Cosmetic Compliance
Intelligence & Solutions
South Korea Cosmetic Regulation
Jan 14, 2021
Lorraine T.S. Li
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CONTENTS

Prior to 2000, Cosmetic was managed as medicine under the Pharmaceutical Affairs Act in South Korea, which held back the industry growth. To facilitate proper safety control and international trade, the South Korean government established the legislation of cosmetics on July 1, 2000. The new legislation regulated the cosmetic manufacturing, importing, and safety evaluating, increasing competitiveness of the K-beauty industry. 

Chapter 1. Regulatory Framework and Competent Authority

1.1. Existing Main Cosmetic Regulations in South Korea

South Korea's law hierarchy contains superordinate laws and supporting rules. The main law, acknowledged as "XXX Act", is an overarching law. It specifies all aspects of requirements related to the subject. The main law along with a presidential decree (Enforcement Decree of XXX Act) and an ordinance of the Prime Minister (Enforcement Rule of XXX Act) forms the superordinate laws. In addition, there are numerous supporting rules to enrich the management scheme.

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The regulations in the law system for the cosmetic industry in S. Korea are:

Superordinate Laws

 

Effective Date

Status

Cosmetics Act

 

(A law comprehensively regulating every aspect of cosmetics management)

2021-08-17

Original Sep.1999

In Force

Enforcement Decree of Cosmetics Act

 

(The regulation guiding the government's supervision)

2020-03-14

Original Mar. 2013

In Force

Enforcement Rule of Cosmetics Act

 

(The regulation detailing the rules for implementation)

2020-09-10

Original Sep.1999

Draft

Supporting Regulations

 

Effective Date

Status

Regulation on Safety Standards, etc. for Cosmetics


(The safety control regulation including the standards of ingredients and other cosmetic safety management matters. Applicable to all manufactured, imported, and distributed cosmetics.)

2020-04-18

Original Sep.1999

In Force

Types, Standards, and Test Methods of Cosmetic Color Additives

 

(Color additives requirements)

2020-12-30

Original Oct. 2011

In Force

Regulation on the Demonstration of Labeling and Advertisement for Cosmetic Products

 

(Label and advertisement standard)

2014-02-12

Original Nov. 2012

Draft

Regulation on the Examination of Designation and Changes of Cosmetics Ingredient Standards

 

(The regulation about applying for a certificate on a new cosmetics ingredient or a new standard of cosmetic)

2020-06-15

Original Jun. 2020

In Force

Standards and Testing Methods of Functional Cosmetics

 

(Quality standards for functional cosmetics)

2020-12-30

Original Jul.2001

In Force

Functional Cosmetics Evaluation Regulation

 

(Requirements about the application dossiers of functional cosmetics)

2020-6-30

Original Aug.2008

In Force

Requirements for Custom Cosmetics Sales Business

 

(The standards of producing a custom cosmetic by blending or dividing a cosmetic)

2020-10-29

Original Oct. 2020

In Force

Requirement on Operating Custom Cosmetics Compounding Manager Qualification Test

 

(Requirement about operating the qualification test for custom cosmetics compounding manager)

2020-09-01

Original Feb. 2020

In Force

Regulation on the Preparation and Storage of Infants and Children Cosmetic Safety Data

 

(The regulation about the safety data preparation and storage for children's cosmetics)

2020-07-24

Original July. 2020

In Force

Regulations on Cosmetic Good Manufacturing and Quality Control Practices

 

(The regulation about cosmetic GMP)

2020-02-25

Original Dec.2000

In Force

Regulation on the Management of Safety Information for Cosmetics  

 

(The regulation about reporting the hazard information about the cosmetics)

2020-06-23

Original Mar. 2011

In Force

Regulations on the Remission of Quality Inspection for Imported Cosmetics


(The regulation details the requirements for applying the remission of import inspection)

2020-02-25

Original Aug. 2009

In Force

Regulation for Notification of Cosmetics Manufacturing & Import Amount and Lists of Ingredients


