10 results on '"Ardizzone, M"'
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2. Résultats d'un dispositif régional de reprise d'activité physique pour les RIC.
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Geneton, S., Messer, L., Demesmay, K., Walther, J., Ardizzone, M., Widawski, L., and Sordet, C.
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Nos patients atteints de rhumatisme inflammatoire chronique (RIC). Le dispositif RAP (reprise d'activité physique) vise l'accompagnement des patients ayant un RIC dans les hôpitaux de Colmar, Mulhouse et Strasbourg. Sa création visant un accompagnement des patients, leur permettant de pratiquer une activité physique adaptée (APA). Programme sur 12 mois, débutant par une consultation multidisciplinaire, puis des séances en présentiel ou par vidéo, 2 fois par semaine pendant 3 mois. Puis, un bilan avec l'enseignant en APA est réalisé. À la suite de ce bilan, un contact mensuel est réalisé jusqu'à M6. À partir du bilan à M6, le patient est autonome dans sa pratique et sera revu à M9 et M12. Le but étant d'accompagner les patients vers une autonomisation de leurs pratiques physiques. Cent cinq patients inclus, 27 ayant une polyarthrite rhumatoïde (PR) et 78 ayant une spondyloarthrite (SA). À M0, 88 % des patients ont un traitement de fond, dont 69 % sous biothérapie. Au total, 37,5 % ont un traitement antalgique. Le DAS a une moyenne de 2,16 et le BASDAI de 4,03. Dix-huit pour cent des patients sont en surpoids et 24,7 % sont en obésité. Résultats au questionnaire de RICCI et GAGNON, mesurant l'activité physique au quotidien (x < 18 inactif et x > 18 : actif) : moyenne à 19/45 points, 44 % des patients sont inactifs et 48 % sont actifs. À noter qu'aucun patient est « très actif », pas de score supérieur à 35. Moyenne au test de marche 6 minutes (TM6) : 64 % de la valeur théorique. À M3, 84 patients, les données suivantes n'ont pas évolué : indice de masse corporel, activité de la maladie, le traitement de fond (dont biothérapie). Au total, 29,7 % des patients prennent des antalgiques. Résultats du RICCI et GAGNON : moyenne à 27/45 points, dont 70 % sont actifs ou très actifs. Moyenne au TM6 à 66 % de la valeur théorique. Dix-sept patients ont été perdus de vu, 3 patients ont déclaré manquer de temps et 1 patient manquer de motivation (n = 21). À M12, 41 patients, idem M3 sur les données n'ayant pas changé. Vingt-quatre pour cent des patients ont un traitement antalgique. Quatre-vingt-quatorze pour cent des patients (n = 39) sont actifs (n = 35) ou très actif (n = 1). Seulement 2 patients sont inactifs/moyenne au TM6 à 75 %. À la fin du dispositif, 57 ont arrêté le suivi (perdus de vue, manque de temps, manque de motivation...) mais à des temps différents du programme. Six patients sont encore entre M9 et M12. Le nombre de patients ayant arrête le dispositif est important, il est expliqué en partie par des difficultés organisationnelles notamment d'un centre (28 patients). Les résultats montrent qu'il est possible d'autonomiser les patients RIC dans leur pratique. Nous pouvons imaginer élargir ce dispositif à d'autres pathologies (maladie de Sjögren, sclérodermie...). La reprise d'activité physique adaptée régulière chez des patients ayant un RIC est possible et bénéfique. Cependant, on peut s'interroger sur les pistes d'amélioration des dispositifs de type « sport-santé », en orientant la réflexion sur les formats (présentiel, vidéo, visio, mixte) afin d'améliorer l'adhésion des patients à la pratique physique régulière. [ABSTRACT FROM AUTHOR]
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- 2024
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3. Implémentation d'un Parcours « Lupus systémique » intégratif en Alsace.
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Scherlinger, M., Dieudonné, Y., Blaison, G., Dervieux, B., Ardizzone, M., Dahan, E., Morruzzi, C., Meyer, L., Barrand, L., Messer, L., Windstein, C., Walther, J., Dory, A., Riviere, M., Gonzalez, M., Carrier, C., Kleinlogel, S., Barthelemy, M., Chatelus, E., and Hinschberger, O.
