HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

DAS-Ø15Ø7-1xMON-ØØ6Ø3-6

Community register of GM food and feed.

Event 1507xNK603
Authorisation holder A) Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, P.O. Box 1014, Johnston, IA 50131-1014, United States
Represented by: Pioneer Overseas Corporation, Avenue des Arts, 44, 1040 Brussels, Belgium;
And

B) Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States
Represented 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 1507 × NK603;
(2) Feed containing, consisting of, or produced from genetically modified maize 1507 × NK603;
(3) Products containing or consisting of genetically modified maize 1507 × NK603 for uses other than those provided for in points (1) and (2), with the exception of cultivation.
Designation The genetically modified maize 1507 × NK603 expresses the cry1F gene, which confers protection against certain lepidopteran pests, the pat gene, which confers tolerance to glufosinate-ammonium based herbicides, and the cp4 epsps gene, which confers tolerance to glyphosate based herbicides.
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 the products containing or consisting of genetically modified maize 1507 × NK603, with the exception of products referred to in point (1) of the raw “Products”.
Method for detection - Event specific real-time quantitative PCR based methods for genetically modified maize DAS-Ø15Ø7-1 and maize MON-ØØ6Ø3-6 validated on maize DAS-Ø15Ø7-1xMON-ØØ6Ø3-6.

- 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 ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF415 (for MON-ØØ6Ø3-6) accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue/
Unique identifier DAS-Ø15Ø7-1xMON-ØØ6Ø3-6
Annex II to the Cartagena Protocol http://bch.cbd.int/database/record.shtml?documentid=115404
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 26/07/2019
Legal bases Commission Implementing Decision (EU) 2019/1306 of 26 July 2019
Authorisation expiration date 28/07/2029
Further information on risk assessment Opinions of the European Food Safety Authority:
http://www.efsa.europa.eu/fr/efsajournal/pub/355
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2018-00509