HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

DP-ØØ4114-3

Community register of GM food and feed.

Event 4114
Authorisation holder Name Pioneer Hi-Bred International, Inc.
Represented by
Pioneer Overseas Corporation
Authorisation holder Address Pioneer Hi-Bred International, Inc.
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.
Products (1) Food 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.
Designation 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.
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 documents accompanying the products containing or consisting of genetically modified maize 4114, with the exception of products referred to in point (1) of the raw “Products”.
Method for detection - Event specific real-time quantitative PCR based method for detection of the genetically modified maize DP-ØØ4114-3.

- Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
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/
Unique identifier DP-ØØ4114-3
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=115316
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation 26/07/2019
Legal base Commission Implementing Decision 2019/1304 (EU) of 26 July 2019
Authorisation expiration date 28/07/2029
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2018-00311