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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-108302-2   |   PDF   |   Print   |  
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published: 03 Aug 2015 last updated: 25 Mar 2025
General Information
Philippines
Determination of the Safety of Syngenta's Combined trait product corn: Bt11 x DAS59122 xMIR604 x TC1507 x GA21 for Direct use as Food, Feed, or Processing
EN
09 Jun 2016
Risk assessment details
  • BCH-LMO-SCBD-104678-8
    SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 - Agrisure® 3122
    | Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
    Show detection method(s)
Methodology and points to consider
Allergenicity and toxicity reports on individual proteins in each event were provided when the single events were submitted for biosafety assessment, all of which received biosafety approvals for food, feed or for processing.
EN
The eight proteins (Cry1Ab, Cry34Ab1, Cry35Ab1, mCry3A, Cry1F, PAT, PMI and EPSPS) show no homology to any known mammalian allergen or toxin. There is no evidence suggesting that the eight proteins will interact to form some new allergen or toxin since each has distinct mode of action and are not likely to interact.
EN
The combined trait product corn:Bt11 x DAS59122 x MIR604 x TC1507 x GA21 is as safe for human food, livestock feed and for processing as its conventional counterparts”. 
EN
After reviewing the scientific data and information relevant to the combined trait product corn Bt11 x DAS59122 x MIR604 x TC1507 x GA21 application of Syngenta Philippines Inc. it is concluded that no interaction was found between/among the combined traits, hence this plant product was found to be as safe as its conventional corn and can substitute for its traditional counterpart for direct use as food, feed or for processing.
EN
A biosafety notification for combined trait product corn: Bt11 x DAS59122 x MIR604 x TC1507 x GA21 and all progenies derived from crosses of the product with any conventionally bredcorn and corn containing approved-biotech events for direct use as food, feed or for processing was issued to Syngenta Philippines Inc.
EN
Bt11 x DAS59122 x MIR604 x TC1507 x GA21 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This LMO will be directly used for food, feed and processing.
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR.Methods and protocols for safe handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines.
EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
The combined trait product Bt11 x DAS59122 xMIR604 x TC1507 x GA21 is intended for direct use as food, feed and for processing.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of Bt11 x DAS59122 xMIR604 x TC1507 x GA21.
EN
Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1

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