HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7 × DAS-4Ø278-9

Community register of GM food and feed.

Event MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9

and four related GM maizes combining four different single GM events:
MON 89034 × 1507 × MON 88017 × DAS-40278-9
MON 89034 × 1507 × 59122 × DAS-40278-9
MON 89034 × MON 88017 × 59122 × DAS-40278-9
1507 × MON 88017 × 59122 × DAS-40278-9

and six related GM maizes combining three different single GM events:
MON 89034 × 1507 × DAS-40278-9
MON 89034 × MON 88017 × DAS-40278-9
MON 89034 × 59122 × DAS-40278-9
1507 × MON 88017 × DAS-40278-9
1507 × 59122 × DAS-40278-9
MON 88017 × 59122 × DAS-40278-9

and four related GM maizes combining two different single GM events:
MON 89034 × DAS-40278-9
1507 × DAS-40278-9
MON 88017 × DAS-40278-9
59122 × DAS-40278-9.
Authorisation holder name Dow AgroSciences LLC, United States
Represented in the Union by Dow AgroSciences Distribution S.A.S., France.
Authorisation holder Address Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States
Represented in the Union by Dow AgroSciences Distribution S.A.S., 1 bis, avenue du 8 mai 1945, 78280 Guyancourt, France.
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 MON-89Ø34-3 expresses the cry1A.105 and cry2Ab2 genes, which confer protection against certain lepidopteran pests.
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 MON-88Ø17-3 expresses a modified cry3Bb1 gene, which provides protection to certain coleopteran pests and the cp4 epsps gene, which confers tolerance to glyphosate-based herbicides.
The genetically modified maize DAS-59122-7 expresses the Cry34Ab1 and Cry35Ab1 genes, which confer protection against certain coleopteran pests and the pat gene, which confers tolerance to glufosinate-ammonium-based herbicides.
The genetically modified maize DAS-4Ø278-9 expresses the aad-1 gene, which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) 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 MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3, DAS-59122-7 and DAS-4Ø278-9 and further verified on maize stack MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9.

- 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 AOCS 0906 (for MON-89Ø34-3) and AOCS 0406 (for MON-88Ø17-3) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm#maize, and ERM®-BF418 (for DAS-Ø15Ø7-1), ERM®-BF424 (for DAS-59122-7) and ERM®-BF433 (for DAS-4Ø278-9) are accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue.
Unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-4Ø278-9,
MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7 × DAS-4Ø278-9,
MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7 × DAS-4Ø278-9,
DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7 × DAS-4Ø278-9,
MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-4Ø278-9,
MON-89Ø34-3 × MON-88Ø17-3 × DAS-4Ø278-9,
MON-89Ø34-3 × DAS-59122-7 × DAS-4Ø278-9,
DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-4Ø278-9,
DAS-Ø15Ø7-1 × DAS-59122-7 × DAS-4Ø278-9,
MON-88Ø17-3 × DAS-59122-7 × DAS-4Ø278-9
MON-89Ø34-3 × DAS-4Ø278-9,
DAS-Ø15Ø7-1 × DAS-4Ø278-9,
MON-88Ø17-3 × DAS-4Ø278-9,
DAS-59122-7 × DAS-4Ø278-9.
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=115436
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 28/11/2019
Legal base Commission Implementing Decision (EU) 2019/2086 of 28 November 2019
Authorisation expiration date 27/11/2029
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2018-00989