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Scientific opinion on application EFSA‐GMO‐BE‐2013‐117 for authorisation of genetically modified maize MON 87427 × MON 89034 × NK603 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company


Naegeli, Hanspeter; Birch, Andrew Nicholas; Casacuberta, Josep; De Schrijver, Adinda; Gralak, Mikołaj Antoni; Guerche, Philippe; Jones, Huw; Manachini, Barbara; Messéan, Antoine; Nielsen, Elsa Ebbesen; Nogué, Fabien; Robaglia, Christophe; Rostoks, Nils; Sweet, Jeremy; Tebbe, Christoph; Visioli, Francesco; Wal, Jean‐Michel; Gennaro, Andrea; Neri, Franco Maria; Paraskevopoulos, Konstantinos (2017). Scientific opinion on application EFSA‐GMO‐BE‐2013‐117 for authorisation of genetically modified maize MON 87427 × MON 89034 × NK603 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company. EFSA Journal, 15(8):e04922.

Abstract

In this opinion, the EFSA Panelon Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON87427xMON89034xNK603 and its three subcombinations, independently of their origin. The GMO Panelhas previously assessed the three single events combined to produce this three-event stack maize and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the three-event stack maize did not give rise to issues regarding food and feed safety or nutrition. In the case of accidental release of viable grains of maize MON87427xMON89034xNK603 into the environment, the three-event stack maize would not raise environmental safety concerns. The GMO Panelconcludes that the three-event stack maize is as safe and as nutritious as the non-GM comparator and the tested non-GM reference varieties in the context of its scope. The GMO Panelconsidered that its previous conclusions on the two-event stack maize MON 89034xNK603 remain valid. For the two maize subcombinations for which no experimental data were provided the GMO Panelassessed the likelihood of interactions among the single events, and concluded that their combination would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed maize MON 89034xNK603 and maize MON 87427xMON 89034xNK603. Since the post-market environmental monitoring plan for the three-event stack maize does not include any provisions for the two subcombinations not previously assessed, the GMO Panelrecommended the applicant to revise the plan accordingly.

Abstract

In this opinion, the EFSA Panelon Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON87427xMON89034xNK603 and its three subcombinations, independently of their origin. The GMO Panelhas previously assessed the three single events combined to produce this three-event stack maize and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the three-event stack maize did not give rise to issues regarding food and feed safety or nutrition. In the case of accidental release of viable grains of maize MON87427xMON89034xNK603 into the environment, the three-event stack maize would not raise environmental safety concerns. The GMO Panelconcludes that the three-event stack maize is as safe and as nutritious as the non-GM comparator and the tested non-GM reference varieties in the context of its scope. The GMO Panelconsidered that its previous conclusions on the two-event stack maize MON 89034xNK603 remain valid. For the two maize subcombinations for which no experimental data were provided the GMO Panelassessed the likelihood of interactions among the single events, and concluded that their combination would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed maize MON 89034xNK603 and maize MON 87427xMON 89034xNK603. Since the post-market environmental monitoring plan for the three-event stack maize does not include any provisions for the two subcombinations not previously assessed, the GMO Panelrecommended the applicant to revise the plan accordingly.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:05 Vetsuisse Faculty > Institute of Veterinary Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
Language:English
Date:2017
Deposited On:27 Jan 2018 10:57
Last Modified:21 Feb 2018 05:46
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
OA Status:Hybrid
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.2903/j.efsa.2017.4922

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