{"id":9319,"date":"2025-12-11T10:57:41","date_gmt":"2025-12-11T02:57:41","guid":{"rendered":"https:\/\/regask.com\/?p=9319"},"modified":"2025-12-11T10:57:41","modified_gmt":"2025-12-11T02:57:41","slug":"la-epa-de-ee-uu-propone-modificaciones-a-las-regulaciones-de-informes-de-pfa-bajo-la-tsca-para-reducir-las-cargas-de-cumplimiento","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/us-epa-proposes-amendments-to-pfas-reporting-regulations-under-tsca-to-reduce-compliance-burdens\/","title":{"rendered":"La EPA de EE. UU. propone modificaciones al Reglamento de Informes de PFAS\u2026"},"content":{"rendered":"<p>El 10 de noviembre de 2025, el <a href=\"https:\/\/www.epa.gov\/\">Agencia de Protecci\u00f3n Ambiental de los Estados Unidos (EPA)<\/a> enmiendas propuestas a <strong>Requisitos de notificaci\u00f3n de PFAS (sustancias perfluoroalquiladas y polifluoroalquiladas) seg\u00fan la TSCA (Ley de Control de Sustancias T\u00f3xicas)<\/strong> para reducir los costos de cumplimiento, en particular para las peque\u00f1as empresas y los importadores, al tiempo que se garantiza el acceso a datos esenciales sobre el uso y la seguridad de los PFAS.<\/p>\n<div class=\"row\"  id=\"row-828427617\">\n\n\t<div id=\"col-715159688\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Resumen de las enmiendas propuestas<\/h3>\n\t<div id=\"gap-374498254\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-374498254 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La EPA pretende mantener la notificaci\u00f3n de actividades significativas de PFAS, pero revisar\u00e1 varios elementos para que el programa sea m\u00e1s pr\u00e1ctico. La propuesta responde a las cr\u00edticas de la industria, que consideraban que la norma anterior de la Administraci\u00f3n Biden era excesivamente onerosa y carec\u00eda de una gu\u00eda clara para el uso de datos.<\/p>\n<p>Los puntos clave incluyen:<\/p>\n<ul>\n<li>Introducci\u00f3n de exenciones para categor\u00edas espec\u00edficas de PFAS.<\/li>\n<li>Correcciones t\u00e9cnicas para aclarar los campos de datos de informes.<\/li>\n<li>Ajustes al plazo de presentaci\u00f3n de informes.<\/li>\n<li>Un per\u00edodo definido de comentarios p\u00fablicos de 45 d\u00edas.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-715159688 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-268540946\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Explicaci\u00f3n de los cambios propuestos<\/h3>\n\t<div id=\"gap-1116508459\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1116508459 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La propuesta introduce <strong>exenciones<\/strong> para PFAS encontrados en:<\/p>\n<ul>\n<li><strong>Mezclas o productos en concentraciones de 0,1 por ciento o inferiores.\u00a0<\/strong><\/li>\n<li><strong>Art\u00edculos importados,<\/strong> incluidos componentes que contienen PFAS.<\/li>\n<li><strong>Ciertos subproductos, impurezas, productos qu\u00edmicos de investigaci\u00f3n y desarrollo,<\/strong> y <strong>intermedios no aislados.\u00a0<\/strong><\/li>\n<\/ul>\n<p>La EPA tambi\u00e9n planea:<\/p>\n<ul>\n<li>Implementar <strong>correcciones t\u00e9cnicas<\/strong> a los campos de datos para mayor claridad.<\/li>\n<li>Modificar el<strong> per\u00edodo de presentaci\u00f3n<\/strong> para mejorar la facilidad de presentaci\u00f3n de informes.<\/li>\n<li>Mantener las obligaciones de presentaci\u00f3n de informes para todos <strong>Fabricantes e importadores activos entre 2011 y 2022.\u00a0<\/strong><\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-268540946 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1923088975\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Cumplimiento e impacto en la industria<\/h3>\n\t<div id=\"gap-1891202072\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1891202072 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Seg\u00fan la evaluaci\u00f3n de la EPA, se espera que las modificaciones:<\/p>\n<ul>\n<li>Reducir los costos generales de cumplimiento para las empresas reguladas.<\/li>\n<li>Proporcionar<strong> mayor certeza regulatoria<\/strong> Para fabricantes e importadores.<\/li>\n<li>Liberar a las empresas de reportar informaci\u00f3n que probablemente no est\u00e9 disponible.<\/li>\n<li>Mantener el acceso de la EPA a los datos PFAS m\u00e1s relevantes para la supervisi\u00f3n regulatoria.