(Necessary matters relevant to notification of cosmetics manufacturing and import amount and ingredients)

2020-02-25

Original Dec. 2012

In Force

Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens 


( fragrance allergens labeling standard)

2019-12-16

Original Dec. 2002

In Force

Cosmetics Barcode Creation and Management Standard


(Barcode labeling standard)

2020-02-25

Original Dec. 2001

In Force

1.2. Competent Authority

In South Korea, two competent authorities take charge of cosmetic safety management: the Ministry of Food and Drug Safety (MFDS) and Korea Pharmaceutical Traders Association (KPTA). MFDS is responsible for formulating cosmetic regulations and reviewing business registrations. KPTA evaluates the safety and effectiveness of cosmetics as well as issues the approval of entry notice of imported products.

Chapter 2. Cosmetic Products

2.1. Definition of Cosmetic Products

In South Korea, "cosmetics" are products applied to human bodies for cleansing, beautifying, promoting attractiveness, or maintaining/improving the health of skin and hair.    

2.2. Classification of Cosmetic Products

Cosmetics can be classified into two main types in South Korea: "general cosmetics" and "functional cosmetics.

Functional Cosmetic

Any of the following cosmetics:

  1. Cosmetics helpful in skin-whitening by preventing the skin pigmentation of melanin;

  2. Cosmetics helpful in skin-whitening by fading melanin pigmentation in skin;

  3. Anti-wrinkle products;

  4. Tanning products;

  5. Sunblocks;

  6. Hair dyes

  7. Depilating agents

  8. Anti-hair loss products

  9. Anti-acne products

  10. Anti-itching products for dry skin

  11. Cosmetics helpful in thinning red lines caused by striae distensae.

General CosmeticsCosmetics not falling into the above category.

In addition, on March 13, 2018, MFDS introduced three new categories: "natural cosmetic", "organic cosmetic", and "custom cosmetic", amending the Cosmetics Act (No. 15488).

Natural Cosmetic

Cosmetics containing animal and plant ingredients and their derivative materials (Natural ingredient concentration > 95%)

Organic Cosmetic

Cosmetics containing organic ingredients and ingredients derived from animals and plants. (Organic ingredient concentration > 10%; Natural ingredients > 95%)

Custom Cosmetic

Any of the following cosmetics:

a) Cosmetics made by mixing the (A) contents of a manufactured or imported cosmetic with (B) the contents of any other cosmetic or raw material;

b) Cosmetics repackaged by dividing the contents of a manufactured or imported cosmetic into smaller amounts;

A natural/organic cosmetic can be either a functional cosmetic or a genearl cosmetis, as long as the relevant product meets the standards of the natual/organic cosmetic. 

However, note that "custom cosmetic" cannot be mixed with functional raw materials, i.e. "custom cosmetic" is subject to "functional cosmetic".  

2.3. Registration of Responsible Cosmetic Distribution Business

(A) Qualification 

To conduct cosmetic distribution business in South Korea, the business entity shall comply with the standards for quality control and responsible post-sale safety control of cosmetics, which are prescribed by Enforcement Rule of Cosmetics Act, and shall employ a "responsible distribution manager" capable of managing such standards.  

Cosmetic Quality Control
  • Keep the records of quality control process

  • Recall the risk products

  • Take necessary education

  • Manage relevant dossiers and records 

Responsible Post-sale Safety Control
  • Collect the safety control information

  • Analyse the safety control information and conduct relevant measures to deal with the risks 

  • Conduct post-sale safety control

(B) Application

The business entity shall apply to MFDS for the registration of "Responsible Cosmetic Distribution Business" with the following dossiers:

1Application letter
2Proofs about complying with the standards for quality control and responsible post-sale safety control of cosmetics
3Qualification certificate of responsible distribution manager

2.4. General Cosmetic Safety Requirements

(A) Ingredient Requirements

MFDS has issued 1032 prohibited ingredients that cannot be added in cosmetics. 

