Nitrosamines are organic substances formed by the reaction of an amine (such as a protein in foods) with a nitrosating agent, such as nitrites that are used as food preservatives.
Nitrosating agents and amines are common naturally occurring compounds found in many different settings and situations. Thus, nitrosamines are widespread in the environment though generally at extremely low levels (order of magnitude: 1 part-per-billion [ppb]). For example, nitrosamines may be found in many food products including beer, fish, fish byproducts, and in meat and cheese products preserved with nitrites. In addition to including nitrites in foods as preservatives, some foods such as spinach naturally contain nitrates, another nitorsating agent. Nitrosamines also form from food in the digestive tract during normal metabolic processes.
Nitrosamines may be formed in cosmetic and personal care products only if they contain both an ingredient that acts as a Nitrosating agent and an amine ingredient, and they are together under manufacturing or storage conditions that favor nitrosamine formation.
Nitrosamines are a class of compounds that have been known for over 100 years. The potential carcinogenicity of nitrosamines has been well studied and of the compounds tested, approximately 90% have been shown to be carcinogenic when administered at high dosages across a number of animal species. As a result of these findings, nitrosamines are considered to be carcinogenic to humans.
Cosmetic and personal care products are formulated to eliminate and reduce the formation of nitrosamines. Most products do not contain any nitrosamines and if they do occur, the levels are typically very low and do not present any health risk to consumers. Both the U.S. Food and Drug Administration (FDA) the European cosmetics trade association (Cosmetics Europe) have issued guidance to manufacturers on how to keep nitrosamines from forming during the manufacturing process.
The FDA monitors for the presence of nitrosamines in cosmetics and periodically publishes the results of product surveys. The FDA has determined that the very low levels found do not represent a public health risk nor has the agency found it necessary to take regulatory action against products. Today, the FDA continues to monitor for potential contamination of cosmetics with nitrosamines.
To help better understand and control the presence of nitrosamines in cosmetics, the cosmetic industry has worked closely with the FDA to conduct research about how they are formed, how to avoid their presence in products and develop very sensitive analytical methods to detect if they are present.
European Union (EU)
The EU addresses the possible health risks that may be associated with the presence of nitrosamines in cosmetic products via the Cosmetics Regulation (EC No. 1223/2009) under Annex II.
Annex II: Annex II (List of Substances Prohibited in Cosmetic) states that nitrosamines must not form part of the composition of cosmetic products above trace levels that are technically unavoidable in Good Manufacturing Practices.
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