Commission Implementing Decision (EU) 2023/2143 of 13 October 2023 renewing the authorisation for placing on the market of products containing, consisting of or produced from genetically modified maize MIR162 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Implementing Decisions (EU) 2016/1685, (EU) 2019/1305 and (EU) 2019/2087 as regards the reference material (notified under document C(2023) 6736)

Genetically modified organism and unique identifier

Article 1

Genetically modified maize ( Zea mays L.) MIR162, as specified in the Annex, is assigned the unique identifier SYN-IR162-4, in accordance with Regulation (EC) No 65/2004.

Renewal of the authorisation

Article 2

The authorisation for placing on the market of the following products is renewed as regards: (a) foods and food ingredients containing, consisting of or produced from genetically modified maize SYN-IR162-4; (b) feed containing, consisting of or produced from genetically modified maize SYN-IR162-4; (c) products containing or consisting of genetically modified maize SYN-IR162-4, for uses other than those provided for in points (a) and (b), with the exception of cultivation.

Labelling

Article 3

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-IR162-4 as referred to in Article 1, with the exception of products referred to in Article 2, point (a).

Method for detection

Article 4

The method set out in point (d) of the Annex shall apply for the detection of genetically modified maize SYN-IR162-4.

Monitoring plan for environmental effects

Article 5

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.

Community register

Article 6

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.

Authorisation holder

Article 7

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

Validity

Article 8

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

Amendment of Implementing Decision (EU) 2016/1685

Article 9

In the Annex, point (d)(3) is replaced by the following: ‘(3) Reference Material: ERM®-BF412 (for SYN-BTØ11-1), ERM®-BF446 (for SYN-IR162-4) and ERM®-BF423 (for SYN-IR6Ø4-5) accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/ and AOCS 0407-A and AOCS 0407-B (for MON-ØØØ21-9) accessible via the American Oil Chemists Society at https://www.aocs.org/crm.’

Amendment of Implementing Decision (EU) 2019/1305

Article 10

In the Annex, point (d)(3) is replaced by the following: ‘(3) Reference Material: ERM®-BF412 (for SYN-BTØ11-1), ERM®-BF446 (for SYN-IR162-4) and ERM®-BF418 (for DAS-Ø15Ø7-1) are accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/, and, AOCS 0407-A and AOCS 0407-B (for MON-ØØØ21-9) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm.’

Amendment of Implementing Decision (EU) 2019/2087

Article 11

In the Annex, point (d)(3) is replaced by the following: ‘(3) Reference Material: ERM®-BF412 (for SYN-BTØ11-1), ERM®-BF446 (for SYN-IR162-4), ERM®-BF423 (for SYN-IR6Ø4-5) and ERM®-BF418 (for DAS-Ø15Ø7-1) are accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/, and AOCS 0411-C and 0411-D (for SYN-Ø53Ø7-1) and AOCS 0407-A and 0407-B (for MON-ØØØ21-9) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm.’

Addressee

Article 12

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, 1050 Brussels, Belgium.

ANNEXSupplementary provisions

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-IR162-4; (2) feed containing, consisting of or produced from genetically modified maize SYN-IR162-4; (3) products containing or consisting of genetically modified maize SYN-IR162-4 for uses other than those provided for in points (1) and (2), with the exception of cultivation. The genetically modified maize SYN-IR162-4 expresses the vip3Aa20 gene, which confers resistance to certain lepidopteran pests, and the pmi gene , which was used as a selectable marker. (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 genetically modified maize SYN-IR162-4, with the exception of the 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 maize SYN-IR162-4; (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®-BF446 is accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/. (e)    Unique identifier: SYN-IR162-4 (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 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 ).