Regulatory Status
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Safety Data
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Dermal Penetration Profile
Skin absorption and penetration characteristics of Azelaic Acid, relevant to systemic exposure and MoS calculations.
Source: J Eur Acad Dermatol 2017
Expert Verdict
Highly versatile depigmenting active with selective targeting of hyperactive abnormal melanocytes while sparing normally pigmented cells, eliminating leukoderma risk. Dual action of reversible tyrosinase inhibition and anti-inflammatory PGE2 reduction is particularly valuable for post-inflammatory hyperpigmentation and darker skin types. US Rx at 15-20%; cosmetic brightening at 10% or less is effective and unrestricted in both EU and US. Endogenous naturally occurring compound with excellent safety profile.
Regulatory Flags
Frequently Asked Questions
Is Azelaic Acid safe in cosmetics?
Highly versatile depigmenting active with selective targeting of hyperactive abnormal melanocytes while sparing normally pigmented cells, eliminating leukoderma risk. Dual action of reversible tyrosinase inhibition and anti-inflammatory PGE2 reduction is particularly valuable for post-inflammatory hyperpigmentation and darker skin types. US Rx at 15-20%; cosmetic brightening at 10% or less is effective and unrestricted in both EU and US. Endogenous naturally occurring compound with excellent safety profile. The EU classifies Azelaic Acid as "permitted". Safety rating: EXCELLENT.
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.
What is the Margin of Safety for Azelaic Acid?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
Compliance Tools
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Related Ingredients
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