Commission Implementing Decision (EU) 2021/1385 of 17 August 2021 renewing the authorisation for the placing on the market of feed and products other than food and feed containing or consisting of genetically modified oilseed rape GT73 (MON-ØØØ73-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021) 5992) (Only the Dutch text is authentic) (Text with EEA relevance)

Article 1

Genetically modified organism and unique identifier

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, 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 genetically modified oilseed rape MON-ØØØ73-7;

• (b) feed containing, consisting of or produced from genetically modified oilseed rape MON-ØØØ73-7;

• (c) products containing or consisting of genetically modified oilseed rape MON-ØØØ73-7 for uses other than those provided for in points (a) and (b), with the exception of cultivation.

Article 3

Labelling

Article 4

Method for detection

The method set out in point (d) of the Annex shall apply for the detection of genetically modified oilseed rape MON-ØØØ73-7.

Article 5

Monitoring plan for environmental effects

Article 6

Community register

The information set out in the Annex shall be entered in the Community register of genetically modified food and feed, as referred to in Article 28(1) of Regulation (EC) No 1829/2003.

Article 7

Authorisation holder

The authorisation holder shall be Bayer CropScience LLC, United States, represented in the Union by Bayer Agriculture B.V., Belgium.

Article 8

Validity

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

Article 9

Addressee

This Decision is addressed to Bayer CropScience LLC, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States, represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040 Antwerp, Belgium.

ANNEX

(a) Applicant and authorisation holder:

Name: Bayer CropScience LLC

Address: 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States,

represented in the Union by: Bayer Agriculture B.V., Scheldelaan 460, 2040 Antwerp, Belgium.

(b) Designation and specification of the products:

• (1) foods and food ingredients containing, consisting of or produced from genetically modified oilseed rape MON-ØØØ73-7;

• (2) feed containing, consisting of or produced from genetically modified oilseed rape MON-ØØØ73-7;

• (3) products containing or consisting of genetically modified oilseed rape MON-ØØØ73-7 for uses other than those provided for in points (1) and (2), with the exception of cultivation. The genetically modified oilseed rape MON-ØØØ73-7 expresses the cp4 epsps and goxv247 genes, which confer tolerance to glyphosate-based herbicides.

(c) Labelling:

• (1) 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 ‘oilseed rape’.

• (2) The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of genetically modified oilseed rapes referred to in point (b), except for foods and food ingredients.

(d) Method for detection:

• (1) Event specific real-time quantitative PCR based method for the detection of genetically modified oilseed rape MON-ØØØ73-7.

• (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: AOCS 0304-B accessible via the American Oil Chemists Society at https://www.aocs.org/crm

(e) Unique identifier:

MON-ØØØ73-7

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

[Biosafety Clearing-House, Record ID number: published in the 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 for environmental effects:

Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC of the European Parliament and of the Council ([^E0001]).

[Link: plan published in the Community register of genetically modified food and feed]

(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 time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

[^E0001]: Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).