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Commission Implementing Decision (EU) 2019/2087 of 28 November 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and genetically modified maize combining two, three, four or five of the single events Bt11, MIR162, MIR604, 1507, 5307 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 8428) (Only the Dutch and French texts are authentic) (Text with EEA relevance)

Type Implementing Decision

Publication 2019-12-06

Last updated 2023-10-17

State In force

Department European Commission, SANTE

Source EUR-Lex

articles 9

Reform history JSON API

Article 1

Genetically modified organisms and unique identifiers

Genetically modified maize (Zea mays L.), 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 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21;

(b) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 for genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307;

(c) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × GA21;

(d) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize Bt11 × MIR162 × MIR604 × 5307 × GA21;

(e) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize Bt11 × MIR162 × 1507 × 5307 × GA21;

(f) the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize Bt11 × MIR604 × 1507 × 5307 × GA21;

(g) the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize MIR162 × MIR604 × 1507 × 5307 × GA21;

(h) the unique identifier SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 for genetically modified maize Bt11 × MIR162 × MIR604 × 1507;

(i) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 for genetically modified maize Bt11 × MIR162 × MIR604 × 5307;

(j) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 for genetically modified maize Bt11 × MIR162 × 1507 × 5307;

(k) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize Bt11 × MIR162 × 5307 × GA21;

(l) the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 for genetically modified maize Bt11 × MIR604 × 1507 × 5307;

(m) the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize Bt11 × MIR604 × 5307 × GA21;

(n) the unique identifier SYN-BTØ11-1 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize Bt11 × 1507 × 5307 × GA21;

(o) the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 for genetically modified maize MIR162 × MIR604 × 1507 × 5307;

(p) the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 for genetically modified maize MIR162 × MIR604 × 1507 × GA21;

(q) the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize MIR162 × MIR604 × 5307 × GA21;

(r) the unique identifier SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize MIR162 × 1507 × 5307 × GA21;

(s) the unique identifier SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize MIR604 × 1507 × 5307 × GA21;

(t) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-Ø53Ø7-1 for genetically modified maize Bt11 × MIR162 × 5307;

(u) the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 for genetically modified maize Bt11 × MIR604 × 5307;

(v) the unique identifier SYN-BTØ11-1 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 for genetically modified maize Bt11 × 1507 × 5307;

(w) the unique identifier SYN-BTØ11-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize Bt11 × 5307 × GA21;

(x) the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 for genetically modified maize MIR162 × MIR604 × 1507;

(y) the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 for genetically modified maize MIR162 × MIR604 × 5307;

(z) the unique identifier SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 for genetically modified maize MIR162 × 1507 × 5307;

(aa) the unique identifier SYN-IR162-4 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize MIR162 × 5307 × GA21;

(bb) the unique identifier SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 for genetically modified maize MIR604 × 1507 × 5307;

(cc) the unique identifier SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize MIR604 × 5307 × GA21;

(dd) the unique identifier DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize 1507 × 5307 × GA21;

(ee) the unique identifier SYN-BTØ11-1 × SYN-Ø53Ø7-1 for genetically modified maize Bt11 × 5307;

(ff) the unique identifier SYN-IR162-4 × SYN-Ø53Ø7-1 for genetically modified maize MIR162 × 5307;

(gg) the unique identifier SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 for genetically modified maize MIR604 × 5307;

(hh) the unique identifier DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 for genetically modified maize 1507 × 5307;

(ii) the unique identifier SYN-Ø53Ø7-1 × MON-ØØØ21-9 for genetically modified maize 5307 × GA21.

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

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’.

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

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.

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 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 in the Union 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	:	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 (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 SYN-BTØ11-1 expresses the cry1Ab gene, which confers protection against certain lepidopteran pests, and the pat gene, which confers tolerance to glufosinate-ammonium-based herbicides.

The genetically modified maize SYN-IR162-4 expresses the vip3Aa20 gene, which confers protection against certain lepidopteran pests, and the pmi gene, which was used as a selectable marker.

The genetically modified maize SYN-IR6Ø4-5 expresses a modified cry3A gene, which provides protection against certain coleopteran pests, and the pmi gene, which was used as a selectable marker.

The genetically modified maize DAS-Ø15Ø7-1 expresses the cry1F gene, which confers protection against certain lepidopteran pests and the pat gene, which confers tolerance to glufosinate-ammonium-based herbicides.

The genetically modified maize SYN-Ø53Ø7-1 expresses the ecry 3.1 Ab gene, which confers resistance to certain coleopteran pests, and the pmi gene, which was used as a selectable marker.

The genetically modified maize MON-ØØØ21-9 expresses the mepsps gene, 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 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) of this Annex.

(d) Method for detection:

(1) The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events SYN-BTØ11-1, SYN-IR162-4, SYN-IR6Ø4-5, DAS-Ø15Ø7-1, SYN-Ø53Ø7-1 and MON-ØØØ21-9 and further verified on maize stack Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21.

(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 (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.

(e) Unique identifiers:

SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1;

SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1;

SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1;

SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1;

SYN-BTØ11-1 × SYN-IR162-4 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1;

SYN-BTØ11-1 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1;

SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;

SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-IR162-4 × SYN-Ø53Ø7-1;

SYN-BTØ11-1 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1;

SYN-BTØ11-1 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1;

SYN-BTØ11-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1;

SYN-IR162-4 × SYN-IR6Ø4-5 × SYN-Ø53Ø7-1;

SYN-IR162-4 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1;

SYN-IR162-4 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1;

SYN-IR6Ø4-5 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9;

SYN-BTØ11-1 × SYN-Ø53Ø7-1;

SYN-IR162-4 × SYN-Ø53Ø7-1;

SYN-IR6Ø4-5 × SYN-Ø53Ø7-1;

DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1;

SYN-Ø53Ø7-1 × MON-ØØØ21-9.

(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 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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