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Scientific Opinion on an application (EFSA-GMO-NL-2010-80) for the placing on the market of herbicide-tolerant genetically modified maize NK603 × T25 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto


Arpaia, Salvatore; Birch, Andrew Nicholas Edmund; Chesson, Andrew; du Jardin, Patrick; Gathmann, Achim; Gropp, Jürgen; Herman, Lieve; Hoen-Sorteberg, Hilde-Gunn; Jones, Huw; Kiss, József; Kleter, Gijs; Lovik, Martinus; Messéan, Antoine; Naegeli, Hanspeter; Nielsen, Kaare Magne; Ovesna, Jaroslava; Perry, Joe; Rostoks, Nils; Tebbe, Christoph (2015). Scientific Opinion on an application (EFSA-GMO-NL-2010-80) for the placing on the market of herbicide-tolerant genetically modified maize NK603 × T25 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto. EFSA Journal, 13(7):4165.

Abstract

Single events NK603 and T25 were combined to produce the stack two-event maize NK603 × T25. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single maize events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as well as compositional data of maize NK603 × T25, did not give rise to food/feed and environmental safety concerns. The EFSA GMO Panel considers that there is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of maize NK603 × T25. There are no indications of an increased likelihood of establishment and spread of feral maize plants. Considering the scope of application EFSA-GMO-NL-2010-80, potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from maize NK603 × T25 to environmental bacteria does not give rise to any safety concern. The post-market environmental monitoring plan and reporting intervals are in line with the scope. In conclusion, the EFSA GMO Panel considers that the information available for maize NK603 × T25 addresses the scientific comments raised by Member States and that maize NK603 × T25, as described in this application, is as safe as its non-GM comparator and non-GM conventional maize varieties with respect to potential effects on human and animal health and the environment in the context of its scope.

Abstract

Single events NK603 and T25 were combined to produce the stack two-event maize NK603 × T25. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single maize events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as well as compositional data of maize NK603 × T25, did not give rise to food/feed and environmental safety concerns. The EFSA GMO Panel considers that there is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of maize NK603 × T25. There are no indications of an increased likelihood of establishment and spread of feral maize plants. Considering the scope of application EFSA-GMO-NL-2010-80, potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from maize NK603 × T25 to environmental bacteria does not give rise to any safety concern. The post-market environmental monitoring plan and reporting intervals are in line with the scope. In conclusion, the EFSA GMO Panel considers that the information available for maize NK603 × T25 addresses the scientific comments raised by Member States and that maize NK603 × T25, as described in this application, is as safe as its non-GM comparator and non-GM conventional maize varieties with respect to potential effects on human and animal health and the environment in the context of its scope.

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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
Uncontrolled Keywords:GMO, maize (Zea mays), CP4 EPSPS, PAT, herbicide tolerant, stack
Date:15 July 2015
Deposited On:03 Feb 2016 11:54
Last Modified:05 Apr 2016 19:57
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
Additional Information:The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.
Publisher DOI:https://doi.org/10.2903/j.efsa.2015.4165

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