Detailing Korean functional cosmetic registration

  •   14 Aug 2017

    Defining a Functional cosmetic in Korea

    Before May 30th 2017 functional cosmetics in Korea only referred to whitening products, anti-wrinkle products and sunscreen products. However, afterwards, MFDS expanded the scope of functional cosmetics and newly designated 5 types of quasi-drug as functional cosmetics.

    Currently, 9 types of cosmetics are defined as functional cosmetics as follows:

    1. Whitening products
    2. Anti-wrinkle products
    3. Sunscreen products
    4. Hair Dyeing, Hair-decolorant products
    5. Products to remove body hair from skin (products that physically remove body hair are excluded)
    6. Hair loss prevention products (coatings and other products that physically make hair appear thicker are excluded)
    7. Acne (pimple) products (Rinse-off products only)
    8. Atopy relieving products
    9. Cosmetics to help thinning red lines caused by stretch marks;

     

    Functional cosmetic registration procedure

    1. General procedure (document required) and time required for registration

    Step

    Contact points

    Things to do

    Time cost

    1

    Exporter/Importer (registered as MAH*)

    Prepare and submit documents as follows to MFDS

    - Formula, BSE, CFS

    - Specification of finished product

    - pH test result with 3 batch no.

    - Efficacy Data, safety data and clinical data

    - Assay and identification method of active ingredients

    - Actual Product

    -

    2

    MFDS**

    Review and issue an approval letter

    3~5 months

    3

    Exporter/Importer (registered as MAH*)

    Submit formula, BSE and CFS to KPTA with approval letter from MFDS

    -

    4

    KPTA***

    Review and issue an approval letter for importing

    About 3 days

    5

    Exporter/Importer (registered as MAH*)

    Submit import approval (by KPTA) to the customs with B/L, Invoice, P/L for custom clearance

    About 1~2 days

    6

    Warehouse

    Storage

    -

    7

    Lab

    Testing by batches before sold on market

    About 15 days

    8

    Warehouse

    Attach Korean label on the package at the warehouse

    About 2 days

    9

    market

    Sell the products to consumer

    -

    *MAH: Market Authorized Holder

    **MFDS: Ministry of Food and Drug Safety

    ***KPTA: Korean Korea Pharmaceutical Traders Association

    1. Documentation requirements