EFSA guidance on the submission of applications for authorisation of genetically modified plants under Regulation (EC) No 1829/2003

Tabs

Article
European Food Safety Authority
Acknowledgements

EFSA wishes to thank its scientific officers Yi Liu, Christina Ehlert, Matthew Ramon and Yann Devos for drafting and the preparatory work on this EFSA guidance; and the following staff members Hermann Broll, Zoltán Divéki, Antonio Fernández Dumont, Luana Giorgini, Ana Gomes, Sonia Hernández Valero, Anna Lanzoni, Stefania Mori, Irina Olaru, Claudia Paoletti and Elisabeth Waigmann for the support provided to the development of this EFSA scientific output.

EFSA Journal
EFSA Journal 2013;11(12):3491
doi
10.2903/j.efsa.2013.3491
Contact
Type
Guidance of EFSA
On request from
EFSA
Question Number
EFSA-Q-2009-00900
Approved
3 December 2013
Published
6 December 2013
Last Updated
17 February 2014. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note

This guidance is currently in use and supersedes any previous versions.

Abstract

This document provides guidance to applicants for submitting an application for authorisation of genetically modified (GM) plants for food and feed uses, import and processing, and/or cultivation in the European Union under Regulation (EC) No 1829/2003. The EFSA submission guidance describes the community procedures in the European Union for handling GM plant applications, and provides instructions to applicants on how to prepare and present data in an application. It is supplemented with seven appendices providing templates of data presentation to be followed by applicants, including a completeness checklist. The earlier versions are now updated to account for requirements outlined in Implementing Regulation (EU) No 503/2013. Instructions for submission described in this EFSA guidance are applicable to all GM plant applications submitted under Articles 5, 11, 17 and 23 of Regulation (EC) No 1829/2003.

Keywords
Application, submission, genetically modified plants, GMO, Regulation (EC) No 1829/2003, Implementing Regulation (EU) No 503/2013