Ingredient Directory
Vegetable (wheat/barley fermentation) / Synthetic

Azelaic Acid

1

Safety Flags
Safety Notes

Acne and brightening serums

Function & Common Use

Function

7-Heptanedicarboxylic acid

Category

ACT

Common In

Pregnancy, considered generally safe but medical review recommended

Origin

Active Ingredient

Concentration Limits

India (CDSCO)

Cosmetic claims: review at >5%; drug boundary in EU/US at >20%

EU Cosmetics Reg.

No

US FDA (21 CFR)

No specific 21 CFR cosmetic limit identified in source checked; EU limit reference: No

Korea (MFDS)

No specific MFDS limit identified in source checked; verify if ingredient is used in a Korean functional cosmetic category

Format restriction: No formal limit

Baby restriction: Leave-on

Pregnancy: No specific restriction identified in source checked; standard cosmetic use

Frequently Asked Questions

Is Azelaic Acid safe to use in skincare?

Azelaic Acid has a High concern rating. Acne and brightening serums

Is Azelaic Acid allowed in India?

Azelaic Acid is currently classified as "EU Annex III (under review)" under Indian cosmetics regulations. The maximum permitted concentration is Cosmetic claims: review at >5%; drug boundary in EU/US at >20%.

What is Azelaic Acid used for in cosmetics?

Azelaic Acid functions as: 7-Heptanedicarboxylic acid. It is commonly found in: Pregnancy, considered generally safe but medical review recommended.

Is Azelaic Acid safe for babies?

Azelaic Acid has baby/child restrictions: Leave-on. Avoid using products containing this ingredient on infants unless specifically formulated and labelled for baby use.

TCS Assessment
Vegetable (wheat/barley fermentation) / Synthetic
Data Confidence
Medium
Based on peer-reviewed safety data, regulatory status, and expert review by The Clean Sheet panel.

Regulatory Status

India (CDSCO)
EU Annex III (under review)
EU
Low
US FDA
Permitted
Korea (MFDS)
Drug at >20% (prescription); cosmetic below
Australia (TGA)
Cosmetic ingredient; standard TGA cosmetic framework applies; no therapeutic goods listing required unless therapeutic claims are made
Canada (NHPID)
Not specifically listed as restricted cosmetic ingredient in NHPID source checked; standard Health Canada cosmetic notification applies

EU Annex: Permitted (drug-cosmetic boundary review required at high %)

Identifiers

CAS123-99-9
EC204-669-1

Want to check if your product contains Azelaic Acid?

Analyse a Product
WhatsApp Community

Join The Clean Sheet™ community

Science-backed beauty tips, ingredient alerts, and early access. Straight to your WhatsApp.

Join for free →