Scientific Opinion on applications (EFSA-GMO-RX-MON863) for renewal of the authorisation for continued marketing of existing feed materials, feed additives and food additives produced from maize MON863, under Regulation (EC) No 1829/2003 from Monsanto

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Article
Panel on Genetically Modified Organisms
Acknowledgements

The EFSA GMO Panel wishes to thank the members of the Working Groups Molecular Characterisation, Food and Feed and Environment for the preparation of this opinion and EFSA’s staff member(s) Jaime Aguilera, Antonio Fernandez Dumont and Karine Lheureux for the support provided to this EFSA scientific output.

EFSA Journal
EFSA Journal 2010; 8(3):1562 [15 pp.].
doi
10.2903/j.efsa.2010.1562
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. Opinion is shared by all members of the Panel. 0 Panel member(s) with minority opinion. 0 members of the Panel did not participate in [part of] the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2007-163
Adopted
10 March 2010
Published
30 March 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This scientific opinion reports on an evaluation of an application (reference EFSA-GMO-RX-MON863[8.1.b/20.1.b]) for renewal of the authorisation for continued marketing of existing feed materials, feed additives and food additives produced from genetically modified (GM) insect resistant maize MON863. Maize MON863 has been modified with a gene encoding the Cry3Bb1 protein which confers protection against coleopteran pests, principally the corn rootworm (Diabrotica spp.). In addition, a selectable marker gene nptII encoding neomycin phosphotransferase II has been introduced. In 2004 the EFSA GMO Panel issued scientific opinions on a Notification for the placing on the market of GM maize MON863 for import and processing and on a request from the European Commission for the placing on the market of foods and food ingredients derived from GM maize MON863. In delivering the present opinion, the EFSA GMO Panel considered the information provided in the application EFSA-GMO-RX-MON863[8.1.b/20.1.b] as well as additional information provided by the applicant and information published in the scientific literature. The new data in the application included bioinformatic analyses using updated databases which confirmed that no relevant similarities exist between the newly expressed proteins and known allergens or proteins toxic to mammals. The EFSA GMO Panel has evaluated the new information provided by the applicant and the scientific literature and concluded that there was no new information that would require changes of its previous scientific opinions on maize MON863 (EFSA, 2004a,b). Therefore, the EFSA GMO Panel reiterates its previous conclusions that GM maize MON863 and its products which are the subject of this application are unlikely to have an adverse effect on human and animal health or the environment in the context of its intended uses (EFSA, 2004a,b).

Keywords
GMO, maize (Zea mays), maize MON863, insect resistance, food and feed safety, environment, risk assessment, renewal, existing product, Regulation (EC) No 1829/2003
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Number of Pages
15