Sorbitan Stearate

The Food and Drug Administration (FDA) allows Sorbitan Stearate to be added to food as a multipurpose food additive. Sorbitan Stearate is also on FDA's list of and flavoring substances and adjuvants that may be added to food.

The safety of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate and Sorbitan Trioleate has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that these ingredients were safe as a cosmetic ingredient under present conditions of concentration and use.CIR Review: The CIR Expert Panel noted that as a class, the Sorbitan esters, including Sorbitan Stearate, are generally mild skin irritants but nonsensitizers. Sorbitan Stearate is not a photosensitizer. Sorbitan Stearate and Sorbitan Laurate were negative in carcinongenicity studies. Based on the available information, the CIR Expert Panel concluded that Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Trioleate were safe as cosmetic ingredients.

FDA: Link to Code of Federal Regulations for Sorbitan Monostearate
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

When made from plants Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate and Sorbitan Trioleate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union. Ingredients of animal origin must comply with the European Union animal by-products regulations.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...

The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-25 mg/kg body weight for the sum of Sorbitan esters of lauric, oleic, palmitic, and stearic acid. http://www.inchem.org/documents/jecfa/jeceval/jec_2185.htm