| 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.
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
The detection method was validated by BfR, AACC and 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-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. |
| Legal base |
Art. 8(1)(a),(b) and 20(1)(a),(b) of the Regulation (EC) No 1829/2003
Directive 90/220/EEC |
| 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. |
| 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) |
