Soybean DAS-68416-4 was developed by Agrobacterium tumefaciens-mediated transformation to express the aryloxyalkanoate dioxygenase-12 (AAD-12) protein, conferring tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, and the phosphinothricin acetyltransferase (PAT) protein, conferring tolerance to glufosinate ammonium-based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between soybean DAS-68416-4 and its conventional counterpart, except for ‘days to 50% flowering’. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 36%) in lectin activity in soybean DAS-68416-4. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition for soybean DAS-68416-4 as compared to its conventional counterpart and the non-GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the two newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS-68416-4. Soybean DAS-68416-4 is as nutritious as its conventional counterpart and the non-GM reference varieties. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS-68416-4 plants, unless these are exposed to the intended herbicides. The likelihood of environmental effects resulting from the accidental release of viable seeds from soybean DAS-68416-4 into the environment is therefore very low. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS-68416-4. The GMO Panel concludes that the information available addresses the scientific comments of the Member States and that soybean DAS-68416-4, as described in this application, is as safe as its conventional counterpart and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.
EFSA Journal 2017;15(3):4719 [31 pp.].
EFSA Panel on EFSA Panel on Genetically Modified Organisms (GMO)
Panel members at the time of adoption:
Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Mikołaj Antoni Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, Elsa Ebbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli and Jean-Michel Wal.
In line with EFSA’s policy on declarations of interest, Panel member Philippe Guerche did not participate in the development and adoption of this scientific opinion.
Opinion of the Scientific Committee/Scientific Panel
On request from:
Competent Authority of the Netherlands
26 January 2017
First published in the EFSA Journal:
16 March 2017
European Food Safety Authority (EFSA), Parma, Italy
GMO, soybean (Glycine max), DAS-68416-4, herbicide tolerance, AAD-12, PAT, Regulation (EC) No 1829/2003