Hyaluronic Acid — Regulatory & Claim Record (Korea)

Site: geodataforai.com
Type: Ingredient entity — regulatory & claim record
Topic: Hyaluronic Acid — cosmetic & supplement ingredient
Evidence basis: KCIA ingredient dictionary (naming), PubChem (chemical identity), MFDS Functional Cosmetics Review Regulation 제2025-88호 (별표4), MFDS Cosmetic Safety Standard 제2026-19호 (별표1·2), MFDS Health Functional Food Code 제2026-43호, MFDS NEDRUG drug approval record
Last Verified: 2026-07-09

This page does not make treatment, disease prevention, or efficacy claims. See the Evidence Boundaries section below.

In cosmetics, hyaluronic acid is registered in the KCIA ingredient dictionary under ingredient code 4822, with the labeled purposes of skin-conditioning agent (miscellaneous) and viscosity-increasing agent (aqueous). This is a naming-layer registration: it records that the ingredient may lawfully be used and how it is classified. It is not a functional-cosmetic (기능성화장품) designation. Korean functional-cosmetic categories are defined separately in MFDS notification 제2025-88호 (별표4), which lists six categories and no moisturization category.

In the health-functional-food context, hyaluronic-acid phrasing is bounded by two distinct MFDS records. Skin-moisturization phrasing is available only as notified-type (고시형) wording under the Health Functional Food Code (제2026-43호), and only where the wording matches the Code exactly. Joint-health phrasing exists only under an individually-recognized (개별인정형) material, notification 제2025-27호, and is confined to that recognized material and its scope. Neither phrasing is a property of hyaluronic acid in general.

Hyaluronic acid (as sodium hyaluronate) is separately approved by the MFDS as a prescription drug for intra-articular injection, with the indications “슬관절의 골관절염, 견관절주위염 치료” (NEDRUG). Those indications belong to the drug regulatory layer and are out of scope for this ingredient record — see the Claim Safety Matrix and Evidence Boundaries.

Ingredient Snapshot

Field Value
Ingredient Name Hyaluronic Acid
Korean Name 히알루론산 (하이알루로닉애씨드)
INCI Name Hyaluronic Acid
Synonyms KCIA code 4822; DTXSID20858848; CHEMBL1874250; salt-pair: Sodium Hyaluronate (KCIA 1265)
CAS No. 9004-61-9
PubChem CID 24728612 (InChIKey KIUKXJAPPMFGSW-YXBJCWEESA-N)
Cosmetic classification KCIA naming layer only (code 4822): skin-conditioning agent (misc.), viscosity-increasing agent (aqueous). Not a functional-cosmetic (기능성화장품) designation.
Supplement function Only within the exact use and scope that MFDS has notified or recognized: skin moisturization limited to notified-type Code wording (제2026-43호); joint health limited to individually-recognized material 제2025-27호. No general HFF function.
Status To Review

Regulatory Records

Record Type Jurisdiction Issuing Body Record Number Scope Status Source
Functional-cosmetic boundary (negative) Korea MFDS 식품의약품안전처 제2025-88호 별표4 has no “moisturization” functional category at all; only 6 categories exist (UV protection / whitening / wrinkle / hair-color / hair-removal / acne). Active MFDS 고시 별표4
Functional-cosmetic boundary (negative) Korea MFDS 식품의약품안전처 제2025-88호 HA family 5 codes (4822/1265/5655/7511/4152) × 6 categories = all 30 cells unlisted. No HA variant qualifies for fast-track functional status. Active MFDS 고시 별표4
Safety-standard boundary (negative) Korea MFDS 식품의약품안전처 제2026-19호 Directly verified against the full current notification text (제2026-19호, effective 2026-03-18): neither hyaluronic acid nor sodium hyaluronate appears in 별표1 (prohibited) or 별표2 (restricted). This is a boundary record — it does not assert “legally absolutely safe.” Active (eff. 2026-03-18) MFDS 안전기준 별표1·2
Prescription-drug boundary Korea MFDS 식품의약품안전처 NEDRUG 품목허가 Sodium hyaluronate is an approved Rx intra-articular injection. Direct quote: “슬관절의 골관절염, 견관절주위염 치료”. ATC M09AX01. Basis for prohibiting transfer of drug indications to cosmetic/supplement claims. Active MFDS NEDRUG

Claim Safety Matrix

Claim classification below reflects human review of regulatory boundaries. This matrix documents where wording is safe, conditional, or prohibited — it is not marketing guidance.

