Risk assessment of N‐nitrosamines in food
Abstract 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‐NA...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-03-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.7884 |
| _version_ | 1827950417631248384 |
|---|---|
| author | EFSA Panel on Contaminants in the Food Chain (EFSA CONTAM Panel) Dieter Schrenk Margherita Bignami Laurent Bodin James Kevin Chipman Jesús delMazo Christer Hogstrand Laurentius (Ron) Hoogenboom Jean‐Charles Leblanc Carlo Stefano Nebbia Elsa Nielsen Evangelia Ntzani Annette Petersen Salomon Sand Tanja Schwerdtle Christiane Vleminckx Heather Wallace Benigni Romualdo Cristina Fortes Stephen Hecht Marco Iammarino Olaf Mosbach‐Schulz Francesca Riolo Anna Christodoulidou Bettina Grasl‐Kraupp |
| author_facet | EFSA Panel on Contaminants in the Food Chain (EFSA CONTAM Panel) Dieter Schrenk Margherita Bignami Laurent Bodin James Kevin Chipman Jesús delMazo Christer Hogstrand Laurentius (Ron) Hoogenboom Jean‐Charles Leblanc Carlo Stefano Nebbia Elsa Nielsen Evangelia Ntzani Annette Petersen Salomon Sand Tanja Schwerdtle Christiane Vleminckx Heather Wallace Benigni Romualdo Cristina Fortes Stephen Hecht Marco Iammarino Olaf Mosbach‐Schulz Francesca Riolo Anna Christodoulidou Bettina Grasl‐Kraupp |
| author_sort | EFSA Panel on Contaminants in the Food Chain (EFSA CONTAM Panel) |
| collection | DOAJ |
| description | Abstract 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% (BMDL10) 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. |
| first_indexed | 2024-04-09T13:25:50Z |
| format | Article |
| id | doaj.art-e273443793d34434ab060cb79c4ee6a6 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-09T13:25:50Z |
| publishDate | 2023-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-e273443793d34434ab060cb79c4ee6a62023-05-10T11:11:19ZengWileyEFSA Journal1831-47322023-03-01213n/an/a10.2903/j.efsa.2023.7884Risk assessment of N‐nitrosamines in foodEFSA Panel on Contaminants in the Food Chain (EFSA CONTAM Panel)Dieter SchrenkMargherita BignamiLaurent BodinJames Kevin ChipmanJesús delMazoChrister HogstrandLaurentius (Ron) HoogenboomJean‐Charles LeblancCarlo Stefano NebbiaElsa NielsenEvangelia NtzaniAnnette PetersenSalomon SandTanja SchwerdtleChristiane VleminckxHeather WallaceBenigni RomualdoCristina FortesStephen HechtMarco IammarinoOlaf Mosbach‐SchulzFrancesca RioloAnna ChristodoulidouBettina Grasl‐KrauppAbstract 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% (BMDL10) 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.https://doi.org/10.2903/j.efsa.2023.7884N‐nitrosamines (N‐NAs)cancergenotoxicityoccurrenceexposurefood |
| spellingShingle | EFSA Panel on Contaminants in the Food Chain (EFSA CONTAM Panel) Dieter Schrenk Margherita Bignami Laurent Bodin James Kevin Chipman Jesús delMazo Christer Hogstrand Laurentius (Ron) Hoogenboom Jean‐Charles Leblanc Carlo Stefano Nebbia Elsa Nielsen Evangelia Ntzani Annette Petersen Salomon Sand Tanja Schwerdtle Christiane Vleminckx Heather Wallace Benigni Romualdo Cristina Fortes Stephen Hecht Marco Iammarino Olaf Mosbach‐Schulz Francesca Riolo Anna Christodoulidou Bettina Grasl‐Kraupp Risk assessment of N‐nitrosamines in food EFSA Journal N‐nitrosamines (N‐NAs) cancer genotoxicity occurrence exposure food |
| title | Risk assessment of N‐nitrosamines in food |
| title_full | Risk assessment of N‐nitrosamines in food |
| title_fullStr | Risk assessment of N‐nitrosamines in food |
| title_full_unstemmed | Risk assessment of N‐nitrosamines in food |
| title_short | Risk assessment of N‐nitrosamines in food |
| title_sort | risk assessment of n nitrosamines in food |
| topic | N‐nitrosamines (N‐NAs) cancer genotoxicity occurrence exposure food |
| url | https://doi.org/10.2903/j.efsa.2023.7884 |
| work_keys_str_mv | AT efsapaneloncontaminantsinthefoodchainefsacontampanel riskassessmentofnnitrosaminesinfood AT dieterschrenk riskassessmentofnnitrosaminesinfood AT margheritabignami riskassessmentofnnitrosaminesinfood AT laurentbodin riskassessmentofnnitrosaminesinfood AT jameskevinchipman riskassessmentofnnitrosaminesinfood AT jesusdelmazo riskassessmentofnnitrosaminesinfood AT christerhogstrand riskassessmentofnnitrosaminesinfood AT laurentiusronhoogenboom riskassessmentofnnitrosaminesinfood AT jeancharlesleblanc riskassessmentofnnitrosaminesinfood AT carlostefanonebbia riskassessmentofnnitrosaminesinfood AT elsanielsen riskassessmentofnnitrosaminesinfood AT evangeliantzani riskassessmentofnnitrosaminesinfood AT annettepetersen riskassessmentofnnitrosaminesinfood AT salomonsand riskassessmentofnnitrosaminesinfood AT tanjaschwerdtle riskassessmentofnnitrosaminesinfood AT christianevleminckx riskassessmentofnnitrosaminesinfood AT heatherwallace riskassessmentofnnitrosaminesinfood AT benigniromualdo riskassessmentofnnitrosaminesinfood AT cristinafortes riskassessmentofnnitrosaminesinfood AT stephenhecht riskassessmentofnnitrosaminesinfood AT marcoiammarino riskassessmentofnnitrosaminesinfood AT olafmosbachschulz riskassessmentofnnitrosaminesinfood AT francescariolo riskassessmentofnnitrosaminesinfood AT annachristodoulidou riskassessmentofnnitrosaminesinfood AT bettinagraslkraupp riskassessmentofnnitrosaminesinfood |