Scientific Opinion on application (EFSA-GMO-UK-2007-48) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MIR604 x GA21 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from

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Article
EFSA Journal 2010; 8(5):1611 [30 pp.].
doi
10.2903/j.efsa.2010.1611
EFSA Panel on Genetically Modified Organisms (GMO)
Panel Members
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 Poeting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal.
Acknowledgement

The GMO Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food/Feed and Environment for the preparation of this opinion and EFSA’s staff members Yann Devos, Zoltán Divéki and Ellen Van Haver for the support provided to this EFSA scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
Competent Authority of the United Kingdom for application (EFSA-GMO-UK-2007-48) submitted by Syngenta Seeds
Question Number
EFSA-Q-2007-196
Adopted
29 April 2010
Published
18 May 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (328.09 KB)328.09 KB
Abstract

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 MIR604 x GA21 for food and feed uses, import and processing. Conventional crossing methods were used in the production of maize 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 mCry3A, PMI and mEPSPS proteins in maize 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 MIR604 x GA21 with its conventional counterpart, except for the newly expressed proteins which provided resistance to certain coleopteran target pests and tolerance to glyphosate-based herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MIR604 x GA21. Considering the intended uses of maize MIR604 x GA21, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize MIR604 x GA21 was required. In case of accidental release of viable maize 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 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 information available for maize MIR604 x GA21 addresses the scientific comments raised by Member States, and that the maize 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 MIR604 x GA21 is unlikely to have an adverse effect on human and animal health and environment in the context of its intended uses.

Summary

Following the submission of an application (Reference EFSA-GMO-UK-2007-48) 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 MIR604 x GA21 (Unique Identifier SYN-IR6Ø4-5 x MON-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-2007-48, 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 Bt11 x MIR604 x GA21 on the market under EU regulatory procedures was taken into account. The scope of application EFSA-GMO-UK-2007-48 is for food and feed uses, import and processing of maize MIR604 x GA21 and all derived products, but excludes cultivation in the EU. The EFSA GMO Panel evaluated maize 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 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 MIR604 x GA21 has been produced by conventional crossing methods between lines containing the single maize events MIR604 and GA21 to combine both the resistance trait against certain coleopteran target pests and the ability to use mannose as sole carbon source in maize MIR604 with tolerance to glyphosate-based herbicides in maize GA21. These single maize events have been the subject of separate risk assessment evaluations by the EFSA GMO Panel. No new genetic modifications were introduced in maize MIR604 x GA21.

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

The comparative agronomic analysis showed that maize MIR604 x GA21 was agronomically equivalent to its conventional counterpart, except for the new traits. The comparative assessment of maize MIR604 x GA21 was based on the compositional analysis of forage and grain derived from maize Bt11 x MIR604 x GA21 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 Bt11 x MIR604 x GA21 for the comparative compositional analysis and concludes that forage and grain from maize MIR604 x GA21 are likely to be compositionally equivalent to those of its conventional counterpart, except for the presence of the newly expressed proteins.

The mCry3A and PMI proteins expressed in maize MIR604 and the mEPSPS protein expressed in maize GA21 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 MIR604 x GA21, 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 MIR604 x GA21. 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 MIR604 x GA21 has been altered.

The EFSA GMO Panel concludes that the maize MIR604 x GA21 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-2007-48 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 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 MIR604 x GA21 grains during transportation and processing, except in the presence of 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 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 MIR604 x GA21 addresses the scientific comments raised by Member States and concludes that the maize 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 MIR604 and GA21 results in no interaction between the single maize events, which would affect the safety of maize 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 MIR604 x GA21 is unlikely to have an adverse effect on human and animal health and on the environment, in the context of its intended uses.
 

Keywords
GMO, maize (Zea mays), MIR604 x GA21, insect resistance, herbicide tolerance, stacked events, risk assessment, food and feed safety, environmental safety, food and feed uses, import, processing, Regulation (EC) No 1829/2003
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Number of Pages
30