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Risk Assessment generated by a regulatory process
(RA)
published: 18 Sep 2008
last updated: 26 Mar 2025
Determination for the Safety Assessment of the Combined Trait Product Corn: MON 863 x MON 810 x NK603 for Direct Use as Food and Feed and for Processing
EN
17 Feb 2005
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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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MON-ØØ863-5 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6 - Roundup Ready™ YieldGard™ maize| Monsanto | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glyphosate)
- DA-BPI Biotechnology Office [ English ]
EN
Based on the different modes of action of the Cry3Bb1, Cry1Ab and CP4 EPSPS proteins, the likelihood of interaction or synergistic effects that would affect the biological activities of the individual proteins is considered highly unlikely. Bioefficacy results demonstrate that MON 863 x MON 810 x NK603 is equivalent to MON 863 for corn rootworm efficacy, to MON 810 for corn borer efficacy, and to NK603 for glyphosate tolerance. These results indicate that combining individual transformation events through traditional breeding does not alter their insecticidal efficacy or herbicide tolerance characteristics.
EN
There are possible unexpected effects of the stacked genes on the metabolism of plants, however, their probability is very, very low since the genes and their products are expressed in different parts of the cells.
EN
The combined trait product corn MON 863 x MON 810 x NK603 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 or feed or for processing is as safe and substantially equivalent to its unmodified counterpart. There is no evidence of interaction of the novel gene products leading to over expression/under expression and/or unintended effects.
EN
A biosafety notification for the combined trait product corn MON 863 x MON 810 x NK603 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 and feed or for processing was issued to Monsanto Philippines. Inc.
EN
Corn MON 863 x MON 810 x NK 603 is found to be safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This application is not for propagation of the combined trait product corn: MON 863 x MON 810 x NK603. This LMO will be directly used for food, feed and for processing.
EN
For the individual events, MON 863, MON 810, and NK 603 in the combined trait product MON 863 x MON 810 x NK 603, diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods can be used.
Methods and protocols for safety handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines.
EN
Methods and protocols for safety handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines.
Yes
Yes
Yes
Yes
Yes
The combined trait product corn MON 863 x MON 810 x NK603 is intended for direct use as food and feed and for processing.
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 this combined trait.
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 this combined trait.
EN
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 this combined trait.
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 this combined trait.
- OECD Consensus Document on Corn [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
