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Agenda

  1. Session 5: ED Criteria

  2. ED criteria: impact on processes and stakeholders

    Valerio Spinosi Valerio Spinosi
    Scientific and Regulatory Officer, ECHA

  3. ED properties of biocidal active substances and co-formulants - where to start and how to proceed

    • Regulatory background on Endocrine Disruptors: history, criteria and available guidance
    • Identification and assessment of ED properties for human health: studies, data bases, QSAR, hazard vs. risk
    • Regulatory consequences: implications on active substance approval/renewal, biocidal product authorisation and derogation options
    • Assessment of ED properties with a focus on co-formulants and disinfection by-products – possible strategies, issues and implications
    Michael Werner Michael Werner
    Managing Director, Prosacon GmbH, Germany

  4. Endocrine disruptors and biocides: Where to start? What to expect?

    • Brief reminder on ED and exclusion criteria for biocidal active substances
    • Entry into force of scientific criteria for identification of ED: implications for active substance approvals and biocidal product authorisations
    • Screening, priority setting, conditions for early review of approved substances, procedure and actors
    • Harmonisation issues regarding substances in products subject to other legal regimes (ppp, medical devices, veterinary hygiene, cosmetics, …)
    • Guidance documents, case law
    Indiana De Seze Indiana De Seze
    Lawyer, EU REG LAW

  5. Q&A

  6. Session 6: Innovation - development of new biocides and alternatives

  7. 5 years BPR – what next?

    • BPR aims – where do we stand?
    • How is the implementation going?
    • Successes, challenges, consequences?
    • What next?
    Camelia Mihai Camelia Mihai
    Team Lead Biocides, Biocides For Europe, Cefic, Belgium

  8. Refreshments

  9. Innovation

    Ian Watt Ian Watt
    Regulatory Sciences and Product Sustainability, Microbial Control, DuPont Specialty Products Division, UK

  10. Innovation within consumer-facing preservation markets

    • Why the need for innovation in preservation ?
    • Multiple stakeholders dictate multiple market preferences
    • Innovation is critical across each element of the product lifetime
    • Industry is actively committed to meeting current and future needs in sustainable next-generation preservation
    Phil Hindley Phil Hindley
    Head, Global Marketing Preservation and Laundry, Lonza Consumer Product Ingredients

  11. Q&A

  12. Session 7: Efficacy

  13. Revision of Efficacy Guidance for PT 14 and PT 19: where are we and what will change

    • Revised Technical Guidance for PT 14 in force since January 2017
      • Which requirements are new?
      • What has changed?
      • What needs to be considered for the next renewal?
    • Revision of Technical Guidance for PT 19 in progress
      • Current status & time frame
      • What changes can be expected?
      • Which new test methods will be included?
    Christiane Stahr Christiane Stahr
    Scientific Officer, German Environment Agency (UBA)

  14. Strategy for efficacy testing for disinfectants in biocidal product families

    • A group of products or a biocidal family?
    • Testing products or dummy products?
    • Worst case testing: check co-formulants!
    • Effect of efficacy on the structure of the family
    Lonne Gerritsen Lonne Gerritsen
    Expert Efficacy and Regulatory Affairs Biocides, Knoell NL B.V., Netherlands

  15. Efficacy Requirements for Product Types 11 and 12

    • No available efficacy guidance but will look at the probable efficacy requirements
    • Likely requirements for the demonstration of efficacy
    • Examine the currently available efficacy tests (including those found outside of the EU) and their fitness for purpose
    • Explore what methodologies could be used to provide additional information in support of product claims
    David Ashworth David Ashworth
    Managing Director, Klarus Consulting Ltd, UK

  16. Q&A

  17. Lunch

  18. Session 8: Enforcement

  19. Developments FORUM subgroup including update on first project REF-6

    Eugen Anwander Eugen Anwander
    Senior Scientific Officer, Institute for Environment and Food Safety, Vorarlberg State Service, Austria & Vice-chair of Echa BPR Enforcement Forum, Finland

  20. Q&A

  21. Refreshments

  22. Session 9: International overviews

  23. Canada - new regulation on treated articles

    • Overview/background on past/present status of treated articles
    • PMRA communication strategy/risk-based approach to compliance and enforcement
    • New regulation publication
    • Issues moving forward/next steps
    Teri Dickinson Teri Dickinson
    Manager, Regulatory Affairs Group, Dell Tech Laboratories Ltd.

  24. Korea - New Regulation

    • Background and current status of K-BPR
    • Key provisions
    • K-BPR -v- EU BPR
    Young-In Kim Young-In Kim
    Chief Researcher, Korea Testing & Research Institute (KTR), South Korea

  25. Q&A

  26. Pre recorded presentation - Latest developments in China with regards to biocides and disinfectants regulations

    • Regulations for pesticides and disinfectants in China
    • Importation requirements for overseas pesticides and disinfectants
    • Latest developments and their impact to overseas companies
    Vivian Tang Vivian Tang
    Head of Agrochemical and Disinfection Products Department, Chemical Inspection and Regulation Service Limited

  27. End of Conference

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