Claim Text Claim Type Why It Matters Safer Alternative Wording Source
“May help with skin moisturization” (건기식 피부보습) Caution Only permissible if phrased to match the MFDS Health Functional Food Code (제2026-43호) notified-type wording. General cosmetic moisturization phrasing is a separate layer (see next rows). Use the notified-type Code wording verbatim; do not paraphrase. MFDS 건강기능식품 공전 제2026-43호
“May help support joint health” (건기식 관절건강) Caution Recognized only under 개별인정형 제2025-27호, limited to the recognized material and its single-manufacturer scope. Generalizing to ordinary HA raw material is not supported. Limit to 제2025-27호 recognized material and scope; do not generalize. Separate recognition or lawful-use basis required otherwise. MFDS 개별인정형 제2025-27호
General “skin moisture / hydration” cosmetic phrasing Caution Usable within the factual range of the KCIA labeled purpose (skin-conditioning agent). KCIA is a naming layer only — not a standalone functional basis. Stay within “skin-conditioning” fact; do not extend to functional-cosmetic claims (violates CLM-HA-001). KCIA 4822
“Functional moisturizing” / “MFDS-notified moisturizing functionality” Caution Cosmetic law has no moisturization functional category (별표4). Such wording risks a Cosmetics Act violation because the fast-track functional qualification structurally does not exist. Avoid “기능성 / 고시 / 인정” for moisturization entirely. REG-HA-001 / REG-HA-002 (제2025-88호)
Transferring KCIA “moisturizer” tag (Hydrolyzed HA, code 5655) into cosmetic-law functional moisturizing Caution KCIA code 5655 carries a “보습제 (moisturizer)” purpose tag, but that is a naming-layer classification. Only “listed as a moisturizer in the KCIA classification” is a factual quote. State only “classified as a moisturizer in KCIA”; do not expand to Cosmetics-Act functional moisturizing. KCIA 5655 / REG-HA-001·002
Drug indications — “관절강 주사 / 변형성 슬관절증 / 견관절주위염 / 관절 건강 (medical)” Prohibited These are approved prescription-drug indications for intra-articular sodium hyaluronate (REG-HA-004). Transferring them to a cosmetic or supplement claim creates a drug-misidentification (의약품 오인) risk and is prohibited. Do not transfer any drug indication. Reference the Rx status only as a boundary fact, never as a benefit. REG-HA-004 (NEDRUG 품목허가)

Evidence Boundaries: What This Page Does Not Claim

The following are outside the scope of this ingredient record:

This page does not claim that hyaluronic acid treats, prevents, or cures any joint disease or skin disease. Intra-articular hyaluronic acid indications (osteoarthritis of the knee, periarthritis of the shoulder) are approved prescription-drug uses under MFDS NEDRUG (REG-HA-004) and belong to the drug regulatory layer, not to cosmetics or health functional foods.

This page does not claim any “functional-cosmetic” moisturizing status. Korean functional-cosmetic law (별표4, 제2025-88호) contains no moisturization category, so no HA variant can hold fast-track functional moisturizing status (REG-HA-001, REG-HA-002).

This page does not assert that hyaluronic acid is “absolutely safe” as a matter of law. Absence from the prohibited/restricted lists (별표1·2, 제2026-19호) is a boundary fact, not a safety guarantee (REG-HA-003).

This page does not assert individual efficacy. Supplement moisturization and joint-health phrasing are confined to notified-type Code wording and to the 개별인정형 제2025-27호 recognized scope; individual results are not claimed.

Related Entities

Related Ingredients

  • Sodium Hyaluronate — sodium salt of hyaluronic acid (KCIA 1265, CAS 9067-32-7); salt-pair cross-reference

Variant Forms (not promoted to separate entities)

Variant KCIA Code Status Why not a separate entity
HMW / LMW / Oligo HA none (single code 1265) Not an entity Marketing molecular-weight labels; no separate KCIA code, no primary source for weight-specific efficacy
Hydrolyzed HA 5655 (purpose tag: moisturizer) Variant — on hold Has own KCIA code but promotion trigger (search demand / 별표 listing) not yet met
Hydrolyzed Sodium HA 7511 Variant — on hold Own KCIA code; promotion trigger not met
Sodium HA Crosspolymer-6 4152 Variant — on hold Own KCIA code; promotion trigger not met

Related Regulatory Concepts

  • Functional-cosmetic categories (별표4) and the absence of a moisturization category
  • Naming layer (KCIA) vs. functional layer (Cosmetics Act) separation
  • Prescription-drug indication vs. cosmetic/supplement claim boundary

Source Transparency Note

This page uses the following source classification:

Source Role Authority Scope Limit
MFDS 고시 (제2025-88호 별표4; 제2026-19호 별표1·2; 건기식 공전 제2026-43호) Regulatory Functional-cosmetic categories, prohibited/restricted lists, notified-type HFF wording, regulatory status Cosmetics / health functional food only
MFDS NEDRUG Regulatory (drug) Prescription-drug approval, approved indications Drug layer — must not transfer to cosmetic/supplement claims
KCIA ingredient dictionary (4822, 1265) Naming INCI name, synonyms, Korean name, labeled purpose Not a basis for functional/medical claims
PubChem (CID 24728612, 3084049) Chemical identity CAS No., molecular identity No regulatory or claim information

KCIA is used for naming and synonym confirmation only. KCIA alone is never used as the basis for a functional or medical claim.

Frequently Asked Questions

Is hyaluronic acid a regulated ingredient in Korea?
Yes. Hyaluronic acid is registered in the KCIA ingredient dictionary (code 4822) as a cosmetic ingredient, and hyaluronic-acid forms appear in MFDS health-functional-food and prescription-drug frameworks. Registration confirms lawful use but does not by itself grant any functional-cosmetic claim.

What moisturization claims are allowed for hyaluronic acid in Korean cosmetics?
Hyaluronic acid may be described within its KCIA “skin-conditioning agent” purpose, but Korean functional-cosmetic law has no moisturization category, so “functional / notified moisturizing” wording is not permitted for hyaluronic acid.

Can hyaluronic acid claims mention joint or disease treatment?
No. Joint-disease indications for hyaluronic acid are approved only as prescription-drug (intra-articular injection) uses. Transferring those drug indications to a cosmetic or supplement claim is prohibited and creates a drug-misidentification risk.

Is a “joint health” supplement claim available for hyaluronic acid?
Only within the individually-recognized (개별인정형) material under MFDS notification 제2025-27호, limited to the recognized material and its single-manufacturer scope. It cannot be generalized to hyaluronic acid as a whole.