Polysorbate 61
Polysorbate 61 is approved for limited food uses with maximum levels set in 21 CFR 172.836; like other polysorbates, it is generally regarded as safe at permitted levels though some emerging research on emulsifiers and the gut microbiome remains under study.
What it is
Polysorbate 61 (polyoxyethylene (4) sorbitan monostearate) is a nonionic surfactant produced by ethoxylating sorbitan monostearate with about 4 moles of ethylene oxide.
Emulsifier and stabilizer in food; primarily found in baked goods and shortenings.
Why it's flagged
- limited research on emulsifier effects on gut microbiome
What regulators actually say
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Regulatory status
United States — FDA
Permitted under 21 CFR 172.836 with maximum allowable use levels in specific foods.
European Union — EFSA
Authorized as E435 family member with established ADI; polysorbate 61 specifically has limited EU food authorization.
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