Commission Implementing Decision (EU) 2024/1828 of 2 July 2024 renewing the authorisation for the placing on the market of feed containing, consisting of and of food and feed products produced from genetically modified maize MON 810 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and repealing Commission Implementing Decision (EU) 2017/1207 (notified under document C(2024) 4493)

• CELEX: Implementing Decision (EU) 2024/1828
• Articles: 11

Article 1 Genetically modified organisms and unique identifiers

Genetically modified maize ( Zea mays L.) MON 810, as specified in point (b) of the Annex to this Decision, is assigned the unique identifiers MON-ØØ81Ø-6, in accordance with Regulation (EC) No 65/2004.

Article 2 Renewal of the authorisation

The authorisation for the placing on the market of the following products is renewed as regards:

(a)

foods and food ingredients produced from genetically modified maize MON-ØØ81Ø-6;

(b)

feed containing, consisting of or produced from genetically modified maize MON-ØØ81Ø-6;

(c)

products containing or consisting of genetically modified maize MON-ØØ81Ø-6, for uses other than those provided for in points (a) and (b), with the exception of cultivation.

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 ‘maize’.

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-ØØ81Ø-6.

Article 5 Monitoring plan 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 Repeal

Implementing Decision (EU) 2017/1207 is repealed.

Article 8 Authorisation holder

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

Article 9 Validity

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

Article 10 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, Haven 627, Scheldelaan 460, B-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, Haven 627, Scheldelaan 460, B-2040 Antwerp, Belgium.

(b)

Designation and specification of the products:

(1)

foods and food ingredients produced from genetically modified maize MON-ØØ81Ø-6;

(2)

feed containing, consisting of or produced from genetically modified maize MON-ØØ81Ø-6;

(3)

products containing or consisting of genetically modified maize MON-ØØ81Ø-6 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

Genetically modified maize MON-ØØ81Ø-6 expresses the Cry1Ab gene, which confers protection against predation by certain lepidopteran insect pests, including the European corn borer ( Ostrinia nubilalis ) and pink borers ( Sesamia spp.).

(c)

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 ‘maize’.

(d)

Method for detection:

(1)

Event specific real-time quantitative PCR based method for detection of the genetically modified maize MON-ØØ81Ø-6;

(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: ERM-BF413 and ERM-AD413 accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/ .

(e)

Unique identifier:

MON-ØØ81Ø-6

(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 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 plan:

Not required.

Note:

inks 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 , ELI: http://data.europa.eu/eli/dir/2001/18/oj ).