Steareth-20

The Food and Drug Administration (FDA) permits fatty alcohols (including stearic alcohol) reacted with polyethylene glycol to be used as indirect food additives as components of textiles and textile fibers.

The safety of Steareth-2, Steareth-4, Steareth-6, Steareth-7, Steareth-10, Steareth-11, Steareth-13, Steareth-15 and Steareth-20 has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that these ingredients were safe as cosmetic ingredients in the present practices of use and concentration. In 2006, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on the Steareth ingredients and reaffirmed the above conclusion.CIR Safety Review: The CIR Expert Panel decided that the data on Steareth-2, -10, and -20 were sufficient to reach a decision on the entire group of Steareth ingredients, including Steareth-4, -6, -11, -13 and -15 because of the chemical similarity of all the Steareths. Steareth-2 and -10 were nontoxic in acute oral toxicity studies. In subchronic testing, Steareth-20 was nontoxic when administered dermally at concentrations of 4%. Steareth-2 and -10, at concentrations up to 60% in water, were at most mildly irritating to eyes and only mild irritants when tested in cosmetic formulations at concentrations up to 60%. Structurally similar polyoxyethylene alkyl ethers were neither mutagenic nor tumor promoters. Steareth-2, -10 and -20 in water were neither primary irritants nor sensitizers to human skin. Steareth-20 was not phototoxic.

Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in the Steareth ingredients. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations.

Link to more information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane.
http://www.cfsan.fda.gov/~dms/cosdiox.html

Link to the FDA Code of Federal Regulations:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Steareth-2, Steareth-4, Steareth-6, Steareth-7, Steareth-10, Steareth-11, Steareth-13, Steareth-15 and Steareth-20 may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union. Ingredients of animal origin must comply with European Union animal by-products regulations.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...