02011D0891 — EN — 11.02.2019 — 001.001

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►B COMMISSION DECISION of 22 December 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236x3006-210-23 (DAS-24236-5xDAS-21Ø23-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2011) 9532) (Only the English text is authentic) (Text with EEA relevance) (2011/891/EU) (OJ L 344 28.12.2011, p. 51)

Amended by:









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COMMISSION DECISION

of 22 December 2011

authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236x3006-210-23 (DAS-24236-5xDAS-21Ø23-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2011) 9532)

(Only the English text is authentic)

(Text with EEA relevance)

(2011/891/EU)







Article 1

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutum) 281-24-236x3006-210-23, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DAS-24236-5xDAS-21Ø23-5, 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 DAS-24236-5xDAS-21Ø23-5 cotton;

(b) feed containing, consisting of, or produced from DAS-24236-5xDAS-21Ø23-5 cotton;

(c) products other than food and feed containing or consisting of DAS-24236-5xDAS-21Ø23-5 cotton for the same uses as any other cotton 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 documents accompanying products containing or consisting of DAS-24236-5xDAS-21Ø23-5 cotton referred to in Article 2(b) and (c).

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.

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Article 6

Authorisation holder

The authorisation holder shall be Dow AgroSciences Distribution S.A.S., France, representing Mycogen Seeds, United States.

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Article 7

Validity

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

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Article 8

Addressee

This Decision is addressed to Dow AgroSciences Distribution S.A.S., 6, rue Jean Pierre Timbaud, 78180 Montigny-le-Bretonneux, France.

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ANNEX

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(a) Applicant and Authorisation holder

Name : Dow AgroSciences Distribution S.A.S.

Address : 6, rue Jean Pierre Timbaud, 78180 Montigny-le-Bretonneux, France.

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(b) Designation and specification of the products

(1) Foods and food ingredients containing, consisting of, or produced from DAS-24236-5xDAS-21Ø23-5 cotton.

(2) Feed containing, consisting of, or produced from DAS-24236-5xDAS-21Ø23-5 cotton.

(3) Products other than food and feed containing or consisting of DAS-24236-5xDAS-21Ø23-5 cotton for the same uses as any other cotton with the exception of cultivation.

The genetically modified DAS-24236-5xDAS-21Ø23-5 cotton (Gossypium hirsutum), as described in the application, expresses the Cry1Ac and Cry1F proteins which confer protection against certain lepidopteran pests and expresses PAT protein, used as a selectable marker, which confers tolerance to the glufosinate-ammonium herbicide.

(c) Labelling

(1) For the purposes of the specific 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 DAS-24236-5xDAS-21Ø23-5 cotton referred to in Article 2(b) and (c) of this Decision.

(d) Method for detection

— Event specific real-time PCR based method for the quantification of DAS-24236-5xDAS-21Ø23-5 cotton.

— Validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at https://irmm.jrc.ec.europa.eu/rmcatalogue

— Reference Material: ERM®-BF422 accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

(e) Unique identifier

DAS-24236-5xDAS-21Ø23-5

(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.