Commission Implementing Decision (EU) 2015/690 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614xLLCotton25 (BCS-GHØØ2-5xACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2762) (Text with EEA relevance)

• CELEX: Implementing Decision (EU) 2015/690
• Articles: 9

Article 1 Genetically modified organism and unique identifier

Genetically modified cotton ( Gossypium hirsutum L. and Gossypium barbadense L.) GHB614xLLCotton25, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier BCS-GHØØ2-5xACS-GHØØ1-3, as provided for in 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 BCS-GHØØ2-5xACS-GHØØ1-3 cotton;

(b)

feed containing, consisting of, or produced from BCS-GHØØ2-5xACS-GHØØ1-3 cotton;

(c)

BCS-GHØØ2-5xACS-GHØØ1-3 cotton in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Article 3 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 the documents accompanying products containing or consisting of BCS-GHØØ2-5xACS-GHØØ1-3 cotton with the exception of products referred to in point (a) of Article 2.

Article 4 Monitoring for environmental effects

1.   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.

2.   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 5 Community register

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

Article 6 Authorisation holder

The authorisation holder shall be Bayer CropScience AG.

Article 7 Validity

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

Article 8 Addressee

This Decision is addressed to Bayer CropScience AG, Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein, Germany.

Schedules & Appendices

ANNEX

ANNEX

(a)    Applicant and Authorisation holder:

Name

:

Bayer CropScience AG

Address

:

Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein — Germany

(b)    Designation and specification of the products:

1.

foods and food ingredients containing, consisting of, or produced from BCS-GHØØ2-5xACS-GHØØ1-3 cotton;

2.

feed containing, consisting of, or produced from BCS-GHØØ2-5xACS-GHØØ1-3 cotton;

3.

BCS-GHØØ2-5xACS-GHØØ1-3 cotton in products containing it or consisting of it for any other than 1 and 2, with the exception of cultivation.

The genetically modified BCS-GHØØ2-5xACS-GHØØ1-3 cotton, as described in the application, expresses the phosphinothricin acetyl transferase (PAT) protein which confers tolerance to glufosinate-ammonium herbicides and the modified 5-enolpyruvyl-shikimate-3-phosphate synthase (2mEPSPS) protein which confers tolerance to glyphosate 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 ‘cotton’;

2.

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of BCS-GHØØ2-5xACS-GHØØ1-3 cotton with the exception of products referred to in point (a) of Article 2.

(d)    Method for detection:

1.

Event specific real-time PCR based method for the quantification of BCS-GHØØ2-5xACS-GHØØ1-3 cotton;

2.

Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from cotton leaves, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx;

3.

Reference Material: AOCS 1108-A, AOCS 0306-A and AOCS 0306-E are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm.

(e)    Unique identifier:

BCS-GHØØ2-5xACS-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: see [ to be completed 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 on the internet ]

(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.