Perhydrosqualene (SQUALANE)
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
Historically from deep-sea shark liver oil (96% squalene content, particularly centrophorus artomarginatus living 600-1000m deep). Plant sources: olive oil (0.8-13 g/kg or 200-7,500 mg/kg depending on cultivar), amaranth seed, sugarcane, rice bran, wheat germ. Squalane is the hydrogenated form, not naturally abundant.
π How It's Made
Produced by hydrogenation of squalene, converting six double bonds to single bonds, creating fully saturated C30H62 molecule. This process makes it odorless, softer, thinner, more skin-friendly, and oxidation-resistant. Modern production uses plant-based squalene from olive oil or biotechnology (genetically modified yeast/bacteria) for sustainability, replacing shark-derived sources.
π Uses in Cosmetics
Used at 10.1 to >50% in 294 cosmetic formulations. Provides moisturizing, antioxidant, UV-protective properties. Enhances delivery of bioactive molecules, extends product shelf life. More stable than squalene due to lack of double bonds. Found in facial oils, moisturizers, serums, and anti-aging products. Non-comedogenic, suitable for all skin types.
π¬ Other Applications
Pharmaceutical applications: vaccine adjuvant (MF59 by Novartis, AS03 by GlaxoSmithKline) to boost immune response and reduce antigen amount needed. Enables solubilization and slow release of lipophilic drugs. Used in vaccines for influenza, tuberculosis, malaria, HIV, schistosomiasis, herpes zoster. Drug delivery systems for increased bioavailability and sustained action.
π‘ Fun Facts
- β’ Squalene discovered in 1906 by Japanese researcher Mitsumaru Tsujimoto from shark liver oil, named from Latin 'squalus' (shark). Chemical formula clarified in 1931 by Professor Kahler, University of Zurich
- β’ Deep-sea sharks store 96% squalene in their liver to maintain buoyancy in waters 600-1000m deep without sunlight
- β’ Shift from shark to plant/biotech sources driven by sustainability - estimated 3 million deep-sea sharks were killed annually for cosmetic squalene before alternatives emerged
Frequently Asked Questions
What is SQUALANE used for in cosmetics?
SQUALANE 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 SQUALANE?
SQUALANE is approved for cosmetic use in all major markets: , with no significant restrictions.
Where can I find official regulation information about SQUALANE?
Official information about SQUALANE 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.