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Risk Assessment generated by a regulatory process
(RA)
published: 15 Sep 2008
last updated: 25 Mar 2025
Determination for the Safety Assessment of Combined Trait Product Corn: Bt11x GA21 for Direct Use as Food, Feed and for Processing
EN
23 Jan 2007
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph,
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SYN-BTØ11-1 × MON-ØØØ21-9 - YieldGard™ Roundup Ready™ maize| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate, Glyphosate)
- DA-BPI Biotechnology Office [ English ]
EN
The three proteins (Cry1Ab, PAT and EPSPS) show no homology to any known mammalian allergen or toxin. There is no evidence suggesting that the three proteins will interact to form some new allergen or toxin. The mode of action of each gene product of Bt11 protein and mEPSPS) protein are different. The products of the Bt 11 gene and mepsps gene are involved in two distinctly metabolic pathways. Stacked trait product corn Bt11 and GA21 do not pose any adverse effect on the metabolism of the plant as evidenced by the fact that the superiority in yield of the hybrid has been maintained.
EN
Results of biochemical analyses have shown that the expression levels of the cry1Ab, pat and mepsps in the stacked hybrid are comparable with that of the counterpart genes in the single events. The PAT protein in the stacked hybrid is present but as already noted, the amount is below the limit of quantitation.
EN
Combined trait product corn BT11x GA21 applied for direct use has shown no evidence of interaction of the resulting gene products and is safe for human food, livestock feed and for processing as its conventional counterparts.
EN
A biosafety notification for combined trait product corn Bt11 x GA21and all progenies derived from crosses of the product with any conventionally-bred corn and corn containing approved-biotech events for direct use as food, feed or for processing was issued to Syngenta Philippines, Inc. Corn Bt11 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
Corn Bt11 X GA21 is found to be safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This application is not for the propagation of the combined trait product corn: Bt11 x GA21. This LMO will be directly used for food, feed and for processing.
EN
Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
EN
Yes
Yes
Yes
Yes
Yes
Bt11 x GA21 corn 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 during the evaluation of this combined trait.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait.
- OECD Consensus Document on Corn [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
