Agenda
- Session 1: Overviews
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Update from the Commission: latest developments in the biocides field
- Endocrine-disruptors
- In situ
- Substitution
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ECHA’s latest updates
- Renewal of active substances approval
- Union Authorisation
- IT updates
- Brexit IT adaptation
-
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
-
Q&A
-
Refreshments
- Session 2: Authorisation/approval related issues
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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
-
BPF Working Group: progress and some feedback from an industry perspective
- New guidance under development for the biocidal product family
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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
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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?
-
Q&A
-
Lunch
- Session 3: Risk Assessment
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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
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Developing guidance for dietary exposure assessment for professional uses
- Dietary risk assessment
- CA residue policy
- Residue limits
- Dietary exposure assessment for professional uses
- Examples
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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
-
Q&A
-
Refreshments
- Session 4: Legal and regulatory issues
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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
-
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
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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
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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
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Biocides and transparency
-
Q&A
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End of day one
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