Main Conference Day 2
Detailed analysis of how this approach optimizes regulatory processes by allowing the simultaneous assessment of multiple products with similar characteristics, compositions, and risk profiles.
Best practices in streamlining the authorization procedure and reducing the administrative burden
The establishment of permissible variations in active and non-active substances
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
Industry responses to the regulatory drivers shaping sustainable pesticide use.
Strategic approaches to product development and portfolio management considering the evolving criteria for low-risk active substances.
Integrating alternative approaches and non-chemical techniques in efficacy demonstrations to align with IPM principles
The adaptation of risk assessment methodologies to address cumulative and synergistic effects as mandated by Article 36 of Regulation (EC) No 396/2005,
Challenges and opportunities presented by the potential revision of the Sustainable Use of Pesticides Directive
The industry's role in contributing to the development of harmonised risk indicators for monitoring progress towards sustainability goals within the framework of Regulation 1107/2009 and broader EU environmental policies.
Regulatory Framework Evolution: Upcoming regulatory changes affecting fertilising products and biostimulants, including new market access pathways and assessment requirements that will impact product registration after summer.
Biostimulant Classification and Market Access: Clarification on the dividing line between plant protection products and biostimulants, with insights on the streamlined assessment process for biostimulants and what products currently exist in the market versus what's coming.
Waste Valorisation Opportunities: Emerging possibilities for transforming waste streams and animal byproducts into valuable agricultural aids, with guidance on regulatory compliance for converting these materials into marketable fertilising products..
- Giel Tettelaar - Chairman - Global Network Group | SERMI Register | ADR Register | EFCI Register | EMCI Register | ICR Coach Register | Yellowflash, Co-Director - IFCI Register
Dedicated time for questions from the audience and open discussion
- 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
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
- 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
Practical challenges and strategic considerations in navigating data protection and transparency requirements throughout the pesticide approval lifecycle.
Addressing the evolving landscape of data sharing and compensation mechanisms (under Article 59 to 62 in light of the European Chemicals Agency's (ECHA) experience with similar provisions in the REACH Regulation.)
The nuanced application of the data protection periods outlined in Article 59 for new active substances and the renewal of approvals.
The potential impact of increased transparency on innovation and competitiveness within the agrochemical sector.
The challenges in implementing the "one substance, one dossier" approach to data sharing
Dedicated time for questions from the audience and open discussion
Global regulatory trends in pesticides and biocides
Cross-cutting issues in pesticide and biocide regulations
Harmonizing Approaches: BPR, PPP, and REACH Intersections
The silver bullet: building a roadmap for regulatory harmonisation
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)