Administrative guidance for the preparation of applications on genetically modified plants
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Note: This administrative guidance was first published on 25 March 2021 and has been updated on 16 December 2022 and on 23 November 2023. A list of changes introduced in December 2022 and November 2023 is provided in Annex A. The main changes are highlighted in the document with a grey shading. To avoid confusion, the previous versions of the guidance have been removed from the EFSA Journal, but are available on request.
Abstract
This document provides guidance to applicants submitting applications on genetically modified plants for food and feed uses, import and processing, and/or cultivation in the European Union, which are to be evaluated by EFSA. It describes the administrative requirements for the preparation and online submission of the dossier to support an application for a new authorisation and for the modification of an existing authorisation for applications submitted to the competent authority of a Member State as of 27 March 2021.
The Transparency Regulation amended the General Food Law by introducing new provisions in the pre‐submission phase and in the application procedure: general pre‐submission advice, notification of information related to studies commissioned or carried out to support an application, public disclosure of non‐confidential version of all information submitted in support of the application and related confidentiality decision‐making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangements laid down by EFSA, are reflected in this guidance.
The guidance describes the procedure and the associated timelines for handling applications on genetically modified plants, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the application (pre‐submission phase) to the adoption and publication of EFSA's scientific opinion.
This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6471/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6472/full