MON-ØØ81Ø-6
EU register of genetically modified food and feed.
| Event | MON810 |
| Authorisation holder Name |
Bayer Agriculture BV, Belgium representing Bayer CropScience LP, United States |
| Authorisation holder Address |
Bayer Agriculture BV Scheldelaan 460, 2040 Antwerp, Belgium On behalf of Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167 – United States. |
| 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) Amended by Commission Implementing Decision (EU) 2019/1579 of 18 September 2019 Commission Implementing Decision 2017/1207/EU of 4 July 2017 Amended by Commission Implementing Decision (EU) 2019/1579 of 18 September 2019 Amended by Commission Implementing Decision (EU) 2021/184 of 12 February 2021 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). Amended by Commission Implementing Decision (EU) 2021/184 of 12 February 2021 *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 |