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The Steareth ingredients (Steareth-2, Steareth-4, Steareth-6, Steareth-7, Steareth-10, Steareth-11, Steareth-13, Steareth-15, Steareth-20) are polyethylene glycol ethers of stearci acid. They are waxy compounds. In cosmetics and personal care products, Steareth ingredients are used in the formulation of personal cleanliness products and deodorants, as well as suntan, fragrance, skin, eye and hair products.
When added to cosmetics and personal care products, the Steareth ingredients reduce the interactive forces between molecules of other liquids so that an emulsion is formed. If an ingredient such as a Steareth is not added to some personal care products, the ingredients in the product would separate like some salad dressings.
The Steareths are prepared by reacting ethylene oxide with stearyl alcohol where the numerical value in the name corresponds to the average number of units of ethylene oxide. For example, Steareth-2 is prepared using an average of 2 units of ethylene oxide reacted with stearyl alcohol.
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.fda.gov/Cosmetics/ProductandIngredientSafety/PotentialContami...
Link to the FDA Code of Federal Regulations:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr...
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 Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_p...
The Steareth ingredients are a series of polyoxyethylene stearyl ethers. In cosmetics and personal care products, the Steareths function mainly as surfactant - emulsifying agents. They may also be used as wetting agents, solubilizers and nonionic surfactants.
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul...
Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/
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