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Risk Assessment generated by a regulatory process
(RA)
last updated: 03 Apr 2025
Safety Assessment of Soybean DAS-81419-2 x DAS-44406-6 for Direct Use as Food, Feed, or for Processing
EN
10 Mar 2020
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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-81419-2 × DAS-444Ø6-6 - Conkesta Enlist E3™ Soybean| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate), Tolerance to 2,4-Dichlorophenoxyacetic acid
- DAS81419xDAS44406.pdf [ English ]
The Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry Biotech Team (BAI-BT), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC) conducted a review of the technical dossier provided in the application and concluded that Soybean DAS-81419-2 x DAS-44406-6 is (1) as safe for human food and animal feed as its conventional counterpart and (2) will not pose any significant risk to health and the environment.
The novel proteins Cry1F, Cry1Ac, AAD-12, PAT, and 2mEPSPS may pose allergenic or toxic risks and may interact in an unknown metabolic pathway.
The likelihood of the potential interaction between expressed materials is low since each protein in the transformation events has a specific mode of action and have different roles in the plant's physiology. The assessors concluded that it is highly unlikely for a synergistic or antagonistic interaction between the novel proteins to arise.
The possible consequences of the potential adverse effects of Soybean DAS-81419-2 x DAS-44406-6 were assessed in terms of the potential allergenicity and toxicity of the novel proteins. Data generated through in silico analysis of sequence similarity to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study were therefore considered in the assessment. The assessors, through the weight-of-evidence approach, concluded that the Cry1F, Cry1Ac, AAD-12, PAT, and 2mEPSPS expressed in Soybean DAS-81419-2 x DAS-44406-6 is not allergenic nor toxic.
The overall risk for Soybean DAS-81419-2 x DAS-44406-6 was assessed by considering the likelihood of exposure to the regulated article, its potential for being allergenic or toxic, and its substantial equivalence with its conventional counterpart.
Considering that the novel proteins are not known to interact in the same metabolic pathway and, through bioinformatic analyses and toxicity studies, have been shown to not pose allergenic or toxic properties, the risk associated with Soybean DAS-81419-2 x DAS-44406-6 is negligible.
Considering that the novel proteins are not known to interact in the same metabolic pathway and, through bioinformatic analyses and toxicity studies, have been shown to not pose allergenic or toxic properties, the risk associated with Soybean DAS-81419-2 x DAS-44406-6 is negligible.
The assessors— after finding that there is enough evidence that the regulated article is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health— recommended for the issuance of a biosafety permit for direct use as food and feed, or for processing, for Soybean DAS-81419-2 x DAS-44406-6.
EN
Based on the evaluation and review of the technical dossier, the assessors considered Soybean DAS-81419-2 x DAS-44406-6 to be safe to the environment, particularly on biodiversity and non-target organisms.
Event-specific qPCR detection protocols for Soybean DAS-81419-2 x DAS-44406-6 is available.
Yes
Yes
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Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