<\/li>\n<li>Apoyar la implementaci\u00f3n equilibrada de la normativa <strong>Secci\u00f3n 8(a)(7) de TSCA.\u00a0<\/strong><\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1923088975 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-801514859\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Fecha l\u00edmite para comentarios<\/h3>\n\t<div id=\"gap-570033859\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-570033859 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<ul>\n<li>El per\u00edodo de comentarios p\u00fablicos de 45 d\u00edas comienza a partir de la publicaci\u00f3n en el <strong>Registro Federal<\/strong>.<\/li>\n<li>Las partes interesadas deben hacer referencia <strong>expediente EPA-HQ-OPPT-2020-0549<\/strong> al enviar comentarios.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-801514859 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-609009705\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Por qu\u00e9 es importante<\/h3>\n\t<div id=\"gap-1334833459\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1334833459 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Estas revisiones est\u00e1n dise\u00f1adas para:<\/p>\n<ul>\n<li>Mejorar la claridad en torno a los umbrales de aplicabilidad de los PFAS.<\/li>\n<li>Agilice las obligaciones de presentaci\u00f3n de informes sin comprometer la calidad de los datos.<\/li>\n<li>Reducir las cargas administrativas para las empresas que gestionan trazas de PFAS.<\/li>\n<li>Aumentar la alineaci\u00f3n entre las expectativas regulatorias y la viabilidad operativa.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-609009705 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1102954648\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Para qui\u00e9n es relevante esta actualizaci\u00f3n<\/h3>\n\t<div id=\"gap-2094330696\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2094330696 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las modificaciones afectan directamente a:<\/p>\n<ul>\n<li><strong>Fabricantes e importadores<\/strong> Manejo de PFAS entre 2011 y 2022.<\/li>\n<li>Empresas que importan o utilizan <strong>materias primas, art\u00edculos,<\/strong> o <strong>componentes<\/strong> que pueden contener trazas de PFAS.<\/li>\n<li>Sectores como productos qu\u00edmicos, bienes de consumo envasados en general y ciencias de la vida con operaciones en EE. UU.<\/li>\n<li>Organizaciones que trabajan con <strong>CMO o CDMO<\/strong>, donde puede existir exposici\u00f3n indirecta a PFAS.<\/li>\n<\/ul>\n<p>Las consideraciones indirectas pero relevantes incluyen:<\/p>\n<ul>\n<li>Verificaci\u00f3n de los niveles de PFAS en equipos de proceso, sistemas de contenedores\/cierres y cadenas de suministro de excipientes.<\/li>\n<li>Mapeo de la cadena de suministro para confirmar si las exenciones se aplican a alg\u00fan socio externo.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1102954648 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2016029690\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Pr\u00f3ximos pasos<\/h3>\n\t<div id=\"gap-801867967\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-801867967 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las partes interesadas deben:<\/p>\n<ul>\n<li>Revisar todas las exenciones y aclaraciones propuestas para evaluar el impacto en la cartera.<\/li>\n<li>Coordinar con los proveedores para confirmar los umbrales de PFAS y la aplicabilidad de las exenciones.<\/li>\n<li>Prepare comentarios o busque aclaraciones durante el per\u00edodo de retroalimentaci\u00f3n de 45 d\u00edas.<\/li>\n<li>Evaluar los riesgos indirectos a trav\u00e9s de CMO, CDMO o socios de fabricaci\u00f3n estadounidenses.<\/li>\n<\/ul>\n<p>Para respaldar este proceso de revisi\u00f3n, las herramientas de inteligencia regulatoria automatizadas pueden ayudar a los equipos a rastrear cambios en las reglas, evaluar la exposici\u00f3n material y preparar respuestas alineadas.