Nitrosamines In Food & Pharmaceuticals

April 19th, 2023

The European Food Safety Authority (EFSA) is currently evaluating how to control and monitor Nitrosamines in food. Exposure to N-nitrosamines can cause serious health risks due to their well-known carcinogenic and genotoxic effects. From cured meat to cereal, N-nitrosamines can be found in different foodstuffs as well as pharmaceuticals. AccuStandard offers N-nitrosamines CRMs, including standards for the new ASTM Test Method D8456.

N-nitrosamines (N-NAs) are a class of organic chemical compounds, some of which are known for their carcinogenic and genotoxic characteristics. They can be found as impurities in pharmaceuticals and as contaminants in food such as cured meat, processed fish, and alcoholic beverages.

As a “Process Contaminant”, N-nitrosamines form as a byproduct during the manufacturing of food and pharmaceuticals. For example, they can be created during the curation or fermentation process of food and beverages. This happens when nitrite salts such as sodium nitrite, which is commonly used as a food preservative, reacts with amines that are naturally found in food. The same mechanism of formation is theorized during drug manufacturing where nitrite salts are added as a reagent while amines are used as a starting material.

N-nitrosamines have been the center of attention when it comes to consumer risk assessments due to their mutagenic effects which comes from their ability to disrupt and destabilize DNA structure. This can result in DNA sequencing irregularities or mutations which may produce cancer.

As a result, many regulations and test methods have been developed to detect and monitor traces of N-nitrosamines in food, water, and pharmaceutical products aiming to reduce the public exposure to those chemicals. Most recently, the European Food Safety Authority (EFSA) issued a new warning about N-nitrosamines and are currently evaluating new regulations for these contaminants.

ASTM D8456, which is designed to test for N-nitrosamines in water, is one of the new test methods that has been published to detect and quantify a group of N-nitrosamines including N-nitrosodimethylamine (NDMA), which the USEPA classifies as potently carcinogenic.

AccuStandard offers a wide selection of N-nitrosamine Certified Reference Materials (CRMs) to support the analysis and the detection of these chemicals. Our products include CRMs for USEPA 8070 (M-8070) and ASTM D8456 which includes all 13 native N-nitrosamine compounds as well as the labeled Internal Standard (D-8456 & D-84556-IS).

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