Cosmetics · Quasi-drug actives

Kojic Acid

コウジ酸 (Kōji-san)

Also known as: 5-Hydroxy-2-(hydroxymethyl)-4H-pyran-4-one

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Why now · 2022 — ongoing

Koji Beyond Sake: Industrial Applications Western Brands Are Discovering

Koji (Aspergillus oryzae) — Japan's national microorganism — is moving from sake/miso into plant-based meats, alternative charcuterie, and bakery applications worldwide.

Read the trend report

At a glance

CategoryCosmetics
INCI nameKojic Acid
Japanese labeling nameコウジ酸
Common Japanese notationsコウジ酸, 麹酸
CAS number501-30-4
OriginFermented (originally identified as a metabolite of Aspergillus oryzae)
Typical functionsQuasi-drug whitening active
Regulatory status in JapanApproved as a quasi-drug (医薬部外品) whitening active by 厚生労働省 (Ministry of Health, Labour and Welfare) within defined concentration ranges.

Kojic acid was first identified by Japanese researchers as a metabolite of Aspergillus oryzae — the same koji mold central to sake, miso, and soy sauce production. Its name comes directly from this fermentation origin (kōji + -san meaning acid). It is used as a quasi-drug whitening active in Japan and as a cosmetic ingredient internationally.

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Classification

Tags below link to other ingredients sharing the same attribute, so you can pivot from one ingredient to its peers.

Common OEM product categories

Finished-product categories where Japanese OEM manufacturers commonly formulate with this ingredient.

  • Medicated whitening serums and lotions
  • Spot-care products
  • Soap bars (whitening positioning)

Ingredient profile

Kojic acid is a pyranone produced by various Aspergillus and Penicillium species during fermentation. Its discovery as a fermentation metabolite of Aspergillus oryzae gave the compound both its name and a particularly Japanese association.

It functions in melanin synthesis as a tyrosinase inhibitor.

OEM applications

In Japanese quasi-drug whitening products, kojic acid is one of the established approved active ingredients. Internationally, kojic acid is used in cosmetic preparations across many markets, with concentration limits varying by jurisdiction.

Regulatory classification in Japan

Approved as a quasi-drug whitening active ingredient by 厚生労働省 (Ministry of Health, Labour and Welfare) within defined concentration ranges.

Regulatory classification in other markets

EUListed in CosIng under Kojic Acid. EU SCCS opinion permits cosmetic use up to 1.0 percent in face and hand products.
USAINCI recognized. Used in cosmetic products.
ChinaPermitted per IECIC listings; verify concentration ranges.
KoreaPermitted under KFDA / MFDS.

Market reference formulations

Example finished products will be added after each product's current full ingredient list has been verified.

All brand names and product names referenced anywhere on this site are the property of their respective owners. Example entries are provided for informational purposes only and do not imply endorsement.

Typical OEM use levels

Formulation ranges per finished-product application. Verify against the cited source before production.

ApplicationTypical rangeRegulatory limitNotes
Quasi-drug whitening serum / lotion (Japan)1%1% per 厚生労働省 quasi-drug notification厚生労働省 医薬部外品有効成分通知

Stability & compatibility

pH range
pH 4–6
Temperature
Light-sensitive; oxidizes to brown-yellow color over time
Incompatibilities
  • Iron ions (forms colored chelates)
  • Strong oxidizers
  • UV exposure

Use opaque packaging and add metal chelators (EDTA / phytate). Common to pair with antioxidants to retard color shift.

Storage requirements

How the receiving OEM facility needs to handle inbound raw material.

Temperature
≤20°C; refrigerated for long-term color retention
Conditions
Dry, sealed, opaque packaging mandatory (oxidizes to brown / yellow)
Shelf life
24 months sealed; visible color shift over time even sealed

EU SCCS (欧州消費者安全科学委員会) + supplier SDS

Supply concentration

Where this ingredient comes from — useful for single-source-risk planning.

Primary regions
Aspergillus oryzae fermentation-derived; production scale is largest in China and Korea
Import dependence
Japanese supply mostly imported; domestic volume small

Alternative ingredients

Related ingredients commonly evaluated as substitutes.

