Functional Cosmetics Review and Reporting

Common situations

Pick the question closest to your case: each one gives the conclusion first, then what changes it, the documents involved and the expected timeline.

1. A buyer is asking for our functional cosmetics certificate in Korea. What document should we provide?

   Short answer The Cosmetics Act has no functional cosmetics "certification" scheme. If the product was reviewed, the evidence is the functional cosmetics review or amended review result notice; if it was reported, it is the entry in the report register. Give the buyer the result notice or report record for that product.

   • The product was reviewed Provide the review or amended review result notice issued by the President of the National Institute of Food and Drug Safety Evaluation.
   • The product is subject to a report Provide the report record showing the report number and report date.
   • The product has not yet been reviewed or reported Complete the product's review or report before making any functional claim.

   Documents

   Functional cosmetics review or amended review result notice, or report record

   Timeline

   Review request 60 days / reports are entered in the register after the requirements are confirmed

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2. Does a whitening cream made with the published ingredients and concentrations still need a functional cosmetics review in Korea?

   Short answer If the type and content of the active ingredient, the efficacy claims, the dosage and administration, and the specifications and test methods are all the same as an item published by the Minister of Food and Drug Safety (식품의약품안전처장), you submit a report instead of a review. If any of them differs, the product is subject to review.

   • All four items match the published item Submit the report for items excluded from review to the President of the National Institute of Food and Drug Safety Evaluation.
   • The content, dosage and administration or another item differs from the published item Obtain a review by submitting the review request with safety and efficacy data and other materials.

   Documents

   Report for items excluded from review or review request; formulation data; specifications and test methods data

   Timeline

   Review 60 days / reports are entered in the register after the requirements are confirmed

3. To launch a sunscreen as a functional cosmetic in Korea, do we need SPF and PA test data?

   Short answer A UV protection product undergoing review must submit evidence for setting its SPF and UVA protection grade (PA). However, products with published ingredients and concentrations may omit this data, and a product identical in all respects to an already reviewed item is handled by report.

   • You seek review for a new formulation Submit the review request including the evidence for setting the SPF and UVA protection grade.
   • Raw materials, content, specifications, dosage and formulation are the same as an already reviewed item If the measured SPF is within minus 20 percent, it is treated as the same efficacy and you submit a report.

   Documents

   Review request or report; evidence for setting the SPF and UVA protection grade; specifications and test methods data

   Timeline

   Review 60 days / in practice, time to prepare test data comes first

4. Can an anti-hair-loss shampoo ever be sold as a functional cosmetic in Korea by report rather than review?

   Short answer For a hair-loss relief functional cosmetic to be subject to a report on the ground that it is identical to an already reviewed item, the existing item must have had its efficacy proven by a comparative test against a control group. Otherwise it is subject to review.

   • Ingredients, content and other items all match a published item Handle it as a report of a published item.
   • The product makes hair look thicker physically, for example by coating It is excluded from the hair-loss relief functional cosmetics category, so it cannot be claimed as functional.

   Documents

   Review request or report; efficacy data (efficacy tests and human application tests); specifications and test methods data

   Timeline

   Review 60 days

5. How long should we allow for a functional cosmetics review in Korea to meet our launch schedule?

   Short answer The processing period for a review request is 60 days. Time to produce safety and efficacy test data and to respond to supplement requests is separate, so build that margin into the launch schedule.

   • The product is subject to a report It is entered in the report register after the requirements are confirmed, without review, so the preparation burden is lighter than for a review.
   • The product is subject to review Plan the schedule as test data preparation → review request → 60-day review → result notice.

   Documents

   Review request; data on origin and development history, safety, efficacy, and specifications and test methods

   Timeline

   Statutory: review 60 days / in practice, test data preparation and supplement time are added

6. We are concerned about functional cosmetics review costs. Are there cases where a report is enough?

   Short answer A report is submitted instead of a review for functional cosmetics identical to a published item, items identical in all respects to an already reviewed item, and items combining reviewed UV protection ingredients with published whitening or anti-wrinkle ingredients. Even for products under review, items with published ingredients and concentrations may omit the origin, safety, efficacy and UV protection evidence data.

   • The product falls under one of the three report cases Submit the report for items excluded from review.
   • The item's specifications and test methods are published You may omit the specifications and test methods data.

