Przejdź do komentarzy
Przejdź do komentarzy

Poradnik dotyczący rozporządzenia w sprawie produktów biobójczych

Poniższa lista zawiera wszystkie poradniki, które są lub będą dostępne na stronie internetowej ECHA. Zostały one opracowane z udziałem państw członkowskich, przedstawicieli branży i akredytowanych zainteresowanych stron. Dokumenty te mają na celu ułatwienie wdrożenia rozporządzenia w sprawie produktów biobójczych (BPR) przez opisanie dobrych praktyk dotyczących wykonania zobowiązań.
 
Obok poradników dotyczących BPR do nowych zgłoszeń składanych na mocy BPR w dziedzinach, w których poradniki dotyczące BPR są obecnie w przygotowaniu, mają zastosowanie poradniki dotyczące dyrektywy w sprawie produktów biobójczych (BPD) i inne dokumenty powiązane. Ponadto dokumenty te nadal obowiązują w odniesieniu do wniosków o włączanie substancji aktywnych do załącznika I i o wydawanie pozwolenia na produkt na podstawie BPD, które mogą być jeszcze w trakcie oceny.
diagram of BPR Guidance structure

 

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 full PDF document (23/05/2018)
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 full PDF document (23/05/2018)
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 (20/04/2018)
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 the Title 1 of Annex II and III of the BPR.
download full PDF document (23/05/2018)
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 full PDF document (23/05/2018)
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 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 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 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 final guidance will be published in the EFSA Journal by July 2018. A pre-publication version of the guidance is available at the link below.
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 on applications for technical equivalence
Reference name:
Guidance on applications for technical equivalence
Description:
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 (29/03/2017)
Additional information on the ECHA website
Read more

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.

Related REACH guidance

Categories Display


Route: .live1