Open AccessEFSA guidance on the submission of applications for authorisation of genetically modified plants under Regulation (EC) No 1829/2003
Publication year - 2013
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2013.3491
Subject(s) - authorization , european union , checklist , microbiology and biotechnology , genetically modified organism , harmonization , food safety , presentation (obstetrics) , business , computer science , political science , risk analysis (engineering) , biology , medicine , food science , international trade , computer security , paleontology , biochemistry , gene , physics , radiology , acoustics
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.