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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)

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)

Implementing Decision (EU) 2021/1385 · Decision · 10 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Genetically modified organism and unique identifier

Article 1

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.

Renewal of the authorisation

Article 2

The authorisation for the placing on the market of the following products is renewed in accordance with the conditions set out in this Decision: (a) feed containing or consisting of genetically modified oilseed rape MON-ØØØ73-7; (b) products containing or consisting of genetically modified oilseed rape MON-ØØØ73-7 for uses other than those provided for in point (a) and other than food, with the exception of cultivation.

Labelling

Article 3

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 the products covered by this Decision.

Method for detection

Article 4

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

Monitoring plan for environmental effects

Article 5

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.

Community register

Article 6

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.

Authorisation holder

Article 7

The authorisation holder shall be Bayer CropScience LP, United States, represented in the Union by Bayer Agriculture BV, Belgium.

Validity

Article 8

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

Addressee

Article 9

This Decision is addressed to Bayer CropScience LP represented in the Union by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX (a)    Applicant and authorisation holder: Name: Bayer CropScience LP Address: 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America Represented in the Union by: Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium. (b)    Designation and specification of the products: (1) feed containing or consisting of genetically modified oilseed rape MON-ØØØ73-7; (2) products containing or consisting of genetically modified oilseed rape MON-ØØØ73-7 for uses other than those provided in point (1) and other than food, 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 the products referred to in points (b)(1) and (2). (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  ( 1 ) . [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. ( 1 )   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 ).

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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