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Évaluation des risques générée par un processus de réglementation (RA)
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published: 16 nov. 2015 last updated: 25 mars 2025
Informations générales
Determination of the Safety of Syngenta's Combined Trait Product Corn: 3272 x Bt11 x MIR604 x GA21 For Direct use as Food, Feed, or Processing
EN
28 juil. 2010
Détails de l’évaluation des risques
  • SYN-E3272-5 × SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-ØØØ21-9 - Modified thermostable alpha-amylase, insect-resistant, herbicide-tolerant maize
    | Résistance aux maladies et aux parasites (Insectes, Coléoptères, Chrysomèle occidentale des racines du maïs (Diabrotica virgifera), Chenille tisseuse (papillons et mites), Pyrale du maïs (Ostrinia nubilalis)), Résistance aux herbicides (Glufosinate, Glyphosate), Gènes marqueurs et gènes rapporteurs sélectables, Utilisation dans les applications industrielles (Production de biocombustibles)
Méthode et points à examiner
3272 x BT11 x MIR604 x GA21 maize produces the six transgenic proteins (AMY797E, Cry1Ab,PAT, mCry3A, PMI and EPSPS. The six proteins show no homology to any known mammalian allergen or toxin.
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There is no evidence that the six proteins will interact to form some new allergen or toxin since each has distinct mode of action and are not likely to interact.
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None of the transgenic proteins produced by 3272 x Bt11 x MIR604 x GA21 maize (AMY797E, Cry1Ab, PAT, mCry3A, PMI, MIR604 PMI and mEPSPS) come from donors known to be a significant cause of food allergy. All proteins have no biologically significant amino acid homology to known allergens, are readily degraded in in vitro digestibility assays and all show no acute oral toxicity in mammalian studies.
EN
After reviewing the scientific data and information relevant to the combined traitsproduct 3272 x BT11 x MIR604 x GA21 maize application of Syngenta Philippines Inc., it is concluded that no interaction was found between/among the combined traits, hence this plant product was found to be as safe as its conventional corn and can substitute for its traditional counterpart for direct use as food, feed and for processing and is therefore approved for direct use as food, or feed or for processing.
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A biosafety notification for combined trait product corn: 3272 xBt11 x MIR604 x GA21 and all progenies derived from crosses of the product with any conventionally bredcorn and corn containing approved-biotech events for direct use as food, feed or for processing was issued to Syngenta Philippines Inc.
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3272 x Bt11 x MIR604 x GA21 is as safe for human food, livestock feed and for processing as its conventional counterparts
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This LMO will be directly used for food, feed and 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.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.
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Partage d’informations avec d’autres bases de données
Oui
Oui
Oui
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Information supplémentaire
The combined trait product 3272 x BT11 x MIR604 x GA21 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 3272 x BT11 x MIR604 x GA21.
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