Scientific Opinion on application (EFSA-GMO-NL-2010-78) for the placing on the market of herbicide-tolerant, increased oleic acid genetically modified soybean MON 87705 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; Anke Meisner, Thomas Frenzel and Hildegard Przyrembel as external experts; and the EFSA’s staff members Anna Christodoulidou, Zoltán Divéki and Christina Ehlert for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2012;10(10):2909 [34 pp.].
doi
10.2903/j.efsa.2012.2909
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, Pagona Lagiou, Martinus Lovik, 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-2010-78) submitted by Monsanto
Question Number
EFSA-Q-2010-00165
Adopted
28 September 2012
Published
30 October 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note

This Scientific Opinion, published on 30 October 2012, has been supplemented with a Statement published on 17 December 2013 (EFSA Journal 2013;11(12):3507), which is available here: Statement complementing the scientific opinion on application EFSA-GMO-NL-2010-78 to cover the safety of soybean MON 87705 oil for commercial frying

Abstract

This scientific opinion is a risk assessment of the genetically modified, herbicide-tolerant, increased oleic acid soybean MON 87705 for food and feed uses, import and processing. MON 87705 contains the soybean FAD2-1A/FATB1-A gene fragments down-regulating endogenous FAD2 and FATB enzymes and the CP4 epsps gene cassette conferring tolerance to glyphosate-containing herbicides. Bioinformatic analyses and genetic stability studies did not raise safety issues. The levels of the CP4 EPSPS protein in soybean MON 87705 have been sufficiently analysed. MON 87705 differs from the conventional counterpart in the fatty acid profile (proportion of (C18:1) oleic acid increased and proportions of (C18:2) linoleic acid and (C16:0) palmitic acid decreased) in seeds and the presence of the CP4 EPSPS protein. Scientific risk assessment of soybean MON 87705 was carried out in the context of the intended use as specified by the applicant, namely its use for food and feed as any conventional soybean except for the oil derived from soybean MON 87705, which is to be used in margarine, salad dressing, mayonnaise and home-use liquid vegetable oil, excluding the use of soybean MON 87705 oil for commercial frying.

The safety assessment identified no concerns regarding potential toxicity and allergenicity of the CP4 EPSPS protein. The altered fatty acid profile did not raise concerns regarding toxicity. The overall allergenicity of the whole plant was not changed by the genetic modification. The estimated changes in intake levels of these fatty acids do not raise nutritional concerns in the context of the intended use as specified by the applicant. A feeding study on broiler chickens confirmed that defatted meal of soybean MON 87705 is as nutritious as meals produced from its conventional counterpart and non-GM reference varieties. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering its intended uses, environmental risks associated with an unlikely, but theoretically possible, horizontal gene transfer from soybean MON 87705 to bacteria have not been identified. Potential biotic and abiotic interactions of soybean MON 87705 were not considered to be an issue owing to the low level of exposure. The monitoring plan is in line with the intended uses of soybean MON 87705.

The EFSA GMO Panel considers that the information available for soybean MON 87705 addresses the scientific comments raised by the Member States and states that soybean MON 87705, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses as proposed by the applicant.

Keywords
GMO, soybean (Glycine max), MON 87705, herbicide tolerant, increased oleic acid, RNAi, CP4 EPSPS, human and animal health, import and processing, Regulation (EC) No 1829/2003
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Number of Pages
34