Scientific Opinion on applications EFSA-GMO-UK-2005-09 and EFSA-GMO-RX-MON531×MON1445 for the placing on the market of food and feed produced from or containing ingredients produced from insect-resistant and herbicide-tolerant genetically modified cotton MON 531 × MON 1445, and for the renewal of authorisation of existing products produced from cotton MON 531 × MON 1445, both under Regulation (EC) No 1829/2003 from Monsanto

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2012;10(3):2608 [31 pp.].
doi
10.2903/j.efsa.2012.2608
Panel members at the time of adoption
Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed and Environment for the preparatory work on this scientific opinion; Boet Glandorf and Willem Seinen as external experts; and the EFSA’s staff members Zoltán Divéki, Christina Ehlert and Andrea Germini for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
from the Competent Authority of the United Kingdom for an application (EFSA-GMO-UK-2005-09) submitted by Monsanto; the European Commission for an application (EFSA-GMO-RX-MON531×MON1445) submitted by Monsanto
Question Number
EFSA-Q-2005-012
EFSA-Q-2007-152
Adopted
8 March 2012
Published in the EFSA Journal
28 March 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This scientific opinion evaluates the risk assessment for the authorisation for (continued) marketing of genetically modified insect-resistant and herbicide-tolerant cotton MON 531 × MON 1445 for food and feed produced from it. Cotton MON 531 × MON 1445 was produced by conventional crossing methods, and the stack is homozygous for the newly introduced traits. The integrity and the stable co-inheritance of the parental events were demonstrated in the stack. Molecular characterisation did not reveal safety issues. No biologically relevant differences were identified in the compositional, phenotypic and agronomic characteristics of cotton MON 531 × MON 1445 in comparison with its conventional counterpart and its composition fell within the range of non-GM cotton varieties, except for the Cry1Ac, CP4 EPSPS and NPTII proteins. No safety issues were identified with regard to toxicity and allergenicity of food and feed produced from cotton MON 531 × MON 1445. A feeding study in catfish confirmed that toasted cottonseed meal from MON 531 × MON 1445 is as nutritious as toasted cottonseed meal from its conventional counterpart and four commercial non-GM cotton varieties. Products from cotton MON 531 × MON 1445 do not contain viable plant parts. The insert structure in cotton MON 531 × MON 1445 may facilitate the stabilisation of the nptII gene in plasmids of environmental bacteria through double homologous recombination. However, considering the overall limited occurrence of horizontal transfer of DNA in plant material to bacteria, and the very low exposure to DNA from cotton MON 531 × MON 1445, the EFSA GMO Panel concludes that it is highly unlikely that cotton MON 531 × MON 1445 will contribute to the environmental prevalence of nptII genes. Potential interactions of cotton MON 531 × MON 1445 with non-target organisms and the abiotic environment were not considered to be an issue because of low exposure levels. A post-market environmental monitoring plan is not required.

Keywords
GMO, cotton, MON 531 × MON 1445, Bollgard® with Roundup Ready®, insect resistance, herbicide tolerance, risk assessment, Regulation (EC) No 1829/2003
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Number of Pages
31