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MON-ØØ81Ø-6

EU register of genetically modified food and feed.

Event MON810
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 produced from MON810 (including food additives)

maize flour, maize gluten, maize semolina, maize starch, maize glucose and maize 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 organism (GMO) 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 05/02/1998, 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 17/02/1997.

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.

Pollen produced from maize MON810 authorised with Commission Decision 2013/649/EU

2.) Feed containing or consisting of MON810 maize1

notified as existing feed falling within the scope of Article 20(1)(a) of Regulation (EC) No 1829/2003, which contains or consists of 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: 98/294/EC, Official Journal L 131 p. 32 - 33 - 05/05/1998.

3.) Feed produced from MON810 maize (feed materials 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.) Seeds for cultivation

Commission Decision 98/294/EC concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220/EEC.

(1) The scope covers any progeny derived from crosses of the product with any traditionally bred maize.

* The authorising decision under Directive 90/220/EEC covers the seeds from inbred lines and hybrids derived from maize line MON 810. Seeds for further food and feed use are included in the notification in accordance with Article 8(1)(a) / Article 20(1)(a) of Regulation (EC) No. 1829/2003 and as referred to in Article 11 of Regulation (EC) No. 641/2004. (11 July 2005)
Designation The insect-protected maize line was generated by particle acceleration technology using two plasmids; PV-ZMBK07 and PV-ZMGT10. The transgenic maize line produced expresses the cry1A(b) gene (origin - Bacillus thuringiensis subsp. kurstaki) which encodes a cry1A(b) insect control protein (Btk).
Labelling Article 13(1) and 25(1) of Regulation (EC) No 1829/2003
Method for detection Event specific Real-time PCR method for the quantification of genetically modified MON-ØØ81Ø-6 maize Validated on ground maize seeds (certified reference materials [CRM IRMM-413]), containing mixtures of genetically modified MON 810 and conventional maize, by the Federal Institute for Risk Assessment (BfR) in collaboration with the American Association of Cereal Chemists (AACC), Joint Research Centre (JRC) of the European Commission (EC) (Institute for Reference Material and Measurement (IRMM), Institute for Health and Consumer Protection (IHCP)), and GeneScan, Berlin, published at http://gmo-crl.jrc.ec.europa.eu/summaries/Mon810_validation_report.pdf
Reference material Reference Material: ERM-BF413k accessible via the Joint Research Centre (JRC) of the European Commission, the Institute for Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
Unique identifier MON-ØØ81Ø-6
Annex II to the Cartagena Protocol Biosafety Clearing House, Record ID 1362, URL:

http://bch.biodiv.org/database/record.aspx?searchid=143338&recordid=1362



Biosafety Clearing House, Record ID 1365, URL:

http://bch.biodiv.org/database/record.aspx?searchid=143338&recordid=1365



Biosafety Clearing House, Record ID 1367, URL:

http://bch.biodiv.org/database/record.aspx?searchid=143338&recordid=1367
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements Not appropriate
Date of authorisation Application for renewal submitted: foods and food ingredients produced from MON810 (including food additives); feed containing or consisting of MON810 maize; feed produced from MON810 maize (feed materials feed additives); seeds for cultivation.
Pollen produced from MON810 maize - 6/11/2013
Legal base 8(1)(a),(b) and 20(1)(a),(b) of the Regulation (EC) No 1829/2003

Directive 90/220/EEC
Art. 7(3) of the Regulation (EC) No 1829/2003 Commission Decision 2013/649/UE of 6 November 2013
Authorisation expiration date Procedure for renewal ongoing: foods and food ingredients produced from MON810 (including food additives); feed containing or consisting of MON810 maize; feed produced from MON810 maize (feed materials feed additives); seeds for cultivation.
Pollen produced from MON810 maize - 5/11/2023
Further information on risk assessment Scientific Committee on Plants, URL:

http://europa.eu.int/comm/food/fs/sc/scp/out02_en.html

(for human health and environment)

UK Advisory Committee on Novel Foods and Processes (for use in food)

EFSA opinion:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2012-00988