COMMISSION IMPLEMENTING DECISION (EU) 2023/1209

of 21 June 2023

authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9 and its sub-combinations DAS-40278-9 x DP4114 x MON 87411, MON 89034 x DP4114 x MON 87411, MON 89034 x DAS-40278-9 x MON 87411, MON 89034 x DAS-40278-9 x DP4114, DP4114 x MON 87411, DAS-40278-9 x MON 87411, DAS-40278-9 x DP4114, MON 89034 x DP4114, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2023) 3937)

(Only the texts in French and Dutch are authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 7(3) and Article 19(3) thereof,

Whereas:

(1) On 9 December 2020, Pioneer Overseas Corporation, based in Belgium, submitted, on behalf of Pioneer Hi-Bred International, Inc., based in the United States, an application to the national competent authority of the Netherlands for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’). The application also covered the placing on the market of products containing or consisting of genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9 for uses other than food and feed, with the exception of cultivation.

(2) In addition, the application covered the placing on the market of products containing, consisting of or produced from ten sub-combinations of the single transformation events constituting genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9. Two sub-combinations included in the application, MON 89034 x MON 87411 and MON 89034 x DAS-40278-9, have already been authorised by, respectively, Commission Implementing Decisions (EU) 2021/65 (2) and (EU) 2019/2086 (3).

(3) This Decision covers maize DP4114 x MON89034 x MON87411 x DAS-40278-9 and all the non-authorised sub-combinations of the single transformation events constituting this maize: DAS-40278-9 x DP4114 x MON 87411, MON 89034 x DP4114 x MON 87411, MON 89034 x DAS-40278-9 x MON 87411, MON 89034 x DAS-40278-9 x DP4114, DP4114 x MON 87411, DAS-40278-9 x MON 87411, DAS-40278-9 x DP4114, MON 89034 x DP4114.

(4) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council (4). It also included the information required pursuant to Annexes III and IV to that Directive and a monitoring plan for environmental effects in accordance with Annex VII to that Directive.

(5) On 9 November 2022, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion (5) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. The Authority concluded that genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9 and its sub-combinations, as described in the application, are as safe as their conventional counterpart and the tested non-genetically modified maize reference varieties with respect to the potential effects on human and animal health and the environment. The Authority also concluded that the consumption of genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9 and its sub-combinations does not represent any nutritional concern.

(6) In its opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(7) The Authority also concluded that the monitoring plan for the environmental effects, submitted by the applicant, consisting of a general surveillance plan, is in line with the intended uses of the products.

(8) Taking into account those conclusions, the placing on the market of products containing, consisting of or produced from genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9 and the sub-combinations DAS-40278-9 x DP4114 x MON 87411, MON 89034 x DP4114 x MON 87411, MON 89034 x DAS-40278-9 x MON 87411, MON 89034 x DAS-40278-9 x DP4114, DP4114 x MON 87411, DAS-40278-9 x MON 87411, DAS-40278-9 x DP4114, MON 89034 x DP4114 should be authorised for the uses listed in the application.

(9) By a letter dated 24 January 2022, Pioneer Hi-Bred International, Inc. requested that the Commission transfers the rights and obligations of Pioneer Hi-Bred International, Inc. pertaining to all pending applications for genetically modified products, to Corteva Agriscience LLC, based in the United States. Corteva Agriscience LLC confirmed their agreement to the change of authorisation holder proposed by Pioneer Hi-Bred International, Inc.. Corteva Agriscience LLC is represented in the Union by Corteva Agriscience Belgium B.V., based in Belgium.

(10) A unique identifier should be assigned to genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9 and to each of its sub-combinations DAS-40278-9 x DP4114 x MON 87411, MON 89034 x DP4114 x MON 87411, MON 89034 x DAS-40278-9 x MON 87411, MON 89034 x DAS-40278-9 x DP4114, DP4114 x MON 87411, DAS-40278-9 x MON 87411, DAS-40278-9 x DP4114, MON 89034 x DP4114, in accordance with Commission Regulation (EC) No 65/2004 (6).

(11) For the products covered by this Decision, no specific labelling requirements, other than those provided for 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 of the European Parliament and of the Council (7), appear to be necessary. However, in order to ensure that the use of those products remains within the limits of the authorisation granted by this Decision, the labelling of those products, with the exception of foods and food ingredients, should contain a clear indication that they are not intended for cultivation.

(12) The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (8).

(13) The opinion of the Authority does not justify the imposition of other specific conditions or restrictions for the placing on the market, for the use and handling or for the protection of particular ecosystems/environment or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e), of Regulation (EC) No 1829/2003.

(14) All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(15) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c), of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (9).

