ECHA updates BPR guidance: version 5.0 on human health assessment released

The European CHemicals Agency (ECHA) has published version 5.0 (2025) of the “Guidance on the Biocidal Products Regulation, Volume III: Human health Parts B+C: Assessment & evaluation”, replacing version 4.0 from 2017.

This edition represents a full revision of the document, introducing substantial changes in structure, content, and scientific references, with the aim of ensuring consistency with regulatory developments and incorporating the latest methodological advances.

Structural revision

Two sections historically included in the guidance – covering dietary risk assessment and livestock exposure – have been removed and relocated to a new standalone document: ECHA Guidance Vol III Part D – Dietary Risk Assessment and Livestock Exposure.

Update of scientific and regulatory bases

A central element of this revision is the expansion of reference sources, encompassing recent EFSA documents and updated OECD guidances. Key topics include:

• Endocrine disruptors (ED): references to the EU criteria established by Delegated Regulation (EU) 2017/2100, the ECHA/EFSA ED Guidance, and the new hazard class introduced under CLP by Delegated Regulation (EU) 2023/707. OECD GD 150 (2018) is also cited for the interpretation of EATS modalities.
• Methodological approach: greater emphasis on Weight of Evidence (WoE), Integrated Approaches to Testing and Assessment (IATA), and Adverse Outcome Pathways (AOPs).
• Testing: reference to more recent OECD documents on skin sensitisation, PBK models, (Q)SAR models and in vitro methods, in line with modern strategies aimed at reducing animal testing.
• Carcinogenicity and immunotoxicity: expanded coverage of non-genotoxic carcinogens, recognition of in vitro studies for the identification of mechanisms of action and for guiding in vivo studies, and the introduction of key characteristics of immunotoxic agents.

 
Alignment with the CLP Regulation

Version 5.0 emphasises the need to read the guidance alongside the CLP Regulation, especially in relation to the hazard identification of substances.

Updated QSAR models

The guidance now provides a more complete list of available models, including VEGA-QSAR, ToxTree, ACD/Labs, TEST, and the OECD QSAR Toolbox.

 
This update, issued eight years after the previous version 4.0, marks a significant step forward: it recognises and updates the information and references required to conduct risk assessment under Regulation (EU) No 528/2012.

For further details, please refer to the official source.