011-MFDS: Cosmetics

“All information in this page are from official MFDS website.”

 

  • [Functional Cosmetics]
  1. What are Functional Cosmetics?

(Basis) Article 2 of the Cosmetics Act (Definitions)

  • Products aiding in the whitening of the skin.
  • Products aiding in improving wrinkles in the skin.
  • Products aiding in tanning skin gently or protecting skin from ultraviolet rays.
  1. What are 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]

  1. Flowchart for the Evaluation of Functional Cosmetics

2.Data to Be Submitted for the Evaluation of Functional Cosmetics

1) Data that verify safety, effectiveness, or function

  • Data concerning the origin and development
  • Data concerning the safety (Provided, that if it is 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 D. 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)

3.Relevant Government Department

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

4.Deadline and Fees

ClassRisk Levels

No. of  Devices

 

Electronic

civil

petitions

By Mail, in-person,

etc.

 

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]
  1. What are 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.’

  1. Scope of Report on Functional Cosmetics

(Basis) Article 10 of the Enforcement Rule of the Cosmetics Act (Scope, etc. of Submission of Reports)

  • 1) Functional cosmetics of which the type and content of ingredients that make the efficacy and effect appear, the efficacy and effect, usage directions and dose, and the standards and test methods are the same as those of a product that is announced by the Minister of MFDS (Common name, Report Product No.1)
  • 2) Products of which all the following matters are the same as those of functional cosmetics that have already received an evaluation [applicable only to the functional cosmetics of the same manufacturer-seller or the same manufacturer (applicable only when products are manufactured by means of a design, development, and production by the manufacturer)]. However, for functional cosmetics defined in subparagraphs 1 through 3 of Article 2 (= whitening and wrinkle-improvement), it is only applicable if the efficacy has been proved through a comparative experiment against a control group (referring to those from which the ingredients that result in efficacy and effects have been removed) that have already received an evaluation (Common name, Report Product No.2):
    • Type, standards, and content (refers to a concentration for liquid forms) of the raw materials that result in the manifestation of efficacy and effects
    • Efficacy and effect (for functional cosmetics that fall under subparagraphs 4 and 5 of Article 2, if the measurements for sun protection factor (SPF) are in the range no greater than –20%, they shall be considered as the same efficacy and effect.)
    • Standards (excluding standards concerning the pH) and test methods
    • Usage directions and dose
    • Formulation [for functional cosmetics that fall under subparagraphs 1 through 3 of Article 2 (= whitening and wrinkle-improvement), liquid and lotion forms shall be considered as the same formulation.]
  1. Relevant Government Department

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

  1. 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.

 Quasi-Drugs



Manufacturing, importing, and product notification and approval process