{"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-27365165\">\n\n\t<div id=\"col-1480093408\" 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-166765216\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-166765216 {\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-1480093408 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-526372440\" 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-1558719008\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1558719008 {\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-526372440 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1935730782\" 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-1504990755\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1504990755 {\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-1935730782 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1139585095\" 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-996254903\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-996254903 {\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-1139585095 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-302648651\" 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-1396901434\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1396901434 {\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-302648651 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1651405417\" 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-1110555828\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1110555828 {\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-1651405417 > .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-2095774601\">\n\n\t<div id=\"col-439886628\" 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-711149834\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-711149834 {\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-1081221336\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1081221336 {\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-439886628 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-797012585\" 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-33710050\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-33710050 {\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-797012585 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1324445415\" 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-1186989387\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1186989387 {\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-1324445415 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1859985862\" 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-1241278675\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1241278675 {\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-1859985862 > .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 3 de noviembre de 2025, la Agencia Nacional de Vigilancia Sanitaria (ANVISA) emiti\u00f3 una actualizaci\u00f3n reglamentaria que modifica el Anexo de la RDC 529\/2021 para incluir dos sustancias recientemente prohibidas utilizadas en productos de higiene personal, cosm\u00e9ticos y perfumes. Este cambio afecta directamente a los fabricantes, importadores y distribuidores que operan en el mercado brasile\u00f1o de cosm\u00e9ticos, ya que todas las actividades relacionadas con estas sustancias\u2026<\/p>","protected":false},"author":43,"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 v28.5 (Yoast SEO v28.6) - 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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