Programme

  1.  

    Chair:

    David Dillon David Dillon
    Senior Managing Scientist, Exponent International Ltd, UK
  2. Registration

  3. Session 1: Overviews
  4. National overview of biocides authorisations

    • Current status of national process for approval of active substances
    • Current status of national process for authorisation of products
    • Management of disagreements
    • Some critical issues
    • Delays and quality of dossiers
    • Transitional period issues
    Maristella Rubbiani Maristella Rubbiani
    Istituto Superiore di Sanità, Italy
  5. ECHA’s latest updates

    • Efficacy
    • Dissemination platform
    • In situ
    • Treated articles
    • BPFs, etc
    Erik van de Plassche Erik van de Plassche
    Chairman of the Biocidal Products Committee, European Chemicals Agency, Finland
  6. Update from the Commission: latest developments in the biocides field (via video link)

    • Review programme – overview
    • Update of information requirements of the BPR
    • Annex I substances (food and feed active substances, nitrogen)
    • Product authorisation – harmonisation and agreement between member states
    • Emergency authorisations
    • The application of Unique Formula Identifier for biocidal products
    • Fact-finding missions – overview report and workshop
    Martinus Nagtzaam Martinus Nagtzaam
    Policy Officer, European Commission, Belgium
  7. Q&A

  8. Refreshments

  9. Session 2: Authorisation/ approval related issues
  10. Biocidal Product Family new guidance

    • Outcome of the Biocidal Product Family working group
    • An industry perspective
    Danielle Van Corven-Kloosterman Danielle Van Corven-Kloosterman
    Regulatory Affairs & Registration Europe Lead, Diversey Europe, Netherlands
  11. Experience with a Biocidal Product Family containing an unstable molecule. Consequences on:

    • Physical chemical tests
    • Efficacy
    • Storage stability
    • Human health risk assessment
    Daniela Romano Daniela Romano
    Regulatory Affair Manager for Biocidal Products, Eurofins Biolab, Italy
  12. Evaluation related issues for biocidal products

    • Applicability of new guidance during evaluation
    • Tips for submitting additional data
    Ieva Igaune Ieva Igaune
    Chemist, Latvian Environment, Geology and Meteorology Centre, Latvia
  13. Evaluation related issues for active substances

    • Transparency for evaluation of substances
    • Applicability of new guidance during evaluation
    • Tips for submitting additional data
    Stephen Carberry Stephen Carberry
    Assistant Agricultural Inspector, Pesticide Control Division, Department of Agriculture, Food and the Marine, Ireland
  14. Industry Experience of Union Authorisation (PT2 and PT4)

    • Practical aspects of requirements
      • tight deadlines
      • availability of support
      • peer-review process
    • Managing National regulations at the same time
    Siobhan Murphy Siobhan Murphy
    Regulatory Specialist, Contec Cleanroom Ltd, UK
  15. Q&A

  16. Lunch

  17. Panel: How do Member States handle resourcing issues covering substances and products

    • Infringements of deadlines for evaluations
    • Advice to other MS/applicants

    Participants:

    • Maristella Rubbiani, Head of Unit, Istituto Superiore di Sanità, Italy
    • Birgitte Skou Cordua, Ecotoxicologist, Pesticides & Biocides, The Danish Environmental Protection Agency, Denmark
    • Ieva Igaune, Chemist, Latvian Environment, Geology and Meteorology Centre, Latvia
    • Stephen Carberry, Assistant Agricultural Inspector, Department of Agriculture, Food and the Marine, Ireland
    • Guido Bellome, Istituto Superiore di Sanità, Italy
  18. Session 3: Risk Assessment
  19. Managing risk assessment of antifouling products – a story on the regulatory challenges from a Danish perspective

    • BPR required risk assessment of PT21 products was but not included in national legislation
    • Requirement for environmental risk assessment initiated development of more area specific risk assessment by NL and UK
    • Danish Pesticide Research program: projects to gain more experience on the fate of PT21 active substances
    • Present and future challenges concerning transitional period and risk assessment of antifouling products
    Birgitte Skou Cordua Birgitte Skou Cordua
    Ecotoxicologist, Danish Environmental Protection Agency, Denmark
  20. Overly conservative Risk Assessment - the problem of compounding safety factors

    • Treated article assessment
    • Silver  - a case study
    Andrew Goodyear Andrew Goodyear
    Partner, ERM, UK
  21. Q&A

  22. Refreshments

  23. Session 4: Efficacy developments
  24. Overview of important efficacy developments

    David Ashworth David Ashworth
    Managing Director, Klarus Consulting Ltd, UK
  25. Latest updates for PT1-5

    Mike Baldry Mike Baldry
    Independent Consultant, Independent Consultant, UK
  26. Q&A

  27. Close of Day One

  28. Drinks reception (sponsored by TEAM Mastery S.r.l.)

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