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Document 02019D1305-20231017

Consolidated text: Commission Implementing Decision (EU) 2019/1305 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × 1507 × GA21 and sub-combinations Bt11 × MIR162 × 1507, MIR162 × 1507 × GA21 and MIR162 × 1507 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 5502) (Only the Dutch and French texts are authentic) (Text with EEA relevance)Text with EEA relevance

Access initial legal act
(

Legal status of the document In force

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ELI: http://data.europa.eu/eli/dec_impl/2019/1305/2023-10-17

02019D1305 — EN — 17.10.2023 — 001.001

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

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COMMISSION IMPLEMENTING DECISION (EU) 2019/1305

of 26 July 2019

authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × 1507 × GA21 and sub-combinations Bt11 × MIR162 × 1507, MIR162 × 1507 × GA21 and MIR162 × 1507 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2019) 5502)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)

(OJ L 204 2.8.2019, p. 69)

Amended by:

 

 

Official Journal

  No

page

date

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COMMISSION IMPLEMENTING DECISION (EU) 2023/2143 of 13 October 2023

  L 

1

17.10.2023



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COMMISSION IMPLEMENTING DECISION (EU) 2019/1305

of 26 July 2019

authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × 1507 × GA21 and sub-combinations Bt11 × MIR162 × 1507, MIR162 × 1507 × GA21 and MIR162 × 1507 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2019) 5502)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)



Article 1

Genetically modified organisms and unique identifiers

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

(a) 

the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × 1507 × GA21;

(b) 

the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × 1507;

(c) 

the unique identifier SYN-IR162-4 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR162 × 1507 × GA21;

(d) 

the unique identifier SYN-IR162-4 × DAS-Ø15Ø7-1 for genetically modified maize (Zea mays L.) MIR162 × 1507.

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 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 Decision 2009/770/EC.

Article 6

Community register

The information set out in the Annex to this Decision 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, Switzerland, represented by Syngenta Crop Protection NV/SA, 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 Syngenta Crop Protection NV/SA, Avenue Louise, 489, 1050 Brussels, Belgium.



ANNEX

(a)    Applicant and Authorisation holder:

Name

:

Syngenta Crop Protection AG

Address

:

Schwarzwaldallee 215, CH-4058 Basel, Switzerland

Represented by Syngenta Crop Protection NV/SA, 489, Avenue Louise, 1050 Brussels, 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 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 SYN-BTØ11-1 maize expresses the Cry1Ab protein, which confers protection against certain lepidopteran pests, and the PAT protein, which confers tolerance to glufosinate-ammonium-based herbicides.

The genetically modified SYN-IR162-4 maize expresses the Vip3Aa20 protein, which confers protection against certain lepidopteran pests, and the PMI protein, which was used as a selectable marker.

The genetically modified DAS-Ø15Ø7-1 maize expresses the Cry1F protein, which confers protection against certain lepidopteran pests, and the PAT protein, which confers tolerance to glufosinate-ammonium-based herbicides.

The genetically modified MON-ØØØ21-9 maize expresses the mEPSPS protein, which confers tolerance to glyphosate-based herbicides.

(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 the accompanying documents of the products containing or consisting of the maize specified in point (e), with the exception of products referred to in point (b)(1) of this Annex.

(d)    Method for detection:

(1) 

The quantitative event-specific PCR detection methods for maize Bt11 × MIR162 × 1507 × GA21 are those validated for genetically modified maize events SYN-BTØ11-1, SYN-IR162-4, DAS-Ø15Ø7-1 and MON-ØØØ21-9.

(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;

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(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.

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(e)    Unique identifiers:

SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1;

SYN-IR162-4 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-IR162-4 × DAS-Ø15Ø7-1.

(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.

[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.

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