What this Korea functional cosmetics launch-cost calculator does
A functional cosmetic in South Korea is not launched solely by finishing a formula and printing a label.
Article 4 of the Cosmetics Act requires a person seeking to market a functional cosmetic to obtain an item-by-item safety and efficacy review or submit a report for an eligible review-exempt item.
A whitening cream that exactly follows a notified standard, an item matching an eligible product previously reviewed for the same responsible seller, and a genuinely new active formula can therefore follow different preparation routes.
The statutory filing fee is only one part of the budget.
Safety, efficacy, human application, SPF or PA, specification and method work, dossier drafting, translation, label changes, sample batches, internal staff time, and launch delay may be materially larger.
This calculator keeps official fees separate from user-entered quotes, then applies item count, shared cost, contingency, a confirmed grant, timeline assumptions, and lost monthly contribution.
Korea-specific scope
This English page preserves Korean law, Korean filing routes, KRW, and the rules effective on April 2, 2026.
It is not a route-classification, claim-approval, testing prescription, or legal opinion tool.
Confirm whether the product is a functional cosmetic, whether Article 10 report eligibility is satisfied, and which evidence is exempt with MFDS or a qualified Korean regulatory adviser before relying on the budget.
The 2026 legal boundary between review and report
Cosmetics Act Article 2(2) covers functions such as whitening, wrinkle improvement, tanning or ultraviolet protection, permanent hair-colour change, non-physical hair removal, relief of hair-loss symptoms, acne-prone skin relief for cleansing products, skin-barrier recovery, and fading red stretch-mark lines.
Enforcement Rule Article 2 expresses the detailed eleven-function scope.
The calculator does not infer legal status from a marketing name because formula, dosage, form, active concentration, evidence, and the exact claim still matter.
Article 10(1)1
Product matching a notified standard
The type and amount of functional ingredients, efficacy and effect, directions and dosage, specification, and test method match the item notified by MFDS.
Article 10(1)2
Item matching an eligible previously reviewed product
The responsible seller, or another legally eligible manufacturer or research body, has a previously reviewed item and all required active, claim, method, dosage, and dosage-form conditions match.
Article 10(1)3
Eligible combination item
A previously reviewed ultraviolet function and a notified whitening or wrinkle function are combined only within the specific identity conditions in Article 10(1)3.
A report is not a cheaper route that an applicant may elect freely
One of the three Article 10 bases must actually apply.
Similar packaging, a similar product name, or an ODM statement by itself does not prove the required identity of the responsible seller, manufacturer status, active ingredient specification and amount, efficacy, directions, test method, or dosage form.
If no report basis has been confirmed, keep the warning visible and obtain a route determination before using the result for an application.
Official filing fees and review time checked for 2026
The amounts below come from Enforcement Rule Article 32 and Annex 9 as checked on August 9, 2026.
The 60-day period appears on Form 7 for a functional cosmetics review request.
It is a review-period anchor, not a guarantee that dossier preparation, deficiency response, review suspension, repeat testing, production, labelling, and distribution readiness will all finish within 60 calendar days.
Korean functional cosmetics review, report, and responsible seller registration fees for 2026 planning| Filing | Electronic | In person or by post | Official review period |
|---|
| Functional cosmetics review, per item | KRW 189,000 | KRW 210,000 | 60 days |
| Review-exempt item report | KRW 0 | KRW 0 | 60-day review not applied |
| New responsible cosmetics seller registration, once | KRW 27,000 | KRW 30,000 | Confirm separately |
Why the report fee is shown as zero
Annex 9 lists a functional cosmetics review request and change-review fees but does not list a separate review-exempt report fee.
The model therefore uses KRW 0 for the statutory report filing line only.
Formula comparison, evidence retention, quality testing, dossier work, translation, label revision, system correction, and internal review remain real costs and should be entered separately.
Evidence scope and why quote fields start at zero
Enforcement Rule Article 9 and Article 4 of the Regulation on the Review of Functional Cosmetics may require origin and development history, safety evidence, efficacy or functional evidence, ultraviolet protection evidence, specifications, test methods, and samples.
The safety set can include single-dose toxicity, primary skin irritation, eye or other mucosal irritation, sensitization, phototoxicity, photosensitization, and human patch evidence.
