SUMMARYThis document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on Bt11 maize, genetically modified to provide protection against specific lepidopteran pests. The maize also contains a gene providing tolerance to the herbicide glufosinate.The opinion is based on a question raised by the Commission relating to an application for the placing on the market of Bt11 maize under Directive 2001/18/EC. The GMO Panel was asked to consider whether there is any scientific reason to believe that placing Bt11 maize on the market, for cultivation, import, processing and use as any other maize (excluding food uses), is likely to cause any adverse effects on human health and the environment (Notification C/F/96/05.10). The question followed a scientific assessment which was made initially by the Competent Authority of France and evaluated subsequently by all other Member States. An assessment of the Bt11 maize was requested by the Commission because of questions raised by several Member States following the evaluations at the national level. When this is the case, EU legislation requires that EFSA carries out a further assessment and provides an opinion.Bt11 maize has been previously evaluated (SCP, 1998a) and approved (EC, 1998) for import, processing and feed use under Directive 90/220/EEC. Bt11 maize has also been evaluated for cultivation under the same Directive (SCP, 2000). Food and food ingredients derived from Bt11 maize have been authorised (EC, 1999) pursuant to Article 5 of Regulation (EC) 258/97. Bt11 sweet maize has also been evaluated (SCF, 2002) and approved (EC, 2004c) for food consumption in the framework of Regulation (EC) 258/97 (EC, 1997).In delivering its opinion the Panel considered the application, additional information provided by the applicant and comments submitted by the Member States. Bt11 maize was assessed with reference to its intended use employing the appropriate principles as described in the 'Guidance Document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed' (EFSA, 2004a). The scientific assessment included examination of the DNA inserted into Bt11 maize and the nature and safety of the newly expressed proteins produced by the transgenic plants with respect to toxicology and allergenicity. Furthermore, a comparative analysis of agronomic traits and composition was undertaken and http://www.efsa.eu.int 2 the safety of the whole product was evaluated. A nutritional and an environmental assessment, including monitoring plan, were both undertaken.Bt11 maize has been developed for protection against specific lepidopteran pests such as the European corn borer (Ostrinia nubilalis) and Sesamia spp. Though the applicant considered that the pat gene for glufosinate ammonium tolerance was a marker gene and would only be used for that purpose, the Panel considered it likely that farmers would grow Bt11 maize with glufosin...