Polysorbate 85

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 demulcentA 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 Cosmetic Ingredient ReviewThe 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 fatty acidA 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 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 UnionUnder 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.