- Abstract
Le lupus systémique (LS) est une maladie auto-immune rare dont la prise en charge diagnostique et thérapeutique implique de nombreux défis. Le délai diagnostique médian est de deux ans et l'absence de parcours de soin bien défini entraîne un retard diagnostique péjoratif et un vécu négatif par les patients. L'objectif de ce travail était d'évaluer de manière systématique les difficultés et freins rencontrés par les patients diagnostiqués d'un LS en Alsace afin d'y répondre par la création d'un parcours LS Alsace. Un groupe de travail pluriprofessionnel comprenant des médecins (rhumatologues, internistes, dermatologues, biologistes, médecins du travail) hospitaliers et libéraux, des pharmaciens, des paramédicaux (infirmiers), ainsi que des patients et représentants d'association de patients ont participé à ce travail. Chaque étape du parcours patient a été étudiée afin d'évaluer les freins et les leviers d'amélioration potentiels. Des solutions ont été discutées au sein du groupe et implémentées en vie réelle afin d'améliorer le parcours des patients. Trois axes principaux ont été identifiés par le groupe de travail : 1/ les délais et difficultés diagnostiques : une sensibilisation des médecins libéraux au LS a été réalisée par le biais de réunions de formations médicales continues et par la diffusion d'une fiche de symptômes/plaintes devant faire évoquer un LS (Fig. 1). Afin d'améliorer l'identification précoce des patients, une fiche d'aide à la prescription du bilan immunologique regroupant symptomatologie et explorations adaptées a été diffusée (Fig. 2). Le rendu des résultats immunologiques a été harmonisé à l'échelle de l'Alsace avec des commentaires permettant au prescripteur d'orienter au mieux le patient. Une ligne de télé-expertise OMNIDOC a été mise en place afin d'accompagner les libéraux dans l'orientation et l'aide à la prise en charge des patients. Enfin, une fois le diagnostic posé, une proposition de verbatim a été élaborée avec médecins et patients afin que l'annonce diagnostique soit la mieux vécue possible ; 2/ la prise en charge thérapeutique : un document formalisant un projet personnalisé de soin (PPS) a été élaboré pour permettre au patient d'avoir une vision globale de sa prise en charge (Fig. 3). En outre, une réunion de concertation pluridisciplinaire présentielle ou à distance a été renforcée afin de discuter des dossiers complexes (i.e., LS réfractaire, grossesse) ; 3/ prise en charge globale : une hospitalisation de jour modulaire est maintenant mise en place, proposant de manière personnalisée des entretiens médicaux, pharmaceutiques, kinésithérapiques, diététiques, d'activité physique adaptée, d'ergothérapie ou de médecine du travail. La prise en charge des comorbidités (ostéoporose, cardiovasculaire) et de la vaccination est également proposée. Enfin, le programme LS développé par l'équipe d'éducation thérapeutique (ETP) vient renforcer l'offre de prise en charge. L'impact de chaque élément du parcours lupus sera évalué par le biais de mesures quantitative et qualitative. Ce parcours intégratif vise à améliorer et à faciliter le diagnostic précoce et la prise en charge globale des patients atteints de LS en Alsace. Ce type de parcours pourrait être étendu à d'autres régions et d'autres pathologies afin de renforcer les parcours de soin. [ABSTRACT FROM AUTHOR]
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- 2024
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4. Assessment of genetically modified maize DP51291 (application GMFF-2021-0071).
