Open AccessAssessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)
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,
Ardizzone Michele,
Álvarez Fernando,
Fernandez Dumont Antonio,
Gennaro Andrea,
Lanzoni Anna,
Neri Franco Maria,
Papadopoulou Nikoletta,
Paraskevopoulos Konstantinos,
De Sanctis Giacomo,
Raffaello Tommaso,
Federici Silvia,
Koukoulanaki Marina
Publication year - 2019
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.2019.5635
Subject(s) - microbiology and biotechnology , biology , environmental safety , animal health , food science , toxicology , agricultural science , zoology , medicine , environmental health , human health
Maize Bt11 × MIR 162 × MIR 604 × 1507 × 5307 × GA 21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR 162, MIR 604, 1507, 5307 and GA 21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead 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 maize events and of the newly expressed proteins in the six–event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐ GM comparator and the non‐ GM reference varieties tested. In the case of accidental release of viable grains of the six‐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 the 34 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the six‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐event stack maize and its subcombinations are as safe as its non‐ GM comparator and the tested non‐ GM reference varieties with respect to potential effects on human and animal health and the environment.