Assessment of genetically modified maize MIR604 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐013)

摘要

Following the submission of application ‐ ‐ ‐013 under Regulation ( ) No 1829/2003 from Syngenta Crop Protection / , the Panel on Genetically Modified Organisms ( ) 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 genetically modified maize 604, for food and feed uses, excluding cultivation within the . 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 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 sequence of the event in maize 604 considered for renewal is identical to the corrected sequence of the originally assessed event, the Panel concludes that there is no evidence in renewal application ‐ ‐ ‐013 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 604.