ANNEXSupplementary provisions
ANNEX (a) Applicant and authorisation holder: Name : Bayer CropScience LLC Address : 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States, represented in the Union by: Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium. (b) Designation and specification of the products: (1) foods and food ingredients containing, consisting of or produced from genetically modified maize MON-8746Ø-4; (2) feed containing, consisting of or produced from genetically modified maize MON-8746Ø-4; (3) products containing or consisting of genetically modified maize MON-8746Ø-4, for uses other than those provided for in points (1) and (2), with the exception of cultivation. The genetically modified maize MON-8746Ø-4 expresses the CspB gene, which confers tolerance to drought. In addition, the nptII gene, conferring kanamycin and neomycin resistance, was used as a selection marker in the genetic modification process. (c) Labelling: (1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2), points (a) and (b), 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 MON-8746Ø-4, with the exception of the products referred to in point (b)(1). (d) Method for detection: (1) event-specific method for the quantification of genetically modified maize MON-8746Ø-4 using real-time PCR; (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 0709-A (for MON-8746Ø-4) and AOCS 0406-A (for the non-genetically modified counterpart) are accessible through the American Oil Chemists Society (AOCS) at https://www.aocs.org/crm . (e) Unique identifier: MON-8746Ø-4 (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. [Link: plan published in the Community register of genetically modified food and feed ] (i) Post-market monitoring requirements: Not required. Note: links to the 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.