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

Soybean, MON 89788, renewal, Articles 11 and 23, Regulation (EC) No 1829/2003
First published in the EFSA Journal
16 November 2018
Adopted
17 October 2018
Type
Scientific Opinion

Abstract

Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto 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 the renewal 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 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 event in soybean MON 89788 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐011 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 89788.

Panel members at the time of adoption

Hanspeter Naegeli, Jean‐Louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst, Michele M Epstein, Leslie George Firbank, Philippe Guerche, Jan Hejatko, Francisco Javier Moreno, Ewen Mullins, Fabien Nogué, Nils Rostoks, Jose Juan Sánchez Serrano, Giovanni Savoini, Eve Veromann and Fabio Veronesi.
Panel on Genetically Modified Organisms
Contact
GMO [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5468
EFSA Journal 2018;16(11):5468
Question Number
On request from
European Commission (DG SANTE)