Scientific Opinion on application (Reference EFSA-GMO-UK-2008-56) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize Bt11 x MIR604 x GA21 , for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds

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 Bt11 x MIR604 x GA21 for food and feed uses, import and processing. Conventional crossing methods were used in the production of maize Bt11 x MIR604 x GA21 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, PMI and mEPSPS proteins in maize Bt11 x MIR604 x GA21 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 Bt11 x MIR604 x GA21 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- and/or glyphosate-based herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize Bt11 x MIR604 x GA21. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to its conventional counterpart and a commercial non-GM maize variety. Considering the intended uses of maize Bt11 x MIR604 x GA21, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize Bt11 x MIR604 x GA21 was required. In case of accidental release of viable maize Bt11 x MIR604 x GA21 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 the glufosinate-ammonium- and/or glyphosate-based 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 Bt11 x MIR604 x GA21 addresses the scientific comments raised by Member States and that the maize Bt11 x MIR604 x GA21, as 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 Bt11 x MIR604 x GA21 is unlikely to have an adverse effect on human and animal health and the environment, in the context of its intended uses. 

© European Food Safety Authority, 2010

Following the submission of an application (Reference EFSA-GMO-UK-2008-56) 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 (GM) maize Bt11 x MIR604 x GA21 (Unique Identifier SYNBTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9) for food and feed uses, import and processing.

In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-UK-2008-56, 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 MIR604 x GA21, Bt11 x GA21 and Bt11 x MIR604 on the market under EU regulatory procedures was taken into account. The scope of application EFSA-GMO-UK-2008-56 is for food and feed uses, import and processing of maize Bt11 x MIR604 x GA21 and all derived products, but excludes cultivation in the EU. The EFSA GMO Panel evaluated maize Bt11 x MIR604 x GA21 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 new proteins, as individual proteins and in combination and the whole food/feed were evaluated with respect to toxicity, allergenicity and nutritional quality. An evaluation of environmental impacts and the post-market environmental monitoring plan was undertaken.

Maize Bt11 x MIR604 x GA21 has been produced by conventional crossing methods between lines containing the single maize events Bt11, MIR604 and GA21 to combine 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 a sole carbon source in maize MIR604 and with the tolerance to glyphosate-based herbicides in maize GA21. These single maize events and the double stacked maize events MIR604 x GA21, Bt11 x GA21 and Bt11 x MIR604 have been the subject of separate assessments by the EFSA GMO Panel. No new genetic modifications were introduced in maize Bt11 x MIR604 x GA21.

Molecular analysis of the DNA inserts present in maize Bt11 x MIR604 x GA21 confirmed that maize Bt11, MIR604 and GA21 inserts are present and that their structures are retained. The expression levels of the Cry1Ab, PAT, mCry3A, PMI and mEPSPS proteins were comparable to those of the respective single maize events.

Based on the results of comparative analysis the EFSA GMO Panel concludes that maize Bt11 x MIR604 x GA21 is compositionally, phenotypically and agronomically equivalent to its conventional counterpart, except for the presence of Cry1Ab, PAT, mCry3A, PMI and mEPSPS proteins in maize Bt11 x MIR604 x GA21. Based on the assessment of data available, including the additional information provided by the applicant in response to the EFSA GMO Panel’s request for maize Bt11 x MIR604 x GA21, its conventional counterpart and for the single maize events, the EFSA GMO Panel is of the opinion that crossing of maize Bt11, MIR604 and GA21 results in no interactions between the single maize events which causes compositional or agronomic changes. The Cry1Ab and PAT expressed in maize Bt11, the Cry3A and PMI expressed in maize MIR604 and mEPSPS expressed in maize GA21 have been assessed previously and no safety concerns were identified. Given all the information provided, the EFSA GMO Panel concludes that interactions between the single maize events that might impact on food and feed safety are unlikely and that the nutritional properties of Bt11 x MIR604 x GA21 maize would be no different from those of the conventional counterpart. The EFSA GMO Panel considers that it is unlikely that the overall allergenicity of the whole maize Bt11 x MIR604 x GA21 has been changed. The nutritional value of maize Bt11 x MIR604 x GA21 has been studied in a feeding study with broilers which confirmed that the nutritional properties of maize Bt11 x MIR604 x GA21 would be no different from those of its conventional counterpart and a commercial non-GM maize variety.

The application EFSA-GMO-UK-2008-56 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 Bt11 x MIR604 x GA21. 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 Bt11 x MIR604 x GA21 grains during transportation and processing, except in the presence of glufosinate-ammonium- and/or glyphosate-based 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 Bt11 x MIR604 x GA21. 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 Bt11 x MIR604 x GA21 addresses the scientific comments raised by Member States and concludes that the maize Bt11 x MIR604 x GA21 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, MIR604 and GA21 results in no interactions between the single maize events which would affect the safety of maize Bt11 x MIR604 x GA21 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 Bt11 x MIR604 x GA21is unlikely to have an adverse effect on human and animal health and on the environment, in the context of its intended uses.
 

GMO, maize (Zea mays), Bt11 x MIR604 x GA21, insect resistant, herbicide tolerant, stacked events, risk assessment, food and feed safety, environmental safety, food and feed uses, import, processing, Regulation (EC) No 1829/2003