Cosmetics

Functional Cosmetics

What are Functional Cosmetics?
  • (Basis) Article 2 of the Cosmetics Act (Definitions)
    • A. Products aiding in the whitening of the skin
    • B. Products aiding in improving wrinkles in the skin
    • C. Products aiding in tanning skin gently or protecting skin from ultraviolet rays
Who Should Request the Evaluation of Functional Cosmetics?
  • With regards to the functional cosmetics, a manufacturer-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.

Evaluation of Functional Cosmetics

Flowchart for the Evaluation of Functional Cosmetics
Data to Be Submitted for the Evaluation of Functional Cosmetics
  • Data that verify safety, effectiveness, or function
    • Data concerning the origin and development
    • Data concerning the safety (Provided, That if it is considered to be scientifically valid, part of data may be omitted by attaching specific evidentiary data.)
      • Single dose toxicity test data
      • Primary skin irritation test data
      • Ocular irritation test or other mucous irritation test data
      • Skin sensitization test data
      • Phototoxicity and photo sensitization test data (remitted if absorbance test data that verify that there is no absorption from the ultraviolet rays are submitted)
      • Patch test data on human
      • Accumulated patch test data on human (applicable only when it is deemed that there is likely to be a safety issue such as the formation of blisters, burn, etc. based on the test data on human)
    • Data concerning the effectiveness or function
      • Efficacy test data
      • Test data on human
    • Evidentiary data for setting up the sun protection factor (SPF), waterproof sun protection factor (SPF), and protection factor of UV-A (PA) (applicable only to cosmetics aiding in protecting skin from ultraviolet rays by blocking or scattering the ultraviolet rays)
  • Data concerning the standards and test methods (including specimens)
Relevant Government Department
  • National Institute of Food and Drug Safety Evaluation (NIFDS), Cosmetics Evaluation Division
Deadline and Fees
Deadline and Fees
Types? Fees? No. of days?
Electronic civil petitions? By mail, in-person,
1. Request for evaluation of functional cosmetics 189,000 KRW 210,000 KRW? 60
2. Evaluation of revision to functional cosmetics
A. With regards to the specifications of raw materials, if a revision is made to the test methods, efficacy and effect (excluding the cases in which submission of data that verify effectiveness or function is omitted), or standards and test methods (excluding pH and methanol) 51,000 KRW 57,000 KRW?? 60
B. Revisions other than those in Section A. 25,000 KRW Coronary stent 15
3. Application for reissuance of notice of examination results for functional cosmetics 1,800 KRW 2,000 KRW 7
  • Electronic Civil Petition: Applications may be submitted through the 'Electronic Civil Petition Window for Cosmetics (http://ezcos.mfds.go.kr) > Report Board > Guidelines and Applications for Electronic Civil Petition > Guidelines and Applications for the Evaluation of Functional Cosmetics.'

Report of Products Excluded from the Evaluation of Functional Cosmetics

Flowchart for the Evaluation of Functional Cosmetics
※ Report may be printed at the steps of Completion of Application and Completion of Processing (= Verification of Requirements)
  • Apply: Applications may be submitted through the 'Electronic Civil Petition Window for Cosmetics (http://ezcos.mfds.go.kr) > Report Board > Report on Functional Cosmetics.’
Relevant Government Department
  • National Institute of Food and Drug Safety Evaluation (NIFDS), Cosmetics Evaluation Division
Deadline and Fees
  • No fees are required for report on functional cosmetics
  • Reports are usually processed on the same day. However, if there are supplementations, or the application is submitted after office hours, there may be a delay.