This document dealing with biological pesticides provides guidance to both industry and regulatory authorities, in the context of applications for the approval of microbial biological control agents (mBCAs), and for the registration of microbial biological control products (mBCPs).

This working document has been prepared to address the assessment of secondary metabolites of microbial biocontrol agents. The main focus of this working document is the assessment of the hazards and risk of secondary metabolites produced during the manufacturing of microbial pest control products and after their application in the field.

The document provides guidance to both industry and regulatory authorities in the context of pre-submission consultations prior to submission of applications for the registration of microbial biological control agents. This document describes the procedure and the information which should be submitted at a pre-submission consultation.

This document provides guidance to national regulatory authorities in providing greater incentives to encourage applicants (manufacturers/registrants) to register agricultural pesticides (including both synthetically and naturally derived products) for minor uses.

This Guidance for Defining Minor Uses of Pesticides is provided to encourage and enhance member countries similarities in their approaches to defining minor uses, and to ensure that those needs are appropriately regulated, managed and addressed in their respective countries.

This document provides guidance to both industry and regulatory authorities on storage stability for different types of microbial pesticide formulations. It includes guidance on the physical and chemical parameters to be assessed for different formulation types before and/or after the storage period, and also describes specific and adequate criteria for the determination of storage stability.

This document provides guidance to both industry and regulatory authorities on how procedures and data requirements can be applied to facilitate the submission of a complete data package/dossier for botanical active substances used in plant protection products, and the subsequent evaluation of this data package/dossier by the regulatory authorities.