Genetically Modified Organisms
Community register of GM food and feed.
|Authorisation holder||A) Pioneer Overseas Corporation
Avenue des Arts 44, B-1040 Brussels, Belgium
On behalf of Pioneer Hi-Bred International, Inc., 7250 NW 62nd Avenue, P. O. Box 552, Johnston, IA 50131-0552, United States
B) Dow AgroSciences Distribution S.A.S.
1 bis, avenue du 8 mai 1945, 78280 Guyancourt, France
On behalf of Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States.
|Products||(1) Food containing, consisting of, or produced from DAS-59122-7 maize;
(2) Feed containing, consisting of, or produced from DAS-59122-7 maize;
(3) maize 59122 in products containing it or consisting of it for any other use than those provided for in points (1) and (2), with the exception of cultivation.
|Designation||Maize 59122, as described in the application, expresses the Cry34Ab1 and Cry35Ab1 proteins, derived from Bacillus thuringiensis, which confer resistance to certain coleopteran pests, including Western corn rootworm, and the PAT protein, derived from Streptomyces viridochromogenes, which confers tolerance to glufosinate-ammonium based herbicides and was used as a selection marker.|
|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 maize 59122, with the exception of food and food ingredients.
|Method for detection||- Event specific real-time quantitative PCR based method for genetically modified maize DAS-59122-7.
- 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||ERM®-BF424 (for DAS-59122-7) accessible via the Joint Research Centre (JRC) of the European Commission, at https://ec.europa.eu/jrc/en/reference-materials/catalogue/|
|Annex II to the Cartagena Protocol||http://bch.cbd.int/database/record.shtml?documentid=102054
|Conditions or restrictions on the placing on the market||Not required.|
|Post-market monitoring requirements||Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.|
|Date of authorisation||03/08/2018|
|Legal bases||Art. 11(3) and Art. 23(3) of the Regulation (EC) No 1829/2003
Commission Implementing Decision (EU) 2018/1109
Amended by Commission Implementing Decision (EU) 2019/241 of 6 February 2019
|Authorisation expiration date||05/08/2028|
|Further information on risk assessment||Opinion of the European Food Safety Authority: