Cosmetics manufacturing & sales
Preparation of application documents for functional cosmetics review and reports for items exempt from review
To sell a product while claiming a function listed in Article 2 of the Enforcement Rule of the Cosmetics Act, such as whitening, wrinkle improvement, UV protection, hair dyeing or bleaching, relief of hair loss symptoms, or relief of acne-prone skin, the product must be reviewed or reported item by item under Article 4 of the Cosmetics Act. The applicant is a cosmetics manufacturer, a responsible cosmetics seller, or a research institution, and the documents are submitted to the President of the National Institute of Food and Drug Safety Evaluation. If the product is the same in key respects as an item announced by the Ministry of Food and Drug Safety or an item already reviewed, a report on an item exempt from review is filed; other products are reviewed on the basis of a review request with safety and efficacy data attached, and the processing period on the form is 60 days.
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 ↗
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. 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. 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. 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. 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)
기능성화장품 심사 제외 품목 보고서(제조,수입)(별지 제10호서식)
- 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
Government fees (review request 189,000 to 210,000 won) and testing institution fees are separate. Our office fee starts from the amount shown above and may vary depending on whether a review or report applies, the number of items, and the volume of test data to organize; we will give you an exact quote after reviewing your documents.
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
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
Must functional cosmetics always be reviewed?
How long does a functional cosmetics review take?
Must test data be attached when filing a report?
If the OEM manufacturer's formula has already been reviewed, can our brand file a report?
What happens if a product is sold with functional claims without a review?
Does an administrative agent handle functional cosmetics review documents?
Contact us
Hwang Yunsang Administrative Office in Songdo, Incheon prepares and submits administrative documents and explains the procedure. If your situation is similar, send us a message.
📍 2697, 26F POSCO Tower-Songdo, 165 Convensia-daero, Yeonsu-gu, Incheon, Republic of Korea · 📞 010-3374-2687 · 🌐 hwangadmin.com
This guide is general information based on public sources. Requirements, documents and deadlines differ by case and by the competent agency, so please confirm them before you proceed.