Main Conference Day 1
Unlimited approvals revolution: Eliminating mandatory renewals for active substances promises to end the approval bottleneck.
Abandoning periodic safety reviews raises profound questions about long-term environmental protection
Biocontrol acceleration measures and the differentiation between synthetic chemicals and biological alternatives
Competitiveness versus safety; the tension between agricultural viability and environmental protection commitments
How the Omnibus balances the Commission's Vision for Agriculture against precautionary principles.
PFAS scrutiny & "Candidates for Substitution" (CfS): The mandate on TFA formation from PFAS may disqualify entire chemical classes based on environmental persistence concerns.
Approval criteria increasingly incorporating competitiveness considerations alongside scientific safety evaluations.
Member State divergence undermines the single market principle.
Protection goals tightening: EFSA's development of Specific Protection Goals for non-target organisms.
Addressing industry concerns about assessment complexity.
The focus on indirect effects and trophic interactions; environmental harm extending beyond direct toxicity to target organisms.
The risk management approaches which successfully balance ecological protection with agricultural viability.
Bringing safeners and synergists under formal approval requirements.
Extending regulatory reach to substances previously considered formulation aids.
The long-term reality of product portfolios needing to adapt to expanded regulatory scope.
Data requirements in IUCLID format; safeners and synergists will face scrutiny comparable to active substances themselves.
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
Comprehensive regulatory review: The REFIT evaluation's five assessment criteria & fundamental questions about whether BPR has achieved its objectives.
Review Programme status addressing the true volume of active substance/product-type combinations that have been assessed.
Will the data protection extension to 2030 resolve capacity constraints?
Expected outcomes from the evaluation report: will BPR face incremental adjustments or fundamental restructuring?
Independent Industry Study: complementary shadow evaluation to Commission's evaluation.
Key findings:
Quantified impact of delays on product portfolios
Economic analysis of administrative burden
Innovation barriers and proposed solutions
- Boris Van Berlo - Senior Sector Group Manager, Biocides for Europe (CEFIC)
The Food and Feed Safety Omnibus streamlining product authorisation procedures.
Alignment between biocides and plant protection products that could streamline or complicate compliance.
Data protection extension
Renewal of actives implementation
Application of new guidance
Union Authorisation improvements and mutual recognition enhancement could transform market access strategies for companies operating across multiple Member States
Estimated cost savings create powerful incentives for industry to proactively shape implementation
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
Assessing how novel mechanisms like RNA interference technology challenge established risk assessment frameworks.
Biocontrol modes of action require more developed evaluation approaches.
The tension between precautionary principles and the need to enable breakthrough technologies
How authorities evaluate substances without historical precedent will determine whether Europe leads or lags in agricultural innovation.
Articles 33 and 43 create competing imperatives—data exclusivity incentivises high-quality dossier generation, whilst mutual recognition obligations and data sharing requirements threaten to erode competitive advantage.
Patent protection strategy becomes increasingly complex; navigating the interaction between regulatory data exclusivity periods and intellectual property rights.
The paradox of data sharing vs. exclusivity: Robust IP frameworks can drive R&D investment in crop protection, while electronic record-keeping requirements and transparency obligations create premarket exclusivity pathways for competitors.
Legal distinctions between plant growth regulators, pesticides, and biostimulants create classification uncertainties that affect market access strategies.
Dual-use products with both biostimulant and plant protection properties face regulatory complexity.
Byproduct utilisation in biostimulants intersects with Circular Economy Act implications, creating both opportunities and compliance challenges.
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
Ethanol classification controversy: The potential CMR classification would trigger Article 5 exclusion criteria, potentially eliminating ethanol from product formulations across multiple product types.
Harmonised CLP classifications create automatic triggers for BPR re-evaluation; classification decisions made in one regulatory context may cascade into product authorisation consequences.
Endocrine disruptor hazard classes and PMT/vPvM represent new classification categories that will reshape biocidal product portfolios.
The interface between CLP classification and BPR authorisation.
The Biocidal Products Committee's support for approval whilst the final classification decision remains pending.
Potential CMR classification scenarios range from business-as-usual to industry transformation requiring wholesale reformulation.
Alternative substances and formulations present efficacy and safety trade-offs that may prove unacceptable for critical applications.
Market impact extends beyond manufacturers to healthcare facilities, food service operations, and consumers who depend on ethanol-based products.
The number of active substances lost in recent years threatens to leave end-users with insufficient options.
Review programme delays and economic viability challenges for niche uses reveal systemic hurdles.
The need for balancing simplified renewal procedures with the need to maintain safety standards that justify substance withdrawals.
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
Dual nature dilemma: The Omnibus presents simultaneously as a deregulation threat and innovation opportunity depending on whether environmental protection or competitiveness takes priority.
Stopping re-registration requirements for synthetic pesticides abandons the periodic safety review principle that has underpinned precautionary regulation.
- Aaldrik Tiktak - Senior Researcher – Soil & Water, PBL Netherlands Environmental Assessment Agency
Subtle differences between BPR, PPP, and CLP endocrine disruptor criteria create compliance complexity that undermines the goal of harmonised assessment.
The distinction between "endocrine mode of action" and "endocrine activity" carries profound implications for which substances face restrictions.
The scale of potential regulatory action.
Future criteria refinements will determine whether ED assessment becomes more, or less stringent.
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
The influence of EFSA plant protection guidance on ECHA biocides assessment; informal harmonisation beneath regulatory structures.
Emerging environmental issues from PFAS to microplastics to antimicrobial resistance demonstrate how risk assessment must continuously adapt to new scientific understanding.
Non-animal testing methods and advances in predictive modelling promise to transform environmental fate studies. Do validation and regulatory acceptance lag?
Real-world monitoring data integration challenges the gap between laboratory studies and actual environmental exposure scenarios
BPR vs PPP: Risk and ED assessments for non-active substances.
The classification trigger cascade: How CLP classification automatically triggers REACH authorisation, BPR exclusion criteria, and PPP renewal implications.
CMR, PBT, vPvB, PMT, and vPvM classifications each carry specific regulatory consequences that compound across multiple frameworks.
The ethanol case study offers real-time examination of how parallel classification and authorisation processes create regulatory uncertainty.
Supply chain communication requirements and downstream user obligations; classification impacts extend far beyond substance manufacturers.
Legal aspects and implications for stakeholders: “Wish” of RAC vs. ATPs and their legal applicability/feasibility of implantation by industry
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
