Cocamidopropyl Betaine

The safety of Cocamidopropyl Betaine and related amidopropyl betaine ingredients has been assessed on several occasions 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.  In 1991, the CIR Expert Panel reviewed the available published scientific literature, and concluded that CAPB was safe for use in rinse-off cosmetic products at the levels of use reported in the available literature.  Due to the potential for skin irritation at higher use concentrations, however the CIR Expert Panel recommended that for cosmetic products intended to remain on the skin for long periods of time (i.e., leave-on products), the concentration of CAPB should not exceed 3%. Based upon new information showing a substantial increase in the number of uses of CAPB, including new uses in aerosol products, and reports of allergic skin reactions in patients who used rinse-off products, the CIR Expert Panel undertook an additional review of CAPB and related amidopropyl betaines in 2012.  The primary inquiry for the 2012 review related to the presence of the 3,3-dimethylaminopropylamine (DMAPA) and 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. amidopropyl dimethylamine (amidoamine) in CAPB and other related amidopropyl betaines.  DMAPA and amidoamine are present in CAPB and other related amidopropyl betaines as manufacturing by-products. DMAPA and amidoamine can sometimes cause allergic skin reactions (i.e., dermal sensitization).  However, literature reviewed by the CIR Expert Panel has shown that when the levels of DMAPA and amidoamine are reduced, the number of people reacting is also reduced.Based on its review of the published scientific literature, the CIR Expert Panel concluded that cosmetics using CAPB and related amidopropyl betaines were safe as long as they were formulated to be non-sensitizing.  The CIR Expert Panel also advised industry to continue minimizing the concentration of these manufacturing by-products.

CAPB and related amidopropyl betaine ingredients have the potential to form by-products called nitrosamines. Nitrosamines are organic substances formed by the reaction of an amine (such as a proteinA naturally occurring complex organic substance present in relatively high amounts in meats, fish, eggs, cheese, legumes. Made of carbon, hydrogen, oxygen, and nitrogen, and sometimes sulfur and phosphorus. in foods or an amine side group on a cosmetic ingredient) with what is called a nitrosating agent (such as nitrites that are used in foods as preservatives).  This potential of certain ingredients to form nitrosamines in the presence of a nitrosating agent is well known to both industry and regulators.  The CIR Expert Panel recommend that CAPB and related amidopropyl betaines not be used in products that also contained nitrosating agents.  This is standard practice for manufacturers of cosmetic and personal care products.