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Scientific Opinion on application EFSA-GMO-NL-2011-97 for the placing on the market of insect-resistant and herbicide-tolerant genetically modified cotton T304-40 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience AG


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 (2013). Scientific Opinion on application EFSA-GMO-NL-2011-97 for the placing on the market of insect-resistant and herbicide-tolerant genetically modified cotton T304-40 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience AG. EFSA Journal, 11(6):3251.

Abstract

Cotton T304-40 contains a single insert consisting of the cry1Ab and the bar expression cassettes, providing insect resistance and herbicide tolerance, respectively. Bioinformatic analyses and genetic stability studies did not raise safety issues. Levels of the Cry1Ab and PAT proteins in cotton T304-40 have been sufficiently analysed. No biologically relevant differences were identified in the compositional analysis when the seed of T304-40 was compared with its conventional counterpart and non-GM cotton varieties. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced Cry1Ab and PAT proteins. Based on the information available, there is no evidence that the genetic modification might significantly change the overall allergenicity of cotton T304-40. Nutritional equivalence of cotton T304-40 to its conventional counterparts was indicated by compositional data. The EFSA GMO Panel concludes that cotton T304-40 is as safe and nutritious as its conventional counterpart and that 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 T304-40 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of cotton T304-40. The EFSA GMO Panel considers that the information available for cotton T304-40 addresses the scientific comments raised by the Member States and states that cotton T304-40, 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.

Abstract

Cotton T304-40 contains a single insert consisting of the cry1Ab and the bar expression cassettes, providing insect resistance and herbicide tolerance, respectively. Bioinformatic analyses and genetic stability studies did not raise safety issues. Levels of the Cry1Ab and PAT proteins in cotton T304-40 have been sufficiently analysed. No biologically relevant differences were identified in the compositional analysis when the seed of T304-40 was compared with its conventional counterpart and non-GM cotton varieties. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced Cry1Ab and PAT proteins. Based on the information available, there is no evidence that the genetic modification might significantly change the overall allergenicity of cotton T304-40. Nutritional equivalence of cotton T304-40 to its conventional counterparts was indicated by compositional data. The EFSA GMO Panel concludes that cotton T304-40 is as safe and nutritious as its conventional counterpart and that 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 T304-40 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of cotton T304-40. The EFSA GMO Panel considers that the information available for cotton T304-40 addresses the scientific comments raised by the Member States and states that cotton T304-40, 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:2013
Deposited On:28 Jan 2014 11:30
Last Modified:08 Dec 2017 03:22
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
Publisher DOI:https://doi.org/10.2903/j.efsa.2013.3251
Official URL:http://www.efsa.europa.eu/en/efsajournal/pub/3251.htm

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