Commission Implementing Decision (EU) 2021/65 of 22 January 2021 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and genetically modified maize combining two or three of the single events MON 87427, MON 89034, MIR162 and MON 87411 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021) 268) (Only the Dutch text is authentic) (Text with EEA relevance)

• CELEX: Implementing Decision (EU) 2021/65
• Articles: 10

Article 1 Genetically modified organisms and unique identifiers

Genetically modified maize ( Zea mays L.), as specified in point (b) of the Annex, are assigned the following unique identifiers, in accordance with Regulation (EC) No 65/2004:

(a)

the unique identifier MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9 for genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411;

(b)

the unique identifier MON-87427-7 × MON-89Ø34-3 × MON-87411-9 for genetically modified maize MON 87427 × MON 89034 × MON 87411;

(c)

the unique identifier MON-87427-7 × SYN-IR162-4 × MON-87411-9 for genetically modified maize MON 87427 × MIR162 × MON 87411;

(d)

the unique identifier MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9 for genetically modified maize MON 89034 × MIR162 × MON 87411;

(e)

the unique identifier MON-87427-7 × MON-87411-9 for genetically modified maize MON 87427 × MON 87411;

(f)

the unique identifier MON-89Ø34-3 × MON-87411-9 for genetically modified maize MON 89034 × MON 87411;

(g)

the unique identifier SYN-IR162-4 × MON-87411-9 for genetically modified maize MIR162 × MON 87411.

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 as referred to in Article 1;

(b)

feed containing, consisting of or produced from genetically modified maize as referred to in Article 1;

(c)

products containing or consisting of genetically modified maize as referred to in Article 1 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 products containing or consisting of genetically modified maize as referred to in Article 1, with the exception of products referred to in point (a) of Article 2.

Article 4 Method for detection

The method set out in point (d) of the Annex shall apply for the detection of genetically modified maize ( Zea mays L.) as referred to in Article 1.

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, 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 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 of America

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.) as referred to in point (e);

(2)

feed containing, consisting of or produced from genetically modified maize ( Zea mays L.) as referred to in point (e);

(3)

products containing or consisting of genetically modified maize ( Zea mays L.) as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified maize MON-87427-7 expresses the cp4

epsps gene, which confers tolerance to glyphosate-based herbicides.

The genetically modified maize MON-89Ø34-3 expresses the cry1A.105 and cry2Ab2 genes, which confer protection against certain lepidopteran pests.

The genetically modified maize SYN-IR162-4 expresses the vip3Aa20 gene, which provides protection against certain lepidopteran pests. In addition, the pmi gene, coding for the PMI protein, was used as selection marker in the genetic modification process.

The genetically modified maize MON-87411-9 expresses the cp4

epsps gene, which confers tolerance to glyphosate-based herbicides, the cry3Bb1 gene and the DvSnf7 dsRNA, which confer protection against corn rootworm ( Diabrotica spp.).

(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 the maize specified in point (e), with the exception of products referred to in point (b)(1).

(d)    Method for detection

(1)

The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-87427-7, MON-89Ø34-3 , SYN-IR162-4 and MON-87411-9 and further verified on maize stack MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9;

(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 0512 (for MON-87427-7), AOCS 0906 (for MON-89Ø34-3), AOCS 1208 (for SYN-IR162-4) and AOCS 0215 (for MON-87411-9) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

(e)    Unique identifiers

MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9;

MON-87427-7 × MON-89Ø34-3 × MON-87411-9;

MON-87427-7 × SYN-IR162-4 × MON-87411-9;

MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9;

MON-87427-7 × MON-87411-9;

MON-89Ø34-3 × MON-87411-9;

SYN-IR162-4 × MON-87411-9.

(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 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 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.