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. 2014 May 16;12(5):3680. doi: 10.2903/j.efsa.2014.3680

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

EFSA Panel on Genetically Modified Organisms (GMO)
PMCID: PMC13159813  PMID: 42125398

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

EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms) , 2014. 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. EFSA Journal 2014;12(5):3680, 26 pp. doi: 10.2903/j.efsa.2014.3680

Panel members: 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

Correspondence: gmo@efsa.europa.eu

Acknowledgement: 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.

Adoption date: 11 April 2014

Published date: 16 May 2014

Question number: EFSA‐Q‐2010‐00106

On request from: Competent Authority of the Netherlands for an application (EFSA‐GMO‐NL‐2010‐77) submitted by Bayer CropScience

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