ANNEX
(a)
Applicants and authorisation holders:
(1)
Name: Bayer CropScience LP
Address: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States;
represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;
and
(2)
Name: Corteva Agriscience LLC
Address: 9330 Zionsville Road, Indianapolis, IN, 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.) referred to in point (e);
(2)
feed containing, consisting of or produced from genetically modified maize ( Zea mays L.) referred to in point (e);
(3)
products containing or consisting of genetically modified maize ( Zea mays L.) 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 MON-89Ø34-3 expresses the cry1A.105 and cry2Ab2 genes, which confer protection against certain lepidopteran pests.
The genetically modified maize DAS-Ø15Ø7-1 expresses the cry1F gene, which confers protection against certain lepidopteran pests, and the pat gene, which confers tolerance to herbicides containing glufosinate-ammonium.
The genetically modified maize MON-88Ø17-3 expresses the cry3Bb1 gene, which confers protection against certain coleopteran pests, and the CP4 epsps gene, which confers tolerance to glyphosate-based herbicides.
The genetically modified maize DAS-59122-7 expresses the cry34Ab1 and cry35Ab1 genes, which confer resistance to certain coleopteran pests, and the pat gene, which confers tolerance to herbicides containing glufosinate-ammonium.
(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 organisms 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 specified 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 MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7, and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;
(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-E (for MON-89Ø34-3), AOCS 0406-D (for MON-88Ø17-3) and AOCS 0406-A (for their non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), at https://www.aocs.org/crm?SSO=True . ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF424 (for DAS-59122-7) are accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/ .
(e)
Unique identifiers:
MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7
MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3
MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7
MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7
DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7
MON-89Ø34-3 × DAS-Ø15Ø7-1
MON-89Ø34-3 × DAS-59122-7
DAS-Ø15Ø7-1 × MON-88Ø17-3
MON-88Ø17-3 × DAS-59122-7
(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 of the European Parliament and of the Council ( 1 ) .
[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.
( 1 ) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC ( OJ L 106, 17.4.2001, p. 1 , ELI: http://data.europa.eu/eli/dir/2001/18/oj ).
