Assessment of genetically modified sugar beet H7-1 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-006)

sugar beet, H7-1, renewal, articles 11 and 23, regulation (EC) No 1829/2003, CP4 EPSPS
First published in the EFSA Journal
16 November 2017
26 October 2017
Scientific Opinion


Following the submission of application EFSA-GMO-RX-006 under Regulation (EC) No 1829/2003 from KWS SAAT SE and Monsanto Company, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified sugar beet H7-1. The data received in the context of this renewal application contained a systematic search and evaluation of literature, updated bioinformatics analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in sugar beet H7-1 considered for renewal is identical to the originally assessed event, the GMO Panel concludes that there is no evidence in the context of this renewal application for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on sugar beet H7-1.

Panel members at the time of adoption

Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Mikołaj Antoni Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, Elsa Ebbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli and Jean-Michel Wal.
Panel on Genetically Modified Organisms
GMO [at]
EFSA Journal 2017;15(11):5065
Question Number
On request from
European Commission (DG SANTE)