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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 Canola RT73 for Direct Use as Food, Feed and for Processing
EN
22 Oct 2008
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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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MON-ØØØ73-7 - Roundup Ready™ canola| Monsanto | Resistance to herbicides (Glyphosate)
- DA-BPI Biotechnology Office [ English ]
EN
Both microorganisms (Agrobacterium sp and Ochrobactrum anthropi) are non-pathogenic to human and animals. All genetic elements used in the transformation vector are non regulatory genes, these structural genes (protein coding sequences: CP4 EPSPS and GOX/GOXv247) are non-pathogenic to humans/animals and no allergenic potential
Both novel proteins, CP4 EPSPS and GOX v247 proteins were found to be heat labile, easily degraded by simulated gastric and intestinal fluids, non allergenic and non toxic. All regulatory genetic elements (promoters [FMV], termination (E9’3) transit signal peptides are also non pathogenic in humans and animals.
Oral gavage studies of CP4 EPSPS and GOX/GOXv247 proteins show no toxic properties. Comparison of amino acid sequence of both CP4 EPSPS and GOX/Gov247 proteins show no significant homology to known allergenic proteins. CP4 EPSPS and GOX/GOXv247 are very susceptible to proteolysis and present only in very small amounts in the plant.
Based on proximate composition, fatty acids analysis and glucosinates analysis, the transgenic lines (RT73) and the Westar (non transgenic lines) were substantially equivalent.
EN
Both novel proteins, CP4 EPSPS and GOX v247 proteins were found to be heat labile, easily degraded by simulated gastric and intestinal fluids, non allergenic and non toxic. All regulatory genetic elements (promoters [FMV], termination (E9’3) transit signal peptides are also non pathogenic in humans and animals.
Oral gavage studies of CP4 EPSPS and GOX/GOXv247 proteins show no toxic properties. Comparison of amino acid sequence of both CP4 EPSPS and GOX/Gov247 proteins show no significant homology to known allergenic proteins. CP4 EPSPS and GOX/GOXv247 are very susceptible to proteolysis and present only in very small amounts in the plant.
Based on proximate composition, fatty acids analysis and glucosinates analysis, the transgenic lines (RT73) and the Westar (non transgenic lines) were substantially equivalent.
No new or altered hazard unique to Canola RT73 was identified compared with the conventional counterpart
EN
The canola event RT73 and all its progenies are as safe as its conventional canola for direct use as food and feed and for processing and shall not pose any significant risk to human and animal health.
EN
A biosafety permit for Canola RT73 and all progenies derived from crosses of the product with any conventionally-bred canola and canola containing approved-biotech events for direct use as food, feed and for processing was issued to Monsanto Philippines Inc. Canola RT73 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
Canola RT73 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This application is not for propagation of this event. This LMO will be directly used for food, feed and for 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.
EN
Yes
Yes
Yes
Yes
Yes
Canola RT73 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 Canola RT73.
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 Canola RT73.
- OECD Consensus Document on Canola [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
