Squalene (SQUALENE)
Global Regulation Summary
Overview of current status across major international markets.
Detailed Regional Status
| Region | Status | Max Conc. | Conditions | Source |
|---|---|---|---|---|
| πͺπΊ EU | Unknown | - | - | Official β |
| πΊπΈ USA | Unknown | - | - | Official β |
| π―π΅ Japan | Unknown | - | - | Official β |
| π°π· Korea | Unknown | - | - | Official β |
| π¬π§ UK | Unknown | - | - | Official β |
πΏ Natural Sources
Deep-sea shark liver oil (96% content, particularly Squalidae family sharks living 600-1000m deep). Plant sources: virgin olive oil (0.8-13 g/kg or 200-7,500 mg/kg depending on cultivar and extraction), amaranth seed, rice bran, wheat germ, sugarcane. Also produced naturally in human sebum and skin.
π How It's Made
Traditionally extracted from deep-sea shark liver oil (Squalidae family). Modern sustainable production: extracted from olive oil during refining process, or produced by genetically modified yeasts and bacteria through fermentation. Genetic and metabolic manipulation significantly improved microbial production yields, offering sustainable alternative to shark harvesting.
π Uses in Cosmetics
Used to soften skin and provide moisturizing benefits. Contains six double bonds (polyunsaturated), making it prone to oxidation - less stable than hydrogenated squalane. Low acute toxicity in cosmetic concentrations, not a significant contact allergen or irritant. Most squalene is converted to squalane for cosmetic use due to stability concerns.
π¬ Other Applications
Critical pharmaceutical use as vaccine adjuvant (MF59, AS03) to boost immune response by facilitating antigen transport to immune cells. Reduces antigen amount needed, enabling faster vaccine production scaling. Used in flu, tuberculosis, malaria, HIV, schistosomiasis, herpes zoster vaccines. Pharmaceutical demand much smaller than cosmetic, but essential for vaccine manufacturing.
π‘ Fun Facts
- β’ Discovered in 1906 by Japanese researcher Mitsumaru Tsujimoto in shark liver oil - named from Latin 'squalus' meaning shark
- β’ Deep-sea sharks use squalene's low density (lighter than water) to maintain buoyancy at 600-1000m depths where they live without swim bladders
- β’ Sustainability crisis led to innovation: estimated 3 million sharks killed annually for cosmetic squalene before plant-based and biotech alternatives became viable in recent decades
Frequently Asked Questions
What is SQUALENE used for in cosmetics?
SQUALENE is primarily used for emollient in cosmetic products. It also serves as skin conditioning, antioxidant. The ingredient is commonly found in moisturizers and skin softening products.
Which countries regulate SQUALENE?
SQUALENE is approved for cosmetic use in all major markets: , with no significant restrictions.
Where can I find official regulation information about SQUALENE?
Official information about SQUALENE 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.