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South Korea - Regulation

In developing the cosmetics industry and improving public health, the Act regulate matters concerning the manufacture, sale, import, and export, etc of cosmetics. The Cosmetic Act has been enforced since July 1, 2000, and the recent amendment came into force on April 7, 2020.

 

Relevant documents are uploaded in the right-side bar ‘Downloadable Content’.

  • Cosmetic Act (Korean and English)

According to the Cosmetic Act, cosmetics include two main categories: functional cosmetics and general cosmetics. Some articles in the Cosmetic Act particularly applies to functional cosmetics. For instance, a person or company who is involved in the sale of a functional cosmetic should process examinations of the safety and effectiveness of each product and report it to MFDS (Ministry of Food and Drug Safety).

1) Functional cosmetics: As determined by ordinance of the Prime Minister, these cosmetics include the following:

  • Cosmetics that help whiten skin
  • Cosmetics that help smoothen or improve skin wrinkles
  • Cosmetics that help tan skin
  • Cosmetics that help protect skin from ultraviolet rays
  • Cosmetics that help change hair colour
  • Cosmetics that help remove body hair
  • Cosmetics that help alleviate alopecia
  • Cosmetics that help alleviate acneiform skin
  • Cosmetics that help alleviate urtication from atopic skin
  • Cosmetics that help thin redlines from stretchmarks

 

2) General cosmetics: These include all cosmetics excluding functional cosmetics.

 1. Main requirement for manufacturers and manufacturer-seller

 

Manufacturer

Manufacturer-Seller

Definition

Manufacturing all or part of the cosmetics*

(*This excludes manufacturing secondary packaging or labelling)

Distributing or selling manufactured or imported cosmetics, or offering or supplying cosmetics to import agency business

Main requirement

-Follow manufacturer-seller’s request and guidance ∙ supervision based on quality control standard

-Prepare and keep documents including manufacturing control standards, product standards, manufacturing control records and quality control records

-Manage hygiene of manufacturing plants, facilities and equipment

-Inspect facilities and equipment regularly to maintain and keep it, in order not to disturb operation

-Do not place any object that might cause harm and ensure there is no release or leakage of harmful substances

-Follow quality control standards

-Follow safety control standards

-Keep product standards and quality control records received from manufacturers

-Prepare and keep import control records attached to imported cosmetics

-Distribute products after thorough quality inspection by serial number

 

*** Anyone who violates these matters shall be fined up to 2 million KRW.

 

2. Contents to be stated on primary or secondary packages

  • Name of the cosmetic
  • Tradename and address of the business operator
  • All ingredients used in manufacturing the relevant cosmetic
  • Volume or weight of contents
  • Manufacturing serial number
  • Use-by date or best before date after opening
  • Price
  • The word “Functional cosmetic” or functional cosmetic logo (only for functional cosmetics)
  • Cautions for use
  • Other matters prescribed by ordinance of the Prime Minister

*** Anyone who violates these matters shall be fined up to 2 million KRW.

3. Prohibition of false labelling and advertising

  • Labelling or advertising that might mislead consumers to think the cosmetics are medicines
  • Labelling or advertising that might mislead consumers to think general cosmetic as functional cosmetic, or labelling or advertising that is different from the examination result of safety and efficacy of functional cosmetic
  • Labelling or advertising that might mislead consumers to think any cosmetic other than a natural or organic cosmetic as a natural or organic cosmetic
  • Other labelling or advertising that might mislead or deceive consumers

***Anyone who violates these matters shall either be sentenced up to one year imprisonment or fined up to 10 million KRW.

 

Source: MFDS (Ministry of Food and Drug Safety)

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