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
    Director Registration Team Europe, 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
    Executive Vice President & Head of Biocides, CEHTRA
  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
    Senior Chemicals Policy 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, Germany
  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, Barrister & Avocat, Steptoe & Johnson LLP, Belgium
  26. Q&A

  27. End of day one

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