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Risk Assessment generated by a regulatory process (RA)
  |  
BCH-RA-PH-280491-1   |   PDF   |   Print   |  
last updated: 01 Oct 2025
General Information
Safety Assessment of Corn MON 95379 for Direct Use as Food, Feed, or for Processing
EN
19 May 2021
Risk assessment details
  • MON-95379-3 - Insect-protected maize
    | Bayer CropScience | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), European corn borer (Ostrinia nubilalis), Fall armyworm (Spodoptera frugiperda))
 After reviewing the risk assessment report and the attached technical dossier, the assessors- Scientific and Technical Review Panel (STRP), Bureau of Animal Industry, BPI Plant Products Safety Services Division, Department of Health– Biosafety Committee (DOH-BC), and 
the Department of Environment and Natural Resources Biosafety Committee (DENR-BC) concurred that (1) Corn MON 95379 is as safe for human food and animal feed as its conventional counterpart and (2) Corn MON 95379 will not pose any significant risk to health and the environment.
EN
Methodology and points to consider
 The novel proteins Cry1B.868 and Cry1Da_7 can potentially be new allergens or toxins, or have homology with known allergens or toxins. 
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It was observed that the Cry proteins, Cry1B.868 is present in grains at 0.0271% and Cry1Da_7 at 0.00026% of the total grain protein. However, it must be noted that Cry1B.868 and Cry1Da_7 proteins expressed in Corn MON 95379 are of similar structure with Bt Cry proteins which have been attested by several studies and literature to be safe for food and feed. Furthermore, the digestibility assay showed that under the animal digestion process, the proteins will be degraded and will not likely pose safety concerns to human and animal health. 
EN
The potential allergenicity and toxicity of the Cry1B.868 and Cry1Da_7 were investigated via sequence analysis to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study. A thorough scientific review of the results of these tests led the assessors to conclude that the Cry1B.868 and Cry1Da_7 proteins expressed in Corn MON 95379 are not toxic or allergenic.
EN
Digestibility assay showed that Cry1B.868 and  Cry1Da_7 were rapidly digested by pepsin and pancreatin within 0.5 and 5 minutes, respectively. Acute oral gavage was also performed on mice, which showed that the observable adverse effect level (NOAEL) for for both proteins was at 5000 mg/kg body weight. Treatment-related effects on animal survival, clinical signs, body weight gain, food consumption or gross pathology were also not observed. Additionally, the bioinformatic analyses of the protein sequence showed no relevant structural similarity to known allergens or toxins. Based on these relevant information, the assessors fond sufficient scientific evidence that Corn MON 95379 is as safe as its  conventional counterpart and shall not pose any significant risk to human and animal health.
EN
Based on the evidences presented, the assessors agreed for the approval and issuance of a biosafety permit for direct use as food and feed or for processing for Corn MON 95379. 
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 The assessors recommended the strict monitoring of the regulated article from the port of entry to the traders/importers storage/warehouse.
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Based on the evaluation and review of literature cited, the DENR-BC considered that  Corn MON 95379 poses no significant adverse effect to the environment and non-target organism.
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Corn MON 95379 is detectable using event-specific real-time quantitative PCR-based method.
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Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
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