{"id":32638,"date":"2024-05-27T10:50:38","date_gmt":"2024-05-27T08:50:38","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/05\/27\/ue-riduzione-microplastiche-per-i-dispositivi-medici\/"},"modified":"2024-05-27T12:18:10","modified_gmt":"2024-05-27T10:18:10","slug":"ue-riduzione-microplastiche-per-i-dispositivi-medici","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/05\/27\/ue-riduzione-microplastiche-per-i-dispositivi-medici\/","title":{"rendered":"UE: reducci\u00f3n de micropl\u00e1sticos en productos sanitarios"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>Con el <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/IT\/TXT\/?uri=CELEX%3A32023R2055\"><strong>Reglamento<\/strong> <strong>(UE) 2023\/2055<\/strong> <strong>de 25 de septiembre de 2023<\/strong><\/a> por el que se modifica el anexo XVII del Reglamento (CE) n\u00ba 1907\/2006, la Comisi\u00f3n Europea ha impuesto <strong>restricciones estrictas<\/strong> al Registro, Evaluaci\u00f3n, Autorizaci\u00f3n y Restricci\u00f3n de Sustancias y Preparados Qu\u00edmicos (REACH) en relaci\u00f3n con las <strong>micropart\u00edculas polim\u00e9ricas sint\u00e9ticas<\/strong>, que no son degradables y son potencialmente nocivas para el medio ambiente y, posiblemente, para la salud humana. Estos pol\u00edmeros est\u00e1n muy extendidos en el medio ambiente y tambi\u00e9n se han encontrado en el agua potable y los alimentos, lo que contribuye a la contaminaci\u00f3n por micropl\u00e1sticos.<\/h2>\n<p>De hecho, el reglamento pretende <strong>limitar el uso de micropl\u00e1sticos<\/strong> <strong>a\u00f1adidos intencionadamente<\/strong> con distintas funciones t\u00e9cnicas en diversos productos de uso cotidiano, lo que afecta a muchos sectores, incluidos los <strong>productos sanitarios<\/strong>.<\/p>\n<p>La restricci\u00f3n utiliza una definici\u00f3n amplia de micropl\u00e1sticos que abarca todas aquellas part\u00edculas de pol\u00edmeros sint\u00e9ticos de 5 mil\u00edmetros o menos que sean org\u00e1nicas, insolubles y resistentes a la degradaci\u00f3n.<\/p>\n<p>Al a\u00f1adir una entrada espec\u00edfica al anexo XVII del Reglamento (CE) n\u00ba 1907\/2006, <strong>el Reglamento (UE) 2023\/2055<\/strong> estipula que las <strong>micropart\u00edculas polim\u00e9ricas sint\u00e9ticas<\/strong> (sustancias como tales o presentes para conferir una caracter\u00edstica buscada) no podr\u00e1n comercializarse en mezclas en una concentraci\u00f3n igual o superior <strong>al 0,01% en peso<\/strong>. El l\u00edmite del 0,01 % corresponde al nivel de concentraci\u00f3n m\u00e1s bajo notificado en el que las micropart\u00edculas de pol\u00edmeros sint\u00e9ticos podr\u00edan seguir influyendo en la funci\u00f3n de un producto.<\/p>\n<p>Esta limitaci\u00f3n tambi\u00e9n se aplicar\u00e1 a <strong>los productos sanitarios<\/strong> que entren en el \u00e1mbito de aplicaci\u00f3n del Reglamento (UE) 2017\/745 a partir del <strong>17 de octubre de 2029 <\/strong>(final del per\u00edodo de transici\u00f3n), a menos que los productos incluyan microesferas, para las que no hay per\u00edodo de transici\u00f3n.<\/p>\n<p>La limitaci\u00f3n del 0,01% en peso <strong>no se<\/strong> <strong>aplica<\/strong> a la comercializaci\u00f3n de <strong>productos para diagn\u00f3stico in vitro<\/strong> y <strong>no se aplica<\/strong> a la comercializaci\u00f3n de las siguientes <strong>micropart\u00edculas polim\u00e9ricas sint\u00e9ticas<\/strong>:<\/p>\n<ul>\n<li><strong>contenidas por medios t\u00e9cnicos<\/strong> para evitar su liberaci\u00f3n al medio ambiente cuando se utilicen de acuerdo con las instrucciones de uso durante el uso final previsto;<\/li>\n<li>cuyas propiedades f\u00edsicas se <strong>modifiquen permanentemente<\/strong> durante el uso final previsto de tal manera que el pol\u00edmero ya no entre en el \u00e1mbito de aplicaci\u00f3n de la prohibici\u00f3n del 0,01 % en peso;<\/li>\n<li><strong>permanentemente incrustado en una matriz<\/strong> s\u00f3lida durante el uso final previsto.<\/li>\n<\/ul>\n<p><strong>Los pol\u00edmeros resultantes de un proceso de polimerizaci\u00f3n que tiene lugar en la<\/strong> <strong>naturaleza<\/strong> tambi\u00e9n est\u00e1n <strong>excluidos<\/strong>de las restricciones del Reglamento, es decir, cuando se trata de sustancias que no han sido modificadas qu\u00edmicamente, independientemente del proceso por el que se hayan extra\u00eddo los pol\u00edmeros.<\/p>\n<p><strong>&gt;&gt;&gt;&gt; <\/strong>Con sus servicios de <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\"><strong>consultor\u00eda en calidad y reglamentaci\u00f3n para el sector m\u00e9dico<\/strong><\/a> Thema puede prestar apoyo en la evaluaci\u00f3n de productos a partir del concepto de dise\u00f1o, a lo largo de la redacci\u00f3n de la documentaci\u00f3n t\u00e9cnica y en la recopilaci\u00f3n de datos para la demostraci\u00f3n de los requisitos generales de seguridad y rendimiento de conformidad con la normativa europea.<\/p>\n<p><strong>Fuente<\/strong><strong>:<br \/>\n<\/strong><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX:32023R2055#d1e726-67-1\"><strong>Reglamento (UE) 2017\/745 <\/strong><\/a><strong>\u00a0<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32614,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-32638","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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