Procedure
Procedure
- Approval Difficulty High
A procedure, such as establishing a corporation, a business plan or a transfer, that takes effect only when the authority reviews and approves it. The authority has wide discretion, so a well-prepared business plan and supporting evidence are important.
- Notification Difficulty Low
You submit the statutory report form and required documents. Once the documents are in order the report is accepted; for some reports the authority checks the contents before accepting it.
We will check the screening/reporting targets and submitted data for functional cosmetics and prepare and submit the relevant application or report. The main examination will be prepared based on the completed test data provided by the manufacturer and testing agency.
Scope & fee
- Report 1 functional cosmetic item exempt from review
- We will prepare and submit a report on items excluded from review by comparing the prescription/reviewed product/notification standards and provided data for 1 functional cosmetic product. Application for main review, new test, clinical trial, translation, and on-site visit are separate.
- Official fee source ↗
- Provision of application and completion test data for functional cosmetics main examination
- We will prepare and submit a review request form, attached index, data table, and 2 pages of expected reasons for exemption by comparing approximately 60 pages of completed data from the manufacturer and testing institution for 1 functional cosmetic product and 1 functional type. Samples and technical data are provided, but actual testing, clinical trials, test method development, new science and technology reports, translation, and on-site visits are separate.
- Official fee source ↗
- 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.
- 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.
- 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.
- 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.
- 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
Confirm the current filing office, jurisdiction, and online availability on the official website.
Official checkDeadlines & processing notes
Deadlines & processing notes
Fees & official charges
Fees & official charges
Included in the basic fee — Initial document review, required-document guidance, basic form preparation, one filing support and responses to up to two supplement requests.
Conditional success fee — For this service, any conditional success fee may be separately agreed within the lawful service scope and stated in a written engagement agreement. No outcome is guaranteed.
Displayed amounts are starting estimates, not statutory or standard rates. The final fee is confirmed after consultation and document review in the engagement agreement. Government fees and actual expenses may change.
Fees & official charges →Basic documents
Basic documents
기능성화장품 심사 제외 품목 보고서(제조,수입)(별지 제10호서식)
기능성화장품 심사의뢰서(제조, 수입)(별지 제7호서식)
기능성화장품 변경심사 의뢰서(별지 제8호서식)
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.
Scope of services
Scope of services
Hwang Yunsang Administrative Agent Office prepares and translates documents for administrative agencies, submits them on your behalf, and guides you through permit, application, and notification procedures. Services that require the principal’s personal appearance, principal’s application, or electronic signature may be limited in delegation.