Cosmetics Registration in South Korea

Regulatory Authority:

National Institute of Food and Drug Safety Evaluation (NIFDS), Cosmetics Evaluation Division

Cosmetic Regulation:

Cosmetic Act

Regulatory Authorities Website :

Welcome to the Ministry of Food and Drug Safety | Minisry of Food and Drug Safety (

Who Must Register:

Responsible Seller who intends to manufacture or sell functional cosmetics by manufacturing or importing them shall undergo an evaluation by the Minister of the Ministry of Food and Drug Safety (MFDS) or shall submit a report to the Minister of the MFDS for safety and effectiveness of each product pursuant to Article 4 of the Cosmetics Act (Examination, etc. of Functional Cosmetics). The same shall apply to any revision to the previously evaluated matters.

Dossier Requirement:

To get first approval from MFDS for functional cosmetics, relevant dossiers required includes:

  • Clinical report for efficacy of the finished product (in case of SPF product, it is SPF clinical report ) => It should be in the format required by MFDS to meet MFDS efficacy report requirement
  • Assay and identification test of active ingredient in the finished product
  • Product specification
  • Formula / BSE / FSC (Free sale certification)
  • Fragrance Spec (if the fragrance ingredient is in the formula)
  • pH test result => 3 batch with 3 pieces
  • Actual product


Those who intend to manufacture or import functional cosmetics are required to have them approved by the MFDS through evaluation 

In case of import, the marketing responsible person shall be registered, and must submit an “Entry Notice of Imported Products Report” before every customs clearance