Commission Implementing Decision (EU) 2023/1208 of 21 June 2023 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 95379 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2023) 3936) (Only the Dutch text is authentic) (Text with EEA relevance)

• CELEX: Implementing Decision (EU) 2023/1208
• Articles: 10

Article 1 Genetically modified organism and unique identifier

Genetically modified maize ( Zea mays L .) MON 95379, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-95379-3, 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 maize MON-95379-3;

(b)

feed containing, consisting of or produced from genetically modified maize MON-95379-3;

(c)

products containing or consisting of genetically modified maize MON-95379-3 for uses other than those provided for in points (a) and (b), 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 ‘maize’.

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 maize MON-95379-3 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 maize MON-95379-3.

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, United States, 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 maize ( Zea mays L.) MON-95379-3;

(2)

feed containing, consisting of or produced from genetically modified maize ( Zea mays L.) MON-95379-3;

(3)

products containing or consisting of genetically modified maize ( Zea mays L.) MON-95379-3 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified maize MON-95379-3 expresses cry1B.868 and cry1Da_7 genes, which confer protection against lepidopteran pests.

(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 ‘maize’.

(2)

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of genetically modified maize MON-95379-3, with the exception of products referred to in point (b)(1) of this Annex.

(d)    Method for detection:

(1)

Event specific real-time PCR based method for the quantification of genetically modified maize MON-95379-3.

(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 0521-A accessible via the American Oil Chemists Society at https://www.aocs.org/crm

(e)    Unique identifier:

MON-95379-3

(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 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 requirements for the use of the food for human consumption:

Not required.

Note: links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.