Regulatory context
Korean regulations for cosmetics are specified in the Cosmetic Enforcement Rules and the Cosmetic Act.
In order to sell cosmetic products, a notification by the Market Authorization Holder (MAH), the importer of the product, to the Korean Pharmaceuticals Traders Association (KPTA) is mandatory. Submission to or registration with the Ministry of Food and Drug Safety (MFDS) for functional cosmetics is also performed by the MAH.
Cosmetics, functional cosmetics and quasi-drugs
As per Article 2 of the Cosmetic Act, Cosmetics “designate products to purify, embellish, add attractiveness and illuminate the appearance in order to maintain or improve the skin or hair’s health via application, rubbing, spraying or any other similar action with superficial effects on the human body.”
Functional cosmetics are cosmetic products “that help to:
· whiten the skin
· decrease wrinkles
· protect from UV rays
· change hair color, remove hair or nourish hair
· correct dryness, cracking or peeling skin”
Quasi-drugs are not included in the definition of cosmetics, as designed by article 2, clause 4, of the Pharmaceutical Affairs Act (drugs). These primarily include antiperspirants, toothpastes and oral care products.
How does it work?
The registration process is different depending on whether the product is classified as a cosmetic, a functional cosmetic or a quasi-drug.
BIORIUS can assist with the registration of cosmetics and functional cosmetics.
For functional cosmetics, preparation of the dossier includes adding documentation for submission or registration to the MFDS (Ministry of Food and Drug Safety). The dossier must be approved before marketing a product and prior to registration.
Formula Review
Toxicological and regulatory assessment of ingredients and impurities.
The first step is to determine the product category (regular or functional).
Upon conclusion of this analysis, a formula review report is issued, which includes a conclusion from the expert who carried out the tests (categorization of the product, toxicological analysis & ingredients review).
The Korean ingredients list and INCI list as well as warnings and precautions for use are also provided upon conclusion of this first step.
Dossier Preparation
For regular cosmetics:
- Required documents for the notification
- Required documents for the cosmetics file (to be provided in case of inspection)
- Useful documents to determine whether or not the product passes safety standards and prove compliance with guidelines
- Required information for the label review
For functional cosmetics, the same documents are evaluated as well as the required documents to submit to or register the product with the MFDS (Ministry of Food and Drug Safety).
Label & Claims Review
Evaluation of product labels (ingredients list, symbols, legal requirements, etc.) and claims substantiation.
Strategic recommendations are provided for updating the label. A table indicating the following elements is provided upon completion of the evaluation:
- Required elements
- Presence of required elements (primary packaging, secondary packaging & leaflet)
- Claims
- Conclusions on each claim
- Comments from the experts – strategic recommendations provided for updating the label
Lastly, the final ingredients list in Korean and the INCI list is provided.
