HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9

Community register of GM food and feed.

Event SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9

and five related GM maizes combining four different single GM events:
SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
SYN-BTØ11-1 × DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × MON-ØØØ21-9,
SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1,
DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9

and nine related GM maizes combining three different single GM events:
SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5,
SYN-BTØ11-1 × DAS-59122-7 × DAS-Ø15Ø7-1,
SYN-BTØ11-1 × DAS-59122-7 × MON-ØØØ21-9,
SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1,
SYN-BTØ11-1 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1,
DAS-59122-7 × SYN-IR6Ø4-5 × MON-ØØØ21-9,
DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9

and six related GM maizes combining two different single GM events:
SYN-BTØ11-1 × DAS-59122-7,
SYN-BTØ11-1 × DAS-Ø15Ø7-1,
DAS-59122-7 × SYN-IR6Ø4-5,
DAS-59122-7 × MON-ØØØ21-9,
SYN-IR6Ø4-5 × DAS-Ø15Ø7-1,
DAS-Ø15Ø7-1 × MON-ØØØ21-9.
Authorisation holder Syngenta Crop Protection NV/SA
489, Avenue Louise, 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 genetically modified maizes (Zea mays L.), specified with their unique identifiers in row 1 "Event";
(2) Feed containing, consisting of, or produced from genetically modified maizes (Zea mays L.), specified with their unique identifiers in row 1 "Event";
(3) genetically modified maizes (Zea mays L.), specified with their unique identifiers in row 1 "Event", in products containing them or consisting of them for any other use than those provided in points (1) and (2), with the exception of cultivation.
Designation The genetically modified maize SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9, as described in the application, is produced by crosses between maize containing SYN-BTØ11-1, DAS-59122-7, SYN-IR6Ø4-5, DAS-Ø15Ø7-1 and MON-ØØØ21-9 events and expresses the Cry1Ab and Cry1F proteins which confers protection against certain lepidopteran pests; Cry34Ab1, Cry35Ab1 and a modified Cry3A proteins which confer protection against certain coleopteran pests; PAT protein which confers tolerance to glufosinate-ammonium herbicides; mEPSPS protein which confers tolerance to glyphosate herbicides and PMI protein which was used as a selection 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 the accompanying documents of the products containing or consisting of the maizes, specified with their unique identifiers in row 1 "Event", with the exception of products referred to in point (1) of row 3 "Products".
Method for detection - Event specific real-time quantitative PCR based methods for SYN-BTØ11-1, DAS-59122-7, SYN-IR6Ø4-5, DAS-Ø15Ø7-1 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 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 maize;
- 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®-BF424 (for DAS-59122-7), ERM®-BF423 (for SYN-IR6Ø4-5) and ERM®-BF418 (for DAS-Ø15Ø7) accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) 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 http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248.
Unique identifier SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
SYN-BTØ11-1 × DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × MON-ØØØ21-9,
SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1,
DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5,
SYN-BTØ11-1 × DAS-59122-7 × DAS-Ø15Ø7-1,
SYN-BTØ11-1 × DAS-59122-7 × MON-ØØØ21-9,
SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1,
SYN-BTØ11-1 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1,
DAS-59122-7 × SYN-IR6Ø4-5 × MON-ØØØ21-9,
DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9,
SYN-BTØ11-1 × DAS-59122-7,
SYN-BTØ11-1 × DAS-Ø15Ø7-1,
DAS-59122-7 × SYN-IR6Ø4-5,
DAS-59122-7 × MON-ØØØ21-9,
SYN-IR6Ø4-5 × DAS-Ø15Ø7-1,
DAS-Ø15Ø7-1 × MON-ØØØ21-9.
Annex II to the Cartagena Protocol http://bch.cbd.int/database/record.shtml?documentid=112254
Conditions or restrictions on the placing on the market Specific conditions in accordance with Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003:
(1) The authorisation holder shall inform the Commission if any of the sub-combinations were to be created via targeted breeding approaches and commercialised.
(2) If it is the case, the authorisation holder shall collate information on the expression levels of the newly expressed proteins.
Monitoring plan for environmental effects Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
Post-market monitoring requirements Not required
Date of authorisation 04/07/2017
Legal base Commission Decision 2017/1209/EU of 4 July 2017
Authorisation expiration date 03/07/2027
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2011-00894

EFSA statement on risk assessment of information on the sub-combination Bt11 x 1507 x GA21
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.5092/full