Open AccessScientific opinion on an application by Dow AgroSciences LLC ( EFSA ‐ GMO ‐ NL ‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS ‐44406‐6 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,
Jones Huw,
Manachini Barbara,
Messéan Antoine,
Nielsen Elsa Ebbesen,
Nogué Fabien,
Robaglia Christophe,
Rostoks Nils,
Sweet Jeremy,
Tebbe Christoph,
Visioli Francesco,
Wal JeanMichel,
Álvarez Fernando,
Ardizzone Michele,
Liu Yi,
Neri Franco Maria,
Ramon Matthew
Publication year - 2017
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.2017.4738
Subject(s) - glyphosate , biology , microbiology and biotechnology , genetically modified organism , genetically modified crops , phytophthora sojae , agronomy , horticulture , transgene , biochemistry , gene , phytophthora
Soybean DAS ‐44406‐6 expresses 5‐enolpyruvyl‐shikimate‐3‐phosphate synthase (2m EPSPS ), conferring tolerance to glyphosate‐based herbicides, aryloxyalkanoate dioxygenase ( AAD ‐12), conferring tolerance to 2,4‐dichlorophenoxyacetic acid (2,4‐D) and other related phenoxy herbicides, and phosphinothricin acetyl transferase ( PAT ), conferring tolerance to glufosinate ammonium‐based herbicides. 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 post‐market 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.