Programme

  1. Registration

  2. CW Welcome

  3. Keynote  Keynote

    Thomas Jakl Thomas Jakl
    Head of Chemical Policy and Biocides, Federal Ministry of Sustainability and Tourism, Austria
  4.  

    Chair:

    David Dillon David Dillon
    Senior Managing Scientist, Exponent International Ltd, UK
  5. Session 1: Overviews of BPR procedures including the status of transitional regimes
  6. Update from the Commission: Latest developments in the biocides field

    • EDs (including update of Annexes II and III and early review),
    • Authorisation of in situ generated products
    • Union authorisations
    • Fact finding missions
    • Art 65 reporting
    • Art 55(3) derogation (in situ nitrogen)
    Martinus Nagtzaam Martinus Nagtzaam
    Policy Officer, European Commission, Belgium
  7. ECHA's latest updates

    • General updates on biocides
    • Review program action plan
    • Lessons learned so far on endocrine disruptors
    Simón Gutiérrez Simón Gutiérrez
    Team Leader in the Biocidal Active Substances Unit, Echa, Finland
  8. Member state overview from Austria

    • Current situation, achievements
    • Challenges
    • Possible solutions
    • Summary and future perspectives
    Nina John Nina John
    Policy Officer, Federal Ministry for Sustainability and Tourism, Competent Authority, Austria
  9. Industry/consultancy overview

    • ED assessment of active substances and co-formulants
    • Implementation of the new BPF concepts
    • Over-conservative risk assessment
    Nathalie Hanon Nathalie Hanon
    Manager CEHTRA SL - EVP, CEHTRA, Spain
  10. Q&A

  11. Refreshments

  12. Session 2: Regulatory issues for authorisation/approval related processes - case studies
  13. The new Safety Biocidal Family

    Robert Narquizian Robert Narquizian
    Chief Business Officer, Salveco, France
  14. The long and winding road to Union Authorisation

    • Desire and reality: the gap from a consultant’s point of view
    • Data requirements: the moving target
    • ECHA process flow: the circle of comments, discussions & revisions
    • Deadlines: the challenge
    • Pitfalls: the do's and don´ts
    Silvia Wagner Silvia Wagner
    Managing Director, spectra Consult, Germany
  15. Mutual recognition lessons learned: Pros and cons of MR in parallel vs in sequence

    • National authorisation, mutual recognition definitions
    • Mutual recognition in parallel: pros and cons
    • Mutual Recognition in sequence: pros and cons
    • Renewal of an authorisation in accordance with Commission Delegated Regulation (EU) No 492/2014
    Emese Szántó Emese Szántó
    EU coordinator for biocidal products, National Public Health Centre, Hungary
  16. Q&A

  17. Lunch

  18. Session 3: Status of Endocrine Disruptor assessments for biocides
  19. The implementation of the guidance for endocrine disruptors from an authority perspective

    • History - where does this ED issue come from?
    • How we deal with ED assessment at Ctgb
    • Consequences of our work
    • Lacunas observed so far
    Peter Okkerman Peter Okkerman
    Scientific assessor, The Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands
  20. Metabolic effects of Endocrine Disrupting Chemicals: Novel testing METhods and adverse outcome pathways (EDCMET) Project

    • Metabolic disorders an increasing cause of health concern 
    • Current ED testing tools do not focus on effects related to the disruption of metabolic processes
    • Several EU funded projects on the overarching “New testing and screening methods to identify endocrine disrupting chemicals” within the “Horizon 2020” framework
    • EDCMET - “Metabolic effects of Endocrine Disrupting Chemicals: novel testing METhods and adverse outcome pathways” 
    • Overarching objective to develop novel testing methods for regulatory purposes, to assess the metabolic effects of EDs 
    Albert Braeuning Albert Braeuning
    Head of Unit Effect-based Analytics and Toxicogenomics, German Federal Institute for Risk Assessment, Germany
  21. Assessment of potential endocrine disrupting properties of biocidal active substances using in silico tools: First experiences under the new EU Guidance Document

    • The new ED guidance – why in silico screening
    • What are in silico methods
    • Reflection on present situation on ED-models
    • ED - in silico screening in practice
    Antje Gerloff-Elias Antje Gerloff-Elias
    Expert Regulatory Ecotoxicologist and Head of QSAR team, Knoell Consult, Germany
  22. Legal issues raised by ED criteria

    • Shifting goal posts
    • Data demands
    • Beyond biocides
    Darren Abrahams Darren Abrahams
    Partner, Barrister & Avocat, Steptoe & Johnson LLP, Belgium
  23. Q&A

  24. Refreshments

  25. Session 4: How has BPR impacted your company, and how have you dealt with the challenges posed?
  26. SME perspective: How to best apply resources for dealing with the BPR

    • Approved active and the choices made to get there
    • What now?
    • Product approvals and new uncertainties
    • Re-registration; the cycle starts over
    • Business aspects of BPR for SMEs
    Cecilia Ohlauson Cecilia Ohlauson
    Head of Regulatory Affairs, I-Tech AB, Sweden
  27. Manufacturer's perspective

    Ilona den Hartog Ilona den Hartog
    Senior Regulatory Specialist, Nouryon (formerly AkzoNobel), Netherlands
  28. Impact of the BPR: Formulator’s perspective

    • Practical experience
      • Changes in strategy
      • Financial adjustments
      • Uncertainties
    • Lessons for the future
    Alice Ngosso Alice Ngosso
    Regulatory Affairs Manager, Vink Chemicals GmbH & Co. KG, Germany
  29. Distributor's perspective

    • Communication in the supply chain for chemicals with potential biocidal use, such as hydrogen peroxide
    • Timely decision making process for product authorization
      • for the distributor
      • for the supplier
      • for the customers
    • Finding the right partners and agreeing a business model
    • Implementation of biocides supply chains
    Kai Mann Kai Mann
    European Product Manager Biocides, Brenntag, Germany
  30. Panel and Q&A

    Impact of new BPR requirements for ongoing and future approval/renewal procedures

    • EDs as actives/non-actives
    • Updates Annexes II & III BPR
    • Change of BPF concept
  31. Close of day one

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