Functional Cosmetics Review and Report

Procedure

Procedure

1. 01

   Confirm the function type: Determine which of the 11 functions in Article 2 of the Enforcement Rule the claims on the container and in advertising correspond to. Temporary hair dyes, physical hair removal products, and products that make hair look thicker by coating are excluded from functional cosmetics.

2. 02

   Classify as review or report: Compare whether the active ingredients and amounts, efficacy, directions and dosage, and specifications and test methods match a notified product, or whether the raw materials, efficacy, specifications, directions, and formulation all match a product already reviewed for the same responsible seller or for the same manufacturer that designed, developed, and produced it. For some types, such as whitening and wrinkle improvement, a report is possible only if the existing product proved efficacy through a comparison with a control group.

3. 03

   Check and organize the submission data: For a review, organize data on origin and development, safety (single-dose toxicity, primary skin irritation, eye mucosa irritation, skin sensitization, phototoxicity and photosensitization, human patch test), efficacy (efficacy test, human application test), and specifications and test methods with samples according to the list. Check whether data may be omitted for products following notified ingredients and amounts or notified specifications and test methods.

4. 04

   Prepare and submit the review request or report: A review uses the Functional Cosmetics Review Request (Form No. 7), and a report uses the Report on Products Exempt from Functional Cosmetics Review (Form No. 10), both submitted to the Director of the National Institute of Food and Drug Safety Evaluation. The report states the name, review number, and result notification date of the already reviewed product, the SPF and similar items, and requires no attachments or fee.

5. 05

   Respond to supplementation requests, receive the result, and manage changes: Reorganize and resubmit data in response to supplementation requests. When the review ends, check the result notice (Form No. 9), or for a report, the report number in the report register. To change reviewed items or transfer the rights, submit a change review request (Form No. 8); the processing period is 60 days for changes to test methods, efficacy, or specifications and 15 days for other changes.

Filing route

Filing route

Deadlines & processing notes

Deadlines & processing notes

Basic documents

Basic documents

Selling or displaying a product with functional claims before receiving the result notice or report number violates Article 15 of the Cosmetics Act, so schedule container and advertising production and the launch after the result is received.