Risk of NDELA in Cosmetic Products
Cosmetics containing as ingredients amines and amino derivatives, particularly di- & triethanolamine (DEA & TEA) may form nitrosamines, if they also contain an ingredient which acts as a nitrosating agent as for example, 2-bromo-2-nitropropane-1,3-diol (Bronopol, Onyxide 500), 5-bromo-5-nitro-1,3-dioxane (Bronidox C) or tris (hydroxymethyl) nitro-methane (Tris Nitro); or if they are contaminated with a nitrosating agent, e.g., sodium nitrite. Amines and their derivatives are mostly present in creams, cream lotions, hair shampoos and cream hair conditioners. The nitrosation may occur during manufacture as well as product storage.
As N-nitrosodiethanolamine (NDELA), one of the nitrosamines, is classified as a potent carcinogen, attention was focused on its risk effect by various health groups. During the past few years, there are a number of recall cases related to the presence of NDELA in cosmetic products in Germany and the Netherlands through RAPEX. The withdrawn products include eyeliner, mascara and shampoo, with NDELA level at 82 ppb to 142 ppm.
FDA expressed its concern about the contamination of cosmetics with nitrosamines in a Federal Register notice dated April 10, 1979, which stated that cosmetics containing nitrosamines may be considered adulterated and subject to enforcement action.
Right now, there is an international method using HPLC-MS-MS with reference to the ISO 15819:2008 (Cosmetics - Analytical methods - Nitrosamines: Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS) to analyze the NDELA content in cosmetic products. If you ever doubt whether your cosmetic products contain the cancer-causing chemical, NDELA, please contact us and we can provide you an answer.
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