Genetically Modified Organisms
Community register of GM food and feed.
|Authorisation holder Name||Bayer Agriculture BV, Belgium
Bayer CropScience LP, United States
|Authorisation holder Address||Bayer Agriculture BV
2040 Antwerp - BELGIUM
On behalf of
Bayer CropScience LP
800 N. Lindbergh Boulevard
St. Louis, Missouri 63167 - United States
|Products||(1) Foods and food ingredients containing, consisting of, or produced from MON-Ø4Ø32-6 soybean;
(2) Feed containing, consisting of, or produced from MON-Ø4Ø32-6 soybean;
(3) Products other than food and feed containing or consisting of MON-Ø4Ø32-6 soybean for the same uses as any other soybean with the exception of cultivation.
|Designation||The genetically modified soybean MON-Ø4Ø32-6, as described in the application, expresses the CP4 EPSPS protein which confers tolerance to the glyphosate herbicide.|
|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 "soybean".
(2) The words "not for cultivation" shall appear on the label of and in documents accompanying products containing or consisting of MON-Ø4Ø32-6 soybean referred to in Article 2(b) and (c).
|Method for detection||- Event specific real-time quantitative PCR based method for genetically modified soybean MON-Ø4Ø32-6.
- Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
|Reference material||- Reference Material: ERM®-BF410 accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm|
|Annex II to the Cartagena Protocol||http://bch.cbd.int/database/record.shtml?documentid=103137|
|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||10/02/2012|
|Legal base||Art. 7(3), and 19(3) of the Regulation (EC) No 1829/2003
Commission Decision 2012/82/EU of 10 February 2012
Amended by Commission Implementing Decision (EU) 2019/1579 of 18 September 2019
Amended by Commission Implementing Decision (EU) 2021/184 of 12 February 2021
|Authorisation expiration date||Renewal ongoing|
|Further information on risk assessment||Opinions of the European Food Safety Authority: