Functional cosmetics in Korea — 60 days of review, or one form
Which file do you submit to put a whitening claim on a Korean label? The functional cosmetics route splits in two, and review carries a 60-day processing period and a fee from KRW 189,000. Which side you land on is decided by notified ingredients and dosage form.
Korea's functional cosmetics system runs on two tracks. Review takes a 60-day processing period at the Ministry's evaluation institute, costs KRW 189,000 online or KRW 210,000 by post, and carries five categories of safety and efficacy data. Use a notified ingredient at its notified level and a single form replaces all of it.
The same whitening cream splits in two on paper
Putting a whitening or anti-wrinkle claim on a Korean label means going through the functional cosmetics system. Treating that as a single procedure is where schedules go wrong. Review at the Ministry's evaluation institute sits on one side; reporting, discharged with a single form, sits on the other.
The gap is wide. Review carries a stated processing period of 60 days and a fee of KRW 189,000 for online filing or KRW 210,000 by visit or post. Reporting means filing the Report on Items Exempt from Functional Cosmetics Review (Form 10 of the Cosmetics Act Enforcement Rule), with no safety or efficacy dossier attached at all. Identical ingredients and identical claim wording can still mean two months on one track and one sheet of paper on the other.
That sets the question to put back to an OEM that answers "yes, we can do functional." Which track — and if it is review, who starts the 60 days and when?
Reporting opens in exactly three cases
The legal basis differs first. Review follows Article 4 of the Cosmetics Act with Article 9 of the Enforcement Rule; reporting follows the same Article 4 with Article 10. Article 10 leaves open three cases and no more.
| Track | Condition | Form |
|---|---|---|
| Report, type 1 | Main ingredient, claim, directions and standards match an MFDS-notified ingredient and level | Form 10 |
| Report, type 2 | Efficacy, ingredient types and levels, standards, directions and dosage form all match a reviewed item | Form 10 |
| Report, type 3 | A reviewed sunscreen item combined with a notified whitening or anti-wrinkle item | Form 10 |
| Review | Everything that fits none of the three | Form 7 plus five data categories |
Reading the table backwards is faster. Fit one of the three cases exactly and you report; miss a single element and you file for review. Because the requirement is that everything match, raising a level by 0.1% breaks a type-2 report, and the 60 days enter the schedule at that moment.
Once on the review track, data attaches in five categories: origin and development history; safety data (six studies — single-dose toxicity, primary skin irritation, mucous membrane irritation, skin sensitization, phototoxicity and photosensitization, and a human patch test); efficacy data (an efficacy study plus a human application study); the basis for the SPF and PA rating on sunscreens; and standards and test methods. A sample goes in with the file.
Thirteen notified ingredients set the capacity of type-1 reporting
The route into type-1 reporting is defined by a list. Whitening holds nine ingredients, anti-wrinkle four, and the permitted levels are fixed with them.
| Function | Notified ingredients and levels |
|---|---|
| Whitening (9) | Niacinamide 2–5% · Arbutin 2–5% · Ethyl ascorbyl ether 1–2% · Broussonetia extract 2% · Ascorbyl glucoside 2% · Ascorbyl tetraisopalmitate 2% · Magnesium ascorbyl phosphate 3% · Alpha-bisabolol 0.5% · Oil-soluble licorice extract 0.05% |
| Anti-wrinkle (4) | Retinol 2,500 IU/g · Retinyl palmitate · Adenosine 0.04% · Polyethoxylated retinamide 0.05–0.2% |
This is where product planning pulls against paperwork. The peptide complexes, fermentation filtrates and proprietary botanical extracts buyers ask about first are not among those thirteen. Differentiating on a new active and launching quickly are hard to hold at the same time.
Read the other way, the list hands you a strategy. Carry the claim on a notified ingredient so the filing goes through reporting, and place the marketing hero somewhere other than the functional main ingredient. Korean brands that get a new item on shelf inside two months are usually built this way.
One level, one form, and the track changes
Niacinamide at 2% gives you a type-1 report. Drop the same ingredient to 1.5% and it falls below the notified band, which makes the whitening claim itself difficult; push it to 6% and it falls above, which sends the item to review. The notified figure is a band, not a floor.
Dosage form carries the same weight. Type-2 reporting requires the form to match, so moving a reviewed cream into an ampoule or a pad ends that eligibility. If a quotation does not separate "same formula, different fill size" from "same formula, different form," the 60 days come back after sample approval.
