy_Evershine
skype: Judy Wang

HLF-TW-10

What are the categories of cosmetics in Korea? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of cosmetics? Website?

Evershine RD：

The term “cosmetic” means any item intended to be used by means of spreading, rubbing, spraying on or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or brightening the appearance, or maintaining or improving the health of skin and hair, which have light effects on the human

The term “functional cosmetics” means cosmetics prescribed by Ordinance of the Prime Minister, falling under any of the following:
(a) Products aiding in the whitening of the skin;
(b) Products aiding in improving wrinkles in the skin;
(c) Products aiding in tanning skin gently or protecting skin from ultraviolet rays;

With regards to the functional cosmetics, a Responsible Seller who intends to manufacture or sell functional cosmetics by manufacturing or importing them shall undergo an evaluation by the Ministry of Food and Drug Safety (MFDS) or shall submit an application to the Minister of the MFDS for safety and effectiveness of each product pursuant to Article 4 of the Cosmetics Act (Examination, etc. of Functional Cosmetics).

【Reference Link】Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=69983&srchFr=&srchTo=&srchWord=Cosmetics+Act&srchTp=7&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-20

If a foreign company wants to sell cosmetics in Korea, no matter if it sets up a 100% subsidiary or branch, does it need to obtain approval from the local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD：

Cosmetics Responsible Person shall register with MFDS cosmetic marketing responsible person (with the regional office that has jurisdiction over where the manufacturing facility is located)
The application documents include:

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller (for a corporation, name and date of birth of the CEO);
3. Trade name of the manufacturer-seller (for a corporation, name of the corporation);
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

A Cosmetics Responsible Person shall hire a Qualified Person who is responsible for the safety and quality of cosmetic products a person who has a qualification as a responsible marketing officer, and the sales officer must complete a training on ensuring safety of cosmetics once a year.
It’s necessary to prepare and maintain written manufacture management standards, written manufacture management records and written quality control records

【Reference Link】Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=69983&srchFr=&srchTo=&srchWord=Cosmetics+Act&srchTp=7&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-30

If a foreign company wants to sell cosmetics in Korea, can it assign a Korean company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

A person who is subject to registration as a manufacturer-seller (hereinafter referred to as the “manufacturer-seller”) pursuant to Article 3 (1) of the Act is as follows:

1. A person who intends to distribute and sell cosmetics produced by him or herself;
2. A person who intends to distribute and sell cosmetics produced by consignment;
3. A person who intends to distribute and sell imported cosmetics;
4. A person who intends to supply or award cosmetics, for the purpose of import agency business (applicable only to electronic commerce).

The Head of the Regional Office of the MFDS in receipt of the application pursuant to the paragraph (2) shall verify the certificate of registered contents for corporations (applicable only to a corporation) through the administrative information that is to be shared among administrative agencies pursuant to Article 36 (1) of the Electronic Government Act.

If the application for registration meets the requirements for registration prescribed in the paragraph 2, the Head of Regional Office of the MFDS shall record the following matters in the registry for cosmetics manufacture-sales business and issue the “certificate of registration for manufacture-sales business” of registration for cosmetics manufacture-sales business.

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller;
3. Trade name of the manufacturer-seller;
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

【Reference Link】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-40

Do foreign companies need to apply for an approval before importing cosmetics sold to Korea?
If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetic packaging and labeling require prior approval? In addition to Korean, which other languages ​​are allowed? Website?

Evershine RD：

Cosmetics Responsible Person shall register with MFDS cosmetic marketing responsible person (with the regional office that has jurisdiction over where the manufacturing facility is located)
The application documents include:

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller;
3. Trade name of the manufacturer-seller;
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

Claims of Cosmetic Labeling
– Name of a cosmetic product
– Name and address of the manufacturer and
– Batch number
– Expiration date or use-by dates after opening
– Price
– All ingredients used to manufacture cosmetics
– Volume or weight
– “Functional Cosmetics” has to be displayed in case
– Precautions for use
– Others required by the Enforcement Rule

【Reference Link】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-45

Are there any professional service organizations in South Korea that can assist in applying for cosmetic product licenses?

Evershine RD：

Biorius
https://biorius.com/

HLF-TW-50

Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required?
What is the application process? Do cosmetic packaging and labeling require prior approval?
In addition to Korean, which other languages ​​are allowed? Website?

