Scientific Opinion on genetically modified cotton T304-40

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Article
GMO, cotton T304-40, Regulation (EC) No 1829/2003, Cry1Ab, PAT, food and feed safety and environment, import and processing
First published in the EFSA Journal
20 June 2013
Adopted
30 May 2013
Last Updated
29 July 2013. This version replaces the previous one/s.
Type
Scientific Opinion
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.

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, Martinus Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks, Christoph Tebbe
Panel on Genetically Modified Organisms
Contact
gmo [at] efsa.europa.eu
doi
10.2903/j.efsa.2013.3251
EFSA Journal 2013;11(6):3251 [31 pp.].
Question Number
On request from
Competent Authority of the Netherlands for application (EFSA-GMO-NL-2011-97) submitted by Bayer CropScience AG
Print on demand
Number of Pages
31