Stearamine

The safety of Lauramine and Stearamine 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 reviewed the scientific data and concluded that the data were insufficient to support the use of these ingredients in cosmetics and personal care products.

CIR Safety Review: Feeding studies of high doses of Stearmine has resulted in changes in the mucosa of the small intestines, although no carcinogenic effects were observed at dietary concentrations up to 500 ppm in a 2-year study. Undiluted Lauramine was a dermal irritant. Little additional data were identified, leading the CIR Expert Panel to conclude that the data were insufficient to assess the safety of these ingredients as used in cosmetic and personal care products. Additional information requested included use information, impurities (especially nitrosamine content), genotoxicity data and dermal irritation and sensitization data in humans.

More information about nitrosamines.

In the European Union, monalkylamines including Lauramine and Stearamine, and monoalkanolamines and their salts may be used if the maximum secondary amine content is limited to 0.5% in the finished products, if the ingredient has a maximum purity of 99%, with a secondary amine concent of 0.5% or less, and a maximum nitrosamine content of 50 microg/kg.

These ingredients must not be used with nitrosating systems and they must be kept in nitrite-free containers (see Annex III). 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…