IUCLID Microbial Active Substances Manual

This manual gives a short introduction to the regulatory background for microbial pesticide active substance application submissions and the relative data requirements. The manual also describes for each IUCLID document included in the "EU PPP Microorganisms - active substance application (product)" working context the information required in each of the fields.

The manual can be used by industry when preparing an application and by evaluators when reviewing an application. IUCLID documents are based on standardised formats and therefore sections within documents are reused in many documents e.g. information on the test material, these sections are called common blocks. There are also entities e.g. literature reference which can be reused in different IUCLID documents. A full description of the information needed is provided for these common blocks and entities. In the documents which use common blocks and entities it is highlighted where specific/additional information is required to summarise a chemical safety study. This manual is updated annually to ensure alignment with the IUCLID format release in October.