EU register of genetically modified food and feed.
|Authorisation holder||A) Dow AgroSciences Europe Ltd.
European Development Centre, 3 Milton Park, Abingdon,
Oxon OX14 4RN, United Kingdom.
On behalf of Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States of America.
B) Monsanto Europe S.A.
Avenue de Tervuren 270-272, B-1150 Brussels - Belgium
on behalf of Monsanto Company - 800 N. Lindbergh Boulevard - St. Louis, Missouri 63167 - United States of America.
|Products||(1) Foods and food ingredients containing, consisting of, or produced from MON-89Ø34-3×DAS-Ø15Ø7-1×MON-ØØ6Ø3-6 maize;
(2) Feed containing, consisting of, or produced from MON-89Ø34-3×DAS-Ø15Ø7-1×MON-ØØ6Ø3-6 maize;
(3) Products, other than food and feed, containing or consisting of MON-89Ø34-3×DAS-Ø15Ø7-1×MON-ØØ6Ø3-6 maize for the same uses as any other maize with the exception of cultivation.
|Designation||The genetically modified maize MON-89Ø34-3×DAS-Ø15Ø7-1×MON-ØØ6Ø3-6 maize, as described in the application, is produced by crosses between maize containing MON-89Ø34-3, DAS-Ø15Ø7-1 and MON-ØØ6Ø3-6 events and expresses the Cry1A.105, Cry2Ab2, Cry1F proteins which confer protection against certain lepidopteran pests such as the European corn borer (Ostrinia nubilalis) and species belonging to the genus Sesamia, the PAT protein which confers tolerance to the glufosinate-ammonium herbicide, and the CP4 EPSPS protein which confers tolerance to the glyphosate herbicide.|
|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-89Ø34-3×DAS-Ø15Ø7-1×MON-ØØ6Ø3-6 maize referred to in Article 2(b) and (c).
|Method for detection||- Event specific real-time quantitative PCR based methods for quantitative detection of genetically modified MON-89Ø34-3, DAS-Ø15Ø7-1 and MON-ØØ6Ø3-6 maizes validated on the single-trait events and verified on MON-89Ø34-3xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize.
- Validated by the European Union Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.
|Reference material||ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF415 (for MON-ØØ6Ø3-6) accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue and AOCS 0906-E and AOCS 0406-A (for MON-89Ø34-3) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm.|
|Annex II to the Cartagena Protocol||Biosafety Clearing House
|Conditions or restrictions on the placing on the market||Not required|
|Post-market monitoring requirements||Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.|
|Date of authorisation||06/11/2013|
|Legal bases||Art. 7(3), and 19(3) of the Regulation (EC) No 1829/2003 Commission Decision 2013/648/UE of 6 November 2013|
|Authorisation expiration date||05/11/2023|
|Further information on risk assessment||Opinion of the European Food Safety Authority: