Commission Implementing Decision (EU) 2019/1302 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × LLCotton25 × MON 15985 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 5501) (Text with EEA relevance.)

• CELEX: Implementing Decision (EU) 2019/1302
• Articles: 10

Article 1 Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutum) GHB614 × LLCotton25 × MON 15985, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier BCS-GHØØ2-5 × ACS-GHØØ1-3 × MON-15985-7, 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 GHB614 × LLCotton25 × MON 15985 cotton;

(b)

feed containing, consisting of or produced from GHB614 × LLCotton25 × MON 15985 cotton;

(c)

products containing or consisting of GHB614 × LLCotton25 × MON 15985 cotton for uses other than those provided for in points (a) and (b) of this Article, 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 and in the documents accompanying products containing or consisting of genetically modified cotton referred to in Article 1, with the exception of food and food ingredients.

Article 4 Method for detection

The method set out in point (d) of the Annex shall apply for the detection of the genetically modified cotton referred to in Article 1.

Article 5 Monitoring plan 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 annual reports on the implementation and the results of the activities set out in the monitoring plan to the Commission in accordance with Decision 2009/770/EC.

Article 6 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 referred to in Article 28(1) of Regulation (EC) No 1829/2003.

Article 7 Authorisation holder

The authorisation holder shall be BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany.

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 SE, Carl-Bosch-Str. 38, D-67063 Ludwigshafen, Germany.

Schedules & Appendices

ANNEX

ANNEX

(a)    Applicant and Authorisation holder:

Name

:

BASF Agricultural Solutions Seed US LLC

Address

:

100 Park Avenue, Florham Park, New Jersey 07932, United States of America

Represented 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 GHB614 × LLCotton25 × MON 15985 cotton;

(2)

feed containing, consisting of or produced from GHB614 × LLCotton25 × MON 15985 cotton;

(3)

products containing or consisting of GHB614 × LLCotton25 × MON 15985 cotton for uses other than those provided in points (1) and (2), with the exception of cultivation.

The genetically modified cotton GHB614 × LLCotton25 × MON 15985, as described in the application, expresses the 2mEPSPS protein which confers tolerance to glyphosate-containing herbicides, the PAT protein which confers tolerance to glufosinate-ammonium based herbicides, the Cry1Ac and the Cry1Ab2 proteins which confer protection against certain lepidopteran pests. In addition, uidA gene, coding for the GUS protein, nptII gene, conferring kanamycin and neomycin resistance, and aadA gene, conferring spectinomycin and streptomycin resistance, were used as selection markers 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) 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 accompanying documents of the products containing or consisting of GHB614 × LLCotton25 × MON 15985 cotton specified in point (e), with the exception of foods and food ingredients.

(d)    Method for detection:

(1)

The quantitative event-specific PCR detection methods for cotton GHB614 × LLCotton25 × MON 15985 are those validated for genetically modified cotton events BCS-GHØØ2-5, ACS-GHØØ1-3 and MON-15985-7. The detection methods have been validated on genomic DNA extracted from leaves BCS-GHØØ2-5, ACS-GHØØ1-3 and MON-15985-7 cotton.

(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), AOCS 0306-E2 (for ACS-GHØØ1-3) and AOCS 0804-D (MON-15985-7) are accessible via the American Oil Chemists' Society (AOCS) at https://www.aocs.org/crm

(e)    Unique identifier:

BCS-GHØØ2-5 × ACS-GHØØ1-3 × MON-15985-7

(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.