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Risk Assessment generated by a regulatory process
(RA)
published: 15 Sep 2008
last updated: 25 Mar 2025
Determination for the Safety Assessment of Sugar beet H7-1 for Direct Use as Food, Feed and for Processing
EN
28 Jul 2010
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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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KM-ØØØH71-4 - Roundup Ready™ sugar beet| Monsanto | Resistance to herbicides (Glyphosate)
- DA-BPI Biotechnology Office [ English ]
EN
Figwort mosaic virus (FMV) and Agrobacterium tumefaciens are phytopathogens meaning they specifically infect plants but not humans and animals. Escherichia coli is a gram negative bacteria and the specific strain used is non-pathogenic belonging to the K12 derived used in DNA cloning and vector construction.
The CP4 EPSPS protein was obtained from the naturally occurring soil-borne plant-symbiotic bacterium Agrobacterium sp. strain CP4. The possibility that the CP4 EPSPS protein would be an allergen in sugar beet lines containing event H7-1 was considered unlikely. This was based on the negligible amount of protein in edible parts of the sugar beet plant, the lack of sequence homology between CP4 EPSPS protein and known allergens, and CP4 EPSPS protein's likely digestion in simulated gastric and intestinal fluids. The results combined with the absence of CP4 EPSPS protein detected in refined sugar suggests that sugar derived from sugar beet lines containing event H7-1 would not pose any greater allergenic risk than non-transgenic sugar beet sugar.Food derived from sugar beet line H7-1 is equivalent to that derived from current commercial varieties of sugar beet in terms of its safety for human consumption.
EN
The CP4 EPSPS protein was obtained from the naturally occurring soil-borne plant-symbiotic bacterium Agrobacterium sp. strain CP4. The possibility that the CP4 EPSPS protein would be an allergen in sugar beet lines containing event H7-1 was considered unlikely. This was based on the negligible amount of protein in edible parts of the sugar beet plant, the lack of sequence homology between CP4 EPSPS protein and known allergens, and CP4 EPSPS protein's likely digestion in simulated gastric and intestinal fluids. The results combined with the absence of CP4 EPSPS protein detected in refined sugar suggests that sugar derived from sugar beet lines containing event H7-1 would not pose any greater allergenic risk than non-transgenic sugar beet sugar.Food derived from sugar beet line H7-1 is equivalent to that derived from current commercial varieties of sugar beet in terms of its safety for human consumption.
The novel protein CP4 EPSPS is heat unstable, easily degraded by simulated gastric and intestinal fluids, non-allergenic and non-toxic. No CP4 EPSPS protein was detected in the processed sugar from sugar beet line H7-1 using western. Bioinformatics analyses, toxicity studies and in vitro biochemical studies demonstrate that the CP4 EPSPS protein is unlikely to cause adverse health effects in humans or other animals.The detailed compositional studies demonstrate that food derived from sugar beet line H7-1 is compositionally equivalent to and as safe as food derived from non-GM sugar beet and other sugar beet lines
EN
Glyphosate Tolerant Sugar beet H7-1 is as safe as its conventional counterpart and is equivalent to other commercially available sugar beet with respect to composition and nutritional quality and does not pose any significant risk to animal and human health.
EN
A biosafety permit for Sugar beet H7-1 and all progenies derived from crosses of the product with any conventionally-bred sugar beet and sugar beet containing approved-biotech events for direct use as food, feed or for processing was issued to Monsanto Philippines Inc. Sugar beet H7-1 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
Sugar beet H7-1 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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This application is not for propagation of this event. This LMO will be directly used for food, feed and for processing.
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Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
EN
Yes
Yes
Yes
Yes
Yes
Sugar beet H7-1 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 Sugar beet H7-1.
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 Sugar beet H7-1.
- OECD Consensus Document on Sugar beet [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |