Soybean DAS–8419–29DAS–44406–6 was developed to provide protection against certainlepidopteran pests and tolerance to 2,4–dichlorophenoxyacetic acid and other related phenoxyherbicides, and glyphosate- and glufosinate ammonium-containing herbicides. The Genetically ModifiedOrganisms (GMO) Panel previously assessed the two single soybean events and did not identify safetyconcerns. No new data on the single soybean events, leading to modification of the original conclusionson their safety have been identified. The molecular characterisation, comparative analysis (agronomic,phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity andnutritional assessment indicate that the combination of the single soybean events and of the newlyexpressed proteins in the two-event stack soybean does not give rise to food and feed safety andnutritional concerns. In the case of accidental release of viable DAS–8419–29DAS–44406–6 seeds intothe environment, soybean DAS–8419–29DAS–44406–6 would not raise environmental safetyconcerns. The post-market environmental monitoring plan and reporting intervals are in line with theintended uses of soybean DAS–8419–29DAS–44406–6. In conclusion, the GMO Panel considers thatsoybean DAS–8419–29DAS–44406–6, as described in this application, is as safe as its conventionalcounterpart and the non-genetically modified soybean reference varieties tested with respect topotential effects on human and animal health and the environmen
Scientific 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 / H. Naegeli, J. Bresson, T. Dalmay, I.C. Dewhurst, M.M. Epstein, L.G. Firbank, P. Guerche, J. Hejatko, F.J. Moreno, E. Mullins, F. Nogué, N. Rostoks, J.J. Sánchez Serrano, G. Savoini, E. Veromann, F. Veronesi, F. Álvarez, M. Ardizzone, G. De Sanctis, Y. Devos, A.F. Dumont, S. Federici, A. Gennaro, J.Á. Gómez Ruiz, A. Lanzoni, F.M. Neri, N. Papadopoulou, K. Paraskevopoulos, T. Raffaello. - In: EFSA JOURNAL. - ISSN 1831-4732. - 18:11(2020). [10.2903/j.efsa.2020.6302]
Scientific 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
G. Savoini;
2020
Abstract
Soybean DAS–8419–29DAS–44406–6 was developed to provide protection against certainlepidopteran pests and tolerance to 2,4–dichlorophenoxyacetic acid and other related phenoxyherbicides, and glyphosate- and glufosinate ammonium-containing herbicides. The Genetically ModifiedOrganisms (GMO) Panel previously assessed the two single soybean events and did not identify safetyconcerns. No new data on the single soybean events, leading to modification of the original conclusionson their safety have been identified. The molecular characterisation, comparative analysis (agronomic,phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity andnutritional assessment indicate that the combination of the single soybean events and of the newlyexpressed proteins in the two-event stack soybean does not give rise to food and feed safety andnutritional concerns. In the case of accidental release of viable DAS–8419–29DAS–44406–6 seeds intothe environment, soybean DAS–8419–29DAS–44406–6 would not raise environmental safetyconcerns. The post-market environmental monitoring plan and reporting intervals are in line with theintended uses of soybean DAS–8419–29DAS–44406–6. In conclusion, the GMO Panel considers thatsoybean DAS–8419–29DAS–44406–6, as described in this application, is as safe as its conventionalcounterpart and the non-genetically modified soybean reference varieties tested with respect topotential effects on human and animal health and the environmenFile | Dimensione | Formato | |
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