SYN-BTØ11-1
EU register of genetically modified food and feed.
| Event | Bt11 |
| Authorisation holder Name | Syngenta Crop Protection AG |
| Authorisation holder Address |
Rosentalstrasse 67, CH-4058 Basel, Switzerland Represented in the Union by: Syngenta Crop Protection NV/SA, Avenue Louise, 489, 1050 Brussels, Belgium |
| Products |
(1) Foods and food ingredients containing, consisting of, or produced from genetically modified maize SYN-BTØ11-1;
(2) Feed containing, consisting of, or produced from genetically modified maize SYN-BTØ11-1; (3) Products other than food and feed containing or consisting of genetically modified maize SYN-BTØ11-1 with the exception of cultivation. |
| Designation | The genetically modified SYN-BTØ11-1 maize, as described in the application, expresses the Cry1Ab protein which confers protection against certain lepidopteran pests and a PAT protein which confers tolerance to glufosinate-ammonium herbicides. |
| Labelling |
(1) For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the 'name of the organism' shall be 'maize'. (2) The words 'not for cultivation' shall appear on the label of and in documents accompanying products containing or consisting of SYN-BTØ11-1 maize referred to in Article 2(b) and (c). |
| Method for detection |
- Event specific real-time quantitative PCR based method for genetically modified maize SYN-BTØ11-1. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at https://gmo-crl.jrc.ec.europa.eu/method-validations |
| Reference material | - Reference Material: ERM®-BF412 accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/ |
| Unique identifier | SYN-BTØ11-1 |
| Annex II to the Cartagena Protocol |
Biosafety Clearing-House: http://bch.cbd.int/database/record-v4.shtml?documentid=101303 https://bch.cbd.int/database/record.shtml?documentid=116331 |
| Conditions or restrictions on the placing on the market | Not required |
| Post-market monitoring requirements | Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC |
| Date of authorisation | 18/08/2021 |
| Legal base |
Commission Decision 2010/419 of 28 July 2010
Amended by Commission Implementing Decision (EU) 2019/60 of 11 January 2019 Commission Implementing Decision (EU) 2021/1392 of 17 August 2021 |
| Authorisation expiration date | 17/08/2031 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority:
https://doi.org/10.2903/j.efsa.2009.977 https://doi.org/10.2903/j.efsa.2021.6347 |