{"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-291042220\">\n\n\t<div id=\"col-641982284\" 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-1272335927\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1272335927 {\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-641982284 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2125033277\" 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-31384414\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-31384414 {\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-2125033277 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-712233936\" 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-492233543\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-492233543 {\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-712233936 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-869966865\" 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-536844710\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-536844710 {\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-869966865 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1035470826\" 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-129531704\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-129531704 {\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-1035470826 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-554209165\" 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-992067013\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-992067013 {\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-554209165 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1723121484\" 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-654598195\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-654598195 {\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-1723121484 > .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-930220590\">\n\n\t<div id=\"col-84589823\" 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-1997874264\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1997874264 {\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-388524304\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-388524304 {\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-84589823 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1277594113\" 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-2122848911\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2122848911 {\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-1277594113 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1096837957\" 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-889803958\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-889803958 {\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-1096837957 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-354071599\" 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-98021491\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-98021491 {\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-354071599 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 10 November 2025, the U.S. Environmental Protection Agency (EPA) proposed amendments to PFAS (perfluoroalkyl and polyfluoroalkyl substances) reporting requirements under TSCA (Toxic Substances Control Act) to reduce compliance costs, particularly for small businesses and importers, while ensuring access to essential PFAS use and safety data.<\/p>","protected":false},"author":41,"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 v27.3 (Yoast SEO v27.4) - 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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