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Casacuberta J, Barro F, Braeuning A, Cubas P, de Maagd R, Epstein MM, Frenzel T, Gallois JL, Koning F, Messéan A, Moreno FJ, Nogué F, Savoini G, Schulman AH, Tebbe C, Veromann E, Ardizzone M, De Santis G, Federici S, Fernandez Dumont A, Gennaro A, Gómez Ruiz JÁ, Goumperis T, Grammatikou P, Kagkli DM, Lenzi P, Lewandowska A, Martin Camargo A, Neri FM, Piffanelli P, Raffaello T, and Xiftou K
- Abstract
Genetically modified maize DP51291 was developed to confer control against susceptible corn rootworm pests and tolerance to glufosinate-containing herbicide; these properties were achieved by introducing the ipd072Aa, pmi and mo-pat expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP51291 and its conventional counterpart needs further assessment, except for phosphorus in forage and manganese, proline, oleic acid (C18:1) and linoleic acid (C18:2) in grain, which do not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the IPD072Aa, PAT and PMI proteins as expressed in maize DP51291 and finds no evidence that the genetic modification would change the overall allergenicity of maize DP51291. In the context of this application, the consumption of food and feed from maize DP51291 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP51291 is as safe as its conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP51291 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP51291. The GMO Panel concludes that maize DP51291 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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5. Comparison of group versus individual patient education for promoting safety skills of patients with autoimmune rheumatic diseases treated with biologics: a multicentre randomised controlled trial.
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Fayet F, Beauvais C, Pereira B, Béranger M, Rodere M, Pallot-Prades B, Peyrard P, Pouplin S, Grandjean M, Chu Miow Lin D, Ardizzone M, Cherillat MS, Tournadre A, Fan A, and Soubrier M
- Abstract
Objective: To evaluate the effectiveness of a nurse-led intervention combining face-to-face and group education sessions for the acquisition of safety skills by patients with autoimmune rheumatic diseases treated with biologics., Methods: This multicentre randomised controlled trial compared two individual patient education sessions against a combination of an individual session at baseline and a group session 3 months later. The primary outcome was a validated questionnaire (BioSecure) scored at 6 and 12 months that assessed competencies and problem-solving abilities to deal with fever, infection, vaccination, and daily situations. Secondary outcomes were fear of disease, anxiety, depression, and arthritis helplessness., Results: A total of 120 patients with rheumatoid arthritis and spondyloarthritis were included (60 in each arm) from 7 French rheumatology departments; 99 patients completed the study at 6 months and 83 at 12 months. The BioSecure score improved at 6 months in both arms (delta from baseline 14.9 ± 16.3 in face-to-face education and 16.0 ± 17.9 in combined education) and was maintained for 12 months but no significant difference was found between arms at 6 and 12 months (p = 0.35 and p = 0.13, respectively). Fear of disease, arthritis helplessness, and anxiety were improved at 6 and 12 months with no difference between arms., Conclusion: Educating patients using individual nurse-led sessions or a combination of individual and group sessions increased their safety skills on biologics, with no superiority shown for the combined format. Given the time and resources required to educate patients, these results could lead to potential cost savings., Trial Registration: Clinical Trials: NCT03838939. Key Points • Face-to-face patient education has been shown effective in promoting safety skills of patients treated with biologics compared to information provided by the rheumatologist in usual care. • This randomised controlled trial showed that a patient education format combining one individual and one group session was not superior to two individual sessions regarding safety skills assessed at 6 and 12 months • Safety skills, fear of disease, arthritis helplessness, and anxiety were improved in both arms. • As the most common barriers to the implementation of patient education are constraints in time and resources, these results could lead to potential cost savings., (© 2024. The Author(s), under exclusive licence to International League of Associations for Rheumatology (ILAR).)
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- 2024
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6. Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-NL-2015-126) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788.
