E433
Polyoxyethylene sorbitan monooleate (Polysorbate 80)
Also known as: Polysorbate 80, Tween 80
Components / composition
Non-ionic surfactant: polyoxyethylene derivative of sorbitan monoesterified with oleic acid.
Common usage in food
Emulsifier in ice cream, baked goods, and vitamin preparations.
Effects on human health
Poorly absorbed; hydrolyzed in GI tract. Used in pharmaceuticals as well as foods.
Risks & considerations
Generally safe at ADI. High doses in animal studies affect gut microbiota — relevance to food exposure debated.
Regulatory approval (EU)
Permitted in specified EU food categories.
US regulatory status (FDA)
Polysorbate 80 is a permitted food additive in the U.S. under 21 CFR 172.840 as a nonionic emulsifier. It is used in ice cream, baked goods, and vitamin preparations. FDA regulates polysorbates as a group with specified food categories and use levels.
Permitted amounts / regulatory limits (EU)
Category-specific limits in Annex II Part E.
Acceptable Daily Intake (ADI)
0–25 mg/kg body weight per day (JECFA, for polysorbates group).