The scope of functional claims is worth checking too. Article 2 of the Enforcement Rule sets 11 categories, among them whitening, anti-wrinkle, UV protection, hair dyeing, depilation, relief of hair-loss symptoms, relief of acne-prone skin, skin barrier recovery and reduction of stretch mark redness. A claim outside that list cannot be taken through the functional route at all, so it has to be caught at the copywriting stage.
December 2025 added one dosage form
An amendment to the Regulation on Review of Functional Cosmetics dated 16 December 2025 added solid dosage forms to those exempt from data submission for whitening, anti-wrinkle and acne-prone skin products. Items planned as sticks or bars gained a lighter route than they had before.
The same amendment reworked hair dye safety standards. Twelve hair dye ingredients came off the prohibited list, and the limit on 2,4-diaminophenol hydrochloride in oxidative hair dyes dropped from 0.5% to 0.02%. Anyone looking at hair color items should re-check existing formulas against that figure.
A growing list of exempt forms means the reporting door widens over time. It widens more slowly than product planning moves, though. For a new form, checking the current annex of the amended regulation beats assuming.
In short
- Functional cosmetics in Korea run on two tracks. Review means a 60-day processing period and a fee of KRW 189,000 online or KRW 210,000 by post.
- Reporting opens only in the three cases under Article 10: matching a notified ingredient, matching a reviewed item in full, or combining the two as specified.
- Type-1 reporting is capped by nine whitening and four anti-wrinkle ingredients. Step outside the level band and the item goes to review.
- Dosage form is a matching requirement. A reviewed cream moved into an ampoule breaks the report, so separate the two cases in the quotation.
- The 16 December 2025 amendment added solid forms to the data-exempt list for whitening, anti-wrinkle and acne-prone skin products.
See which ingredients are moving right now in today's ingredient signal, and work through category price bands and cost structure in the product planner.
*Sources: Government24 service guide, Functional Cosmetics Review Application (accessed 25 October 2026 — processing period 60 days, fee KRW 189,000 online and KRW 210,000 by visit or post, five document categories, handled by the Ministry's National Institute of Food and Drug Safety Evaluation) / Korea Easy Law, Functional Cosmetics Review and Report Submission (Cosmetics Act Article 4, Enforcement Rule Articles 9 and 10, Forms 7 and 10) / MFDS, partial amendment to the Regulation on Review of Functional Cosmetics (16 December 2025 — solid dosage form added, 12 hair dye ingredients removed from the prohibited list, 2,4-diaminophenol hydrochloride 0.5% to 0.02%) / Medivibe, Functional Cosmetics Review Documents and Timeline (six safety studies, two efficacy studies, 60-day period) / Cheonghyo Administrative Agency, Functional Cosmetics Review and Reporting (report types 1, 2 and 3; 11 functional categories under Article 2) / Dr Oracle Ingredient Research, Nine Whitening and Four Anti-wrinkle Notified Ingredients (ingredients and levels)*
What this means for your Korean private label product
Rules like this (functional cosmetics) land on the brand owner, but most of the evidence comes from the manufacturer. As a Korean private label (OEM/ODM) partner we prepare the formula data, test reports and label review your filing needs.
Korean cosmetics private label — cost, MOQ and timeline →
Start a sample request · Browse ready formulations
Questions people ask
Review means submitting safety and efficacy data per item and waiting 60 days. Reporting applies when the product matches a notified ingredient, or matches an already-reviewed item exactly, and it is discharged with one form — Form 10 of the Enforcement Rule — with no test dossier attached.
The stated processing period is 60 days, with a fee of KRW 189,000 for online filing and KRW 210,000 by visit or post. Any request for supplementary data runs on its own clock, so plan for longer than 60 days.
Nine for whitening and four for anti-wrinkle. Levels are fixed as well — niacinamide 2–5%, arbutin 2–5%, adenosine 0.04% — and stepping outside the band moves the product from reporting to review.
Second-type reporting requires efficacy, ingredient types and levels, standards, directions and the dosage form all to match. Changing a cream into an ampoule breaks the form match, so reporting no longer applies.
An amendment dated 16 December 2025 added solid dosage forms to the list of forms exempt from data submission for whitening, anti-wrinkle and acne-prone skin products. Sticks and bars now carry a lighter paperwork load than before.