Scientific opinion on application (EFSA-GMO-NL-2009-73) for the placing on the market of insect-resistant and herbicide-tolerant genetically modified soybean MON 87701 × MON 89788 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 Groups on Molecular Characterisation, Food and Feed, and Environment, for the preparatory work on this scientific opinion, and the EFSA’s staff members Jaime Aguilera, Christina Ehlert and Andrea Germini, for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2012;10(2):2560 [34 pp.].
doi
10.2903/j.efsa.2012.2560
Panel members at the time of adoption
Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright and Jean-Michel Wal
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands for an application (EFSA-GMO-NL-2009-73) submitted by Monsanto
Question Number
EFSA-Q-2009-00761
Adopted
26 January 2012
Published
15 February 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This scientific opinion is an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect-resistant and herbicide-tolerant soybean MON 87701 × MON 89788 for food and feed uses, import and processing. Soybean MON 87701 × MON 89788 was produced by conventional crossing methods, and the F1 plant is hemizygous for all newly introduced traits. The soybean contains the Cry1Ac and CP4 epsps genes conferring resistance against certain lepidopteran target pests and tolerance to glyphosate-based herbicides. No biologically relevant differences were identified in the composition or agronomic and phenotypic characteristics of soybean MON 87701 × MON 89788, as compared with its comparator, except that it expresses the Cry1Ac and CP4 EPSPS proteins. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of soybean MON 87701 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering its intended use as food and feed, environmental risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean MON 87701 × MON 89788 to bacteria have not been identified. Potential interactions of soybean MON 87701 × MON 89788 with the biotic and abiotic environment were not considered to be an issue owing to the low level of exposure. The monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87701 × MON 89788. In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87701 × MON 89788 addresses the scientific comments raised by Member States and that the soybean MON 87701 × MON 89788, as described in this application, is as safe as its comparator with respect to potential effects on human and animal health and the environment, in the context of its intended uses.

Keywords
GMO, soybean (Glycine max), MON 87701 × MON 89788, insect-resistant, herbicide-tolerant, human and animal health, import and processing, Regulation (EC) No 1829/2003
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Number of Pages
34