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MON-ØØ863-5

EU register of genetically modified food and feed.

Event MON 863
Authorisation holder Name Monsanto Europe S.A.
Authorisation holder Address Monsanto Europe S.A.

Avenue de Tervuren 270-272

B-1150 Brussels - BELGIUM
Products 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 Joint Research Centre (JRC) of the European Commission, URL: http://www.irmm.jrc.be
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 Not appropriate
Date of authorisation 13/01/2006: foods and food ingredients derived from MON 863 maize.

10/08/2005: feed containing or consisting of MON 863 maize; other products containing or consisting of GT73 with the exception of cultivation.

Application for renewal submitted: food additives produced from MON 863 maize; feed materials produced from MON 863 maize (feed materials and feed additives).
Legal base Regulation (EC) No 258/97

Article 19(3) of Directive 2001/18/EC

Art. 8 and 20 of the Regulation (EC) No 1829/2003
Authorisation expiration date 12/01/2016: foods and food ingredients derived from MON 863 maize.

09/08/2015: feed containing or consisting of MON 863 maize; other products containing or consisting of MON 863 maize with the exception of cultivation.

Procedure for renewal ongoing: food additives produced from MON 863 maize; feed materials produced from MON 863 maize (feed materials and feed additives).
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)