RegulatoryExperiencesofBiopesticidesinUK,EU.pptVIP

An Industry PerspectiveRegulatory Experiences of Biopesticides in UK, EU elsewhere IBMA Member Products Full range of biopesticides Eight registered biopesticides in UK From the 4 product groups as per REBECA Macrobials Botanicals Microbials Semiochemicals Exosect Product Experiences SCLP’s predominantly 1st registered product through PSD scheme Experience with GENOEG Registration experience in New Zealand USA Australia South Africa Several EU countries Biorationale Biopesticide Consultant product experiences Submission to various EU member states Main experience Microbials Macrobials From the 4 product groups as per REBECA Macrobials Botanicals Microbials Semiochemicals Expectations of regulators Traditional view of regulators Level of expectation of regulators Hesitance to talk to regulators Change needed and occurring on all sides Experience with SME’s 5-10% investment of income for multinationals versus 50% investment of income for BCA manufacturers SME annual trials budgets of around ￡30k No R money just D money Lack of optimisation Start ups with no income stream Terminology used in regulation OLD Comply with Needed by regulators From one side regulators recognise Mollify regulators NEW Interfaces with industry Consulting with industry Guidance, help and facilitation PSD Experiences Drivers Cabinet Office influence Pilot scheme SME Liaison Officer Outcomes More proportional fee structure Predictable timeframe Pre-submission process EU Experiences Variability between MS Political influence Lending particular assistance UK NL BE DE IT FR Mutual Recognition EU Experiences List 4 evaluations and Annex1 listing SCLP’s as a model for Semiochemicals Mutual Recognition Transference from national registrations to Annex3 product registrations Proposed new regulations and the place of biopesticides Precautionary principle USA Experience USA EPA Pragmatic Good dialogue with notifier Compliance with OECD guidelines High number of specialist staff experience Sta