Is Azelaic Acid safe in cosmetics?
Azelaic Acid has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
Azelaic Acid
Also known as: Emery 1110, ZK 62498, Emery 1144, Empol 1144, 4-02-00-02055 (+14 more)
INCI: AZELAIC ACID
Azelaic Acid (CAS 123-99-9) is a cosmetic active ingredient functioning as Reversible tyrosinase inhibitor; selective antiproliferative and cytotoxic. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
Function
Reversible tyrosinase inhibitor; selective antiproliferative and cytotoxic agent against abnormal hyperactive melanocytes while sparing normally pigmented cells; anti-inflammatory; anti-keratinization; antibacterial (P. acnes)
Editorial assessment
EXCELLENT
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Prescription drug at 15% (Finacea — rosacea) and 20% (Azelex — acne/hyperpigmentation). Cosmetic use at 10% or less permitted under FD&C Act without drug classification. Drug claims (treating rosacea, acne) at any concentration trigger FDA drug classification regardless of concentration.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Azelaic Acid.
Calculate MoS for your specific formulation with the MoS Calculator.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Azelaic Acid, relevant to systemic exposure and MoS calculations.
Absorption %
10-18%
Penetration Level
epidermis
Penetration Depth
epidermis
Molecular Weight
188.2 Da
Log P
1.57
Systemic Absorption
minimal
Topical Bioavailability
6-14%
Safety Margin Factor
moderate
Vehicle Dependent
Yes — absorption varies by formulation
Source: J Eur Acad Dermatol 2017
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (III - Restricted)
Max: (a) leave on products should not excceding 0.3%(b) Rise off product not exceeding 10%.
ASEAN Cosmetic Directive (II)
Ref: A1141
JPKR Japan/Korea Cosmetics
Korea (Prohibited): Pharmaceutical only; not in cosmetics
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Restricted · max (a) leave on products should not excceding 0.3%(b) Rise off product not exceeding 10%
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| ASEAN | banned | - | All cosmetic products prohibited |
| KR | prohibited | - | - |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Serum | 5–20 | 20 | SCCS Opinion |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Deodorizer
Flavouring and nutrient
Fragrance
pH regulating agent
Regulatory List Membership (1)
FDA Indirect Food Contact Additives
Editorial summary
Preliminary editorial summary for Azelaic Acid — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
tyrosinase-inhibitor
brightening
selective-melanocyte-targeting
no-leukoderma-risk
anti-inflammatory
pge2-reduction
antibacterial
pih
melasma
fitzpatrick-iv-vi-preferred
rx-15pct-finacea
rx-20pct-azelex
cosmetic-to-10pct
natural-origin
endogenous
eu-unrestricted
no-us-cosmetic-restriction
endocrine_disruptor
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Azelaic Acid by CAS number or substance name.
Studies
6
Lowest NOAEL
1000 mg/kg bw/day
Highest NOAEL
1500 mg/kg bw/day
ECHA
Known Synonyms
Emery 1110
ZK 62498
Emery 1144
Empol 1144
4-02-00-02055
Azelaic acid, technical grade
BRN 1101094
EINECS 204-669-1
Heptanedicarboxylic acid
Acidum azelaicum
UNII-F2VW3D43YT
1,7-Heptanedicarboxylate
1,9-Nonanedioate
Anchoate
Azalaic acid
Azelaicacidtech
Azelainic acid
Azelate
Azelex
Chemical Function
Deodorizer
pH regulating agent
Fragrance
Flavouring and nutrient
Regulatory Lists
pharmaceutical
Indirect additives food contact (10/2018)
Canada; pharmaceutical
Europe
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
AZELAIC ACID
ChEMBL ID
CHEMBL1238
Max Phase
4
Adverse Event Associations
3124
Frequently Asked Questions
Is Azelaic Acid allowed in the EU?
Azelaic Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Azelaic Acid do in cosmetics?
Azelaic Acid functions as: Reversible tyrosinase inhibitor; selective antiproliferative and cytotoxic agent against abnormal hyperactive melanocytes while sparing normally pigmented cells; anti-inflammatory; anti-keratinization; antibacterial (P. acnes). It is classified as a Active Ingredient in our database. CAS number: 123-99-9.
Is Azelaic Acid used outside cosmetics?
Azelaic Acid also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Azelaic Acid compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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