Genetically Modified Organisms

SYN-Ø53Ø7-1 × SYN-BTØ11-1 × MON-ØØØ21-9 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3;

EU register of genetically modified food and feed.

Event Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21

And thirty sub-combinations:

Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21;
Bt11 × GA21 × MIR162 × MIR604 × MON 89034;
5307 × GA21 × MIR162 × MIR604 × MON 89034;
5307 × Bt11 × MIR162 × MIR604 × MON 89034;
5307 × Bt11 × GA21 × MIR604 × MON 89034;
5307 × Bt11 × GA21 × MIR162 × MON 89034;
GA21 × MIR162 × MIR604 × MON 89034;
Bt11 × MIR162 × MIR604 × MON 89034;
Bt11 × GA21 × MIR604 × MON 89034;
Bt11 × GA21 × MIR162 × MON 89034;
5307 × MIR162 × MIR604 × MON 89034;
5307 × GA21 × MIR604 × MON 89034;
5307 × GA21 × MIR162 × MON 89034;
5307 × Bt11 × MIR604 × MON 89034;
5307 × Bt11 × MIR162 × MON 89034;
5307 × Bt11 × GA21 × MON 89034;
MIR162 × MIR604 × MON 89034;
GA21 × MIR604 × MON 89034;
GA21 × MIR162 × MON 89034;
Bt11 × MIR604 × MON 89034;
Bt11 × MIR162 × MON 89034;
Bt11 × GA21 × MON 89034;
5307 × MIR604 × MON 89034;
5307 × MIR162 × MON 89034;
5307 × GA21 × MON 89034;
5307 × Bt11 × MON 89034;
MIR604 × MON 89034;
GA21 × MON 89034;
Bt11 × MON 89034;
5307 × MON 89034;
MIR162 × MON 89034.
 
Authorisation holder Name Syngenta Crop Protection AG represented in the Union by Syngenta Crop Protection
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) food and food ingredients containing, consisting of or produced from genetically modified maize referred to in “Unique identifiers” row;

(2) feed containing, consisting of or produced from genetically modified maize referred to in “Unique identifiers” row;

(3) products containing or consisting of genetically modified maize referred to in “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-Ø53Ø7-1 expresses the ecry3.1Ab gene, which confers resistance to certain coleopteran pests. In addition, the pmi gene coding for the PMI protein was used as a selection marker in the genetic modification process.

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 MON-ØØØ21-9 expresses the mepsps gene, which confers tolerance to glyphosate-based herbicides.

The genetically modified maize SYN-IR162-4 expresses the vip3Aa20 gene, which confers protection against certain lepidopteran pests. In addition, the pmi gene coding for the PMI protein was used as a selection marker in the genetic modification process.

The genetically modified maize SYN-IR6Ø4-5 expresses a modified cry3A gene, which provides protection against certain coleopteran pests. In addition, the pmi gene coding for the PMI protein was used as a selection marker in the genetic modification process.

The genetically modified maize MON-89Ø34-3 expresses the cry1A.105 and cry2Ab2 genes, which confer protection against certain lepidopteran pests.
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 genetically modified maize referred to in "Unique identifier" row, with the exception of the products referred to in point 1 of the "Products" row.
Method for detection (1) The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events SYN-Ø53Ø7-1, SYN-BTØ11-1, MON-ØØØ21-9, SYN-IR162-4, SYN-IR6Ø4-5 and MON-89Ø34-3 and further verified on maize SYN-Ø53Ø7-1 × SYN-BTØ11-1 × MON-ØØØ21-9 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3.
(2) 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) and ERM®-BF423 (for SYN-IR6Ø4-5) and are accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/ AOCS 0906 and AOCS 0406 (for MON-89Ø34-3), 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-Ø53Ø7-1 × SYN-BTØ11-1 × MON-ØØØ21-9 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-BTØ11-1 × MON-ØØØ21-9 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3
SYN-Ø53Ø7-1 × MON-ØØØ21-9 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-BTØ11-1 × MON-ØØØ21-9 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-BTØ11-1 × MON-ØØØ21-9 × SYN-IR162-4 × MON-89Ø34-3;
MON-ØØØ21-9 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-BTØ11-1 × MON-ØØØ21-9 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-BTØ11-1 × MON-ØØØ21-9 × SYN-IR162-4 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × MON-ØØØ21-9 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × MON-ØØØ21-9 × SYN-IR162-4 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-BTØ11-1 × SYN-IR162-4 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-BTØ11-1 × MON-ØØØ21-9 × MON-89Ø34-3;
SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3;
MON-ØØØ21-9 × SYN-IR6Ø4-5 × MON-89Ø34-3;
MON-ØØØ21-9 × SYN-IR162-4 × MON-89Ø34-3;
SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-BTØ11-1 × SYN-IR162-4 × MON-89Ø34-3;
SYN-BTØ11-1 × MON-ØØØ21-9 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-IR6Ø4-5 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-IR162-4 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × MON-ØØØ21-9 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × SYN-BTØ11-1 × MON-89Ø34-3;
SYN-IR6Ø4-5 × MON-89Ø34-3;
MON-ØØØ21-9 × MON-89Ø34-3;
SYN-BTØ11-1 × MON-89Ø34-3;
SYN-Ø53Ø7-1 × MON-89Ø34-3;
SYN-IR162-4 × MON-89Ø34-3.
Annex II to the Cartagena Protocol To be provided later.
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 29/01/2024
Legal base Commission Implementing Decision (EU) 2024/391 of 26 January 2024
Authorisation expiration date 28/01/2034
Further information on risk assessment Opinion of the European Food Safety Authority
https://doi.org/10.2903/j.efsa.2023.8011
Version: 1.1.3