Sorbitan Monostearate
Also known as: E491
EFSA reevaluated sorbitan esters (E 491-495) in 2017 and established a group ADI of 10 mg sorbitan/kg bw/day (a reduction from the prior 25 mg/kg bw/day JECFA value). The Panel concluded no safety concern for the reported uses, but the lowered ADI reflects updated toxicological evaluation.
What it is
Sorbitan monostearate, a non-ionic emulsifier formed by esterifying sorbitan with stearic acid.
Emulsifier and stabilizer; modifies crystallization in fats and prevents separation.
Why it's flagged
- lowered ADI (EFSA 2017)
- potential digestive effects at very high intake
What regulators actually say
"The ANS Panel established a group ADI of 10 mg sorbitan/kg body weight (bw) per day applicable to the food additives E 491-495."
"Sorbitan monostearate may be safely used in food in accordance with the conditions prescribed."
Regulatory status
United States — FDA
Approved as a food additive in 21 CFR 172.842 with use restrictions.
European Union — EFSA
Authorized E 491; group ADI 10 mg sorbitan/kg bw/day (EFSA, 2017).
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