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Assessment of genetically modified maize MON  87427 ×  MON  89034 ×  MIR 162 ×  MON  87411 and subcombinations, for food and feed uses, under Regulation ( EC ) No 1829/2003 (application EFSA ‐ GMO ‐ NL ‐2017‐144)
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,
Álvarez Fernando,
Ardizzone Michele,
De Sanctis Giacomo,
Fernandez Dumont Antonio,
Gennaro Andrea,
Gómez Ruiz Jose Ángel,
Lanzoni Anna,
Neri Franco Maria,
Papadopoulou Nikoletta,
Paraskevopoulos Konstantinos
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.2019.5848
Subject(s) - genetically modified maize , microbiology and biotechnology , environmental safety , biology , genetically modified organism , zea mays , genetically modified crops , food safety , toxicology , agronomy , food science , transgene , medicine , environmental health , genetics , human health , gene
Maize MON  87427 ×  MON  89034 ×  MIR 162 ×  MON  87411 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON  87427, MON  89034, MIR 162 and MON  87411. The genetically modified organism ( GMO ) Panel previously assessed the four single maize events and four of the subcombinations and did not identify safety concerns. No new data on the single maize events or the four subcombinations that could lead to modification of the original conclusions on their safety were 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 and ds RNA in the four‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four‐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 four‐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 six 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 four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐ GM comparator and tested non‐ GM reference varieties with respect to potential effects on human and animal health and the environment.

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