Agenda
Please note: all timings are listed in CET; to view start times in your local time zone, please click here.
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Coffee and registration
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Welcome and introduction by the moderator
- Session 1: Overviews
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European Commission overview
- Implementation dialogue on biocides, food safety simplification omnibus, BPR evaluation
- Derogations for sulfuryl fluoride for cultural heritage protection
- REACH microplastics restriction – impact on biocides
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ECHA overview
- Update on active substance approval
- Update on union authorisation (UA)
- Evolution of ECHA IT tools for biocides
- What is coming up from ECHA on biocides
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Member state overview
- Update on active substances in Austria
- Updated guidelines
- Ideas for improving the BPR
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Industry perspective on classification of biocide active substances
- Interplay between BPR and CLP
- Exclusion and substitution criteria
- Biocidal Products Committee versus Committee for Risk Assessment opinion
- Practical and regulatory consequences
- Case study on ethanol
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Q&A
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Refreshment break and networking
- Session 2: Member state competent authority (MS CA) perspectives on the latest BPR developments
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Upcoming renewals: Wave of active substance reassessments, impact for competent authorities
- The competent authority experience
- Critical issues
- A case study
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First experiences in Denmark: What is necessary for creating successful dossiers for product and active substance renewals
- Dossier evaluation in MS CAs
- Moving to IUCLID: information requirements for renewal of active substances
- Systematic improvements of BPR processes from application to authorisation
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Connecting the dots – interplay between regulatory developments and objectives of the BPR from a German competent authority perspective
- Interplay between different actors in the evaluation process
- Parameters that can(not) be influenced
- How tightening the procedures may affect the “scaffolding” of the evaluation process over time
Jana-Alina Zur
Regulatory Officer, Federal Institute for Occupational Safety and Health (BAuA), Federal Office for Chemicals (BfC) -
Q&A
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Brief intro to CHEMTREC webinar next week: International regulatory requirements for emergency response and how to comply with local requirements
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Lunch and networking
- Session 3: Consultation for BPR revision – implementation of the current BPR and lessons for the future
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Taking environmental risk assessment of biocides to the next level
- Streamlining risk assessments for the environment
- Reducing environmental impacts through biocides
- Simplification and environmental protection measures need to complement each other
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Value and opportunities for science in biocidal dossiers: Acceptance of realistic data in risk assessment refinements
- Realistic data have become disruptors of the BPR process
- Importance of realistic data to ensure useful products remain available for consumers
- Opportunities and alignment for study protocol development or application of models
- Examples of realistic data
- Strengthening partnerships and collaborations between industry and authority stakeholders
- Benefits of accelerated alignment and approval, improved efficiencies, reduced uncertainties, enhancement of scientific integrity
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Modernizing the BPR: scientific progress and regulatory implementation
- Implementation of the BPR and opportunities to use non-animal methods
- Aligning the BPR with the Commission’s roadmap for phasing out animal testing
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Q&A
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Refreshment break and networking
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Data-based economic analysis of the European biocides market, with impacts on financial market strategy
- Biocides market at a regulatory crossroad
- Market structure and economic trends
- Regulatory environment and market behaviour
- Role of socio-economic analysis
- REFIT — economic opportunities
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Industry perspective on the REFIT
- “REFIT” versus “revision”
- What to take into account for the REFIT evaluation
- Ideas for how to improve the BPR and its implementation
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The BPR — REFIT or redraw? A start to the discussion
- Recap of the member state workshop on the evaluation of the BPR
- Issues to reflect upon in the evaluation
- Ideas from the field
Peter van Kampen
Senior Policy Officer Biocides, Dutch Ministry of Infrastructure and Water Management -
Q&A and REFIT panel discussion with one or two suggestions from each participant
- Harmonisation
- Implementation and simplification of the current BPR
- Active substance approvals, product authorisations and renewal processes
- The role of risk assesment
- Collaboration between the different stakeholders
- Measures to foster innovation in the biocides sector
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Networking drinks reception
Join us for relaxed networking, drinks and appetizers with our speakers and attendees
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Close of day one