Commission Implementing Decision (EU) 2021/1392 of 17 August 2021 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize Bt 11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021)5999) (Only the Dutch and French texts are authentic) (Text with EEA relevance)

• CELEX: Implementing Decision (EU) 2021/1392
• Articles: 10

Article 1 Genetically modified organism and unique identifier

Genetically modified maize ( Zea mays L.) Bt11, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier SYN-BTØ11-1, 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 in accordance with the conditions set out in this Decision:

(a)

foods and food ingredients containing, consisting of or produced from genetically modified maize SYN-BTØ11-1;

(b)

feed containing, consisting of or produced from genetically modified maize SYN-BTØ11-1;

(c)

products containing or consisting of genetically modified maize SYN-BTØ11-1 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 the products containing or consisting of genetically modified maize SYN-BTØ11-1, 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 SYN-BTØ11-1.

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 Authorisation holder

The authorisation holder shall be Syngenta Crop Protection AG, represented in the Union by Syngenta Crop Protection NV/SA.

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 Syngenta Crop Protection AG, Rosentalstrasse 67, CH-4058 Basel, Switzerland, represented in the Union by Syngenta Crop Protection NV/SA, Avenue Louise, 489, BE-1050 Brussels, Belgium.

Schedules & Appendices

ANNEX

ANNEX

(a)    Applicant and authorisation holder:

Name: Syngenta Crop Protection AG

Address: Rosentalstrasse 67, CH-4058 Basel, Switzerland

Represented in the Union by: Syngenta Crop Protection NV/SA, Avenue Louise, 489, 1050 Brussels, Belgium.

(b)    Designation and specification of the products:

(1)

foods and food ingredients containing, consisting of or produced from genetically modified maize SYN-BTØ11-1;

(2)

feed containing, consisting of or produced from genetically modified maize SYN-BTØ11-1;

(3)

products containing or consisting of genetically modified maize SYN-BTØ11-1 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified maize SYN-BTØ11-1, as described in the application, expresses the Cry1Ab protein, which confers resistance against certain lepidopteran pests and the PAT protein, which confers tolerance to the glufosinate-ammonium herbicide.

(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 ‘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 SYN-BTØ11-1, with the exception of products referred to in point (b)(1).

(d)    Method for detection:

(1)

Event specific real-time PCR based method for the detection of genetically modified maize SYN-BTØ11-1.

(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®-BF412 accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://crm.jrc.ec.europa.eu/

(e)    Unique identifier:

SYN-BTØ11-1

(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 ).