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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-46809-8   |   PDF   |   Print   |  
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published: 18 Sep 2008 last updated: 25 Mar 2025
General Information
Determination for the Safety Assessment of Corn NK 603 for Direct Use as Food, Feed and for Processing
EN
10 Sep 2008
Risk assessment details
Methodology and points to consider
EN
CP4 EPSPS has a low likelihood of adverse effects based on an assessment of its allergenic and toxicological potential.  The donor organism for CP4 EPSPS, Agrobacterium sp. strain CP4 is not known to cause human pathogenicity or allergenicity.  The results of bioinformatics analyses indicate that CP4 EPSPS is not similar to known allergens, toxins or other pharmacologically active proteins relevant to animal or human health,  CP4 EPSPS is rapidly digested in simulated digestive tract matrices. Absence of both structural and immunological similarities of CP4 EPSPS with known allergens indicate that CP4 EPSPS is unlikely to be an allergen.
CP4 EPSPS produced no adverse effects at a high dose in an acute oral rodent toxicity study.  The NOEL was found to be 572 mg/kg, the highest dose level tested.  
These results show that the CP4 EPSPS protein produced in NK603 will not cause adverse effects to human and animal health.
Glyphosate residue analysis of soil, corn grain and stover indicated that glyphosate applications did not produce any detectable level, thus lending support to worldwide reports on safety form the ecological standpoint. Glyphosate breakdown (through microbial action) does not produce secondary metabolites that can accumulate in the soil, thus repeated application for the chemical season after season will not pose a risk. Glyphosate has no adverse effects on soil, aquatic life, ecology and wildlife.
EN
Corn NK 603, does not pose a food or feed safety risk.  The CP4 EPSPS protein will not cause significant adverse effects in man or animals.Corn NK 603 is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and the environment.
EN
Corn NK 603 is substantially equivalent to other commercially available corn with respect to composition and nutritional quality and does not pose any significant risk through consumption by both animals (for feed) and humans (for food).
EN
A biosafety permit for Corn NK 603 and all progenies derived from crosses of the product with any conventionally-bred corn and corn containing approved-biotech events for direct use as food, feed and for processing was issued to Monsanto Philippines. Inc. Corn NK 603 is found to be as safe as its conventional counterpart and does not pose and significant risk to human and animal health.
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Corn NK 603 is found to be as safe as its conventional counterpart and does not pose and significant risk to human and animal health.
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This application is also for propagation of Corn NK  603. 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 quantitative and semi-quantitative and detection of transgenes.  For higher sensitivity, real-time PCR.
EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
Corn NK 603 is intended for direct use as food, feed and for processing. This application is also intended for   propagation.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of Corn NK 603.
EN
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