Thursday, September 24, 2009

In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-UK-2007-49, additional information provided by the applicant and scientific comments submitted by the Member States. Further information from applications for placing the single maize events Bt11 and GA21 on the market under EU regulatory procedures was taken into account, where appropriate. The scope of application EFSA-GMO-UK-2007-49 is for food and feed uses, import and processing of maize Bt11xGA21 and all derived products, but excludes cultivation in the European Union (EU). The EFSA GMO Panel evaluated maize Bt11xGA21 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 (EFSA, 2006a) and for the risk assessment of GM plants containing stacked transformation events (EFSA, 2007a). The scientific risk assessment evaluation 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 Bt11xGA21 has been produced by crosses between maize inbred lines containing the single events Bt11 and GA21 to combine the resistance trait against certain lepidopteran target pests and tolerance to glufosinate-ammonium-based herbicides in maize Bt11 with tolerance to glyphosate-based herbicides in maize GA21. These single maize events have been the subject of earlier risk assessment evaluations by the EFSA GMO Panel. No new genetic modifications were introduced in maize Bt11xGA21.

Molecular analysis of the DNA present in maize Bt11xGA21 confirmed that both maize Bt11 and GA21 inserts are present and that their structures are retained. With regard to protein expression for Cry1Ab and PAT, the overall protein levels were generally similar between maize Bt11xGA21 and Bt11. For the mEPSPS protein, the overall concentrations were also generally similar between maize Bt11xGA21 and GA21. The proteins Cry1Ab, PAT and mEPSPS have been evaluated previously and no safety concerns were identified. The EFSA GMO Panel found no evidence of any interactions between the newly expressed Cry1Ab, PAT and mEPSPS proteins.

The results of the compositional analysis of grain and forage material of maize Bt11xGA21, collected at field trials in the United States (US), indicated that, with the exception of the newly expressed proteins, maize Bt11xGA21 is compositionally and agronomically equivalent to its non-GM maize counterpart and conventional maize. Based on the comprehensive data available, including responses of the applicant to questions posed by the EFSA GMO Panel, the Panel concluded that there was no indication that crossing maize Bt11 with maize GA21 results in an interaction between the newly expressed proteins affecting composition and agronomic characteristics. Furthermore, the nutritional properties of maize Bt11xGA21 do not differ from those of its non-GM maize counterpart, whilst the overall allergenicity of the whole plant is not changed.

The application EFSA-GMO-UK-2007-49 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 Bt11xGA21. 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 Bt11xGA21 grains during transportation and processing for food and feed uses. Taking into account the scope of the application, both the rare occurrence of feral maize plants and the low levels of exposure through other routes indicate that the risk to target and non-target organisms is extremely low. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of maize Bt11xGA21. Furthermore, the EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the general surveillance plan.

In conclusion, the EFSA GMO Panel considers that the information available for maize Bt11xGA21 addresses the scientific comments raised by the Member States and that maize Bt11xGA21 is as safe as its non-GM maize counterpart with respect to effects on human and animal health and the environment. Therefore, the EFSA GMO Panel concludes that maize Bt11xGA21 is unlikely to have any adverse effect on human and animal health or on the environment in the context of its intended uses.

Opinion