Programme

  1. Coffee and Registration

  2. Session 1 - Overviews
  3. ECHA overview

    Valerio Spinosi Valerio Spinosi
    Scientific and Regulatory Officer, ECHA
  4. Update from the Commission

    • Latest policy developments in relation to the implementation of the scientific criteria for the determination of endocrine disrupting properties
    • Implementation of the interim approach on maximum residue limits
    • Management of product authorisations for in situ cases
    • reporting on the implementation of the BPR

    via video link

    Martinus Nagtzaam Martinus Nagtzaam
    Policy Officer, European Commission, Belgium
  5. Q&A for video link

  6. Member State Overview from France

    • Feedback on the BPR implementation from an MS perspective: quantitative outcomes and progress
    • Interest and difficulties encountered in the harmonization of the assessment and in the working procedures
    • Focus on a key stage in the BPR implementation: From the approval of the active substance to the product(s) application. What are the main challenges for IND and for eCA ? Recommendations for dossier preparation
    • Overview of the expected challenges for the BPR implementation. How to best prepare ourselves?
    Catherine Gourlay-Francé Catherine Gourlay-Francé
    Deputy Director, Regulated Product Assessment Directorate, ANSES
  7. The first five years with BPR – what next?

    Gosia Oledska Gosia Oledska
    Senior Regulatory Specialist Biocide EMEA, Ecolab
  8. Q&A

  9. Refreshments

  10. Session 2 - Product Authorisation
  11. Experiences with approval of Biocidal Product Families

    Marcel Hulsman Marcel Hulsman
    Account Manager Biocides, Ctgb, NL Board for the Authorisation of Plant Protection Products and Biocides
  12. Feedback from the BPF Working Group discussions – possible changes to and limitations on BPF applications

    Adrian Gray Adrian Gray
    Senior Regulatory Manager, Johnson & Johnson
  13. Dow experience with BPF submissions under BPR

    • Introduction
    • Concept of Biocidal Product Families (BPF)
    • Example of Glutaraldehyde BPF
    • Example of CMIT/MIT BPF
    • Outlook for next 2-3 years (upcoming BPR submissions for blends)
    Mandy Osterloh Mandy Osterloh
    Regulatory Manager, Dow Microbial Control
  14. Q&A

  15. Lunch

  16. Session 2 - Product Authorisation continued
  17. In-situ generation; substances and devices – requirements and equivalence

    • Evolvement of evaluation of in-situ systems, from BPD to BPR
    • Different types of system in scope
    • Use of devices
    • Implications to Technical Equivalence
    • Determining the data requirements
    Sara Kirkham Sara Kirkham
    Director, Arrow Regulatory Ltd
  18. Union Authorization of Biocidal Product Families of disinfectant active substances – experiences from the consultancy perspective

    • Regulatory requirements of biocidal product families
    • Definition of meta SPCs considering C&L and intended uses
    • Definition of concentration ranges of meta SPCs: Impact on classification and risk assessments
    • Approaches for efficacy testing: Identification of reference products and read-across
    • Identification of and dealing with Substances of Concern (SoCs)
    Michael Werner Michael Werner
    Senior Regulatory Affairs Manager, Prosacon GmbH, Germany
  19. The future of BPFs: how to balance workload and cost for industry as well as regulators

    • How BPFs can reduce workload for industry and eCAs
    • Case study: the ‘risk envelope’ in practice
    • BPF flexibility restrictions: impact and consequences
    • The future of BPFs
    An Vanden Bosch An Vanden Bosch
    Senior Project Scientist, ARCHE Consulting
  20. Q&A

  21. Refreshments

  22. Session 3 - Enforcement
  23. An Overview of the ECHA FORUM subgroup & treated articles (1st enforcement project)

    Eugen Anwander Eugen Anwander
    Senior Scientific Officer, Institute for Environment and Food Safety, Vorarlberg State Service, Austria & Chair of ECHA BPR Enforcement FORUM, Finland
  24. Competent Authorities panel session on enforcement

    • verifiability of label claims
    • legal consequences
    • options to ensure conformity with the BPR
    • tips for industry

    Moderator: Eugen Anwander,  Senior Scientific Officer, Institute for Environment and Food Safety, Vorarlberg State Service, Austria & Chair of ECHA BPR Enforcement FORUM

    Participants:

    • Rosemarie Greiwe, Senior Desk Officer for Chemical Safety, Ministry of Labour, Health and Social Affairs of North Rhine-Westphalia, Germany;
    • Heribert Buergy, Head of Section Market Control and Advice, Federal Office of Public Health, Switzerland;
    • Joe Hermes, Chemical Substances and Products Unit, Ministry of Sustainable Development and Infrastructure, Luxemburg
    • Jorun Holme, Senior Adviser, Section for Chemicals and Product Control, Norwegian Environment Agency, Norway
  25. Close of Day one