MON-88Ø17-3 x MON-ØØ81Ø-6
EU register of genetically modified food and feed.
| Event | MON88017xMON810 |
| Authorisation holder Name | Bayer CropScience LP |
| Authorisation holder Address |
800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America Represented in the Union by: Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium |
| Products |
(1) Foods and food ingredients containing, consisting of, or produced from genetically modified maize MON-88Ø17-3 × MON-ØØ81Ø-6;
(2) Feed containing, consisting of, or produced from genetically modified maize MON-88Ø17-3 × MON-ØØ81Ø-6; (3) Products other than food and feed containing or consisting of genetically modified maize MON-88Ø17-3 × MON-ØØ81Ø-6 with the exception of cultivation. |
| Designation | The genetically modified maize MON-88Ø17-3xMON-ØØ81Ø-6, as described in the application, expresses a modified Cry3Bb1 protein which provides protection to certain coleopteran pests, Cry1Ab protein which confers protection against certain lepidopteran insect pests and the CP4 EPSPS protein which confers tolerance to glyphosate herbicides. |
| 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 genetically modified maize MON-88Ø17-3 × MON-ØØ81Ø-6referred to in Article 2(b) and (c). |
| Method for detection |
- Event-specific real-time quantitative PCR methods validated for genetically modified maize MON-88Ø17-3 and MON-ØØ81Ø-6 and verified on MON-88Ø17-3 x MON-ØØ81Ø-6 maize.
- Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at https://gmo-crl.jrc.ec.europa.eu/method-validations |
| Reference material | - Reference material: AOCS 0406-D2 (for MON-88Ø17-3) accessible via the American Oil Chemists Society at https://www.aocs.org/crm and ERM®-BF413 (for MON-ØØ81Ø-6) accessible via the Joint Research Centre JRC) of the European Commission accessible at https://crm.jrc.ec.europa.eu/ |
| Unique identifier | MON-88Ø17-3xMON-ØØ81Ø-6 |
| Annex II to the Cartagena Protocol |
Biosafety Clearing-House http://bch.cbd.int/database/record-v4.shtml?documentid=101317 https://bch.cbd.int/database/record.shtml?documentid=116333 |
| 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 | 18/08/2021 |
| Legal base |
Commission Decision 2010/429 of 28 July 2010
Amended by Commission Implementing Decision (EU) 2019/1579 of 18 September 2019 Amended by Commission Implementing Decision (EU) 2021/184 of 12 February 2021 Commission Implementing Decision (EU) 2021/1393 of 17 August 2021 |
| Authorisation expiration date | 17/08/2031 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority: https://doi.org/10.2903/j.efsa.2009.1192 https://doi.org/10.2903/j.efsa.2021.6375 |