How to Obtain Functional Cosmetics Review or File a Report — Review Documents for Whitening, Anti-Wrinkle, and Sunscreen Products and the 60-Day Processing Period

Procedure

1. 1. Confirm whether the product is a functional cosmetic and its function type

   Article 2 of the Enforcement Rule designates 11 types as functional cosmetics: whitening (2 types), wrinkle relief or improvement, tanning the skin evenly, UV protection, changing hair color, hair removal, relief of hair loss symptoms, relief of acne-prone skin (body cleansing products only), restoring skin barrier function, and lightening red stretch-mark lines. Products that change hair color only temporarily, remove hair physically, or make hair look thicker by coating are excluded. First determine which type the efficacy claims planned for the container and advertising fall under.

2. 2. Determine whether the product requires review or a report

   If the type and content of the active ingredient, the efficacy, the directions and dosage, and the standards and test methods are the same as an item announced by the Ministry of Food and Drug Safety, the product is subject to a report. A report can also be used where the product is the same in raw materials and content, efficacy, standards and test methods, directions and dosage, and formulation as an item already reviewed for the same responsible seller or the same manufacturer (where it manufactured by designing, developing, and producing the product). If these conditions are not met, the product must be reviewed.

3. 3. Prepare review data and obtain test data

   A review requires data on origin and development history, safety (single-dose toxicity, primary skin irritation, eye mucosa irritation, skin sensitization, phototoxicity and photosensitization, and human patch tests), efficacy (efficacy tests and human application tests), and standards and test methods, together with samples. The tests are conducted by a testing institution, and the result data are attached. For items whose active ingredient and content are announced, the data from origin through the UV protection basis may be omitted, and for items whose standards and test methods are announced, those data may be omitted.

4. 4. Prepare and submit the review request or report

   A review is requested with the Functional Cosmetics Review Request (Form No. 7), and a report is filed with the Report on Functional Cosmetic Items Exempt from Review (Form No. 10), both submitted to the President of the National Institute of Food and Drug Safety Evaluation. The review request fee is 189,000 won for electronic filing and 210,000 won for in-person or postal filing, while the report has no attachments and no fee. The processing period on the review request form is 60 days.

5. 5. Receive the result notice and manage change reviews

   When the review is complete, a Functional Cosmetics Review and Change Review Result Notice (Form No. 9) is issued, and for a report, a report number is entered in the report register. To change reviewed matters or to transfer the rights, a Functional Cosmetics Change Review Request (Form No. 8) must be submitted; the processing period is 60 days for changes to test methods, efficacy, or standards and 15 days for other changes.

Required documents

• Functional Cosmetics Review Request (Enforcement Rule of the Cosmetics Act, Form No. 7) or Report on Functional Cosmetic Items Exempt from Review (same Enforcement Rule, Form No. 10)
• Data on origin and development history (for a review)
• Safety data: single-dose toxicity, primary skin irritation, eye mucosa irritation, skin sensitization, phototoxicity and photosensitization, and human patch test data (test results from a testing institution attached)
• Efficacy or function data: efficacy test and human application test data (test results from a testing institution attached)
• Basis data for setting the sun protection factor and UVA protection grade (for UV protection products)
• Data on standards and test methods, with samples
• For a change review: Functional Cosmetics Change Review Request (same Enforcement Rule, Form No. 8), the result notice previously received, and documents proving the reason for the change (a transfer agreement in the case of a transfer)
• Letter of authorization (where an administrative agent submits on your behalf)

Fees

Generally in the range of several hundred thousand won in the industry · We provide a quote after consultation based on whether a review or report applies, the number of items, and the volume of test data to organize. Government fees (review request 189,000 to 210,000 won) and testing institution fees are separate.

See fees and official charges for this service →

Legal basis and review date

• Cosmetics Act, Article 4
• Cosmetics Act, Article 15
• Cosmetics Act, Article 36
• Enforcement Rule of the Cosmetics Act, Article 2
• Enforcement Rule of the Cosmetics Act, Article 9
• Enforcement Rule of the Cosmetics Act, Article 10
• Enforcement Rule of the Cosmetics Act, Article 32
• Enforcement Rule of the Cosmetics Act, Annex 9
• Enforcement Rule of the Cosmetics Act, Form No. 7
• Enforcement Rule of the Cosmetics Act, Form No. 8
• Enforcement Rule of the Cosmetics Act, Form No. 10

Checked against the statutes on 2026-10-15

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

• Selling or displaying a product bearing functional claims before receiving the review result notice or report number violates Article 15 of the Cosmetics Act, so schedule container and advertising production after the result is received.
• In determining report eligibility, a sun protection factor whose measured value is within minus 20 percent is treated as the same efficacy, but depending on the type only solutions, lotions, and creams are treated as the same formulation, so recheck the report conditions whenever the formula changes.

Frequently asked questions