Following the request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of polyoxyethylene sorbitan monolaurate (polysorbate 20, E 432), polyoxyethylene sorbitan monooleate (polysorbate 80, E 433), polyoxyethylene sorbitan monopalmitate (polysorbate 40, E 434), polyoxyethylene sorbitan monostearate (polysorbate 60, E 435) and polyoxyethylene sorbitan tristearate (polysorbate 65, E 436) used as food additives. Polysorbates (E 432–E 436) are authorised as food additives in the European Union (EU).
The Scientific Committee on Food (SCF) allocated a group Acceptable Daily Intake (ADI) of 10 mg/kg bw/day for polysorbates 20, 40, 60, 65 and 80 (SCF, 1985). The basis was a No Observed Effect Level (NOEL) equivalent to 1 460 mg/kg bw/day in the diet in the 90-day study in rats with polyoxyethylene sorbitan monostearate (polysorbate 60) (BIBRA, 1981; cited in SCF, 1985).……
