SYN-BT011-1 x SYN-IR162-4 x SYN-IR604-5 x DAS-01507-1 x SYN-05307-1 x MON-00021-9
EU register of genetically modified food and feed.
| Event |
Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21, and six related GM maizes combining five different single GM events: Bt11 × MIR162 × MIR604 × 1507 × 5307 Bt11 × MIR162 × MIR604 × 1507 × GA21 Bt11 × MIR162 × MIR604 × 5307 × GA21 Bt11 × MIR162 × 1507 × 5307 × GA21 Bt11 × MIR604 × 1507 × 5307 × GA21 MIR162 × MIR604 × 1507 × 5307 × GA21 and twelve related GM maizes combining four different single GM events: Bt11 × MIR162 × MIR604 × 1507 Bt11 × MIR162 × MIR604 × 5307 Bt11 × MIR162 × 1507 × 5307 Bt11 × MIR162 × 5307 × GA21 Bt11 × MIR604 × 1507 × 5307 Bt11 × MIR604 × 5307 × GA21 Bt11 × 1507 × 5307 × GA21 MIR162 × MIR604 × 1507 × 5307 MIR162 × MIR604 × 1507 × GA21 MIR162 × MIR604 × 5307 × GA21 MIR162 × 1507 × 5307 × GA21 MIR604 × 1507 × 5307 × GA21 and eleven related GM maizes combining three different single GM events: Bt11 × MIR162 × 5307 Bt11 × MIR604 × 5307 Bt11 × 1507 × 5307 Bt11 × 5307 × GA21 MIR162 × MIR604 × 1507 MIR162 × MIR604 × 5307 MIR162 × 1507 × 5307 MIR162 × 5307 × GA21 MIR604 × 1507 × 5307 MIR604 × 5307 × GA21 1507 × 5307 × GA21 and five related GM maizes combining two different single GM events: Bt11 × 5307 MIR162 × 5307 MIR604 × 5307 1507 × 5307 5307 × GA21. |
| Authorisation holder name |
Syngenta Crop Protection AG, Switzerland Represented in the Union by Syngenta Crop Protection NV/SA, Belgium |
| Authorisation holder Address |
Syngenta Crop Protection AG, Rosentalstrasse 67, CH-4058 Basel, Switzerland
Represented in the Union by Syngenta Crop Protection NV/SA, Avenue Louise, 489, 1050 Brussels, Belgium. |
| Products |
(1) foods and food ingredients containing, consisting of, or produced from genetically modified maize (Zea mays L.) as referred to in the “unique identifiers” row; (2) feed containing, consisting of, or produced from genetically modified maize (Zea mays L.) as referred to in the “unique identifiers” row; (3) products containing or consisting of genetically modified maize (Zea mays L.) as referred to in the “unique identifiers” row for uses other than those provided for in points (1) and (2), with the exception of cultivation. |
| Designation |
The genetically modified maize SYN-BTØ11-1 expresses the cry1Ab gene, which confers protection against certain lepidopteran pests, and the pat gene, which confers tolerance to glufosinate-ammonium-based herbicides. The genetically modified maize SYN-IR162-4 expresses the vip3Aa20 gene, which confers protection against certain lepidopteran pests, and the pmi gene, which was used as a selectable marker. The genetically modified maize SYN-IR6Ø4-5 expresses a modified cry3A gene, which provides protection against certain coleopteran pests, and the pmi gene, which was used as a selectable marker. The genetically modified maize DAS-Ø15Ø7-1 expresses the cry1F gene, which confers protection against certain lepidopteran pests and the pat gene, which confers tolerance to glufosinate-ammonium-based herbicides. The genetically modified maize SYN-Ø53Ø7-1 expresses the ecry3.1Ab gene, which confers resistance to certain coleopteran pests, and the pmi gene, which was used as a selectable marker. The genetically modified maize MON-ØØØ21-9 expresses the mepsps gene, which confers tolerance to glyphosate-based herbicides. |
| Labelling |
(1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 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 the products containing or consisting of the maize specified with their unique identifiers, with the exception of products referred to in point (1) of the “Products” row. |
| Method for detection |
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events SYN-BTØ11-1, SYN-IR162-4, SYN-IR6Ø4-5, DAS-Ø15Ø7-1, SYN-Ø53Ø7-1 and MON-ØØØ21-9 and further verified on maize stack Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21. Validated by the EU 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®-BF412 (for SYN-BTØ11-1), ERM®-BF446 (for SYN-IR162-4), ERM®-BF423 (for SYN-IR6Ø4-5) and ERM®-BF418 (for DAS-Ø15Ø7-1) are accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/, and AOCS 0411-C and 0411-D (for SYN-Ø53Ø7-1) and AOCS 0407-A and 0407-B (for MON-ØØØ21-9) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm. |
| Unique identifier |
SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; and it’s sub-combinations: SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1; SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1; SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1; SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1; SYN-BTØ11-1 × SYN-IR162-4 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1; SYN-BTØ11-1 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-BTØ11-1 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1; SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9; SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR162-4 × SYN-Ø53Ø7-1; SYN-BTØ11-1 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1; SYN-BTØ11-1 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1; SYN-BTØ11-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1; SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1; SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1; SYN-IR162-4 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1; SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-Ø53Ø7-1; SYN-IR162-4 × SYN-Ø53Ø7-1; SYN-IR6Ø4-5 × SYN-Ø53Ø7-1; DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1; SYN-Ø53Ø7-1 × MON-ØØØ21-9. |
| Annex II to the Cartagena Protocol | https://bch.cbd.int/database/record.shtml?documentid=115432 |
| Conditions or restrictions on the placing on the market | Not required |
| Monitoring plan | |
| Post-market monitoring requirements | Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC |
| Date of authorisation | 28/11/2019 |
| Legal base |
Commission Implementing Decision (EU) 2019/2087 of 28 November 2019 Commission Implementing Decision (EU) 2023/2143 of 13 October 2023 https://eur-lex.europa.eu/eli/dec_impl/2023/2143/oj |
| Authorisation expiration date | 27/11/2029 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority: https://doi.org/10.2903/j.efsa.2019.5635 |