EUROPE – EFSA: Guidance document on active substance applications for approval and renewal and on MRL applications

EFSA published on 03 March 2021 a technical report describing the administrative requirements for the preparation and submission of the dossier to support an application for the approval, the amendment or the renewal of approval of an active substance, and for applications for setting of maximum residue levels (MRLs). This guidance document is applicable for all applications submitted as of 27 March 2021.

This document describes the procedures and the timelines for handling these applications and also includes the new requirements related to the implementation of the Transparency Regulation (Regulation (EU) 2019/1381). The different support initiatives available and the interaction between the applicant, EFSA members and RMS/Co-RMS from the preparation of the application (pre-submission phase) to the adoption and publication of the EFSA’s conclusions or reasoned opinions are presented.

Eventually, a practical guidance for applicants and Member States also describes the key technical points for preparing dossiers and assessment reports under Regulation (EC) No 1107/2009 with the aim to enhance their quality.


To download: 

EFSA Supporting publication 2021:EN-6464: Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the maximum residue level (MRL) application procedure


See also our previous articles: 

EUROPE-EFSA: Guidance on active substance applications for approbation and renewal


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