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South Korean most important legal foundation for regulation and administration of cosmetics is the “Cosmetic Act”. Numerous other regulations and standards expand upon this to provide a comprehensive framework to manage cosmetics in South Korea. These regulations are enacted and executed by Ministry of Food and Drug Safety (MFDS), South Korean competent authority which also deals with cosmetic registration issues.
Pursuant to “Cosmetic Act”, cosmetics in South Korea are divided into two categories: general cosmetics and functional cosmetics. General cosmetics are permitted to be manufactured/imported without registration but are subject to post-market supervision. Functional cosmetics are subject to a complex evaluation and approval procedure by MFDS before marketing. Currently there are 9 types of functional cosmetics.
Before conducting any commercial operations related to cosmetic products, an enterprise should register for the type of cosmetic business. According to “Cosmetic Act”, an enterprise intending to manufacture cosmetics shall be registered as a “manufacturer" while an enterprise that intends to import cosmetics shall be registered as a “Marketing authorization holder (MAH)".
Part 1 Regulatory Framework and Competent Authority
1 Existing Main Cosmetic Regulations in South Korea
2 Competent Authority of Cosmetics
Ministry of Food and Drug Safety (MFDS) is South Korea competent authority, which is responsible for formulating cosmetic regulations and registering functional cosmetics
South Korea Pharmaceutical Traders Association (KPTA) is responsible for issuing importing cosmetic approval and supervising cosmetic trading.
Part 2 Cosmetic Products
Cosmetics in South Korea are defined as products which are rubbed or sprayed on the human body in order to clean, beautify the appearance, change, brighten, maintain or promote the health of skin and hair.
In South Korea, cosmetics are divided into two categories: General cosmetics and Functional cosmetics.
For general cosmetics, manufacturers or importers are permitted to manufacturer/import and market without registration/filing but are subject to post-market supervision. If a product contains nanomaterial, you must verify the safety of the product, and the concentration of nanomaterials used must be labeled.
For functional cosmetics, you have to complete a complex registration procedure with MFDS to get an approval letter before manufacturing or importing. In addition, to import functional cosmetics, enterprises should get one more approval from KPTA after registration with MFDS.
3 Manufacturer/importer Registration
Before applying for approval to sell functional cosmetics, enterprises should first register as a cosmetic business. According to “Cosmetic Act”, an enterprise intending to manufacture cosmetics shall be registered as a “manufacturer" while an enterprise that intends to import cosmetics shall be registered as a “Marketing authorization holder (MAH)".
If you want to get an approval from MFDS to conduct activities associated with functional cosmetics, you should register as MAH. MAH is responsible for issues such as product registration, quality, safety, labeling, advertising, QC, claim, custom clearances, etc. MAH has to designate and register an employee as a cosmetic supervisor at MFDS. Qualifications of the cosmetic supervisor include:
Bachelor’s degree in chemistry or biology
Over 2 years of work experience in cosmetics QC field with 4-year college diploma
The cosmetic supervisor is required to attend training held by MFDS.
If a cosmetic importer attaches South Korean label on the package of cosmetic, the importer is required to register as Cosmetic Manufacturer with MFDS. In this case, the cosmetic importer should be both a cosmetic manufacturer & cosmetic importer (MAH).
4 Functional Cosmetics
To manufacture or import functional cosmetic in South Korea it is required that the product undergoes a complex evaluation and approval procedure. Before exploring details, you should understand the definition and scope of functional cosmetics. Functional cosmetics refer to products that aid in functionally improving or changing the condition of skin or hair. Currently, only the following 9 kinds of products are categorized as functional cosmetics:
1. Whitening products
2. Anti-wrinkle products
4. Hair Dyeing, hair-decolorant products, bleach agent
5. Epilating agent
6. Alleviating hair loss agent
7. Acne (pimple) products (Rinse-off products only)
8. Alleviating atopic skin dryness products
9. Cosmetics to help thin red lines caused by stretch marks
In South Korea, there is a regulatory mechanism under which a quasi-drug can be recategorized as a functional cosmetic or general cosmetic. If a manufacturer wants to convert a quasi-drug product to functional cosmetics, it must submit a list of documents to the MFDS, then MFDS will evaluate and decide whether this quasi-drug can be regulated as functional cosmetics. The application documents include:
MAH’s name/product name/manufacturer
Evidence to show whether the product is ODM or OEM
Assay & test methods
Once quasi-drugs are designated as functional cosmetics, they can be manufactured or imported in compliance with functional cosmetics registration requirement.
