Scientific Opinion on application EFSA-GMO-RX-MON531 for renewal of the authorisation for continued marketing of existing cottonseed oil, food additives, feed materials and feed additives produced from MON 531 cotton that were notified under Articles 8(1)(a), 8(1)(b) and 20(1)(b) of Regulation (EC) No 1829/2003 from Monsanto

Tabs

Article
Panel on Genetically Modified Organisms
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed Safety and Environment for the preparatory work on this scientific opinion, Willem Seinen as external expert and EFSA’s staff members Yann Devos (ENV), Zoltán Divéki (MC), Andrea Germini (FF), Ana Gomes (MC), Karine Lheureux (ENV) and Nancy Podevin (MC) for the support provided to this EFSA scientific opinion.

EFSA Journal
EFSA Journal 2011;9(9):2373 [30 pp.].
doi
10.2903/j.efsa.2011.2373
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
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2007-151
Adopted
7 September 2011
Published
16 September 2011
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 cotton MON531 for food and feed produced from it. MON531 was transformed via Agrobacterium. It contains single copies of functional Cry1Ac and NPTII expression cassettes; two fragments of the Cry1Ac cassette and aadA as non-functional elements. Stability of the inserted DNA was confirmed over several generations. Bioinformatic analyses and the levels of recombinant proteins did not reveal safety concerns. Analysis of compositional, phenotypic and agronomic characteristics indicated that MON531 is not different from its conventional counterpart and is compositionally within the range observed among conventional cotton varieties, except for Cry1Ac and NPTII. Safety assessment of Cry1Ac and NPTII proteins and cotton MON531 identified no concerns regarding potential toxicity and allergenicity. Products from MON531 do not contain viable plant parts. The aadA and oriV sequences in MON531 may facilitate the stabilisation of nptII through double homologous recombination in plasmid sequences in the environment. However, considering the expected low frequency of gene transfer from MON531 to bacteria compared to that between bacteria, and the very low exposure to MON531 DNA, the GMO Panel concludes that gene transfer from MON531 to bacteria does not indicate a risk to human or animal health or to the environment in the context of its intended uses. The exposure of potentially sensitive non-target organisms to Cry1Ac protein is likely to be low and of no biological relevance. A PMEM plan is not required. The EFSA GMO Panel considers that information available for cotton MON531 addresses the questions raised by the Member States and that cotton MON531, as described in this application, is as safe as its conventional counterpart and is unlikely to have adverse effects on human and animal health and the environment in the context of its intended uses.

Keywords
GMO, cotton, MON 531, insect resistance, risk assessment, food and feed safety, environment, food and feed produced from, Regulation (EC) No 1829/2003, renewal
Print on demand
Number of Pages
30