Assessment of genetically modified maize MON 88017 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐014)

Maize, MON 88017, renewal, Articles 11 and 23, Regulation (EC) No 1829/2003
First published in the EFSA Journal
11. März 2020
Adopted
29. Januar 2020
Type
Scientific Opinion

Abstract

Following the submission of application EFSA‐GMO‐RX‐014 under Regulation (EC) No 1829/2003 from Monsanto Company 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 and herbicide‐tolerant genetically modified maize MON 88017, 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. Under the assumption that the DNA sequence of the event in maize MON 88017 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‐014 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 88017.

Panel on Genetically Modified Organisms
Contact
GMO_secretariat_applications [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6008
EFSA Journal 2020;18(3):6008
Question Number
On request from
European Commission (DG SANTE)