<\/p>\n<p><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> Es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA de Agentic que permite a organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar IA de Agentic avanzada con expertos en el sector, RegASK ofrece informaci\u00f3n predictiva, pr\u00e1ctica y oportuna, y automatizaci\u00f3n integral, optimizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de 157 pa\u00edses. <a href=\"https:\/\/regask.com\/es\/producto\/\">M\u00e1s informaci\u00f3n<\/a> o <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reserve una demostraci\u00f3n ahora.\u00a0<\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2016029690 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1017878017\">\n\n\t<div id=\"col-1432029104\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-100343246\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-100343246 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfQu\u00e9 categor\u00edas de PFAS est\u00e1n exentas seg\u00fan las modificaciones propuestas?<\/h4>\n\t<div id=\"gap-1051540574\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1051540574 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La propuesta exime los PFAS en mezclas o productos en <strong>0,1 por ciento o menos,<\/strong> as\u00ed como PFAS en<strong> art\u00edculos importados, subproductos, impurezas, investigaci\u00f3n y desarrollo de productos qu\u00edmicos,<\/strong> y <strong>intermedios no aislados.<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1432029104 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1757056615\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00a0\u00bfQui\u00e9n est\u00e1 obligado a informar en virtud de esta propuesta?<\/h4>\n\t<div id=\"gap-954811065\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-954811065 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los requisitos de presentaci\u00f3n de informes siguen aplic\u00e1ndose a <strong>Fabricantes e importadores activos entre 2011 y 2022. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1757056615 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-793745528\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfCu\u00e1ndo comienza el per\u00edodo de comentarios y cu\u00e1nto dura?<\/h4>\n\t<div id=\"gap-1579954653\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1579954653 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>A <strong>Per\u00edodo de comentarios p\u00fablicos de 45 d\u00edas<\/strong> comienza con la publicaci\u00f3n en el <strong>Registro Federal<\/strong> bajo expediente<strong> EPA-HQ-OPPT-2020-0549.<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-793745528 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1838505349\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfC\u00f3mo puede RegASK ayudar a las empresas a responder a estos cambios?<\/h4>\n\t<div id=\"gap-713236857\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-713236857 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> apoya a las empresas mediante el seguimiento de las actualizaciones regulatorias relacionadas con PFAS, el an\u00e1lisis de los impactos a nivel de material y proveedor, y permite una retroalimentaci\u00f3n estructurada y oportuna durante los per\u00edodos de comentarios p\u00fablicos utilizando inteligencia artificial agente y orientaci\u00f3n experta.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1838505349 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El 10 de noviembre de 2025, la Agencia de Protecci\u00f3n Ambiental de los Estados Unidos (EPA) propuso enmiendas a los requisitos de notificaci\u00f3n de PFAS (sustancias perfluoroalquiladas y polifluoroalquiladas) en virtud de la TSCA (Ley de Control de Sustancias T\u00f3xicas) para reducir los costos de cumplimiento, en particular para las peque\u00f1as empresas e importadores, al tiempo que se garantiza el acceso a datos esenciales sobre el uso y la seguridad de las PFAS.<\/p>","protected":false},"author":43,"featured_media":9326,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,47],"tags":[],"class_list":["post-9319","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-esg-horizon-scanning-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US EPA Proposes Amendments to PFAS Reporting Regulations<\/title>\n<meta name=\"description\" content=\"The US EPA proposes amendments to PFAS reporting regulations under TSCA to ease compliance for small businesses and importers.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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