Polyoxyethylene Sorbitan Monooleate
Also known as: E433, Polysorbate 80
EFSA 2015 set a group ADI of 25 mg/kg bw/day for polysorbates and concluded no concern for genotoxicity, carcinogenicity, or developmental toxicity. Substantial scientific debate continues about effects of synthetic emulsifiers on gut microbiota and intestinal inflammation (Chassaing et al.
What it is
Polyoxyethylene sorbitan monooleate (Polysorbate 80 / Tween 80), a non-ionic synthetic emulsifier.
Emulsifier, stabilizer, dispersant in dairy, ice cream, dressings, and sauces.
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 80 may be safely used in or on food in accordance with the following prescribed conditions"
Regulatory status
United States — FDA
Approved 21 CFR 172.840 with use restrictions
European Union — EFSA
Authorised; group ADI 25 mg/kg bw/day (EFSA 2015)
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