Scientific Opinion on an application (EFSA-GMO-BE-2011-98) for the placing on the market of herbicide-tolerant genetically modified soybean FG72 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience.

Soybean FG72 was developed by biolistic transformation to express the HPPD W336 and 2mEPSPS proteins, which confer tolerance to isoxaflutole- and glyphosate-based herbicides. The molecular characterisation of soybean FG72 did not give rise to safety issues. The agronomic and phenotypic characteristics of soybean FG72 tested under field conditions revealed no biologically relevant differences between soybean FG72 and its conventional counterpart that would give rise to any food and feed or environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins HPPD W336 and 2mEPSPS, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean FG72. The nutritional characteristics of soybean FG72 is not expected to differ from that of non-GM soybean varieties. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering the scope of this application, 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 soybean FG72 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application. In conclusion, the EFSA GMO Panel considers that the information available for soybean FG72 addresses the scientific comments raised by Member States and that soybean FG72, as described in this application, is as safe as its conventional counterpart and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.