ANNEX
(a) Applicant and authorisation holder:
Name
:
Corteva Agriscience LLC
Address
:
9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States
Represented in the Union by Corteva Agriscience Belgium BV, Rue Montoyer 25, 1000 Brussels, Belgium.
(b) Designation and specification of the products:
(1)
foods and food ingredients containing, consisting of or produced from genetically modified maize as referred to in point (e);
(2)
feed containing, consisting of or produced from genetically modified maize as referred to in point (e);
(3)
products containing or consisting of genetically modified maize as referred to in point (e); for uses other than those provided for in points (1) and (2), with the exception of cultivation.
The genetically modified maize DP-ØØ4114-3 expresses the cry1F, cry34Ab1 and cry35Ab1 genes, which confer protection against certain lepidopteran and coleopteran pests and the pat gene, which confers tolerance to glufosinate ammonium-based herbicides.
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 MON-87411-9 expresses the dvSnf7 dsRNA gene, which confers protection against western corn rootworm, cry3Bb1 gene, which confers protection against certain coleopteran pests and CP4 EPSPS protein, which confers tolerance to glyphosate 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.
(c) 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 genetically modified maize referred to in point (e), with the exception of the products referred to in point (b)(1).
(d) Method for detection:
(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events DP-ØØ4114-3, MON-89Ø34-3, MON-87411-9, DAS-4Ø278-9 and further verified on maize DP-ØØ4114-3 x MON-89Ø34-3 x MON-87411-9 x DAS-4Ø278-9;
(2)
Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;
(3)
Reference Material: AOCS 0906-E2 (for MON-89Ø34-3) and AOCS 0215-B (for MON-87411-9) are accessible via the American Oil Chemist Society at https://www.aocs.org/crm#maize; ERM ® -BF439 a-e (for DP-ØØ4114-3) and ERM ® -BF433 a-d (for DAS-4Ø278-9) are accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/.
(e) Unique identifier:
DP-ØØ4114-3 x MON-89Ø34-3 x MON-87411-9 x DAS-4Ø278-9;
DAS-4Ø278-9 x DP-ØØ4114-3 x MON-87411-9;
MON-89Ø34-3 x DP-ØØ4114-3 x MON-87411-9;
MON-89Ø34-3 x DAS-4Ø278-9 x MON-87411-9;
MON-89Ø34-3 x DAS-4Ø278-9 x DP-ØØ4114-3;
DP-ØØ4114-3 x MON-87411-9;
DAS-4Ø278-9 x MON-87411-9;
DAS-4Ø278-9 x DP-ØØ4114-3;
MON-89Ø34-3 x DP-ØØ4114-3.
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified ].
(g) Conditions or restrictions on the placing on the market, use or handling of the products:
Not required.
(h) Monitoring plan for environmental effects:
Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC.
[Link: plan published in the Community register of genetically modified food and feed ]
(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.
