Guidance on biocides legislation
Guidance on biocides legislation
Guidance on biocides legislation
The ECHA Guidance on biocides legislation describes how to fulfil the information requirements set by the Biocidal Products Regulation, Regulation (EU) 528/2012) (BPR) and how to perform the required assessments. It also explains the guiding principles for the evaluation of the applications to be performed by the authorities.
In addition to the BPR guidance, Biocidal Products Directive (BPD) guidance and other related documents are still considered applicable for new submissions under the BPR in the areas where the BPR guidance is under preparation. Furthermore these documents are still valid in relation to the applications for active substances for Annex I inclusion or applications for product authorisation under the BPD that may still be under evaluation. In addition, the Competent
Authorities for Biocidal Products, dealing with the implementation of the BPR, discuss in their meetings (4 to 5 per year) implementation issues. The group is also consulted by the Commission on delegated acts that the Commission is empowered to adopt pursuant to the BPR. All documents discussed in the meetings are published on Circabc.
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
- Read more
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
- Read more
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.