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Risk Assessment generated by a regulatory process
(RA)
published: 03 Nov 2014
last updated: 25 Mar 2025
Decision for the Safety Assessment of Syngenta's corn Bt11 x MIR162 x MIR604 x GA21 for Direct Use as food and feed or for processing
EN
28 Jul 2010
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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 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 - Agrisure Viptera® 4 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, Glyphosate), Selectable marker genes and reporter genes
- DA-BPI Biotechnology Office [ English ]
The six proteins (Cry1Ab, PAT,Vip3Aa20, mCry3A, PMI and EPSPS) show no homology to any known mammalian allergen or toxin.
EN
Based on the modes of action of the Cry1Ab, PAT, Vip3Aa20, mCry3A, PMI and EPSPS proteins, and
the location of these proteins’ accumulation in the plant cells, there is no known mechanism of interaction among the gene products that could lead to adverse effects in human and animals.
EN
the location of these proteins’ accumulation in the plant cells, there is no known mechanism of interaction among the gene products that could lead to adverse effects in human and animals.
There is no evidence suggesting that the six proteins will interact to form some new allergen or toxin since each has distinct mode of action and are not likely to interact.
EN
After reviewing the scientific data and information relevant to the combined trait product corn Bt11 x
MIR162 x MIR604 x GA21 application of Syngenta Philippines, Inc.,it is concluded that no interaction found between/among the combined traits. Hence, this plant product was found to be as safe as its conv
entional corn and can substitute for its traditional counterpart for direct use as food, feed and for processing and is therefore approved for direct use as food, or feed or for processing.
EN
MIR162 x MIR604 x GA21 application of Syngenta Philippines, Inc.,it is concluded that no interaction found between/among the combined traits. Hence, this plant product was found to be as safe as its conv
entional corn and can substitute for its traditional counterpart for direct use as food, feed and for processing and is therefore approved for direct use as food, or feed or for processing.
A biosafety notification for combined trait product : corn Bt11 x MIR162 x MIR604 x GA21 and 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.
EN
approved - biotech events for direct use as food, feed or for processing was issued to Syngenta Philippines Inc.
BT11 X MIR162 X MIR604 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
Yes
Yes
Yes
Yes
Yes
The combined trait product BT11 X MIR162 X MIR604 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 MIR162 X MIR604 XGA21.
EN
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 MIR162 X MIR604 XGA21.
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
