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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-TH-277923-5   |   PDF   |   Print   |  
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published: 29 Mar 2025 last updated: 13 May 2025
General Information
Bt11 x MIR604
EN
04 Dec 2022
Risk assessment details
  • SYN-BTØ11-1 × SYN-IR6Ø4-5 - Agrisure™ CB/LL/RW maize
    | Syngenta | 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
The stacked event Bt11 x MIR604 maize obtained from conventional breeding of genetically modified maize event Bt11 and event MIR604 to express Bt-toxin (Cry1Ab) which provide protection to European corn borer (ECB), the mCry3A protein (modified version of Cry3A of Bacillus thuringiensis subsp. terebrionis) which provide protection from larval corn rootworm (CRW) damage, and enzyme phosphinothricin N-acetyl transferase (PAT) which confers tolerance to glufosinate-ammonium herbicide.Maize Bt11 was generated by using PAT protein as a selectable marker enabling identification of transformed plant cells as well as a source of resistance to the herbicide known as glufosinate ammonium.According to the existing scientific data and information available during the safety assessment, it is concluded that the stacked event Bt11 x MIR604 maize is substantially equivalent to its conventional counterpart in terms of morphology, nutrition, toxicity and allergenicity. 
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