What Is It?
The Steareth ingredients (Steareth-3, Steareth-5, Steareth-8, Steareth-14, Steareth-16, Steareth-21, Steareth-25, Steareth-27, Steareth-30, Steareth-40, Steareth-50, Steareth-80, Steareth-100, Steareth-200) are polyethylene glycol ethers of stearic acid. They are waxy compounds. In cosmetics and personal care products, Steareth ingredients are used in the formulation of a wide variety of cosmetics and personal care products including makeup, lotions, personal cleanliness products and deodorants, as well as suntan, fragrance, skin, eye and hair care products.
Why Is It Used?
The following functions have been reported for the Steareth ingredients.
- An ingredient that helps two substances that normally do not mix to become dissolved or dispersed in one another. Also called a surface active agent. – cleansing agent – Steareth-16, Steareth-21, Steareth-25, Steareth-27, Steareth-30, Steareth-40, Steareth-50, Steareth-80, Steareth-100
- Surfactant – emulsifying agent – Steareth-3, Steareth-5, Steareth-8, Steareth-14, Steareth-16, Steareth-21
- Surfactant – solubilizing agent – Steareth-21, Steareth-25, Steareth-27, Steareth-30, Steareth-40, Steareth-50, Steareth-80, Steareth-100
The Steareth ingredients 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-5 is prepared using an average of 5 units of ethylene oxide reacted with stearyl alcohol.
The Food and Drug Administration (FDA) permits fatty alcohols (including stearic Alcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages.) reacted with polyethylene glycol to be used as indirect food additives as components of textiles and textile fibers. The safety the Steareth ingredients has been assessed by the The Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel as part of the review of the alkyl PEG An organic compound that contains an oxygen atom bound to two hydrocarbon groups. An ether compound is often represented by R-O-R’. group of ingredients. The CIR Expert Panel evaluated the scientific data and concluded that the Steareth ingredients were safe for use in cosmetic products when formulated to be non-irritating.
CIR Safety Review:
Based on similar structures, the CIR Expert Panel determined that the alkyl PEG ether compounds, including the Steareth ingredients could be reviewed together. Developmental and reproductive toxicity studies as well as mutagenicity data were all negative for these compounds. These compounds can irritate the skin. Therefore, the CIR Expert Panel concluded that the Steareth ingredients, as well as the other alkyl PEG ether ingredients were safe as used when formulated to be nonirritating. 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.
More information about 1,4-dioxane.
Link to the FDA Code of Federal Regulations: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Steareth-3, Steareth-5, Steareth-8, Steareth-14, Steareth-16, Steareth-21, Steareth-25, Steareth-27, Steareth-30, Steareth-40, Steareth-50, Steareth-80, Steareth-100 and Steareth-200 may be used in cosmetics and personal care products marketed in Europe according to the Under the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions.. 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_packaging/co0013_en.htm
More Scientific Information
The Steareth ingredients are a series of polyoxyethylene stearyl ethers. In cosmetics and personal care products, the Steareths function mainly as surfactant – cleansing agents, surfactant – emulsifying agents and surfactant – solublizing agents.
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/default.htm
Substances Generally Recognized As Safe (“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): 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/