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RESEARCH PRODUCT

Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐007)

Efsa Panel On Genetically Modified Organisms (Gmo)Hanspeter NaegeliAndrew Nicholas BirchJosep M. CasacubertaAdinda De SchrijverMikołaj Antoni GralakPhilippe GuercheHuw JonesBarbara ManachiniAntoine MesséanElsa Ebbesen NielsenFabien NoguéChristophe RobagliaNils RostoksJeremy SweetChristoph TebbeFrancesco VisioliJean‐michel WalHermann BrollAntonio Fernandez DumontIrina Olaru

subject

0301 basic medicinemaïsVeterinary (miscellaneous)gmo[SDV]Life Sciences [q-bio]2405 ParasitologyogmTP1-1185Plant SciencemaizeMicrobiologyzea mays03 medical and health sciences0404 agricultural biotechnology1110 Plant Sciencearticles 11 and 23TX341-6411106 Food ScienceNK603xMON8102. Zero hungerrenewal030109 nutrition & dieteticsNutrition. Foods and food supplymaize; NK603xMON810; renewal; articles 11 and 23; Regulation (EC) No1829/2003indian cornChemical technology2404 MicrobiologyRegulation (EC) No 1829/2003maize;NK603 x MON810;renewal;articles 11 and 23;Regulation (EC) No 1829/2003NK603 x MON81010079 Institute of Veterinary Pharmacology and Toxicology04 agricultural and veterinary sciences040401 food scienceSettore AGR/02 - Agronomia E Coltivazioni Erbacee3401 Veterinary (miscellaneous)Scientific OpinionSettore AGR/11 - Entomologia Generale E ApplicataRegulation (EC) No1829/2003570 Life sciences; biologyAnimal Science and ZoologyParasitology1103 Animal Science and ZoologyNK603 x MON810Regulation (EC) No 1829/2003Food Science

description

Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor:European Commission (DG SANTE)Question number:EFSA-Q-2017-00028; Following the submission of application EFSA-GMO-RX-007 under Regulation (EC) No 1829/2003 from Monsanto, 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 of the herbicide-tolerant and insect-resistant genetically modified maize NK603 x MON810. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic 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 events in maize NK603 x MON810 considered for renewal is identical to the sequence of the originally assessed events, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-007 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize NK603 x MON810.

10.2903/j.efsa.2018.5163https://hal.archives-ouvertes.fr/hal-01740356/document