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MON-Ø4Ø32-6

Products subject to Commission Decisions on withdrawal from the market

Event MON 40-3-2
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.) Food containing, consisting of, or produced from MON 40-3-2 soybean (including food additives)



notified as existing food falling within the scope of Article 8(1)(a) of Regulation (EC) No 1829/2003, which contains, consists of or is produced from a genetically modified organism (GMO) and which has been placed on the market in accordance with Part C to the Directive 90/220/EEC before the entry into force of Regulation (EC) No 258/97, Decision to grant consent: 96/281/EC, Official Journal L 107/10 - 30/04/1996.

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 or consisting of MON 40-3-2 soybean (1)



notified as existing feed falling within the scope of Article 20(1)(a) of Regulation (EC) No 1829/2003, which contains or consists of a genetically modified organism (GMO) and which has been placed on the market in accordance with Part C to the Directives 90/220/EEC, Decision to grant consent: 96/281/EC, Official Journal L 107/10 - 30/04/1996.



3.) Feed produced from MON 40-3-2 soybean (feed materials and feed additives)



notified as existing feeds 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 MON 40-3-2 soybean with the exception of cultivation

96/281/EC: Commission Decision of 3 April 1996 concerning the placing on the market of genetically modified soya beans (Glycine max L.) with increased tolerance to the herbicide glyphosate, pursuant to Council Directive 90/220/EEC.



(1) The scope covers any progeny derived from crosses of the product with any traditionally red soya bean lines.
Designation The product consists of a soya bean (Glycine max L. cv A5403) line (40-3-2) in which the following sequences have been inserted:



- a single copy of the gene coding for glyphosate tolerance CP4 5 enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) from Agrobacterium sp. strain CP4, and the chloroplast transit peptide (CTP) coding sequence from Petunia hybrida with the promoter P-E35S from cauliflower mosaic virus and the nopaline synthase gene terminator from Agrobacterium tumefaciens.
Labelling Article 13(1) and 25(1) of Regulation (EC) No 1829/2003
Method for detection Event-specific Real-Time PCR method for Quantitation of Genetically Modified Soybean MON-Ø4Ø32-6

This detection method is under validation by the Joint Research Centre (JRC) of the European Commission, URL: http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
Reference material Joint Research Centre (JRC) of the European Commission, URL: http://www.irmm.jrc.be

Fluka Chemie AG, URL: http://www.sigmaaldrich.com
Unique identifier MON-Ø4Ø32-6
Annex II to the Cartagena Protocol Biosafety Clearing House, Record ID 1363, URL:

http://bch.biodiv.org/database/record.aspx?searchid=143486&recordid=1363

Biosafety Clearing House, Record ID 1364, URL:

http://bch.biodiv.org/database/record.aspx?searchid=143486&recordid=1364

Biosafety Clearing House, Record ID 1368, URL:

http://bch.biodiv.org/database/record.aspx?searchid=143486&recordid=1368
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements Not appropriate
Date of authorisation Application for renewal submitted: food containing, consisting of, or produced from MON 40-3-2 soybean (including food additives); feed containing or consisting of MON 40-3-2 soybean; feed produced from MON 40-3-2 soybean (feed materials and feed additives); other products containing or consisting of MON 40-3-2 soybean with the exception of cultivation.
Legal base Art. 8(1)(a),(b) and 20(1)(a),(b) of the Regulation (EC) No 1829/2003

Article 19(3) of Directive 2001/18/EC
Authorisation expiration date Procedure for renewal ongoing: food containing, consisting of, or produced from MON 40-3-2 soybean (including food additives); feed containing or consisting of MON 40-3-2 soybean; feed produced from MON 40-3-2 soybean (feed materials and feed additives); other products containing or consisting of MON 40-3-2 soybean with the exception of cultivation.
Further information on risk assessment UK Advisory Committee on Novel Foods and Processes (ACNFP), 1995

Advice of the UK Advisory Committee on Releases to the Environment (ACRE), 2000

Scientific Committee on Food, URL: http://europa.eu.int/comm/food/fs/sc/scf/out33_en.html