SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x MON-ØØØ21-9
EU register of genetically modified food and feed.
| Event |
Bt11 × MIR162 × MIR604 × GA21, and it’s sub-combinations: Bt11 × MIR162 × MIR604, Bt11 × MIR162 × GA21, Bt11 × MIR604 × GA21, MIR162 × MIR604 × GA21, Bt11 × MIR162, Bt11 × MIR604, Bt11 × GA21, MIR162 × MIR604, MIR162 × GA21, MIR604 × GA21. |
| Authorisation holder |
Syngenta Crop Protection NV/SA Avenue Louise 489, 1050 Brussels, Belgium On behalf of Syngenta Crop Protection AG, Rosentalstrasse 67, CH-4058 Basel, Switzerland. |
| Products |
(1) Foods and food ingredients containing, consisting of, or produced from the GMOs, specified with their unique identifiers in row 1 "Event";
(2) Feed containing, consisting of, or produced from the GMOs, specified with their unique identifiers in row 1 "Event"; (3) Products, other than food and feed, containing or consisting of the GMOs, specified with their unique identifiers in row 1 "Event", for the same uses as any other maize with the exception of cultivation. |
| Designation | The genetically modified maize SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 maize, as described in the application, is produced by crosses between maize containing SYN-BTØ11-1, SYN-IR162-4, SYN-IR6Ø4-5 and MON-ØØØ21-9 events and expresses the Cry1Ab and Vip3Aa20 proteins which confer protection against certain lepidopteran pests; Cry3A protein which confers protection against certain coleopteran pests; mEPSPS protein which confers tolerance to the glyphosate herbicide and PMI protein which 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 from the GMOs, specified with their unique identifiers in row 1 "Event" and referred to in Article 2(b) and (c). |
| Method for detection |
Event specific real-time quantitative PCR based methods for SYN-BTØ11-1, SYN-IR162-4, SYN-IR6Ø4-5 and MON-ØØØ21-9 maizes; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 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 | Reference Material: ERM®-BF412 (for SYN-BTØ11-1), ERM®-BF446 (for SYN-IR162-4) and ERM®-BF423 (for SYN-IR6Ø4-5) accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/ and AOCS 0407-A and AOCS 0407-B (for MON-ØØØ21-9) accessible via the American Oil Chemists Society at https://www.aocs.org/crm. |
| Unique identifier |
SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9; and it’s sub-combinations: SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5; SYN-BTØ11-1 × SYN-IR162-4 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-ØØØ21-9; SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR162-4; SYN-BTØ11-1 × SYN-IR6Ø4-5; SYN-BTØ11-1 × MON-ØØØ21-9; SYN-IR162-4 × SYN-IR6Ø4-5; SYN-IR162-4 × MON-ØØØ21-9; SYN-IR6Ø4-5 × MON-ØØØ21-9. |
| Annex II to the Cartagena Protocol | https://bch.cbd.int/database/record.shtml?documentid=110991 |
| Conditions or restrictions on the placing on the market | Specific conditions for the placing on the market as mentioned in the Commission Implementing Decision (EU) 2016/1685 |
| Post-market monitoring requirements | Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC. |
| Date of authorisation | 19/09/2016 |
| Legal bases |
Commission Decision 2016/1685 of 16 September 2016 Amended by Commission Implementing Decision (EU) 2019/60 of 11 January 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 | 18/09/2026 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority: https://doi.org/10.2903/j.efsa.2015.4297 https://doi.org/10.2903/j.efsa.2017.4745 |