Azelaic Acid
Also known as: Nonanedioic acid
Last updated:
Azelaic acid is a dicarboxylic acid used in cosmetics for its anti-inflammatory, antibacterial, and brightening effects. It is permitted globally in cosmetics, typically at concentrations up to 10%. In the US, FDA-approved prescription products contain 15-20% azelaic acid for rosacea (Finacea) and acne (Azelex). In the EU, products above 10% are typically classified as medicinal.
Regulatory status by market
| Market | Status | Detail | Source |
|---|---|---|---|
| European Union | Permitted | Cosmetic use up to 10%; drug pathway above | Not on Annex II or III |
| United Kingdom | Permitted | Mirrors EU | UK Cosmetics Regulation |
| United States | Conditionally permitted | Cosmetic use generally up to 10%; FDA-approved Rx products at 15-20% | FDA approval (Finacea, Azelex) |
| Canada | Permitted | — | Not on Hotlist |
Safety profile
Azelaic acid is well-tolerated with mild and transient initial tingling or redness common at first use. CIR has reviewed azelaic acid and concluded it is safe at cosmetic concentrations. It is generally considered safe during pregnancy by most healthcare providers, making it a popular alternative to retinol and salicylic acid during pregnancy.
Common uses
- Acne and rosacea serums (cosmetic ≤10%)
- Pigmentation and brightening products
- Anti-inflammatory skincare for sensitive skin
Primary sources
Regulatory status is current to the "Last updated" date above. Always verify against the regulator's authoritative publication for the specific market and product category before relying on this summary for compliance decisions.
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