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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


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; Lagiou, Pagona; Lovik, Martinus; Messéan, Antoine; Naegeli, Hanspeter; Nielsen, Kaare Magne; Ovesna, Jaroslava; Perry, Joe; Rostoks, Nils; Tebbe, Christoph (2012). 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. EFSA Journal, 10(10):2909.

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.

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.

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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:30 October 2012
Deposited On:07 Mar 2013 08:27
Last Modified:05 Apr 2016 16:36
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
Publisher DOI:https://doi.org/10.2903/j.efsa.2012.2909
Official URL:http://www.efsa.europa.eu/en/efsajournal/pub/2909.htm
Related URLs:http://www.efsa.europa.eu/en/efsajournal/ (Organisation)
Permanent URL: https://doi.org/10.5167/uzh-75265

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