02017D1211 — EN — 11.02.2019 — 001.001

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►B COMMISSION IMPLEMENTING DECISION (EU) 2017/1211 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (DAS-24236-5 × DAS-21Ø23-5 × MON-88913-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2017) 4495) (Only the English text is authentic) (Text with EEA relevance) (OJ L 173 6.7.2017, p. 38)

Amended by:









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COMMISSION IMPLEMENTING DECISION (EU) 2017/1211

of 4 July 2017

authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (DAS-24236-5 × DAS-21Ø23-5 × MON-88913-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2017) 4495)

(Only the English text is authentic)

(Text with EEA relevance)







Article 1

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutum L.) 281-24-236 × 3006-210-23 × MON 88913, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DAS-24236-5×DAS-21Ø23-5×MON-88913-8, 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 DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton;

(b) feed containing, consisting of, or produced from DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton;

(c) DAS-24236-5×DAS-21Ø23-5×MON-88913-8 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

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 of the European Parliament and of the Council ( 1 ), 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 products containing or consisting of DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton with the exception of the products referred to in point (a) of Article 2.

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 the format set out in 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 referred to 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-24236-5×DAS-21Ø23-5×MON-88913-8 cotton;

(2) feed containing, consisting of, or produced from DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton;

(3) DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton in products containing it or consisting of it for any other than (1) and (2), with the exception of cultivation.

The genetically modified DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton, as described in the application, expresses the phosphinothricin acetyl transferase (PAT) protein which confers tolerance to glufosinate-ammonium herbicides and the modified CP4 5-enolpyruvyl-shikimate-3-phosphate synthase (CP4EPSPS) protein which confers tolerance to glyphosate herbicides, Cry1F and Cry1Ac proteins, conferring protection against certain lepidopteran insect pests.

(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 products containing or consisting of DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton with the exception of products referred to in point (a) of Article 2.

(d) Method for detection:

(1) Event specific real-time quantitative PCR based methods for DAS-24236-5, DAS-21Ø23-5 and MON-88913-8 cottons; the detection methods have been validated on genomic DNA extracted from seeds DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton and on genomic DNA extracted from seeds of the single-trait events and verified on genomic DNA extracted from seeds of DAS-24236-5×DAS-21Ø23-5×MON-88913-8 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:

— ERM®-BF422 for 281-24-236 × 3006-210-23 cotton is accessible via accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://crm.jrc.ec.europa.eu/ and

— AOCS 0906-D and AOCS 0804-A for MON 88913 cotton is accessible via the American Oil Chemists Society at https://www.aocs.org/crm

(e) Unique identifier:

DAS-24236-5×DAS-21Ø23-5×MON-88913-8

(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 for environmental effects:

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.