The European Commission has published a new guidance document that aims to provide a practical approach on how the data requirements on metabolites can be applied in the approval of microorganisms as active substances at EU-level and the authorisation of plant protection products at MS level. This guidance document addresses metabolites present in the active substance and the plant protection product and also those produced by the microorganism after application (in situ production).
To determine whether the microorganism is producing a metabolite of concern, the guidance document is organised according to a “step-by-step” procedure. The described approach implies that the assessment of all metabolites produced by a microorganism through an evaluation as performed for chemical active substances is not required, not feasible and unnecessary from a risk perspective, however parts of such assessment are needed under certain circumstances described in this document. The approach ensures that applicants provide all available data on metabolites including any indication of hazardous effects of any of these metabolites. For those metabolites for which a hazard is identified, this identified hazard is followed-up on by generating additional data where needed for a focused risk assessment for those particular metabolites.
This document has been finalised in the Standing Committee on Plants, Animals, Food and Feed on 23/10/2020. It will apply to applications submitted from 01/11/2021 onwards.
SANCO/2020/12258 of 23/10/2020 – Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances in accordance with Regulation (EC) No 1107/2009
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