Main Conference Day 2
- Maristella Rubbiani - Senior Advisor, Rud Pedersen Public Affairs
Water Quality Monitoring Framework:
How Ctgb uses monitoring data to identify structural exceedances of the Regulatory Acceptable Concentration (RAC) in surface water
The process for re-evaluating products
PFAS Policy Decisions:
Netherlands' approach to PFAS in plant protection products
Water Framework Directive Integration:
Your ministry's intention to align authorisation criteria with WFD requirements
The 2027 deadline and what it means for product authorisations
How monitoring data informs both regulatory frameworks simultaneously
- Lindy Messchendrop - Policy Advisor, ctgb - Dutch Board for the Authorisation of Plant Protection Products and Biocides
EU regulatory framework creates significant approval delays for Low-Risk Pesticides compared to the US, with missing data requirements for botanicals, semiochemicals, and dsRNA products hindering market access despite EU policy commitments.
Survey of 19 EU Member States reveals substantial disparities in National Authority expertise, resources, application fees, and assessment timelines, undermining harmonised and efficient Low-Risk Pesticide evaluation across the Union.
Concrete regulatory reforms are needed—including dedicated expert teams, harmonised waiver criteria, fast-track procedures, and novel assessment tools—to accelerate authorisation whilst maintaining rigorous safety standards aligned with Regulation 1107/2009.
- João Godinho - Ph.D. Candidate, Agricultural Economics and Rural Policy Group, Wageningen University
- Maristella Rubbiani - Senior Advisor, Rud Pedersen Public Affairs
- David Ashworth - Biocides Expert, Klarus Consulting
The development and launch of sustainable biocidal products affords in-depth knowledge both from the marketing, regulatory and technical point of view. These fields of expertis need to work very closely together to warrant the successful authorization and placing of these future promising products onto the EU market.
However, the constantly and ever changing regulatory scene in the biocides area represents big hurdles and causes further challenges for SME applicants when planning and implementing biocidal product authorizations according to the BPR.
Additional regulatory and/or technical requirements are to be fulfilled even at an already advanced evaluation stage of biocidal product applications having been submitted well before the adoption of such requirements. This additional unforeseeable regulatory burden causes further delays in evaluation procedures thereby creating uncertainties and rendering the product authorization timelines even more unpredictable which may have a negative impact on the competiveness of applicants.
Moreoever, the unknown outcome of active substance (re-)approvals and the associated uncertainties in active substance availability constitute further challenges for prospective applicants. This requires constant adjustment of biocidal product authorization strategies as well as a re-considerations of the original market needs with a focus on the intended uses and life cycle of potential sustainable biocidal products.
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
Hazard-Driven Regulation Risks Losing Beneficial Biocides: BPR's hazard-based exclusion criteria overlook real-world risk assessment and exposure scenarios, threatening to eliminate substances with significant environmental and safety benefits.
Quantifying Climate Benefits Ignored by Regulators: Marine antifouling biocides like Selektope® deliver measurable carbon emission reductions through improved fuel efficiency—environmental contributions systematically excluded from EU regulatory decision-making despite alignment with climate goals.
- Cecilia Ohlauson, PhD - Director Regulatory Affairs & Sustainability, I-Tech
- David Ashworth - Biocides Expert, Klarus Consulting
- Maristella Rubbiani - Senior Advisor, Rud Pedersen Public Affairs
Machine-readable labels enable regulatory oversight and supply chain transparency.
Electronic record-keeping requirements transform IPM documentation and audit trails.
Implementation & interoperability; harmonised labelling format across EU Member States for simplicity in compliance
Integration with application equipment and farm management software.
- Anne Alix - Policy and Risk Management Leader EMEA & Co-Chair, Corteva AgriScience, CropLife Europe & AgriGuide
- Michael Kurzmeier - Manager Digital Innovation and Compliance, Agrexis
- Stefano Ravagli - Technical Regulatory Manager (Consultant to DIACHEM S.p.A.), Independent
- Maristella Rubbiani - Senior Advisor, Rud Pedersen Public Affairs
- David Ashworth - Biocides Expert, Klarus Consulting
- Pierre Cruse - Biocides Policy Team Leader, HSE
Industry challenges navigating complex approval processes under CLP
Managing transitions to safer alternatives whilst maintaining product efficacy
The cascading compliance implications of new hazard classifications
- Diana Kättström - Expert Safe and Sustainable Chemistry, IVL Swedish Environmental Research Institute
Ethical and scientific imperative: The Commission roadmap to phase out animal testing reflects both animal welfare concerns and recognises that in vitro methods and predictive modelling may provide better human-relevant data
OECD guideline developments and validation studies demonstrate technical feasibility.
Opportunities exist for companies that develop and validate New Approach Methodologies ahead of regulatory requirements.
- Tess Renahan - Advisor, PETA Science Consortium International e.V.
- David Ashworth - Biocides Expert, Klarus Consulting
