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Genetically Modified Organisms

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 MON-ØØ81Ø-6 maize, including pollen;
(2) Feed containing, consisting of or produced from MON-ØØ81Ø-6 maize;
(3) MON-ØØ81Ø-6 maize in products containing it or consisting of it for any other use than food or feed or cultivation.
(4) MON-ØØ81Ø-6 maize seeds for cultivation
Designation The genetically modified MON-ØØ81Ø-6 maize as described in the applications expresses the Cry1Ab protein, derived from Bacillus thuringiensis subsp. kurstaki, which confers protection against predation by certain lepidopteran insect pests, including the European corn borer (Ostrinia nubilalis) and pink borers (Sesamia spp.).
Labelling Article 13(1) and 25(1) of Regulation (EC) No 1829/2003
Article 4(6) of Regulation (EC) No 1830/2003
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
http://bch.cbd.int/database/record.shtml?documentid=101792

Maize MON810 pollen: http://bch.cbd.int/database/record.shtml?documentid=112243

Maize MON810 for food and feed: http://bch.cbd.int/database/record.shtml?documentid=112245
Conditions or restrictions on the placing on the market Cultivation prohibited in the following territories: (cf the list in Annex to the Decision)"
Monitoring plan Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Dates of authorisation 03/08/1998: seeds for cultivation
06/11/2013: pollen produced from MON810 maize
04/07/2017: foods and food ingredients produced from MON810; feed containing or consisting of MON810 maize; renewal of feed produced from MON810 maize (feed materials feed additives);
Legal base Food produced from and feed containing, consisting of or produced from MON810 maize:

Commission Implementing Decision 2013/649/EU of 6 November 2013 (pollen only)
Commission Implementing Decision 2017/1207/EU of 4 July 2017

Seeds for cultivation
Commission Decision 98/294/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220/EEC* and consent granted by the French authorities on 3 August 1998 (Journal Officiel de la République Française, 5 August 1998).
Commission Implementing Decision (EU) 2016/321 of 3 March 2016 adjusting the geographical scope of the authorisation for cultivation of genetically modified maize (Zea mays L.) MON 810 (MON-ØØ81Ø-6).

*products notified as existing products pursuant to Article 20 of Regulation (EC) No 1829/2003
Authorisation expiration dates 05/11/2023: Pollen produced from MON810 maize
03/07/2027: foods and food ingredients produced from MON810 (except pollen); feed containing, consisting or produced from MON810 maize
No expiration date as long as the renewal application is pending: MON 810 seeds for cultivation.
Further information on risk assessment EFSA opinions:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2012-00988
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2009-00656
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2009-00657
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2009-00658