EFSA Journal (Jun 2013)
Scientific Opinion on application (EFSA-GMO-UK-2006-34) for the placing on the market of genetically modified maize 3272 with a thermotolerant alpha-amylase, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG
Abstract
Maize 3272 contains a single insert consisting of the amy797E and the pmi cassettes, expressing a thermotolerant alpha-amylase (AMY797E) and a phosphamannose isomerase (PMI). Bioinformatic analyses and genetic stability studies did not raise safety issues. The levels of the AMY797E and PMI proteins in maize 3272 have been sufficiently analysed. In the absence of an appropriately performed comparative assessment, the EFSA Panel on Genetically Modified Organisms (GMO) was not in the position to conclude either on the compositional, agronomic and phenotypic characteristics of maize 3272 or on its nutritional assessment, on the basis of the data provided. The safety assessment could therefore not be completed, and has focused mainly on the newly expressed proteins. No indications of safety concern over the toxicity of the AMY797E and PMI proteins and over the allergenicity of the PMI protein were identified. The Panel could not conclude on the potential for de novo allergic sensitisation of the AMY797E protein. The Panel has identified a gap in the data on the agronomic and phenotypic characterisation of GM maize 3272 and considers that uncertainty over these characteristics remains. However, considering the scope of this application, a weight of evidence approach from different sources of available data and the poor ability of maize to survive outside cultivated land, the Panel concluded that there is very little likelihood of any adverse environmental impacts due to the accidental release into the environment of viable grains from maize 3272. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with a theoretically possible horizontal gene transfer from maize 3272 to prokaryotes have been analysed and did not raise safety concerns. The monitoring plan and reporting intervals were in line with the intended uses of maize 3272.
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