Polyoxyethylene Sorbitan Monostearate
Also known as: E435, Polysorbate 60
EFSA's 2015 re-evaluation set a group ADI of 25 mg/kg bw/day for polysorbates (E432–E436); concluded no concern for genotoxicity, carcinogenicity, or developmental toxicity. Synthetic emulsifiers in this class are subject to ongoing scientific debate regarding gut microbiota and intestinal inflammation effects (Chassaing 2015 Nature).
What it is
Polyoxyethylene sorbitan monostearate (Polysorbate 60), a non-ionic synthetic emulsifier.
Emulsifier, stabilizer, defoamer in baked goods, dairy, and dressings.
Why it's flagged
- Possible gut microbiota disruption
- Intestinal inflammation in animal models
What regulators actually say
"Group ADI of 25 mg/kg body weight per day for polysorbates 20, 40, 60, 65 and 80"
"Polysorbate 60 may be safely used in or on food in accordance with the following prescribed conditions"
Regulatory status
United States — FDA
Approved 21 CFR 172.836 (polysorbate 60)
European Union — EFSA
Authorised; group ADI 25 mg/kg bw/day
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