Request a Demo
Korea defines functional cosmetics as products that aid in brightening skin, improving wrinkles in skin, tanning skin gently or protecting skin from sun's ultraviolet radiation. Functional cosmetics are subject to more stringent evaluation than general cosmetics. Based on the definition three kinds of products are confirmed as functional cosmetics: anti-aging products, whitening products and sunscreens.
All these three kinds of products are subject to the supervision of Korea Ministry of Food and Drug Safety. The manufacture and import shall strictly comply with related regulations.
Obligations
To conduct cosmetic business in Korea, 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". Enterprise must first successfully attain these qualifications before they can register their products with the MFDS. After obtaining the approval from MFDS, the enterprise can proceed with manufacture or import.
Registration dossiers
With respect to registration application, companies shall prepare and submit the following documents for approval.
Products specification
PH test results with 3 batch no.
Efficacy data (SPF for sunscreens)
Assay and identification method of active ingredients contained by the product
Product sample (5 pieces)
Formula
Bovine spongiform encephalopathy
Free Sale Certification
Fragrance specification if have
Ingredients
MFDS released a positive ingredient list for functional cosmetics (click here to see the list). Enterprise using ingredients falling within the scope of this positive list are exempt from submission of clinical and efficacy reports. Otherwise, clinical data, efficacy data and assay and identification methods are required, which prolongs the time for enterprises to obtain the approval.
If an approved ingredient is used (e.g. anti-wrinkle & whitening), it takes about 7 days to obtain the approval. However, for unapproved ingredients, 4~6 months is necessary.
Testing
Enterprises shall have their products tested in an appointed testing institution in Korea. Products need to be tested by each batch number and about 5 pieces are needed for each product testing. The required testing items are based on each specific product.
Labeling
Labeling Requirement | Product Name | Label manufacturer name | MAH name | Lot No. | Expiry Date (or PAO+ MFG Date) | Price | Label manufacturer & MAH Address | Centent, Weight | Caution for use | Full ingredient list | Function, Efficacy & Effects | Function Usage & Contents | *Function *Word | Country of origin | Manufacturer & Address | |
Sample/Tester (primary or secondary) | o | X | o | X | X | Sample | X | X | X | X | X | X | X | X | X | |
10g or less (primary or secondary) | o | X | o | X | X | o | X | X | X | X | X | X | X | X | X | |
10g-50g | Primary package | o | o | o | o | o | X | X | X | X | X | X | X | X | X | X |
Secondary package 1) | o | o | o | o | o | o | o | o | o | 2) | 3)o | 3)o | 3)o | o | o | |
Above 50g | Primary package | o | o | o | o | o | X | X | X | X | X | X | X | X | X | X |
Secondary package 1) | o | o | o | o | o | o | o | o | o | o | o | o | o | o | o | |
Note: 1) Addition of "Fair Trade Commission Notice", "Customer Service Phone Number", "Bar Code" and "Recycling Mark". | ||||||||||||||||
Claims
The claim of functional cosmetics is based on the active ingredient contained and can only be marked after getting an approval. Claiming "anti-aging, anti-wrinkle (fine-line, etic.)", "whitening", "SPF, PA and sun protection" without an approval of functional cosmetics is prohibited. But if using "brightening or lightening" enterprises do not need the approval.
We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
