The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, the Netherlands.
Food Allergy Research and Resource Program, University of Nebraska, Lincoln, USA.
Food Chem Toxicol. 2020 Dec;146:111831. doi: 10.1016/j.fct.2020.111831. Epub 2020 Nov 7.
Previously, we published selected Eliciting Dose (ED) values (i.e. ED01 and ED05 values) for 14 allergenic foods, predicted to elicit objective allergic symptoms in 1% and 5%, respectively, of the allergic population (Remington et al., 2020). These ED01 and ED05 values were specifically presented and discussed in the context of establishing Reference Doses for allergen management and the calculation of Action Levels for Precautionary Allergen Labeling (PAL). In the current paper, we publish the full range of ED values for these allergenic foods and provide recommendations for their use, specifically in the context of characterizing risks of concentrations of (unintended) allergenic proteins in food products. The data provided in this publication give risk assessors access to full population ED distribution information for 14 priority allergenic foods, based on the largest threshold database worldwide. The ED distributions were established using broad international consensus regarding suitable datapoints and methods for establishing individual patient's NOAELs and LOAELs and state of the art statistical modelling. Access to these ED data enables risk assessors to use this information for state-of-the-art food allergen risk assessment. This paper contributes to a harmonization of food allergen risk assessment and risk management and PAL practices.
此前,我们发布了部分过敏原食品的诱发性剂量 (ED) 值(即 ED01 和 ED05 值),这些食品预计会在过敏人群中分别引发 1%和 5%的客观过敏症状 (Remington 等人,2020 年)。这些 ED01 和 ED05 值是在为过敏原管理制定参考剂量和计算预防性过敏原标签 (PAL) 的行动水平的背景下特别提出和讨论的。在当前的论文中,我们公布了这些过敏原食品的完整 ED 值范围,并提供了它们的使用建议,特别是在描述食品中(无意)过敏原蛋白浓度的风险方面。本出版物提供的数据使风险评估人员能够根据全球最大的阈值数据库,获得 14 种优先过敏原食品的全人群 ED 分布信息。ED 分布是基于建立个体患者的 NOAEL 和 LOAEL 以及最先进的统计模型的广泛国际共识而确定的。这些 ED 数据的获取使风险评估人员能够将这些信息用于最先进的食物过敏原风险评估。本文有助于食物过敏原风险评估和风险管理以及 PAL 实践的协调统一。