Agenda
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Chair:
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Registration
- Session 1: Overviews
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National overview of biocides authorisations
- Current status of national process for approval of active substances
- Current status of national process for authorisation of products
- Management of disagreements
- Some critical issues
- Delays and quality of dossiers
- Transitional period issues
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ECHA’s latest updates
- Efficacy
- Dissemination platform
- In situ
- Treated articles
- BPFs, etc
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Update from the Commission: latest developments in the biocides field (via video link)
- Review programme – overview
- Update of information requirements of the BPR
- Annex I substances (food and feed active substances, nitrogen)
- Product authorisation – harmonisation and agreement between member states
- Emergency authorisations
- The application of Unique Formula Identifier for biocidal products
- Fact-finding missions – overview report and workshop
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Q&A
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Refreshments
- Session 2: Authorisation/ approval related issues
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Biocidal Product Family new guidance
- Outcome of the Biocidal Product Family working group
- An industry perspective
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Experience with a Biocidal Product Family containing an unstable molecule. Consequences on:
- Physical chemical tests
- Efficacy
- Storage stability
- Human health risk assessment
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Evaluation related issues for biocidal products
- Applicability of new guidance during evaluation
- Tips for submitting additional data
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Evaluation related issues for active substances
- Transparency for evaluation of substances
- Applicability of new guidance during evaluation
- Tips for submitting additional data
Stephen Carberry
Assistant Agricultural Inspector, Pesticide Control Division, Department of Agriculture, Food and the Marine, Ireland -
Industry Experience of Union Authorisation (PT2 and PT4)
- Practical aspects of requirements
- tight deadlines
- availability of support
- peer-review process
- Managing National regulations at the same time
- Practical aspects of requirements
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Q&A
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Lunch
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Panel: How do Member States handle resourcing issues covering substances and products
- Infringements of deadlines for evaluations
- Advice to other MS/applicants
Participants:
- Maristella Rubbiani, Head of Unit, Istituto Superiore di Sanità, Italy
- Birgitte Skou Cordua, Ecotoxicologist, Pesticides & Biocides, The Danish Environmental Protection Agency, Denmark
- Ieva Igaune, Chemist, Latvian Environment, Geology and Meteorology Centre, Latvia
- Stephen Carberry, Assistant Agricultural Inspector, Department of Agriculture, Food and the Marine, Ireland
- Guido Bellome, Istituto Superiore di Sanità, Italy
- Session 3: Risk Assessment
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Managing risk assessment of antifouling products – a story on the regulatory challenges from a Danish perspective
- BPR required risk assessment of PT21 products was but not included in national legislation
- Requirement for environmental risk assessment initiated development of more area specific risk assessment by NL and UK
- Danish Pesticide Research program: projects to gain more experience on the fate of PT21 active substances
- Present and future challenges concerning transitional period and risk assessment of antifouling products
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Overly conservative Risk Assessment - the problem of compounding safety factors
- Treated article assessment
- Silver - a case study
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Q&A
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Refreshments
- Session 4: Efficacy developments
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Overview of important efficacy developments
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Latest updates for PT1-5
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Q&A
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Close of Day One
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Drinks reception (sponsored by TEAM Mastery S.r.l.)
