MON-ØØ863-5 x MON-ØØ6Ø3-6
EU register of genetically modified food and feed.
|Authorisation holder Name||Monsanto Europe S.A.
On behalf of
|Authorisation holder Address||Monsanto Europe S.A.
Scheldelaan 460, Haven 637
B-2040 Antwerpen, Belgium
On behalf of
800 N. Lindbergh Boulevard, St Louis
Missouri 63617, United States of America
|Products||(1) Foods and food ingredients containing, consisting of, or produced from MON-ØØ863-5xMON-ØØ6Ø3-6 maize;
(2) Feed containing, consisting of, or produced from MON-ØØ863-5xMON-ØØ6Ø3-6 maize;
(3) Products other than food and feed containing or consisting of MON-ØØ863-5xMON-ØØ6Ø3-6 maize for the same uses as any other maize with the exception of cultivation.
|Designation||The genetically modified maize MON-ØØ863-5xMON-ØØ6Ø3-6, as described in the application, expresses a modified Cry3Bb1 protein which provides protection to certain coleopteran pests and CP4 EPSPS protein which confers tolerance to glyphosate herbicides. 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-ØØ6Ø3-6 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-ØØ6Ø3-6 maize validated on MON-ØØ863-5xMON-ØØ6Ø3-6.
- 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®-BF415 (for MON-ØØ6Ø3-6) accessible via the joint Research Centre (JRC) of the European Commission, the institute of Reference Materials and Measurements (IRMM) http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm|
|Unique identifier||MON-ØØ863-5 x MON-ØØ6Ø3-6|
|Annex II to the Cartagena Protocol||Biosafety Clearing House
|Conditions or restrictions on the placing on the market||Not applicable|
|Post-market monitoring requirements||Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC|
|Date of authorisation||02/03/2010|
|Legal base||Art. 7(3), and 19(3) of the Regulation (EC) No 1829/2003
Commission Decision 2010/141/EU of 2 March 2010
|Authorisation expiration date||01/03/2020|
|Further information on risk assessment||Opinion of the European Food Safety Authority: