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Scientific Opinion on application EFSA-GMO-UK-2007-41 for the placing on the market of herbicide-tolerant genetically modified cotton MON 88913 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-UK-2007-41 for the placing on the market of herbicide-tolerant genetically modified cotton MON 88913 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto. EFSA Journal, 11(7):3311.

Abstract

Cotton MON 88913 contains one insert consisting of the CP4 epsps expression cassette, providing herbicide tolerance. Bioinformatics-supported identification of hazards linked to the formation of new open reading frames caused by the insertion could not be completed due to the use of an outdated toxin database. Genetic stability studies did not raise safety issues. No biologically relevant differences which would raise safety concerns were identified in the composition or agronomic and phenotypic characteristics of plants and seeds obtained from cotton MON 88913 compared with its conventional counterpart and non-genetically modified reference varieties. Based on all the available information, there are no indications that the newly expressed CP4 EPSPS protein in cotton MON 88913 may be allergenic or toxic. Cotton MON 88913 was found to be as nutritious as commercially available varieties and it is unlikely that the overall allergenicity of the whole plant is changed. There are no indications of an increased likelihood of establishment and spread of feral cotton plants. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from cotton MON 88913 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of cotton MON 88913. The EFSA GMO Panel considers, however, that the information available for cotton MON 88913 is not sufficient to reach a final overall conclusion due to the use of an outdated toxin database for bioinformatic analyses.

Abstract

Cotton MON 88913 contains one insert consisting of the CP4 epsps expression cassette, providing herbicide tolerance. Bioinformatics-supported identification of hazards linked to the formation of new open reading frames caused by the insertion could not be completed due to the use of an outdated toxin database. Genetic stability studies did not raise safety issues. No biologically relevant differences which would raise safety concerns were identified in the composition or agronomic and phenotypic characteristics of plants and seeds obtained from cotton MON 88913 compared with its conventional counterpart and non-genetically modified reference varieties. Based on all the available information, there are no indications that the newly expressed CP4 EPSPS protein in cotton MON 88913 may be allergenic or toxic. Cotton MON 88913 was found to be as nutritious as commercially available varieties and it is unlikely that the overall allergenicity of the whole plant is changed. There are no indications of an increased likelihood of establishment and spread of feral cotton plants. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from cotton MON 88913 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of cotton MON 88913. The EFSA GMO Panel considers, however, that the information available for cotton MON 88913 is not sufficient to reach a final overall conclusion due to the use of an outdated toxin database for bioinformatic analyses.

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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:28 Jan 2014 10:30
Last Modified:16 Feb 2018 19:31
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
OA Status:Green
Publisher DOI:https://doi.org/10.2903/j.efsa.2013.3311
Official URL:http://www.efsa.europa.eu/en/efsajournal/pub/3311.htm

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