ANNEXSupplementary provisions
ANNEX (a) Applicant and authorisation holder: Name : BASF Agricultural Solutions US LLC Address : 100 Park Avenue, Florham Park, NJ 07932, United States, represented in the Union by BASF SE, Carl-Bosch-Str. 38, D-67063, Ludwigshafen, Germany. (b) Designation and specification of the products: (1) foods and food ingredients containing, consisting of or produced from genetically modified cotton BCS-GHØØ2-5 × ACS-GHØØ1-3; (2) feed containing, consisting of or produced from genetically modified cotton BCS-GHØØ2-5 × ACS-GHØØ1-3; (3) products containing or consisting of genetically modified cotton BCS-GHØØ2-5 × ACS-GHØØ1-3 for uses other than those provided for in points (1) and (2), with the exception of cultivation. The genetically modified cotton BCS-GHØØ2-5 × ACS-GHØØ1-3 expresses the pat and the 2mEPSPS genes, which confer tolerance to glufosinate-ammonium-based and glyphosate-based herbicides. (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 ‘cotton’. (2) The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying the products containing or consisting of the genetically modified cotton BCS-GHØØ2-5 × ACS-GHØØ1-3, 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 cotton BCS-GHØØ2-5, ACS-GHØØ1-3 further verified on genetically modified cotton stack BCS-GHØØ2-5 × ACS-GHØØ1-3; (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: AOCS 1108-A (for BCS-GHØØ2-5), AOCS 0306-E (for ACS-GHØØ1-3) and AOCS 0306-A (for the non-GM counterpart) is accessible via the American Oil Chemists Society (AOCS), at https://www.aocs.org/crm?SSO=True . (e) Unique identifier: BCS-GHØØ2-5 × ACS-GHØØ1-3 (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 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 the 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 ).