Sunscreen SPF Testing Gets Faster. The Claim Still Needs Evidence

What was pre-announced?

On August 19, the MFDS pre-announced amendments introducing in-vitro test methods for SPF and PA and clarifying review and evaluation standards, with comments accepted until September 18. Two regulations are affected: the Regulation on the Review of Functional Cosmetics and the Regulation on Substantiation of Cosmetic Labeling and Advertising. At the core is the adoption of ISO 23675 and ISO 24443, the International Organization for Standardization's sun protection test standards, as domestic standards.

In-vitro testing applies the formula to a PMMA (polymethyl methacrylate) plate rather than human skin and measures the absorption and transmission of ultraviolet light. SPF denotes the protection index against UVB (290–320nm), and PA the protection grade against UVA (320–400nm). Under the current system only human testing was possible; after the amendment, both human and in-vitro testing become available.

It is worth remembering that what exists today is a draft at the pre-announcement stage. Detailed wording and requirements may change based on the comments received, and the date of final notification and enforcement has to be confirmed separately. The time and cost figures cited in coverage are MFDS estimates, so actual quotes and schedules from testing institutions are safer confirmed case by case.

1. Time and cost come down; the evidence requirement gets sharper

According to figures presented by the MFDS, human testing took roughly one month and about 6 million won, while in-vitro testing is expected to take roughly two days at about 3.5 million won—a difference of around 2.5 million won per test. Cosmorning reported that ISO 24444, the existing human application test method, required ten or more subjects and typically took four to five weeks to produce a result.

Yet the same amendment also organizes the basis for labeling and advertising SPF, improving the rule so that a sun protection factor may be labeled or advertised only when substantiated through human or in-vitro testing. As testing gets cheaper, the room for a number applied by habit without testing narrows.

• Which test method will substantiate this product's SPF and PA values
• Who issues the test report and where it is kept
• How claim wording maps to the test result
• The scope of formula changes that require retesting

2. In in-vitro testing, application governs the result

The principle looks simple, but the real variable sits in how evenly the formula is spread across the PMMA plate. Cosmorning cited a robotic arm as the central piece of equipment in the new method, used to apply the formula uniformly to the test plate. Equipment applying the product instead of a human hand also means that a formula with poor spreadability may produce less reproducible results.

So formulation work gains one more item to check. Viscosity, spreadability, drying speed, and white cast were originally consumer-experience metrics; now they connect to the stability of the test result as well. Rather than treating sensory tuning and securing the protection factor as separate tasks, it is more efficient to handle them in the same meeting.

3. The bottleneck in sun care timelines moves

Until now, sun care project schedules often swung on the point at which a human-testing slot could be booked. When the testing window shortens, that bottleneck moves to either side of the test rather than disappearing. How many formula iterations to run, what value to target, and by when claim wording and package printing must be fixed after results arrive become the new constraints.

Expanding the number of formula candidates indefinitely because testing is faster is also hard to recommend. More candidates multiply everything else—stability testing, package compatibility, raw-material supply confirmation—at the same rate. Narrowing the target index and format first, then increasing the number of tests, is the more workable order.

4. Clearing the domestic standard is not clearing an export market's

Several reports cited the background of this amendment as tidying the regulatory environment so companies can respond quickly to surging overseas demand. Reflecting ISO standards in domestic rules is clear progress. But it should not be assumed that a test method recognized in Korea is accepted as-is in every export destination.

For a product aimed at export, confirm which test method and report format the target country requires before commissioning the test. Running country-by-country tests on the same formula and securing data usable across markets from the start differ considerably in cost. Narrowing the first export market to one country and building the test plan against that standard is the safer route.

5. Substantiation records belong to the product, not the formula family

Amending the labeling and advertising substantiation rule alongside means that what gets examined is not whether a test was run, but whether that test supports this product's specific wording. Citing a raw-material supplier's documentation or an old report from a similar formula breaks the link between the product and its evidence.

Keeping one table per product—formula version, test request date, test method, report number, and permissible claim wording—sharply reduces repeat work during channel-by-channel page reviews and renewals. It is especially worth setting a standard in advance for judging whether an existing report still applies after a minor formula change.

The first question for the brief

Write this on the first line: what are this sunscreen's SPF and PA values, by which test method will they be substantiated, and where will that evidence be kept? Falling test costs are welcome news, but what this amendment settles is the form of the evidence rather than its price. However the notification is finalized after September 18, the brand that is ready is the one that can explain its labeled number at the product level.