{"id":2024,"date":"2026-04-30T20:22:41","date_gmt":"2026-04-30T20:22:41","guid":{"rendered":"https:\/\/link2america.us\/?page_id=2024"},"modified":"2026-04-30T20:27:32","modified_gmt":"2026-04-30T20:27:32","slug":"maquillaje-cosmeticos-usa-mocra","status":"publish","type":"page","link":"https:\/\/link2america.us\/es\/cosmetici-usa-mocra\/","title":{"rendered":"Registro de Cosm\u00e9ticos EE. UU. MoCRA | Cumplimiento de la FDA para Empresas Italianas"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Vender cosm\u00e9ticos en Estados Unidos es una gran oportunidad para las empresas italianas, pero requiere el cumplimiento de normativas precisas impuestas por la Food and Drug Administration.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Con la introducci\u00f3n del&nbsp;<strong>MoCRA (Ley de Modernizaci\u00f3n de la Regulaci\u00f3n de Cosm\u00e9ticos)<\/strong>, la regulaci\u00f3n se ha vuelto m\u00e1s rigurosa, haciendo obligatorio el registro de los establecimientos, el registro de productos (product listing) y el cumplimiento de nuevos requisitos de seguridad y etiquetado.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En esta gu\u00eda descubrir\u00e1s todo lo necesario para la&nbsp;<strong>registro de cosm\u00e9ticos en EE. UU.<\/strong>&nbsp;y c\u00f3mo podemos apoyarte en el proceso.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Qu\u00e9 es el MoCRA y por qu\u00e9 es fundamental para vender cosm\u00e9ticos en los EE. UU.<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u00c9l&nbsp;<strong>MoCRA<\/strong>&nbsp;es la reforma normativa m\u00e1s importante en el sector cosm\u00e9tico estadounidense de las \u00faltimas d\u00e9cadas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Esta normativa introduce obligaciones clave para todas las empresas que deseen comercializar productos cosm\u00e9ticos en Estados Unidos:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>registro de establecimientos cosm\u00e9ticos de la FDA<\/li>\n\n\n\n<li>listado de productos de cosm\u00e9tica<\/li>\n\n\n\n<li>adaptaci\u00f3n de etiquetas<\/li>\n\n\n\n<li>gestione eventos adversos<\/li>\n\n\n\n<li>controles m\u00e1s estrictos por parte de la FDA<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Las empresas que no cumplen con estas reglas se arriesgan a:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>bloqueo de importaciones<\/li>\n\n\n\n<li>retirada de los productos del mercado<\/li>\n\n\n\n<li>sanciones y cartas de advertencia<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Qui\u00e9n debe registrar los cosm\u00e9ticos en EE. UU.<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">El registro MoCRA es obligatorio para:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>fabricantes de cosm\u00e9ticos<\/li>\n\n\n\n<li>due\u00f1o de marca (incluso marca blanca)<\/li>\n\n\n\n<li>empresas que venden en Amazon EE. UU.<\/li>\n\n\n\n<li>distribuidores\/importadores<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udc49 Las empresas italianas tambi\u00e9n deben cumplir con estas obligaciones, incluso si producen en Europa.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Requisitos de la MoCRA: qu\u00e9 debes hacer para cumplir con la normativa<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Registro de establecimiento ante la FDA (Facility Registration)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Para vender cosm\u00e9ticos en EE. UU. es necesario:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>obtener un&nbsp;<strong>Identificador de establecimiento FEI (Facility Establishment Identifier)<\/strong><\/li>\n\n\n\n<li>Registrar\u00e9 el establecimiento en la FDA<\/li>\n\n\n\n<li>actualizar el registro cada 2 a\u00f1os<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">2. Listado de productos de cosm\u00e9tica<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Cada producto debe estar registrado en la FDA con:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ingredientes (INCI)<\/li>\n\n\n\n<li>categor\u00eda de producto<\/li>\n\n\n\n<li>datos de la empresa<\/li>\n\n\n\n<li>informaci\u00f3n sobre la Persona Responsable<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">3. Etiquetado conforme a la FDA<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Las etiquetas deben incluir:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>nombre del producto<\/li>\n\n\n\n<li>cantidad neta<\/li>\n\n\n\n<li>lista de ingredientes<\/li>\n\n\n\n<li>advertencias<\/li>\n\n\n\n<li>contactos para eventos adversos<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">4. Gestione eventi avversi<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Las empresas deben:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>supervisar\u00e9 la seguridad de los productos<\/li>\n\n\n\n<li>informar sobre eventos graves en un plazo de 15 d\u00edas<\/li>\n\n\n\n<li>mantener los registros actualizados<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">5. Agente de EE. UU. para empresas extranjeras<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Las empresas no estadounidenses deben nombrar a un&nbsp;<strong>Agente de EE. UU.