ANSES : Public consultation on guidelines for the issue of approval decisions

As of next summer, ANSES, in addition to its role of scientific assessment, will also issue approvals for plant protection products, fertilisers and crop supports and adjuvants.

For transparency, ANSES has developed guidelines to clarify the principles applied by the Agency for issuing approval decisions. These guidelines are subject to public consultation from 12 May 2015 to 5 June 2015.

What can we learn?

• Decisions taken by the Agency shall be notified to the applicant and will be published in the electronic register of decisions of ANSES, accessible on the Agency website as soon as possible. The conclusions of the assessment will be published in parallel on the same website.

Non-confidential parts of the zonal “Registration Report” (parts A and B), produced by ANSES, will also be made available on its website to provide access in much more detail to the results of the assessment.

• In some cases, further assessment of the dossier by the DAMM may be required by the nature of the application and / or the result of the assessment, in order to prepare the draft decision. The cases identified are:
  • the case where all or part of the risk management measures associated with the results of the assessment raises questions in terms of feasibility and acceptability in practice to ensure its effectiveness;
  • the case where new data from either the assessment, including data subsequent to the renewal of approval of active substance, or of monitoring networks;
  • the case where data on sanitary and phytosanitary consequences of plant protection issues deserve to be taken into account in the decision process;
  • the case where the product contains an active substance leading to the implementation of comparative assessment and where a thorough analysis on practical / economic consequences of various possible alternatives is needed.
• The comparative assessment of the product is made in compliance with European guidelines:
  • guidance document SANCO / 11507/2013 Rev.12, “Guidance Document on Comparative Assessment and Substitution of Plant Protection Products in according with Regulation (EC) No 1107/2009”, published by the European Commission dated 10 October 2014;
  • EPPO guidelines PP 1/271 (1), “Guidance on comparative assessment”, published in 2011 by the European and Mediterranean Plant Protection Organisation.

When it is implemented, comparative assessment will be a specific document showing responses at different stages of the process. This document will be attached to the conclusions of the assessment and made public with the conclusions of the assessment.

https://www.anses.fr/fr/documents/Lignes_directrices_PPP.pdf