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Casacuberta J, Barro F, Braeuning A, Cubas P, de Maagd R, Epstein MM, Frenzel T, Gallois JL, Koning F, Messéan A, Moreno FJ, Nogué F, Savoini G, Schulman AH, Tebbe C, Veromann E, Ardizzone M, Dumont AF, Ferrari A, Gonzalez ABG, Gómez Ruiz JÁ, and Goumperis T
- Abstract
Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA-GMO-NL-2015-126). The applicant conducted a 90-day feeding study on GM soybean MON 87705 and provided a proposal for post-market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90-day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment-related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommendations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion. Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA-GMO-NL-2015-126 and in the supplementary toxicity study, is as safe as its non-GM comparator and the non-GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope of this application., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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7. Assessment of genetically modified maize DP910521 (application GMFF-2021-2473).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Naegeli H, Moreno FJ, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, De Sanctis G, Dumont AF, Gennaro A, Gómez Ruiz JÁ, Grammatikou P, Goumperis T, Lenzi P, Lewandowska A, Camargo AM, Neri FM, Piffanelli P, Raffaello T, and Xiftou K
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Genetically modified (GM) maize DP910521 was developed to confer resistance against certain lepidopteran insect pests as well as tolerance to glufosinate herbicide; these properties were achieved by introducing the mo-pat, pmi and cry1B.34 expression cassettes. The molecular characterisation data and bioinformatic analyses did not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP910521 and its conventional counterpart needs further assessment except for the levels of iron in grain, which do not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Cry1B.34, PAT and PMI proteins as expressed in maize DP910521. The GMO panel finds no evidence that the genetic modification impacts the overall safety of maize DP910521. In the context of this application, the consumption of food and feed from maize DP910521 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP910521 is as safe as its conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of maize DP910521 material into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP910521. The GMO Panel concludes that maize DP910521 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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8. Assessment of genetically modified maize MON 95275 (application GMFF-2022-5890).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Naegeli H, Moreno FJ, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, De Sanctis G, Silvia F, Dumont AF, Gennaro A, Gómez Ruiz JÁ, Grammatikou P, Goumperis T, Kagkli DM, Lenzi P, Lewandowska A, Camargo AM, Neri FM, Piffanelli P, Raffaello T, and Xiftou K
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Genetically modified maize MON 95275 was developed to confer protection to certain coleopteran species. These properties were achieved by introducing the mpp75Aa1.1 , vpb4Da2 and DvSnf7 expression cassettes. The molecular characterisation data and bioinformatic analyses reveal similarity to known toxins, which was further assessed. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MON 95275 and its conventional counterpart needs further assessment. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Mpp75Aa1.1 and Vpb4Da2 proteins and the DvSnf7 dsRNA and derived siRNAs as expressed in maize MON 95275 and finds no evidence that the genetic modification would change the overall allergenicity of maize MON 95275. In the context of this application, the consumption of food and feed from maize MON 95275 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 95275 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of maize MON 95275 material into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 95275. The GMO Panel concludes that maize MON 95275 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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9. Assessment of genetically modified maize MON 94804 (application GMFF-2022-10651).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, De Sanctis G, Gennaro A, Gómez Ruiz JÁ, Grammatikou P, Goumperis T, Jacchia S, Lenzi P, Lewandowska A, Camargo AM, Neri FM, Piffanelli P, Raffaello T, and Xiftou K
- Abstract
Genetically modified (GM) maize MON 94804 was developed to achieve a reduction in plant height by introducing the GA20ox_SUP suppression cassette. The molecular characterisation and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the agronomic/phenotypic and compositional differences identified between maize MON 94804 and its conventional counterpart needs further assessment, except for ear height, plant height and levels of carbohydrates in forage, which do not raise safety or nutritional concerns. The Panel on Genetically Modified Organisms (GMO Panel) does not identify safety concerns regarding the toxicity and allergenicity of the GA20ox_SUP precursor-miRNA and derived mature miRNA as expressed in maize MON 94804 and finds no evidence that the genetic modification would change the overall allergenicity of maize MON 94804. In the context of this application, the consumption of food and feed from maize MON 94804 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 94804 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 94804 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 94804. The GMO Panel concludes that maize MON 94804 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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10. Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-159).
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Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Ardizzone M, Camargo AM, De Sanctis G, Federici S, Fernandez A, Gennaro A, Gómez Ruiz JÁ, Goumperis T, Grammatikou P, Kagkli DM, Lenzi P, Neri FM, Papadopoulou N, and Raffaello T
- Abstract
Genetically modified maize DP202216 was developed to confer tolerance to glufosinate-ammonium-containing herbicides and to provide an opportunity for yield enhancement under field conditions. These properties were achieved by introducing the mo-pat and zmm28 expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP202216 and its comparator needs further assessment, except for the levels of stearic acid (C18:0), which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the PAT and ZMM28 proteins as expressed in maize DP202216, and finds no evidence that the genetic modification would change the overall allergenicity of maize DP202216. In the context of this application, the consumption of food and feed from maize DP202216 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP202216 is as safe as the comparator and non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP202216 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP202216. The GMO Panel concludes that maize DP202216 is as safe as its comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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