Overall, 32 N-NAs have been investigated for their presence in food. The opinion evaluates the toxicity of N-NAs to animals and humans, estimates the dietary exposure of the European Union (EU) population to N-NAs and assesses the human health risks to the EU population due to the estimated dietary exposure. The CONTAM Panel concluded that the MOE for TCNAs at the P95 exposure is highly likely (98–100% certain) to be less than 10,000 for all age groups, which raises a health concern.įollowing a request from the European Commission, the Panel on Contaminants in the Food Chain (CONTAM Panel) has provided a scientific opinion on the human health risks related to the presence of N-nitrosamines ( N-NAs) in food. Two major uncertainties were (i) the high number of left censored data and (ii) the lack of data on important food categories. MOEs ranged from 3,337 to 48 at the P95 exposure excluding some infant surveys with P95 exposure equal to zero. ‘Meat and meat products’ is the main food category contributing to TCNA exposure.

TCNAs exposure ranged from 0 to 208.9 ng/kg bw per day across surveys, age groups and scenarios. Dietary exposure was assessed for two scenarios, excluding (scenario 1) and including (scenario 2) cooked unprocessed meat and fish. Occurrence data were available for five food categories across TCNAs.

Analytical results on the occurrence of N-NAs were extracted from the EFSA occurrence database (n = 2,817) and the literature (n = 4,003). The lower confidence limit of the benchmark dose at 10% (BMDL 10) was 10 μg/kg body weight (bw) per day, derived from the incidence of rat liver tumours (benign and malignant) induced by NDEA and used in a margin of exposure (MOE) approach. The in vivo data available to derive potency factors are limited, and therefore, equal potency of TCNAs was assumed. N-NAs are genotoxic and induce liver tumours in rodents. NDMA, NMEA, NDEA, NDPA, NDBA, NMA, NSAR, NMOR, NPIP and NPYR. The risk assessment was confined to those 10 carcinogenic N-NAs occurring in food (TCNAs), i.e. EFSA was asked for a scientific opinion on the risks to public health related to the presence of N-nitrosamines ( N-NAs) in food.

Soft aim undetectable