Glyceryl Stearate
Safety Information
U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) includes glyceryl stearate (also called glyceryl monostearate) in its list of direct food additives affirmed as Generally Recognized As Safe (GRAS“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.).
Expert Panel for Cosmetic Ingredient Safety
The safety of glyceryl stearate and glyceryl stearate SE has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that glyceryl stearate and glyceryl stearate SE were safe for use in cosmetics and personal care products.
The Expert Panel reviewed chronic studies of glyceryl stearate that showed no adverse effects on reproduction and no carcinogenic effects.
Human exposure studies of products containing glyceryl stearate and glyceryl stearate SE, as well as clinical experience, have shown these compounds to be nonsensitizing, nonphototoxic and nonphotosensitizing.
If they are made from plants, glyceryl stearate and glyceryl stearate SE 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..
Ingredients made from animal sources must comply with the European Union animal by-products regulations.
Resources
Glyceryl Stearate
What Is It?
Glyceryl stearate and glyceryl stearate SE are esterification products of glycerin and stearic acid. Glyceryl stearate is a white or cream-colored wax-like solid.
Glyceryl stearate SE is a “self-emulsifying” form of glyceryl stearate that also contains a small amount of sodium and or potassium stearate.
Why Is It Used?
Scientific Facts
Glyceryl stearate is made by reacting glycerin with stearic acid, a 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. obtained from animal and vegetable fats and oils.
Glyceryl stearate SE is produced by reacting an excess of stearic acid with glycerin.
The excess stearic acid is then reacted with potassium and/or sodium hydroxide yielding a product that contains glyceryl stearate as well as potassium stearate and/or sodium stearate.
Glyceryl stearate and glyceryl stearate SE are esterification products of glycerin and stearic acid.
Glyceryl Stearate is used as a skin conditioning agent – emollient and a surfactantAn ingredient that helps two substances that normally do not mix to become dissolved or dispersed in one another. Also called a surface active agent. – emulsifying agent in cosmetics and personal care products. It is also used to stabilize a product, decrease water evaporation, make the product freeze-resistant and keep it from forming surface crusts.
Glyceryl stearate reduces the greasiness of oils used in certain cosmetics and personal care products.
Glyceryl stearate SE is used as a surfactant – emulsifying agent. It needs no other auxiliary emulsifier to form a stable emulsionA mixture of two liquids that normally cannot be mixed, in which one liquid is dispersed in the other liquid as very fine droplets. Emulsifying agents are often used to help form the emulsion and stabilizing agents are used to keep the resulting emulsion from separating. The most common emulsions are oil-in-water emulsions (where oil droplets are dispersed in water) and water-in-oil emulsions (where water droplets are dispersed in oil). unlike glyceryl stearate, which requires a surfactant to yield a stable preparation.