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Leitlinien zur Biozid-Gesetzgebung

Die nachstehende Liste enthält sämtliche Leitlinien, die auf dieser Website bereits jetzt verfügbar sind oder in Kürze zur Verfügung stehen werden. Die Dokumente wurden mit Beteiligung der Mitgliedstaaten, der Industrie und akkreditierter Interessenvertreter erarbeitet. Diese Dokumente sollen die Anwendung der Verordnung über Biozidprodukte (BPR) erleichtern, indem bewährte Vorgehensweisen zur Erfüllung der Verpflichtungen beschrieben werden.
 
Neben BPR-Leitlinien werden auch Leitlinien zur Richtlinie über Biozidprodukte (BPD) und andere verwandte Dokumente als für neue Einreichungen unter der BPR in den Bereichen, in denen die BPR-Leitlinien noch im Vorbereitungsstadium sind, anwendbar erachtet. Des Weiteren sind diese Dokumente in Bezug auf die Anträge auf Aufnahme von Wirkstoffen in Anhang I oder Anträge auf Produktzulassung unter der BPD, die sich noch im Bewertungsstadium befinden, immer noch gültig.
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, Part A Information Requirements
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 (28/11/2014)
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 Information Requirements
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 (28/11/2014)
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 (11/12/2017)
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 Information Requirements
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 (28/11/2014)
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 Information Requirements
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 (28/11/2014)
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:
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
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)



 
 

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

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