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Guidance on the Biocidal Products Regulation SUPERSEDED GUIDANCE - NEWER VERSION AVAILA BLE Guidance on the Biocidal Products Regulation Volume II Efficacy - Assessment and Evaluation (Parts B+C) Version 2.0 December 2017 Guidance on the BPR: Volume II Parts B+C 2 Version 2.0 December 2017 LEGAL NOTICE This document aims to assist users in complying with their obligations under the Biocidal Products Regulation (BPR). However, users are reminded that the text of the BPR is the only authentic legal reference and that the information in this document does not constitute legal advice. Usage of the information remains under the sole responsibility of the user. The European Chemicals Agency does not accept any liability with regard to the use that may be made of the information contained in this document. Guidance on the BPR: Volume II Efficacy - Assessment and Evaluation (Parts B+C) Reference: ECHA-17-G-28-EN Cat. Number: ED-07-17-062-EN-N ISBN: 978-92-9020-259-2 DoI: 10.2823/532500 Publ.date: December 2017 Language: EN © European Chemicals Agency, 2017 If you have questions or comments in relation to this document please send them (quote the reference and issue date) using the information request form. The information request form can be accessed via the Contact ECHA page at: http://echa.europa.eu/contact. European Chemicals Agency Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland Guidance on the BPR: Volume II Parts B+C Version 2.0 December 2017 3 DOCUMENT HISTORY Version Comment Date Version 1.0 First edition February 2017 Version 2.0 Update to PT8 December 2017 The text has been revised as follows: To add a new Appendix 12; To revise section 5.5.8.3 to remove temporary footnote re. the new Appendix 12; To add a new footnote to section 5.5.8.2.2.3, Use Class 2, Test Species; To re-number Appendices after the new Appendix 12 and revise all cross references to these Appendices. Guidance on the BPR: Volume II Parts B+C 4 Version 2.0 December 2017 PREFACE The Guidance on the Biocidal Products Regulation (BPR) is to be applied to applications for active substance approval and product authorisation as submitted from 1 September 2013, the date of application (DoA) of the Biocidal Product Regulation (the BPR). This document describes the BPR obligations and how to fulfil them. The scientific guidance provides technical scientific advice on how to fulfil the information requirements set by the BPR (Part A), how to perform the risk assessment and the exposure assessment for the evaluation of the human health and environmental aspects and how to asses and evaluate the efficacy to establish the benefit arising from the use of biocidal products and that it is sufficiently effective (Parts B & C). In addition to the BPR guidance, the 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 substance approval or applications for product authorisation under the BPD that may still be under evaluation. Also the Commission has addressed some of the obligations in further detail in the Biocides competent authorities meetings documents which applicants are advised to consult. Please see ECHA Biocides Guidance website for links to these documents: [https://echa.europa.eu/guidance- documents/guidance-on-biocides-legislation]. Applicability of Guidance Guidance on applicability of new guidance or guidance related documents for active substance approval is given in the published document “Applicability time of new guidance and guidance-related documents in active substance approval” available on the BPC Webpage1 [https://echa.europa.eu/about-us/who-we-are/biocidal-products-committee] and for applicability of guidance for product authorisation, please see the CA-document CA- july2012-doc6.2d (final), available on the ECHA Guidance page [https://echa.europa.eu/documents/10162/23036409/ca-july12-doc_6_2d_final_en.pdf]. 1 Link available under Working Procedures (right column) [https://echa.europa.eu/about-us/who-we- are/biocidal-products-committee] Guidance on the BPR: Volume II Parts B+C Version 2.0 December 2017 5 Table of Contents LEGAL NOTICE .................................................................................................. 2 DOCUMENT HISTORY ......................................................................................... 3 PREFACE .......................................................................................................... 4 LIST OF ABBREVIATIONS ................................................................................... 16 GLOSSARY OF TERMS ........................................................................................ 18 1. GENERAL INTRODUCTION ............................................................................... 22 2. CLAIMS ........................................................................................................ 22 2.1 INTRODUCTION ....................................................................................... 22 2.2 LABEL CLAIMS AND DIRECTIONS FOR USE .................................................. 23 3. GENERAL CONSIDERATIONS FOR THE DEVELOPMENT AND REPORTING OF EFFICACY DATA 24 3.1 EFFICACY ................................................................................................ 24 3.1.1 Efficacy tests .................................................................................. 24 3.1.2 Test report ..................................................................................... 25 3.2 RESISTANCE ........................................................................................... 26 4. ACTIVE SUBSTANCE APPROVAL ....................................................................... 26 4.1 INTRODUCTION ....................................................................................... 26 4.2 GENERAL PRINCIPLES .............................................................................. 27 4.2.1 Intended use .................................................................................. 27 4.2.2 Evaluation of efficacy ....................................................................... 27 4.2.2.1 Active substance efficacy (part A): .......................................... 27 4.2.2.2 Product efficacy (part B): ....................................................... 29 4.2.3 Overall evaluation for active substance approval ................................. 29 4.2.4 Link to risk assessment .................................................................... 29 4.3 ACTIVE SUBSTANCES WHICH ARE NOT INTENDED TO BE USED IN ISOLATION 30 4.4 “DUMMY PRODUCTS” ................................................................................ 31 4.5 ACTIVE SUBSTANCES USED IN TREATED MATERIALS AND TREATED ARTICLES 31 4.5.1 Efficacy assessment for active substance approval ............................... 31 4.5.2 Efficacy assessment for active substances in specific PTs ...................... 31 5. PRODUCT AUTHORISATION............................................................................. 33 5.1 EVALUATION OF EFFICACY AT PRODUCT AUTHORISATION STAGE ................. 33 5.2 PRODUCT FAMILIES ................................................................................. 33 5.2.1 Background .................................................................................... 33 5.2.2 Worst case testing ........................................................................... 34 5.2.3 Take formulation types and chemical composition into account ............. 37 5.2.4 Allowing for the addition of new products in a family ............................ 38 5.2.5 Deviation in meta SPC’s ................................................................... 39 5.2.6 Minimum concentration needed ......................................................... 40 5.3 TREATED ARTICLES .................................................................................. 40 5.3.1 The basic distinction between material protection and protection of humans or animals ........................................................................................ 42 Guidance on the BPR: Volume II Parts B+C 6 Version 2.0 December 2017 5.4 DISINFECTANTS (MAIN GROUP 1) .............................................................. 44 5.4.0 General .......................................................................................... 44 5.4.0.1 Introduction ......................................................................... 44 5.4.0.2 Dossier requirements ............................................................ 45 5.4.0.3 Label claim .......................................................................... 45 5.4.0.3.1 Target Organisms .................................................... 46 5.4.0.3.2 Areas of Use ............................................................ 47 5.4.0.3.3 Sites of Application ................................................... 47 5.4.0.3.4 Directions for use (Methods of application) .................. 48 5.4.0.3.5 Other interfering parameters ..................................... 48 5.4.0.4 Efficacy testing ..................................................................... 48 5.4.0.4.1 Tiered approach ....................................................... 48 5.4.0.4.2 Standard test methods ............................................. 50 5.4.0.4.3 Data requirements ..................................................
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