Commission Implementing Decision (EU) 2023/416 of 22 February 2023 authorising the placing on the market of products containing, consisting of or produced from genetically modified oilseed rape MON 94100 (MON-941ØØ-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2023) 1135) (Only the Dutch text is authentic) (Text with EEA relevance)

• CELEX: Implementing Decision (EU) 2023/416
• Articles: 10

Article 1 Genetically modified organism and unique identifier

Genetically modified oilseed rape ( Brassica napus L.) MON 94100, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-941ØØ-2, 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-941ØØ-2;

(b)

feed containing, consisting of or produced from genetically modified oilseed rape MON-941ØØ-2;

(c)

products containing or consisting of genetically modified oilseed rape MON-941ØØ-2, for uses other than those provided for in points (a) and (b) of this Article, 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, 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 containing or consisting of genetically modified oilseed rape MON-941ØØ-2, as referred to in Article 1, with the exception of products referred to in Article 2, point (a).

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-941ØØ-2.

Article 5 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 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 LP, represented in the Union by Bayer Agriculture BV.

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 LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States, represented in the Union by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.

Schedules & Appendices

ANNEX

ANNEX

(a)

Applicant and authorisation holder:

Name: Bayer CropScience LP

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

Represented in the Union by: Bayer Agriculture BV, 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-941ØØ-2;

(2)

feed containing, consisting of or produced from genetically modified oilseed rape MON-941ØØ-2;

(3)

products containing or consisting of genetically modified oilseed rape MON-941ØØ-2 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified oilseed rape MON-941ØØ-2 expresses the dmo gene, which confers tolerance to dicamba-based herbicides.

(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 ‘oilseed rape’.

(2)

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of oilseed rape MON-941ØØ-2, with the exception of products referred to in point (b)(1).

(d)

Method for detection:

(1)

Event specific real-time quantitative PCR based method for detection of the genetically modified oilseed rape MON-941ØØ-2;

(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 0421-A is accessible via the American Oil Chemists Society at https://www.aocs.org/crm?SSO=True

(e)

Unique identifier:

MON-941ØØ-2

(f)

Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

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

Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC

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

(i)

Post-market monitoring plan:

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.