Agenda
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Coffee and Registration
- Session 1 - Overviews
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ECHA overview
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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
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Q&A for video link
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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?
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The first five years with BPR – what next?
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Q&A
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Refreshments
- Session 2 - Product Authorisation
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Experiences with approval of Biocidal Product Families
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Feedback from the BPF Working Group discussions – possible changes to and limitations on BPF applications
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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)
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Q&A
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Lunch
- Session 2 - Product Authorisation continued
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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
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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)
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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
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Q&A
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Refreshments
- Session 3 - Enforcement
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An Overview of the ECHA FORUM subgroup & treated articles (1st enforcement project)
Eugen Anwander
Senior Scientific Officer, Institute for Environment and Food Safety, Vorarlberg State Service, Austria & Vice-chair of Echa BPR Enforcement Forum, Finland -
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
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Close of Day one
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