LegalizeCommission Implementing Decision (EU) 2015/699 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton T304-40 (BCS-GHØØ4-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2782) (Text with EEA relevance)
Article 1
Genetically modified organism and unique identifier
Genetically modified cotton (Gossypium hirsutum) T304-40, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier BCS-GHØØ4-7, as provided for in Regulation (EC) No 65/2004.
Article 2
Authorisation
The following products are authorised for the purposes of Articles 4(2) and 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-GHØØ4-7 cotton;
- (b) feed containing, consisting of, or produced from BCS-GHØØ4-7 cotton;
- (c) BCS-GHØØ4-7 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
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’.
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of T304-40 cotton with the exception of products referred to in point (a) of Article 2.
Article 4
Monitoring 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 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 BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany.
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 BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen, Germany.
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, 67063 Ludwigshafen, Germany.
(b) Designation and specification of the products
- (1) foods and food ingredients containing, consisting of, or produced from BCS-GHØØ4-7 cotton;
- (2) feed containing, consisting of, or produced from BCS-GHØØ4-7 cotton;
- (3) BCS-GHØØ4-7 cotton in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.
The genetically modified T304-40 cotton, as described in the application, expresses the Cry1Ab protein which confers protection against certain lepidopteran pests and PAT protein which confers tolerance to glufosinate ammonium-based herbicides.
(c) Labelling
- (1) for the purposes of the specific 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 documents accompanying products containing or consisting of T304-40 cotton with the exception of products referred to in point (a) of Article 2.
(d) Method for detection
- — event-specific real-time PCR-based method for the quantification of T304-40 cotton,
- — validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx Reference Material: ERM-BF429 accessible via the Joint Research Centre (JRC) of the European Commission, the Institute for Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
(e) Unique identifier
BCS-GHØØ4-7
(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
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.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.