4.1 Registration procedure
Generally, to sell the products listed above, an evaluation procedure is required: 1. MAH submit required dossiers to MFDS to get an approval letter, 2. Submit MFDS approval letter to KPTA to get import approval, 3. Submit KPTA approval to the custom with B/L, Invoice, P/L, 4. Store products at warehouse temporarily, 5. Test samples and get approval from the lab, 6. Attach South Korean label on the package. Details see the table:
4.2 Dossiers Required
To get first approval from MFDS for functional cosmetics, relevant dossiers required includes:
4.3 Exemption based on the positive list system
If your product uses ingredients that are already approved by MFDS to use in certain functional cosmetic within limitation, it doesn’t require clinical& efficacy data (No.1 documentation of above table). MFDS has listed approved ingredients and their limited concentration for each type of functional cosmetics. For example, for anti-wrinkle products, following 4 ingredients are approved:
Retinyl Palmitate 10000 IU/g
Polyethoxylated Retinamide 005%-0.2%
The concentration should be exactly as above for anti-wrinkle products.
If you manufacturer/import anti-wrinkle products with only these approved ingredients, you don’t have to provide clinical & efficacy data and it will take about 7 days to get approval from. This procedure is called “submission procedure”. Currently, there are 4 approved ingredients for anti-wrinkle products, 9 approved ingredients for whitening products, 27 ingredients for sunscreen products, 45 ingredients for hair dye products,1 ingredient for hair removing products, 1 ingredient for acne products and no allowed ingredient for anti-hair loss product, atopy products and products to help thin red lines caused by stretch marks. For specific approved ingredients for each functional cosmetic, you may reference Webinar given by South Korea cosmetic senior expert Tiger Kim on CL.
If you have to use unapproved ingredients in your formula or your product type doesn’t have approved ingredient, you must submit the clinical data, efficacy data (with identification of active ingredients) when applying for approval from MFDS. This procedure is called “approval process” and will take 4-6 months to get functional approval.
5 Product testing
After getting approval from MFDS and from KPTA (for imported cosmetics), your product has to undergo lab. The requirements for lab testing include:
All the products (salable, sample, tester) must be tested by each batch number;
The test items are different according to each cosmetic category. E.g. cream, the testing items are content, pH, and mercury. (for details you may consult us by sending e-mail to firstname.lastname@example.org);
5 product samples are needed for each product test;
The product should be tested at a testing lab located in South Korea.
6 Claims for functional cosmetics
MFDS has stringent requirements for functional cosmetics claims:
If you get approval as Anti-wrinkle product, you can claim anti-wrinkle, fine lines, etc. But you can’t claim “anti-aging”.
If you get an approval as whitening product, you can claim whitening. But if you can’t get approval as functional whitening product, you have you claim as “brightening or lightening” instead.
If you get approval as a sunscreen product, you can claim SPF, PA and Sun protection. But if you can’t get approval as sunscreen, you should attach overlabel on that claim.
Part 3 Label Requirement
Manufacturers and importers are required to use safe containers and packaging to prevent toxic poisoning of children due to misuse. The information indicated on labels varies based on cosmetic category, dosage etc.
1. Cosmetics with volume contents of 10g and less, should indicate:
Product name/ MAH’s name/ Retail price/ Lot No/ Expiry date
2. Cosmetics with volume contents of between 11g and 50g:
Product name/ Name & address & phone of MAH/ Maximum limit ingredients/ Volume contents/ Barcode/ Country of origin/ Cautions for use/ Lot No/ Expiry date/ Efficacy/ Directions/ “Functional” word in Korean
3. Cosmetics with volume contents of more than 50g:
Product name/ Name & address & phone of MAH/ Maximum limit ingredients/ Volume contents/ Barcode/ Country of origin/ Cautions for use/ Lot No/ Expiry date/ Efficacy/ Directions/ “Functional” word in South Korean/ “Full ingredients” must be included on the label.