IUCLID 6.8 MRL Application manual

This manual provides an introduction to the regulatory framework for MRL submissions and the requirements describing the conditions in which an MRL application is needed. The manual can be used by applicants when preparing an application for an "MRL Application" and by evaluators when reviewing these applications.

The manual describes the working context for an EU PPP MRL application and the information required in each field for every IUCLID 6.8 document it includes. IUCLID documents are based on standardised formats and several sections, called common blocks, are reused in many documents throughout the dossier (e.g. information on the test material). The manual also describes how to provide the information in Entities e.g. the literature reference entity, which can be reused in different IUCLID documents. For the documents which use common blocks and entities the manual additionally highlights where specific/additional information is required to summarise a chemical safety study.

This manual is updated annually to ensure alignment with the latest IUCLID format release, the last one being April 2024.