ANNEXSupplementary provisions
ANNEX (a) Authorisation holder: Name : Dow AgroSciences Europe Address : European Development Centre, 3 Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom. On behalf of Dow AgroSciences LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, USA (b) Designation and specification of the products: (1) foods and food ingredients containing, consisting of, or produced from soybean DAS-68416-4; (2) feed containing, consisting of, or produced from soybean DAS-68416-4; (3) soybean DAS-68416-4 in products containing it or consisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation. DAS-68416-4 soybean expresses the AAD-12 protein, which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, and the PAT protein, which confers tolerance to glufosinate ammonium-based 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 ‘soybean’; (2) The words ‘not for cultivation’ shall appear on the label of the products and in the accompanying documents of the products containing or consisting of soybean DAS-68416-4 with the exception of products referred to in point (a) of Article 2. (d) Method for detection: (1) Event specific real-time quantitative PCR based method for DAS-68416-4 soybean; the detection method is validated on the single-trait event using genomic DNA extracted from seeds of DAS-68416-4 soybean; (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: ERM®-BF432 accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/. (e) Unique identifier: DAS-68416-4; (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 conforming 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 the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.