Squalane

Cosmetic grade at not less than 92 per cent purity is the volume article for olive-derived material, where the balance is other hydrogenated branched hydrocarbons carried through from the deodoriser distillate. Sugarcane squalane produced by fermentation reaches 98 to 99 per cent purity because the biosynthetic route delivers a single molecule, and this higher-purity grade is preferred where cold stability, colour and odour must be tightly controlled. Ultra-refined grades above 99.5 per cent are made for injectable and ophthalmic use and for vaccine adjuvant applications, tested against pharmacopoeial rather than cosmetic criteria.

The material is otherwise sold to a single specification and is not offered in particle size or physical form variants, since it is a low viscosity liquid. Differentiation in trade is therefore by feedstock and certification, covering olive against sugarcane against rice bran origin, organic and vegan certification, non-genetically-modified declarations for the fermentation route, and traceability documentation confirming that the material is not of shark origin.

Squalane is regulated as a cosmetic ingredient. In the European Union it falls under Regulation (EC) No 1223/2009, is not restricted or prohibited by the annexes to that regulation, and is labelled under the INCI name squalane, with the safety assessment held in the product information file. In the United States it is a cosmetic ingredient under the Federal Food, Drug, and Cosmetic Act as amended by the Modernization of Cosmetics Regulation Act, with facility registration and product listing obligations applying to the finished product. The Cosmetic Ingredient Review expert panel has assessed squalane and squalene and concluded they are safe in cosmetic use under the conditions described in its report.

Pharmaceutical use is covered by separate monographs. Squalane appears in pharmacopoeial texts as an excipient, and material intended for injectable emulsions is manufactured and tested to those standards rather than to a cosmetic specification. Where the ingredient is used in a food or supplement context, its status is determined by the applicable national food ingredient rules, and the shark-derived origin question is handled through species declarations and supply chain documentation rather than through a specific regulatory prohibition in most markets.