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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.

The table below gives the guidance documents in the five Volumes with links to the guidance documents and provides a summary of the development to date.

 

  Volume I
Identity/phys-chemical/analytical
methodology
Volume II
Efficacy
Volume III
Human health
Volume IV
Environment
Part A Guidance Guidance Guidance Guidance
Part B Under development Under development Guidance Guidance
Part C Under development Under development Under development Under development
Volume V Specific Guidance
  Active substances and suppliers (Article 95 list) Guidance
  Technical equivalence Guidance
  Micro-organisms Guidance

 

Biocidal Products Regulation

 

Volume I Identity/physico-chemical properties/analytical methodology

 

 

Part A: Identity/physico-chemical properties/analytical methodology, Information Requirements

 

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
Part B: Identity/physico-chemical properties/analytical methodology, Assessment

 

Reference name:
Guidance on the BPR: Volume I Identity/physico-chemical properties/analytical methodology, Part B Assessment
Description:
This Guidance is under development
Part C: Identity/physico-chemical properties/analytical methodology, Evaluation

 

Reference name:
Guidance on the BPR: Volume I Identity/physico-chemical properties/analytical methodology, Part C Evaluation
Description:
This Guidance is under development

Volume II Efficacy

 

Part A: Volume II Efficacy, 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
Part B: Efficacy, Assessment

 

Reference name:
Guidance on the BPR: Volume II Efficacy, Part B Assessment
Description:
This Guidance is under development

Part C: Efficacy, Evaluation

 

Reference name:
Guidance on the BPR: Volume II Efficacy, Part C Evaluation
Description:
This Guidance is under development

 

Volume III Human health

 

Part A: Human Health, 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
Part B: Human Health, Assessment

 

Reference name:
Guidance on the BPR: Volume III Human Health, Part B Assessment
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. The Guidance on Exposure Assessment (Chapter 3) should be read together with the Biocides Human Health Exposure Methodology Document available at the link below.
download full PDF document (13/10/2015)
 
Additional information on the ECHA website
Biocides Human Health Exposure Methodology
Part C: Human Health, Evaluation

 

Reference name:
Guidance on the BPR: Volume III Human Health, Part C Evaluation
Description:
This Guidance is under development

 

Volume IV Environment

 

Part A: Environment, 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
Part B: Environment, Assessment

 

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)

Part C: Environment, Evaluation

 

Reference name:
Guidance on the BPR: Volume IV Environment, Part C Evaluation
Description:
This Guidance is under development

 

Volume V Specific Guidance

 

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 (19/08/2013)
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 (10/12/2014)
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 (26/08/2015)


Note: this guidance is currently being updated. For the latest draft, please see: http://echa.europa.eu/support/guidance/consultation-procedure/ongoing-bpr

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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