This article aims to provide you a general understanding of how South Korea cosmetics are regulated. Due to the major change of the overarching cosmetic regulation (South Korea Cosmetics Act) in 2019, this article suits the readers who is already in or planning to enter the South Korea cosmetics market.
Overview of the Cosmetics Act
The cosmetic products sold in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS) under the regulation that it’s published: Cosmetics Act. It is the overarching regulation as well as with the Cosmetics notice from the Korean government.
According to the Cosmetic Act, cosmetic products in Korea are divided into General cosmetics and Functional cosmetics. Two categories are required to register in different authorities. South Korea Pharmaceutical Traders Association (KPTA) is responsible for general cosmetics registration and usually will take 7 days to complete the process. And Ministry of Food and Drug Safety (MFDS) is in charge of the functional cosmetics safety evaluation and registration which usually will take 4 to 6 months to complete the application.
An important role called Marketing Authorization Holder (MAH) is introduced in the article which will be responsible for all your importing and registration process.
There are two major authorities you may be dealing with when importing cosmetics to South Korea. Ministry of Food and Drug Safety (MFDS) and South Korea Pharmaceutical Traders Association (KPTA). The cosmetics importing and trading will be governed by KPTA and the MFDS is responsible for make the cosmetic regulations and registering functional cosmetics.
Overarching regulation: Cosmetics Act, it provides definitions of cosmetic definition. General policy on cosmetic supervises, GMP, industry obligations, advertisements.
The rules to explain the overarching law and detailed the specific act:
- Enforcement Decree of Cosmetics Act
- Enforcement Rule of Cosmetics Act
Products and Ingredients safety rule:
- Regulation on Safety Standards for Cosmetics
Cosmetics Definition in Cosmetics Act:
According to Cosmetics Act, the term “Cosmetics” defined as 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 body”.
The term “functional cosmetics” means cosmetics prescribed by Ordinance of the Prime Minister, falling under any of the following:
- whitening of the skin;
- improving wrinkles in the skin;
- tanning skin gently or protecting skin from ultraviolet rays;
- changing or removing the color of hair, or nourishing hair;
- preventing or improving dryness, splits, loss, cornification, etc. resulting from weakened functions of skin or hair;
In terms of the cosmetic definitions above, cosmetic products are divided into general cosmetics and functional cosmetics. The following table will help you to classify your products category.
|1) Whitening product
2) Anti-wrinkle product
3) Sunscreen products
4) Hair Dye products (permanent hair dye products are excluded)
5) Other products fit the definition above
Besides, please be aware that some of the products may not fall into the cosmetics category and will be categorized as Quasi Drug which will show the following:
- Sanitary napkins
- Anti-hair fall products,
- Hair dye (Permanent hair dye)
- Mouth Refreshers
- Hand sanitizer
- Antiperspirant Antiseptic
The role of Marketing Authorization Holder (IMPORTANT)
According to the Cosmetic Act, a Marketing Authorization Holder System has been introduced to charge of the cosmetic products registration, importing and marketing in South Korea Markets. The Marketing authorization holder (MAH) can be your primary importer or a third-party company like a registration agency or shipping and warehousing company but only they have granted the MAH License from MFDS.
Let’s take a look at how the Cosmetic Act defines the responsibility of the role of MAH:
(Article 11 of the Regulation)
- Marketing Authorization Holder shall comply with the Quality Control Standards
- Marketing Authorization Holder shall comply with the Good Safety Practice Standards
- Marketing Authorization Holder shall keep the product master file and quality control standards submitted by manufacturers.
- Marketing Authorization Holder shall prepare and keep import control records on imported cosmetics.
- Sales after quality control test by batch
- Import permission by KPTA through the electronic document interchange (EDI) method for customs clearance.
- New data and information obtained in regards to the safety and efficacy of products that can affect the public health (including case reports of side effects from using cosmetic products) shall be reported and necessary safety measures are taken.
Registration for General and Functional Cosmetics
Free sales certificate
|Specification of the finished product
Assay and identification method of active ingredients in the product
Other documents are required by MFDS
Ingredients Requirements in the Cosmetics Act
Negative ingredients list for cosmetics are provided as follows:
- Forbidden ingredients
- The restricted usage ingredients list of Sterilization & Preservative, UV filters, and Other functional ingredients.
Marketing Authorization Holders should annually report the ingredient list used in cosmetics to MFDS and MFDS develops Database on the ingredient list.
Labeling Requirements in the Cosmetics Act
Korean labeling with volume contents of 10g and less:
- Name of product
- Name of Marketing Authorization Holder and Manufacturer
- Lot No.
- Expiry date or PAO(In case of indicating PAO, mfg. date should be labeled together with PAO)
Korean labeling with volume contents over 10g:
- Name of product
- Name & address of MAH and Manufacturer
- Name of all ingredients (descending order) for exceeding 50ml(g)
- Name of designated ingredients* for exceeding 10ml(g) and 50ml(g) and less
- The volume or weight of contents (It should be ml or g.)
- In case of functional cosmetic, the word of “기능성화장품” (functional cosmetic)
- Cautions in use that is designated by enforcement regulation of cosmetic law
- In the case of functional cosmetic, efficacy, how to use, cautions approved by MFDS
- Bar code
- Call center information and homepage address and phrase(“Exchange or refund if the product has problems”)
Animal testing on cosmetics and ingredients is banned in South Korea in 2017 under the law of the Cosmetics Act.