South Korea's MFDS cosmetic ingredient rules explained

South Korea runs its own cosmetic ingredient control system, built on its own law and its own Ministry, and it does not track the EU annex-by-annex. A formulator who assumes a substance cleared for the EU market is automatically fine for Korea, or the reverse, is working from the wrong text. This article sets out how the Korean system is built, what its 'functional cosmetics' category adds on top of ordinary safety control, and three cases from the site's own Korean records where the Korean and EU limits genuinely diverge.

The Cosmetics Act and the MFDS

Cosmetics in Korea are governed by the Cosmetics Act (화장품법), administered by the Ministry of Food and Drug Safety (MFDS, 식품의약품안전처). The Act sets the legal framework — manufacturer and importer obligations, product notification, labeling, and enforcement — and delegates the technical detail of which ingredients may or may not be used, and at what concentration, to a subordinate notice issued by the MFDS.

MFDS cosmetics safety standards: the regulation and its annexes

That subordinate notice is the Regulation on Safety Standards, etc. for Cosmetics (화장품 안전기준 등에 관한 규정). It carries its own MFDS notice number and is published and amended through Korea's official legislation portal, law.go.kr, which is also the source URL the site records for every Korean rule. The regulation organizes ingredient control into two annexes: Annex 1 lists ingredients that may not be used in cosmetics at all (prohibited ingredients), and Annex 2 lists ingredients that may be used only within stated limits (restricted ingredients), grouped by type — preservatives, UV filters, hair-dye substances, and a further group of other restricted materials, each entry carrying its own maximum concentration and, where relevant, a permitted product scope and label warning. The site's own Korean data mirrors this split exactly: of the 1,320 published Korean rule records the site currently holds, 1,077 are prohibited-ingredient entries citing Annex 1, and 243 are restricted-ingredient entries citing Annex 2, tracked via /api/v1/jurisdictions/kr/rules/.

Negative list, positive lists, and what the site holds

Korea's rules mix both kinds of list. Annex 1 is a negative list: the substances on it may not be used in cosmetics. Annex 2 works differently for the ingredients most often compared across markets: only the preservatives, UV filters and hair-dye substances it names may be used for those functions, at the limits it sets, and a new one needs MFDS approval before it can be used - in effect a positive list. Colorants are controlled by a separate MFDS regulation on the types, standards and test methods of colorants for cosmetics, which is also a positive list. For every other ingredient, appearing on neither annex does not mean the regulator has declared it safe: it falls outside MFDS's specific ingredient controls, and the manufacturer carries responsibility for its safety under the Cosmetics Act. The site's Korean records cover Annex 1 and Annex 2 only - 1,077 prohibited and 243 restricted - and do not include the colorant regulation. Absence from the site's data is never presented as absence from the law, and a record's presence is identity evidence for a substance, not a verdict on whether it may be used.

Functional cosmetics: a category the EU does not have

Alongside ordinary cosmetics, Korean law defines a separate class called functional cosmetics (기능성화장품): products claiming to help whiten skin, improve wrinkles, or protect skin from ultraviolet radiation (sunscreen), among other defined functions added over time such as hair-loss relief or stretch-mark reduction. A product making one of these claims needs more than compliance with the ordinary safety standards. If its functional ingredient, concentration, and intended use match an ingredient-use combination MFDS has already recognized, the company can file a simplified report. If not, the product needs a full MFDS evaluation supported by efficacy and safety data. Claim wording is policed too: a product cleared as 'anti-wrinkle' can use that term but cannot claim broader 'anti-aging' effects it was not evaluated for. This pre-market efficacy review is the piece the EU's Cosmetics Regulation does not have; the EU controls ingredient safety through its annexes but does not operate a separate government approval step for whitening, anti-wrinkle, or sunscreen efficacy claims.

How often the standards change

The Regulation on Safety Standards, etc. for Cosmetics is amended by numbered MFDS announcements rather than on a fixed annual cycle — for example, Announcement No. 2025-63 (2 September 2025) revised the standards, including a change to the Annex 2 entry for cyclopentasiloxane, with a multi-year lead time before the new limit takes effect. The site tracks each Korean record against the specific notice version it was imported from (the source_version field returned by the API, for example '2026-19' for entries current as of the site's most recent import) rather than assuming a stable annual edition, precisely because MFDS revises individual annex entries piecemeal and on its own schedule.

Where Korea and the EU set different limits: three worked examples

The following three cases come directly from the site's published Korean rule records, cross-checked against the corresponding EU-family entries in the same ingredient's jurisdiction list.

