Functional Cosmetics Review and Reporting
Functional cosmetics are not certified — they are either reviewed by the President of the National Institute of Food and Drug Safety Evaluation or covered by a report. The Cosmetics Act Enforcement Rule Art. 2 lists eleven functional categories; review takes 60 days and costs KRW 189,000.
How We Handle It
Scope Check
Confirm the product falls within the functional categories of Enforcement Rule Art. 2. Claims outside that list may be neither reviewed nor advertised.
Route Decision
Determine whether the item qualifies for reporting, because it matches a published item or an already reviewed one, or requires full review (Enforcement Rule Art. 10(1)).
Data Preparation
Compile origin and development history, safety data, efficacy or function data, UV protection factor evidence, and specifications and test methods. Published items may omit some of these.
Filing
Submit the Form 7 review request or the Form 10 report for items excluded from review to the President of the NIFDS.
Review
The NIFDS reviews the justification of raw materials and quantities, the appropriateness of claimed efficacy, and the clarity of dosage and administration (Enforcement Rule Art. 9(4)). The processing period is 60 days.
Result
A review produces a Form 9 result notice; a report is entered in the functional cosmetics report register once the requirements are confirmed.
Changes
Any change to reviewed particulars or to a submitted report requires a further review or a fresh report (Act Art. 4(1), second sentence).
Frequently Asked Questions
Q. Is there a functional cosmetics certification?
A. No. The Cosmetics Act has no certification scheme for functional cosmetics. Article 4(1) requires anyone seeking recognition of a product as a functional cosmetic to undergo a safety and efficacy review by the Minister of Food and Drug Safety, or to submit a report, for each item. In practice the President of the NIFDS carries out this work (Enforcement Rule Arts. 9 and 10). The correct term is review or report, not certification.
Q. How many functional categories are there?
A. Article 2(2) of the Cosmetics Act sets five heads, and Enforcement Rule Art. 2 specifies eleven categories: two whitening functions (preventing melanin deposition and lightening deposited pigment), wrinkle improvement, tanning, UV protection, hair colour change including bleaching and decolouring, hair removal, hair loss symptom relief, acne-prone skin relief, skin barrier function restoration, and relief of red lines caused by stretch marks.
Q. Review or report — which applies?
A. Enforcement Rule Art. 10(1) lists three cases that require only a report: a product whose active ingredient type and content, efficacy, dosage and administration, and specifications and test methods are the same as an item published by the Minister; a product identical in raw material type, specification and content, efficacy, specifications and test methods, dosage and formulation to an already reviewed item; and a UV protection product whose ingredients match an already reviewed item. Everything else requires review.
Q. Who may apply?
A. Cosmetics manufacturers, cosmetics responsible distributors, and the universities, research institutes and laboratories designated under Arts. 6(1) and 14-2 of the Basic Research Promotion and Technology Development Support Act (Enforcement Rule Art. 9(1)). Actual distribution additionally requires prior registration as a cosmetics responsible distributor.
Q. Where do I file?
A. With the President of the National Institute of Food and Drug Safety Evaluation. Reviews use the Form 7 review request, amended reviews use the Form 8 request, and reports use the Form 10 report for items excluded from review (Enforcement Rule Arts. 9(1), 9(3) and 10(2)).
Q. What are the timeline and fees?
A. Review takes 60 days (Form 7). Fees are KRW 189,000 for a review request (KRW 210,000 if filed in person or by post); KRW 51,000 (57,000) for an amended review changing a raw material test method, efficacy or specifications and test methods; KRW 25,000 (28,000) for other amendments; and KRW 1,800 (2,000) to reissue the result notice (Enforcement Rule Annex 9).