Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003


Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2015;13(6):4129
Panel Members
Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks and Christoph Tebbe.

The Panel wishes to thank the members of the Working Group on Guidance for the risk assessment of GMO renewal applications: Christer Andersson, Jürgen Gropp, Hanspeter Naegeli, Fabien Nogué, Nils Rostoks and Jeremy Sweet for the preparatory work on this scientific opinion and, EFSA staff: Antonio Fernandez Dumont, Ana Gomes, Sylvie Mestdagh, Claudia Paoletti, Matthew Ramon and Elisabeth Waigmann for the support provided to this scientific opinion.

Guidance of the Scientific Committee/Scientific Panel
On request from
Question Number
27 May 2015
Published in the EFSA Journal
18 June 2015
European Food Safety Authority (EFSA), Parma, Italy

According to Articles 11(6) and 23(6) of Regulation (EC) No 1829/2003 on genetically modified food and feed, the European Food Safety Authority should publish detailed guidance to assist applicants in the preparation and presentation of their applications for the renewal of authorisations of that genetically modified food and feed. This guidance document describes the data requirements for renewal applications, which should contain a copy of the authorisation, post-market monitoring and post-market environmental monitoring reports, systematic search and evaluation of literature, updated bioinformatics and any additional documents or studies performed by or on behalf of the applicant during the authorisation period. The applicant is requested to assess the collected information and conclude whether the previous risk assessment remains valid. The applicant can also propose amending or complementing the original conditions of the authorisation, including the monitoring plan(s).

renewal authorisation, GM food and feed, Regulation (EC) No 1829/2003, Articles 11 and 23
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