Efficacy evidence can include mechanism or efficacy testing, human application studies, and SPF, water-resistance, or PA support where applicable.
Potential exemptions
Notified ingredients and amounts, notified specifications and test methods, eligible previously reviewed items, and the detailed exemptions in Article 6 of the review regulation may reduce the dossier. Exemption must be confirmed against the actual formula and route.
No invented market average
Laboratory scope, sample count, study design, ODM responsibilities, translation volume, and adviser work vary too widely for a single reliable default. Every commercial quote therefore begins at KRW 0 until the user enters evidence.
Per-item versus shared cost
Studies, dossier drafting, label revision, and samples are entered per item and multiplied by item count. Training, a shared contract, a common system, or one brand-level project may be entered once as shared cost.
Contingency boundary
The user-selected contingency rate applies to non-statutory external quotes only. It does not increase a fee fixed by Annex 9, and it is a planning assumption rather than a legal rate.
How the cost and timeline formulas work
1. Statutory fee
A review uses KRW 189,000 electronically or KRW 210,000 by in-person or postal filing for each item.
A report uses KRW 0 for each item because Annex 9 has no report line.
If selected, one responsible seller registration fee of KRW 27,000 or KRW 30,000 is added to the project rather than multiplied by item count.
2. Cash budget
Add all per-item quotes, multiply by item count, and add shared project cost.
Multiply that non-statutory external cost by the contingency percentage, then add statutory fees.
Subtract only a confirmed grant and floor net cash outlay at zero.
3. Economic cost and recovery units
Internal labour equals hours per item multiplied by item count and internal hourly cost.
Launch-delay cost equals estimated days divided by 30 and multiplied by monthly lost contribution.
Total economic cost adds net cash, internal labour, and delay, while recovery units round up total economic cost divided by contribution per unit sold.
4. Parallel or sequential preparation
Parallel mode uses the longest of dossier, testing, labelling, and other prerequisite work.
Sequential mode adds every duration.
A review then adds 60 official review days, a report adds zero review days, and both add the user's deficiency and administration buffer.
Worked example: two electronically reviewed SKUs
Assume two cream SKUs require review and are filed electronically.
Per item, enter KRW 800,000 safety testing, KRW 1,500,000 efficacy evidence, KRW 300,000 quality testing, KRW 500,000 dossier work, KRW 200,000 labelling, KRW 400,000 sample production, and KRW 100,000 other cost.
Add KRW 1,000,000 shared cost, 10% contingency, a confirmed KRW 1,000,000 grant, 40 internal hours per item at KRW 50,000 per hour, KRW 2,000,000 monthly delay loss, and KRW 20,000 contribution per unit.
Worked launch-cost example for two electronically reviewed Korean functional cosmetic items| Line | Formula | Result |
|---|
| Review filing fees | KRW 189,000 × 2 | KRW 378,000 |
| All item-specific quotes | KRW 3,800,000 × 2 | KRW 7,600,000 |
| Non-statutory external cost | KRW 7,600,000 + KRW 1,000,000 shared | KRW 8,600,000 |
| Contingency | KRW 8,600,000 × 10% | KRW 860,000 |
| Cash budget before grant | KRW 378,000 + KRW 8,600,000 + KRW 860,000 | KRW 9,838,000 |
| Net cash outlay | KRW 9,838,000 − KRW 1,000,000 grant | KRW 8,838,000 |
| Internal labour | 40 hours × 2 × KRW 50,000 | KRW 4,000,000 |
| Launch-delay cost | 165 days ÷ 30 × KRW 2,000,000 | KRW 11,000,000 |
| Total economic cost | KRW 8,838,000 + KRW 4,000,000 + KRW 11,000,000 | KRW 23,838,000 |
| Recovery units | KRW 23,838,000 ÷ KRW 20,000 | 1,192 units |
Dossier preparation is 30 days, testing 90 days, labelling 20 days, and other work 10 days in parallel, so preparation is 90 days.
Adding the 60-day review and a 15-day deficiency buffer gives 165 days, or 5.5 planning months.
These inputs demonstrate the formula and are not Korean market-price estimates.
Step-by-step use
- Confirm the legal route.
Compare the actual formula and evidence with Article 10 and select review or report only after confirming the filing basis.
- Choose the channel and item count.
Electronic and paper review fees differ, and the review fee is charged per item.