Quick answers

What is Kojic Acid?
Kojic acid was first identified by Japanese researchers as a metabolite of Aspergillus oryzae — the same koji mold central to sake, miso, and soy sauce production. Its name comes directly from this fermentation origin (kōji + -san meaning acid). It is used as a quasi-drug whitening active in Japan and as a cosmetic ingredient internationally.
What is the regulatory status of Kojic Acid in Japan?
Approved as a quasi-drug (医薬部外品) whitening active by 厚生労働省 (Ministry of Health, Labour and Welfare) within defined concentration ranges.
What products typically use Kojic Acid?
Medicated whitening serums and lotions / Spot-care products / Soap bars (whitening positioning)
Where does Kojic Acid come from?
Fermented (originally identified as a metabolite of Aspergillus oryzae)
What is the INCI / JSCI labeling name for Kojic Acid?
INCI: Kojic Acid / JSCI: コウジ酸

Japanese OEM factories whose published profile references this ingredient. Auto-detected from manufacturer descriptions; verify capabilities directly.

FAQ for OEM buyers

Q. What is the regulatory status of kojic acid in Japan, the EU, and the US?

Japan approves it as a quasi-drug whitening active; the EU SCCS has assessed it safe at up to 1% in face/hand cosmetics; in the US it is used as a cosmetic ingredient with no specific OTC monograph status. South Korea also recognizes brightening claims at controlled levels.

Sources · Last reviewed: 2026-04-26

Q. What is the typical Japanese quasi-drug use level?

Quasi-drug whitening formulations typically use kojic acid at around 1.0% (the validated approval level); finished product pH and packaging significantly affect color and odor stability.

Sources · Last reviewed: 2026-04-26

  • 厚生労働省 (Ministry of Health, Labour and Welfare) — quasi-drug approval files for kojic acid
Q. What stability/quality issues should buyers expect?

Kojic acid is prone to discoloration (yellow-brown) and degradation in the presence of metal ions, light, and elevated pH. Chelators (EDTA, sodium phytate), antioxidants, and opaque packaging are standard countermeasures.

Sources · Last reviewed: 2026-04-26

  • Industry knowledge — kojic acid formulation practice

Industry-knowledge claim — not yet pinned to a single primary source

Q. Are there allergen or sensitization concerns?

Japanese and EU safety assessments have identified contact sensitization potential at higher use levels, which is why the SCCS limit is 1% in face/hand products and excluded for body lotion. Patch testing is recommended for high-strength formulations.

Sources · Last reviewed: 2026-04-26

Use cases

  • Medicated whitening cream/serum

    Positioning
    Mainstream Japan quasi-drug whitening line
    Typical usage level
    1% (Japan quasi-drug)
    Formulation notes
    Use chelators, antioxidant, and opaque packaging; pair with vitamin C derivatives for combined claims.

    Sources

    • Industry knowledge — kojic acid Japan formulations

    Industry-knowledge claim — not yet pinned to a single primary source

  • Brightening soap (Asia/global export)

    Positioning
    Mass-market Asian brightening bar/liquid soap
    Formulation notes
    Common in Philippines/SE Asia exports at higher levels; check destination-market regulatory caps.

    Sources

    • Industry knowledge — Asian brightening soap market

    Industry-knowledge claim — not yet pinned to a single primary source

  • Spot-treatment ampoule

    Positioning
    Targeted dark-spot serum, often combined with arbutin
    Formulation notes
    Stabilize with low pH (3.5–5.0) and chelators; airless pump packaging.

    Sources

    • Industry knowledge — spot-treatment ampoule formulation

    Industry-knowledge claim — not yet pinned to a single primary source

  • EU brightening face cream

    Positioning
    Brightening positioning under EU cosmetics regulation
    Typical usage level
    ≤1.0% (face/hands per SCCS opinion)
    Formulation notes
    Only face/hand use; exclude body lotion to comply with SCCS opinion.

    Sources

    • SCCS Opinion SCCS/1637/21 (Kojic Acid)

Search the academic literature

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Official regulatory databases

External links to public Japanese / international regulatory authorities. We are not affiliated.

References

  1. Japan 医薬品医療機器総合機構 PMDA (Pharmaceuticals and Medical Devices Agency) — quasi-drug active ingredient approval registry
  2. EU SCCS opinion on kojic acid

Last updated: 2026-04-22. Ingredient entries are reviewed at least annually against current regulatory listings.

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