Open AccessEFSA guidance on the submission of applications for authorisation of genetically modified food and feed and genetically modified plants for food or feed uses under Regulation (EC) No 1829/2003
Author(s) -
AUTHOR_ID
Publication year - 2011
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.2011.2311
Subject(s) - genetically modified organism , european union , authorization , microbiology and biotechnology , risk assessment , food safety , novel food , business , biology , food science , computer science , international trade , computer security , gene , biochemistry
This document is intended to provide guidance to applicants submitting under Regulation (EC) No 1829/2003 an application for authorisation of genetically modified food and feed and genetically modified plants for food and feed uses including cultivation in the European Union. It complements two recently updated guidance documents of the EFSA Panel on genetically modified organisms, the Guidance for risk assessment of food and feed from genetically modified plants and the Guidance on the environmental risk assessment of genetically modified plants . This EFSA submission guidance describes the community procedures in the European Union for processing such applications, and provides instructions to applicants on how to prepare and present data in an application to be submitted to EFSA. It is supplemented with ten appendices such as examples of data presentation and a completeness checklist to be filled by the applicants. Instructions described in this EFSA guidance are applicable to applicants submitting under Regulation (EC) No 1829/2003 an application for renewal of authorisation of existing products produced from genetically modified plants.