(16) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chair. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifiers

Genetically modified maize (

Zea mays

L.), as specified in point (b) of the Annex to this Decision, is assigned the following unique identifiers, in accordance with Regulation (EC) No 65/2004:

(a) the unique identifier DP-ØØ4114-3 x MON-89Ø34-3 x MON-87411-9 x DAS-4Ø278-9 for genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9;

(b) the unique identifier DAS-4Ø278-9 x DP-ØØ4114-3 x MON-87411-9 for genetically modified maize DAS-40278-9 x DP4114 x MON 87411;

(c) the unique identifier MON-89Ø34-3 x DP-ØØ4114-3 x MON-87411-9 for genetically modified maize MON 89034 x DP4114 x MON 87411;

(d) the unique identifier MON-89Ø34-3 x DAS-4Ø278-9 x MON-87411-9 for genetically modified maize MON 89034 x DAS-40278-9 x MON 87411;

(e) the unique identifier MON-89Ø34-3 x DAS-4Ø278-9 x DP-ØØ4114-3 for genetically modified maize MON 89034 x DAS-40278-9 x DP4114;

(f) the unique identifier DP-ØØ4114-3 x MON-87411-9 for genetically modified maize DP4114 x MON 87411;

(g) the unique identifier DAS-4Ø278-9 x MON-87411-9 for genetically modified maize DAS-40278-9 x MON 87411;

(h) the unique identifier DAS-4Ø278-9 x DP-ØØ4114-3 for genetically modified maize DAS-40278-9 x DP4114;

(i) the unique identifier MON-89Ø34-3 x DP-ØØ4114-3 for genetically modified maize MON 89034 x DP4114.

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 and its sub-combinations as referred to in Article 1;

(b) feed containing, consisting of or produced from genetically modified maize and its sub-combinations as referred to in Article 1;

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

Article 4

Method for detection

The method set out in point (d) of the Annex shall apply for the detection of genetically modified maize and its sub-combinations 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 Corteva Agriscience LLC, represented in the Union by Corteva Agriscience Belgium B.V.

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 Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana, 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium B.V., Rue Montoyer 25, 1000 Brussels, Belgium.

Done at Brussels, 21 June 2023.

For the Commission

Stella KYRIAKIDES

Member of the Commission

(1)

OJ L 268, 18.10.2003, p. 1

(2) 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 (

OJ L 26, 26.1.2021, p. 37

(3) Commission Implementing Decision (EU) 2019/2086 of 28 November 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9 and genetically modified maize combining two, three or four of the single events MON 89034, 1507, MON 88017, 59122 and DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (

OJ L 316, 6.12.2019, p. 87

(4) 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

(5) EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2022. Scientific Opinion on assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS-40278-9 and sub-combinations for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2020-171). EFSA Journal 2022; 20(11):7619, https://doi.org/10.2903/j.efsa.2022.7619

(6) Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (

OJ L 10, 16.1.2004, p. 5

(7) Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (

OJ L 268, 18.10.2003, p. 24

(8) Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (

OJ L 275, 21.10.2009, p. 9

(9) Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (

OJ L 287, 5.11.2003, p. 1

ANNEX

(a)

Applicant and authorisation holder:

Name

Corteva Agriscience LLC

Address

9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States

Represented in the Union by Corteva Agriscience Belgium BV, Rue Montoyer 25, 1000 Brussels, Belgium.

(b)

Designation and specification of the products:

(1) foods and food ingredients containing, consisting of or produced from genetically modified maize as referred to in point (e);

(2) feed containing, consisting of or produced from genetically modified maize 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 maize DP-ØØ4114-3 expresses the

cry1F, cry34Ab1

and

cry35Ab1

genes, which confer protection against certain lepidopteran and coleopteran pests and the

pat

gene, which confers tolerance to glufosinate ammonium-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 MON-87411-9 expresses the

dvSnf7 dsRNA

gene, which confers protection against western corn rootworm,

cry3Bb1

gene, which confers protection against certain coleopteran pests and CP4 EPSPS protein, which confers tolerance to glyphosate herbicides.

The genetically modified maize DAS-4Ø278-9 expresses the

aad-1

gene, which confers tolerance to 2, 4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) 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 genetically modified maize referred to in point (e), with the exception of the 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 DP-ØØ4114-3, MON-89Ø34-3, MON-87411-9, DAS-4Ø278-9 and further verified on maize DP-ØØ4114-3 x MON-89Ø34-3 x MON-87411-9 x DAS-4Ø278-9;

(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 0906-E2 (for MON-89Ø34-3) and AOCS 0215-B (for MON-87411-9) are accessible via the American Oil Chemist Society at https://www.aocs.org/crm#maize; ERM

-BF439 a-e (for DP-ØØ4114-3) and ERM

-BF433 a-d (for DAS-4Ø278-9) are accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/.

(e)

Unique identifier:

DP-ØØ4114-3 x MON-89Ø34-3 x MON-87411-9 x DAS-4Ø278-9;

DAS-4Ø278-9 x DP-ØØ4114-3 x MON-87411-9;

MON-89Ø34-3 x DP-ØØ4114-3 x MON-87411-9;

MON-89Ø34-3 x DAS-4Ø278-9 x MON-87411-9;

MON-89Ø34-3 x DAS-4Ø278-9 x DP-ØØ4114-3;

DP-ØØ4114-3 x MON-87411-9;

DAS-4Ø278-9 x MON-87411-9;

DAS-4Ø278-9 x DP-ØØ4114-3;

MON-89Ø34-3 x DP-ØØ4114-3.

(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.