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 B.V., 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 ( Zea mays L.) and its sub-combinations as referred to in point (e);
(2)
feed containing, consisting of or produced from genetically modified maize ( Zea mays L.) and its sub-combinations as referred to in point (e);
(3)
products containing or consisting of genetically modified maize ( Zea mays L.) and its sub-combinations 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-2Ø2216-6 expresses the mo-pat gene, which confers tolerance to herbicides containing glufosinate-ammonium, and the zmm28 gene, which extends and increases the expression of the endogenous ZMM28 protein, providing an opportunity for yield enhancement under field conditions.
The genetically modified maize MON-ØØ6Ø3-6 expresses the cp4 epsps gene which confers tolerance to glyphosate-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.
(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 and its sub-combinations as referred to in point (e), with the exception of 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-2Ø2216-6 , MON-ØØ6Ø3-6 and DAS-4Ø278-9 and further verified on maize stack DP-2Ø2216-6 × MON-ØØ6Ø3-6 × DAS-4Ø278-9;
(2)
validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at https://gmo-crl.jrc.ec.europa.eu/method-validations
(3)
reference material: ERM®-BF433 a-d (for DAS-4Ø278-9), ERM®-BF444 a-e (for DP-2Ø2216-6), and ERM®-BF415 a-g (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/ .
(e)
Unique identifiers:
DP-2Ø2216-6 × MON-ØØ6Ø3-6 × DAS-4Ø278-9
DP-2Ø2216-6 × MON-ØØ6Ø3-6
DP-2Ø2216-6 × DAS-4Ø278-9
(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 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 through the updating of the Community register of genetically modified food and feed.
