Biopesticide Registration Services in Europe

Sustainable use of environmental resources encouraged the development of biological products to balance the usage of synthetic chemicals in PPP. Auxilife’s extensive experience and expertise sufficiently support you for the registration of microbial, semiochemicals, and plant or natural extracts in the EU. The European Union's Biopesticide Products Regulation (EC No. 1107/2009) presents a complex landscape for companies seeking to register their biopesticides within the EU market. Auxilife Understands these challenges and provides comprehensive support throughout your biopesticidal product’s life span.

Biopesticides are not recognized by the EU as a distinct regulatory category from other PPPs. However, a more focused strategy for biopesticides containing microorganisms has been adopted by regulatory changes that went into effect in November2022. Microscopic organisms, including bacteria, fungi, viruses, and protozoa, have the potential for use in plant biocontrol due to their inherent parasitic or pathogenic properties towards insect pests and other plant pathogens. These microbial agents have been utilized globally, including within the European Union (EU). Our team of experts can help you navigate the intricacies of agrochemicals regulatory consultations and ensure a smoother path to successful registration.

Key Biopesticide Products Registration Regulation Services:

 

    • Strategic advice and guidance:

Auxilife serves as a bridge between biopesticide developers and regulatory bodies, ensuring product approvals through meticulous regulatory compliance. This process involves the compilation of comprehensive dossiers, the execution of scientific and risk assessments, and effective communication with regulatory authorities. Auxilife’s team of scientific experts maintains continuous vigilance over regulatory updates and modifications to guarantee the safety, efficacy, and environmental sustainability of biopesticides.

Auxilife provides expert biopesticide consultancy services. Auxilife offers consultancy services with valuable expertise and support throughout the data generation, monitoring and conducting the studies, by collaborating with certified laboratories (like GLP) worldwide. Our team excels at designing field trials as per EPPO zones and creating registration plans for your biopesticide.

    • Risk assessment :
      1. Dietary exposure assessment
      2. Non-dietary exposure assessment
      3. Environmental fate and behaviour assessment (focusing on surface water, soil, and groundwater)
      4. Ecotoxicological assessment (encompassing aquatic and terrestrial ecosystems)

        Biopesticide risk assessment plays a vital role in evaluating product safety and performance. Auxilife employs this technique to ensure compliance with EU and national regulations, while also identifying and proposing strategic mitigations for potential risks. The assessment focuses on key areas such as:

    • Data Gap Analysis:

    • To ensure a smooth registration process, Auxilife’s team thoroughly analyses all crucial data points for your biopesticide. This includes different sections as follows:

      1. Chemistry
      2. Residues
      3. Bio-efficacy
      4. Toxicology
      5. Fate and behaviour in the environment
      6. Ecotoxicology 
    • Dossier preparation:
      Our expertise lies in the comprehensive preparation of regulatory dossiers for both active ingredients and biopesticide formulations, ensuring compliance with European Union (EU) regulations. This encompasses the development of Draft Registration Reports, which integrate core assessments and accommodate any necessary national addendums as mandated by Regulation (EU) No. 283/2013 for active substances and Regulation (EU) No. 284/2013 for product formulations. Furthermore, we possess extensive experience in generating and submitting dossiers in the IUCLID format, a standardized system facilitating biopesticide registration within the EU.
    • Project Management:
      Auxilife leverages collaborative expertise to tailor a biopesticide registration strategy for the EU. This strategy integrates your goals with our regulatory knowledge, outlining a roadmap for success. Our approach encompasses preliminary assessments, clear timelines, and consistent communication, ensuring a smooth journey from dossier preparation to final approval.

    General Services:

    • Authorization and renewal of active substances and biopesticide products
    • Dossier preparation for active substances and products
    • Technical equivalency
    • Data matching
    • Conducting, and monitoring field trials and preparation of Biological Assessment Dossier (BAD).
    • Human and environmental risk assessment
    • Endocrine disruptor assessment for active and co-formulants
    • Mutual/Zonal recognition application in EU countries
    • Classification and labelling of hazards

    List of countries we served as Biopesticide Products Regulation Consultant in Europe:

    Auxilife has successfully provided its services to all 27 member states of the European Union, encompassing nations such as Italy, France, Denmark, Spain, Czech Republic, Sweden, Malta, Poland, Netherlands, Germany, Lithuania, and many others.