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Risk Assessment generated by a regulatory process
(RA)
published: 27 May 2015
last updated: 25 Mar 2025
Determination of the Safety of Pioneer's High Oleic Soybean 305423 For Direct Use as Food and Feed or for Processing
EN
09 Sep 2013
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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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DP-3Ø5423-1 - TREUS™, Plenish™ Soybean| Pioneer Hi-Bred Production Inc. | Changes in quality and/or metabolite content (Lipid and fatty acids), Resistance to herbicides (Sulfonylurea)
- DA-BPI Biotechnology Office [ English ]
There is no evidence to indicate that exposure to these fatty acids is associated with adverse effects in humans.
EN
Soybean, the donor organism of gm-fad2-1 and gm-hra is grown commercially and has a long history of safe use on both human food and stock feed. Gm-hra which encodes for a modified version of the soybean acetolactate synthase gene has no known pathogenicity to humans, animals and non target organisms
EN
There is no known adverse effect of this target substance when ingested in higher amount as this fatty acid is comparable to the oleic acid content in other commercial oils which have a history of safe use.
EN
High Oleic Soybean 305423 is as safe as its conventional counterpart taking into account its dietary source and nutritional impact of changes in fatty acid composition. High Oleic Soybean 305423 is safe to humans, animals and as nutritious as conventional soybean.
EN
A biosafety permit for High Oleic Soybean 305423 and all progenies derived from crosses of the product with any conventional soybean containing approved-biotech events for direct use was issued to Pioneer Hi-Bred Philippines, Inc. (PHPI)
EN
High Oleic Soybean 305423 and all progenies from crosses of this product except when stacked with other biotech traits has undergone satisfactory assessment and found to be as safe as conventional soybean and can be a substitute for its traditional counterpart as food and feed or for processing
EN
This application is not for propagation of this event. This LMO will be directly used for food, feed and for processing.
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.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
Yes
Yes
Yes
Yes
Yes
High Oleic Soybean 305423 (Soybean Event DP-305423-1) is intended for direct use as food, 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 and DA Regulatory Agencies during the evaluation of Soybean Event DP-305423-1.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of Soybean Event DP-305423-1.
- OECD Consensus Document on soybean [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
