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MON-ØØØ73-7

EU register of genetically modified food and feed.

Event GT73
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 produced from GT73 oilseed rape (refined oil and food additives)



refined oil notified as existing food falling within the scope of Article 8(1)(a) of Regulation (EC) No 1829/2003, which is produced from a genetically modified organisms (GMOs) and which has been placed on the market in accordance with Art. 5 of Regulation (EC) No 258/97, notification forwarded to Member States on 21/11/1997, opinion on substantial equivalence by the UK Advisory Committee on Novel Foods and Processes, confirmation by the UK Ministry of Agriculture, Fisheries and Food on 24/01/1996 and 15/07/1997.

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.



2.) Feed containing and consisting of GT73 oilseed rape



Commission Decision of 31 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of an oilseed rape product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide glyphosate.

Commission Recommendation of 16 August 2005 concerning the measures to be taken by the consent holder to prevent any damage to health and the environment in the event of the accidental spillage of an oilseed rape (Brassica napus L., GT73 line ¿ MON-00073-7) genetically modified for tolerance to the herbicide glyphosate.



3.) Feed produced from GT73 oilseed rape (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).



4.) Other products containing or consisting of GT73 oilseed rape with the exception of cultivation



Commission Decision of 31 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of an oilseed rape product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide glyphosate.

Commission Recommendation of 16 August 2005 concerning the measures to be taken by the consent holder to prevent any damage to health and the environment in the event of the accidental spillage of an oilseed rape (Brassica napus L., GT73 line ¿ MON-00073-7) genetically modified for tolerance to the herbicide glyphosate.
Designation Oilseed rape (Brassica napus L.), with tolerance to the herbicide glyphosate, derived from the oilseed rape GT73 line, which has been transformed with Agrobacterium tumefaciens, using the vector PV-BNGT04. The product contains the following DNA in two cassettes:



(a) Cassette 1



A 5-enolpyruvylshikimate-3-phospate synthase (epsps) gene derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers glyphosate tolerance, under the regulation of the modified figwort mosaic virus promoter (P-CMoVb), terminator sequences from the pea rbcS E9 gene encoding the small subunit of ribulose bisphosphate carboxylase/oxygenase and the N-terminal chloroplast transit peptide CTP2 sequence from the epsps gene of Arabidopsis thaliana.



(b) Cassette 2



The variant 247 of the original glyphosate oxidoreductase gene (goxv247) derived from Ochrobactrum anthropi strain LBAA, which confers glyphosate tolerance, under the regulation of the modified figwort mosaic virus promoter (P-CMoVb), terminator sequences from Agrobacterium tumefaciens and the N-terminal chloroplast transit peptide sequence CTP1 from the ribulose bisphosphate carboxylase/oxygenase (Arab-ssu1a) gene of Arabidopsis thaliana. The product does not contain the adenyltransferase gene (aad) encoding resistance to streptomycin and spectinomycin, as present in the transformation vector used.
Labelling Article 13(1) and 25(1) of Regulation (EC) No 1829/2003
Method for detection Event specific real-time quantitative detection PCR method for MON-ØØØ73-7 oilseed rape

Validated by the Joint Research Centre (JRC) of the European Commission, URL:  http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
Reference material The American Oil Chemists' Society (AOCS)

2211 W. Bradley Ave., Champaign, IL USA 61821
Unique identifier MON-ØØØ73-7
Annex II to the Cartagena Protocol Biosafety Clearing House, Record ID 1360, URL:

http://bch.biodiv.org/database/record.aspx?searchid=143158&recordid=1360
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements Not appropriate
Date of authorisation 21/02/2007: feed containing and consisting of GT73 oilseed rape; other products containing or consisting of GT73 oilseed rape with the exception of cultivation.

Application for renewal submitted: foods produced from GT73 oilseed rape (refined oil and food additives); feed produced from GT73 oilseed rape (feed materials and feed additives).
Legal bases Art. 8(1)(a),(b) and 20(1)(b) of the Regulation (EC) No 1829/2003

Article 19(3) of Directive 2001/18/EC
Authorisation expiration date 20/02/2017: feed containing and consisting of GT73 oilseed rape; other products containing or consisting of GT73 with the exception of cultivation.

Procedure for renewal ongoing: foods produced from GT73 oilseed rape (refined oil and food additives); feed produced from GT73 oilseed rape (feed materials and feed additives).
Further information on risk assessment European Food Safety Authority, The EFSA Journal (2004) 29, 1-19, URL:

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620772413.htm (for processing and feed use)



UK Advisory Committee on Novel Foods and Processes (regarding food)