In South Korea, cosmetic products – whether they are cosmetics, functional cosmetics or “quasi-drugs” – are regulated by the “Cosmetic Act” and are subjected to notifications and registrations. EcoMundo will assist you in ensuring the compliance of your products.

 

  REGULATORY SUPPORT, COMPLIANCE PROCEDURES
AND REGISTRATION

  • 1. Preliminary
    study

    Step 1 – Preliminary study

    In Korea, cosmetic products are classified according to three categories:

    • cosmetic ,
    • functional cosmetic
    • “quasi-drug”

    This preliminary study phase determines the classification of your different products depending on their formulas, claims and your position on the market.

  • 2. Registration
    & Notification

    Step 2 – File creation, registration and notification

    1. Compliance of your labels and claims

    EcoMundo experts verify the mandatory statements which must be included on your packaging and accompany you throughout the procedure for ensuring compliance of your claims in accordance with the guidelines published by KFDA.

    2. File creation and safety assessment

    The “Cosmetic Act” in force in Korea distinguishes between the registration and notification procedures depending on the product category:

    3. Registration of cosmetic products

    Le “Cosmetic Act” en vigueur en Corée différencie les procédures d’enregistrement et de notification selon la catégorie de produit :

    • General cosmetic products must be notified to the KPTA (Korean Pharmaceuticals Traders Association).
    • Functional cosmetic products require the submission of a pre-marketing authorisation application.