Guide for applicants of Plant Protection Product and for authorization in Italy

Comparative assessment and substition

This document provides guidance for comparative assessment (CA), in the authorisation process of a plant protection product (PPP) which contains an active substance that has been identified as a candidate for substitution (Regulation (EC) No 1107/2009, article 24 and 50) and provides assistance to applicants in collecting the necessary information.

It is based on Guidance document on Comparative Assessment and Substitution of PPPs in accordance with Regulation (EC) No 1107/2009 (SANCO/11507/2013 -rev. 12) and EPPO standard PP 1/271 “ Guidance on comparable assessment”. It also takes into account the guidance documents already made available by the UK (Comparative Assessment and substitution: guide for UK applicants for plant protection products authorisation), Portugal and Greece which were examined and generally agreed in the framework of the South Member States (SMS) Steering Committee.

The aim of the document is to enable both applicants and Ministry of Health (Ministry) to quickly identify those uses of plant protection products where a substitution would not be appropriate, even when a significantly safer alternative exists. A comparative assessment will only be undertaken by Ministry where it is identified that a substitution may be appropriate.

SUMMARY

- Legal requirements
- Procedure:
-- Presentation of information
-- Regulation action at the end of CA
- Instructions for completing Annex 2, the form ‘applicant information to support the process of comparative assessment’ for Italy (IT-CA)
- Annex 1 - National addenda to the draft Registration Report (dRR): “Applicant conclusion on Comparative assessment and substitution”
- Annex 2 - Form: Applicant information to support the process of comparative assessment

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Fonte: Ministero della Salute

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