Programme
Timings are in CET (Central European Time)
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Moderator: Dave Dillon, Senior Regulatory and Compliance Analyst, Chemical Watch, UK
- Session 1: Overviews
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Welcome and introduction
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European Commission overview
- Active substances – state of play of review programme, early review
- Covid-19 and impact on biocides
- Renewal of anticoagulant rodenticides
- Clarifications on same biocidal products authorisation and mutual recognition
- Clarifications on simplified authorisation procedure
- Update on court cases
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Echa updates and developments
- General update on guidance development
- Update on efficacy guidance
- Article 75 (1)(g) requests
- Approval of active substances project (ASAP) update
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Availability of biocidal products for disinfection on the Polish market, given Covid-19 demands
- Analysis of available disinfectants before the pandemic
- Progress in registration of disinfectants during Covid-19 crisis, challenges and applied solutions
- Lesson learned and future planning
Karolina Pastuszko
Chief Specialist, The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products -
An industry perspective on biocidal opportunities and challenges on the horizon
- Review programme progress and industry feedback
- Impact of changing regulation, guidance and norms on biocidal actives and products
- Review programme and innovations
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Q&A and panel discussion
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Networking and break
- Session 2: Regulatory processes in the European biocides sector
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Rodenticides renewal so far and a look ahead to the upcoming 2nd active substance renewals in 2022
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Company experiences of biocidal product families
- Planning your family and getting started
- Challenges faced
- Lessons learned in the authorisation process
- Interactions with competent authorities
- Examples from wood preservation
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Navigating the EU and GB BPR: The impact of the UK’s withdrawal and challenges responding to two separate regimes
- End of transition period, 1 year on – implications for businesses
- Maintain compliance in the EU and UK
- Transitional arrangements under the GB BPR
- First experiences and challenges in responding to the GB BPR regime
Silvia Segna
Senior Chemicals Policy Executive, Chemical Industries Association, Manager of CIA Biocides Sector Network, CIA, UK -
Q&A and panel discussion
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Networking, lunch and Chemical Watch demo 13.10-13.50
- Session 3: Testing and modelling updates
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Mitigation of bottlenecks in ecotoxicological EDC testing capacities
- Capacity issues and challenges of labs for ecotoxicological EDC testing
- Mitigation options for potential bottlenecks
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Key aspects of the BPR Annexes Amendments on testing requirements
- Significant changes to the BPR data requirements
- Technical/cost issues
- Recent Echa guidance on the design of the extended one generation study
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Animal welfare aspects of the BPR Annexes Amendments on testing requirements
- Significant impact on the number of animals used for testing
- Welfare concerns
Marina Pereira
Regulatory Science Advisor, Research & Toxicology Department, Humane Society International -
Efsa guidance on dermal absorption: A practical approach to human risk assessment on biocides
- Why dermal absorption is considered in human risk assessment
- Efsa dermal absorption guidance – history and development
- Dermal absorption study design
- Waiving testing and using Efsa default values
- Extrapolation of data between formulations
- Impact of dermal absorption on the human risk assessment for biocidal products
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Q&A and panel discussion
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Networking and break
- Session 4: The assessment of endocrine disrupting chemicals (EDC) under the BPR
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Member state status update on EDC assessment in relation to the requirements of the guidance
Vera Ritz
Head of Unit Steering and Overall Assessment Biocides, Federal Institute for Risk Assessment (BfR) -
Three years of EDC assessments under BPR: Experiences and developments.
- Updates to Annex II & III of BPR;
- EDC under further EU Regulations – CLP, REACH
- National ED programmes.
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Overview of discussions on EDC criteria at horizontal level
- Inclusion of EDCs under the CLP Regulation
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Q&A and panel discussion
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End of day 1
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