Open AccessScientific opinion on application ( EFSA ‐ GMO ‐ NL ‐2011‐96) for the placing on the market of genetically modified insect‐resistant and herbicide‐tolerant cotton GHB 119, for food and feed uses, import and processing under Regulation ( EC ) No 1829/2003 from Bayer CropScience AG
Author(s) -
Andrew Nicholas Birch,
Josep Casacuberta,
Adinda De Schrijver,
Mikołaj Antoni Gralak,
Philippe Guerche,
Huw Jones,
Barbara Manachini,
Antoine Messéan,
Hanspeter Naegeli,
Elsa Nielsen,
Fabien Nogué,
Christophe Robaglia,
Nils Rostoks,
Jeremy Sweet,
Christoph C. Tebbe,
Francesco Visioli,
JeanMichel Wal
Publication year - 2016
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2016.4586
Subject(s) - microbiology and biotechnology , genetically modified crops , bt cotton , genetically modified organism , biology , food safety , bacillus thuringiensis , agronomy , toxicology , transgene , food science , gene , bacteria , genetics
Cotton GHB 119 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 GHB 119 did not give rise to safety issues. The agronomic, phenotypic and compositional characteristics of cotton GHB 119 tested under field conditions revealed no relevant differences between cotton GHB 119 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 GHB 119. The nutritional characteristics of cotton GHB 119 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 GHB 119 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 GHB 119 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 GHB 119 addresses the scientific comments raised by the Member States and that cotton GHB 119, 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.