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Polysorbate 20 and the other Polysorbate ingredients (Polysorbate 21, Polysorbate 40, Polysorbate 60, Polysorbate 61, Polysorbate 65, Polysorbate 65, Polysorbate 80, Polysorbate 81, Polysorbate 85) are a series of general purpose hydrophilic, nonionic surfactants. The Polysorbates are used in a variety of products including skin fresheners, skin care products, skin cleansing products, makeup bases and foundations, shampoos, permanent waves and fragrance powders.
The Polysorbate ingredients help other ingredients to dissolve in a solvent in which they would not normally dissolve. They also help to form emulsions by reducing the surface tension of the substances to be emulsified.
Polysorbates are surfactants that are produced by reacting the polyol, sorbitol, with ethylene oxide. The number in the name of the Polysorbate indicates the average number of moles of ethylene oxide that has been reacted per mole of sorbitol. The polyoxyethylenated sorbitan is then reacted with fatty acids obtained from vegetable fats and oils such as lauric acid, palmitic acid, stearic acid and oleic acid. Polysorbates function to disperse oil in water as opposed to water in oil
The Food and Drug Administration (FDA) permits Polysorbate 20, Polysorbate 60, Polysorbate 65 and Polysorbate 80 to be directly added to food as adjuvants of flavoring agents or as multipurpose additives. FDA also includes Polysorbate 20, Polysorbate 40, Polysorbate 60, Polysorbate 65, Polysorbate 80 and Polysorbate 85 on its list of indirect food additives as emulsifiers and/or surface active agents. Polysorbate 80 has FDA approval as an ophthalmic demulcent and may be used in Over-The-Counter (OTC) ophthalmic drug products. The safety of Polysorbate 20, Polysorbate 21, Polysorbate 40, Polysorbate 60, Polysorbate 61, Polysorbate 65, Polysorbate 80, Polysorbate 81 and Polysorbate 85 has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Polysorbate 20, 21, 40, 60, 61, 65, 80, 81 and 85 were safe as cosmetic ingredients.
CIR Safety Review: The Polysorbates are a series of polyoxyethylenated sorbitan esters that differ with respect to the number of polymerized oxyethylene subunits and the number and type of fatty acid groups present. The CIR Expert Panel reviewed data showing that Polysorbates were not mutagens or complete carcinogens. The available data indicated that these ingredients were used in numerous preparations without clinical reports of significant adverse effects.
FDA: Link to Code of Federal Regulations for information about the direct food uses for Polysorbate 20, Polysorbate 60, Polysorbate 65 and Polysorbate 80
FDA: Link to Code of Federal Regulations for information about the indirect food uses for Polysorbates
FDA: Link to Code of Federal Regulations for information about the OTC drug uses for Polysorbate 80
The Polysorbate ingredients may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.
The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-25 mg/kg body weight for the sum of Polyoxyethylene (20) sorbitan esters of lauric, oleic, palmitic, and stearic acid.
The Polysorbates are polyoxyethylenated sorbitan esters. They function as a general purpose, hydrophilic, nonionic surfactants (emulsyfing and stabilizing agent) in cosmetics and personal care products and can aid in the dissolution of many other ingredients used in the final product.
Find out more about the regulation of Food Additives by the Food and Drug Administration
Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration
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