The European Food Safety Authority (EFSA) cleared the safety of Dow AgroSciences’ Enlist E3 soybeans (event: DAS-44406-6) for food and feed uses, import and processing in its scientific opinion report.
Soybean DAS-44406-6 was developed by Agrobacterium tumefaciens
(also known as Rhizobium radiobacter
)-mediated transformation of cotyledonary nodes derived from germinated soybean (G. max) cv. Maverick seeds. It expresses the AAD-12, 2mEPSPS and PAT proteins, which confer tolerance to 2,4-D, glyphosate
-based and glufosinate ammonium-containing herbicides.
EFSA’s GMO Panel considers that the molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food/ feed safety.
The agronomic and phenotypic characteristics revealed no relevant differences between soybean DAS-44406-6 and its conventional counterpart, except for pod count, seed count and yield. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 31%) in lectin activity in soybean DAS-44406-6. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition of soybean DAS-44406-6 as compared to its conventional counterpart and non-GM reference varieties.
There were no concerns regarding the potential toxicity and allergenicity of the three newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS-44406-6. Soybean DAS-44406-6 is as nutritious as its conventional counterpart and the non-GM soybean reference varieties tested.
There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS-44406-6 plants, unless exposed to the intended herbicides. The likelihood of environmental effects from the accidental release of viable seeds from soybean DAS-44406-6 into the environment is therefore very low. The postmarket environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS-44406-6.
In conclusion, the GMO Panel considers that the information available for soybean DAS-44406-6 addresses the scientific comments raised by Member States and that soybean DAS-44406-6, 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.