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Agenda

  1. Registration

  2. Introduction to Efficacy Requirements under the BPR

    • What is efficacy and why is it important in a regulatory context
    • Role of efficacy: Active substance approval  vs. product
    • Product evaluation inc. role of Biocidal Product Families
    • Labels and claim substantiation
    • Dossier requirements for a biocidal product
    • Test Methods
    • Performance standards
    • Study design
    • Quality/expectations for individual reports and dataset
    David Dillon David Dillon
    Independent Biocides Expert
    Eva Perendreu-Mata Eva Perendreu-Mata
    Regulatory project manager & Senior Efficacy specialist for Biocides, Exponent International Ltd, UK

  3. Overview of Available Guidance for Efficacy

    • Which PTs are currently covered within ECHA Guidance
    • Role of ECHA and ECHA BPC EFF WG
    • Guidance development and Revisions (inc. PEG process)
    • Status and value of Guidance
    • Update on current activities
    • Other issues: efficacy and co-formulants

  4. Refreshment break

  5. Deep Dive into Efficacy and claim substantiation for PT18 & PT19 products

    • Scope of PT18 and PT19 products
    • Global vision of the main insect pests and their lifecycles
    • Focus on some key flying & crawling Insect pests
    • Practical efficacy testing before creating a biocide dossier
    • Consideration of new method and existing (relevant) standard methods available
    • How do we assess efficacy against insects
    • What is needed for a valid assessment
    • Claim Support
      • General PT18 claims
      • Specific claims
    • Consideration of formulation technology
      • Aerosols
      • Baits
      • Emanating devices (Mat/vapourisers/coils)
    • Claim support :PT19 Repellents and attractants
    • Available Guidance
      • Current PT 18 and PT19
      • On-going revisions

  6. Lunch

  7. Deep Dive into Efficacy and claim substantiation for Disinfectant Products (PTs 1-4)

    • Scope of Products falling under PTs 1-4
    • Background to efficacy testing of disinfectants
    • Overview of relevant types/groups of microrganisms
    • Discussion of available  Standard test methods (EN, OECD, ASTM other)
    • Acceptable test methods & testing strategies
    • Discussion of tiered testing
      • Phase 2, Step1
      • Phase 2, Step 2
      • Phase 3 type studies  - Field (Semi- field Trials)
    • Importance of  test conditions
    • Relevant test organisms
    • Claim substantiation
    • Performance Norms
    • Development and use of Claim matrices
    • Examination of examples for PT1, PT2 , PT3 and PT4 products

  8. Refreshment break

  9. Efficacy of Disinfection in Drinking Water (PT5)

    • Overview of the 6 application groups within PT5
    • Data requirements and test methods
    • Relevant test organisms and test conditions
    • Performance Norms

  10. Recap of Day

  11. Questions and close of day

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