Glyceryl Oleate
What Is It?
Glyceryl Oleate, also called, Glyceryl Monooleate, is obtained from naturally occurring oils and fats. It occurs as a clear amber or pale yellow liquid. In cosmetics and personal care products, it is predominantly used in the formulation of lipsticks, eye shadows, makeup bases, and skin care products.
Why Is It Used?
Glyceryl Oleate helps to form emulsions by reducing the surface tension of the substances to be emulsified. It also functions as a skin conditioning agent – emollient.
Scientific Facts
Glyceryl Oleate is the esterAn organic compound formed by the reaction of an acid with an alcohol. of glycerin and oleic acid. It is produced from oils that contain high concentrations of oleic acid, such as olive oil, peanut oil, teaseed oil or pecan oil.
Safety Information
The Food and Drug Administration (FDA) includes Glyceryl Oleate on its list of direct food substances considered 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.). The safety of Glyceryl Oleate 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 Glyceryl Oleate was safe as a cosmetic ingredient in the present practices of use and concentration. In 2004, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Glyceryl Oleate and reaffirmed the above conclusion.
CIR Safety Review: The metabolic products of Glyceryl Oleate are glycerol and oleic acid. Data on the safety of glycerides, glycerol, oleic acid and sodium oleate were supportive of the safety of Glyceryl Oleate. A single exposure to undiluted Glyceryl Oleate in dermal irritation studies produced only minimal irritation.
In a 4-week dermal toxicity/phototoxicity study, product formulations containing up to 5% Glyceryl Oleate produced slight reversible dermal irritation. Minimal to moderate eye irritation was produced by undiluted Glyceryl Oleate. Long term oral exposure to large doses of Glyceryl Oleate was not clearly associated with tumor formation. Irritation, sensitization or phototoxic effects were not observed in humans exposed to formulations containing Glyceryl Oleate. Based on the information included in the report, the CIR Expert Panel concluded that Glyceryl Oleate was safe as a cosmetic ingredient.
FDA: Link to Code of Federal Regulations for Glyceryl Monooleate
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
When derived from plant sources, Glyceryl Oleate 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 of animal origin must comply with the European Union animal by-products regulations.
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
The Joint FAO/WHO Expert Committee on Food Additives has not restricted the daily intake of Glyceryl Oleate in food. No safety concern was identified at current levels of intake when used as a flavoring agentIngredients that impart a flavor or a taste to a product..
http://www.inchem.org/documents/jecfa/jeceval/jec_932.htm
More Scientific Information
Glyceryl Oleate is the glyceryl 1-monoester of oleic acid. Glyceryl esters comprise a subgroup of esters which are primarily 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. mono- and diglycerides or triglycerides modified by reaction with other alcohols.
Resources
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/defaul…
Substances Generally Recognized As Safe (GRAS): 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/