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Genetically Modified Organisms

MON-ØØ863-5

Products subject to Commission Decisions on withdrawal from the market

Event MON 863
Authorisation holder Name Monsanto Europe S.A.
On behalf of
Monsanto Company
Authorisation holder Address Monsanto Europe S.A.
Scheldelaan 460, Haven 637
B-2040 Antwerpen, Belgium
On behalf of
Monsanto Company
800 N. Lindbergh Boulevard, St Louis
Missouri 63617, United States of America
Products market withdrawal 1.) Foods and food ingredients derived from MON 863 maize



Commission Decision 2006/68/EC of 13 January 2006, OJ L 034 , 07/02/2006



2.) Food additives produced from MON 863 maize



notified as existing food additives within the meaning of Article 8 (1)(b) of Regulation (EC) 1829/2003, authorised under Directive 89/107/EEC and complying with the relevant specifications laid down under this legislation.





3.) Feed containing or consisting of MON 863 maize

Commission Decision of 8 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm.



4.) Feed produced from MON 863 maize (feed materials and feed additives)



notified as existing feed falling within the scope of Article 20(1)(b) of Regulation (EC) No 1829/2003, namely as feed materials and feed additives (subject to Directive 70/524/EEC) which are produced from a genetically modified organism (GMO).



5.) Other products containing or consisting of MON 863 maize with the exception of cultivation



Commission Decision of 8 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm.
Designation The genetically modified maize MON 863 was generated by transformation of Zea mays cell culture line AT824 (initiated from immature embryos of an inbred maize line AT) with a MluI restriction fragment from plasmid PV-ZMIR13 using particle acceleration technology. The DNA fragment used for transformation carried two expression cassettes; a selectable marker gene nptII encoding neomycin phosphotransferase II and a trait gene encoding a variant Bacillus thuringiensis Cry3Bb1 insecticidal protein. The nptII gene was regulated by the 35S promoter and used the NOS 3' polyadenylation sequence as terminator. Regulation of the variant cry3Bb1 gene involved: a CaMV 35S promoter containing four tandem copies of the AS-1 element (Lam and Chua, 1990); the untranslated 5'mRNA leader sequence of the wheat major chlorophyll a/b-binding protein; the rice actin intron (ract1); a 3' nontranslated region of the wheat heat shock protein 17.3 which terminates transcription and directs polyadenylation. The linear DNA fragment used for transformation was prepared by digestion of plasmid PV-ZMIR13 with restriction endonuclease MluI, separation of the fragments by agarose gel electrophoresis and isolation of the DNA fragment that encoded the cry3Bb1 and nptII expression cassettes. Thus, the MluI fragment used for transformation was not expected to contain plasmid backbone DNA sequences. The variant Cry3Bb1 protein expressed in MON 863 maize has seven amino acid differences from wild type Cry3Bb1 and was designed to enhance its expression in plants and insecticidal activity against corn rootworm.
Labelling Article 13(1) and 25(1) of Regulation (EC) No 1829/2003
Method for detection Event specific real-time quantitative PCR based method for genetically modified MON-ØØ863-5 maize

Validated by the Joint Research Centre (JRC) of the European Commission, URL: http://gmo-crl.jrc.it/
Reference material - Reference Material: ERM®-BF416 (for MON-ØØ863-5) accessible via the joint Research Centre (JRC) of the European Commission, the institute of Reference Materials and Measurements (IRMM) http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
Unique identifier MON-ØØ863-5
Annex II to the Cartagena Protocol
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements
Date of authorisation 02/03/2010
Legal base Commission Decision on the withdrawal from the market of MON863 2016/87/EU of 22 January 2016
Authorisation expiration date
Further information on risk assessment European Food Safety Authority, The EFSA Journal (2004) 49, 1-25, URL: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753820_1178620772339.htm (under Part C of Directive 2001/18/EC)



European Food Safety Authority, The EFSA Journal (2004) 50, 1-25, URL: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620772383.htm (under Article 4 of the Novel Food Regulation (EC) No 258/97)