{"id":1639,"date":"2014-06-02T12:51:54","date_gmt":"2014-06-02T12:51:54","guid":{"rendered":"http:\/\/infos.orchidali.com\/?p=1639"},"modified":"2014-06-02T12:51:54","modified_gmt":"2014-06-02T12:51:54","slug":"delais-de-reponse-aux-questions-de-lefsa-durant-les-procedures-devaluation-des-dossiers-soumis","status":"publish","type":"post","link":"https:\/\/science-nutrition.com\/en\/2014\/06\/02\/delais-de-reponse-aux-questions-de-lefsa-durant-les-procedures-devaluation-des-dossiers-soumis\/","title":{"rendered":"D\u00e9lais de r\u00e9ponses aux questions de l’EFSA durant les proc\u00e9dures d’\u00e9valuation des dossiers soumis"},"content":{"rendered":"

L\u2019EFSA a publi\u00e9 un rapport indiquant les d\u00e9lais de r\u00e9ponse aux “stop-the-clock” en fonction des dossiers soumis et des types de questions. L\u2019EFSA mettra en place ces temps indicatifs 3 mois apr\u00e8s la publication de ce document soit mi-juillet 2014.<\/p>\n

A titre d’exemples:<\/p>\n

Dossiers pr\u00e9parations pour nourrissons et pr\u00e9parations de suite<\/span><\/strong><\/p>\n

– Composition, puret\u00e9, variation entre lots: 2 mois<\/span><\/strong>,<\/p>\n

– Nouvelle analyse statistique des donn\u00e9es: 2 mois<\/span><\/strong>,<\/p>\n

– Informations manquantes concernant le processus de production (ex.:\u00a0 conditions de production): 15 jours calendaires<\/span><\/strong>,<\/span><\/p>\n

– Etude suppl\u00e9mentaire relative \u00e0 la biodisponibilit\u00e9: 2 mois<\/span><\/strong>,<\/p>\n

– Clarification li\u00e9 aux \u00e9tudes cliniques fournies, mise \u00e0 disposition des rapports d’\u00e9tudes ou des donn\u00e9es brutes: 1 mois<\/span><\/strong>,<\/p>\n

– Mise \u00e0 jour de la revue de la litt\u00e9rature: 2 mois<\/span><\/strong>,<\/p>\n

Dossiers all\u00e9gations, Article 14<\/span><\/strong><\/p>\n

– Composition, puret\u00e9, variation entre lots: 2 mois<\/span><\/strong>,<\/p>\n

– Nouvelle analyse statistique des donn\u00e9es: 2 mois<\/span><\/strong>,<\/p>\n

– Informations manquantes concernant le processus de production (ex.:\u00a0 conditions de production): <\/strong>15 jours calendaires<\/span><\/strong>,
\n<\/strong><\/p>\n

– Clarification li\u00e9 aux \u00e9tudes cliniques fournies, mise \u00e0 disposition des rapports d’\u00e9tudes ou des donn\u00e9es brutes: 1 mois<\/span><\/strong>,<\/p>\n

– Mise \u00e0 jour de la revue de la litt\u00e9rature: 2 mois<\/span><\/strong>,<\/p>\n

Dossiers all\u00e9gations, Article 13.5<\/span><\/strong><\/p>\n

– Composition, puret\u00e9, variation entre lots: 15 jours calendaires<\/span><\/strong>,<\/p>\n

– Nouvelle analyse statistique des donn\u00e9es: 15 jours calendaires<\/span><\/strong>,<\/p>\n

– Informations manquantes concernant le processus de production (ex.:\u00a0 conditions de production): 15 jours calendaires<\/span><\/strong>,<\/p>\n

– Clarification li\u00e9 aux \u00e9tudes cliniques fournies, mise \u00e0 disposition des rapports d’\u00e9tudes ou des donn\u00e9es brutes: 15 jours calendaires<\/span><\/strong>,<\/p>\n

– Mise \u00e0 jour de la revue de la litt\u00e9rature: 15 jours calendaires<\/span><\/strong>,<\/p>\n

Dossiers Novel foods<\/span><\/strong><\/span><\/p>\n

– Composition, donn\u00e9es analytiques,variation entre lots, tests de stabilit\u00e9: 2 mois<\/span><\/strong>,<\/p>\n

– Informations manquantes concernant le processus de production (ex.:\u00a0 conditions de production): 15 jours calendaires<\/span><\/strong>,<\/p>\n

– Etude suppl\u00e9mentaire relative \u00e0 la biodisponibilit\u00e9: 2 mois<\/span><\/strong>,<\/p>\n

– ADME (absorption, distribution, metabolism, excretion): 9 mois<\/span><\/strong>,<\/p>\n

– Bacterial reverse mutation test: 6 mois<\/span><\/strong>,<\/p>\n

– test pour l’induction de mutations de g\u00e8nes dans les cellules de mammif\u00e8res: 6 mois<\/span><\/strong>,<\/p>\n

– Etude de toxicit\u00e9 oralesub-chronique de 90 jours chez le\u00a0 rongeur: 12 mois<\/span><\/strong>,<\/p>\n

– Toxicit\u00e9 chronique : 3 ans<\/span><\/strong> (variable selon l’esp\u00e8ce animale),<\/p>\n

– Neurotoxicit\u00e9 chez le rongeur: 9 mois<\/span><\/strong>,<\/p>\n

– Utilisation pr\u00e9alable du nouvel ingr\u00e9dient ou sa source: 2 mois<\/span><\/strong>,<\/p>\n

– Revue de la litt\u00e9rature des \u00e9tudes humaines: 2 mois<\/span><\/strong>…<\/p>\n

Source: cliquez ici<\/a><\/p>\n<\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

L\u2019EFSA a publi\u00e9 un rapport indiquant les d\u00e9lais de r\u00e9ponse aux “stop-the-clock” en fonction des dossiers soumis et des types de questions.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[31,294,53,27,297],"tags":[344,32,345],"class_list":["post-1639","post","type-post","status-publish","format-standard","hentry","category-allegations-sante-nutrition","category-autres-reglements","category-novel-food","category-recherche","category-reglementation-2","tag-dossiers-reglementaires","tag-efsa","tag-stop-the-clock"],"yoast_head":"\nD\u00e9lais de r\u00e9ponses aux questions de l'EFSA durant les proc\u00e9dures d'\u00e9valuation des dossiers soumis - Orchidali - When feeding is health<\/title>\n<meta name=\"description\" content=\"Conseil scientifique et r\u00e9glementaire en alimentation\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/science-nutrition.com\/en\/2014\/06\/02\/delais-de-reponse-aux-questions-de-lefsa-durant-les-procedures-devaluation-des-dossiers-soumis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"D\u00e9lais de r\u00e9ponses aux questions de l'EFSA durant les proc\u00e9dures d'\u00e9valuation des dossiers soumis - 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