European Union | BCH-DEC-EU-110991 | Country's Decision or any other Communication | Biosafety Clearing-House

Loading...
  |  

Country's Decision or any other Communication (DEC)

last updated: 12 Oct 2016
Amendment
Yes
  • BCH-DEC-EUR-101307-2 Country's Decision or any other Communication European Commission Decision 2010/426/EU authorising the placing on the market for food and feed uses of genetically modified maize Bt11xGA21 (SYN-BTØ11-1xMON-ØØØ21-9))
    SYN-BTØ11-1 x MON-ØØØ21-9 - YieldGard™ Roundup Ready™ maize | Maize, Corn
  • BCH-DEC-EUR-103013-1 Country's Decision or any other Communication EU Commission Decision 2011/892/EU on the placing on the market for food and feed uses of genetically modified maize MIR604xGA21 (SYN-IR604-5xMON-00021-9)
    SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ RW Rootworm-Protected Roundup Ready™ maize | Maize, Corn
  • BCH-DEC-EUR-103015-1 Country's Decision or any other Communication EU Commission Decision 2011/893/EU on the placing on the market for food and feed uses of genetically modiified maize Bt11xMIR604
    SYN-BTØ11-1 x SYN-IR6Ø4-5 - Agrisure™ CB/LL/RW maize | Maize, Corn
  • BCH-DEC-EUR-103017-1 Country's Decision or any other Communication EU Commission Decision 2011/894/EU on the placing on the market for food and feed uses of genetically modified maize Bt11xMIR604xGA21 (SYN-BT011-1xSYN-IR604-5xMON-00021-9)
    SYN-BTØ11-1 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ 3000GT Maize | Maize, Corn
Syngenta asked the Commission to repeal those four Decisions once authorisation was given to Bt11xMIR162xMIR604xGA21 maize and all sub-combinations including Bt11xGA21 maize, MIR604xGA21 maize, Bt11xMIR604 maize, and Bt11xMIR604xGA21 maize.
EN
General information
COMMISSION IMPLEMENTING DECISION (EU) 2016/1685 of 16 September 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21, and genetically modified maizes combining two or three of the events Bt11, MIR162, MIR604 and GA21, and repealing Decisions 2010/426/EU, 2011/892/EU, 2011/893/EU and 2011/894/EU
EN
16 Sep 2016
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFP)
LMOs for direct use as food or feed, or for processing (LMOs-FFP)
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
No
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
Specific conditions in accordance with Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003: (1) The authorisation holder shall inform the Commission if the sub-combinations SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5, SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9, SYN-BTØ11-1 × SYN-IR162-4, SYN-IR162-4 × SYN-IR6Ø4-5 and/or SYN-IR162-4 × MON-ØØØ21-9 were to be created via targeted breeding approaches and commercialised.
(2) If it is the case, the authorisation holder shall collate information on the expression levels of the newly expressed proteins.
EN
LMOs created via targeted breeding approaches may have expression levels of the transgenes different from those created by conventional breeding crosses.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-101252-11 Living Modified Organism SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure Viptera® 4 Maize
    Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-101251-11 Living Modified Organism SYN-BTØ11-1 x SYN-IR162-4 x MON-ØØØ21-9 - Agrisure® Viptera™ 3110 Maize
    Mannose tolerance Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-43635-9 Living Modified Organism SYN-BTØ11-1 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ 3000GT Maize
    Syngenta Crop Protection AG | Mannose tolerance, Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate, Glyphosate), Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-104749-3 Living Modified Organism SYN-BTØ11-1 x SYN-IR162-4 - Insect Resistant Maize
    Syngenta Crop Protection AG | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate), Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-43624-10 Living Modified Organism SYN-BTØ11-1 x SYN-IR6Ø4-5 - Agrisure™ CB/LL/RW maize
    Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate), Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-16121-8 Living Modified Organism SYN-BTØ11-1 x MON-ØØØ21-9 - YieldGard™ Roundup Ready™ maize
    Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
  • BCH-LMO-SCBD-43630-9 Living Modified Organism SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ RW Rootworm-Protected Roundup Ready™ maize
    Syngenta Crop Protection AG | Mannose tolerance, Resistance to diseases and pests (Insects, Coleoptera (beetles)), Resistance to herbicides (Glyphosate), Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-110983-1 Living Modified Organism SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 - Insect resistant, herbicide tolerant maize
    Syngenta France SAS | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate), Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-110984-2 Living Modified Organism SYN-IR162-4 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
    Syngenta France SAS | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate), Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-110985-1 Living Modified Organism SYN-IR162-4 x SYN-IR6Ø4-5 - Insect resistant maize
    Syngenta France SAS | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-110986-3 Living Modified Organism SYN-IR162-4 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
    Syngenta France SAS | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate), Selectable marker genes and reporter genes
  • BCH-RA-EUR-110990-3 Risk Assessment generated by a regulatory process Scientific Opinion on an application by Syngenta (EFSA-GMO-DE-2009-66) for placing on the market of herbicide tolerant and insect resistant maize Bt11 × MIR162 × MIR604 × GA21 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/20031
    SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure Viptera® 4 Maize | Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes | SYN-BTØ11-1 x SYN-IR162-4 x MON-ØØØ21-9 - Agrisure® Viptera™ 3110 Maize | Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes | SYN-BTØ11-1 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ 3000GT Maize | Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes | SYN-BTØ11-1 x SYN-IR162-4 - Insect Resistant Maize | Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes | SYN-BTØ11-1 x SYN-IR6Ø4-5 - Agrisure™ CB/LL/RW maize | Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes | SYN-BTØ11-1 x MON-ØØØ21-9 - YieldGard™ Roundup Ready™ maize | Resistance to diseases and pests, Resistance to herbicides | SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ RW Rootworm-Protected Roundup Ready™ maize | Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes | SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 - Insect resistant, herbicide tolerant maize | Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes | SYN-IR162-4 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize | Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes | SYN-IR162-4 x SYN-IR6Ø4-5 - Insect resistant maize | Resistance to diseases and pests, Selectable marker genes and reporter genes | SYN-IR162-4 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize | Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes
Document on the decision, communication, notification or declaration
Additional Information
Detection methods for the single events maize Bt11, MIR162, MIR604 and GA21 and methods for the stack (Bt11xMIR162xMIR604xGA21) respectively validated and verified by the European Union Reference Laboratory for GM Food and Feed (EURL GMFF) available at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
Records referencing this document Show in search
Record type Field Record(s)