Furthermore, the manufacturer shall only use the restricted preservatives, restricted UV-filter ingredientsrestricted hair dye ingredients, and other restricted ingredients under the specific conditions given in relevant requirements due to safety problems.

If the enterprise intends to use a non-specified restricted ingredient, the enterprise needs to apply to MFDS for the approval. The application dossiers contain:

1Application letter
2A summary of all submitting documents 
3The origin, development process, usage standard, and usage situation of the ingredient
4Properties of the ingredient
5Safety and efficacy documents (if necessary)
6Data of the ingredient standard and test method

More information of S. Korean cosmetic ingredients can be found at ChemLinked Cosmelist.

(B) Microbial Limits:

1

The total aerobic bacterial count in infant and children's cosmetics or eye make-ups : less than 500 cfu/g or cfu/mL

2

The bacteria in wet tissue: less than 100 cfu/g or 100 cfu/ml;

The fungi in wet tissue: less than 100 cfu/g or 100 cfu/ml;

3

Microorganisms in other cosmetics: less than 1000 cfu/g or 1000 cfu/ml;

4

Escherichia Coli: negative;

Pseudomonas Aeruginosa: negative;

Staphylococcus Aureus: negative

(C) Migration Amount

The substances that might migrate from cosmetic packages shall be:

1

Lead in powder product with clay material: less than 50㎍/g;

Lead in other products: less than 20㎍/g.

2

Nickel in eye make-ups: less than 35㎍/g;

Nickel in make-ups: less than 30㎍/g;

Nickel in other products: less than 10㎍/g.

3

Arsenic: less than 10㎍/g.

4

Hydrargyrum: less than 1㎍/g.

5

Antimony: less than 10㎍/g.

6

Cadmium: less than 5 ㎍/g.

7

Dioxane: less than 100㎍/g.

8

Methanol in wet tissue: less than 0.002%(v/v);

Methanol in other cosmetics: less than 0.2(v/v) %.

9

Formaldehyde in wet tissue: less than 20㎍/g;

Formaldehyde in other cosmetics: less than 2000㎍/g.

10

Phthalate group (total amount of DBP, BBP and DEHP): less than 100㎍/g.


(D) Label Requirement

General Label Items:

a) Product name;

b) Trade name and address of the business operator;

c) All ingredients;

d) Volume or weight of contents;

e) Manufacturing number;

f) Use-by date;

g) Price;

h) Cautions for use;

i) Bar code.

Label Information for Special Situations:

a) For an imported cosmetic: the manufacturing country, manufacturing company's name, and location

b) For a functional cosmetic: the efficacy and use methods;

c) For a function cosmetic with the efficacy of "anti-hair loss", "anti-acne", "anti-itching" or "thinning red lines": "Not a medicine for curing or preventing a disease (질병의 예방 및 치료를 위한 의약품이 아님)"

d) For a children's cosmetic: the contents of preservatives  

e) For a natural or organic cosmetic: the contents of natural or organic ingredients

Nevertheless, some information can be omitted depending on the cosmetic dosage. Consult with ChemLinked for more information. 

2.5. Functional Cosmetics

To sell functional cosmetics in South Korea, the enterprise is required to apply for a function certificate of the relevant cosmetics to MFDS. Nevertheless, for functional cosmetics manufactured following Standards and Testing Methods of Functional Cosmetics with the approved ingredients for functional cosmetics, some document review can be exempted.

The dossiers for the function certificate application involve:

1. Data concerning the origin and explanations on development;

 

2. Data concerning safety:

(a) Data of single-dose toxicity tests;

(b) Data of primary skin irritation tests;

(c) Data of eye mucous membrane irritation or other mucous membrane irritation tests;

(d) Data of skin sensitization tests;

(e) Data of phototoxicity and photosensitization tests;

(f) Data of human insult patch tests;

 

3. Data concerning efficacy:

(a) Data of effects tests;

(b) Data of human trials;

 

4. Evidential data for establishing ultraviolet ray-protection factor and the protection grade of ultraviolet A (limited to sunblock cosmetics);

 

5. Data concerning standards and testing methods (including clinical specimens).

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(Logo of Functional Cosmetic)

The word "functional cosmetic (기능성화장품)" or a functional cosmetic logo can be labeled on a qualified functional cosmetic.

