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MON-ØØ6Ø3-6

EU register of genetically modified food and feed.

Event NK603
Authorisation holder Name Monsanto Europe S.A.
Authorisation holder Address Avenue de Tervuren 270-272, B-1150 Brussels, Belgium



On behalf of:



Monsanto Company, 800 N. Lindbergh Bld., St. Louis, Missouri 63167
Products 1.) Food containing, consisting of, or produced from NK603 maize



Commission Decision of 3 March 2005 authorising the placing on the market of foods and food ingredients derived from genetically modified maize line NK 603 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council.



2.) Food additives produced from NK603 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 NK603 maize



Commission Decision of 19 July 2004 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 NK603) genetically modified for glyphosate tolerance.



4.) Feed produced from NK603 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 NK603 maize with the exception of cultivation



Commission Decision of 19 July 2004 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 NK603) genetically modified for glyphosate tolerance.

Designation Genetically modified maize line NK 603 contains the following DNA sequences in two intact cassettes:

A 5-enolpyruvylshikimate-3-phosphate synthase (epsps) gene derived from Agrobacterium spec. strain CP (CP4 EPSPS), which imparts tolerance to glyphosate, under the regulation of the rice actin 1 gene promoter, terminator sequence from Agrobacterium tumefaciens and the chloroplast transit peptide sequence from the epsps gene of Arabidopsis thaliana.

A 5-enolpyruvylshikimate-3-phosphate synthase (epsps) gene derived from Agrobacterium spec. strain CP (CP4 EPSPS), which imparts tolerance to glyphosate, under the regulation of an enhanced 35S promoter derived from cauliflower mosaic virus, terminator sequence from Agrobacterium tumefaciens and the chloroplast transit peptide sequence from the epsps gene of Arabidopsis thaliana.
Labelling "Genetically modified maize" or "produced from genetically modified maize"
Method for detection Event specific real-time quantitative PCR based method for genetically modified NK 603 maize

Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL), to be published at :

URL:  http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
Reference material IRMM-415 produced by the Joint Research Centre (JRC) of the European Commission.
Unique identifier MON-ØØ6Ø3-6
Annex II to the Cartagena Protocol -
Scientific Opinion http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620772552.htm
Conditions or restrictions on the placing on the market Not applicable
Monitoring plan See Commission Decision of 19 July 2004 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 NK603) genetically modified for glyphosate tolerance.
Post-market monitoring requirements Not appropriate
Date of authorisation Application for renewal submitted: food additives produced from NK603 maize; foods and food ingredients derived from NK603 maize; feed produced from NK603 maize (feed materials and feed additives); feed containing or consisting of NK603 maize; other products containing or consisting of NK603 maize with the exception of cultivation.
Legal base Article 7 of Regulation (EC) No 258/97

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

Art. 8(1)(b) and 20(1)(b) of the Regulation (EC) No 1829/2003
Authorisation expiration date Procedure for renewal ongoing: food additives produced from NK603 maize; foods and food ingredients derived from NK603 maize; feed produced from NK603 maize (feed materials and feed additives); feed containing or consisting of NK603 maize; other products containing or consisting of NK603 maize with the exception of cultivation