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Glycerin is a sugar alcohol that can be synthesized or obtained from natural sources, and is used safely in some cosmetic and personal care products such as soaps, toothpaste, shaving cream, and skin and hair care products. After water, glycerin is the most frequently used cosmetic ingredient documented through the FDA’s Voluntary Cosmetic Reporting Program.
Glycerin is a well-known humectant that prevents the premature loss of moisture from cosmetics and personal care products so they don’t dry out. Other functions that have been reported for glycerin include, hair conditioning agent, oral care agent, skin conditioning agent—skin protectant and viscosity decreasing agent.
Glycerin—sometimes called Glycerol—is a natural component of all animal and vegetable fats and oils. It can be synthesized from carbohydrate materials (e.g., cane or corn syrup sugar) or from substances such as propylene. The synthetic form is chemically identical to naturally-occurring glycerin. Long-term laboratory studies show that the body handles synthetically derived glycerin the same way it handles naturally derived glycerin.
The Food and Drug Administration (FDA) includes glycerin on its list of food additives considered Generally Recognized As Safe (GRAS), and on its list of approved direct and indirect food additives. Glycerin is also an FDA approved active ingredient in over-the-counter (OTC) skin protectant drug products, ear drying products and it is an approved demulcent for the eyes.
U.S. Cosmetic Ingredient Reivew
The safety of glycerin has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. In 2014, CIR evaluated available scientific data for glycerin, which demonstrated low oral and dermal (skin) adverse effects following single and repeated doses. In addition, data showed that there were no reported allergic skin reactions in human clinical studies.
In multiple laboratory reproduction and developmental safety studies, glycerin did not produce any adverse effects on parental reproductive capability or growth development, fertility or reproductive performance of their offspring. In a human fertility study of male employees who manufacture synthetic glycerin, who would be expected to be exposed to higher levels of the material, there were no differences observed in sperm counts or percentage of normally shaped sperm compared with a group who did not work with glycerin.
In addition, in multiple laboratory studies showed that glycerin did not cause genetic mutations. In several laboratory studies where both natural and synthetic glycerin were administered orally for up to two years, there was no evidence of increased tumor incidence (i.e., glycerin does not cause cancer).
Evaluating all of the scientific data, CIR concluded that glycerin is safe as a cosmetic and personal care product ingredient under current conditions of use (i.e., up to 78% in leave-on products, 68% in rinse-off products).
European Union (EU)
Glycerin may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union. Glycerin derived from raw materials of animal origin must comply with European Union animal by-products regulations.
Food and Drug Administration regulation of glycerin:
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