| 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 |
(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/statusofdoss.htm
|
| 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 |
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 2010/140/EU of 2 March 2010
|
| Authorisation expiration date |
01/03/2020 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2004-112 |
