Commission Implementing Decision (EU) 2019/1306 of 26 July 2019 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 5503) (Text with EEA relevance.)

• CELEX: Implementing Decision (EU) 2019/1306
• Articles: 10

Article 1 Genetically modified organism and unique identifier

Genetically modified maize ( Zea mays L.) 1507 × NK603, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6, 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 1507 × NK603;

(b)

feed containing, consisting of, or produced from genetically modified maize 1507 × NK603;

(c)

products containing or consisting of genetically modified maize 1507 × NK603 for uses other than those provided for in points (a) and (b) of this Article, with the exception of cultivation.

Article 3 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 1507 × NK603, 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 1507 × NK603.

Article 5 Monitoring plan for environmental effects

1.   The authorisation holders 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 holders shall submit to the Commission joint 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 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 holders

1.   The authorisation holders shall be:

(a)

Pioneer Hi-Bred International, Inc., United States, represented by Pioneer Overseas Corporation, Belgium; and

(b)

Dow AgroSciences LLC, United States, represented by Dow AgroSciences Distribution S.A.S., France.

2.   Both authorisation holders shall be responsible for fulfilling the duties imposed on authorisation holders by this Decision and Regulation (EC) No 1829/2003.

Article 8 Validity

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

Article 9 Addressees

This Decision is addressed to:

(a)

Pioneer Overseas Corporation, Avenue des Arts 44, 1040 Brussels, Belgium; and

(b)

Dow AgroSciences Distribution S.A.S., 6, rue Jean Pierre Timbaud, 78180 Montigny le Bretonneux, France.

Schedules & Appendices

ANNEX

ANNEX

(a)    Applicants and authorisation holders:

Name

:

Pioneer Hi-Bred International, Inc.

Address

:

7100 NW 62nd Avenue, P.O. Box 1014, Johnston, IA 50131-1014, United States

Represented by: Pioneer Overseas Corporation, Avenue des Arts, 44, 1040 Brussels, Belgium;

and

Name

:

Dow AgroSciences LLC

Address

:

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

Represented by: Dow AgroSciences Distribution S.A.S., 6, rue Jean Pierre Timbaud, 78180 Montigny le Bretonneux, France.

(b)    Designation and specification of the products:

(1)

foods and food ingredients containing, consisting of or produced from genetically modified maize 1507 × NK603;

(2)

feed containing, consisting of or produced from genetically modified maize 1507 × NK603;

(3)

products containing or consisting of genetically modified maize 1507 × NK603 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified maize 1507 × NK603 expresses the cry 1F gene, which confers protection against certain lepidopteran pests, the pat gene, which confers tolerance to glufosinate-ammonium based herbicides, and the cp4 epsps gene, which confers tolerance to glyphosate based herbicides.

(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 1507 × NK603, with the exception of products referred to in point (b)(1) of this Annex.

(d)    Method for detection:

(1)

Event specific real-time quantitative PCR based methods for genetically modified maize DAS-Ø15Ø7-1 and maize MON-ØØ6Ø3-6 validated on maize DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6.

(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®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF415 (for MON-ØØ6Ø3-6) accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue/

(e)    Unique identifier:

DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6

(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 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 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 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 ).