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Genetically Modified Organisms

MON-ØØ863-5 x MON-ØØ81Ø-6

Products subject to Commission Decisions on withdrawal from the market

Event MON863 x MON810
Authorisation holder Name Monsanto Europe S.A.
On behalf of
Monsanto Company
Authorisation holder Address Monsanto Europe S.A.
Scheldelaan 460, Haven 637
B-2040 Antwerpen, Belgium
On behalf of
Monsanto Company
800 N. Lindbergh Boulevard, St Louis
Missouri 63617, United States of America
Products market withdrawal (1) Foods and food ingredients containing, consisting of, or produced from MON-ØØ863-5xMON-ØØ81Ø-6 maize;
(2) Feed containing, consisting of, or produced from MON-ØØ863-5xMON-ØØ81Ø-6 maize;
(3) Products other than food and feed containing or consisting of MON-ØØ863-5xMON-ØØ81Ø-6 maize for the same uses as any other maize with the exception of cultivation.
Designation The genetically modified maize MON-ØØ863-5xMON-ØØ81Ø-6, as described in the application, expresses a modified Cry3Bb1 protein which provides protection to certain coleopteran pests and Cry1Ab protein which confers protection against certain lepidopteran insect pests. A nptII gene, conferring kanamycin and neomycin resistance, was used as a selectable marker.
Labelling (1) For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the 'name of the organism' shall be 'maize'.

(2) The words 'not for cultivation' shall appear on the label of and in documents accompanying products containing or consisting of MON-ØØ863-5xMON-ØØ81Ø-6 maize referred to in Article 2(b) and (c).
Method for detection - Event specific real-time quantitative PCR based methods for genetically modified maize MON-ØØ863-5 and MON-ØØ81Ø-6 maize validated on MON-ØØ863-5xMON-ØØ81Ø-6.

- Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
Reference material - Reference Material: ERM®-BF416 (for MON-ØØ863-5) and ERM®-BF413 (MON-ØØ81Ø-6) accessible via the joint Research Centre (JRC) of the European Commission, the institute of Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
Unique identifier MON-ØØ863-5xMON-ØØ81Ø-6
Annex II to the Cartagena Protocol
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements
Date of authorisation 02/03/2010
Legal base Commission Decision on the withdrawal from the market of MON863xMON810 2016/87/EU of 22 January 2016
Authorisation expiration date
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2004-112