02015D0701 — EN — 24.09.2019 — 001.001

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►B COMMISSION IMPLEMENTING DECISION (EU) 2015/701 of 24 April 2015 authorising the placing on the market of food containing or consisting of genetically modified oilseed rape GT73, or food and feed produced from that genetically modified organism pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2786) (Only the Dutch and French texts are authentic) (Text with EEA relevance) (OJ L 112 30.4.2015, p. 86)

Amended by:









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COMMISSION IMPLEMENTING DECISION (EU) 2015/701

of 24 April 2015

authorising the placing on the market of food containing or consisting of genetically modified oilseed rape GT73, or food and feed produced from that genetically modified organism pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2015) 2786)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)







Article 1

Genetically modified organism and unique identifiers

Genetically modified oilseed rape (Brassica napus L.) GT73, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØØ73-7, 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 MON-ØØØ73-7 oilseed rape, with the exception of isolated seed protein;

(b) feed produced from MON-ØØØ73-7 oilseed rape.

Article 3

Labelling

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 ‘oilseed rape’.

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 Bayer Agriculture BVBA, Belgium, representing Monsanto Company, United States of America.

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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 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. foods and food ingredients containing, consisting of, or produced from MON-ØØØ73-7 oilseed rape, with the exception of isolated seed protein;

2. feed produced from MON-ØØØ73-7 oilseed rape.

The genetically modified MON-ØØØ73-7 oilseed rape, as described in the applications, expresses the CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) and glyphosate oxidoreductase variant 247 (GOXv247) proteins which confer tolerance to glyphosate-based herbicides.

(c) Labelling

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 ‘oilseed rape’.

(d) Method for detection

— Event-specific real-time PCR based method for the quantification of MON-ØØØ73-7 oilseed rape.

— 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/statusofdossiers.aspx

— Reference Material: AOCS 0304-A and AOCS 0304-B are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

(e) Unique identifier

MON-ØØØ73-7

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

Biosafety Clearing-House (to be entered in the Community 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

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC (to be entered in the Community register of genetically modified food and feed when notified).

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

Not required.