Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)

Following the submission of application EFSA-GMO-RX-011 under Regulation (EC) No 1829/2003 fromMonsanto Europe, 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 therenewal of authorisation application for the herbicide-tolerant genetically modified soybean MON 89788,for food and feed uses, excluding cultivation within the European Union. The data received in the contextof this renewal application contained post-market environmental monitoring reports, a systematic searchand evaluation of literature, updated bioinformatic analyses and additional documents or studiesperformed by or on behalf of the applicant. The GMO Panel assessed these data for possible newhazards, modified exposure or new scientific uncertainties identified during the authorisation period andnot previously assessed in the context of the original application. Under the assumption that the DNAsequence of the event in soybean MON 89788 considered for renewal is identical to the sequence of theoriginally assessed event, the GMO Panel concludes that there is no evidence in renewal applicationEFSA-GMO-RX-011 for new hazards, modified exposure or scientific uncertainties that would change theconclusions of the original risk assessment on soybean MON 89788.Peer Reviewe