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Risk Assessment generated by a regulatory process
(RA)
last updated: 03 Apr 2025
Safety Assessment of Corn MON810 x TC1507 x NK603 for Commercial Propagation
EN
11 Oct 2018
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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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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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DAS-Ø15Ø7-1 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6 - Maize resistant to Lepidoptera and tolerant to glufosinate and glyphosate herbicides| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate, Glyphosate)
- MON810 x TC1507 x NK603.pdf [ English ]
After reviewing the risk assessment report and the attached technical dossier, the assessors, namely, the Scientific and Technical Review Panel (STRP), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC), concluded that (1) Corn MON810 x TC1507 x NK603 is as safe for human food and animal feed as its conventional counterpart and that (2) Corn MON810 x TC1507 x NK603 will not pose any significant risk to health and the environment.
The novel proteins expressed by Corn MON810 x TC1507 x NK603— Cry1F, Cry1Ab, PAT, and Cp4EPSPS— may pose allergenic or toxic characteristics. These proteins may also interact in a novel metabolic pathway that may cause unintended effects.
The assessors noted that the novel proteins have distinct modes of action. Further, the assessors concurred that if single transformation events are safe, then the multi-stacked product derived through their conventional breeding will not pose an unexpected risk. In light of these, the assessors concluded that the potential adverse effect of Corn MON810 x TC1507 x NK603 is highly unlikely to be realized.
Allergenicity and toxicity characteristics of the novel proteins were investigated by conducting sequence similarity search to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study. Results of these tests provide evidence that the novel proteins expressed in Corn MON810 x TC1507 x NK603 are neither allergenic nor toxic.
To assess unintended effects of the novel proteins to non-target organisms, the assessors considered the multi-location field trial data provided by the technology developer. The data supports the conclusion that the novel proteins expressed in Corn MON810 x TC1507 x NK603 are safe to non-target arthropods.
To assess unintended effects of the novel proteins to non-target organisms, the assessors considered the multi-location field trial data provided by the technology developer. The data supports the conclusion that the novel proteins expressed in Corn MON810 x TC1507 x NK603 are safe to non-target arthropods.
Based on bioinformatic analyses, food and feed safety studies, and field trial data, the assessors concluded that Corn MON810 x TC1507 x NK603 does not pose risks to human and animal health, and to the environment.
In light of the above conclusions, the assessors recommended for the issuance of a biosafety permit for the commercial propagation of Corn MON810 x TC1507 x NK603.
EN
Field trial data generated under contained and open-field settings across multiple locations showed that the novel proteins are expressed similarly and that these do not pose risks to non-target organisms.
Corn MON810 x TC1507 x NK603 and its constituent single transformation events can be detected via event-specific quantitative real-time quantitative PCR.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
