MON-ØØ6Ø3-6 x MON-ØØ81Ø-6
EU register of genetically modified food and feed.
| Event | NK603xMON810 |
| Authorisation holder |
Bayer CropScience LP 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America Represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium. |
| Products |
(1) Foods and food ingredients containing, consisting of, or produced from MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize;
(2) Feed containing, consisting of, or produced from MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize; (3) Products other than food and feed containing or consisting of MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize for the same uses as any other maize with the exception of cultivation. |
| Designation | The genetically modified maize MON-ØØ6Ø3-6xMON-ØØ81Ø-6, as described in the application, is produced by crosses between maize containing MON-ØØ6Ø3-6 and MON-ØØ81Ø-6 events and expresses the CP4 EPSPS protein which confers tolerance to glyphosate herbicides and the Cry1Ab protein which confers protection against certain lepidopteran insect pests (Ostrinia nubilalis, Sesamia spp.). |
| 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-ØØ6Ø3-6xMON-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-ØØ6Ø3-6 and MON-ØØ81Ø-6 maize validated on MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize.
-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®-BF413 (for MON-ØØ81Ø-6) and ERM®-BF415 (for MON-ØØ6Ø3-6) accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue/ |
| Unique identifier | MON-ØØ6Ø3-6xMON-ØØ81Ø-6 |
| Annex II to the Cartagena Protocol |
Biosafety Clearing House http://bch.cbd.int/database/record.shtml?documentid=102083 http://bch.cbd.int/database/record.shtml?documentid=114238 |
| 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 | 19/12/2018 |
| Legal bases |
Art. 7(3), 11(3), 19(3) and 23(3) of Regulation (EC) No 1829/2003 COMMISSION IMPLEMENTING DECISION (EU) 2018/2045 Amended by Commission Implementing Decision (EU) 2019/1579 of 18 September 2019 Amended by Commission Implementing Decision (EU) 2021/184 of 12 February 2021 |
| Authorisation expiration date | 18/12/2028 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority: http://registerofquestions.efsa.europa.eu/roqFrontend/questionDocumentsLoader?question=EFSA-Q-2018-00063 http://www.efsa.europa.eu/de/efsajournal/doc/309.pdf |