Assessment of genetically modified maize MIR162 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-025)

EFSA J. 2022 Sep 22;20(9):e07562. doi: 10.2903/j.efsa.2022.7562. eCollection 2022 Sep.

Abstract

Following the submission of application EFSA-GMO-RX-025 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, 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 genetically modified maize MIR162, for food and feed uses, excluding cultivation within the EU. 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. The GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-025 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MIR162.

Keywords: Articles 11 and 23; MIR162; Regulation (EC) No 1829/2003; maize; renewal.