Bt11 food/feed renewal

Bt11 currently has four different autorisations for food and feed uses, granted between 1998 and 2004 under different regulations.
The authorisation for "foods and food ingredients containing, consisting of or produced from Bt11 maize" is still valid until 2014, but the current renewal application under Regulation 1829/2003 covers all uses as food, feed and food/feed additives. At the same time applications are made for several Bt11 hybrids.

This application was processed at a time that the application for Bt11 cultivation and as feed under Directive 2001/18 had a positive opinion from the GMO Panel, but met with requests for further assessments by member states and the EU Commission. As of October 2009, the cultivation application is still pending.

Bt11 produces the Bt toxin Cry1Ab against lepidoptera such as European corn borer (ECB, Ostrinia nubilalis and a herbicide tolerance against glufosinate-based herbicides such as Liberty or Basta. It was initially claimed that this herbicide tolerance was only meant as a marker and that Bt11 would not be marketed as herbicide tolerant, but the trait was later taken up in the assessment of Bt11 as food.

Comments on the opinion of the GMO Panel: 

No comments were given in the public consultation at the EU.

Question number: 
EFSA-Q-2007-146
Application number: 
EFSA-GMO-RX-Bt11
Application date: 
29/06/2007
Type: 
renewal
Aplication accepted: 
17/03/2008
Status: 
opinion adopted
Deadline: 
20/01/2009
Petitioner: 
Syngenta
Applicant/Requester: 
European Commission - DG SANCO
Opinion number: 
ON-977
Opinion adopted: 
28/01/2009
Opinion published: 
17/02/2009
Consultation deadline: 
17/03/2009
Application status at EU level: 
pending