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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.  Also the Commission may have addressed some of the obligations in further detail in the Biocides competent authorities meetings documents which applicants are advised to consult.

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 (23/02/2017)
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 (21/02/2017)
 
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, Part B Risk Assessment (active substances)
Description:
This Guidance provides technical advice on how to perform the hazard and exposure assessment and risk characterisation for biocidal active substances with respect to environmental risk assessment.
download full PDF document (15/04/2015)
 

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)



 
 

Transitional Guidance documents

The Transitional Guidance documents are available for use until they are incorporated into the BPR guidance structure. More information

Related REACH guidance

Guidance on data sharing
Reference name:
Guidance on data sharing
Description:
According to Article 63(1) and (4) of the Biocidal Products Regulation (EU) No 528/2012, applicants "shall make every effort to reach an agreement [with data owners] on the results of the tests or studies requested by the prospective applicant." and "Compensation for data sharing shall be determined in a fair, transparent and non-discriminatory manner having regard to the guidance established by the Agency", where reference is then made to the Guidance on data sharing originally generated by ECHA for the purposes of the REACH Regulation(Regulation (EC) No 1907/2006 - REACH). NB: In the context of data sharing for the BPR purposes, the text is to be read having the terminology of the BPR in mind.
 
download full PDF document (3/4/2012)
 
Explanatory note
To support the reader, ECHA has issued a short note clarifying which chapters of the above guidance document are of particular relevance to applicants under the BPR.
 
download full PDF document (29/08/2013)
 
Guidance in a nutshell on data sharing
Sections 2.4, 3.3, 4.1 and 5.3 may be of particular relevance for applicants under the BPR. NB: the text is to be read having the terminology of the BPR in mind.
 
download full PDF document

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