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Selling cosmetics in South Korea

In South Korea, cosmetics are regulated by the Ministry of Food and Drug Safety (MFDS) under the Cosmetics Act. A registered responsible cosmetic distributor places each product on the market, reports its bill of materials before sale, and answers for quality and post-market safety. Functional cosmetics are examined or reported first, and labels are in Korean.

Updated · Each section links to the official source it comes from

Regulator
Ministry of Food and Drug Safety (MFDS)
Main law
Cosmetics Act (화장품법)
Who places it on the market
Responsible cosmetic distributor (책임판매업자)
Functional cosmetics
MFDS examination or report before sale
Label language
Korean; Chinese characters and foreign languages may be added
Animal testing
Distribution of animal-tested cosmetics banned, with exceptions

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Who is the registered manufacturer and the responsible cosmetic distributor? Read more
  2. 2Is the product a functional cosmetic that needs an MFDS examination or report? Read more
  3. 3Is each raw material allowed, and are preservatives, colourants and sunscreens within the notified standards? Read more
  4. 4Has the bill of materials been reported before distribution? Read more
  5. 5Does the outer package carry the required statements in Korean? Read more
  6. 6Can each claim be substantiated, and is a recall plan ready if one is needed? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Business registration and the responsible distributor

Who may make and place cosmetics on the Korean market.

  • A cosmetic manufacturing business or responsible cosmetic distribution business registers with MFDS (Article 3, Cosmetics Act).
  • The responsible cosmetic distribution business distributes or sells cosmetics, or supplies them for import agency, while controlling their quality and safety (Article 2).
  • A responsible distributor complies with the quality management and post-market safety management standards, and employs a responsible distribution manager (Article 3(3)).
  • The responsible distributor reports its production or import performance and the bill of materials to MFDS; the list of raw materials is reported before the cosmetic is distributed or sold (Article 5(5)).
  • Responsible distribution managers receive education on safety and quality management every year (Article 5(7)).

How we help: Compliant Always keeps the registrations and bill of materials report with each product, and shows what is missing or due. Ask about this

Functional cosmetics and products for children

Cosmetics with stated effects, and those labelled for infants or children.

  • Functional cosmetics are those aiding skin whitening, improving wrinkles, gentle tanning or UV protection, changing hair colour or nourishing hair, and preventing dryness or hair loss, as prescribed by Prime Ministerial Decree (Article 2).
  • A manufacturer, responsible distributor or named university or research institute undergoes an MFDS examination, or submits a report, before selling a functional cosmetic (Article 4).
  • Functional cosmetics without an examination or report may not be sold, imported, stored or displayed for sale (Article 15).
  • A responsible distributor labelling or advertising a cosmetic as usable by infants or children prepares and keeps safety data by product: the product and manufacturing method, the safety evaluation, and evidence of efficacy (Article 4-2).

How we help: Compliant Always keeps the examination or report, and the safety data by product, with the product they cover. Ask about this

Ingredients and safety standards

What may go into a cosmetic, and what may not be sold.

  • MFDS designates and publicly notifies raw materials that cannot be used in cosmetics (Article 8(1)).
  • Preservatives, pigments and sunscreens may be used only where MFDS has notified standards for their use (Article 8(2)).
  • Cosmetics that are deteriorated, contaminated by pathogens, made with prohibited raw materials, or imitate food so they may be eaten may not be sold (Article 15).
  • Responsible distributors and customised cosmetic sellers use childproof containers and packaging for the items Prime Ministerial Decree sets (Article 9).
  • Responsible distributors may not distribute or sell cosmetics tested on animals, or made with raw materials tested on animals, except in listed cases such as testing required by an export market's law (Article 15-2).

How we help: Compliant Always reads your formula against the notified lists and keeps the evidence for each restricted ingredient with the product. Ask about this

Labelling, claims and recall

What the package states, and what a label or advert may say.

