Nitrosamines: EFSA Opinion published
Nitrosamines are chemical compounds, some of which are considered genotoxic and carcinogenic, formed by the reaction between nitrosating agents with substances that have amine groups.
Various sources of exposure
The sources of exposure are many, certainly smoke and emissions from some industrial production, but food is one of the main for humans. In fact, nitrosamines have been found in several food products, first and foremost meat and meat products, processed fish. But also cocoa, beer and other alcoholic beverages, processed vegetables, cereals, and milk and dairy products.
The presence of N-nitrosamines in food may be due to the addition of nitrites as preserving agents, as in the case of cured meats or in the production of some processed fish. In other cases, such as vegetables like leafy vegetables or pickled/salted vegetables, it can be found because its natural presence in the food for which a high level of nitrates, precursors of nitrites, is attributed.
EFSA’s scientific opinion
The 28 of March 2023, the European Food Safety Authority published a Scientific Opinion regarding the risk assessment of consumer exposure to N-nitrosamines.
32 nitrosamines have been investigated in foods, among those 23 are carcinogenic. However, based on literature and occurrence data, 10 N-nitrosamines were considered for EFSA’s risk assessment, also referred to as TCNAs (ten carcinogenic N-NAs occurring in food).
The assessment found out that TCNAs are a health concern for consumers of all age groups, and therefore it is necessary to discuss possible risk management measures.
Mérieux NutriSciences’ experience
Mérieux NutriSciences’ analytical developments for the determination of nitrosamines started in 2009, first on tobacco matrix, then food, cosmetics and pharma.
… Nitrosamines in Pharma
Following the presence of nitrosamine impurities in blood pressure drugs, alerts from regulatory authorities around the world have notified. Thus, the various international authorities implemented a control and monitoring plan to support companies in verifying the formation of these impurities in their products.
With more than 15 years of activity in research and analysis, the Pharma Laboratories and R&D division of Mérieux NutriSciences have activated a new unit dedicated to the implementation and validation of targeted methods. Developing different strategies and approaches for the determination of nitrosamines in pharmaceutical products through sophisticated mass spectrometry technologies.
… Nitrosamines in Food
Today, although without clear and defined legislative references, the risk assessment published by EFSA seems to suggest the arrival of risk assessment and management measures in food as well.
Specific methods based on mass spectrometry have been available at Mérieux NutriSciences for years at R&D level in food such as meat, cured meat, fish and beer while on drinking water a validated and accredited method for the detection of NDMA (N-nitroso dimethylamines) capable of reaching LOQ 10 ppt has been active since 2015. Experience in the pharmaceutical field leads to reflect on the current generic concept of nitrosamine as understood by EFSA in food versus the much more risky, concrete and real concept of NDRSIs (Nitrosamine drug substance-related impurities) as understood by EMA at the pharmaceutical level.
What will happen tomorrow?
