Expert Guidance for Biopesticide Compliance & Innovation
Biopesticides offer sustainable, innovative solutions for crop protection, but their regulatory approval process remains highly complex. At Blue Frog Scientific, we are true experts in biopesticide registration, with real-world experience and a proven track record of securing approvals for microbials, plant extracts, semiochemicals, and other biological plant protection products under Regulation (EC) No 1107/2009.
Our specialist biopesticide team combines scientific expertise with hands-on regulatory experience, ensuring that your active substances and formulated products meet the evolving requirements of EFSA and HSE.
Biopesticide Registration: A Specialist Approach
The registration process for biopesticides differs significantly from that of chemical pesticides, requiring bespoke strategies to address:
- Unique Data Requirements – Unlike chemical pesticides, biopesticides often face non-standard data expectations, requiring scientifically justified testing waivers, adapted study designs, and weight-of-evidence approaches
- Regulatory Uncertainty & Evolving Guidelines – EFSA and HSE frequently refine their approach to microbials, semiochemicals, and natural substances, making regulatory foresight and engagement critical to approval success
- Mode of Action & Risk Assessment Complexity – Biopesticides require specialist risk assessments that account for living organisms, metabolites, and environmental interactions, demanding expert scientific evaluation
Our deep understanding of biopesticide regulations allows us to streamline approvals, ensure reliability and relevance of studies, and ensure compliance while addressing efficacy, safety, and environmental risk assessment challenges.
Comprehensive Biopesticide Regulatory Services
Strategic Regulatory Support:
- Regulatory Strategy Development – Crafting tailored submission plans to address EU and UK-specific regulatory challenges
- Pre-Submission Engagement – Supporting early regulatory discussions with EFSA, RMS, and HSE to align expectations and optimise dossier success
Dossier Preparation & Compliance:
- Data Gap Analysis & Study Planning – Identifying critical data gaps and developing cost-effective, compliant testing strategies
- Efficacy & Mode of Action Justifications – Ensuring that biopesticides meet regulatory efficacy criteria without excessive data burdens
- Active Substance & Product Dossier Compilation – Preparing IUCLID dossiers, draft Registration Reports (dRRs), and other regulatory submission documents
Safety Assessment:
- Human Health & Environmental Risk Assessments – Conducting specialist exposure modelling, risk assessments, and metabolite evaluations
Advocacy & Stakeholder Engagement:
- Regulatory Authority Liaison – Engaging with EFSA, HSE, and RMS authorities throughout the evaluation process
- Scientific Justifications & Waivers – Supporting data waivers, weight-of-evidence arguments, and dossier defence during regulatory review
With first-hand experience in successful biopesticide approvals, our team brings deep technical expertise, regulatory foresight, and strategic problem-solving to every project. We understand the regulatory nuances of biopesticides and work proactively to overcome obstacles, accelerate approvals, and minimise unnecessary data requirements.
Get in touch to discuss how we can support your biopesticide registration in the EU and UK.
