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RESEARCH PRODUCT

Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Hanspeter NaegeliAndrew Nicholas BirchJosep M. CasacubertaAdinda De SchrijverMikołaj Antoni GralakPhilippe GuercheHuw JonesBarbara ManachiniAntoine MesséanElsa Ebbesen NielsenFabien NoguéChristophe RobagliaNils RostoksJeremy SweetChristoph TebbeFrancesco VisioliJean‐michel WalFernando ÁLvarezMichele ArdizzoneGiacomo De SanctisAntonio Fernandez DumontJosé ÁNgel Ruiz GómezAnna LanzoniNikoletta PapadopoulouKonstantinos Paraskevopoulos

subject

0301 basic medicineVeterinary (miscellaneous)[SDV]Life Sciences [q-bio]Plant Science010501 environmental sciences01 natural sciencesMicrobiology[SHS]Humanities and Social Sciences03 medical and health sciences1507 × NK603[SDV.IDA]Life Sciences [q-bio]/Food engineering[SDV.BV]Life Sciences [q-bio]/Vegetal Biology[SPI.GPROC]Engineering Sciences [physics]/Chemical and Process Engineering0105 earth and related environmental sciences2. Zero hungerrenewalGmoRegulation (EC) No 1829/2003Maize030104 developmental biologyScientific Opinion[SDE]Environmental Sciences1507 x NK603ParasitologyAnimal Science and ZoologyArticles 11 and 23Food ScienceRegulation (EC) No 1829/2003

description

International audience; Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 x NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained 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. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 x NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 x NK603 (EFSA, 2006). (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

10.2903/j.efsa.2018.5347https://hal.inrae.fr/hal-02628962