EUROPE – EFSA: Update of the guidance on active substance applications for approval and renewal and on MRL applications

The EFSA document “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” has been updated on 3 June 2024.

This document, first published on 3 March 2021, provides guidance on the preparation and submission of dossiers and assessment reports for the peer-review of applications related to pesticide active substances. It is therefore addressed to both applicants preparing an application, and Member States preparing an assessment report on such an application.

The guidance contains a chapter dedicated to maximum residue levels (MRL) setting applications and confirmatory data within the scope of Regulation (EC) No 396/2005.

Additions/changes are in particular:

• clarifications on the pre-submission phase;
• updates linked to recent developments of IUCLID and guidance documents;
• new sections on dossier re-submission;
• more concise information related to transparency and confidentiality requirements and information on when to use Portalino to submit confidentiality requests;
• clarification on where to retrieve background documents (e.g. final DAR/RAR);
• information on the possibility to submit a new application after a withdrawal.

Besides, 2 new appendices are provided:

• new Appendix B provides a form to be used for submitting justified requests for removal of information from certain EFSA outputs and background documents (e.g. the peer review report) with a view to assisting EFSA in implementing relevant confidentiality decisions and pending confidentiality requests (e.g. on the dossier or assessment reports);
• new Appendix C contains a checklist to support the Reporting Member State in the verification of the admissibility of the applications submitted in IUCLID format.

The list of major changes introduced in this updated guidance document, compared to the initial version, is in Annex A, and main changes are also greyed in the guidance document.

To download: 

EFSA Supporting publication 2021:EN-6464, 3 June 2024: 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

Appendix A: Completeness checklist for assessment reports

Appendix B: Justification form for requests for removal pertaining to information in the NAS conclusions, Reasoned Opinion (MRL), the Technical Report related to confirmatory data, the Peer Review Report and MRL background documents

Appendix C: Admissibility checklist

Annex A: List of main changes introduced in the 2024 version of the guidance document

See also our previous articles: 

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

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