Following the submission of application EFSA-GMO-NL-2010-80 under Regulation (EC) No 1829/2003 from Monsanto, 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 herbicide-tolerant genetically modified (GM) maize NK603 × T25 (Unique Identifier MONØØ6Ø3-6 × ACS-ZMØØ3-2). The scope of application EFSA-GMO-NL-2010-80 is for food and feed uses, import and processing, but excludes cultivation within the European Union (EU).
The single maize events NK603 (expressing CP4 EPSPS) and T25 (expressing PAT) were assessed previously and no concerns were identified for human and animal health or environmental safety. No safety issue has been identified by updated bioinformatic analyses, or reported by the applicant, concerning the two single events since the publication of those scientific opinions. Consequently, the EFSA GMO Panel considers that its previous conclusions on the safety of the single maize events remain valid.
The two-event stack maize NK603 × T25 was produced by conventional crossing to produce maize tolerant to glyphosate- and glufosinate-ammonium-based herbicides. The EFSA GMO Panel evaluated maize NK603 × T25 with reference to the scope and appropriate principles described in its guidelines for the risk assessment of genetically modified (GM) plants and derived food and feed, the environmental risk assessment of GM plants and the post-market environmental monitoring of GM plants. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins. An evaluation of the comparative analyses of the compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expressed 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. In accordance with the EFSA GMO Panel guidance documents applicable to this application (EFSA, 2006, 2007), “Where all single events have been assessed, the risk assessment of stacked events should focus mainly on issues related to a) stability, b) expression of the events and c) potential interactions between the events”. Additional information received after May 2011 was assessed according to 2011 guidance (EFSA GMO Panel, 2011a).
The molecular data establish that the transformation events stacked in maize NK603 × T25 have the same molecular properties and characteristics as the single transformation events. Comparison of the levels of the CP4 EPSPS and PAT proteins between the stack and the corresponding single events did not reveal an interaction that manifests at protein or trait expression level. From the molecular characterisation, no indications of interactions between the events based on the biological functions of the newly expressed proteins were identified.
Based on the agronomic and phenotypic characteristics of maize NK603 × T25 under the tested conditions (not treated with the intended herbicide), some differences were observed in maize NK603 × T25 compared with its conventional counterpart. None of the significant differences observed needed further assessment for its potential environmental impact. Similarly, the EFSA GMO Panel concluded that none of the differences identified in the agronomic and phenotypic characteristics and in the composition of grain and forage obtained from maize NK603 × T25 needed further assessment regarding food and feed safety.
The safety assessment identified no concerns regarding the potential toxicity of the newly expressed proteins CP4 EPSPS and PAT in maize NK603 × T25. The EFSA GMO Panel found no reason to suggest that the presence of the two proteins in combination would result in interactions producing effects different from those of the individual proteins. Similarly, no indications of safety concerns were identified regarding allergenicity of the individual newly expressed proteins or their mixture in maize NK603 × T25, or regarding potential changes in its overall allergenicity. Maize NK603 × T25 is as nutritious as non-GM conventional maize varieties.
Considering the scope of application EFSA-GMO-NL-2010-80, there is no requirement for scientific information on possible environmental effects associated with the cultivation of maize NK603 × T25 in Europe. There are no indications of an increased likelihood of establishment and spread of feral maize NK603 × T25 plants in the event of accidental release into the environment of viable GM maize seeds. Potential interactions of maize NK603 × T25 with the biotic and abiotic environment were not considered to be a relevant issue by the EFSA GMO Panel. The unlikely but theoretically possible transfer of the recombinant genes from maize NK603 × T25 to environmental bacteria does not give rise to safety concerns owing to the lack of a selective advantage in the context of the scope of this application. The post-market environmental monitoring plan provided by the applicant and the reporting intervals are in line with the scope of application EFSA-GMO- NL-2010-80.
In delivering its scientific opinion, the EFSA GMO Panel took into account application EFSA-GMO- NL-2010-80, additional information provided by the applicant, scientific comments submitted by the Member States and relevant scientific publications. In conclusion, the EFSA GMO Panel is of the opinion that the two-event stack maize NK603 × T25, as described in this application, is as safe as its non-GM comparator and non-GM conventional maize varieties with respect to potential effects on human and animal health and the environment in the context of its scope.