Following the submission of an application (Reference EFSA-GMO-UK-2007-50) under Regulation (EC) No 1829/2003 from Syngenta Seeds, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on the safety of insect resistant and herbicide tolerant genetically modified maize Bt11xMIR604 (Unique Identifier SYNBTØ11-1xSYN-IR6Ø4-5) for food and feed uses, import and processing.
In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-UK-2007-50, additional information provided by the applicant and scientific comments submitted by Member States. Further information from applications for placing the single maize events Bt11, MIR604 and GA21, as well as the stacked maize events Bt11xMIR604 x GA21 on the market under EU regulatory procedures was taken into account. The scope of application EFSA-GMO-UK-2007-50 is for food and feed uses, import and processing of maize Bt11xMIR604 and all derived products, but excludes cultivation in the EU. The EFSA GMO Panel evaluated maize Bt11xMIR604 with reference to the intended uses and appropriate principles described in the EFSA GMO Panel Guidance Documents for the risk assessment of GM plants and derived food and feed and for the risk assessment of GM plants containing stacked transformation events. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and expression of target proteins. A comparative analysis of agronomic traits and composition was undertaken and the safety of the new proteins as individual proteins and in combination and the whole food/feed were evaluated with respect to potential toxicity, allergenicity and nutritional quality. An evaluation of environmental impacts and the post-market environmental monitoring plan was undertaken.
Maize Bt11xMIR604 has been produced by conventional crossing methods between lines containing the single maize events Bt11 and MIR604 to combine both the lepidopteran resistance trait and tolerance to glufosinate-ammonium herbicides in maize Bt11 with the coleopteran resistance trait and the ability to use mannose as sole carbon source in maize MIR604. These single maize events have been the subject of separate evaluations by the EFSA GMO Panel. No new genetic modifications were introduced in maize Bt11xMIR604.
Molecular analysis of the DNA present in maize Bt11xMIR604 confirmed that maize Bt11 and MIR604 inserts are present and that their structures are retained. The expression levels of the Cry1Ab, PAT, mCry3A and PMI proteins in maize Bt11xMIR604 were comparable to those of respective single maize events.
The comparative agronomic analysis showed that maize Bt11xMIR604 was agronomically equivalent to its conventional counterpart, except for the new traits. The comparative assessment of maize Bt11xMIR604 was based on the compositional analysis of forage and grain derived from maize Bt11xMIR604xGA21 which is in accordance with the EFSA GMO Panel’s guidance document on GM plants containing stacked transformation events. Based on all data available, and in this specific case, the EFSA GMO Panel accepts the use of maize Bt11xMIR604xGA21 for the comparative compositional analysis and concludes that forage and grain from maize Bt11xMIR604 are likely to be compositionally equivalent to those of its conventional counterpart, except for the presence of the newly expressed proteins.
The Cry1Ab and PAT proteins in maize Bt11 and mCry3A and PMI proteins expressed in maize MIR604 have been assessed previously as described in the scientific opinions of the EFSA GMO Panel on the single maize events, and no safety concerns have been identified. Regarding the safety and nutritional properties of whole food and feed products derived from maize Bt11xMIR604, the EFSA GMO Panel considers it unlikely that interactions among the single maize events will occur that may impact on the food and feed safety and the nutritional properties of maize Bt11xMIR604. The EFSA GMO Panel bases this consideration on the known functional characteristics of the newly expressed proteins and on the outcomes of the comparative analysis of compositional, phenotypic and agronomic characteristics. In addition, the EFSA GMO Panel considers it unlikely that the overall allergenicity of maize Bt11xMIR604 has been altered.
The EFSA GMO Panel concludes that the maize Bt11xMIR604 assessed in this application is as safe and nutritious as its conventional counterpart in the context of its intended uses.
The application EFSA-GMO-UK-2007-50 concerns food and feed uses, import and processing, but excludes cultivation in the EU. Therefore, there is no requirement for scientific assessment of possible environmental effects associated with the cultivation of maize Bt11xMIR604. There are no indications of an increased likelihood of establishment and spread of feral maize plants in case of accidental release into the environment of viable maize Bt11xMIR604 grains during transportation and processing, except in the presence of glufosinate ammonium herbicides. Taking into account the scope of the application, the rare occurrence of feral maize plants and the low levels of exposure through other routes, the risk to non-target organisms is considered to be extremely low. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of maize Bt11xMIR604. Furthermore, the EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the general surveillance plan.
The EFSA GMO Panel considers that the information available for maize Bt11xMIR604 addresses the scientific comments raised by the Member States, and concludes that the maize Bt11xMIR604, assessed in this application, is as safe as its conventional counterpart and other appropriate comparators. In addition, the EFSA GMO Panel is of the opinion that crossing of maize Bt11 and MIR604 results in no interactions between the single maize events which would affect the safety of maize Bt11xMIR604 with respect to potential effects on human and animal health, and on the environment in the context of its intended uses. The EFSA GMO Panel concludes that maize event Bt11xMIR604 is unlikely to have an adverse effect on human and animal health and the environment, in the context of its intended uses.