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Évaluation des risques générée par un processus de réglementation
(RA)
published: 18 sept. 2008
last updated: 25 mars 2025
Determination for the Safety Assessment of Soybean 40-3-2 for Direct Use as Food, Feed and for Processing
EN
22 juil. 2008
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Autorité nationale compétente :Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesTéléphone : (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Télécopieur :Site Web : http://www.da.gov.ph,
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MON-Ø4Ø32-6 - Roundup Ready™ soybean| Monsanto | Résistance aux herbicides (Glyphosate)
- DA-BPI Biotechnology Office [ English ]
FR
Antinutrients such as trypsin inhibitors are known to be present in small amounts in all soybeans. The level of these components in soybean 40-3-2 are comparable to the levels in conventional soybean.
Soybean naturally contains multiple endogenous allergens. However introduction of the gene encoding the CP4 EPSPS protein in soybean 40-3-2 caused no discernable changes either quantitatively or qualitatively in the composition of the endogenous protein allergens. Additionally, the CP4 EPSPS synthase does not contain significant sequences with homology relevant to allergy or celiac disease.
All soybean protein-derived food and the majority of feed is heated prior to consumption, thus the catalytically inactive form of CP4EPSPS is expected to be present at low levels in food and feed derived from glyphosate tolerant soybean (GTS) 40-3-2.
The allergenic potential of soybean 40-3-2 and the products derived from these soybeans is not significantly different than other soybean varieties. EPSPS proteins are a diverse set of related proteins typically present in foods and feeds and are not known to be commonly allergenic.
EN
Soybean naturally contains multiple endogenous allergens. However introduction of the gene encoding the CP4 EPSPS protein in soybean 40-3-2 caused no discernable changes either quantitatively or qualitatively in the composition of the endogenous protein allergens. Additionally, the CP4 EPSPS synthase does not contain significant sequences with homology relevant to allergy or celiac disease.
All soybean protein-derived food and the majority of feed is heated prior to consumption, thus the catalytically inactive form of CP4EPSPS is expected to be present at low levels in food and feed derived from glyphosate tolerant soybean (GTS) 40-3-2.
The allergenic potential of soybean 40-3-2 and the products derived from these soybeans is not significantly different than other soybean varieties. EPSPS proteins are a diverse set of related proteins typically present in foods and feeds and are not known to be commonly allergenic.
The low dietary exposure to the CP4EPSPS protein and lack of toxicity or allergenicity of EPSPS proteins in general does not contradict any of the food safety models. The glyphosate tolerant soybeans 40-3-2 do not present any public health and food safety concerns for direct use as food and food processing.
EN
Soybean 40-3-2 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
EN
A biosafety permit for soybean 40-3-2 and all progenies derived from crosses of the product with any conventionally-bred soybean and soybean containing approved-biotech events for direct use as food, feed or for processing was issued to Monsanto Philippines Inc. Soybean 40-3-2 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
EN
The raw whole soybean 40-3-2 seeds should be completely heat treated to deactivate the naturally present trypsin inhibitors found in all soybeans.
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.
EN
Oui
Oui
Oui
Oui
Oui
Soybean 40-3-2 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 40-3-2.
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 40-3-2.
- OECD Consensus Document on soybean [ English ]
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| Décision de pays ou tout autre communication | Évaluation des risques | 1 | |
