Short answer: Korea's regulator has drafted rules that accept internationally standardised in-vitro test data as substantiation for SPF and PA claims — previously human panel testing dominated — while narrowing the waiver that let later brands ride an already-reviewed sunscreen dossier for free. The drafts are not final, but the direction is clear enough to plan against.
Korea is one of the few markets where a sunscreen claim is not just a label decision but a regulatory classification. Products making sun-protection claims fall into the functional cosmetics class, which requires either a formal review or a filed report before the product can reach a shelf. In August 2026 the Ministry of Food and Drug Safety put two draft amendments on the table that reshape how the efficacy evidence behind those claims is produced.
This guide explains the two-tier system the drafts sit inside, what each notice changes, how in-vitro testing compares with the human-panel method, and what a brand planning a Korean-market sunscreen should do while the final text is pending.
The two-tier system in one paragraph
Korea separates ordinary cosmetics from functional cosmetics. Ordinary products notify before marketing and carry the usual safety obligations. Functional products — those claiming sun protection, brightening, wrinkle improvement, hair-loss relief, acne-related benefits and a growing list of others — must pass an MFDS review or file a report that matches a product already reviewed, with efficacy data behind the claim. The claim decides the category, and the category decides the evidence. A brand entering Korea therefore makes its claims strategy and its regulatory strategy as one decision, at brief stage, not at artwork stage.
For sunscreens specifically, the permitted UV filters, their concentration limits and the functional review are all governed by Korean lists, which is why formulating a sunscreen for a regulated market always starts from the destination's filter set rather than the factory's default.
What the two draft notices change
The Ministry posted two draft notices on 18 August 2026, with comments closing on 18 September 2026. They were filed as a single policy move and share a desk officer; one amends the review regulation for functional cosmetics, the other amends the labelling and advertising substantiation regulation.
The review-regulation draft does three things. First, it adds test data generated by internationally standardised in-vitro methods as an acceptable basis for setting the SPF value and the PA grade. Second, it narrows the conditions under which a new product can skip the efficacy data package by referencing a product that has already been reviewed. Third, it tightens how ingredient quantities are documented in the dossier.
The substantiation draft does one thing with wide effect. It recognises in-vitro data as substantiation for SPF and PA claims in labelling and advertising, where the previous text recognised human application test data alone. That removes the exclusivity of the human test — it does not abolish it. An existing human-panel result remains valid; a sponsor starting from zero now chooses between routes.
Both documents remain drafts until the final text publishes. Nothing in this guide should be actioned as if the amendment were already in force; the useful move now is preparation, not submission.
Human panels versus in-vitro plates
The two routes measure the same quantity in different ways, and the trade-offs between them explain why the draft matters commercially.
| Dimension | Human panel test | In-vitro plate test |
|---|---|---|
| Method basis | Application on human volunteers under a solar simulator | Roughened PMMA plates loaded with product, irradiated under a solar simulator |
| Standard named in the drafts | Existing human application test framework | ISO 23675 (SPF, published December 2024); ISO 24443 (UVA protection factor) |
| Duration | Typically weeks, panel scheduling dependent | Days, laboratory throughput dependent |
| Cost profile | Highest-cost option, volunteer-dependent | Materially lower; equipment and plate preparation driven |
| Variability | Biological variability between panellists | Plate loading and product spreading technique |
| What it does not do | — | Not a substitute for other safety evidence |
Two details in the drafts deserve attention. The named in-vitro standards are the double-plate SPF method and the UVA-PF method — the third recent international method, a hybrid spectroscopy approach measured on skin, is not named. And Korean coverage describing the change as measuring SPF "instead of people" overstates it: the drafts widen what counts as evidence, they do not remove the human route.
Why the narrowed waiver matters more than the faster test
The cheaper test is the headline; the waiver change is the budget line. Until now, a brand introducing a sunscreen similar to one already reviewed could, under defined conditions, file a report referencing the existing dossier and skip running its own efficacy test. That waiver is what most market entries actually used, and the draft narrows the conditions under which it applies.
The combined effect: the per-test cost falls, but the number of products expected to carry their own test data rises. A range launch that previously planned one test and several reference filings may now need data per SKU. For a brand with a multi-shade or multi-SPF-level sunscreen line, the dossier-planning question shifts from "who can we reference" to "which SKUs justify their own data".
For manufacturers this also changes what the lab must support. Producing a Korean-market sunscreen already requires filter and formulation discipline for other destinations; the Korean drafts add an evidence-package dimension — the formulation, the process and the test sample need to match what the dossier describes, which puts weight on batch documentation and change control.
What to do while the final text is pending
Three preparation steps are safe regardless of how the final text lands.
Map your claims per SKU. Decide which products carry SPF/PA claims and therefore enter the functional route, and which could launch without those claims on the ordinary route. This is a positioning decision with a regulatory price tag attached.
Line up the evidence options. Ask your laboratory partners which route they can support — a human-panel facility, an ISO 23675-capable lab, or both — and get indicative lead times for each. The drafts make the in-vitro route realistic for the first time; capacity, not regulation, may become the bottleneck.
Treat the waiver as uncertain. Do not build a launch plan on referencing an existing dossier until the final text confirms what conditions survive. Build a plan that works either way: reference filing if it remains available, own data if it does not.
And as always for this market, the filing is made through the local responsible party in Korea; a factory-side document set — the batch documents that ship with production — feeds that filing but does not replace it.
Common misreadings of the drafts
"In-vitro replaces human testing." No. The drafts add in-vitro data as acceptable substantiation beside human data. Existing human results stay valid, and the human route remains open.
"The amendment is in force." The notices were drafts with a September 2026 comment deadline. Korean regulatory practice distinguishes sharply between posted drafts and effective rules; confirm the final text before committing test spend.
"Cheaper tests mean cheaper market entry overall." The per-test cost falls, but the narrowed waiver can push more SKUs onto their own data. Net cost depends on the shape of your range, not on the test price alone.
FAQ
Q: What are Korea's 2026 SPF testing changes? A: Two MFDS draft notices posted on 18 August 2026 (comment period closed 18 September 2026) would accept internationally standardised in-vitro test data — the ISO 23675 SPF method and the ISO 24443 UVA-PF method — as substantiation for SPF and PA claims, alongside the existing human panel route. They also narrow the waiver that let later products reference an already-reviewed dossier.
Q: Can I use in-vitro SPF data for a Korean functional cosmetics filing? A: Under the drafts, yes — but the notices had not been finalised as of this writing. The draft review regulation adds in-vitro data as an acceptable basis for SPF value and PA grade; verify the final published text before relying on it for a submission.
Q: Does the human sunscreen test still work in Korea? A: Yes. The drafts widen what counts as evidence rather than removing the human application test. A sponsor holding an existing human-panel result keeps it, and new sponsors can still choose the human route.
Q: Why did Korea narrow the sunscreen dossier waiver? A: The stated policy direction is that more products should carry their own substantiation data rather than riding an earlier product's dossier. The drafts tighten the conditions for the waiver at the same time as they make individual testing cheaper and faster — a deliberate trade of per-test cost against data coverage per SKU.