Hofman-Caris Roberta, Dingemans Milou, Reus Astrid, Shaikh Sanah Majid, Muñoz Sierra Julian, Karges Ursula, der Beek Tim Aus, Nogueiro Eugénia, Lythgo Christopher, Parra Morte Juan Manuel, Bastaki Maria, Serafimova Rositsa, Friel Anja, Court Marques Daniele, Uphoff Andreas, Bielska Lucie, Putzu Claudio, Ruggeri Laura, Papadaki Paschalina
EFSA J. 2023 Aug 28;21(8):e08194. doi: 10.2903/j.efsa.2023.8194. eCollection 2023 Aug.
This guidance document provides a tiered framework for risk assessors and facilitates risk managers in making decisions concerning the approval of active substances (AS) that are chemicals in plant protection products (PPPs) and biocidal products, and authorisation of the products. Based on the approaches presented in this document, a conclusion can be drawn on the impact of water treatment processes on residues of the AS or its metabolites in surface water and/or groundwater abstracted for the production of drinking water, i.e. the formation of transformation products (TPs). This guidance enables the identification of actual public health concerns from exposure to harmful compounds generated during the processing of water for the production of drinking water, and it focuses on water treatment methods commonly used in the European Union (EU). The tiered framework determines whether residues from PPP use or residues from biocidal product use can be present in water at water abstraction locations. Approaches, including experimental methods, are described that can be used to assess whether harmful TPs may form during water treatment and, if so, how to assess the impact of exposure to these water treatment TPs (tTPs) and other residues including environmental TPs (eTPs) on human and domesticated animal health through the consumption of TPs via drinking water. The types of studies or information that would be required are described while avoiding vertebrate testing as much as possible. The framework integrates the use of weight-of-evidence and, when possible alternative (new approach) methods to avoid as far as possible the need for additional testing.
本指导文件为风险评估人员提供了一个分层框架,并有助于风险管理人员就植物保护产品(PPP)和生物杀灭产品中作为化学物质的活性物质(AS)的批准以及产品授权做出决策。基于本文档中提出的方法,可以得出关于水处理过程对用于生产饮用水的地表水和/或地下水中AS或其代谢物残留的影响的结论,即转化产物(TP)的形成。本指导意见有助于识别因接触饮用水生产过程中产生的有害化合物而引发的实际公共卫生问题,并且重点关注欧盟(EU)常用的水处理方法。分层框架确定了在取水地点的水中是否可能存在来自PPP使用的残留物或来自生物杀灭产品使用的残留物。文中描述了包括实验方法在内的方法,可用于评估水处理过程中是否可能形成有害的TP,如果是,则评估通过饮用水摄入TP接触这些水处理TP(tTP)和其他残留物(包括环境TP(eTP))对人类和家养动物健康的影响。描述了所需的研究类型或信息,同时尽可能避免进行脊椎动物试验。该框架整合了证据权重的使用,并在可能的情况下采用替代(新方法)方法,以尽可能避免进行额外测试的必要性。