Scientific Opinion on application (Reference EFSA-GMO-UK-2007-50) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize Bt11xMIR604, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds

GMO, maize (Zea mays), Bt11, MIR604, Bt11xMIR604, glufosinate-tolerant, insect-resistant, Cry1Ab, PAT, mCry3A and PMI, risk assessment, stacked events, food safety and feed safety, human and animal health, environment, import, processing, Regulation (EC)
First published in the EFSA Journal
18 May 2010
29 April 2010
Scientific Opinion


This scientific opinion reports on an evaluation of a risk assessment for placing on the market the genetically modified insect resistant and herbicide tolerant maize Bt11xMIR604 for food and feed uses, import and processing. Conventional crossing methods were used in the production of maize Bt11xMIR604 from lines of the respective single maize events. The structure of the inserts in the single maize events as well as the phenotypes were both retained in the stacked maize events. The expression levels of the Cry1Ab, PAT, mCry3A and PMI proteins in maize Bt11xMIR604 were demonstrated to be comparable with those of the respective single maize events. The comparative analysis of compositional, phenotypic and agronomic characteristics indicated equivalence of maize Bt11xMIR604 with its conventional counterpart, except for the newly expressed proteins, which provided resistance to certain lepidopteran and coleopteran target pests and tolerance to glufosinate-ammonium herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize Bt11xMIR604. Considering the intended uses of maize Bt11xMIR604, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize Bt11xMIR604 was required. In case of accidental release of viable maize Bt11xMIR604 grains into the environment during transportation and processing, there are no indications of increased likelihood of establishment or survival of feral maize plants except in the presence of glufosinate- ammonium herbicides. It is highly unlikely that the recombinant DNA will transfer and establish in the genome of bacteria in the environment or human and animal digestive tracts. In conclusion, the EFSA GMO Panel considers that the information available for maize Bt11xMIR604 addresses the scientific comments raised by Member States and that the maize Bt11xMIR604, assessed in this application, is as safe as its conventional counterpart and other appropriate comparators with respect to potential effects on human and animal health and the environment, in the context of its intended uses. The EFSA GMO Panel concludes that maize Bt11xMIR604 is unlikely to have an adverse effect on human and animal health and on the environment, in the context of its intended uses.

Panel members at the time of adoption

Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal.
Panel on Genetically Modified Organisms
gmo [at]
EFSA journal 2010; 8(5):1614
Question Number
On request from
Competent Authority of The United Kingdom for an application (EFSA-GMO-UK-2007-50) submitted by Syngenta Seeds