Open AccessAssessment of genetically modified maize NK603 × T25 × DAS‐40278‐9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2019‐164)
Author(s) -
Mullins Ewen,
Bresson JeanLouis,
Dalmay Tamas,
Dewhurst Ian Crawford,
Epstein Michelle M,
Firbank Leslie George,
Guerche Philippe,
Hejatko Jan,
Naegeli Hanspeter,
Moreno Francisco Javier,
Nogué Fabien,
Rostoks Nils,
Sánchez Serrano Jose Juan,
Savoini Giovanni,
Veromann Eve,
Veronesi Fabio,
Ardizzone Michele,
De Sanctis Giacomo,
Fernandez Dumont Antonio,
Federici Silvia,
Gennaro Andrea,
Gomez Ruiz Jose Angel,
Kagkli Dafni Maria,
Lanzoni Anna,
Neri Franco Maria,
Papadopoulou Nikoletta,
Paraskevopoulos Konstantinos,
Raffaello Tommaso
Publication year - 2021
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.2021.6942
Subject(s) - genetically modified maize , zea mays , environmental safety , microbiology and biotechnology , biology , agronomy , event (particle physics) , genetically modified crops , transgene , medicine , biochemistry , human health , environmental health , gene , physics , quantum mechanics
Maize NK603 × T25 × DAS‐40278‐9 (three‐event stack maize) was produced by conventional crossing to combine three single events: NK603, T25 and DAS‐40278‐9. The GMO Panel previously assessed the three single maize events and two of the subcombinations and did not identify safety concerns. No new data on the single maize events or the two subcombinations were identified that could lead to modification of the original conclusions on their safety. 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 maize events and of the newly expressed proteins in the three‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the three‐event stack maize, as described in this application, is as safe as the non‐GM comparator and the selected non‐GM reference varieties. In the case of accidental release of viable grains of the three‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in one of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the three‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the three‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the three‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the selected non‐GM reference varieties with respect to potential effects on human and animal health and the environment.