HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

DAS-Ø15Ø7-1 × DAS-59122-7 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6

Community register of GM food and feed.

Event DAS-Ø15Ø7-1 × DAS-59122-7 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6;

and four related GM maizes combining three different single GM events:
DAS-Ø15Ø7-1 × DAS-59122-7 × MON-ØØ81Ø-6;
DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;
DAS-Ø15Ø7-1 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6;
DAS-59122-7 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6;

and four related GM maizes combining two different single GM events:
DAS-Ø15Ø7-1 × DAS-59122-7;
DAS-Ø15Ø7-1 × MON-ØØ81Ø-6;
DAS-59122-7 × MON-ØØ81Ø-6;
DAS-59122-7 × MON-ØØ6Ø3-6.
Authorisation holder Name Pioneer Hi-Bred International
Represented by
Pioneer Overseas Corporation
Authorisation holder Address Pioneer Hi-Bred International, Inc.
7100 NW 62nd Avenue, P.O. Box 1014, Johnston, IA 50131-1014, U.S.A.
Represented by Pioneer Overseas Corporation, Avenue des Arts, 44, 1040 Brussels, Belgium.
Products (1) foods and food ingredients containing, consisting of, or produced from genetically modified maize (Zea mays L.) specified with their unique identifiers in row 1 "Event";
(2) feed containing, consisting of, or produced from genetically modified maize (Zea mays L.) specified with their unique identifiers in row 1 "Event";
(3) genetically modified maize (Zea mays L.) specified with their unique identifiers in row 1 "Event" in products containing them or consisting of them for uses other than those provided for in points (1) and (2), with the exception of cultivation.
Designation DAS-Ø15Ø7-1 maize expresses the Cry1F protein which confers protection against certain lepidopteran pests and the PAT protein, which confers tolerance to glufosinate-ammonium based herbicides.

DAS-59122-7 maize expresses Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain coleopteran pests and the PAT protein, which confers tolerance to glufosinate-ammonium based herbicides.

MON-ØØ81Ø-6 maize expresses the Cry1Ab protein, which confers protection against certain lepidopteran pests.

MON-ØØ6Ø3-6 maize expresses the CP4 EPSPS protein, which confers tolerance to glyphosate-containing 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 the accompanying documents of the products containing or consisting the maize specified with their unique identifiers in row 1 "Event", with the exception of foods and food ingredients.
Method for detection - The quantitative event-specific PCR detection methods for maize 1507 × 59122 × MON 810 × NK603 are those validated for genetically modified maize events DAS-Ø15Ø7-1, DAS-59122-7, MON-ØØ81Ø-6 and MON-ØØ6Ø3-6.

- Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
Reference material ERM®-BF418 (for DAS-Ø15Ø7-1), ERM®-BF424 (for DAS-59122-7), ERM®-BF413 (for MON-ØØ81Ø-6) and ERM®-BF415 (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue/
Unique identifier DAS-Ø15Ø7-1 × DAS-59122-7 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6;
DAS-Ø15Ø7-1 × DAS-59122-7 × MON-ØØ81Ø-6;
DAS-59122-7 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;
DAS-Ø15Ø7-1 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6;
DAS-59122-7 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6;
DAS-Ø15Ø7-1 × DAS-59122-7;
DAS-Ø15Ø7-1 × MON-ØØ81Ø-6;
DAS-59122-7 × MON-ØØ81Ø-6;
DAS-59122-7 × MON-ØØ6Ø3-6.
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=114236
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 03/08/2018
Legal base Commission Decision 2018/1110 (EU) of 03 August 2018
Authorisation expiration date 05/08/2028
Further information on risk assessment Opinions of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionDocumentsLoader?question=EFSA-Q-2017-00672
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2005-247
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2005-248
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2005-123