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Évaluation des risques générée par un processus de réglementation
(RA)
published: 12 déc. 2013
last updated: 25 mars 2025
Determination of the Safety of Monsanto's Corn MON 89034 For Direct use as Food, Feed, and for Processing
EN
15 janv. 2007
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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-89Ø34-3 - YieldGard™ VT Pro™| Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites))
- DA-BPI Biotechnology Office [ English ]
Mice acute oral toxicity studies demonstrated that the two proteins: Cry1A.105 and Cry2Ab2, are not acutely toxic and do not cause any adverse effects even at the highest dose level test, which are
2072 and 2198 mg/kg body weight for Cry1A.105 and Cry2Ab2 proteins. Cry1A.105 and Cry2Ab2 proteins do not share any amino acid sequence similarities with known allergens, gliadins, glutenins, or proteins toxins which have adverse effects to mammals.
2072 and 2198 mg/kg body weight for Cry1A.105 and Cry2Ab2 proteins. Cry1A.105 and Cry2Ab2 proteins do not share any amino acid sequence similarities with known allergens, gliadins, glutenins, or proteins toxins which have adverse effects to mammals.
Bacillus thuringiensis (Bt), the donor organism for the Cry1A.105 and Cry2Ab2 proteins is found naturally in soil. Bt strains have been used commercially in the US since 1958 to produce
microbial-derived products with insecticidal activities. The extremely low mammalian toxicity of Bt based insecticide products has been demonstrated in numerous safety studies and there are no
confirmed cases of allergic reactions to Cry proteins in applicators of microbial-derived Bt products during the past 45 years of use. There are no known reports of allergy or toxicity to Bt or
to these cry proteins.
microbial-derived products with insecticidal activities. The extremely low mammalian toxicity of Bt based insecticide products has been demonstrated in numerous safety studies and there are no
confirmed cases of allergic reactions to Cry proteins in applicators of microbial-derived Bt products during the past 45 years of use. There are no known reports of allergy or toxicity to Bt or
to these cry proteins.
A thorough assessment of the allergenicity and toxicity potential of the Cry1A.105 and Cry2Ab2 proteins based on extensive studies demonstrate the safety of the two proteins due to the
lack of allergenic potential and the lack of acute toxicity when ingested, and their similarity to Cry proteins that have a history of safe use. The results on the estimation of protein levels, and a
dietary safety assessment based on anticipated exposure and the results of acute toxicology tests show that there are no meaningful risk to human or animal health from dietary exposure to the two
proteins based on the large margins of exposure (MOE) obtained.
lack of allergenic potential and the lack of acute toxicity when ingested, and their similarity to Cry proteins that have a history of safe use. The results on the estimation of protein levels, and a
dietary safety assessment based on anticipated exposure and the results of acute toxicology tests show that there are no meaningful risk to human or animal health from dietary exposure to the two
proteins based on the large margins of exposure (MOE) obtained.
The results on the estimation of protein levels, and a dietary safety assessment based on anticipated exposure and the results of acute toxicology tests show that there are no meaningful risk to human or animal health from dietary exposure to the two proteins based on the large margins of exposure (MOE) obtained.
EN
A biosafety permit for Corn MON 89034 and all progenies derived from crosses of the product with any conventionally-bred corn and corn containing approved-biotech events for direct use as
food, feed or for processing was issued to Monsanto Philippines Inc. Corn MON 89034 is as safe for human food, livestock feed and for processing as its conventional counterparts.
food, feed or for processing was issued to Monsanto Philippines Inc. Corn MON 89034 is as safe for human food, livestock feed and for processing as its conventional counterparts.
Corn MON 89034 is as safe for human food, livestock feed and for processing as its conventional counterparts.
EN
This LMO will be directly used for food, feed and processing. This application is also for propagation of Corn MON 89034.
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
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
Oui
Oui
Oui
Oui
Oui
Corn MON 89034 is intended for direct use as food, feed and for processing and for propagation.
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 this event.
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 this event.
- OECD Consensus Document on Corn [ English ]
| Type de fichier | Champs | Fichier(s) : | |
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| Décision de pays ou tout autre communication | Évaluation des risques | 2 | |