<\/strong>, que act\u00faa como punto de contacto con la FDA.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Atenci\u00f3n: cuando un cosm\u00e9tico se convierte en medicamento (OTC)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Uno de los errores m\u00e1s comunes se refiere a la clasificaci\u00f3n del producto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Si un cosm\u00e9tico contiene:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FPS (protector solar)<\/li>\n\n\n\n<li>alegaciones terap\u00e9uticas<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">podr\u00eda ser clasificado como&nbsp;<strong>medicamento OTC<\/strong>, con requisitos mucho m\u00e1s complejos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udc49 Una evaluaci\u00f3n preliminar es fundamental.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Servicios de registro de cosm\u00e9ticos en EE. UU. (MoCRA)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Link2America apoya a las empresas italianas en la gesti\u00f3n completa del cumplimiento de la normativa de la FDA.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 An\u00e1lisis preliminar MoCRA<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>verificar productos y variantes<\/li>\n\n\n\n<li>clasificaci\u00f3n de cosm\u00e9tico frente a OTC<\/li>\n\n\n\n<li>identificaci\u00f3n de criticidad<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 Registro de establecimiento ante la FDA<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>solicitud FEI<\/li>\n\n\n\n<li>registro de instalaciones<\/li>\n\n\n\n<li>actualizaciones peri\u00f3dicas<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 Listado de productos cosm\u00e9ticos<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>registro de productos<\/li>\n\n\n\n<li>gestionar variantes<\/li>\n\n\n\n<li>soporte t\u00e9cnico<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 Servicio de agente en EE. UU.<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Apoyo en el nombramiento del agente estadounidense para empresas extranjeras.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 Soporte de Persona Responsable<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Asistencia en la gesti\u00f3n de obligaciones normativas.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 Revisi\u00f3n de etiquetas<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Verificaci\u00f3n preliminar de la conformidad con las normas de la FDA.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Por qu\u00e9 elegir Link2America<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Somos un socio operativo en los Estados Unidos para empresas italianas que desean entrar en el mercado estadounidense.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Te apoyamos con:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>experiencia directa en el mercado estadounidense<\/li>\n\n\n\n<li>enfoque pr\u00e1ctico y operativo<\/li>\n\n\n\n<li>red de profesionales locales<\/li>\n\n\n\n<li>asistencia en italiano e ingl\u00e9s<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center\">COMPLETA EL CUESTIONARIO<\/h2>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n            <div \n                class=\"elfsight-widget-contact-form elfsight-widget\" \n                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UU.<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00bfCu\u00e1nto cuesta registrar un cosm\u00e9tico en EE. UU.?<\/strong><br>Depende del n\u00famero de productos y de la complejidad del proyecto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00bfSiempre se necesita un agente de EE. UU.?<\/strong><br>S\u00ed, para las empresas no estadounidenses es obligatorio.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00bfCu\u00e1nto tiempo toma el registro?<\/strong><br>Depende de la integridad de los datos y del n\u00famero de productos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00bfPuedo vender en Amazon sin registrarme?<\/strong><br>No, el cumplimiento de las normativas es necesario para evitar bloqueos.<\/p>","protected":false},"excerpt":{"rendered":"<p>Vendere cosmetici negli Stati Uniti \u00e8 una grande opportunit\u00e0 per le aziende italiane, ma richiede il rispetto di precise normative imposte dalla&nbsp;Food and Drug Administration. Con l\u2019introduzione del&nbsp;MoCRA (Modernization of Cosmetics Regulation Act), la regolamentazione \u00e8 diventata pi\u00f9 rigorosa, rendendo obbligatoria la registrazione degli stabilimenti, il product listing e il rispetto di nuovi requisiti di [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2025,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-2024","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Registrazione Cosmetici USA MoCRA | FDA Compliance per Aziende Italiane - Link2America Consulenti Mercati USA e LATAM<\/title>\n<meta name=\"description\" content=\"Registrazione cosmetici USA secondo MoCRA: supporto FDA completo per aziende italiane. Facility registration, product listing, US Agent e compliance etichette. 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