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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


Arpaia, Salvatore; Birch, Andrew N E; Chesson, Andrew; du Jardin, Patrick; Gathmann, Achim; Gropp, Jürgen; Herman, Lieve; Hoen-Sorteberg, Hilde-Gunn; Jones, Huw; Kiss, Jozsef; Kleter, Gijs; Lovik, Martinus; Messéan, Antoine; Naegeli, H; Nielsen, Kaare Magne; Ovesna, Jaroslava; Perry, Joe; Rostoks, Nils; Tebbe, Christoph (2013). 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. EFSA Journal, 11(10):3355.

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.

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.

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Additional indexing

Item Type:Journal Article, not refereed, further contribution
Communities & Collections:05 Vetsuisse Faculty > Institute of Veterinary Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
Language:English
Date:2013
Deposited On:27 Jan 2014 13:06
Last Modified:08 Dec 2017 03:16
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
Publisher DOI:https://doi.org/10.2903/j.efsa.2013.3355
Official URL:http://www.efsa.europa.eu/en/efsajournal/pub/3355.htm

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