Abstract
This Scientific Opinion reports on an evaluation of a risk assessment for placing on the market of genetically modified maize GA21 for food and feed uses, import, processing and cultivation. Maize GA21 was developed through particle bombardment and contains a single insertion locus consisting of modified maize epsps (mepsps) gene, conferring tolerance to glyphosate-based herbicides. Bioinformatic analyses and levels of the mEPSPS protein were considered sufficient. The comparative analysis of compositional, agronomic and phenotypic characteristics indicated that maize GA21 is not different from the conventional counterpart and its composition fell within the range observed among non-GM maize varieties, except for the presence of the mEPSPS protein in maize GA21. The safety assessment of maize GA21 identified no concerns regarding potential toxicity and allergenicity. A feeding study with broiler chickens confirmed that maize GA21 is as nutritious as its conventional counterpart. The EFSA GMO Panel considers that maize GA21 is unlikely to raise additional environmental safety concerns compared to conventional maize, but that its cultivation management could result in environmental harm under certain conditions. The EFSA GMO Panel therefore recommends managing the use of glyphosate on maize GA21 within diversified cropping regimes that have similar or reduced environmental impacts compared with conventional maize cultivation. The EFSA GMO Panel recommends the deployment of case-specific monitoring to address (1) changes in botanical diversity within fields due to novel herbicide regimes, and (2) resistance evolution to glyphosate in weeds due to novel herbicide regimes. The EFSA GMO Panel agrees with the general surveillance plan of the applicant, but requests that its proposals to strengthen general surveillance are implemented. The EFSA GMO Panel concludes that the information available for maize GA21 addresses the scientific comments raised by Member States and that maize GA21, as described in this application, is as safe as its conventional counterpart and commercial maize varieties with respect to potential adverse effects on human and animal health. If subjected to appropriate management measures, the cultivation management of maize GA21 is unlikely to raise safety concerns for the environment.