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


Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2013;11(6):3251 [31 pp.].
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

The Panel wishes to thank the members of the Standing Working Groups on Molecular Characterisation, Food and Feed Safety Assessment and Environmental Risk Assessment on GMO applications, including Christer Andersson, Thomas Frenzel, Marco Nuti and Jean-Michel Wal for the preparatory work on this scientific opinion, and the EFSA staff members, Zoltán Divéki, Christina Ehlert, Yi Liu and Sylvie Mestdagh for the support provided to this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands for application (EFSA-GMO-NL-2011-97) submitted by Bayer CropScience AG
Question Number
30 May 2013
Published in the EFSA Journal
20 June 2013
Last Updated
29 July 2013. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy

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.

GMO, cotton T304-40, Regulation (EC) No 1829/2003, Cry1Ab, PAT, food and feed safety and environment, import and processing
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