Commission Implementing Decision (EU) 2019/1304 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 4114 (DP-ØØ4114-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 5491) (Text with EEA relevance.)

• CELEX: Implementing Decision (EU) 2019/1304
• Articles: 10

Article 1 Genetically modified organism and unique identifier

Genetically modified maize ( Zea mays L.) 4114, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DP-ØØ4114-3, in accordance with Regulation (EC) No 65/2004.

Article 2 Authorisation

The following products are authorised for the purposes of Articles 4(2) and 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 4114;

(b)

feed containing, consisting of or produced from genetically modified maize 4114;

(c)

products containing or consisting of genetically modified maize 4114 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 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 products containing or consisting of genetically modified maize 4114, with the exception of foods and food ingredients.

Article 4 Method for detection

The method set out in point (d) of the Annex shall apply for the detection of genetically modified maize 4114.

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 referred to in Article 28(1) of Regulation (EC) No 1829/2003.

Article 7 Authorisation holder

The authorisation holder shall be Pioneer Hi-Bred International, Inc., United States, represented by Pioneer Overseas Corporation, 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 Pioneer Overseas Corporation, Avenue des Arts 44, 1040 Brussels, Belgium.

Schedules & Appendices

ANNEX

ANNEX

(a)    Applicant and authorisation holder:

Name

:

Pioneer Hi-Bred International, Inc.

Address

:

7100 NW 62nd Avenue, P.O. Box 1014, Johnston, IA 50131-1014, U.S.A.

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

(b)    Designation and specification of the products:

(1)

foods and food ingredients containing, consisting of or produced from genetically modified maize 4114;

(2)

feed containing, consisting of or produced from genetically modified maize 4114;

(3)

products containing or consisting of genetically modified maize 4114 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified maize 4114 expresses the Cry1F (truncated version), Cry34Ab1 and Cry35Ab1 proteins providing protection against specific lepidopteran and coleopteran pests, and the PAT protein conferring tolerance to glufosinate-ammonium 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 genetically modified maize 4114, 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 method for detection of the genetically modified maize DP-ØØ4114-3.

(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®-BF439 is accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue/

(e)    Unique identifier:

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 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 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 register of genetically modified food and feed.