2.6. Export Procedure

The overseas enterprise needs to establish a "responsible cosmetic distributor" as an importer at first. The importer will take charge of the cosmetic's quality and safety as well as distribute the products in S. Korea. Also, the "responsible cosmetic distributor" should apply for the registration of "responsible cosmetic distribution business" to MFDS, reporting the product's ingredients and manufacturing methods.

Each time before export, the distributor should submit an "entry notice of imported products" to KPTA and get an approval.

The dossiers for applying the approval include:

NoDossierSubmission Method
1Application letter for the approval of "Entry notice of imported products"Online submission
2Certificate of responsible cosmetic distributor (Copy)By mail/ Online submission 
3Certificate of business registration (Copy)By mail/ Online submission
4Documents about Functional Cosmetics (only for functional cosmetics) (Copy)By mail/ Online submission
5

Manufacture certificate

(A notarial certificate including the information of product name, ingredient name, ingredient specifications, etc.) (Original version)

By mail/ Online submission
6

Sale certificate

(A certificate issued by the export country government, evidencing the fact that the product has been sold in the relevant region.) (Original version)

By mail/ Online submission
7

TSE(BSE) related documents

(Certificates verifying the products are manufactured without raw materials divided from TSE (Transmissible Spongiform Encephalopathy) or BSE (Bovine Spongiform Encephalopathy) infected animals) (Original version)

By mail only

The importer can move to the next step and apply for an import declaration to the Korea Customs Service (KCS) after receiving the approval from KPTA. The KCS will check KPTA's approval as well as the packing list, invoice, B/L (bill of lading), etc. Products without the KPTA's permission are not permitted to pass through customs.

The export flow chart is listed below:

微信截图-20210325150034.png(Cosmetic Export Flow Chart) 

Note only after finishing all inspections, can the products be attached with labels in Korean and sold in S. Korea.

Chapter 3. Natural and Organic Cosmetics

Before selling or import natural or organic cosmetics, the enterprise needs to apply for a certificate to MFDS. MFDS will certify a cosmetic that is made following Regulations on the Standards of Natural and Organic Cosmetic Products.

The approved ingredients for "natural cosmetics" or "organic cosmetics" are:

1. Natural Ingredients

2. Natural Derived Ingredients

3. Water

4. Other Permitted Ingredients

5. Permitted Synthetic Preservatives and Denaturants

6. Ingredients containing both natural and petrochemical moiety

Detailed information of the above ingredients: ChemLinked Cosme-List: (South Korea) Permitted Ingredients in Natural and Organic Cosmetics

The product can be labeled with "natural cosmetic" or "organic cosmetic" after obtaining MFDS' approval. The figures are as below:

 0000.png

(Natural Cosmetic Label and Organic Cosmetic Label)

Chapter 4. Custom Cosmetic

Any enterprise intending to conduct custom cosmetic business in S. Korea shall employ a "custom cosmetic compounding manager" to control the product safety. The enterprise needs to file a report of "custom cosmetic sales business" indicating the compounding manager's qualification certificate with MFDS. The authority will issue a certificate of completion of the report to the applicant after confirming the details.

All cosmetic ingredients are applicable for custom cosmetics, excluding:

  1. Prohibited ingredients,

  2. Restricted ingredients (restricted preservatives, restricted UV-filter ingredients, restricted hair dye ingredients, and other restricted ingredients)

  3. Functional Ingredients

The sellers should blend or divide the cosmetics for the customers following the Requirements for Custom Cosmetics Sales Business.

ChemLinked Services about S. Korea Cosmetics

  • Regulation Monitoring and Interpretation

  • One-step service for exporting cosmetics to S. Korea

  • Consulting service about ingredient compliance

  • Consulting service about custom clearance

Contact us at contact@chemlinked.com