Polyoxyethylene Sorbitan Monopalmitate
Also known as: E434, Polysorbate 40
EFSA's 2015 re-evaluation set a group ADI of 25 mg/kg bw/day for polysorbates including E434, finding low acute toxicity and no concern for genotoxicity, carcinogenicity, or developmental toxicity. However, EFSA flagged that high-consumer toddlers in non-brand-loyal scenarios approach the ADI (24.5 mg/kg bw/day).
What it is
Polyoxyethylene (20) sorbitan monopalmitate, a non-ionic surfactant ester of sorbitol/palmitic acid with ~20 ethylene oxide units (Polysorbate 40).
Emulsifier and stabilizer that helps oil-in-water systems remain homogeneous.
Why it's flagged
- potential gut microbiome disruption
- high exposure in toddlers approaches ADI
What regulators actually say
"The Panel allocated a group ADI of 25 mg/kg bw/day... the estimated exposure of toddlers at the highest level... remains very close to the ADI (24.5 mg/kg bw/day)."
Regulatory status
United States — FDA
Permitted as a direct food additive under 21 CFR 172.840 with specified maximum use levels
European Union — EFSA
Authorised under Regulation (EC) 1333/2008; group ADI of 25 mg/kg bw/day (EFSA Journal 2015;13(7):4152)
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