Orientation relative à la législation des biocides

La liste ci-dessous comprend l'ensemble des documents d'orientation disponibles, ou qui le seront, sur le présent site web. Ceux-ci ont été élaborés avec la participation des États membres, de l'industrie et des parties prenantes accréditées. Leur objectif est de rendre la mise en oeuvre du règlement sur les produits biocides (RPB) plus aisée en décrivant les bonnes pratiques concernant la façon de remplir les obligations.

En plus de l'orientation relative au RPB, l'orientation relative à la directive sur les produits biocides (DPB) ainsi que d'autres documents connexes sont considérés comme applicables aux nouvelles soumissions dans le cadre du RPB dans les domaines dans lesquels l'orientation relative au RPB est encore en cours de préparation. En outre, ces documents demeurent valides en ce qui concerne les demandes d'inclusion de substances actives dans l'Annexe I ou les demandes d'autorisation de produits dans le cadre du RPB qui sont encore sous évaluation.

Biocidal Products Regulation

Volume I Identity/physico-chemical properties/analytical methodology

Parts A+B+C: Information Requirements, Assessment and Evaluation

Reference name:: Guidance on the BPR: Volume I Identity/physico-chemical properties/analytical methodology (Parts A+B+C)
Description:: This Guidance describes the information requirements for active substances and biocidal products in accordance with the Title 1 of Annex II and Annex III of the BPR, including technical advice on how to perform the hazard and exposure assessment and risk characterisation for biocidal active substances and products.
Download introduction to guidance (29/03/2022)
Download guidance (29/03/2022)
Additional information on the ECHA website: Read more

Volume II Efficacy

Part A: Information Requirements

Reference name:: Guidance on the BPR: Volume II Efficacy (Part A)
Description:: This Guidance describes the information requirements for active substances and biocidal products in accordance with the Title 1 of Annex II and III of the BPR.
Download introduction to guidance (29/03/2022)
Download guidance (29/03/2022)
Additional information on the ECHA website: Read more

Parts B+C: Assessment and Evaluation

Reference name:: Guidance on the BPR: Volume II Efficacy, Assessment + Evaluation (Parts B+C)
Description:: This Guidance provides technical advice on how to perform the hazard and exposure assessment and risk characterisation for biocidal active substances and products with respect to efficacy
download full PDF document (11/08/2023)
Additional information on the ECHA website: Read more

Volume III Human health

Part A: Information Requirements

Reference name:: Guidance on the BPR: Volume III Human Health (Part A)
Description:: This Guidance describes the information requirements for active substances and biocidal products in accordance with Title 1 of the amended Annex II and III of the BPR, applicable from 15 April 2022.
Download introduction to guidance (29/03/2022)
Download guidance (29/03/2022)
Additional information on the ECHA website: Read more

Parts B+C: Assessment and Evaluation

Reference name:: Guidance on the BPR: Volume III Human Health, Assessment + Evaluation (Parts B+C)
Description:: This Guidance provides technical advice on how to perform the hazard and exposure assessment and risk characterisation for biocidal active substances and products with respect to human health risk assessment and evaluation.
download full PDF document (11/12/2017)
Additional information on the ECHA website: Biocides Human Health Exposure Methodology

Volume IV Environment

Part A: Information Requirements

Reference name:: Guidance on the BPR: Volume IV Environment (Part A)
Description:: This Guidance describes the information requirements for active substances and biocidal products in accordance with the Title 1 of Annex II and III of the BPR.
Download introduction to guidance (29/03/2022)
Download guidance (29/03/2022)
Additional information on the ECHA website: Read more

Parts B+C: Assessment and Evaluation

Reference name:: Guidance on the BPR: Volume IV Environment, Assessment & Evaluation (Parts B+C)
Description:: This Guidance provides technical advice on how to perform the hazard and exposure assessment and risk characterisation for biocidal active substances and biocidal products with respect to environmental risk assessment.
download full PDF document (25/10/2017)

Volume V Specific Guidance

Guidance on Disinfection By-Products

Reference name:: Guidance on Disinfection By-Products
Description:: This guidance document deals with the risk assessment for human health and the environment of Disinfection By-Products that is applicable for the authorisation of products under the EU Biocidal Products Regulation (BPR, Regulation (EU) 528/2012).
download full PDF document (23/01/2017)

Guidance on applications for technical equivalence

Reference name:

Guidance on applications for technical equivalence

Description:

Note: Version 2.0 of this Guidance replaces the document “Recommendations for applicants on information requirements for technical equivalence Tier II” which has now been removed from our website.

This Guidance informs potential applicants about their obligations resulting from the provisions of Article 54 of the BPR: when they need to apply for an assessment of technical equivalence and on the procedural steps in making that application.
The Guidance also informs potential applicants about the assessment conducted by the Agency and the approach used for assessing the technical equivalence of the alternative source of an active substance versus its reference source.
download full PDF document (12/07/2018)

Additional information on the ECHA website

Guidance on active substance suppliers

Reference name:: Guidance on active substance suppliers
Description:: This Guidance describes the obligations under Article 95 of the BPR and explains the regulatory consequences.
download full PDF document (29/03/2017)
Additional information on the ECHA website: Read more

Guidance on micro-organisms

Reference name:: Guidance on micro-organisms
Description:: This Guidance provides technical advice on the information requirements, the hazard and exposure assessment, the risk characterisation and the evaluation of the active substances and biocidal products in accordance with Annex II, Title 2 and Annex III, Title 2 of the BPR for micro-organisms.
download full PDF document (29/03/2017)

Guidance for identification of endocrine disruptors

Reference name:

Guidance on endocrine disruptors

Description:

This Guidance was developed jointly by ECHA and the European Food Safety Authority (EFSA) with support by the Joint Research Centre (JRC) and describes how to identify endocrine disruptors in the context of the Biocidal Products Regulation (EU) No 528/2012 and the Plant Protection Products Regulation (EC) No 1107/2009 in accordance with the scientific criteria for the determination of endocrine disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 and Commission Regulation (EU) 2018/605. The guidance document has been published in the EFSA Journal.

Link to the Guidance (07/06/2018, amended 23/07/2018)
Link to Supporting Publication

Additional information on the ECHA website

Guidance to assess the risks to bees from the use of biocides

Reference name:: Guidance to assess the risks to bees from the use of biocides
Description:: This Guidance provides technical advice on how to perform the hazard and exposure assessment and risk characterisation for biocidal active substances and biocidal products with respect to assessment of risks to bees from the use of biocides.
download full PDF document (02/2024)
appendix B [XLSX]
Additional information on applicability: The applicability and timeline of implementation of the guidance, agreed by the Member States Competent Authority meeting, is available here.

ECHA/EFSA guidance on the impact of water treatment processes of residues of active substances in drinking water

Reference name:: ECHA/EFSA guidance on the impact of water treatment processes of residues of active substances in drinking water.
Description:: The guidance helps you identifying, water residues that require assessment, what water treatment transformation products are formed; and how to conduct a risk assessment that considers consumption of drinking water.
Download guidance document from EFSA website (08/2023)
Additional information on applicability: The applicability and timeline of implementation of the guidance, agreed by the Member States Competent Authority meeting, is available here.

Superseded Biocides Guidance documents

When a guidance document from Volumes I to V of the BPR Guidance is updated and a new version is published, the “old” version is removed from the Guidance webpage and stored on a separate page for reference.

More information

Related REACH guidance

Guidance on data sharing