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Risk Assessment
Record information and status
Record ID
110990
Status
Published
Date of creation
2016-10-12 15:55 UTC (Joachim.Kreysa@ec.europa.eu)
Date of last update
2016-10-12 16:07 UTC (Joachim.Kreysa@ec.europa.eu)
Date of publication
2016-10-12 16:07 UTC (Joachim.Kreysa@ec.europa.eu)

General Information
Country
  • European Union
Title of risk assessment
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
Date of the risk assessment
2015-10-29
Competent National Authority(ies) responsible for the risk assessment
European Food Safety Authority (EFSA) GMO Panel
European Food Safety Authority
Largo N. Palli 5/A 

Parma
Italy, 43121
Phone:+39 0521 036566
Email:Elisabeth.Waigmann@efsa.europa.eu
Url:http://www.efsa.europa.eu/
Contact details of the main responsible risk assessor
Mr Per Bergman
Acting Head of Unit
GMO Unit
European Food Safety Authority (EFSA)
European Food Safety Authority
Largo N. Palli 5/A 
Parma
Italy, 43121
Phone:+39 0521 036 354
Email:Per.Bergman@efsa.europa.eu
Url:European Food Safety Authority
Risk assessment details
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
Show detection method(s)
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
Show detection method(s)
SYN-BTØ11-1 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ 3000GT 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
Show detection method(s)
SYN-BTØ11-1 x SYN-IR162-4 - Insect Resistant Maize
Mannose tolerance Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Show detection method(s)
SYN-BTØ11-1 x SYN-IR6Ø4-5 - Agrisure™ CB/LL/RW maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Show detection method(s)
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
Show detection method(s)
SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ RW Rootworm-Protected Roundup Ready™ maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera) Resistance to herbicides - Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate
Show detection method(s)
SYN-IR162-4 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
SYN-IR162-4 x SYN-IR6Ø4-5 - Insect resistant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Selectable marker genes and reporter genes
Show detection method(s)
SYN-IR162-4 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Methodology and points to consider
LMO detection and identification methods proposed
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) are available at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx

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