Public consultation on nitrosamines in food: draft opinion explained

Nitrosamines (or more formally N-Nitrosamines) are chemical compounds that can form in food as a result of food preparation and processing. They have been found in several types of foodstuffs such as cured meat products, processed fish, cocoa, beer and other alcoholic beverages. Nitrosamines may also be present in a variety of other foods such as cooked meat, processed vegetables, cereals, milk and dairy products, or fermented, pickled and spiced foods. Some nitrosamines are genotoxic (may damage DNA Et komplekst kædelignende molekyle, der bærer det genetiske materiale, og som findes i levende organismer og nogle vira. DNA (deoxyribonukleinsyre) er i stand til at kopiere sig selv og bærer instruktionerne for alle de proteiner, der bruges til at skabe og opretholde liv.) and carcinogenic (can cause cancer). EFSA’s draft opinion assesses the risks to public health related to the presence of nitrosamines in food.

Prof. Bettina Grasl-Kraupp is the chair of the working group of the EFSA Panel on Contaminants in the Food Chain (CONTAM) that drafted the opinion on nitrosamines, currently under public consultation until 22 November 2022.

Could you briefly describe the work you have done? What are the main results?

We started by evaluating the potential harm caused by nitrosamines to humans and animals. We then assessed the health risks for the EU population Gruppe af mennesker, dyr eller planter fra samme art.. The assessment concludes that it is highly likely that for all age groups dietary exposure to nitrosamines is above the level that could indicate a health concern.

How did you assess the risk from these genotoxic and carcinogenic substances?

When assessing genotoxic and carcinogenic substances that are unintentionally present in the food chain, EFSA calculates a margin of exposure ( MOE Eksponeringsmarginen (MOE) er et værktøj, der anvendes ved risikovurdering til at undersøge sikkerhedsproblemer som følge af tilstedeværelsen af et potentielt giftigt stof i fødevarer eller dyrefoder.) for consumers. The MOE is a ratio of two factors: the dose at which a small but measurable adverse effect is observed, and the level of exposure to a substance for a given population. In general, a ratio above 10,000 indicates a low concern for consumers.

In our assessment, we considered the incidence of liver tumours in rodents as the key harmful effect from exposure to nitrosamines. We applied the carcinogenic potency of the most potent nitrosamine (N-nitrosodiethylamine, or NDEA) to the other nitrosamines found in food to generate a worst-case scenario.

Is this assessment linked to EFSA’s opinion on nitrates and nitrites published in 2017?

Nitrites may be linked to the formation of nitrosamines. As part of our re-evaluation of the safety of nitrites and nitrates conducted in 2017, EFSA’s experts noticed high nitrosamine levels in meat products but did not have sufficient information to link these levels to nitrites intentionally added to food.

What are the current knowledge gaps? What additional information would you like to receive during the public consultation?

We are interested in receiving feedback on all aspects of our opinion, in particular on the exposure assessment scenarios used, to reduce uncertainty in the calculation of exposure through the diet. The uncertainty is due to the high proportion of occurrence results below the limits of quantification and the limited availability of data for the dietary exposure assessment of nitrosamines.

How can academia and other interested parties contribute to the final opinion?

The draft scientific opinion is open for public consultation until 22 November 2022 and this is a good opportunity to send feedback and comments. We welcome all input!

• Public consultation: Risk assessment of N-nitrosamines in food