Programme

Timings are in CET (Central European Time)

  1.  

    Moderator: Dave Dillon, Senior Regulatory and Compliance Analyst, Chemical Watch, UK

  2. Session 1: Overviews
  3. Welcome and introduction

    David Dillon David Dillon
    Senior Regulatory and Compliance Analyst, Chemical Watch
  4. European Commission overview

    • Active substances – state of play of review programme, early review
    • Covid-19 and impact on biocides
    • Renewal of anticoagulant rodenticides
    • Clarifications on same biocidal products authorisation and mutual recognition
    • Clarifications on simplified authorisation procedure
    • Update on court cases
    Marta Cainzos Garcia Marta Cainzos Garcia
    Policy Officer, European Commission, DG SANTE
  5. Echa updates and developments

    • General update on guidance development
    • Update on efficacy guidance
    • Article 75 (1)(g) requests
    • Approval of active substances project (ASAP) update
    Simón Gutiérrez Alonso Simón Gutiérrez Alonso
    Team Leader in the Biocidal Active Substances Unit, Echa, Finland
  6. Availability of biocidal products for disinfection on the Polish market, given Covid-19 demands

    • Analysis of available disinfectants before the pandemic
    • Progress in registration of disinfectants during Covid-19 crisis, challenges and applied solutions
    • Lesson learned and future planning
    Karolina Pastuszko Karolina Pastuszko
    Chief Specialist, The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  7. An industry perspective on biocidal opportunities and challenges on the horizon

    • Review programme progress and industry feedback
    • Impact of changing regulation, guidance and norms on biocidal actives and products 
    • Review programme and innovations
    Andrea Wegner Andrea Wegner
    Senior Regulatory Affairs Manager, Ecolab Deutschland GmbH
  8. Q&A and panel discussion

  9. Networking and break

  10. Session 2: Regulatory processes in the European biocides sector
  11. Rodenticides renewal so far and a look ahead to the upcoming 2nd active substance renewals in 2022

    Boris Van Berlo Boris Van Berlo
    Sector Group Manager, Biocides for Europe, Cefic, Belgium
  12. Company experiences of biocidal product families

    • Planning your family and getting started
    • Challenges faced
    • Lessons learned in the authorisation process
    • Interactions with competent authorities
    • Examples from wood preservation
    Olivia Allen Olivia Allen
    Regulatory Manager, Arxada
  13. Navigating the EU and GB BPR: The impact of the UK’s withdrawal and challenges responding to two separate regimes

    • End of transition period, 1 year on – implications for businesses
    • Maintain compliance in the EU and UK
    • Transitional arrangements under the GB BPR
    • First experiences and challenges in responding to the GB BPR regime
    Silvia Segna Silvia Segna
    Senior Chemicals Policy Executive, Chemical Industries Association, Manager of CIA Biocides Sector Network, CIA, UK
  14. Q&A and panel discussion

  15. Networking, lunch and Chemical Watch demo 13.10-13.50

  16. Session 3: Testing and modelling updates
  17. Mitigation of bottlenecks in ecotoxicological EDC testing capacities

    • Capacity issues and challenges of labs for ecotoxicological EDC testing
    • Mitigation options for potential bottlenecks
    Viktoria Urban Viktoria Urban
    Regulatory Scientific Expert Ecotoxicology, Vali Consulting GmbH
  18. Key aspects of the BPR Annexes Amendments on testing requirements

    • Significant changes to the BPR data requirements
    • Technical/cost issues
    • Recent Echa guidance on the design of the extended one generation study
    Scott Samuels Scott Samuels
    Principal Consultant – Human Safety: Toxicologist, ERM
  19. Animal welfare aspects of the BPR Annexes Amendments on testing requirements

    • Significant impact on the number of animals used for testing
    • Welfare concerns
    Marina Pereira Marina Pereira
    Regulatory Science Advisor, Research & Toxicology Department, Humane Society International
  20. Efsa guidance on dermal absorption: A practical approach to human risk assessment on biocides

    • Why dermal absorption is considered in human risk assessment
    • Efsa dermal absorption guidance – history and development
    • Dermal absorption study design
    • Waiving testing and using Efsa default values
    • Extrapolation of data between formulations
    • Impact of dermal absorption on the human risk assessment for biocidal products
    Siân Wright-Williams Siân Wright-Williams
    Senior Toxicologist and Team Leader, Staphyt Ltd
  21. Q&A and panel discussion

  22. Networking and break

  23. Session 4: The assessment of endocrine disrupting chemicals (EDC) under the BPR
  24. Member state status update on EDC assessment in relation to the requirements of the guidance

    Vera Ritz Vera Ritz
    Head of Unit Steering and Overall Assessment Biocides, Federal Institute for Risk Assessment (BfR)
  25. Three years of EDC assessments under BPR: Experiences and developments.

    • Updates to Annex II & III of BPR; 
    • EDC under further EU Regulations – CLP, REACH
    • National ED programmes.
    Daniela Fruth Daniela Fruth
    Regulatory Toxicologist, knoell Germany GmbH
  26. Overview of discussions on EDC criteria at horizontal level

    • Inclusion of EDCs under the CLP Regulation
    Jordane Wodli Jordane Wodli
    Policy Officer, European Commission
  27. Q&A and panel discussion

  28. End of day 1

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