Assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐016)

Maize, Bt11, renewal, Articles 11 and 23, Regulation (EC) No 1829/2003
First published in the EFSA Journal
13 gennaio 2021
25 novembre 2020
Scientific Opinion


Following the submission of application EFSA-GMO-RX-016 under Regulation (EC) No 1829/2003 fromSyngenta the Panel on Genetically Modied Organisms of the European Food Safety Authority wasasked to deliver a scientic risk assessment on the data submitted in the context of the renewal ofauthorisation application for the insect-resistant and herbicide-tolerant genetically modied maize Bt11,for food and feed uses, excluding cultivation within the European Union. The data rece ived in thecontext of this renewal application contained post-market environmental monitoring reports, asystematic search and evalua tion of literature, updated bioinformatic analyses, and additionaldocuments or studies performed by or on behalf of the applicant. The GMO Panel assessed these datafor possible new hazards, modied exposure or new scientic uncertainties identied during theauthorisation period and not previously assessed in the context of the original application. Under theassumption that the DNA sequences of the event in maize Bt11 considered for renewal is identical tothe sequence of the originally assessed events, the GMO Panel concludes that there is no evidence inrenewal application EFSA-GMO-RX-016 for new hazards, modied exposure or scientic uncertaintiesthat would change the conclusions of the original risk assessment on maize Bt11.

Panel on Genetically Modified Organisms
GMO_secretariat_applications [at]
EFSA Journal 2021;19(1):6347
Question Number
On request from
European Commission (DG SANTE)
© 2021 European Food Safety Authority. EFSA