One of the most common obstacles facing developers of innovative biocontrol products in Europe is not the science — it is the data. Building a compliant data package under Regulation (EC) No 1107/2009 for a micro-organism, a semiochemical or a plant-based preparation requires navigating a framework that was designed primarily for conventional chemical pesticides, and that is still evolving to accommodate the specificities of biological agents.

This briefing provides a practical, expert-led overview of the data requirements and risk assessment approaches applicable to innovative biocontrol solutions in the EU — covering both the regulatory framework and the science behind the key endpoints. Particular attention is given to non-target organism assessment and environmental fate, where the gaps between guidance and practice are most significant.

Designed for anyone involved in developing, registering or assessing biocontrol products in the EU market.

Topics covered

• ✓ Data requirements under Reg. 1107/2009: how they apply to micro-organisms, macro-organisms, semiochemicals and plant extracts
• ✓ Differentiated approaches: where biocontrol products get a lighter data burden — and where they don’t
• ✓ Non-target organism risk assessment: current EFSA guidance, endpoints and practical challenges
• ✓ Environmental fate for biocontrol active substances: what’s required, what’s not, and where guidance is still lacking
• ✓ Building a dossier in practice: lessons from recent submissions and evaluations
• ✓ Outlook: how the EU regulatory framework for biocontrol is evolving under Farm to Fork and related policy drivers