02015D0693 — EN — 24.09.2019 — 001.001

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►B COMMISSION IMPLEMENTING DECISION (EU) 2015/693 of 24 April 2015 renewing the authorisation for existing genetically modified cotton MON 1445 (MON-Ø1445-2) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2766) (Only the French and Dutch texts are authentic) (Text with EEA relevance) (OJ L 112 30.4.2015, p. 48)

Amended by:









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COMMISSION IMPLEMENTING DECISION (EU) 2015/693

of 24 April 2015

renewing the authorisation for existing genetically modified cotton MON 1445 (MON-Ø1445-2) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2015) 2766)

(Only the French and Dutch texts are authentic)

(Text with EEA relevance)







Article 1

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutum L. and Gossypium barbadense L.) MON 1445, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-Ø1445-2, as provided for in Regulation (EC) No 65/2004.

Article 2

Renewal of authorisation

The authorisation for the placing on the market of the following products is renewed for the purposes of Articles 11 and 23 of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:

(a) food produced from MON-Ø1445-2 cotton;

(b) feed produced from MON-Ø1445-2 cotton.

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, the ‘name of the organism’ shall be ‘cotton’.

Article 4

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 5

Authorisation holder

The authorisation holder shall be Bayer Agriculture BVBA, Belgium, representing Monsanto Company, United States of America.

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Article 6

Validity

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

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Article 7

Addressee

This Decision is addressed to Bayer Agriculture BVBA, Scheldelaan 460, 2040 Antwerp, Belgium.

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ANNEX

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(a) Applicant and authorisation holder

Name : Bayer Agriculture BVBA

Address : Scheldelaan 460, 2040 Antwerp, Belgium

On behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.

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(b) Designation and specification of the products

1. Food produced from MON-Ø1445-2 cotton.

2. Feed produced from MON-Ø1445-2 cotton.

The genetically modified MON-Ø1445-2 cotton, as described in the application, expresses the CP4 EPSPS protein which confers tolerance to glyphosate-containing herbicides. An nptII gene, conferring kanamycin and neomycin resistance, and aadA gene, conferring spectinomycin and streptomycin resistance, were used as selective markers in the genetic modification process.

(c) Labelling

For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘cotton’.

(d) Method for detection

1. Event-specific real-time PCR based method for the quantification of MON-Ø1445-2 cotton.

2. Validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

3. Reference Material: AOCS 0804-B and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

(e) Unique identifier

MON-Ø1445-2

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity

Not applicable.

(g) Conditions or restrictions on the placing on the market, use or handling of the products

Not required.

(h) Monitoring plan for environmental effects

Not required.

(i) Post-market monitoring requirements for the use of the food for human consumption

Not required.