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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 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 Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry (BAI), 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 risks to humans, animals, and to the environment.
The gene products, CPP4 EPSPS and PAT, 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 metabolic pathway with no known mechanism of interaction that could lead to adverse effects. Therefore, interaction is highly unlikely and will not 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 due to the different modes of action and metabolic pathway. In addition, scientific evidence from toxicity studies and reference have shown that the regulated article will not cause significant adverse health effects to humans and animals.
Based on the available relevant information, the assessors concluded that Canola MON 88302 × RF3 × MS8 will not pose any significant risks to humans, animals and the environment.
The assessors recommended the approval and issuance of a biosafety permit for direct use as food and feed, or for processing of Canola MON 88302 × RF3 × MS8.
EN
After a thorough scientific review and evaluation of the documents provided by the applicant, the DENR-BC considered the regulated article safe to the environment and biodiversity.
The quantitative event-specific PCR detection methods are those individually validated for MON 88302, RF3, MS8 events and further verified on Canola MON 88302 × RF3 × MS8.
Yes
Yes
Yes
Yes
Yes
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