Main Conference Day 2
- David Ashworth - Biocides Expert, Klarus Consulting
In the context of the European Commission’s proposed roadmap to phase out animal testing, this presentation will:
- Examine the current state of BPR implementation
- Evaluate emerging scientific approaches
- Explore anticipated regulatory changes
- Tess Renahan - Advisor, PETA Science Consortium International e.V.
Exploring pathways such as the Same Biocidal Product procedure (SBP), Union Authorization, and product family concept.
The potential to expedite market access for eligible biocidal products and the inherent limitations in terms of product scope, data requirements, and regulatory scrutiny.
The technical and legal intricacies of leveraging simplified authorization routes, including the application of Article 25 for low-risk biocidal products.
Dedicated time for questions from the audience and open discussion
- David Ashworth - Biocides Expert, Klarus Consulting
Development of innovative feedback mechanisms linking real-time groundwater monitoring data to pesticide authorization processes, showcasing the Netherlands' pioneering approach to creating dynamic regulatory responses based on post-authorization environmental surveillance data.
Implementation of integrated assessment frameworks that bridge the gap between theoretical authorization models and actual environmental monitoring results, providing crucial insights for both industry stakeholders and regulatory authorities on the effectiveness of current risk assessment methodologies.
Establishment of collaborative data-sharing platforms between industry, regulatory bodies, and EFSA, enabling evidence-based refinement of authorization criteria through systematic analysis of groundwater monitoring data and its correlation with predicted environmental concentrations.
- Aaldrik Tiktak - Senior Researcher – Soil & Water, PBL Netherlands Environmental Assessment Agency
An initially mix of technical /regulatory analysis of latest trends in EFSA scientific opinions on pesticidal active substances, and how these are matching (nor not matching) with the political objectives set by the new European Commission on competitiveness and strategic autonomy, closing the session with a broader political analysis.
- Géraldine Meunier - Senior Technical Adviser, EPPA
- Eduardo Mulas - Partner, EPPA
Dedicated time for questions from the audience and open discussion
- David Ashworth - Biocides Expert, Klarus Consulting
- Relevant product types, tiered approaches for DRA, worst case consumer exposure (WCCE) assessment
- The MRL dilemma: Status for biocides and the potential consquences for biocidal product authorization
- Animal safety assessments and identified additional needs in real life scenarios
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
The regulatory landscape surrounding the restriction of Per- and Polyfluoroalkyl Substances (PFAs) in biocidal products
The scientific basis for their classification as Substances of Very High Concern (SVHCs) due to their persistence, bioaccumulation potential, and toxicity (PBT) characteristics
Exploring the complex interplay between the BPR, REACH Regulation, and emerging national and international initiatives aimed at phasing out PFAs in various applications.
The multifaceted regulatory landscape surrounding the use of ethanol in biocidal products
Examining the complexities of ethanol’s dual status as both a biocidal active substance and a common solvent.
Exploring the challenges in demonstrating efficacy and establishing appropriate risk mitigation measures
Strategic approaches to address potential classification changes under CLP, all within the context of the BPR's risk-benefit analysis framework.
Dedicated time for questions from the audience and open discussion
- David Ashworth - Biocides Expert, Klarus Consulting
- Imme Gerke - Founder - IDRG.eu, Global Regulatory Strategist, IDRGplantprotection
- Data Protection Compliance: Key developments in Articles 33 & 43 decisions affecting agricultural data management and reporting requirements
- Mancozeb Ruling Impact: Analysis of the recent Mancozeb decision and its consequences for crop protection strategies and product formulations
- Alternative Solutions Landscape: Emerging opportunities in synergies, safeners, and biocontrol methods as regulatory frameworks evolve
- Claudio Mereu - Joint Managing Partner, TBA
Dedicated time for questions from the audience and open discussion
During this fireside chat, we will:
Explore the evolving regulatory landscape for BPR and PPPR
Examine how non-animal testing methodologies are being adopted across both regulatory domains
Identify opportunities for harmonized approaches and discussing OECD test guideline developments applicable to both sectors
Discuss how the Commission's roadmap for phasing out animal testing will impact both regulations, with particular focus on implementation challenges and opportunities for scientific and regulatory convergence
- Tess Renahan - Advisor, PETA Science Consortium International e.V.
An opportunity for open discussion and debate between the panel, moderator and the audience
The future of European chemical regulations – essential uses and sustainability
Regulatory simplification: balancing efficiency and thoroughness
Global regulatory trends in pesticides and biocides
Cross-cutting issues in pesticide and biocide regulations
The road ahead: preparing for future regulatory challenges in pesticides and biocides.
- Boris Van Berlo - Senior Sector Group Manager, Biocides for Europe (CEFIC)
- Eduardo Mulas - Partner, EPPA