Philippines | BCH-RA-PH-258564 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 06 Jan 2022
General Information
Determination for the Safety Assessment of CORN MZHG0JG for Direct Use as Food, Feed and for Processing
EN
Date not available
Risk assessment details
  • SYN-ØØØJG-2 - Herbicide tolerant maize
    | Syngenta Seeds GmbH | Resistance to herbicides (Glufosinate, Glyphosate)
Glufosinate herbicide tolerance - eliminates herbicidal activity of glufosinate (phosphinothricin) herbicides by acetylation
 
Glyphosate herbicide tolerance - decreases binding affinity for glyphosate, thereby increasing tolerance to glyphosate herbicide
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Methodology and points to consider
Corn has phytic acid which reduces the availability of phosphorus in monogastric animals. Raffinose and trypsin inhibitors are also present in corn. A potential toxicant in roots and leaves, DIMBOA (2-4-hydroxy-7 methoxy-2H-1,4- benzoxacin-3 (4H)-one, has been reported and its level among corn varieties varied and its amount decreases as the corn grows.

EN
Trypsin inhibitors activities are destroyed during toasting or heating. For phytic acid, adding phytase into the diets of poultry and swine will release phytinbond phosphorus that decreased phytic acid in the diet.
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For the analysis of antinutrients, there is no significant differences between the levels of ferulic acid, inositol, phytic acid, trypsin inhibitor and raffinose in MZHG0JG compared to the non-transgenic comparator. The level of ρ-coumaric acid observed was significantly higher in MZHG0JG than the non-trangenic corn. The same was observed in MZHG0JG + TSH including inositol which also exhibited significantly higher level than the non-transgeninc comparator. In the MZHG0JG corn, and MZHG0JG corn + TSH, the mean levels of antinutrients were within the ranges for the reference varieties. In reference to ILSI Database, mean levels of anti-nutrients in MZHG0JG corn and MZHG0JG corn + TSH were within the ranges. Based on the results of the analysis, no statistical differences between the levels of anti-nutrients of MZHG0JG and the non-transgenic corn were observed that can be considered as biologically relevant.

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Thorough scientific review and evaluation concludes that CORN MZHG0JG applied for human food and animal feed is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health.

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The corn event has been approved as food and feed in US and Canada, and as food in New Zealand. The assessors agreed with the report that the transgenic plant is not a source of allergens. This was further confirmed by the results of gastric fluid digestibility studies, SDS-PAGE analysis and Western blot analysis. Consumption of corn as food may not drastically change due to the availability of transgenic corn varieties like MZHG0JG corn. Assessment from these countries proved the transgenic corn is not materially different in composition, safety, and other relevant parameters from corn-derived food and feed found in the market.
 
EN
Systematic comparison of the mEPSPS amino acid sequence with those of the sequences of known or putative protein toxins in the NCBI Entrez Protein database (NCBI version 2016) and in the Syngenta Toxin database (version 2016) with the use of BLAST confirmed that mEPSPS is neither a toxic protein nor it shares significant sequence similarity with other known or putative toxins.
 
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The application of CORN MZHG0JG is not for propagation. This LMO will be directly used for food, feed and for processing.

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Diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods may be used.

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Information sharing with other databases
No
Additional information
mEPSPS and PAT are expressed independently of each other to retain their functional properties. The mEPSPS and PAT are integrated within the corn nuclear genome. Expression of the proteins were validated and confirmed by a series of tests that applied Southern blot, nucleotide sequencing of the nuclear genome and examination of inheritance pattern of the transgene over 3 generations of the transgenic MZHG0JG corn. The assessors confirmed that the expressed proteins do not interact with each other. They act as independent system conferring tolerance to herbicides of glufosinate or glyphosate composition.
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