Commission Implementing Decision (EU) 2019/2082 of 28 November 2019 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified cotton LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 7481) (Only the German text is authentic) (Text with EEA relevance)
Genetically modified organism and unique identifier
Genetically modified cotton ( Gossypium hirsutum ) LLCotton25, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier ACS-GHØØ1-3, in accordance with Regulation (EC) No 65/2004.
Renewal of the authorisation
The authorisation for the placing on the market of the following products is renewed in accordance with the conditions set out in this Decision:
(a)
foods and food ingredients containing, consisting of, or produced from genetically modified cotton ACS-GHØØ1-3;
(b)
feed containing, consisting of, or produced from genetically modified cotton ACS-GHØØ1-3;
(c)
products containing or consisting of genetically modified cotton ACS-GHØØ1-3 for uses other than those provided for in points (a) and (b), with the exception of cultivation.
Labelling
1. For the purposes of the labelling requirements laid down in Articles 13(1) and 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 the products containing or consisting of genetically modified cotton LLCotton25, with the exception of products referred to in point (a) of Article 2.
Method for detection
The method set out in point (d) of the Annex shall apply for the detection of genetically modified cotton LLCotton25.
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 to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.
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.
Authorisation holder
The authorisation holder shall be BASF Agricultural Solutions Seed US LLC, United States, represented by BASF SE, Germany.
Validity
This Decision shall apply for a period of 10 years from the date of its notification.
Addressee
This Decision is addressed to BASF SE, Carl-Bosch-Str. 38, D-67063 Ludwigshafen, Germany.
Supplementary provisions
ANNEXSupplementary provisions
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 genetically modified cotton LLCotton25;
(2)
feed containing, consisting of or produced from genetically modified cotton LLCotton25;
(3)
products containing or consisting of genetically modified cotton LLCotton25 for uses other than those provided in points (1) and (2), with the exception of cultivation.
The genetically modified cotton LLCotton25 expresses the bar gene which confers tolerance to glufosinate-ammonium based herbicides.
(c) Labelling:
(1)
For the purposes of the labelling requirements laid down in Articles 13(1) and 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 the products containing or consisting of genetically modified cotton LLCotton25, with the exception of products referred to in point (b)(1).
(d) Method for detection:
(1)
Event specific real-time PCR based method for the detection of genetically modified cotton LLCotton25.
(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 0306-A3 and AOCS 0306-E2 accessible via the American Oil Chemists Society at https://www.aocs.org/crm
(e) Unique identifier:
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 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 ).
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.