Salicylic acid: a lower general limit, tied to functional-cosmetics use

Salicylic acid (CAS 69-72-7) is restricted in both systems, but not identically. Korea's Annex 2 entries cap it at 2% in rinse-off, human-body-cleansing products and 3% in rinse-off hair products, prohibit both concentrations in products marketed for infants or for children aged 13 or under (shampoo excepted), and separately allow 0.5% only when salicylic acid is used as the active ingredient of a functional cosmetic — any other use at that concentration is prohibited outright. The EU/GB Annex III-family entry (mirrored in Great Britain's consolidated rules, ASEAN, and New Zealand) instead sets 3% in rinse-off hair products, 2% in other rinse-off products, and 0.5% in a named set of specific leave-on categories (body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant), with the age cut-off set at under 3 years rather than under 13. The concentration bands look similar at a glance, but the age threshold and the condition attached to the 0.5% tier are both different.

Hydroquinone: prohibited outright in Korea, narrowly permitted in the EU/GB family

Hydroquinone (CAS 123-31-9) is a clean example of outright divergence rather than a difference of degree. The site's Korean record for hydroquinone is a straight prohibition, with no listed exception. The Great Britain consolidated rule (mirroring the EU's own Annex II/III treatment) instead carries both a general prohibition and a narrow carve-out: hydroquinone is permitted at up to 0.02% (after mixing for use) in artificial nail systems, for professional use only, with skin-contact warnings. So a nail-system formulation legally sold in the EU or GB under that carve-out has no equivalent permitted use in Korea's Annex 2 — the Korean prohibition does not include a nail-system exception in the site's data.

Triclosan: a matching concentration cap, but a different list of permitted product types

Triclosan (CAS 3380-34-5) shows a subtler kind of divergence. Both Korea and the EU cap it at 0.3% and prohibit it outside a defined list of product types — but the lists differ. The EU's Annex V entry 25 names toothpaste, hand soaps, body soaps/shower gels, non-spray deodorants, face powders and blemish concealers, and certain nail products for cleaning fingernails and toenails before applying artificial nails. Korea's Annex 2 entry, in the site's record, names rinse-off human-body-cleansing products, non-spray deodorant, face powder, and foundation used locally to conceal skin blemishes — it does not carry toothpaste or the nail-cleaning use across into the same 0.3% permission. Two regulators arriving at the same number does not mean they arrived at the same rule.

Reading the Korean text against the English

For all three examples above, and for the great majority of the site's 1,320 Korean records, the controlling legal text is Korean, published on law.go.kr, and no official English translation is attached at the record level — the site marks this explicitly as translation status 'none'. Any English rendering of a Korean ingredient name, condition, or product-type description on the site or elsewhere is a translation for convenience, not the legal text itself. Where a discrepancy is possible, the Korean original on law.go.kr governs, and a company selling into Korea should confirm current wording there or through Korean regulatory counsel rather than relying on a secondary English summary, including this one.

Using the site's Korean data

The site's Korea page at cosingchecker.com/regulations/kr/ lists the jurisdiction's published rule count and source. To compare a specific ingredient's status across Korea, the EU, and the site's other tracked markets side by side, use cosingchecker.com/market-compare/; to see where jurisdictions diverge on the same substance more broadly, cosingchecker.com/market-divergence/ surfaces those cases directly. As with every jurisdiction on the site, a Korean record is identity evidence that MFDS has addressed a given substance under a given notice — it is not a safety verdict, and it is not legal advice.

Sources

• MFDS International Risk Information (Cosmetics Act, Regulation on safety standard of cosmetics) — https://www.mfds.go.kr/eng/brd/m_60/view.do?seq=69774
• MFDS official site — https://www.mfds.go.kr/eng/index.do
• Korea Law Information Center, source text for MFDS administrative rules cited on the site's Korean records — https://www.law.go.kr/admRulInfoP.do?admRulSeq=2100000276068
• MFDS data portal, Korean cosmetics ingredient search (site's cited official source for KR records) — https://data.mfds.go.kr/OPCAA01F01/search?selectedTab=tab1&taskDivsCd=4&taskDivsDtlCd=12
• CIRS Group, 'South Korea Revises Cosmetic Safety Standards' (MFDS Announcement No. 2025-63, cyclopentasiloxane) — https://www.cirs-group.com/en/cosmetics/south-korea-revises-cosmetic-safety-standards
• ChemLinked, 'South Korea Cosmetic Ingredients Requirements' (negative list, Annex 1/Annex 2 structure) — https://cosmetic.chemlinked.com/cosmepedia/regulatory-requirements-for-cosmetic-ingredients-in-south-korea
• ChemLinked, 'Decoding South Korea Functional Cosmetic Regulation' — https://cosmetic.chemlinked.com/expert-article/decoding-south-korea-functional-cosmetic-regulation
• CosIng Checker API, Korea jurisdiction rules — https://cosingchecker.com/api/v1/jurisdictions/kr/rules/
• CosIng Checker API, jurisdictions list and published rule counts — https://cosingchecker.com/api/v1/jurisdictions/
• CosIng Checker, EU Annex V entry 25, Triclosan — https://cosingchecker.com/annex/v/v-25-triclosan/