Nonanedioic Acid (AZELAIC ACID)
Global Regulation Summary
Overview of current status across major international markets.
Detailed Regional Status
| Region | Status | Max Conc. | Conditions | Source |
|---|---|---|---|---|
| 🇪🇺 EU | Unknown | - | - | Official ↗ |
| 🇺🇸 USA | Unknown | - | - | Official ↗ |
| 🇯🇵 Japan | Unknown | - | - | Official ↗ |
| 🇰🇷 Korea | Unknown | - | - | Official ↗ |
| 🇬🇧 UK | Unknown | - | - | Official ↗ |
🌿 Natural Sources
Found in wheat, rye, and barley grains. Produced naturally by Malassezia furfur (Pityrosporum ovale), a yeast that lives on normal skin. First detected in rancid fats. Can be extracted from date palm vegetable oil.
🏭 How It's Made
Industrially produced by ozonolysis of oleic acid; side product is nonanoic acid. Extraction involves oxidation synthesis of oleic acid from date palm vegetable oil followed by purification. Commercially available as cosmetic grade Azepur99® (99% minimum purity). Vegetable-based production uses sustainable sources.
💄 Uses in Cosmetics
Concentration ranges 3-20%: cosmetics use 10%, medical devices/pharmaceuticals use 20%. Best solvents: glycols, polyglycols, glycerin, and polyglyceryl derivatives for stable translucent solutions. Often combined with niacinamide, salicylic acid, or glycolic acid. Treats acne, rosacea, melasma through tyrosinase inhibition and antimicrobial action.
🔬 Other Applications
Used as bio-based building block for biodegradable polymers. Food industry applications as preservative. First approved for clinical acne treatment nearly 40 years ago; FDA approved 15% gel for rosacea in 2003 and 20% cream for acne.
💡 Fun Facts
- • Discovery in dermatology dates to the 1970s when significant depigmentation was found in pityriasis versicolor lesions by a Rome dermatologist
- • Patients using it for hyperpigmentation coincidentally discovered it improved their acne, leading to its dual-purpose use
- • Produced naturally by yeast living on everyone's skin - your body is already familiar with this molecule from birth
Frequently Asked Questions
What is AZELAIC ACID used for in cosmetics?
AZELAIC ACID is primarily used for skin conditioning in cosmetic products. It also serves as antimicrobial, antioxidant. The ingredient is commonly found in moisturizers, lotions, and creams.
Which countries regulate AZELAIC ACID?
AZELAIC ACID is approved for cosmetic use in all major markets: , with no significant restrictions.
Where can I find official regulation information about AZELAIC ACID?
Official information about AZELAIC ACID regulations can be found on government websites: EU CosIng database, US FDA Cosmetics page, Japan MHLW cosmetics standards, UK Government cosmetics guidance, and Korea MFDS. Always verify regulatory status with these official sources before making formulation decisions.
Disclaimer
The information on this website is for educational and informational purposes only and is not intended as medical advice. While we strive for accuracy based on official government databases, cosmetic regulations change frequently. Always consult with a qualified professional or refer to the latest official regulatory documents for compliance. We are not responsible for any actions taken based on the information provided here.