PEG-20 Laurate

The Food and Drug Administration (FDA) has reviewed the safety of PEG Dilaurate ingredients and approved their use as indirect food additives for use as components of paper and paperboard used as food packaging. The safety of the PEG Dilaurate and PEG Laurate ingredients 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 PEG-2, -4, -6, -8, -12, -20, -32, -75 and -150 Dilaurate and PEG-2, -4, -6, -8, -9, -10, -12, -14, -20, -32, -75, -150 Laurate and PEG-2 Laurate SE are safe for use in cosmetics and personal care products at concentrations up to 25%.

CIR Safety Review: The PEG Dilaurate and PEG Laurate ingredients are similar to the PEG Stearate and PEG Distearate ingredients, and to the components polyethylene glycol and lauric acid, all of which are addressed in previous safety assessments. Fatty acids such as lauric acid were absorbed, digested, and transported in the body. In short-term feeding studies, PEG Laurate ingredients were irritating to the gastrointestinal tract, but not necrotizing. In chronic oral toxicity studies, there was some evidence of liver damage and hyperplasia in several tissues.

PEG Stearate, and PEG Distearate ingredients did not cause reproductive or developmental toxicity, and were not carcinogenic. Likewise, PEGs were not carcinogenic. Although kidney toxicity was observed in burn patients treated with a PEG-based cream, no evidence of systemic toxicity or sensitization was found in studies with intact skin.

Based on the data on the PEG Dilaurate and the PEG Laurate ingredients, on the data available on the component ingredients, and on the data available on similar PEG 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. esters, it was concluded that these ingredients were safe for use in cosmetics and personal care products at concentrations up to 25%. Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in the PEG Dilaurate and PEG Laurate ingredients. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations.

More information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane.

FDA Code of Federal Regulations for Polyethylene Glycol Dilaurate 

PEG Dilaurate and PEG Laurate 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..

EU Cosmetic Regulation