The application is supposed to be submitted by a Korean agent.
Cosmetics Responsible Person shall register with MFDS cosmetic marketing responsible person (with the regional office that has jurisdiction over where the manufacturing facility is located)
The application documents include:

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller (for a corporation, name and date of birth of the CEO);
3. Trade name of the manufacturer-seller (for a corporation, name of the corporation);
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

Claims of Cosmetic Labeling
– Name of a cosmetic product
– Name and address of the manufacturer and
– Batch number
– Expiration date or use-by dates after opening
– Price
– All ingredients used to manufacture cosmetics
– Volume or weight
– “Functional Cosmetics” has to be displayed in case
– Precautions for use
– Others required by the Enforcement Rule

【Reference Link】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-55

Are there any professional service organizations in South Korea that can assist in applying for a license for cosmetic products in the name of a foreign company?

Evershine RD：

Biorius
https://biorius.com/

HLF-TW-60

What documents are required when importing approved cosmetics into Korea? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

The marketing responsible person shall submit an “Entry Notice of Imported Products Report” before customs clearance
Those who intend to manufacture or import functional cosmetics are required to have them approved by the MFDS through evaluation.
Data requirement:

1. Data that verify safety, effectiveness, or function

• Data concerning the origin and the details of R&D
• Data concerning the safety
• Data that verify effectiveness, or function
• Sun Protection Factor (SPF), waterproof Sun Protection Factor (SPF),  and Protection Factor of UV-A (PA) data

2. Data concerning the standards and test methods (Including samples)

【Reference Link】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-70
What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

The manufacturer-seller who intends to sell functional cosmetics by manufacturing or importing them pursuant shall attach the following documents and receive an examination by the Ministry of Food and Drug:

1. Data on the details about the origin and development.
2. Data on safety:
3. Data on toxicity test with single dose;
4. Data on primary dermal irritation study;
5. Data on ocular and other membranes irritation studies;
6. Data on skin sensitization test;
7. Data on phototoxicity and photo sensitization test;
8. Data on patch test on a human body.
9. Data on efficacy and functions:
10. Data on efficacy test;
11. Data on application to a human body.
12. Evidentiary data about establishing the sun protection factor (SPF) and the protection factor of UV-A (PA) (applicable only to cosmetics aiding in protecting skin from ultraviolet rays by blocking or scattering the ultraviolet rays).
13. Data on the standards and test methods (including the clinical specimen).

However, where the Minister of the MFDS has publicly announced the ingredient and content that indicate the efficacy and effects of a product, submission of the data in subparagraphs 1 through 4 may be omitted.
And for products of which standards and test methods are publicly announced, submission of the data in subparagraph 5 may be omitted.

【Reference Link】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-75
Can the South Korean cosmetics audit agency accept inspection data from overseas inspection agencies?
If yes, any accredited institutions? Website?

Evershine RD：

There are no special regulations.
International testing agencies such as UL SGS are acceptable.

HLF-TW-77
Which cosmetic inspection agencies in South Korea can provide cosmetic inspection services? Website?

Evershine RD：

SGS https://www.sgsgroup.kr/en

KTR http://www.ktr.or.kr/eng/testevaluation/cosmetic/contentsid/982/index.do

HLF-TW-80
After a foreign subsidiary imports cosmetics and entrusts a distributor in Korea to sell it, does the distributor need a cosmetics business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

Cosmetics sell agent shall register with MFDS cosmetic marketing responsible person (with the regional office that has jurisdiction over where the manufacturing facility is located)
The application documents include:

1. Registration number and date of registration;
2. Name and date of birth of the manufacturer-seller (for a corporation, name and date of birth of the CEO);
3. Trade name of the manufacturer-seller (for a corporation, name of the corporation);
4. Location of the manufacture-sales establishment;
5. Name and date of birth of the manufacture-sales manager;
6. Manufacture-sales type.

A Cosmetics Responsible Person must report the safety information of cosmetics to the MFDS every half year; A cosmetic marketing responsible person must promptly report to the MFDS within 15 days of discovery of a serious adverse event.
If the cosmetic products have quality defects, MFDS has the right to issue a restraining order of Prohibition of sales, recall, disposal, adding precautions for use, etc.

【Reference Link】Enforcement Rule of the Cosmetics Act

https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=70212&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

HLF-TW-85

Are there any companies in South Korea specializing in legal services related to cosmetic sales and consumer rights?

Evershine RD：

Kim&Chang https://www.kimchang.com/en/expertise/view/health

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Seoul Evershine BPO Service Limited Corp.
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E-mail: sel4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of China (GMT+8)
The Engaging Manager from Headquarter
Ms. Judy Wang, CPA(Taiwan) Speaks in both English and Chinese.
WeChat: Judy_Evershine
skype: Judy Wang

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