Scientific Opinion on application EFSA-GMO-NL-2011-93 for the placing on the market of the herbicide-tolerant genetically modified soybean MON 87708 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

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Article
Panel on Genetically Modified Organisms
Acknowledgements

The Panel wishes to thank the members of the Working Group on Molecular Characterisation, Food and Feed Safety Assessment and Environmental Risk Assessment on GMO applications, including Christer Andersson, Annette Poëting, Sirpa Kärenlampi and Fabien Nogué for the preparatory work on this scientific opinion, and EFSA staff: Zoltán Divéki, Christina Ehlert, Antonio Fernández Dumont and Sylvie Mestdagh for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2013;11(10):3355 [30 pp.].
doi
10.2903/j.efsa.2013.3355
Panel members at the time of adoption
Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks and Christoph Tebbe
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands for an application (EFSA-GMO-NL-2011-93) submitted by Monsanto
Question Number
EFSA-Q-2011-00122
Adopted
12 September 2013
Published
3 October 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Soybean MON 87708 contains a single insert consisting of the dmo expression cassette. The DMO (dicamba mono-oxygenase) proteins confer tolerance to dicamba-based herbicides. Bioinformatic analyses of the inserted DNA and flanking regions do not raise safety issues. The levels of DMO proteins in soybean MON 87708 have been sufficiently analysed. The stability of the genetic modification has been demonstrated. No differences were identified in the compositional data of forage and seeds obtained from soybean MON 87708 or in its agronomic and phenotypic characteristics that would require further assessment with regard to safety by the GMO Panel. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the DMO proteins, or of soybean MON 87708. The compositional data indicating that soybean MON 87708 is as nutritious as non-GM soybean varieties were supported by the outcome of a chicken study. There are no indications of an increased likelihood of establishment and spread of feral GM soybean plants. Considering the scope of this application, potential interactions of soybean MON 87708 with the biotic and abiotic environment were not considered to be an issue. Environmental risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean MON 87708 to bacteria have not been identified. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87708. In conclusion, the GMO Panel considers that the information available for soybean MON 87708 addresses the scientific comments raised by the Member States, and that the soybean MON 87708, as described in this application, is as safe as its conventional counterpart and non-GM soybean reference varieties with respect to potential effects on human and animal health or the environment, in the context of its intended uses.

Keywords
GMO, soybean MON 87708, Regulation (EC) No 1829/2003, DMO protein, food and feed safety, environment, import and processing
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Number of Pages
30