TALLAMIDE DEA.

The CIR Expert Panel concluded that diethanolamides, including Tallamide DEA, are safe when formulated to be non-irritating and when free diethanolamine (DEA) levels do not exceed safe concentrations. Its use is specifically advised against in cosmetic products where N-nitroso compounds could form. The EU Cosmetics Directive (Annex III) imposes strict restrictions on fatty acid dialkanolamides, including a maximum secondary amine content of 0.5% in the finished product, prohibition with nitrosating systems, a secondary amine content limit of 5% in raw materials, a nitrosamine content restriction of 50 µg/kg, and storage in nitrite-free containers. The FDA acknowledges a 1998 NTP animal study linking topical DEA and related ingredients to cancer but states it did not establish a human cancer link, noting a decrease in their usage. However, Cocamide DEA, a related ingredient, is listed on California's Proposition 65 as a chemical that can cause cancer. Inhalation studies of Tallamide DEA produced sensory and pulmonary irritation at low concentrations. Related diethanolamides, particularly when undiluted or in cumulative applications, have demonstrated mild to severe skin and eye irritation. Free diethanolamine, which can be present as a residual impurity or formed from diethanolamides, is known to irritate the eyes, skin, nose, and throat.