EFSA gave positive opinion for GM maize from Monsanto

The European Food Safety Authority (EFSA) has given a positive safety assessment to the application EFSA-GMO-BE-2015-125 under Regulation (EC) No 1829/2003 from Monsanto.

The application from Monsanto is asking for authorisation of genetically modified (GM) maize (Zea mays L.) MON 87403 (unique identifier MON-874Ø3-1).The scope of the application EFSA-GMO-BE-2015-125 is for import, processing, and food and feed uses of maize MON 87403 within the European Union (EU), but excludes cultivation in the EU.

In delivering its scientific opinion, the GMO Panel took into account the application EFSA-GMO-BE-2015-125, additional information provided by the applicant, scientific comments submitted by the Member States and relevant scientific publications. The GMO Panel concludes that maize MON 87403, as described in this application, is as safe as its conventional counterpart and the tested non-GM maize reference varieties with respect to potential effects on human and animal health and the environment.

Maize MON 87403 was developed to increase ear biomass at early reproductive phase through the expression of a modified AtHB17 gene from Arabidopsis thaliana, encoding a plant transcription factor of the HD-Zip II family. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87403 and its conventional counterpart were identified. The compositional analysis of maize MON 87403 did not identify differences that require further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the AtHB17Δ113 protein, as expressed in maize MON 87403. The nutritional value of food and feed derived from maize MON 87403 is not expected to differ from that of food and feed derived from non-genetically modified (GM) maize varieties.

Based on the outcome of the studies considered in the comparative analysis and molecular characterisation, the GMO Panel concludes that maize MON 87403 is as safe and nutritious as the conventional counterpart and the non-GM maize reference varieties tested. In the case of accidental release of viable maize MON 87403 grains into the environment, maize MON 87403 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87403.

In conclusion, the GMO Panel considers that maize MON 87403, as described in this application, is as safe as its conventional counterpart and the tested non-GM maize reference varieties with respect to potential effects on human and animal health and the environment.