Programme

  1. Session 1: Overviews
  2. Update from the Commission: latest developments in the biocides field

    • Endocrine-disruptors
    • In situ
    • Substitution
    Martinus Nagtzaam Martinus Nagtzaam
    Policy Officer, European Commission, Belgium
  3. ECHA’s latest updates

    • Renewal of active substances approval
    • Union Authorisation
    • IT updates
    • Brexit IT adaptation
    Valerio Spinosi Valerio Spinosi
    Scientific and Regulatory Officer, ECHA
  4. Member State overview from the Netherlands

    • EU Fact Finding Mission in the Netherlands
    • BPR workload and available resources
    • First experiences with Union Authorisation
    • First Experiences with Biocidal Product Families
    Ingrid Becks Ingrid Becks
    Manager Board Advice and Project Planning, Deputy Secretary/Deputy Director, Ctgb
  5. Q&A

  6. Refreshments

  7. Session 2: Authorisation/approval related issues
  8. Annex I inclusion

    • Basic functioning of Annex I
    • Simplified authorisation route
    • Update of Annex I for food and feed substances
    • On-going discussions in CA meeting on Annex I
    Martinus Nagtzaam Martinus Nagtzaam
    Policy Officer, European Commission, Belgium
  9. BPF Working Group: progress and some feedback from an industry perspective

    • New guidance under development for the biocidal product family
    Danielle Van Corven-Kloosterman Danielle Van Corven-Kloosterman
    Regulatory Affairs & Registration Europe Lead, Diversey Europe, Netherlands
  10. Management of in-situ product authorisation

    • Brief introduction of the concept of in-situ, including a) categories of in-situ generated biocidal systems (IGS) and b) variants of precursors.
    • In the light of the various categories and variants, information needed to apply for authorisation of an IGS is presented.
    • What is the role of the device in the assessment prior IGS authorisation?
    • Some thoughts about the options of an IGS biocidal product family concept.
    • Open the floor for suggestions for ‘fit for purpose’ regulatory guidance for in-situ product authorisation
    Lucas Kalkers Lucas Kalkers
    Policy Officer, Ctgb
  11. The challenge of a successful technical equivalence application

    • When is it needed?
    • Who needs to apply for it it?
    • At what level: Tier I or Tier II?
    • What are the requirements?
    • What could the impact be for the business?
    Nathalie Hanon Nathalie Hanon
    Manager CEHTRA SL, CEHTRA, Spain
  12. Q&A

  13. Lunch

  14. Session 3: Risk Assessment
  15. Dietary risk assessment for non-professional use of biocidal products - adapting the IDREAM model to the EU

    • Current risk assessment requirements and approaches under the BPR
    • Drivers for developing a higher tier exposure model
    • Current development of the EU IDREAM model and next steps
    Namali Corea Namali Corea
    Associate Manager, Toxicology, SC Johnson
  16. Developing guidance for dietary exposure assessment for professional uses

    • Dietary risk assessment
    • CA residue policy
    • Residue limits
    • Dietary exposure assessment for professional uses
    • Examples
    Stephan Gregorini Stephan Gregorini
    Senior Manager, Regulatory Assurance Consumer Product Ingredients EMEA – Lonza AG
  17. Experiences with nanosilver: creating a substance dossier including human health and environmental risk assessment - an SME’s perspective

    • Introduction to nanosilver: production, applications, benefits
    • BPR data requirements for nanomaterials
    • OECD WPMN sponsorship programme and availability of data
    • Risk assessment and substance dossier creation
    Gregor Schneider Gregor Schneider
    Head of Business Unit „agpure® nanosilver“, RAS AG
  18. Q&A

  19. Refreshments

  20. Session 4: Legal and regulatory issues
  21. Grouping for in-situ biocides? Regulatory considerations/practical issues

    • Short introduction of related legislation
    • Which combinations have been notified?
    • A spot of chemistry
    • Guidelines involved
    • Current issues, such as family groupings
    • Grouping approaches/issues for in-situ systems based on devices
    Francesca Fasano Francesca Fasano
    Head of Business Unit Agro/Biocides, Chemsafe Srl, Italy
  22. Brexit - State of play and implications for chemical policy

    • Update on policy developments, Article 50 negotiations and withdrawal agreement
    • Transposition of EU chemicals legislation into UK law
    • Transition arrangements and what a transition would mean for industry
    • Future UK/EU relationship and implications for businesses operating in the biocides sector
    Silvia Segna Silvia Segna
    REACH Executive, Chemical Industries Association, Manager of CIA Biocides Sector Network, CIA, UK
  23. Brexit – consequences and recommendations for companies

    • Consequences for UK companies on EU market
    • Consequences for EU companies on UK market
    • Field report from a biocidal products authorisation consortium
    • Recommendations for action
    Henning Krueger Henning Krueger
    Managing Director, Pure Sodium Hypochlorite Biocidal Products Group EWIV
  24. Five years of BPR data sharing: Recap and lessons learned

    • BPR scope of data sharing
    • Relation to other data sharing regimes
    • Vertebrate versus invertebrate data sharing
    • "Every effort" requirement
    • ECHA data sharing decisions
    • The growing influence of the Board of Appeal
    • Some conclusions
    Koen Van Maldegem Koen Van Maldegem
    Partner, Competition Regulatory and Trade, Fieldfisher LLP, Belgium
  25. Biocides and transparency

    Darren Abrahams Darren Abrahams
    Partner, Steptoe, Belgium
  26. Q&A

  27. End of day one

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