Assessment of genetically modified soybean GMB151 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐153)

• Published in: EFSA journal 2021-04, Vol.19 (4), p.e06424-n/a
• Main Authors: Naegeli, Hanspeter, Bresson, Jean Louis, 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, Fernandez, Antonio, Gennaro, Andrea, Gómez Ruiz, Jose Ángel, Kagkli, Dafni Maria, Lanzoni, Anna, Neri, Franco Maria, Papadopoulou, Nikoletta, Paraskevopoulos, Konstantinos, Raffaello, Tommaso, Streissl, Franz, De Sanctis, Giacomo
• Format: Article
• Language: English
• Subjects: Accidental release; Allergenicity; Animal health; Biotechnology; Carbohydrates; Cry14Ab‐1; Environmental monitoring; Food; Food consumption; Food safety; Genetic modification; Genetically modified organisms; GMB151; GMO; Herbicide resistance; Herbicides; HPPD‐4; Hydroxyphenylpyruvate dioxygenase; import and processing; Life Sciences; Nematodes; Palmitic acid; Proteins; Regulation (EC) 1829/2003; Risk assessment; Safety; Scientific Opinion; Seeds; soybean (Glycine max); Soybeans; Systematic review; Toxicity; Vegetal Biology
• ISSN: 1831-4732; 1831-4732; 2314-9396
• DOI: 10.2903/j.efsa.2021.6424

Soybean GMB151 was developed to confer tolerance to 4‐hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor herbicides and resistance to nematodes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between soybean GMB151 and its conventional counterpart needs further assessment, except for palmitic acid and heptadecenoic acid in seeds and carbohydrate and crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the HPPD‐4 and Cry14Ab‐1 proteins as expressed in soybean GMB151, and finds no evidence that the genetic modification would change the overall allergenicity of soybean GMB151. In the context of this application, the consumption of food and feed from soybean GMB151 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that soybean GMB151 is as safe as the conventional counterpart and non‐GM soybean reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean GMB151 seeds 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 soybean GMB151. The GMO Panel concludes that soybean GMB151 is as safe as its conventional counterpart and the tested non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment.