Cosmetic Claim Substantiation in Korea: What to Prepare

In short: cosmetic claim substantiation in Korea is something you prepare before the claim goes on a pack or a web page. Article 14 of the Cosmetics Act says businesses and sellers must be able to substantiate the factual claims in their labelling and advertising, and if the Ministry of Food and Drug Safety (MFDS) asks for evidence, it must arrive within 15 days.

Accepted evidence is human application testing, non-human (in vitro) testing, or survey data of equal standing, and it must relate directly to the claim.

This guide is based on Articles 13 and 14 of the Cosmetics Act, Article 23 of its Enforcement Rule, and the MFDS notice Regulation on Substantiation of Cosmetic Labelling and Advertising. We read the provisions in the Korean law portal¹ and in the compilation published by the Korea Cosmetic Association (Korean). Translations are ours.

Step 1: Understand the cosmetic claim substantiation duty

Article 14 has three working parts:

• Be able to prove it (para. 1). Business operators and sellers must be able to substantiate the factual matters in labelling and advertising they have made. Resellers are covered, not only brand owners.
• Request and deadline (paras. 2–3). When MFDS needs to judge whether a claim may deceive or mislead consumers (Article 13(1)4), it can ask for evidence, specifying what it wants. The evidence must be submitted within 15 days of the request; MFDS can extend this for justifiable reasons.
• Stop order (para. 4). If the business does not submit within the period and keeps advertising, MFDS must order the advertising stopped until the evidence is submitted.

Step 2: Sort your claims into three groups

Substantiation does not rescue every claim. Article 13(1) prohibits labelling or advertising that:

1. may be mistaken for a medicine;
2. presents a non-functional cosmetic as a functional cosmetic, or differs from the safety and efficacy review of a functional cosmetic; or
3. otherwise deceives consumers or may mislead them.

Before writing copy, it helps to sort claims like this:

(The examples are illustrations; MFDS standards decide individual cases.)

Step 3: Choose the right type of evidence

Enforcement Rule Article 23(2) sets the scope and requirements:

• Test results: human application test data, non-human test data, or survey data of equal or higher standing.
• Survey results: sampling, questions and method must fit the purpose of the survey and statistical practice.
• Method: scientific and objective, widely known academically or generally accepted in the industry.

The MFDS regulation (Article 3) adds that evidence must be produced by objective, scientific procedures, and that its content must be directly related to what the advertisement claims. That is why a raw-material supplier’s ingredient study alone rarely supports a claim about the finished product.

Step 4: Check the test lab and test requirements

Article 4 of the MFDS regulation sets common requirements for test results:

• Related to the advertised content, scientific and objective, with reliability and reproducibility.
• Performed by a Korean or foreign university or a specialised cosmetics research institute (including a corporate lab that works independently of manufacturing and sales), and issued by the head of that institution.
• Carried out under standardised procedures, including documented equipment maintenance.
• Backed by documented quality-assurance work.
• For foreign data, able to provide a Korean summary together with the original.

Human application tests must be run under the supervision of a relevant specialist physician or a person with at least five years’ testing experience at a hospital, university or specialised institute, and must follow ethical principles based on the Declaration of Helsinki, with written consent.

Step 5: Keep each claim and its evidence together

Enforcement Rule Article 23(3) lists what a submission must state: the method; the name, representative, address and phone number of the testing or survey body; the content and results; and any parts you want withheld as trade secrets, with reasons.

A practical habit: keep one file per claim containing the exact wording, the test report, the lab details and where the claim is used. If the wording changes, recheck the evidence.

Step 6: Respond to an MFDS request

Start by identifying exactly which claim the request names, and submit evidence that answers that claim. Under Article 14(5), once you have submitted evidence to MFDS, you may refuse a request for the same material from another agency under laws such as the Act on Fair Labeling and Advertising; under Article 14(6), MFDS will share it with that agency on request unless there is a special reason not to.

If you cannot produce evidence, taking the claim down is the realistic option. Continuing to advertise without submitting leads to a stop order.

Step 7: Apply the same rule to export copy

Product sheets and listing copy given to overseas buyers become someone’s advertising too. Rules differ by market, but “no factual claim without evidence” works everywhere. For the legal functional categories in Korea, see Korean functional cosmetics; for how marketing terms differ from legal functions, see what slow ageing means.

Related pages

SEONGWOO GLOBAL is a Korean cosmetics wholesale exporter with companies in Seoul and Hong Kong. If you are preparing product materials for export, tell us the market and channel first.

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Notes

1. Korea’s Ministry of Government Legislation, 화장품법, verified 2026-10-25. ↩