Polysorbate
Polysorbates are FDA-approved emulsifiers (21 CFR 172.836-172.842). Animal studies have raised concerns about gut microbiome disruption and intestinal inflammation at high doses, but human evidence is limited.
What it is
A class of nonionic surfactants and emulsifiers (Polysorbate 20, 60, 65, 80) made from sorbitol esterified with fatty acids and ethoxylated.
Emulsifier; stabilizer; defoamer.
Why it's flagged
- potential gut microbiome effects (animal studies)
- ADI exceedance possible in heavy consumers
What regulators actually say
"Polysorbate 80 is permitted as a direct food additive when used in accordance with good manufacturing practice."
"The Panel established a group ADI of 25 mg/kg bw/day for polysorbates (E432-E436)."
Regulatory status
United States — FDA
Permitted as direct food additive (21 CFR 172.836-172.842)
European Union — EFSA
Permitted (E432-E436); ADI 25 mg/kg bw/day
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