ANNEX

(a) Applicant and authorisation holder:

Name

:

Pioneer Overseas Corporation

Address

:

Avenue des Arts 44, 1040 Brussels, Belgium

On behalf of Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, PO Box 1014, Johnston, IA 50131-1014, United States of America

(b) Designation and specification of the products:

1.

foods and food ingredients containing, consisting of, or produced from DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6 maize;

2.

feed containing, consisting of, or produced from DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6 maize;

3.

products other than food and feed containing or consisting of DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6 maize, as described in the application, is produced by crosses between maize containing DAS-59122-7, DAS-Ø15Ø7 and MON-ØØ6Ø3-6 events and expresses the Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain coleopteran pests, the Cry1F protein which confers protection against certain lepidopteran pests, the PAT protein, used as a selectable marker, which confers tolerance to the glufosinate-ammonium herbicide and the CP4 EPSPS protein which confers tolerance to glyphosate herbicide.

(c) Labelling:

1.

for the purposes of the specific 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 products containing or consisting of DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6 maize referred to in Article 2(b) and (c) of this Decision.

(d) Method for detection:

  • event specific real-time quantitative PCR-based methods for genetically modified maize DAS-59122-7, DAS-Ø15Ø7 and MON-ØØ6Ø3-6 maize validated on DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6 maize,

  • validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

  • reference material: ERM®-BF424 (for DAS-59122-7), ERM®-BF418 (for DAS-Ø15Ø7) and ERM®-BF415 (for MON-ØØ6Ø3-6) accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue

(e) Unique identifier:

DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6.

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

Biosafety Clearing House, Record ID: see [to be completed when notified].

(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h) Monitoring plan:

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

[Link: plan published on the Internet]

(i) Post-market monitoring requirements for the use of the food for human consumption:

Not required.

Note: Links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.