Cocoyl Sarcosine

The Food and Drug Administration (FDA) reviewed the safety of Lauroyl Sarcosine, Stearoyl Sarcosine, and Sodium Lauroyl Sarcosinate and approved their use as indirect food additives for use in cellophane having incidental contact with food. N-Acyl Sarcosines such as Lauroyl, Oleoyl, or Sarcosines with the combined fatty acids of coconut oil have been approved as anti-static and/or anti-fogging agents for food packaging material.

The safety of acyl sarcosines and sarcosinates has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Cocoyl Sarcosine, Lauroyl Sarcosine, Myristoyl Sarcosine, Oleoyl Sarcosine, Stearoyl Sarcosine, Sodium Cocoyl Sarcosinate, Sodium Lauroyl Sarcosinate, Sodium Myristoyl Sarcosinate, Ammonium Cocoyl Sarcosinate and Ammonium Lauroyl Sarcosinate were safe as used in rinse-off products, and safe for use in leave-on products at concentrations of 5% or less. The data were insufficient to determine the safety for use in products where the sarcosines and sarcosinates were likely to be inhaled. The CIR Expert Panel cautioned that these ingredients may be susceptible to nitrosamine formation.CIR Safety Review: The CIR Expert Panel conducted previous safety assessments on each of the fatty acids that appear in these Acyl Sarcosines and Sarcosinates (coconut acid, oleic acid, lauric acid, myristic acid, stearic acid). In each case the fatty acid was safe for use in cosmetic formulations.

The acyl sarcosines and sarcosinates had low oral toxicity. They were not mutagenic. These ingredients were nonirritating and nonsensitizing to skin, although they enhanced the penetration of other ingredients through the skin.

The CIR Expert Panel concluded that the acyl sarcosines and sarcosinates were safe as used in rinse-off products. They may be safely used in leave-on products at concentrations up to 5%, the highest concentration tested in clinical irritation and sensitization studies. Because of the absence of data on inhalation toxicity of these ingredients, the CIR Expert Panel concluded that the available data were not sufficient to support the safety of acyl sarcosines and sarcosinates as cosmetic ingredients in products where they are likely to be inhaled.

The CIR Expert Panel also acknowledged that sarcosine may be nitrosated to form N-nitrososarcosine, a potentially carcinogenic compound. Therefore, these ingredients should not be used in cosmetics and personal care products in which N-nitroso compounds may be formed.

More information about nitrosamines

Link to FDA Code of Federal Regulations for N-acyl sarcosines
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

The aryl sarcosines and sarcosinates may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...