What Is It?
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.
Why Is It Used?
The Polysorbate ingredients help other ingredients to dissolve in a Substances, usually liquids, that are used to dissolve other substances. 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 A demulcent is an agent that forms a soothing film when put onto the surface of a mucous membrane, such as the inside of the mouth. A demulcent is meant to relieve the irritation of the inflamed mucous membrane. 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 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. 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 A natural organic compound that consists of a carboxyl group (oxygen, carbon and hydrogen) attached to a chain of carbon atoms with their associated hydrogen atoms. The chain of carbon atoms may be connected with single bonds, making a ‘saturated’ fat; or it may contain some double bonds, making an ‘unsaturated’ fat. The number of carbon and hydrogen atoms in the chain is what determines the qualities of that particular fatty acid. Animal and vegetable fats are made up of various combinations of fatty acids (in sets of three) connected to a glycerol molecule, making them triglycerides. 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 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 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..
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.
More Scientific Information
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
- Food Ingredients and Packaging
- Food Contact Substances
- 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.)
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