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Risk Assessment generated by a regulatory process
(RA)
last updated: 02 Oct 2025
Safety Assessment of Canola MON 88302 x RF3 x MS8 for Direct Use as Food and Feed, or for Processing
EN
Date not available
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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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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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MON-883Ø2-9 × ACS-BNØØ5-8 × ACS-BNØØ3-6 - Male sterile, herbicide tolerant canola| Monsanto | Changes in physiology and/or production (Reproduction, Male sterility), Resistance to herbicides (Glufosinate, Glyphosate)
- Consolidated_Report_Canola_Tri_Stack.pdf [ English ]
After reviewing the technical dossier provided by the applicant, the Scientific and Technical Review Panel (STRP), the Bureau of Animal Industry (BAI), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC) concurred that Canola MON 88302 x RF3 x MS8 is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and to the environment.
The gene products, CP4 EPSPS and PAT protein, expressed by the multi-stack canola line may pose allergenic or toxic risks. These novel proteins may also interact in the same metabolic pathway such that an unintended adverse effect is created.
The novel proteins have been shown to have distinct modes of action and therefore, is unlikely to interact with each other. The likelihood of interaction among the novel proteins is not considered significant enough to affect the stability and expression level of each other.
The presence of CP4 EPSPS and PAT proteins will not interact to produce any new allergens or toxins. This is due to the different modes of action and metabolic pathway which have no known mechanism of interaction that could lead to adverse effects.[
Considering the unlikely probability of interaction among the novel proteins and the absence of allergenic or toxic characteristics of these proteins, the assessors concluded that Canola MON 88302 x RF3 x MS8 does not pose risks to human and animal health, and to the environment.
The assessors recommended for the approval and issuance of a biosafety permit for direct use as food and feed, or for processing of Canola MON 88302 x RF3 x MS8.
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The Department of Environment and Natural Resources (DENR BC), after a thorough scientific review and evaluation of the provided documents considered the regulated article safe to the environment, particularly on biodiversity.
The quantitative event-specific PCR detection methods are those individually validated for genetically modified Canola MON 88302, Ms8 and Rf3 and further verified on Canola stack MON 88302 x Ms8 x Rf3.
Yes
Yes
Yes
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Yes
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
