Schrenk Dieter, Bignami Margherita, Bodin Laurent, Chipman James Kevin, Del Mazo Jesús, Hogstrand Christer, Ron Hoogenboom Laurentius, Leblanc Jean-Charles, Nebbia Carlo Stefano, Nielsen Elsa, Ntzani Evangelia, Petersen Annette, Sand Salomon, Schwerdtle Tanja, Vleminckx Christiane, Wallace Heather, Romualdo Benigni, Cristina Fortes, Stephen Hecht, Marco Iammarino, Mosbach-Schulz Olaf, Riolo Francesca, Christodoulidou Anna, Grasl-Kraupp Bettina
EFSA J. 2023 Mar 28;21(3):e07884. doi: 10.2903/j.efsa.2023.7884. eCollection 2023 Mar.
EFSA was asked for a scientific opinion on the risks to public health related to the presence of -nitrosamines (-NAs) in food. The risk assessment was confined to those 10 carcinogenic -NAs occurring in food (TCNAs), i.e. NDMA, NMEA, NDEA, NDPA, NDBA, NMA, NSAR, NMOR, NPIP and NPYR. -NAs are genotoxic and induce liver tumours in rodents. The 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) 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 -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.
欧洲食品安全局(EFSA)被要求就食品中存在的亚硝胺(-NAs)对公众健康的风险提供科学意见。风险评估仅限于食品中出现的10种致癌亚硝胺(TCNAs),即N-亚硝基二甲胺(NDMA)、N-亚硝基甲乙胺(NMEA)、N-亚硝基二乙胺(NDEA)、N-亚硝基二丙胺(NDPA)、N-亚硝基二丁胺(NDBA)、N-亚硝基甲胺(NMA)、N-亚硝基-S-烯丙基-L-半胱氨酸(NSAR)、N-亚硝基吗啉(NMOR)、N-亚硝基哌啶(NPIP)和N-亚硝基吡咯烷(NPYR)。亚硝胺具有遗传毒性,可在啮齿动物中诱发肝肿瘤。可用于推导效力因子的数据有限,因此,假定TCNAs具有同等效力。基准剂量10%(BMDL)的较低置信限为每天10μg/kg体重(bw),源自NDEA诱导的大鼠肝肿瘤(良性和恶性)发生率,并用于暴露边际(MOE)方法。亚硝胺出现情况的分析结果从EFSA出现情况数据库(n = 2817)和文献(n = 4003)中提取。有五种食品类别提供了TCNAs的出现情况数据。针对两种情况评估了膳食暴露,不包括(情况1)和包括(情况2)未加工的熟肉和鱼。在各项调查、年龄组和情况下,TCNAs的暴露量范围为每天0至208.9 ng/kg bw。“肉类和肉类产品”是导致TCNAs暴露的主要食品类别。在排除一些P95暴露量为零的婴儿调查后,P95暴露量下的MOE范围为3337至48。两个主要的不确定性因素是:(i)大量左删失数据,以及(ii)重要食品类别缺乏数据。CONTAM小组得出结论,对于所有年龄组,P95暴露量下TCNAs的MOE极有可能(98%-100%确定)小于10000,这引发了对健康的担忧。