Assessment of genetically modified soybean MON 87708 × MON 89788 × A5547‐127, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐135)

• Published in: EFSA journal 2019-07, Vol.17 (7), p.e05733-n/a
• Main Authors: Naegeli, Hanspeter, Bresson, Jean‐Louis, Dalmay, Tamas, Dewhurst, Ian Crawford, Epstein, Michele, 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, Fernandez Dumont, Antonio, Papadopoulou, Nikoletta, Ardizzone, Michele, Devos, Yann, Gennaro, Andrea, Ruiz Gómez, Jose Ángel, Lanzoni, Anna, Neri, Franco Maria, Paraskevopoulos, Konstantinos, Raffaello, Tommaso, De Sanctis, Giacomo
• Format: Article
• Language: English
• Subjects: Accidental release; Allergenicity; Animal health; Comparative analysis; CP4 EPSPS; DMO; Environmental monitoring; Feeds; Food; Food safety; Genetic modification; Genetically modified organisms; GMO; Herbicides; import and processing; Life Sciences; MON 87708 × MON 89788 × A5547‐127; Nutrition assessment; PAT; Protein expression; Proteins; Regulation (EC) 1829/2003; Risk assessment; Safety; Scientific Opinion; Seeds; soybean (Glycine max); Soybeans
• ISSN: 1831-4732; 1831-4732; 2314-9396
• DOI: 10.2903/j.efsa.2019.5733

Soybean MON 87708 × MON 89788 × A5547‐127 (three‐event stack soybean) was produced by conventional crossing to combine three single events: MON 87708, MON 89788 and A5547‐127. The GMO Panel previously assessed the three single events and did not identify safety concerns. No new data on the single 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 three‐event stack soybean does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the three‐event stack soybean, as described in this application, is as safe as and nutritionally equivalent to its conventional counterpart and the non‐GM reference varieties tested. The nutritional impact of food/feed derived from the three‐event stack soybean is expected to be the same as that of food/feed derived from the conventional counterpart and non‐GM reference varieties. In the case of accidental release of viable seeds of the three‐event stack soybean into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the three‐event stack soybean. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the three‐event stack soybean 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.