What Is Polysorbate 60?
An FDA compliance policy guide gives polyoxyethylene (20) sorbitan monostearate as the chemical name for polysorbate 60. FDA regulations at 21 CFR 172.836 allow polysorbate 60 as an emulsifier in whipped edible oil topping, alone or with certain other emulsifiers, at a maximum of 0.4 percent of the weight of the finished topping, and in cakes and cake mixes, where, when used alone, it may not exceed 0.46 percent of the cake or cake mix on a dry-weight basis.
In its 2015 re-evaluation of polysorbates E 432 to E 436, the European Food Safety Authority panel said acute toxicity is very low and there is no concern regarding genotoxicity, carcinogenicity or developmental toxicity, and allocated a group acceptable daily intake of 25 mg per kg of body weight per day. The Cosmetic Ingredient Review panel issued a tentative amended report in March 2015 with a conclusion that polysorbates are safe as used in cosmetics when formulated to be nonirritating.
Sources checked September 15, 2026. Every point below links the page it came from.
The sources behind this answer
- Medical referenceAn FDA compliance policy guide gives polyoxyethylene (20) sorbitan monostearate as the chemical name for polysorbate 60. US FDA ↗
- Regulatory filingFDA regulations allow polysorbate 60 as an emulsifier in whipped edible oil topping at up to 0.4 percent of the finished topping. US FDA, 21 CFR 172.836 (eCFR) ↗
- Regulatory filingFDA regulations say polysorbate 60 used alone in cakes and cake mixes may not exceed 0.46 percent on a dry-weight basis. US FDA, 21 CFR 172.836 (eCFR) ↗
- Government sourceEFSA allocated a group acceptable daily intake for polysorbates E 432 to E 436 of 25 mg per kg of body weight per day in 2015. European Food Safety Authority, via PubMed Central ↗
- Government sourceEFSA said polysorbates have very low acute toxicity and raise no concern for genotoxicity, carcinogenicity or developmental toxicity. European Food Safety Authority, via PubMed Central ↗
- Medical referenceThe Cosmetic Ingredient Review panel concluded in 2015 that polysorbates are safe as used in cosmetics when formulated to be nonirritating. Cosmetic Ingredient Review ↗
Sources checked September 15, 2026. A brand statement is the company’s own claim, which we report but have not verified. Our grades are model-based estimates, not lab tests.