Open AccessScientific Opinion on an application by Dow AgroSciences (EFSA‐GMO‐NL‐2013‐116) for placing on the market of genetically modified insect‐resistant soybean DAS‐81419‐2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
Author(s) -
Naegeli Hanspeter,
Birch Andrew Nicholas,
Casacuberta Josep,
De Schrijver Adinda,
Gralak Mikołaj Antoni,
Guerche Philippe,
Jones Huw,
Manachini Barbara,
Messéan Antoine,
Nielsen Elsa Ebbesen,
Nogué Fabien,
Robaglia Christophe,
Rostoks Nils,
Sweet Jeremy,
Tebbe Christoph,
Visioli Francesco,
Wal JeanMichel,
Divéki Zoltán,
FernándezDumont Antonio,
Gennaro Andrea,
Lanzoni Anna,
Maria Neri Franco,
Paraskevopoulos Konstantinos
Publication year - 2016
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2016.4642
Subject(s) - cry1ac , biology , microbiology and biotechnology , genetically modified crops , genetically modified organism , abiotic component , glufosinate , agronomy , glyphosate , transgene , gene , ecology , genetics
Soybean DAS‐81419‐2 was developed by Agrobacterium tumefaciens ‐mediated transformation. It expresses the Cry1F and Cry1Ac proteins to confer resistance to certain lepidopteran species and the PAT protein that confers tolerance to glufosinate ammonium‐based herbicides and that was used as a selectable marker gene. The molecular characterisation of soybean DAS‐81419‐2 did not give rise to safety issues. The agronomic, phenotypic and compositional characteristics of soybean DAS‐81419‐2 tested under field conditions revealed no relevant differences between soybean DAS‐81419‐2 and its conventional counterpart that would give rise to any food and feed or environmental safety concerns. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry1Ac and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS‐81419‐2. The nutritional value of soybean DAS‐81419‐2 is not expected to differ from that of non‐GM soybean varieties and no post‐market monitoring of food/feed is considered necessary. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS‐81419‐2 plants, unless these plants are exposed to glufosinate ammonium‐based herbicides or infested by insect pests that are susceptible to the Cry1F and Cry1Ac proteins. This will not result in different environmental impacts compared to conventional soybean. 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 DAS‐81419‐2 to bacteria have not been identified. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS‐81419‐2. The GMO Panel concludes that the soybean DAS‐81419‐2 is as safe and as nutritious as its conventional counterpart and the tested non‐GM reference varieties in the context of its scope.