Scientific opinion on GM cotton GHB119

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Article
GMO, cotton GHB119, Regulation (EC) No 1829/2003, Cry2Ae, PAT, insect resistance, herbicide tolerance, import and processing
First published in the EFSA Journal
21 October 2016
Adopted
21 September 2016
Type
Scientific Opinion
Abstract

Cotton GHB119 was developed by Agrobacterium tumefaciens-mediated transformation. It expresses the Cry2Ae and phosphinothricin acetyltransferase (PAT) proteins which, respectively, confer resistance to certain lepidopteran species and tolerance to glufosinate ammonium-based herbicides. The molecular characterisation of cotton GHB119 did not give rise to safety issues. The agronomic, phenotypic and compositional characteristics of cotton GHB119 tested under field conditions revealed no relevant differences between cotton GHB119 and its conventional counterpart that would give rise to any food and feed or environmental safety concern. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry2Ae and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of cotton GHB119. The nutritional characteristics of cotton GHB119 are not expected to differ from those of non-GM cotton varieties. There are no indications of an increased likelihood of establishment and spread of feral cotton GHB119 plants. Considering the scope of this application, 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 GHB119 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application. In conclusion, the EFSA GMO Panel considers that the information available for cotton GHB119 addresses the scientific comments raised by the Member States and that cotton GHB119, as described in this 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 the scope of this application.

Panel members at the time of adoption
Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Mikołaj Antoni Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, Elsa Ebbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli and Jean-Michel Wal
Panel on Genetically Modified Organisms
Contact
GMO [at] efsa.europa.eu
doi
10.2903/j.efsa.2016.4586
EFSA Journal 2016;14(10):4586 [27 pp.].
Question Number
On request from
Competent Authority of the Netherlands
Print on demand
Number of Pages
27