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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-279669-1   |   PDF   |   Print   |  
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last updated: 07 Jul 2025
General Information
Safety Assessment of Corn MON 95275 for Direct Use as Food, Feed, or for Processing
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Date not available
Risk assessment details
  • MON-95275-7 - Coleoptera-protected maize
    | Bayer CropScience | Resistance to diseases and pests (Insects, Coleoptera (beetles), Colorado potato beetle (Leptinotarsa decemlineata), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi))
After reviewing the scientific data and relevant information, the Department of Agriculture - Bureau of Plant Industry (DA-BPI) has concluded that (1) Corn MON 95275 is compositionally equivalent to its conventional counterpart and (2) does not pose any safety concerns to human or animal health.
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Methodology and points to consider
 The novel proteins DvSnf7.1, Mpp75Aa1.1 derived from Brevibacillus laterosporus, and Vpb4Da2 derived from Bacillus thuringiensis can potentially be new allergens or toxins, or have homology with known allergens or toxins.
EN
The safety of the Corn MON 95275 for human and animal consumption were established through numerous studies and assessment, including toxicological and allergenicity assessment of the proteins. Mpp75Aa1.1 and Vpb4Da2 proteins by 
pepsin were subjected to digestibility testing, where the results showed rapid degradation of the proteins by pepsin and pancreatin. This indicates that exposure is unlikely. 
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The FASTA sequence alignment showed that the novel proteins lack both structurally and immunologically relevant similarities to known allergens, gliadins, and glutenins.
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The safety of the Corn MON 95275 for human and animal consumption were established through numerous studies and assessment, including toxicological and allergenicity assessment of the proteins. The digestibility test showed rapid degradation of Mpp75Aa1.1 and Vpb4Da2 proteins by pepsin and pancreatin. 

Furthermore, the nutritional data has shown that Corn MON 95275 is compositionally equivalent to the conventional control in levels of nutrients, anti-nutrients, and secondary metabolites in grain and forage. 
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Based on the submitted scientific data and relevant information, the assessor concluded that Corn MON 95275 is compositionally equivalent to its conventional counterpart and does not pose any safety concerns to human or animal health.  Therefore, the approval and issuance of a biosafety for direct use as food and feed, or for processing for Corn MON 95275 was recommended.

The risk assessor additionally set condition that need to be complied with by the applicant such as providing reference materials (positive and negative controls) of the transformation event for laboratory analysis to monitor compliance. 
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Corn MON 95275 is applied for direct use, hence the scope of the risk assessment for the application did not cover considerations on the receiving environment.
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Corn MON 95275 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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Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1