Two listed combinations waive the hair-loss dossier

The scalp is skin, but the wording goes elsewhere

What blocks a scalp line in Korea is rarely the formula. A shampoo or tonic for the scalp follows the same rules as any ordinary cosmetic — until the word "hair loss" reaches the label, at which point it crosses into functional-cosmetics territory.

That border was drawn fairly recently. In May 2017, products for relief of hair-loss symptoms were reclassified from quasi-drugs to functional cosmetics. Older product files and newer ones were therefore written under two different systems, and the certificates a buyer receives often arrive mixed.

Two combinations decide whether you file

The point is that the MFDS fixed the ingredients and their contents in advance. Use a listed combination as given and the safety and efficacy dossier is waived; step outside it and you substantiate the claim yourself.

The raw-material side is already settled. An amendment to the Standards and Test Methods for Functional Cosmetics (Notice No. 2018-111) created ingredient specifications for dexpanthenol, biotin, l-menthol, zinc pyrithione and zinc pyrithione solution (50%). With specifications in place, hitting the content figure matters more than finding a supplier.

One cell in that table is deliberately blank. Dexpanthenol's content in combination A is reported two ways: a 2020 Cosmorning article puts it at 0.2%, a 2022 Hidoc article at 0.1%. Every other figure agrees across both.

A factor of two is not a rounding question in a formula. If combination A is your route, open the current annex of the Regulation on Review of Functional Cosmetics rather than trusting a news article. Which combination fits your target price is worth laying out in the product planner.

Choose the test route and your panel narrows

Substantiating it yourself runs into a second constraint at the design stage. Reporting indicates that the human-application-test guideline for hair-loss-relief cosmetics, as revised in 2018, limits subjects to androgenetic alopecia — telogen effluvium and alopecia areata sit outside it.

The planning consequence is larger than it looks. A scalp line aimed at women still has to be substantiated on an androgenetic-alopecia panel. Guidelines change, so confirm the current edition before you sign with a testing body.

The label gets one phrase

A complete file does not buy you more words. The permitted expression stops at helping relieve hair-loss symptoms. "Prevents hair loss" is already outside it, and growth or regrowth claims are further out still.

That last row catches people out. Because Article 2 of the Enforcement Rule excludes coating-type thickening products from the hair-loss category altogether, such a design can neither go through functional review nor carry hair-loss wording. It is the single most common failure when an overseas product page is translated and uploaded as is.

Read the other way, a short label means scalp products compete on the ingredient list and the price instead. Where ingredient demand is moving sits in today's ingredient signal.

In short

• Relief of hair-loss symptoms is one of the 11 functional categories in Article 2 of the Enforcement Rule, moved over from quasi-drugs in May 2017.
• Either of two listed ingredient-and-content combinations waives the safety and efficacy dossier; outside them, a human application test is required.
• Dexpanthenol in combination A is reported as both 0.1% and 0.2%. Check the current annex of the Regulation on Review of Functional Cosmetics before formulating.
• Reporting says the human-application-test guideline limits subjects to androgenetic alopecia, so confirm the current edition even for a women's line.
• The label stops at helping relieve hair-loss symptoms. Prevention and growth claims are out, and coating-type thickening products are excluded from the category.

*Sources: the 11 functional categories and the exclusion of physical coating are Article 2 of the Enforcement Rule of the Cosmetics Act (effective 2 Apr 2026, Prime Ministerial Decree No. 2109). The listed combinations and the waiver of safety and efficacy data are from Cosmorning, "탈모 증상 완화 기능성화장품 심사자료 면제" (7 Oct 2020), reporting the proposed amendment to the Regulation on Review of Functional Cosmetics. The 0.1% dexpanthenol figure and the May 2017 reclassification are from Hidoc (25 Mar 2022) and Kyunghyang Shinmun (24 Sep 2021). The clinical-test waiver and the androgenetic-alopecia limit on the guideline are from Health Kyunghyang (14 Dec 2021). The ingredient specifications are from Cosmorning, "탈모완화 기능성화장품 원료규격 신설" (1 Jan 2019), on Notice No. 2018-111 amending the Standards and Test Methods for Functional Cosmetics. Confirm contents and permitted wording against the official notices.*