Scientific Opinion on application (EFSA-GMO-NL-2010-77) for the placing on the market of herbicide-tolerant genetically modified cotton GHB614 × LLCotton25 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2014;12(5):3680 [26 pp.].
doi
10.2903/j.efsa.2014.3680
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, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks, Christoph Tebbe
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed Risk Assessment and Environmental Risk Assessment for the preparatory work on this scientific opinion; and EFSA staff: Hermann Broll, Antonio Fernandez Dumont, Ana Gomes and Sylvie Mestdagh for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands for an application (EFSA-GMO-NL-2010-77) submitted by Bayer CropScience
Question Number
EFSA-Q-2010-00106
Adopted
11 April 2014
Published in the EFSA Journal
16 May 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Cotton GHB614 × LLCotton25 was produced by conventional crossing. The EFSA GMO Panel previously assessed the two single cotton events GHB614 and LLCotton25 and did not identify safety concerns. Integrity of the inserts was retained in the two-event stack cotton. No differences requiring further food and feed safety assessment were identified in the compositional analysis of cotton GHB614 × LLCotton25 except for a higher level of gossypol. The EFSA GMO Panel further assessed this difference and considers that it is of no safety relevance for animals and humans. Expression analysis and safety assessment of the newly expressed proteins identified no concerns regarding their potential toxicity and allergenicity. No indications of safety issues regarding the overall allergenicity of cotton GHB614 × LLCotton25 were identified. There are no indications of an increased likelihood of establishment and spread of feral cotton plants. Considering the scope of the application, potential interactions of cotton GHB614 × LLCotton25 with the biotic and abiotic environment were not considered a relevant issue. Environmental risks associated with an unlikely but theoretically possible horizontal gene transfer from cotton GHB614 × LLCotton25 to bacteria have not been identified. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 × LLCotton25.

Keywords
GMO, cotton (Gossypium hirsutum L. and Gossypium barbadense L.), GHB614 × LLCotton25, herbicide tolerant, stack, Regulation (EC) No 1829/2003
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Number of Pages
26