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Agenda

  1. Coffee and registration

    Claudio Mereu Moderator: Claudio Mereu
    Partner, EU Regulatory, Fieldfisher LLP, Belgium

  2. Keynote

    Andrej Kobe Andrej Kobe
    Policy Officer, Sustainable Chemicals, DG Environment, European Commission
  3. Session 1: Current practice for Reach substance evaluation

  4. ECHA overview of REACH substance evaluation

    Claudio Carlon Claudio Carlon
    Head of Biocidal Active Substance Unit, European Chemicals Agency, Finland

  5. Industry case study: How to address a listing of your substance proactively

    Jonathan Crozier Jonathan Crozier
    Secretary General, Formacare, Sector Group of Cefic, Belgium

  6. MS perspective: Process, case studies and strategies

    Christian Unkelbach Christian Unkelbach
    Scientific Officer, Federal Institute for Occupational Health and Safety, Germany

  7. Refreshments and networking

  8. Achievements, challenges and recommendations from an NGO perspective

    • Survey of achievements under evaluation
    • Bottle-necks in the substance evaluation process
    • Member states’ lack of regulatory follow-up after substance evaluation
    Elise Vitali Elise Vitali
    Policy officer on chemicals, European Environmental Bureau, Belgium

  9. Q&A and panel discussion:

    Based on experiences with a substance by substance approach what is working well and what could be further improved?

    Christian Unkelbach Christian Unkelbach
    Scientific Officer, Federal Institute for Occupational Health and Safety, Germany
    Jonathan Crozier Jonathan Crozier
    Secretary General, Formacare, Sector Group of Cefic, Belgium
    Claudio Carlon Claudio Carlon
    Head of Biocidal Active Substance Unit, European Chemicals Agency, Finland
    Elise Vitali Elise Vitali
    Policy officer on chemicals, European Environmental Bureau, Belgium
    Mariana Fernandes de Barros Mariana Fernandes de Barros
    REACH Manager, Product Stewardship Programme, Cefic, Belgium

  10. Lunch

  11. Session 2: Current Reach substance evaluation decisions and conclusions
  12.  

    Moderator

    Claudio Mereu Claudio Mereu
    Partner, EU Regulatory, Fieldfisher LLP, Belgium

  13. Regulatory follow-up to substance evaluation decisions and conclusions

    • Introduction
    • SEv decisions follow-up: how it works in FR / FR statistics / positive and negative points from FR experience / proposals for improvement
    • SEv conclusions follow-up: how it works in FR / FR statistics / positive and negative points from FR experience / proposals for improvement
    • Conclusion
    Michel Franz Michel Franz
    REACH Unit Head, Ministry for an Ecological and Solidary Transition, France

  14. The enforcement of substance evaluation decisions/conclusions

    Otilija Špūrienė Otilija Špūrienė
    Senior advisor, Environmental Protection Agency, Lithuania

  15. ECHA’s Board of Appeal decisions on substance evaluations

    • The Board of Appeal’s main decisions on substance evaluation;
    • Recent General Court judgments on the Board of Appeal’s powers of review
    Marc Goodacre Marc Goodacre
    Legal Advisor, Registry of the Board of Appeal, ECHA, Finland

  16. Challenging substance evaluation decisions before ECHA's Board of Appeal

    Claudio Mereu Claudio Mereu
    Partner, EU Regulatory, Fieldfisher LLP, Belgium

  17. Refreshments and networking

  18. Q&A and panel discussion: The evolution of substance evaluation

    • How lessons learned from substance evaluations can inform future work
    • The role of ECHA’s Board of Appeal in substance evaluation
    • Interactions between the evaluating member states, ECHA and registants during the final stage of the evaluation
  19. Session 3: Work in progress towards optimizing the process - assessment in groups of substances
  20.  

    Moderator

    Claudio Carlon Claudio Carlon
    Head of Biocidal Active Substance Unit, European Chemicals Agency, Finland

  21. Industry experience with first combined compliance check - a pilot case that could define the model for the future of ECHA’s combined evaluation

    • The first time compliance check (CCH) and Substance Evaluation (SEv) take place in parallel 
    • The first time both processes take place on a group of metals 
    • The first time the SEv decisions were circulated to all registrants
    Caroline Braibant Caroline Braibant
    Secretary-General, International Antimony Association, Belgium

  22. Substance evaluation on groups of substances

    • How to address concerns for multiple substances by requesting further information on only a sub-set of substances in a group or a category
    Petra van Kesteren Petra van Kesteren
    Senior advisor REACH, Netherlands National Institute for Public Health and the Environment, The Netherlands

  23. Concerns about animal testing for substance evaluations

    • Animal testing principles under REACH
    • Mechanisms in REACH for avoiding testing on animals
    • Substance evaluation compared to dossier evaluation
    • Concerns about substance evaluation and testing on animals
    • Improvements following appeals
    • Scope for further improvements to substance evaluation
    • The future of REACH, obligations for testing only as a last resort and the promotion of alternative methods
    Dr Emma Grange Dr Emma Grange
    Director of Science & Regulatory Affairs, Cruelty Free Europe

  24. Q&A and panel discussion:

    • What do we need to generate information on a group of substances?
    • What are the implications for animal testing?
    • How can we make the grouping approach work between all the stakeholders? (communication, costs, etc)

  25. End of conference

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