{"id":9267,"date":"2025-11-26T17:39:14","date_gmt":"2025-11-26T09:39:14","guid":{"rendered":"https:\/\/regask.com\/?p=9267"},"modified":"2025-11-26T17:40:59","modified_gmt":"2025-11-26T09:40:59","slug":"la-agencia-nacional-de-vigilancia-sanitaria-anvisa-de-brasil-prohibe-dos-sustancias-en-productos-cosmeticos-de-higiene-personal-y-perfumes","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/brazils-anvisa-prohibits-two-substances-in-cosmetics-personal-hygiene-products-and-perfumes\/","title":{"rendered":"ANVISA de Brasil proh\u00edbe dos sustancias en cosm\u00e9ticos\u2026"},"content":{"rendered":"<p>El 3 de noviembre de 2025, el <strong><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/english\">Agencia Nacional de Vigilancia Sanitaria (ANVISA)<\/a><\/strong> emiti\u00f3 una actualizaci\u00f3n regulatoria modificando el Anexo de <strong>RDC 529\/2021<\/strong> Incluye dos sustancias recientemente prohibidas en productos de higiene personal, cosm\u00e9ticos y perfumes. El cambio afecta directamente a fabricantes, importadores y distribuidores que operan en el mercado brasile\u00f1o de cosm\u00e9ticos, ya que todas las actividades relacionadas con estas sustancias estar\u00e1n restringidas a partir de principios de 2026.<\/p>\n<div class=\"row\"  id=\"row-892644023\">\n\n\t<div id=\"col-346693441\" 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 la actualizaci\u00f3n<\/h3>\n\t<div id=\"gap-1171770764\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1171770764 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>ANVISA ha a\u00f1adido formalmente <strong>\u00d3xido de difenil(2,4,6-trimetilbenzol)fosfina (CAS 75980-60-8)<\/strong> y <strong>N,N-dimetil-p-toluidina (CAS 99-97-8)<\/strong> a la lista nacional de ingredientes prohibidos. Desde <strong>1 de febrero de 2026,<\/strong> Se prohibir\u00e1 la fabricaci\u00f3n, importaci\u00f3n, registro, comercializaci\u00f3n y uso de cualquier producto que contenga estas sustancias. ANVISA cancelar\u00e1 los registros de los productos asociados despu\u00e9s de esta fecha, exigiendo a las empresas que retiren del mercado brasile\u00f1o los productos restantes que no cumplan con las normas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-346693441 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1407417831\" 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>Detalles de la Actualizaci\u00f3n Regulatoria<\/h3>\n\t<div id=\"gap-456291451\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-456291451 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La enmienda a <strong>RDC 529\/2021<\/strong> Se introducen dos sustancias prohibidas adicionales en el Anexo reglamentario. Una vez que la resoluci\u00f3n entre en vigor, no se permitir\u00e1 en Brasil ninguna formulaci\u00f3n nueva o existente que contenga estos ingredientes. Las empresas deben suspender la fabricaci\u00f3n o importaci\u00f3n de los productos afectados y tramitar las correspondientes cancelaciones de registro. Tras la fecha l\u00edmite, no se permitir\u00e1 la comercializaci\u00f3n ni el uso de los productos restantes que contengan estas sustancias.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1407417831 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1717142050\" 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 de cumplimiento<\/h3>\n\t<div id=\"gap-1175999259\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1175999259 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>1 de febrero de 2026\u00a0<\/strong><\/p>\n<p>Esta fecha marca el inicio de la aplicaci\u00f3n total, que abarca las prohibiciones de fabricaci\u00f3n, las restricciones a la importaci\u00f3n, las cancelaciones de registros y la prohibici\u00f3n de comercializar o utilizar los productos afectados.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1717142050 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1503369332\" 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-1171414616\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1171414616 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n fortalece la supervisi\u00f3n de la seguridad de los ingredientes en el sector cosm\u00e9tico brasile\u00f1o y alinea las expectativas regulatorias con la evoluci\u00f3n de los est\u00e1ndares de seguridad de los productos. Proporciona claridad a los fabricantes y reduce la presencia de sustancias potencialmente peligrosas en la cadena de suministro, a la vez que garantiza un cronograma de cumplimiento estructurado sin imponer cargas innecesarias.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1503369332 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-266030277\" 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>\u00bfQui\u00e9n se ve afectado?<\/h3>\n\t<div id=\"gap-72767131\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-72767131 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para los equipos de asuntos regulatorios, funciones de calidad y cumplimiento, unidades de desarrollo de productos, fabricantes, importadores y distribuidores que tratan con <strong>productos de higiene personal, cosm\u00e9ticos y perfumes<\/strong> Destinado al mercado brasile\u00f1o.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-266030277 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1552748657\" 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-253958235\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-253958235 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las partes interesadas deben revisar todas las formulaciones actuales para confirmar la presencia de las sustancias recientemente prohibidas e iniciar la reformulaci\u00f3n o la suspensi\u00f3n de la producci\u00f3n cuando sea necesario. Las empresas deben preparar el retiro de productos del mercado para aquellos productos que no cumplen con las normas y asegurarse de que toda la documentaci\u00f3n relacionada se actualice con suficiente antelaci\u00f3n a la fecha de entrada en vigor. A medida que las organizaciones se preparan para cumplir con los nuevos requisitos de ANVISA, el aprovechamiento de la inteligencia regulatoria estructurada puede facilitar una planificaci\u00f3n del cumplimiento m\u00e1s r\u00e1pida y reducir el riesgo operativo.