Squalene and squalane are moisturising ingredients used in cosmetics. Squalene is an unsaturated branched chain hydrocarbon found in shark liver oil, certain plant oils, or derived through fermentation. Squalane is a saturated version of squalene.
In the European Union, squalane is not subject to any restrictions.
Use of squalene in cosmetics
Squalene (CAS 111-02-4/ 7683-64-9) is a skin conditioning and emollient, hair conditioning, and solvent. In the EU, some ingredients of animal origin are not allowed in cosmetics, especially to preserve biodiversity or to avoid spreading zoonoses. Over the past years, the European Commission has put in place several restrictions in relation to shark fishing. Consequently, squalene is not allowed in cosmetics when derived from sharks, as regulated by Annex II (list of forbidden ingredients) of the EU Cosmetics Regulation. On the other hand, cosmetics can contain plant-based squalene.
Ingredients compliance
Typically, cosmetics do not display the ingredients’ origin and therefore, knowing the origin of squalene contained in products found on shelves is not easy. Nonetheless, brand-owners placing cosmetics on the EU market must comply with the EU Regulation and compile a compliant Product Information File (PIF), which can be regularly inspected by competent authorities.
Your Responsible Person should therefore have the regulatory knowledge to guide brand-owners in the compilation of a compliant PIF. If you have questions on compliance of cosmetics in Europe or United States, contact us here.
References:
CosIng (2024). Ingredient: SQUALENE. Retrieved on 14/08/2024.
PCPC (2024). Protecting Biodiversity. Retrieved on 14/08/2024.
European Parliament (2013). Parliamentary question – E-011224/2013(ASW). Retrieved 14/08/2024.
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