Nitrosamines

Certain cosmetics and personal care products, processed and cured meats, some medications, tobacco smoke, contaminated drinking water, and occupational exposures

Nitrosamines are a group of chemical compounds that can form when certain amines react with nitrosating agents, such as nitrites, under suitable conditions. They may occur unintentionally during the manufacturing, processing, or storage of consumer products, including cosmetics, medications, and foods. Nitrosamines can also be found in tobacco smoke and certain environmental sources. Many nitrosamines are known or suspected carcinogens, although their toxicity varies by compound. Because they are often present as impurities or reaction byproducts rather than intentionally added ingredients, they are generally not identified on product labels. Examples include N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-nitrosodiethanolamine (NDELA), and N-nitrosopyrrolidine (NPYR). Nitrosamines are subject to regulatory controls in several jurisdictions because of concerns about their potential carcinogenicity. In the European Union, the Cosmetics Regulation (EC) No 1223/2009 prohibits specified nitrosamines and establishes restrictions intended to prevent nitrosamine formation in cosmetic products. In the United States, the Food and Drug Administration provides guidance for identifying, evaluating, and controlling nitrosamine impurities in medications, including recommended acceptable intake limits for individual compounds. These requirements apply to specified nitrosamines, product formulations, or impurity levels rather than constituting a universal ban on all nitrosamines.