Scientific Opinion on applications (EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985) for the placing on the market of insect-resistant genetically modified cotton MON 15985 for food and feed uses, import and processing, and for the renewal of authorisation of existing products produced from cotton MON 15985, both under Regulation (EC) No 1829/2003 from Monsanto

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2014;12(7):3770 [42 pp.].
doi
10.2903/j.efsa.2014.3770
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 Opsahl Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks and Christoph Tebbe.
Acknowledgements

: The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed Risk Assessment and Environment Risk Assessment for the preparatory work on this scientific opinion; and EFSA staff: Hermann Broll, Zoltán Divéki and Andrea Gennaro for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the United Kingdom for an application (EFSA-GMO-UK-2008-57) submitted by Monsanto; European Commission for an application (EFSA-GMO-RX-MON15985) submitted by Monsanto
Question Number
EFSA-Q-2008-385
EFSA-Q-2007-145
Adopted
2 July 2014
Published in the EFSA Journal
28 July 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Cotton MON 15985 was developed by biolistic transformation of cotton MON 531 to express Cry2Ab2 and GUS in addition to the Cry1Ac and NPTII proteins. Cry proteins in MON 15985 confer resistance to major lepidopteran cotton pests, whereas the GUS and NPTII proteins were used as markers during product development. Molecular characterisation of MON 15985 did not give rise to safety issues. The EFSA GMO Panel could not conclude on the potential occurrence of unintended effects for agronomic and phenotypic characteristics owing to data limitations. Compositional data gave no indication of unintended effects for which further assessment was needed. The Panel concludes that cotton MON 15985, as described in these applications, is as safe and nutritious as its conventional counterpart and other non-genetically modified varieties, and considers it unlikely that the overall allergenicity of the whole plant is changed. Environmental risk assessment was restricted to the exposure through faecal material from animals fed with cotton products of MON 15985 and its accidental spillage. Following a weight of evidence approach and considering the poor ability of cotton to survive outside cultivated land, despite the agronomic and phenotypic data limitations, the Panel concludes that there is very low likelihood of any adverse environmental impacts. The aadA and oriV sequences in MON 15985 may facilitate the stabilisation of nptII through double homologous recombination. However, considering the limited presence of intact DNA from MON 15985 in feed and the limited occurrence of horizontal transfer of DNA from plant material to bacteria, the Panel concludes that it is highly unlikely that nptII from MON 15985 will be transferred to bacteria.

Keywords
GMO, cotton, risk assessment, MON 15985, Genuity® Bollgard II®, insect resistance, Cry1Ac, Cry2Ab2
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Number of Pages
42