Parma, Italy
June 21, 2012
EFSA Journal 2012;10(6):2756 [27 pp.]. doi:10.2903/j.efsa.2012.2756
Type: Opinion of the Scientific Committee/Scientific Panel
On request from: Competent Authority of Germany on an application (EFSA-GMO-DE-2010-82) submitted by Syngenta
Question number: EFSA-Q-2010-00972
Adopted: 31 May 2012
Published: 21 June 2012
Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract
This scientific opinion reports an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect-resistant maize MIR162 for food and feed uses, import and processing. Maize MIR162 contains a single insert consisting of the vip3Aa20 and pmi expression cassettes. The Vip3Aa20 protein confers resistance against certain lepidopteran pests and phosphomannose isomerase (PMI) serves as a selection marker. Bioinformatic analyses of the inserted DNA and flanking regions do not raise safety concerns. The levels of Vip3Aa20 and PMI proteins in maize MIR162 have been sufficiently analysed. The stability of the genetic modification has been demonstrated. Comparative analyses established that there are no biologically relevant differences in the compositional, agronomic or phenotypic characteristics of maize MIR162 compared with its conventional counterpart, and its composition falls within the range of non-GM commercial varieties, except for the expression of the Vip3Aa20 and PMI proteins. The safety assessment identified no concerns regarding potential toxicity and allergenicity of Vip3Aa20 and PMI proteins or of maize MIR162. A feeding study on broiler chickens confirmed that grain produced by maize MIR162 is as nutritious as that produced by its conventional counterpart and a non-GM commercial variety. There are no indications of an increased likelihood of establishment and spread of feral maize plants. Considering its intended use as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize MIR162 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of maize MIR162. In conclusion, the EFSA GMO Panel considers that information available for maize MIR162 addresses scientific comments raised by Member States and that maize MIR162, as described in this application, is as safe as its conventional counterpart and non-GM commercial varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.
Summary
Following the submission of an application (EFSA-GMO-DE-2010-82) under Regulation (EC) No 1829/2003 from Syngenta, 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 genetically modified (GM) maize MIR162 (unique identifier SYN-IR162-4) for food and feed uses, import and processing.
In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-DE-2010-82, additional information supplied by the applicant, scientific comments submitted by European Union (EU) Member States and relevant scientific publications. The scope of the application EFSA-GMO-DE-2010-82 is for food and feed uses, and import and processing of maize MIR162 within the EU in the same way as any non-GM maize, but excludes cultivation in the EU. The EFSA GMO Panel evaluated maize MIR162 with reference to the intended uses and appropriate principles described in the guidance documents of the EFSA GMO Panel for the risk assessment of GM plants and derived food and feed (EFSA, 2006, 2011a). The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and expression of the corresponding proteins. An evaluation of the comparative analyses of composition, agronomic and phenotypic traits was undertaken, and the safety of the new proteins and of the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of environmental impacts and the post-market environmental monitoring plan was also undertaken.
The molecular characterisation data establish that the genetically modified maize MIR162 contains one copy of an intact vip3Aa20 expression cassette and a pmi cassette in a single locus. No other parts of the plasmid used for transformation are present in maize MIR162. The results of the bioinformatic analyses of the inserted DNA and the flanking regions do not raise safety concerns. The levels of Vip3Aa20 and PMI proteins in maize MIR162 have been sufficiently analysed and the stability of the genetic modification has been demonstrated.
The EFSA GMO Panel compared the composition and phenotypic and agronomic characteristics of maize MIR162 with those of its conventional counterpart and assessed all statistically significant differences identified. The Panel came to the conclusion that there are no biologically relevant differences in the composition or agronomic or phenotypic characteristics of maize MIR162 compared with its conventional counterpart, and that the composition falls within the range of non-GM commercial varieties, except for the expression of the Vip3Aa20 and PMI proteins. The safety assessment of the newly expressed proteins and the whole crop included an analysis of data from analytical and bioinformatics studies, as well as in vitro and in vivo studies. The Panel concluded that maize MIR162 is as safe as its conventional counterpart and that the overall allergenicity of the whole plant is not changed. A feeding study with broiler chickens confirmed that grain produced by maize MIR162 is as nutritious as that produced by its conventional counterpart and a non-GM commercial variety. In conclusion, the EFSA GMO Panel is of the opinion that maize MIR162 is as safe and as nutritious as its conventional counterpart and non-GM commercial varieties, and concludes that this maize and derived products are unlikely to have adverse effects on human and animal health, in the context of its intended uses.
The application EFSA-GMO-DE-2010-82 concerns food and feed uses, import and processing. Therefore, there is no requirement for scientific information on possible environmental effects associated with the cultivation of maize MIR162. 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 MIR162 grains during transport and processing for food and feed uses. Considering its intended use as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize MIR162 to bacteria have not been identified. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of maize MIR162. 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 MIR162 addresses scientific issues indicated by the guidance documents of the EFSA GMO Panel and the scientific comments raised by the Member States, and that the maize MIR162, as described in this application, is as safe as its conventional counterpart and non-GM commercial varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.
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