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New rules to accelerate the approval and authorisation of biological plant protection products – Microbials/Microorganisms
On 8th February 2022 the SCOPAFF written procedure for voting the four regulations on microorganims was officially closed and the new data requirements for microbials was released to the final approval stages in European Parliament. Read online on the European Commission website what the EU Member states have approved new rules to accelerate the approval and authorisation of biological plant protection products containing microorganisms to reduce reliance on chemical pesticides. IBMA reaction: IBMA thanks the European Commission for their work to revise the microbial data requirements (DRs). In particular, we appreciate that the weight of evidence approach can replace the systematic use of animal studies to address tox and pathogenicity end points and and there is conditionality in the requirements. However, IBMA Executive Director Jennifer Lewis underlines: ´´Unfortunately these changes appear unable to speed up microbials authorization. In fact, there is little fundamental change to the existing DRs: which is a disappointing missed opportunity to align European Commission policies to the goals of Farm to Fork. ´´ The most significant change is the incorporation of the secondary metabolite guidance, which stems from a chemical definition of a metabolite, and is now driving the new data requirements and will create some technically unrealistic studies for microbial metabolites that are not of safety concern. This highlights the need for more experts on microbials within the European Commission and Member States to ensure relevant evaluation of the microbial products. Currently it takes up to 10 years for microbials to reach the market. A fast track system must be implemented immediately for microbials and other biocontrol in order to meet the Farm to Fork Strategy objectives for pesticide reduction.