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Commission Implementing Decision (EU) 2021/1389 of 17 August 2021 authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021)5996) (Only the German text is authentic) (Text with EEA relevance)

Type Implementing Decision

Publication 2021-08-24

Last updated 2026-07-29

State In force

Department European Commission, SANTE

Source EUR-Lex

articles 9

Reform history JSON API

Article 1

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutum and Gossypium barbadense) GHB614 × T304-40 × GHB119, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8, in accordance with Regulation (EC) No 65/2004.

Article 2

Authorisation

The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:

(a) foods and food ingredients containing, consisting of or produced from genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8;

(b) feed containing, consisting of or produced from genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8;

(c) products containing or consisting of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 for uses other than those provided for in points (a) and (b), with the exception of cultivation.

Article 3

Labelling

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 ‘cotton’.

The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8, with the exception of products referred to in point (a) of Article 2.

Article 4

Method for detection

The method set out in point (d) of the Annex shall apply for the detection of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8.

Article 5

Monitoring plan for environmental effects

The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.

The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Article 6

Community register

The information set out in the Annex shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28(1) of Regulation (EC) No 1829/2003.

Article 7

Authorisation holder

The authorisation holder shall be BASF Agricultural Solutions US LLC, United States, represented in the Union by BASF Agricultural Solutions Belgium NV, Belgium.

Article 8

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Article 9

Addressee

This Decision is addressed to BASF Agricultural Solutions US LLC, 2 T.W. Alexander Dr., Durham, NC 27713, United States, represented in the Union by BASF Agricultural Solutions Belgium NV, Technologiepark-Zwijnaarde 101, 9052 Ghent, Belgium.

ANNEX

(a) Applicant and authorisation holder: Name: BASF Agricultural Solutions US LLC Address: 2 T.W. Alexander Dr., Durham, NC 27713, United States, represented in the Union by BASF Agricultural Solutions Belgium NV, Technologiepark-Zwijnaarde 101, 9052 Ghent, Belgium.

(b) Designation and specification of the products:
(1) foods and food ingredients containing, consisting of or produced from genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8;
(2) feed containing, consisting of or produced from genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8;
(3) products containing or consisting of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 for uses other than those provided for in points (1) and (2), with the exception of cultivation. The genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 expresses the 2mepsps gene, which confers tolerance to glyphosate based herbicides, the bar gene, which confers tolerance to glufosinate-ammonium based herbicides, the cry1Ab, and the cry2Ae genes, which confer resistance to certain lepidopteran pests.

(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 ‘cotton’;
(2) The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8, with the exception of foods and food ingredients.

(d) Method for detection:
(1) The quantitative event-specific PCR detection methods for cotton GHB614 × T304-40 × GHB119 are those validated for genetically modified cotton events BCS-GHØØ2-5, BCS-GHØØ4-7 and BCS-GHØØ5-8. The detection methods have been validated on genomic DNA extracted from leaves of BCS-GHØØ2-5, BCS-GHØØ4-7, BCS-GHØØ5-8 and verified on genomic DNA extracted from leaves of BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8.
(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 1108-A5 (for BCS-GHØØ2-5) is accessible via the American Oil Chemists’ Society (AOCS) at https://www.aocs.org/crm. ERM-BF429 (for BCS-GHØØ4-7) and ERM-BF428 (BCS-GHØØ5-8) are accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/

(e) Unique identifier: BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8

(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 of the European Parliament and of the Council ([^E0001]). [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.

[^E0001]: 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).

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