16 - 18 September 2025
Novotel Barcelona City
Barcelona, Spain
Main Conference Day 1
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
A comprehensive analysis of the Biocidal Product Regulation (BPR) implementation
Critical insights into the ongoing Review Programme and its implications for product portfolios and market access.
Key successes and persistent challenges faced by industry stakeholders
- Claudio Carlon - Head of Unit at ECHA for Active Substances, European Chemicals Agency (ECHA)
Comprehensive analysis of the Biocidal Product Regulation (BPR) implementation progress
Key successes such as an examination of mutual recognition procedures and product authorization streamlining
Obstacles like the complexities in demonstrating efficacy while maintaining safety standards
Impact on product portfolios and market access for the industry.
- Boris Van Berlo - Senior Sector Group Manager, Biocides for Europe (CEFIC)
Extension of the review program
Amendments to the Regulations on changes, same biocidal products and renewals
Major regulatory shifts (eg. new hazard classification under the CLP)
- Natalie Konings - Biocidal Law Expert, TBA
- Maristella Rubbiani - Senior Advisor, Rud Pedersen Public Affair
The status and future trajectory of the Plant Protection Products (PPP) Renewal Programme under Regulation (EC) No 1107/2009.
A comprehensive analysis of the AIR (Approval of Active Substances, Safeners and Synergists) renewal cycles, including the forthcoming 7th renewal programme encompassing 68 active substances scheduled for review between 2029 and 2035.
The interplay between scientific risk assessment methodologies and regulatory timelines.
Strategic methodologies for maintaining market authorization for key active substances.
Possible Annex II revision of Reg1107/2009
The new requirements for co-formulants
- Stefano Ravagli - Technical Regulatory Manager, DIACHEM S.p.A.
Approach for precision use categorization for PPP in arable and permanent crops.
Approach to develop specialized risk assessment frameworks and mitigation measures for precision application categories, incorporating metrics to quantify risk reduction potential and optimize PPP use efficiency.
Creation of standardized documentation for authorities in alignment with the principles of the European Compendium on Risk Mitigation Measures and Precision Applications.
- Anne Alix - Co - Chair (+ EU Regulatory Policy/Risk Assessment Leader, CORTEVA), Corteva Agriscience & EU Precision Application Task Force (EUPAF)
Defining clear and harmonized terminology when addressing low-risk pesticides, within the EU framework
Overview of current regulatory framework for LRPs in the EU, and identification of main aspects that may profit from improved guidance or recommendations for an adapted Risk Assessment
The current availability of resources and expertise at the Member State level to assess new potential LRPs, and key areas for improvement.
- João Godinho - Ph.D. Candidate, Agricultural Economics and Rural Policy Group, Wageningen University
An exploration of cutting-edge strategies for driving innovation within the constraints of the Biocidal Product Regulation.
Transforming compliance challenges into opportunities for product development and market differentiation.
Practical approaches to capitalize on emerging trends in green chemistry and sustainable biocidal solutions.
Evaluation and approval of the precursors and the generated active substance.
Strategies for demonstrating efficacy.
Addressing safety concerns
Innovative approaches to comply with BPR requirements while maximizing the potential of these dynamic biocidal solutions.
An opportunity for all participating speakers to take questions from the audience and for the audience to deep dive into queries and considerations from the presentations thus far.
- Can big data analytics and blockchain technology revolutionise the pesticide approval process?
- Examining the integration of high-throughput screening methodologies, environmental monitoring datasets, and post-market surveillance information to enhance risk assessment paradigms.
- Addressing the regulatory challenges and opportunities presented by the exponential growth in data volume, velocity, and variety in supporting evidence-based decision-making throughout the product lifecycle.
- Strategic considerations for integrating multi-omics data in the evaluation of non-target organism effects Evaluating the application of artificial intelligence in automating the systematic review process for the preparation of draft assessment reports (DARs).
The complex regulatory landscape for biological plant protection products under Regulation (EC) No 1107/2009
Examining the nuanced application of Annex II requirements for microorganisms, semiochemicals, and botanicals, while exploring the evolving risk assessment paradigms for these diverse biological agents.
implementation of tiered approaches for environmental fate modelling and non-target organism testing.
The evaluation of potential antimicrobial resistance development.
Navigating the intricate interplay between 1107/2009 and other relevant legislative frameworks such as the Sustainable Use of Pesticides Directive (2009/128/EC) and the impending revision of the Micro-organisms Directive (2009/41/EC).
- Alessandra Moccia - Vice-President, IBMA (International Biocontrol Manufacturer Association)
An opportunity for all participating speakers to take questions from the audience and for the audience to deep dive into queries and considerations from the presentations thus far.
