Commission Implementing Decision (EU) 2024/2627 of 8 October 2024 authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton COT102 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2024) 6938)
Genetically modified organism and unique identifier
Genetically modified cotton ( Gossypium hirsutum L.) COT102, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier SYN-IR1Ø2–7, in accordance with Regulation (EC) No 65/2004.
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 SYN-IR1Ø2–7;
(b)
feed containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;
(c)
products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 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 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 the products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 as referred to in Article 1, with the exception of products referred to in Article 2, point (a).
Method for detection
The method set out in point (d) of the Annex shall apply for the detection of genetically modified cotton SYN-IR1Ø2–7.
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 the format set out in Decision 2009/770/EC.
Community register
The information set out in the Annex 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 Syngenta Crop Protection AG, Switzerland, represented in the Union by Syngenta Crop Protection NV/SA, Belgium.
Validity
This Decision shall apply for a period of 10 years from the date of its notification.
Addressee
This Decision is addressed to Syngenta Crop Protection AG, Rosentalstrasse 67, CH-4058 Basel, Switzerland, represented in the Union by Syngenta Crop Protection NV/SA, avenue Louise, 489, 1050 Brussels, Belgium.
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
(a)
Applicant and Authorisation holder:
Name: Syngenta Crop Protection AG
Address: Rosentalstrasse 67, CH-4058 Basel, Switzerland
Represented in the Union by: Syngenta Crop Protection NV/SA, avenue Louise, 489, 1050 Brussels, Belgium.
(b)
Designation and specification of the products:
(1)
foods and food ingredients containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;
(2)
feed containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;
(3)
products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 for uses other than those provided for in points (1) and (2), with the exception of cultivation.
The genetically modified cotton SYN-IR1Ø2–7 expresses the Vip3Aa19 gene, which confers resistance to certain lepidopteran pests. In addition, an aph4 gene, conferring hygromycin B resistance, was used as a selection marker 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 documents accompanying the products containing or consisting of genetically modified cotton SYN-IR1Ø2–7, with the exception of products referred to in point (b)(1) of this Annex.
(d)
Method for detection:
(1)
Event specific real-time PCR based method for the quantification of genetically modified cotton SYN-IR1Ø2–7.
(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 1012-C2 and AOCS 1012-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm .
(e)
Unique identifier:
SYN-IR1Ø2–7
(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 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.
[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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.