  • The outer package states the name, the business's trade name and address, the ingredients, volume or weight, batch number, use-by date or period after opening, price, the functional cosmetic wording or logo where relevant, and cautions for use (Article 10(1)).
  • The primary package inside a secondary package states the name, trade name, batch number, and use-by date and period after opening (Article 10(2)).
  • Statements are in easily readable Korean characters, in a conspicuous place; Chinese characters and foreign languages may also be used (Article 12).
  • No label or advert may suggest the cosmetic is a medicine, or a functional cosmetic when it is not, or otherwise mislead (Article 13).
  • Business operators and sellers can substantiate their claims, and submit the evidence within 15 days of an MFDS request (Article 14).
  • A business operator that becomes aware of a hazardous cosmetic on the market recalls it without delay and reports a recall plan to MFDS in advance (Article 5-2).

How we help: Compliant Always sets the required statements beside what your package shows, and keeps the evidence for each claim with the label version it supports. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Responsible cosmetic distributorRegistration, quality and post-market safety management, the bill of materials report, labelling and recall.Registrations, reports and the evidence for each claim kept with the product.
ManufacturerRegistration, facility standards and the records and tests the Decree sets.Batch records and test reports kept with each lot.
BrandWhat the label and advertising claim, and the evidence behind it.The package read against the statements, with the evidence in one place.
SellerLabelling the price, and not making false or misleading claims.Product documents ready for the retailer or platform that asks.

National ministries and local government

Product law in South Korea is national. Each Act names the minister in charge, such as the Minister of Food and Drug Safety for food and cosmetics, and the Minister of Trade, Industry and Resources for electrical, consumer and children's products.

Many licences, reports and inspections under those Acts are handled by a Mayor or Do Governor or the head of a Si/Gun/Gu, so the local office named in the Act is often the one a business deals with.

Questions businesses ask

Who regulates cosmetics in South Korea?
The Ministry of Food and Drug Safety (MFDS), under the Cosmetics Act.
What is a responsible cosmetic distributor?
A business registered with MFDS that distributes or sells cosmetics, or supplies them for import agency, while controlling their quality and safety. It employs a responsible distribution manager (Articles 2 and 3, Cosmetics Act).
Does an importer of cosmetics need to register?
A person supplying cosmetics for import agency business while controlling their quality and safety runs a responsible cosmetic distribution business, which registers with MFDS (Articles 2 and 3).
What is a functional cosmetic in Korea?
A cosmetic aiding whitening, wrinkle improvement, gentle tanning or UV protection, hair colour or nourishment, or preventing dryness or hair loss, as set by Prime Ministerial Decree. It is examined by MFDS or reported before sale (Articles 2 and 4).
Do I report ingredients to MFDS?
Yes. The responsible distributor reports production or import performance and the bill of materials; the list of raw materials is reported before the cosmetic is distributed or sold (Article 5(5), Cosmetics Act).
What must a Korean cosmetics label show?
Name, trade name and address, ingredients, volume or weight, batch number, use-by date or period after opening, price, functional cosmetic wording where relevant, and cautions for use (Article 10, Cosmetics Act).
Must cosmetics labels be in Korean?
Yes. The statements are in easily readable Korean characters in a conspicuous place; Chinese characters and foreign languages may also be placed (Article 12, Cosmetics Act).
Does Korea ban animal-tested cosmetics?
Responsible distributors may not distribute or sell cosmetics tested on animals, or made with animal-tested raw materials, except in listed cases such as testing required by an export market's law (Article 15-2).
What about cosmetics for babies and children?
A responsible distributor labelling a cosmetic as usable by infants or children prepares and keeps safety data by product, including a safety evaluation (Article 4-2, Cosmetics Act).
How fast must claim evidence reach MFDS?
Within 15 days of a request, unless MFDS extends the period for good cause (Article 14, Cosmetics Act).
What happens if a cosmetic is found to be hazardous?
The business operator recalls it without delay, or takes the measures needed to, and reports a recall plan to MFDS in advance (Article 5-2, Cosmetics Act).
How does Compliant Always help with selling in South Korea?
Our team reads the rules for the markets you sell in, from Korean law and the regulators' own pages. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in South Korea and what your paperwork needs to show.

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