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EFSA finds health risks from nitrosamines in food


There is a health risk from a group of compounds that can form in food during processing, according to the European Food Safety Authority (EFSA).

EFSA assessed the public health risk related to nitrosamines. Ten nitrosamines in food are carcinogenic, meaning they can cause cancer, and genotoxic, which means they may damage DNA.

Nitrosamines have been found in foodstuffs like cured meat products, processed fish, cocoa, beer, and other alcoholic beverages. They may also be present in other foods such as cooked meat, processed vegetables, cereals, milk, and dairy products, or fermented, pickled, and spiced foods. 

Dieter Schrenk, chair of the panel on Contaminants in the Food Chain, said the assessment revealed that for all age groups across the EU, the level of exposure to nitrosamines in food is a concern.

“Based on animal studies, we considered the incidence of liver tumors in rodents as the most critical health effect. To ensure a high level of consumer protection, we created a worst-case scenario for our risk assessment. We assumed that all nitrosamines found in food had the same potential to cause cancer in humans as the most harmful nitrosamine, although that is unlikely,” he said.

Evaluation of data and past work
Nitrosamines are formed by a reaction between nitrites and certain amines. Cured meats often contain detectable levels of nitrosamines due to the use of nitrite as a preserving agent and are affected by additional factors, such as temperature, pH, and processing conditions.

Food consumption data from an EFSA database was used for the dietary exposure assessment. Analytical results from the EFSA contaminant database and the literature on Nitrosamine concentrations in food were used to assess dietary exposure. Information relevant for hazard identification and characterization was identified by a literature review.

EFSA evaluated the potential harm caused by nitrosamines to humans and animals and assessed consumer exposure.

When assessing genotoxic and carcinogenic substances in the food chain, EFSA calculates a margin of exposure for consumers. The MOE is a ratio of the dose at which a small but measurable adverse effect is observed, and the level of exposure to a substance for a population. In general, a ratio above 10,000 indicates a low concern for consumers. In this assessment, the panel concluded that calculated MOEs are below 10,000 in two scenarios, which raises a health concern.

EFSA held a public consultation on the draft opinion in late 2022 and 12 comments were received including from the UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), German Federal Institute for Risk Assessment (BfR) and French Agency for Food, Environmental and Occupational Health & Safety (Anses).

In 2017, another EFSA panel published a risk assessment of nitrates and nitrites as food additives. It found consumer exposure was within safe levels.

There is no EU regulation on the presence of Nitrosamines in food or drinking water. EFSA’s opinion will now be shared with the European Commission, which will discuss with national authorities what if any, risk management measures are needed.

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