   Documents

   Report for items excluded from review or review request; the required data that cannot be waived

   Timeline

   Review 60 days / reports are entered in the register after the requirements are confirmed

7. If I hire an administrative agent for a functional cosmetics review in Korea, what will they handle?

   Short answer With your written authorization, an administrative agent checks whether the product falls within the functional categories and whether it needs review or a report, organizes the list of required data, prepares the review request or report, files it with the National Institute of Food and Drug Safety Evaluation and responds to supplements. The agent does not design or conduct toxicity, efficacy or human application tests, interpret results, set specifications and test methods, or design efficacy claims.

   • Test data is already available The agent organizes the data to meet form requirements and submits it with the review request.
   • No test data is available Have a testing laboratory carry out the tests first, then prepare the submission documents from the results.

   Documents

   Letter of authorization; cosmetics responsible distributor or manufacturer registration details; formulation data; test reports

   Timeline

   Review 60 days / the outcome is decided by the National Institute of Food and Drug Safety Evaluation

8. If we import a functional product already sold overseas, does it need a new review in Korea?

   Short answer To sell a product as a functional cosmetic in Korea, each product must be reviewed by the President of the National Institute of Food and Drug Safety Evaluation or covered by a report. Imported products follow the same standards, and cosmetics responsible distributor registration is needed first for distribution in Korea.

   • Ingredients, content and other items match a Korean published item Handle it by submitting a report.
   • The formulation differs from the Korean published items Organize the overseas test data to meet Korean submission requirements and obtain a review.

   Documents

   Review request or report; data on origin and development history, safety and efficacy; specifications and test methods data (including samples)

   Timeline

   Review 60 days / in practice, time to organize overseas data is added

9. How do we apply for a dual-function product claiming both whitening and UV protection in Korea?

   Short answer An item that combines the ingredients and content of an already reviewed UV protection functional cosmetic with published whitening or anti-wrinkle ingredients and content, and in which raw materials, efficacy, specifications, dosage and formulation are all the same, is subject to a report. Other combinations require review.

   • You add published whitening or anti-wrinkle ingredients to a reviewed UV protection formulation Confirm that all items match and submit a report.
   • You use a new ingredient or new content Prepare data for each function and submit a review request.

   Documents

   Report or review request; existing review result notice (UV protection item); formulation data

   Timeline

   Review 60 days / reports are entered in the register after the requirements are confirmed

10. If we change the formulation or directions of a reviewed functional cosmetic, do we need another review?

    Short answer To change reviewed items, submit an amended review request for functional cosmetics to the President of the National Institute of Food and Drug Safety Evaluation, attaching the earlier review result notice and documents proving the reason for the change. For a reported item, submit the report again.

    • You change the content of a reviewed item Submit an amended review request.
    • You change the content of a reported item Submit the report again with the changed content.

    Documents

    Amended review request for functional cosmetics; existing review result notice; proof of the reason for the change

    Timeline

    In practice, it depends on the scope of the change and any supplements

11. What documents do we need to transfer the rights to a reviewed functional cosmetic to another company?

    Short answer When the reviewed party changes through a transfer of rights, you also submit an amended review request, attaching the transfer agreement as proof of the reason for the change.

    • The acquiring company holds cosmetics responsible distributor registration Submit the amended review request with the existing result notice and the transfer agreement.
    • The acquiring company does not yet hold responsible distributor registration To sell the product, it must obtain responsible distributor registration first.

    Documents

    Amended review request for functional cosmetics; existing review result notice; transfer agreement

    Timeline

    In practice, it depends on any supplements

12. How should we respond to a supplement request in a functional cosmetics review in Korea?

    Short answer First identify which standard the request concerns (the justification of raw materials and quantities, the fit of the efficacy claims to the category, or the clarity of dosage and administration), then revise and resubmit the matching data.

    • Form entries or the list of submitted data are incomplete Organize the missing documents and entries and submit a supplement.
    • The test data itself is insufficient Have a testing laboratory run additional tests and submit the results as supplementary data.
    • The dosage and administration wording was flagged as unclear Revise it into clear wording that leaves no room for misuse and resubmit.

    Documents

    Supplement request; revised submission data; additional test data (where applicable)

    Timeline

    Review 60 days / the overall schedule extends by the time the supplement takes