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<p>In August 2023, European Food Safety Authority (EFSA) and European Chemicals Agency (ECHA) published guidance (applicable from April 2026) to assess the impact of drinking water treatment (DWT) processes on residues of plant protection products and biocides (hereafter referred to as EFSA/ECHA guidance). This guidance addresses an important regulatory need by introducing new experimental approaches to evaluate transformations of active substances and their environmental transformation products during drinking water treatment. However, while the regulatory intent of the EFSA/ECHA guidance is clear, its practical implementation presents significant challenges. The experimental concepts are described at a high level, but key testing parameters, operational conditions and analytical considerations are insufficiently specified, and no recognized or validated protocols were available at the time of publication. As a result, implementation of the guidance within such a short timeline risks inconsistent experimental design, poor reproducibility and limited comparability of data across laboratories and studies. To address these challenges, CropLife Europe (CLE) has undertaken a coordinated effort to establish the scientific and technical foundations required to operationalize the EFSA/ECHA guidance. This work focuses on the development of harmonized experimental and analytical frameworks for DWT simulation, including definition of representative treatment conditions, standardized sampling and sample-preparation procedures, and fit-for-purpose analytical workflows. The CLE approach combines targeted quantification with non-target and suspect screening by high-resolution mass spectrometry (HRMS) to detect and elucidate transformation products, enabling reproducible, robust data generation that aligns with the EFSA/ECHA guidance. The overarching objective of these efforts is not to reinterpret the regulatory intent of the EFSA/ECHA guidance, but to enable its consistent and scientifically robust application. By establishing practical testing protocols and best-practice recommendations, the CLE framework aims to improve repeatability and reproducibility of DWT studies across industry, facilitate meaningful comparison of results, and provide a reliable evidence base for regulatory evaluation and decision-making. This policy brief outlines the rationale, methodology and scope of the CLE approach and advocates for its adoption and further validation to support harmonized implementation of the EFSA/ECHA guidance.</p>

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From lab to legislation: a harmonized experimental approach to drinking water treatment assessments

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月15日

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  • Patrick Olaf Helmer,
  • David Pelzer,
  • Tom Boultwood,
  • Michael Swift,
  • Sonja Weishaupt,
  • Hannah Jakubovic,
  • Michael Kubicki

摘要

In August 2023, European Food Safety Authority (EFSA) and European Chemicals Agency (ECHA) published guidance (applicable from April 2026) to assess the impact of drinking water treatment (DWT) processes on residues of plant protection products and biocides (hereafter referred to as EFSA/ECHA guidance). This guidance addresses an important regulatory need by introducing new experimental approaches to evaluate transformations of active substances and their environmental transformation products during drinking water treatment. However, while the regulatory intent of the EFSA/ECHA guidance is clear, its practical implementation presents significant challenges. The experimental concepts are described at a high level, but key testing parameters, operational conditions and analytical considerations are insufficiently specified, and no recognized or validated protocols were available at the time of publication. As a result, implementation of the guidance within such a short timeline risks inconsistent experimental design, poor reproducibility and limited comparability of data across laboratories and studies. To address these challenges, CropLife Europe (CLE) has undertaken a coordinated effort to establish the scientific and technical foundations required to operationalize the EFSA/ECHA guidance. This work focuses on the development of harmonized experimental and analytical frameworks for DWT simulation, including definition of representative treatment conditions, standardized sampling and sample-preparation procedures, and fit-for-purpose analytical workflows. The CLE approach combines targeted quantification with non-target and suspect screening by high-resolution mass spectrometry (HRMS) to detect and elucidate transformation products, enabling reproducible, robust data generation that aligns with the EFSA/ECHA guidance. The overarching objective of these efforts is not to reinterpret the regulatory intent of the EFSA/ECHA guidance, but to enable its consistent and scientifically robust application. By establishing practical testing protocols and best-practice recommendations, the CLE framework aims to improve repeatability and reproducibility of DWT studies across industry, facilitate meaningful comparison of results, and provide a reliable evidence base for regulatory evaluation and decision-making. This policy brief outlines the rationale, methodology and scope of the CLE approach and advocates for its adoption and further validation to support harmonized implementation of the EFSA/ECHA guidance.