TY - JOUR
T1 - Assessment of genetically modified sugar beet H7-1 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-006)
AU - European Food Safety Authority Panel on Genetically Modified Organisms
AU - Naegeli, Hanspeter
AU - Birch, Andrew Nicholas
AU - Casacuberta, Josep
AU - De Schrijver, Adinda
AU - Gralak, Mikolaj Antoni
AU - Guerche, Philippe
AU - Jones, Huw
AU - Manachini, Barbara
AU - Messean, Antoine
AU - Nielsen, Elsa Ebbesen
AU - Nogue, Fabien
AU - Robaglia, Christophe
AU - Rostoks, Nils
AU - Sweet, Jeremy
AU - Tebbe, Christoph
AU - Visioli, Francesco
AU - Wal, Jean Michel
AU - Fernandez-Dumont, Antonio
AU - Gennaro, Andrea
AU - Ramon, Matthew
N1 - Publisher Copyright:
© 2016 European Food Safety Authority.
PY - 2017/11/16
Y1 - 2017/11/16
N2 - 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.
AB - 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.
KW - Articles 11 and 23
KW - CP4 EPSPS
KW - H7-1
KW - Regulation (EC) No 1829/2003
KW - Renewal
KW - Sugar beet
UR - http://www.scopus.com/inward/record.url?scp=85133251836&partnerID=8YFLogxK
U2 - 10.2903/J.EFSA.2017.5065
DO - 10.2903/J.EFSA.2017.5065
M3 - Article
AN - SCOPUS:85133251836
SN - 1831-4732
VL - 15
JO - EFSA Journal
JF - EFSA Journal
IS - 11
M1 - 5065
ER -