Open AccessScientific Opinion on application EFSA ‐ GMO ‐ NL ‐2016‐132 for authorisation of genetically modified of insect‐resistant and herbicide‐tolerant soybean DAS –81419–2 × DAS –44406–6 for food and feed uses, import and processing submitted in accordance with Regulation ( EC ) No 1829/2003 by Dow Agrosciences LCC
Author(s) -
Naegeli Hanspeter,
Bresson JeanLouis,
Dalmay Tamas,
Dewhurst Ian Crawford,
Epstein Michelle M,
Firbank Leslie George,
Guerche Philippe,
Hejatko Jan,
Moreno Francisco Javier,
Mullins Ewen,
Nogué Fabien,
Rostoks Nils,
Sánchez Serrano Jose Juan,
Savoini Giovanni,
Veromann Eve,
Veronesi Fabio,
Álvarez Fernando,
Ardizzone Michele,
De Sanctis Giacomo,
Devos Yann,
Dumont Antonio Fernandez,
Federici Silvia,
Gennaro Andrea,
Gómez Ruiz Jose Ángel,
Lanzoni Anna,
Neri Franco Maria,
Papadopoulou Nikoletta,
Paraskevopoulos Konstantinos,
Raffaello Tommaso
Publication year - 2020
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.2020.6302
Subject(s) - genetically modified organism , microbiology and biotechnology , food safety , glyphosate , genetically modified crops , biology , animal health , food science , transgene , zoology , biochemistry , gene
Abstract Soybean DAS –8419–2 × DAS –44406–6 was developed to provide protection against certain lepidopteran pests and tolerance to 2,4–dichlorophenoxyacetic acid and other related phenoxy herbicides, and glyphosate‐ and glufosinate ammonium‐containing herbicides. The Genetically Modified Organisms ( GMO ) Panel previously assessed the two single soybean events and did not identify safety concerns. No new data on the single soybean events, leading to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the two‐event stack soybean does not give rise to food and feed safety and nutritional concerns. In the case of accidental release of viable DAS –8419–2 × DAS –44406–6 seeds into the environment, soybean DAS –8419–2 × DAS –44406–6 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS –8419–2 × DAS –44406–6. In conclusion, the GMO Panel considers that soybean DAS –8419–2 × DAS –44406–6, as described in this application, is as safe as its conventional counterpart and the non‐genetically modified soybean reference varieties tested with respect to potential effects on human and animal health and the environment.