- Transfer itemized quotes without duplication.
Use laboratory, ODM, adviser, translator, and designer quotations, checking whether VAT and a bundled service are already included.
- Separate shared and internal cost.
Enter common training or systems once, while internal hours are entered as an average per filing item.
- Model task dependency and buffer.
Use parallel only where work can genuinely overlap and add time for deficiency response, report correction, document collection, and internal approval.
- Read cash and economics separately.
Net cash outlay supports funding plans, while total economic cost supports pricing, contribution, and recovery-volume decisions.
Practical scenarios
ODM product based on a notified formula
Do not treat the ODM statement as the complete legal analysis. Confirm formula identity, claims, dosage, specification, method, filing party, and retained evidence in writing, then enter ODM dossier, quality, label, and internal-review cost even if the report fee is zero.
Proprietary whitening active under review
Separate safety, efficacy, human application, and specification work. If testing takes the longest, it controls the parallel preparation timeline even when drafting and labelling start earlier.
Imported functional cosmetic
Foreign evidence generally needs the original and a Korean summary, and a complete translation may be requested where necessary. Enter translation and document-verification cost and add time for overseas manufacturer responses.
Portfolio launch with multiple SKUs
Multiply per-item statutory and quoted costs, but count true brand-level work once. The model assumes preparation can overlap, so adjust duration if filings or production must run sequentially.
Frequently asked questions
Does a report mean MFDS does not check anything?
The report replaces the Article 9 review only for an eligible Article 10 item. The National Institute of Food and Drug Safety Evaluation receives the item-by-item report and checks the legal requirements before recording the report details.
Is the statutory report fee really KRW 0?
Annex 9 checked on August 9, 2026 lists a review request fee but no separate review-exempt report fee. The calculator applies zero only to that filing line and leaves every study, dossier, quality, label, translation, and internal cost for the user to enter.
Does the 60-day review period guarantee a launch in 60 days?
No. The Form 7 processing period is not the whole commercial launch calendar. Preparation, deficiencies, review holds, repeat studies, manufacturing, packaging, and distribution readiness may sit outside it.
Can all study cost be removed when a notified active is used?
Some evidence may be omitted under the proviso to Enforcement Rule Article 9 and Article 6 of the review regulation. The remaining scope depends on the actual formula, specification, method, and filing basis, so remove a quote only after confirming the exemption.
May colour or fragrance variants be counted as one item?
The legal filing unit can depend on formula, active, dosage form, claim, and application structure. The calculator does not classify filing units, so confirm the actual item count before multiplying costs.
Does paying the responsible seller fee complete registration?
No. KRW 27,000 or KRW 30,000 is only the Annex 9 filing fee. Qualifications, responsible manager, facilities, documents, quality and safety systems, and processing time remain outside this calculation.
Official sources and maintenance boundary
- Cosmetics Act Articles 2, 4, and 32, law ID 002015, MST 270323, effective April 2, 2026.
- Enforcement Rule Articles 2, 9, 10, and 32, Annex 9, Forms 7 and 10, law ID 008741, MST 285249, effective April 2, 2026.
- MFDS Notice 2025-88, Regulation on the Review of Functional Cosmetics, administrative serial 2100000269812, effective December 16, 2025.
- MFDS Guide to Functional Cosmetics Review and Report and the February 2025 review question-and-answer guide as procedural support.
The official-source check date is August 9, 2026.
Recheck Annex 9, the filing forms, Article 10, the review notice, current e-petition charges, and the actual product dossier on the filing date.
Important limitations
- The calculator does not classify a product within the eleven functional-cosmetics categories.
- It does not determine Article 10 report eligibility, formula identity, evidence exemption, required study design, claim legality, or likely review outcome.
- It does not provide Korean market averages for laboratories, consultants, ODM work, translation, design, or production.
- It does not decide VAT recovery, accounting treatment, grant eligibility, responsible seller registration eligibility, or an actual launch date.
- For multiple items, it assumes preparation can overlap unless the user changes duration inputs to reflect a sequential project.
Build the launch budget from confirmed evidence
Confirm the route and filing-unit count first, then replace every zero quote with the itemized figures obtained from the laboratory, ODM, and regulatory team.
Separating statutory fees, cash, internal effort, and delay makes the funding requirement and recovery target much easier to explain.