TY - JOUR
T1 - Risk assessment of N-nitrosamines in food
T2 - EFSA Journal
AU - Schrenk, D.
AU - Bignami, M.
AU - Bodin, L.
AU - Chipman, J.K.
AU - del Mazo, J.
AU - Hogstrand, C.
AU - Hoogenboom, L.
AU - Leblanc, J.-C.
AU - Nebbia, C.S.
AU - Nielsen, E.
AU - Ntzani, E.
AU - Petersen, A.
AU - Sand, S.
AU - Schwerdtle, T.
AU - Vleminckx, C.
AU - Wallace, H.
AU - Romualdo, B.
AU - Cristina, F.
AU - Stephen, H.
AU - Marco, I.
AU - Mosbach-Schulz, O.
AU - Riolo, F.
AU - Christodoulidou, A.
AU - Grasl-Kraupp, B.
AU - Panel), EFSA Panel on Contaminants in the Food Chain (EFSA CONTAM
N1 - Funding Information:
The acyclic volatile ‐NAs NDMA, NMEA, NDEA, NDPA are genotoxic both in and assays, while the evidence for NDIPA and NMBA is limited to assays. The genotoxic/carcinogenic potential of NEIPA and NMVA is supported by QSAR read‐across analyses. The genotoxicity of acyclic non‐volatile NAs has been demonstrated for NDBA, NDBzA ( and ) and NMA, NMAMBA (only ). QSAR/read across indicate the genotoxic/carcinogenic potential of NDIBA and NSAR. Genotoxic properties characterise the cyclic volatile ‐NAs NMOR, NPIP, NPYR (both and ) and NTHZ ( ). No indication of genotoxicity is provided for the cyclic non‐volatile ‐NAs either by assays (NPRO, NHPRO) or studies (NPIC). The genotoxic potential of aromatic ‐NA NDPheA remains uncertain. N in vitro in vivo in vitro N‐ in vitro in vivo in vitro N in vitro in vivo in vitro N in vitro in silico N
Publisher Copyright:
© 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
PY - 2023/3
Y1 - 2023/3
N2 - EFSA was asked for a scientific opinion on the risks to public health related to the presence of N-nitrosamines (N-NAs) in food. The risk assessment was confined to those 10 carcinogenic N-NAs occurring in food (TCNAs), i.e. NDMA, NMEA, NDEA, NDPA, NDBA, NMA, NSAR, NMOR, NPIP and NPYR. N-NAs are genotoxic and induce liver tumours in rodents. The in vivo data available to derive potency factors are limited, and therefore, equal potency of TCNAs was assumed. 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. Analytical results on the occurrence of N-NAs were extracted from the EFSA occurrence database (n = 2,817) and the literature (n = 4,003). Occurrence data were available for five food categories across TCNAs. Dietary exposure was assessed for two scenarios, excluding (scenario 1) and including (scenario 2) cooked unprocessed meat and fish. TCNAs exposure ranged from 0 to 208.9 ng/kg bw per day across surveys, age groups and scenarios. ‘Meat and meat products’ is the main food category contributing to TCNA exposure. MOEs ranged from 3,337 to 48 at the P95 exposure excluding some infant surveys with P95 exposure equal to zero. Two major uncertainties were (i) the high number of left censored data and (ii) the lack of data on important food categories. 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.
AB - EFSA was asked for a scientific opinion on the risks to public health related to the presence of N-nitrosamines (N-NAs) in food. The risk assessment was confined to those 10 carcinogenic N-NAs occurring in food (TCNAs), i.e. NDMA, NMEA, NDEA, NDPA, NDBA, NMA, NSAR, NMOR, NPIP and NPYR. N-NAs are genotoxic and induce liver tumours in rodents. The in vivo data available to derive potency factors are limited, and therefore, equal potency of TCNAs was assumed. 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. Analytical results on the occurrence of N-NAs were extracted from the EFSA occurrence database (n = 2,817) and the literature (n = 4,003). Occurrence data were available for five food categories across TCNAs. Dietary exposure was assessed for two scenarios, excluding (scenario 1) and including (scenario 2) cooked unprocessed meat and fish. TCNAs exposure ranged from 0 to 208.9 ng/kg bw per day across surveys, age groups and scenarios. ‘Meat and meat products’ is the main food category contributing to TCNA exposure. MOEs ranged from 3,337 to 48 at the P95 exposure excluding some infant surveys with P95 exposure equal to zero. Two major uncertainties were (i) the high number of left censored data and (ii) the lack of data on important food categories. 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.
KW - cancer
KW - exposure
KW - food
KW - genotoxicity
KW - margin of exposure (MOE)
KW - N-nitrosamines (N-NAs)
KW - occurrence
UR - http://www.scopus.com/inward/record.url?scp=85153711441&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2023.7884
DO - 10.2903/j.efsa.2023.7884
M3 - Article
SN - 1831-4732
VL - 21
JO - EFSA J.
JF - EFSA J.
IS - 3
M1 - e07884
ER -