Latest assessment criteria, data requirements, and regulatory implications for biocidal active substances and products.
Navigating the complex intersection of endocrine disruptor identification and biocide regulation
Strategies for addressing data gaps, leveraging new scientific approaches, and preparing for future regulatory developments that may impact product approvals and market access.
New CLP hazard classes for ED
Elucidating the intricate balance between in vitro and in vivo methodologies in Endocrine Disruptor (ED) assessments within the context of the Biocidal Products Regulation (BPR)
A critical analysis of high-throughput screening assays, adverse outcome pathways (AOPs), and integrated approaches to testing and assessment (IATA) for identifying endocrine-active substances in biocidal products.
Advancements in ED testing strategies, including the application of New Approach Methodologies (NAMs)
The integration of toxicokinetic and toxicodynamic data, and the utilization of weight-of-evidence approaches to optimize the balance between in vitro mechanistic data and in vivo apical endpoints in regulatory decision-making processes for biocidal active substances under the BPR framework.
Dedicated time for questions from the audience and open discussion
Insights into the technical and procedural nuances of the latest assessment criteria for endocrine disruptors in pesticides.
The application of the weight of evidence approach in evaluating endocrine activity and adversity.
The use of in silico methods such as (Q)SAR models for prioritizing substances with potential endocrine disrupting properties.
The strategic considerations for designing and interpreting higher-tier studies to address endocrine-specific endpoints.
New CLP hazard classes for ED
- Alice Tagliati - Senior Ecotoxicologist & Risk Assessor, Enviresearch
Designing robust efficacy studies.
Examining the implementation of the revised EPPO (European and Mediterranean Plant Protection Organization) standards for efficacy evaluation.
The integration of resistance risk assessment as mandated by Commission Regulation (EU) No 546/2011
The emerging role of digital technologies and precision agriculture in generating robust field trial data.
The complex interplay between efficacy demonstrations and the principles of integrated pest management (IPM) as outlined in Directive 2009/128/EC on the sustainable use of pesticides.
The European Green Deal's ambitious targets for reducing pesticide use and risk.
Dedicated time for questions from the audience and open discussion
Examining the ongoing initiatives and regulatory frameworks aimed at global harmonisation of biocide regulations.
Focussing on the interplay between the EU Biocidal Products Regulation (BPR), US FIFRA, and other international regulatory regimes.
Progress in areas such as mutual recognition of efficacy data, alignment of active substance evaluation criteria, and standardization of risk assessment methodologies for human health and environmental endpoints.
Technical and legal challenges impeding full regulatory convergence.
Exploring potential solutions such as the implementation of Globally Harmonised System (GHS).
Principles in biocide regulations and the development of internationally accepted guidelines for novel biocidal technologies and nanomaterials.
- Boris Van Berlo - Senior Sector Group Manager, Biocides for Europe (CEFIC)
- Claudio Carlon - Head of Unit at ECHA for Active Substances, European Chemicals Agency (ECHA)
Innovative bio-substances in biocides and their regulatory pathways.
Examining the interplay between scientific advancements and regulatory requirements.
The challenges of fostering innovation while maintaining stringent safety and efficacy standards for biocidal active substances and products.
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
Highlight the challenges in balancing innovation protection with market competition.
The potential impacts on product portfolios and agricultural practices considering the ongoing discussions on the sustainable use of pesticides and the Farm to Fork strategy.
Ambitious targets for reducing overall pesticide use and risk by 50% by 2030.
The proposed revisions to the Sustainable Use of Pesticides Directive (2009/128/EC), and the evolving criteria for active substance approval and renewal.
Promoting agroecological practices, enhancing biodiversity, and fostering the development and adoption of low-risk plant protection products within the framework of Integrated Pest Management (IPM) principles.
The potential reconfiguration of data requirements to better address ecosystem services and long-term agricultural sustainability in the context of climate change adaptation and mitigation measures outlined in the European Green Deal.
The transformative potential of digital technologies and artificial intelligence in revolutionizing pesticide risk assessment methodologies within regulatory frameworks.
Examining the integration of machine learning and large language models (LLMs) for predictive toxicology.
The utilization of big data analytics for environmental fate modelling, and the application of in silico approaches such as quantitative structure-activity relationship (QSAR) models for prioritizing substances of concern.
Addressing the regulatory challenges and opportunities presented by these emerging technologies in streamlining the approval process.
Enhancing the implementation of cumulative risk assessment as mandated by Article 36 of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin.
- Maristella Rubbiani - Senior Advisor, Rud Pedersen Public Affair