Glyceryl Stearate Citrate

The Food and Drug Administration (FDA) reviewed the safety of Glyceryl Diesters (Diglycerides) and approved their use as indirect food additives. Mono- and diglycerides are affirmed 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.) direct food ingredients. They are often blended together and added directly to food. The safety of the Glyceryl Diesters 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 Dilaurate, Glyceryl Diarachidate, Glyceryl Dibehenate, Glyceryl Dierucate, Glyceryl Dihydroxystearate, Glyceryl Diisopalmitate, Glyceryl Diisostearate, Glyceryl Dilinoleate, Glyceryl Dimyristate, Glyceryl Dioleate, Glyceryl Diricinoleate, Glyceryl Dipalmitate, Glyceryl Dipalmitoleate, Glyceryl Distearate, Glyceryl Palmitate Lactate, Glyceryl Stearate Citrate, Glyceryl Stearate Lactate, and Glyceryl Stearate Succinate were safe for use in cosmetics and personal care products provided that the content of the biologically active form, the 1,2-diester, is not high enough to cause an effect.

CIR Safety Review: CIR The Expert Panel considered that the available safety test data indicated that diglycerides in the 1,3-diester form do not present any significant toxicity risk, nor are these ingredients irritating, sensitizing or photosensitizing. Whereas no data were available regarding reproductive or developmental toxicity, there was no reason to suspect any such toxicity because the dermal absorption of these ingredients was negligible.

The CIR Expert Panel noted that depending on the chain length and structure, the 1,3-diglycerides might contain some 1,2-diglycerides. Some 1,2-diglycerides, especially those with carbon chains less than 14 in length and mixed saturated/unsaturated fatty acids, may have a tumor promotion potential.

With the exception of Glyceryl Dilaurate, with 12 carbons in both 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. chains, the diglycerides considered in this safety assessment have at least one fatty acid chain of 14 carbons or longer and none have mixed saturated/unsaturated fatty acid moieties. Glyceryl Dilaurate was a mild primary irritant, but not a skin sensitizer in maximization tests.

An eye shadow containing 1.5% Glyceryl Dilaurate did not induce skin irritation in a single insult patch test, but mild skin irritation reactions to a foundation containing the same concentration were observed. A trade mixture containing Glyceryl Dibehenate did not induce irritation or significant cutaneous intolerance in a 48 hour occlusive patch test. In maximization tests, neither an eye shadow nor a foundation containing 1.5% Glyceryl Dilaurate was a skin sensitizer. Sensitization was not induced in subjects patch tested with 50% Glyceryl Dioleate in a repeated insult, occlusive patch test. Glyceryl Palmitate Lactate (50%) did not induce skin irritation or sensitization in subjects patch tested in a repeat insult patch test.

The CIR Panel considered it important that a 21-week use study of a prototype lotion containing 0.5% Glyceryl Dilaurate (a 12-carbon chain fatty acid) indicated no evidence of scaling, inflammation, or neoplasms in biopsy specimens. Also, DNA synthesis assays on Glyceryl Dilaurate and Glyceryl Distearate indicated that neither substance altered cellThe basic structural and functional unit of all organisms; cells may exist as independent units of life or may form colonies or tissues as in higher plants and animals. proliferation (as determined by DNA synthesis) in normal human dermal fibroblasts in vitroExperiments performed in a test tube or another artificial, controlled environment, rather than in a whole animal. at doses up to 10 microg/ml.

Link to FDA Code of Federal Regulations for Fatty Acids reacted with Glycerin (mono- and diglycerides) and Mono- and Diglyceride mixtures

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

All 18 Glyceryl Diesters 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 European Union animal by-products regulations.

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…