TheDose

Polysorbate 60

Also known as Polyoxyethylene (20) sorbitan monostearate, Tween 60, PEG(20) sorbitan monostearate, Sorbitan monostearate, poly(oxy-1,2-ethanediyl) derivatives

CIR

Safe

CIR Expert Panel says: safe as used in cosmetics.”

Polysorbate 60 (polyoxyethylene (20) sorbitan monostearate; Tween 60; CAS 9005-67-8) is a nonionic emulsifier produced by ethoxylation of sorbitan monostearate with approximately 20 ethylene oxide units. Its HLB value of approximately 14.9 makes it a versatile O/W emulsifier used in creams, lotions, and other water-based formulations. The CIR Expert Panel originally assessed Polysorbate 60 and eight other polysorbates (20, 21, 40, 61, 65, 80, 81, 85) in 1984 (JACT 3(5):1-82) and concluded they are safe as cosmetic ingredients. The Panel issued an amended final report in June 2015 reaffirming this conclusion with updated use data and toxicology. The QRT row carries SQ (Safe Qualified) status with the Detail 'safe as used when formulated to be non-irritating', consistent with the qualification applied to all polysorbates in the group assessment. Like all ethoxylated ingredients, Polysorbate 60 may contain trace 1,4-dioxane as a manufacturing byproduct; the CIR 2015 assessment considered this and concluded safety was unaffected when modern vacuum-stripping controls are applied.


Nonionic O/W emulsifier with HLB approximately 14.9: creates stable emulsions in creams and lotions; widely used at typical cosmetic concentrations of 0.5–5%

Non-ionic compatibility: does not interact with most anionic or cationic ingredients, allowing broad formulation flexibility

Higher HLB than Polysorbate 20 (~16.7) makes Polysorbate 60 better suited to emulsification (rather than solubilization), offering formulators a complementary option within the polysorbate series

CIR Expert Panel concluded safe as used in cosmetics:1-82, 1984; reaffirmed in the June 2015 amended polysorbates assessment) — same assessment clears Polysorbates 20, 21, 40, 61, 65, 80, 81, and 85


Concerns
  • · Rare contact sensitization reports exist in the patch-test literature at low prevalence; CIR qualified safety with the formulation-to-be-non-irritating condition

1,4-Dioxane trace impurity (documented byproduct in the byproducts section) — a recognized manufacturing byproduct of the ethoxylation process; industry standard is vacuum stripping to reduce residual levels below ~10 ppm, and the CIR 2015 polysorbates assessment considered this when concluding safety

As a nonionic surfactant/emulsifier, Polysorbate 60 can enhance skin penetration of co-formulated ingredients; formulators should consider consequences when paired with actives that should remain at the surface


CIR Expert Panel
Approved
safe as used when formulated to be non-irritating
[1]
CIR Expert Panel · Jul 1, 2018Live

CIR Quick Reference Table (12/2017, revised 07/2018) — Polysorbate 60 row: Finding=SQ, Detail='safe as used when formulated to be non-irr…

Polysorbate 60 | SQ | safe as used when formulated to be non-irritating | JACT 3(5):1-82, 1984; Final report 06/2015 available from CIRQRT-122017revised072018.pdf, p. 108
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[2]
CIR Expert Panel · Jun 1, 2015

CIR Amended Safety Assessment of Polysorbates as Used in Cosmetics (Final Amended Report, June 2015). Scope covers Polysorbates 20, 21, 4…

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Sources
2
PubMed citations
0
Evidence quality
limited
Last verified
Re-reviewed when a new CIR / SCCS opinion publishes.