Polyoxyethylene Sorbitan Tristearate
Also known as: E436, Polysorbate 65
Polysorbate 65 (E436) is approved as a food additive in the EU and US with established ADIs. EFSA reaffirmed an ADI of 25 mg/kg bw/day in 2015.
What it is
Polyoxyethylene (20) sorbitan tristearate (Polysorbate 65, E436) is a non-ionic surfactant produced by ethoxylating sorbitol esters of stearic acid.
Emulsifier and stabilizer.
Why it's flagged
- emerging research on polysorbate effects on gut microbiota in animal models
What regulators actually say
"Polysorbate 65 (polyoxyethylene (20) sorbitan tristearate) may be safely used in food in accordance with the following prescribed conditions."
"The Panel established a group ADI of 25 mg/kg bw per day expressed as the sum of polysorbates (E 432-436)."
Regulatory status
United States — FDA
Approved as direct food additive (21 CFR 172.838)
European Union — EFSA
Approved as E436 with group ADI of 25 mg/kg bw/day for polysorbates
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