HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms


Community register of GM food and feed.

Event 40-3-2
Authorisation holder Name Bayer Agriculture BV, Belgium
Bayer CropScience LP, United States
Authorisation holder Address Bayer Agriculture BV
Scheldelaan 460
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
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
Unique identifier MON-Ø4Ø32-6
Annex II to the Cartagena Protocol
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: