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 A complex chain-like molecule that carries the genetic material, present in living organisms and some viruses. DNA (deoxyribonucleic acid) is capable of copying itself and carries the instructions for all the proteins used to create and sustain life.) 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 Community of humans, animals or plants from the same species.. The assessment concludes that it is highly likely that for all age groups dietary exposure For the purposes of risk assessment, measurement of the amount of a substance consumed by a person or animal in their diet that is intentionally added or unintentionally present (e.g. a nutrient, additive or pesticide). 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 The margin of exposure (MOE) is a tool used in risk assessment to explore safety concerns arising from the presence of a potentially toxic substance in food or animal feed.) for consumers. The MOE is a ratio of two factors: the dose The total amount of a substance (e.g. a chemical or nutrient) given to, consumed or absorbed by an individual organism, population or ecosystem. at which a small but measurable adverse effect A change in the health, growth, behaviour or development of an organism that impairs its ability to develop or survive is observed, and the level of exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. 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 The number of new events occurring within a specified time period within a defined geographical area; for example, the number of flu cases per year in Europe. of liver tumours in rodents as the key harmful effect from exposure to nitrosamines. We applied the carcinogenic potency A measure of the capacity of a chemical substance to exert an effect, described in terms of the relationship between the dose used and the magnitude of the resulting effect. 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 One of the key steps in risk assessment, this relates to a thorough evaluation of who, or what, has been exposed to a hazard and a quantification of the amounts involved. scenarios used, to reduce uncertainty Scientific concept used in risk assessment to describe all types of limitations in available knowledge at the time an assessment is conducted, with the agreed resources, that affect the probability of possible outcomes to the assessment. in the calculation of exposure through the diet. The uncertainty is due to the high proportion of occurrence The fact or frequency of something (e.g. a disease or deficiency in a population) happening. 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 Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment. 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