Steareth-21
Steareth-21 is a PEG-based emulsifier reviewed by the CIR Expert Panel as part of the steareth family safety assessment, concluded safe as used (up to ~7% in cosmetics) when formulated to be non-irritating. Manufacturing concern: ethoxylation can leave 1,4-dioxane impurities (IARC Group 2B, possible carcinogen); reputable manufacturers strip 1,4-dioxane to trace levels.
What it is
Polyethylene glycol (PEG-21) ether of stearyl alcohol — an ethoxylated nonionic surfactant/emulsifier (21 ethylene oxide units).
Emulsifier / surfactant — primarily cosmetic, not a food ingredient.
Why it's flagged
- 1,4-dioxane manufacturing contamination if not purified
- ethylene oxide residue concerns
What regulators actually say
"The CIR Expert Panel concluded that the Steareth ingredients were safe as used when formulated to be nonirritating; small amounts of 1,4-dioxane, a by-product of ethoxylation, may be present and can be controlled by purification."
"Steareth-21 is a polyethylene glycol ether of stearic acid that functions as an emulsifier and surfactant."
Regulatory status
United States — FDA
Cosmetic ingredient; not an approved food additive
European Union — EFSA
Cosmetic ingredient under EU 1223/2009; PEG impurity limits apply
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