Genetically Modified Organisms
Community register of GM food and feed.
|Authorisation holder Name||Pioneer Overseas Corporation|
|Authorisation holder Address||Address: Avenue des Arts 44, B-1040 Brussels, Belgium
On behalf of Pioneer Hi-Bred International, Inc. - 7100 NW 62nd Avenue – P.O. Box 1014 – Johnston, IA 50131-1014 - United States of America.
|Products||1) Foods and food ingredients containing, consisting of, or produced from DP-3Ø5423-1 soybean
2) Feed containing, consisting or produced from DP-3Ø5423-1 soybean
3) Products other than food and feed containing or consisting of 3Ø5423-1 soybean for the same uses as any other soybean with the exception of cultivation
|Designation||Genetically modified DP-3Ø5423-1 soybean has a reduced expression of the soybean enzyme omega-6 desaturase, which results in a high oleic acid and reduced linoleic acid profile, and expresses an optimized Glycine max-hra gene, which confers tolerance to acetolactate synthase-inhibiting herbicides.|
|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 ’soybean’.
For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ’with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
The words 'not for cultivation' shall appear on the label of and in documents accompanying products containing or consisting of DP-3Ø5423-1 soybean with the exception of products referred to in point (a) of Article 2.
|Method for detection||Event specific real-time PCR based method for the quantification of DP-3Ø5423-1 soybean;
Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at:
|Reference material||ERM-BF426 accessible via the Joint Research Centre (JRC) of the European
Commission, the Institute for Reference Materials and Measurements (IRMM) at:
|Annex II to the Cartagena Protocol||To be completed|
|Conditions or restrictions on the placing on the market||https://bch.cbd.int/database/record.shtml?documentid=108091|
|Monitoring plan||Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC|
|Post-market monitoring requirements||Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003 (Art.5 and Annex II(g) of Commission Decision 2015/698/UE of 24 April 2015)|
|Date of authorisation||24/04/2015|
|Legal base||Art. 7(3) and 19(3) of the Regulation (EC) No 1829/2003
Commission Decision 2015/698/UE of 24 April 2015
|Authorisation expiration date||26/04/2025|
|Further information on risk assessment||Opinion of the European Food Safety Authority: