Following the submission of an application (EFSA-GMO-BE-2011-98) under Regulation (EC) No 1829/2003 from Bayer CropScience, 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) soybean (Glycine max L.) FG72 (Unique Identifier MST-FGØ72-2). The scope of application EFSA-GMO-BE-2011-98 is for import, processing, and food and feed uses of soybean FG72 within the European Union (EU), but it excludes cultivation in the EU.
The EFSA GMO Panel evaluated soybean FG72 with reference to the scope and appropriate principles described in its guidelines for the risk assessment of GM plants. The evaluation addressed the following components of the risk assessment: the molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins; the comparative analyses of compositional, agronomic and phenotypic characteristics; the safety of the newly expressed proteins and the whole food/feed with respect to potential toxicity, allergenicity and nutritional characteristics; and the environmental risk assessment and the post-market environmental monitoring plan.
Soybean FG72 was developed by biolistic transformation of callus cells. It expresses the HPPD W336 and 2mEPSPS proteins, which confer tolerance to isoxaflutole- and glyphosate-based herbicides. The molecular characterisation data established that soybean FG72 contains one functional insert consisting of two copies of the hppdPfW336 and 2mepsps expression cassettes, which confer the intended traits. There is also a second, non-functional insert, consisting of a non-coding plasmid fragment. Bioinformatic analyses and genetic stability studies were performed and the results did not give rise to safety issues. The levels of the newly expressed proteins present in soybean FG72 were obtained and reported adequately.
The agronomic, phenotypic and compositional characteristics of soybean FG72 were compared with those of the conventional counterpart under field conditions. Differences were noted in soybean FG72 for two agronomic endpoints (i.e. plant health and days to maturity), but they did not give rise to any food and feed or environmental safety concerns. No differences requiring further assessment with regard to safety by the EFSA GMO Panel were identified at analyses of compositional data of forage or grains obtained from soybean FG72.
The safety assessment of the newly expressed proteins and the whole food/feed was performed. No concerns were identified regarding the potential toxicity or allergenicity of the newly expressed 2mEPSPS and HPPD W336 proteins in soybean FG72. There was no evidence that the genetic modification might significantly change the overall allergenicity of soybean FG72. Based on the comparative analysis, the nutritional characteristics of food and feed derived from soybean FG72 is not expected to differ from that of food and feed derived from non-GM soybean varieties. The EFSA GMO Panel concluded that soybean FG72 is as safe and nutritious as its conventional counterpart and non-GM soybean reference varieties.
Application EFSA-GMO-BE-2011-98 covers the import, processing, and food and feed uses of soybean FG72, and excludes cultivation. Therefore there is no requirement for a scientific assessment of possible environmental effects associated with the cultivation of this GM soybean. The EFSA GMO Panel concluded that there are no indications of an increased likelihood of establishment and spread of feral soybean FG72 plants in case of accidental release into the environment of viable GM soybean seeds. Potential interactions with the biotic and abiotic environment were not considered to be an issue by the EFSA GMO Panel. Risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean FG72 to bacteria have not been identified. The PMEM plan provided by the applicant is in line with the scope of the application and the requirements of the EFSA GMO Panel for post-market environmental monitoring of GM plants. The EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the monitoring plan.
In delivering its scientific opinion, the EFSA GMO Panel took into account application EFSA-GMO-BE-2011-98, additional information provided by the applicant, scientific comments submitted by the Member States and relevant scientific publications. 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.