<\/p>\n<p><a href=\"https:\/\/regask.com\/es\/\">RegASK&#039;\u2019<\/a>Las capacidades de monitoreo impulsadas por IA e inteligencia regulatoria pueden ayudar a las organizaciones a rastrear cambios a nivel de ingredientes, evaluar el impacto en el cumplimiento y coordinar acciones espec\u00edficas del mercado de manera eficiente. <strong><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> es un l\u00edder <strong>Plataforma de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con inteligencia artificial de Agentic<\/strong> que permite a las organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar la IA avanzada de Agentic 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.<\/p>\n<p><strong><a href=\"https:\/\/regask.com\/es\/producto\/\">M\u00e1s informaci\u00f3n<\/a> o <\/strong><a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong>Reserve una demostraci\u00f3n ahora.<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1552748657 > .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-618735823\">\n\n\t<div id=\"col-1351374689\" 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-1737766632\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1737766632 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW8821953 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW8821953 BCX0\"> \u00bfQu\u00e9 sustancias a\u00f1adi\u00f3 ANVISA a la lista prohibida?<\/span><\/span><\/h4>\n\t<div id=\"gap-370018734\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-370018734 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>ANVISA agreg\u00f3 <strong>\u00d3xido de difenil(2,4,6-trimetilbenzol)fosfina (CAS 75980-60-8)<\/strong> y <strong>N,N-dimetil-p-toluidina (CAS 99-97-8)<\/strong> a la lista de sustancias prohibidas para cosm\u00e9ticos, productos de higiene personal y perfumes.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1351374689 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1116825807\" 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><span class=\"TextRun MacChromeBold SCXW87280065 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW87280065 BCX0\">\u00bfCuando entra en vigor la prohibici\u00f3n?<\/span><\/span><\/h4>\n\t<div id=\"gap-265469916\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-265469916 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW156553360 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW156553360 BCX0\">Las restricciones comienzan el\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW156553360 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW156553360 BCX0\">1 de febrero de 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW156553360 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW156553360 BCX0\"><strong>,<\/strong> cubriendo la fabricaci\u00f3n, importaci\u00f3n, registro, comercializaci\u00f3n y uso de los productos afectados.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1116825807 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1325463454\" 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>\u00bfQu\u00e9 pasa con los registros de productos existentes que contienen estas sustancias?<\/h4>\n\t<div id=\"gap-1282703595\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1282703595 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>ANVISA cancelar\u00e1 los registros de productos no conformes despu\u00e9s del 1 de febrero de 2026, y las empresas deber\u00e1n retirar del mercado los art\u00edculos restantes.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1325463454 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-767696838\" 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 pueden las empresas prepararse para estos cambios regulatorios y gestionar el cumplimiento de manera eficiente?<\/h4>\n\t<div id=\"gap-880851443\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-880851443 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Mediante la revisi\u00f3n de formulaciones, la planificaci\u00f3n de reformulaciones, la gesti\u00f3n de retiros de productos y el uso de herramientas de inteligencia regulatoria como <a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> monitorear las prohibiciones de ingredientes y alinear los flujos de trabajo de cumplimiento con los requisitos de ANVISA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-767696838 > .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 November 3, 2025, the National Health Surveillance Agency (ANVISA) issued a regulatory update amending the Annex of RDC 529\/2021 to include two newly prohibited substances used in personal hygiene products, cosmetics, and perfumes. The change directly impacts manufacturers, importers, and distributors operating in the Brazilian cosmetics market, as all activities involving these substances will&#8230;<\/p>","protected":false},"author":41,"featured_media":9271,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[37,33,512],"tags":[],"class_list":["post-9267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-personal-care-cosmetics","category-news","category-brazil-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Brazil\u2019s ANVISA Prohibits Two Substances in Cosmetics<\/title>\n<meta name=\"description\" content=\"ANVISA has prohibited two substances in cosmetics. 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