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Transitional Guidance on the Biocidal Products Regulation

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Transitional Guidance on the Biocidal Products Regulation SUPERSEDED GUIDANCE - NEWER VERSION AVAILA BLE Transitional Guidance on the Biocidal Products Regulation Transitional Guidance on Efficacy Assessment for Product Type 18, Insecticide, Acaricides & other Biocidal Products against Arthropods and Product Type 19, Repellents & Attractants September 2016 TRANSITIONAL GUIDANCE Transitional Guidance on PT18 + PT19 2 September 2016 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. Transitional Guidance on Efficacy Assessment for Product Type 18 Insecticide, Acaricides & other Biocidal Products against Arthropods and Product Type 19 Repellents & Attractants. Publ.date: September 2016 Language: EN © European Chemicals Agency, 2016 If you have questions or comments in relation to this document please send them (indicating the document reference, issue date, chapter and/or page of the document which your comment refers) using the Guidance feedback form. The feedback form can be accessed via the ECHA website or directly via the following link: https://comments.echa.europa.eu/comments_cms/FeedbackGuidance.aspx European Chemicals Agency Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland Transitional Guidance on PT18 + PT19 3 September 2016 PREFACE This Transitional Guidance is to be applied to applications for active substance approval and product authorisation submitted under the Biocidal Product Regulation (EU) No 528/2012 (the BPR). This document describes the BPR obligations and how to fulfil them This Transitional Guidance replaces part of Appendices to Chapter 7 (page 187 to 200) from the Technical Notes for Guidance (TNsG) on Product evaluation in support of Directive 98/8/EC (Biocidal Product Directive - BPD). This document deals with the evaluation of efficacy tests for biocidal products of product type 18 (insecticide, acaricides and other biocidal products against arthropods) and product type 19 (repellents and attractants) as far as invertebrates are concerned. A “Transitional Guidance” is a document that has been initiated under the “old” Biocidal Products Directive 98/8/EC and because it has been finalised before the relevant new BPR guidance document has been fully developed, it is being made available as a Transitional Guidance document until such time as the relevant new document is ready for publication. This Transitional Guidance document has had a Public Consultation by the Commission and this document is now finalised and waiting for inclusion into Volume II Efficacy Assessment and Evaluation (Parts B+C) of the new BPR guidance structure: there will be no further consultation on this document and it will be added to Volume II Efficacy Assessment and Evaluation (Parts B+C) following its consultation and before publication. NOTE to the reader: This Transitional Guidance will be reformatted when it is incorporated into the New Guidance Structure. When this is completed, the finalised version will be uploaded onto the website of ECHA. No consultation will be made to do this. Transitional Guidance on PT18 + PT19 4 September 2016 Table of Contents LEGAL NOTICE ................................................................................................... 2 PREFACE ........................................................................................................... 3 1. INTRODUCTION ............................................................................................. 9 1.1 AIM 9 1.2 GLOBAL STRUCTURE OF THE ASSESSMENT ................................................. 9 1.3 DOSSIER REQUIREMENTS .......................................................................... 10 1.3.1 Test design ..................................................................................... 11 1.3.2 Test examples ................................................................................. 11 1.3.3 Laboratory versus (semi) field trials ................................................... 11 1.3.4 The importance of controls on efficacy studies ..................................... 12 1.3.5 Specific data to support label claims ................................................... 12 1.3.6 Examples of specific label claims with respect to target organisms ......... 13 1.3.7 Examples of broad label claims with respect to target organisms............ 13 1.3.8 The distinction between professional and consumer products ................. 14 1.3.9 The distinction between principal target and secondary/ incidental target pests ............................................................................................ 14 1.3.10 Claims for residual efficacy .............................................................. 14 1.3.11 Claims relating to storage of a bait product ....................................... 14 1.3.12 Claims relating to outdoor use ......................................................... 15 1.3.13 Mode of action ............................................................................... 15 1.3.14 Resistance ..................................................................................... 15 1.4 METHODOLOGY OF ASSESSMENT ............................................................... 16 1.4.1 Assessment of specific claims ............................................................ 17 1.5 ASSESSMENT OF AUTHORISATION ............................................................. 17 1.5.1 Norms and criteria ........................................................................... 17 1.5.2 Assessment ..................................................................................... 18 2. GENERAL CLAIMS: CRAWLING INSECTS, FLYING INSECTS, ACARICIDE ................ 18 2.1 INTRODUCTION ........................................................................................ 18 2.1.1 Crawling insects ............................................................................... 18 2.1.2 Flying insects ................................................................................... 18 2.1.3 Insecticide, acaricide and other arthropods.......................................... 18 2.2 DOSSIER REQUIREMENTS .......................................................................... 18 2.2.1 Test species .................................................................................... 19 2.2.2 Laboratory tests and field trials .......................................................... 19 2.3 ASSESSMENT OF AUTHORISATION ............................................................. 20 2.3.1 Norms and criteria ........................................................................... 20 3. COCKROACHES .............................................................................................. 20 3.1 INTRODUCTION ........................................................................................ 20 3.1.1 Biology ........................................................................................... 20 3.2 DOSSIER REQUIREMENTS .......................................................................... 20 3.2.1 Test species .................................................................................... 21 3.2.2 Laboratory tests and field trials .......................................................... 21 3.2.2.1 Screening Studies (No- Choice Test) ........................................ 21 3.2.2.2 Determination of residual efficacy ............................................ 21 3.2.2.3 Palatability tests with bait products .......................................... 22 3.2.2.4 Simulated use ....................................................................... 22 3.2.2.5 Field trial .............................................................................. 23 3.2.3 Requirements per type of claim ......................................................... 23 3.3 ASSESSMENT OF AUTHORISATION ............................................................. 24 Transitional Guidance on PT18 + PT19 5 September 2016 3.3.1 Norms and criteria ........................................................................... 24 4. ANTS ............................................................................................................ 25 4.1 INTRODUCTION ........................................................................................ 25 4.1.1 Biology ........................................................................................... 25 4.2 DOSSIER REQUIREMENTS .......................................................................... 26 4.2.1 Test species .................................................................................... 26 4.2.2 Laboratory tests and field trials .......................................................... 26 4.2.2.1 Screening studies for direct spray or general surface treatments . 27 4.2.2.2 Palatability tests with bait products .......................................... 27 4.2.2.3 Simulated use studies ............................................................ 27 4.2.2.4 Field trials for all claims .......................................................... 28 4.2.3 Requirements per type
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