Scientific Opinion on an application (Reference EFSA-GMO-NL-2011-100) for the placing on the market of the herbicide-tolerant, increased oleic acid genetically modified soybean MON 87705 × 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/Feed safety and Environment on GMO applications for the preparatory work on this scientific opinion, and EFSA staff: Anna Lanzoni, Sylvie Mestdagh, and Irina Olaru, for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2015;13(7):4178 [30 pp.].
doi
10.2903/j.efsa.2015.4178
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 Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks and Christoph Tebbe.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands
Question Number
EFSA-Q-2011-00954
Adopted
25 June 2015
Published
16 July 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The EFSA GMO Panel previously assessed the two single events combined to produce soybean MON 87705 × MON 89788 and did not identify safety concerns. No new data on the single events affecting the previous conclusions were identified. No differences in composition requiring further assessment were observed between soybean MON 87705 × MON 89788 and its comparator, except for the intended trait i.e. an altered fatty acid profile. Nutritional assessment on soybean MON 87705 × MON 89788 oil and oil-containing food products did not identify concerns on human health and nutrition. There are no concerns regarding the use of feedingstuffs from defatted soybean meal MON 87705 × MON 89788. The EFSA GMO Panel is of the opinion that soybean MON 87705 × MON 89788 is as safe, and at least as nutritious, as its comparator and commercial soybean varieties. 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 soybean MON 87705 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. 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 soybean MON 87705 × MON 89788 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 of the application. The EFSA GMO Panel considers that the information available for soybean MON 87705 × MON 89788 addresses the scientific comments raised by Member States. The EFSA GMO Panel concludes, considering the scope of the application, that soybean MON 87705 × MON 89788 is as safe as its comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment. The GMO Panel recommends a post-market monitoring plan, focusing on import data and, if needed, on consumption data for the European population, for the marketed foods and feed.

Keywords
GMO, soybean (Glycine max (L.) Merr.), CP4 EPSPS, herbicide tolerant, increased oleic acid, stack
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Number of Pages
30