Polysorbates are emulsifiers with mild surfactant properties and are used primarily to solubilize essential oils into water based cosmetics. Recently we were approached by a client concerned that the Polysorbates 20, 60 and 80 carried by Essential Wholesale& Labs might be “contaminated” with ethylene oxide and/or 1,4-dioxane.
The implication being that the Polysorbates might have been exposed to dangerous chemicals as a result of carelessness or negligence. Actually, Polysorbates use ethylene oxide as a raw material in the manufacturing process. Therefore, residual ethylene oxide and 1,4-dioxane, which is a by-product of the ethoxylations, are unavoidable. Therefore we cannot claim our Polysorbates are “free” of residual ethylene oxide and 1,4-dioxane. However the manufacturer of our Polysorbates does have processing steps included in the manufacture of the Polysorbates we use to reduce residual ethylene oxide and 1,4-dioxane to low levels. The specifications for the products listed below include the specifications for residual ethylene oxide and 1,4-dioxane:
Product Residual EO Residual 1,4-Dioxane
Polysorbate 20 1 ppm 10 ppm
Polysorbate 60 1 ppm 5 ppm
Polysorbate 80 1 ppm 10 ppm
Typical levels of both residual ethylene oxide and 1,4-dioxane are less than 1 ppm.
Our clients concern over Polysorbates developed after reading an article online warning consumers that ethylene oxide and 1,4-dioxane cause cancer. The fact is, The International Agency for Research on Cancer classifies ethylene oxide as a known human carcinogen. This is in the wake of a 2003 study of 7,576 women working at commercial sterilization facilities who were exposed to ethylene oxide on a daily basis. This group had a higher incidence of breast cancer than the general populace. Follow up research on people undergoing chronic exposure to ethylene oxide at work concluded “There was little evidence of any excess cancer mortality for the cohort as a whole, with the exception of bone cancer based on small numbers. Positive exposure-response trends for lymphoid tumors were found for males only. The reasons for the sex specificity of this effect are not known. There was also some evidence of a positive exposure-response for breast cancer mortality.” 1,4-dioxane as a possible human carcinogen, is as yet unproven.
Polysorbates are considered non-toxic and safe as used in the concentrations found in cosmetic and personal care products. Please consider that Polysorbates are used in manufacturing at a maximum of 1% of the total compound, and then recall that typical levels of both residual ethylene oxide and 1,4-dioxane are less than 1 ppm of the Polysorbate. Any residual ethylene oxide or 1,4-dioxane in a finished cosmetic base would be present in quantities too infinitesimal for detection, let alone to cause a health concern. All the same, we take our customers concerns very seriously and we are currently investigating how we could replace Polysorbates with an emulsifier that is even safer still, but works just as well. Until then, we hope you will continue to feel confident using Essential Wholesale & Labs cosmetic bases that do contain Polysorbates, keeping in mind we do offer a variety of sulfate free shampoos, gels and conditioners which are polysorbate free and that in our Organically Preserved Bases we offer Essential Certified Cleanser, Essential Certified Creme and Essential Certified Lotion which are each polysorbate free.