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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 NK 603 for Direct Use as Food and Feed and for Processing
EN
16 Nov 2004
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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-ØØ6Ø3-6 - Roundup Ready™ YieldGard™ maize| Monsanto | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Insects, Coleoptera (beetles)), Resistance to herbicides (Glyphosate)
- DA-BPI Biotechnology Office [ English ]
EN
Based on the different modes of action of CP4 EPSPS and Cry3Bb1, 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 NK 603 is equivalent to MON 863 for corn rootworm bioefficacy, and to NK 603 glyphosate tolerance. These results indicate that combining individual transformation events through traditional breeding does not alter their insecticidal efficacy or herbicide tolerance characteristics.
EN
No interaction or synergistic effects are expected since there are different modes of action and binding sites of the proteins produced i.e., CP4 EPSPS, Cry3Bb1 and even the marker of NPTII. The biological activities of CP4 EPSPS and Cry3Bb1 are different and there is no possibility in terms of conceivable mechanisms that will produce interaction of these two (2) introduced proteins.
EN
The combined trait product corn MON 863 x 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 or feed or for processing is as safe and substantially equivalent to its unmodified counterpart. There is no evidence of interaction of the two 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 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 or for processing was issued to Monsanto Philippines, Inc. Corn MON 863 x NK 603 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
Corn MON 863 x NK 603 is found to be as 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 NK 603. This LMO will be directly used for food, feed and for processing.
EN
For the individual events, MON 863 and NK 603, in the combined trait product MON 863 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 safe 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 safe 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 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 product.
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 product.
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 product.
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 product.
- OECD Consensus Document on Corn [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
