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Évaluation des risques générée par un processus de réglementation (RA)
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last updated: 28 avr. 2026
Informations générales
Risk assessment of cotton event DAS-21023-5 × DAS-24236-5 × SYN-IR102-7 × DAS-81910-7 - Technical Opinion 6657/2019.
EN
03 oct. 2019
Détails de l’évaluation des risques
  • DAS-24236-5 × DAS-21Ø23-5 × SYN-IR1Ø2-7 × DAS-8191Ø-7 - Herbicide tolerant, insect resistant cotton
    | Monsanto do Brasil Ltda | Résistance aux antibiotiques (Hygromycine), Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites)), Résistance aux herbicides (Glufosinate), Gènes marqueurs et gènes rapporteurs sélectables, Tolerance to 2,4-Dichlorophenoxyacetic acid
DAS-21023-5 × DAS-24236-5 × SYN-IR102-7 × DAS-81910-7 cotton was developed by classical genetic improvement, resulting from the cross between DAS-21023-5 × DAS-24236-5 cotton × SYN-IR102-7 with DAS-81910-7 cotton whose commercial release was approved by CTNBio.
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Méthode et points à examiner
There were no physiological or morphological changes in the animals tested, indicating the absence of adverse effects in the human and animal food chain.
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Data gathered in the process, including field, greenhouse and laboratory studies, demonstrate that growing and consuming DAS-21023-5 × DAS-24236-5 × SYNIR102-7 × DAS-81910-7 cotton is as safe as to the environment and human and animal health as conventional cotton.
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DAS-21023-5 × DAS-24236-5 × SYNIR102-7 × DAS-81910-7 cotton is as safe as its conventional equivalents.
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DAS-21023-5 × DAS-24236-5 × SYNIR102-7 × DAS-81910-7 cotton is equivalent in agronomic characteristics to conventional isoline cotton and does not show a tendency to proliferate as a weed or as an invasive plant in ecosystems; Proteins Cry1F, Cry1Ac and Vip3Aa19 show efficacy against target pest species, with no evidence that they can cause any adverse effect on communities of non-target organisms and there is no accumulation of proteins Cry1F, Cry1Ac and Vip3Aa19 in the soil and the degradation of crop residues of the cotton DAS-21023-5 × DAS-24236-5 × SYN-IR102-7 × DAS81910-7 in the soil is equivalent to what occurs in conventional isoline cotton; Its parents, cotton DAS-21023-5 × DAS-24236-5, cotton SYNIR102-7 and cotton DAS-81910-7 are approved and in commercial cultivation. in several countries, and DAS-21023-5 × DAS-24236-5 × SYN-IR102-7 cotton is approved in the US.
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Studies carried out show that the Vip3Aa19 protein poses a negligible risk to non-target birds, wild mammals, aquatic organisms and non-target foliar and beneficial soil organisms. Concentrations of Vip3Aa19 available in cotton-based animal feed fabrics were far below the highest doses of Vip3Aa19 tested, which had no adverse effects on the species tested. The Vip3Aa19 protein is expressed at low concentrations in cotton pollen SYN-IR102-7 and the properties of cotton pollen (heavy, sticky and not carried by the wind) result in a low potential for dispersal for aquatic organisms. In tests with pollinators (bees) and beneficial omnivorous insects (ladybugs and lacewings), incorporation of pollen expressing high concentrations of Vip3Aa19 into their diets did not result in adverse effects at concentrations greater than what these organisms are exposed to from SYN-IR102 cotton. -7. Likewise, tests with earthworms did not demonstrate any adverse effects when they were exposed to the Vip3Aa19 protein in the soil at concentrations higher than those found in SYNIR102-7 cotton. Collembola did not demonstrate any adverse effects when exposed to dietary concentrations of Vip3Aa19 greater than expected from ingestion of material from SYN-IR102-7 cotton. Furthermore, testing in aquatic environments using high concentrations of Vip3Aa19, much higher than in pollen from SYN-IR102-7 cotton, did not result in an adverse effect on sensitive indicator invertebrate species. All available evidence indicates that no non-Lepidopteran species will be directly impacted by cotton plants that express the Vip3Aa19 protein.
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The event cotton DAS-21023-5 × DAS-24236-5 × SYN-IR102-7 × DAS81910-7 is not potentially a cause of significant environmental degradation, keeping with the biota an identical relationship to that of conventional cotton.
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CTNBio considered that the request complies with the rules and legislation in force aimed at ensuring the biosafety of the environment, agriculture, human and animal health, and concluded that DAS-21023-5 × DAS-24236-5 × SYN-IR102-7 × DAS-81910-7 cotton is substantially equivalent to conventional cotton, and its consumption is safe for human and animal health.
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Molecular traddicional methods. 
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Partage d’informations avec d’autres bases de données
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Information supplémentaire
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