Schrenk Dieter, Bignami Margherita, Bodin Laurent, Chipman James Kevin, Del Mazo Jesús, Grasl-Kraupp Bettina, Hogstrand Christer, Hoogenboom Laurentius Ron, Leblanc Jean-Charles, Nebbia Carlo Stefano, Nielsen Elsa, Ntzani Evangelia, Petersen Annette, Sand Salomon, Vleminckx Christiane, Wallace Heather, Barregård Lars, Ceccatelli Sandra, Cravedi Jean-Pierre, Halldorsson Thorhallur Ingi, Haug Line Småstuen, Johansson Niklas, Knutsen Helle Katrine, Rose Martin, Roudot Alain-Claude, Van Loveren Henk, Vollmer Günter, Mackay Karen, Riolo Francesca, Schwerdtle Tanja
EFSA J. 2020 Sep 17;18(9):e06223. doi: 10.2903/j.efsa.2020.6223. eCollection 2020 Sep.
The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances (PFASs) in food. Based on several similar effects in animals, toxicokinetics and observed concentrations in human blood, the CONTAM Panel decided to perform the assessment for the sum of four PFASs: PFOA, PFNA, PFHxS and PFOS. These made up half of the lower bound (LB) exposure to those PFASs with available occurrence data, the remaining contribution being primarily from PFASs with short half-lives. Equal potencies were assumed for the four PFASs included in the assessment. The mean LB exposure in adolescents and adult age groups ranged from 3 to 22, the 95th percentile from 9 to 70 ng/kg body weight (bw) per week. Toddlers and 'other children' showed a twofold higher exposure. Upper bound exposure was 4- to 49-fold higher than LB levels, but the latter were considered more reliable. 'Fish meat', 'Fruit and fruit products' and 'Eggs and egg products' contributed most to the exposure. Based on available studies in animals and humans, effects on the immune system were considered the most critical for the risk assessment. From a human study, a lowest BMDL of 17.5 ng/mL for the sum of the four PFASs in serum was identified for 1-year-old children. Using PBPK modelling, this serum level of 17.5 ng/mL in children was estimated to correspond to long-term maternal exposure of 0.63 ng/kg bw per day. Since accumulation over time is important, a tolerable weekly intake (TWI) of 4.4 ng/kg bw per week was established. This TWI also protects against other potential adverse effects observed in humans. Based on the estimated LB exposure, but also reported serum levels, the CONTAM Panel concluded that parts of the European population exceed this TWI, which is of concern.
欧盟委员会要求欧洲食品安全局对食品中全氟烷基物质（PFASs）对人体健康的风险进行科学评估。基于动物身上的几种类似效应、毒代动力学以及人体血液中观察到的浓度，CONTAM专家组决定对四种PFASs的总和进行评估：全氟辛酸（PFOA）、全氟壬酸（PFNA）、全氟己烷磺酸（PFHxS）和全氟辛烷磺酸（PFOS）。在有出现数据的那些PFASs中，这四种物质占下限（LB）暴露量的一半，其余贡献主要来自半衰期短的PFASs。评估中纳入的四种PFASs被假定具有同等效力。青少年和成年年龄组的平均LB暴露量在3至22之间，第95百分位数为每周9至70纳克/千克体重（bw）。幼儿和“其他儿童”的暴露量高出两倍。上限暴露量比LB水平高4至49倍，但后者被认为更可靠。“鱼肉”、“水果和水果制品”以及“蛋类和蛋制品”对暴露的贡献最大。基于动物和人体的现有研究，对免疫系统的影响被认为是风险评估中最关键的。从一项人体研究中，确定1岁儿童血清中四种PFASs总和的最低基准剂量下限（BMDL）为17.5纳克/毫升。使用生理药代动力学（PBPK）模型，估计儿童血清中17.5纳克/毫升的这一水平相当于母亲长期每日暴露量为0.63纳克/千克bw。由于随着时间的积累很重要，因此确定了每周4.4纳克/千克bw的可耐受摄入量（TWI）。该TWI也能预防在人体中观察到的其他潜在不良影响。基于估计的LB暴露量以及报告的血清水平，CONTAM专家组得出结论，欧洲部分人群超过了这一TWI，这令人担忧。
