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Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

Authors :
EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel)
Hanspeter Naegeli
Jean‐Louis Bresson
Tamas Dalmay
Ian Crawford Dewhurst
Michelle M Epstein
Leslie George Firbank
Philippe Guerche
Jan Hejatko
Francisco Javier Moreno
Ewen Mullins
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Fernando Álvarez
Michele Ardizzone
Antonio Fernandez Dumont
Andrea Gennaro
Jose Ángel Gómez Ruiz
Anna Lanzoni
Franco Maria Neri
Nikoletta Papadopoulou
Matthew Ramon
Source :
EFSA Journal, Vol 17, Iss 1, Pp n/a-n/a (2019)
Publication Year :
2019
Publisher :
Wiley, 2019.

Abstract

Abstract Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations 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 indicates that the combination of the single maize events and of the newly expressed proteins in the four‐event stack maize does not give rise to food/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 for which no experimental data were provided, 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. No post‐market monitoring for food/feed is necessary. The GMO Panel concludes that the four‐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.

Details

Language :
English
ISSN :
18314732
Volume :
17
Issue :
1
Database :
Directory of Open Access Journals
Journal :
EFSA Journal
Publication Type :
Academic Journal
Accession number :
edsdoj.3919ff7e6a714fa6acef4098568a6202
Document Type :
article
Full Text :
https://doi.org/10.2903/j.efsa.2019.5522