More Simon John, Bampidis Vasileios, Benford Diane, Bennekou Susanne Hougaard, Bragard Claude, Halldorsson Thorhallur Ingi, Hernández-Jerez Antonio F, Koutsoumanis Konstantinos, Naegeli Hanspeter, Schlatter Josef R, Silano Vittorio, Nielsen Søren Saxmose, Schrenk Dieter, Turck Dominique, Younes Maged, Benfenati Emilio, Castle Laurence, Cedergreen Nina, Hardy Anthony, Laskowski Ryszard, Leblanc Jean Charles, Kortenkamp Andreas, Ragas Ad, Posthuma Leo, Svendsen Claus, Solecki Roland, Testai Emanuela, Dujardin Bruno, Kass George En, Manini Paola, Jeddi Maryam Zare, Dorne Jean-Lou Cm, Hogstrand Christer
EFSA J. 2019 Mar 25;17(3):e05634. doi: 10.2903/j.efsa.2019.5634. eCollection 2019 Mar.
This Guidance document describes harmonised risk assessment methodologies for combined exposure to multiple chemicals for all relevant areas within EFSA's remit, i.e. human health, animal health and ecological areas. First, a short review of the key terms, scientific basis for combined exposure risk assessment and approaches to assessing (eco)toxicology is given, including existing frameworks for these risk assessments. This background was evaluated, resulting in a harmonised framework for risk assessment of combined exposure to multiple chemicals. The framework is based on the risk assessment steps (problem formulation, exposure assessment, hazard identification and characterisation, and risk characterisation including uncertainty analysis), with tiered and stepwise approaches for both whole mixture approaches and component-based approaches. Specific considerations are given to component-based approaches including the grouping of chemicals into common assessment groups, the use of dose addition as a default assumption, approaches to integrate evidence of interactions and the refinement of assessment groups. Case studies are annexed in this guidance document to explore the feasibility and spectrum of applications of the proposed methods and approaches for human and animal health and ecological risk assessment. The Scientific Committee considers that this Guidance is fit for purpose for risk assessments of combined exposure to multiple chemicals and should be applied in all relevant areas of EFSA's work. Future work and research are recommended.
本指导文件描述了欧洲食品安全局（EFSA）职责范围内所有相关领域（即人类健康、动物健康和生态领域）对多种化学物质联合暴露的统一风险评估方法。首先，对关键术语、联合暴露风险评估的科学依据以及评估（生态）毒理学的方法进行了简要回顾，包括这些风险评估的现有框架。对这一背景进行了评估，从而形成了一个对多种化学物质联合暴露进行风险评估的统一框架。该框架基于风险评估步骤（问题设定、暴露评估、危害识别与表征以及包括不确定性分析在内的风险表征），对整体混合物方法和基于成分的方法均采用分层和逐步推进的方式。对基于成分的方法给予了特别考虑，包括将化学物质分组到共同评估组、使用剂量相加作为默认假设、整合相互作用证据的方法以及评估组的细化。本指导文件附有案例研究，以探讨所提议的方法和途径在人类和动物健康以及生态风险评估中的应用可行性和应用范围。科学委员会认为，本指导文件适用于对多种化学物质联合暴露的风险评估，应在EFSA工作的所有相关领域中应用。建议开展未来的工作和研究。
