Main Conference Day 1
- Pavel Glukhov - Partner, EU Focus Group
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.
Streamlined authorisation procedures through enhanced Union Authorisation and mutual recognition mechanisms, enabling simultaneous multi-Member State market access with reduced administrative burden
Cross-regulatory alignment between plant protection products and biocides frameworks creates opportunities for unified compliance approaches whilst requiring careful navigation of potential divergent requirements
Strategic incentives from extended data protection periods, revised active substance renewal processes, and estimated cost savings drive proactive industry engagement in shaping implementation across the EU single market
What's changed under Regulation (EU) 2026/1123: New mandatory labelling elements, enhanced safety communication requirements, and key differences from the repealed Regulation (EU) No 547/2011.
Safe application as the regulatory priority: How the amended regulation strengthens user protection through clearer hazard communication, application instructions, and environmental safeguards.
Implementation timeline and transitional provisions: Compliance deadlines for new products versus existing market authorisations, grace periods for label updates, and coordination with Member State enforcement authorities.
- 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 - Director, Biocides for Europe (CEFIC)
European Commission and ECHA developments
Biocidal product families
Borderline cases and secondary claims
- Natalie Konings - Partner, Partner, Bird & Bird LLP
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
- Pavel Glukhov - Partner, EU Focus Group
Synergists framework: 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.
- Claudio Mereu - Partner, Bird & Bird LLP
- Adrian Parra Garcia - Senior Associate, Bird & Bird LLP
An industry case study detailing the regulatory process and experience for biocontrol products
- Pascal Michaux - Board Director & Managing Partner, EU Focus Group
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
- David Ashworth - Biocides Expert, Klarus Consulting
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.
- Ankur Grover - Principal Regulatory Specialist, European Biocide Active Substance, Ecolab
- 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
Ending contradictory conclusions: The OSOA framework and Common Data Platform promise to resolve divergent risk assessments when ECHA and EFSA evaluate the same active substance across biocidal and plant protection regulations.
Implementation timeline reality: The roadmap extends through 2029, meaning benefits remain years away whilst current assessment bottlenecks and duplicated data requirements persist today.
Strategic dossier preparation: Understanding which data will be shared across regulations versus remaining regulation-specific is critical for companies navigating both BPR and PPP frameworks.
- Claudio Mereu - Partner, Bird & Bird LLP
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
How "general alignment" translates into practice remains ambiguous—will UK automatically adopt EU additions or conduct independent assessments that could reach different conclusions?
HSE's retained Article 59 powers signal that UK-specific SVHCs could emerge where domestic risk assessments diverge from European opinions.
The retrospective review of post-Brexit EU additions creates uncertainty for substances added between 2021-2026—facing potential dual timelines.
- Pierre Cruse - Biocides Policy Team Leader, HSE
Recent landmark cases at EU level: Annulment proceedings, judicial review of ECHA decisions, and General Court rulings affecting substance authorisation and restriction processes
National-level disputes: Member State administrative court challenges, divergent enforcement interpretations, and cross-border compliance implications
Regulatory authority perspective: How litigation influences agency decision-making, guidance development, and stakeholder engagement strategies
Practical risk mitigation: Early warning signs of potential disputes, documentation best practices, and when to engage legal counsel
Emerging litigation trends: Classification disputes, data protection challenges, and procedural fairness questions likely to shape future case law
- Claudio Mereu - Partner, Bird & Bird LLP
- Natalie Konings - Partner, Partner, Bird & Bird LLP
- Adrian Parra Garcia - Senior Associate, Bird & Bird LLP
- Michael Werner - Head of Regulatory Affairs, Stockmeier Chemie GmbH & Co. KG
