What is it?
An emulsifier made by joining sorbitol, a sugar alcohol, with oleic acid, a fatty acid found in olive and other vegetable oils. It helps oil and water mix and stay mixed in creams, lotions, makeup and hair products. It is also a permitted food emulsifier (E 494) and an inactive ingredient in medicines, including some taken by mouth.
Key information
- The CIR Expert Panel concluded in 1985, and again in a re-review published in 2019, that sorbitan oleate is safe as used in cosmetics.
- It is not ethoxylated; polysorbate 80 (PEG-20 sorbitan oleate) is a different ingredient.
- As food additive E 494 it falls under a group acceptable daily intake of 10 mg per kilogram of body weight, set by EFSA in 2017.
- Allergic reactions are uncommon but documented, mostly in people already being patch-tested for dermatitis.
More information
The European Food Safety Authority (EFSA) describes sorbitan esters as made by directly esterifying sorbitol with fatty acids, using an acidic and a caustic catalyst, which yields a mixture of related compounds. No ethylene oxide is used. Its ethoxylated relatives, the polysorbates such as polysorbate 80 (PEG-20 sorbitan oleate), are different ingredients that fall under our PEG and ethoxylates ratings.
The Cosmetic Ingredient Review (CIR) Expert Panel concluded in 1985 that sorbitan oleate is safe as used and reaffirmed that in a review of 21 sorbitan esters published in 2019. In 2014 it was reported in 311 products, at up to 3 percent in leave-on and 7 percent in rinse-off products. Undiluted, it was minimally irritating to rabbit skin. Formulas with up to 2 percent did not cause allergic sensitization in repeat patch tests on volunteers, although several products with 1.75 to 2 percent were mildly irritating in 21-day cumulative irritation tests; the ingredient responsible was not identified.
Allergy is the main caveat. In patch testing of people with suspected contact dermatitis, about 0.6 percent reacted to sorbitan oleate at 5 percent and up to 2.7 percent at 20 percent. Its relative sorbitan sesquioleate causes reactions more often. One report described allergic reactions to 20 percent sorbitan oleate in three of 23 patients with chronic leg ulcers, and cross-reactions among sorbitan esters have been reported.
As a food additive, sorbitan monooleate (E 494) was re-evaluated by EFSA in 2017 with the other sorbitan esters. EFSA set a group acceptable daily intake of 10 mg per kilogram of body weight per day, expressed as sorbitan, found no concern for genotoxicity and saw no indication of cancer in long-term studies in mice and rats.
Sources: Cosmetic Ingredient Review: Safety assessment of sorbitan esters as used in cosmetics (draft final amended report, 2014); Cosmetic Ingredient Review: Quick reference table of safety conclusions (September 2022); EFSA Journal (2017): Re-evaluation of sorbitan esters (E 491 to E 495) as food additives
