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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 Oct 2025
Safety Assessment of Canola MON 94100 for Direct Use as Food, 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-941ØØ-2 - Dicamba-tolerant canola| Bayer CropScience | Resistance to herbicides
- CANOLA_MON94100_CONSOLIDATED_REPORT.pdf [ English ]
After a thorough scientific review and evaluation of the documents provided by the applicant, the assessors- Scientific and Technical Review Panel (STRP), Bureau of Animal Industry (BAI), Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), Department of Environment and Natural Resources-Biosafety Committee (DENR-BC), and the Department of Health-Biosafety Committee (DOH-BC) -concurred that (1) Canola MON 94100 is as safe for human food and animal feed as its conventional counterpart and (2) Canola MON 94100 will not pose any significant risk to health and the environment.
The novel protein Dicamba Mono-Oxygenase (DMO), obtained from Stenotrophomonas maltophilia strain DI-6, can potentially be new allergens or toxins, or share biologically significant similarity with known allergens or toxins.
Enzyme linked immunosorbent assay (ELISA) showed that the mean DMO protein was highest in roots and lowest in grains. However, the prevalence of the DMO protein is very small relative to the total protein harvested in canola seeds and consumption is minimal via refined oil. Furthermore, digestibility assay demonstrated that the novel protein is readily digested in Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF) within 0.5 seconds and 5 minutes, respectively. Results further showed that the novel protein is functionally inactivated by heat. Based on these relevant information, exposure and corresponding risk are considered negligible to very minimal.
An acute oral gavage study demonstrated that DMO did not yield any treatment related effects on survival, clinical observations, body weight, food consumption and gross necropsy with a corresponding No Observed Effect Level (NOEL) of 140 mg/kg body weight. Bioinformatic, chemical, biochemical, and molecular analyses also showed that the expressed novel DMO protein has no significant homology with known toxins or allergens.
The novel protein has been shown to have no significant homology with known toxins or allergens. Digestibility assay further demonstrated that the DMO protein is readily digested and is functionally inactivated by heat. In view of these, the overall risk for Canola MON 94100 is considered negligible to very minimal.
Based on the evidences presented by the applicant, the assessors concluded that Canola MON 94100 is as safe as its conventional counterpart. Additionally, the assessors recommended the the issuance of a biosafety permit for direct use as food and feed or for processing of Canola MON 94100.
The assessors recommended that the strict monitoring of the regulated article from the port of entry to the traders/importers storage/warehouse be conducted and that appropriate packaging is ensured to avoid possible spillage or unwanted release during transport/import.
After a comprehensive review and evaluation of the documents and scientific evidence from literature submitted by the applicant, the DENR-BC concluded that the regulated article poses no significant adverse effect to the environment.
Canola MON 94100 event is detectable using event-specific real-time quantitative PCR-based method.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
