{"id":5475,"date":"2025-08-02T08:47:20","date_gmt":"2025-08-02T13:47:20","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=5475"},"modified":"2026-01-27T13:18:20","modified_gmt":"2026-01-27T18:18:20","slug":"decision-944-cosmetic-products","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/decision-944-cosmetic-products\/","title":{"rendered":"La Decisi\u00f3n 944 y su impacto en la armonizaci\u00f3n normativa de productos cosm\u00e9ticos en la Comunidad Andina"},"content":{"rendered":"<p class=\"translation-block\">El 24 de junio de 2025, la Comisi\u00f3n de la Comunidad Andina (CAN) aprob\u00f3 la <strong>Decisi\u00f3n N.\u00ba 944,<\/strong> una modificatoria clave de la <strong>Decisi\u00f3n 833,<\/strong> con el objetivo de actualizar y optimizar el marco normativo comunitario aplicable a los <strong>productos cosm\u00e9ticos.<\/strong> Esta norma busca mejorar la armonizaci\u00f3n legislativa entre los pa\u00edses miembros de la CAN (Bolivia, Colombia, Ecuador y Per\u00fa), considerando avances tecnol\u00f3gicos, pr\u00e1cticas regulatorias modernas y la necesidad de reducir cargas innecesarias en los tr\u00e1mites sanitarios.<\/p>\n<p><b>Cambios normativos relevantes<\/b><\/p>\n<p><b>Enfoque general y objetivo normativo<\/b><\/p>\n<p class=\"translation-block\">La Decisi\u00f3n 944 no solo ratifica los principios de armonizaci\u00f3n establecidos en la Decisi\u00f3n 833 \u2014relativos a la producci\u00f3n, almacenamiento, importaci\u00f3n, comercializaci\u00f3n, control de calidad y vigilancia sanitaria de productos cosm\u00e9ticos\u2014 sino que adem\u00e1s introduce un enfoque m\u00e1s moderno y flexible. Esto se refleja en la simplificaci\u00f3n de requisitos y en una mayor claridad t\u00e9cnica para la presentaci\u00f3n de solicitudes de Notificaci\u00f3n Sanitaria Obligatoria (NSO).<\/p>\n<p><b>Sustituci\u00f3n del Art\u00edculo 9: Notificaci\u00f3n Sanitaria Obligatoria<\/b><\/p>\n<p class=\"translation-block\">Uno de los cambios m\u00e1s relevantes es la <strong>modificaci\u00f3n integral del art\u00edculo 9, <\/strong>referido al procedimiento de presentaci\u00f3n de la NSO. La Decisi\u00f3n 944 establece nuevas exigencias t\u00e9cnicas para sustentar adecuadamente la informaci\u00f3n del producto cosm\u00e9tico. Entre ellas destacan:<\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\" class=\"translation-block\">Inclusi\u00f3n de la <strong>denominaci\u00f3n gen\u00e9rica<\/strong> del producto cosm\u00e9tico.<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" class=\"translation-block\">Detalle de la <strong>presentaci\u00f3n comercial.<\/strong><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" class=\"translation-block\">Presentaci\u00f3n de la <strong>f\u00f3rmula cuantitativa,<\/strong> especialmente en caso de ingredientes restringidos y el uso de <strong>nanomateriales.<\/strong><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" class=\"translation-block\">Presentaci\u00f3n de la <strong>f\u00f3rmula cuantitativa,<\/strong> especialmente en caso de ingredientes restringidos y el uso de <strong>nanomateriales.<\/strong><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" class=\"translation-block\"><strong>Instrucciones de uso<\/strong> m\u00e1s precisas.<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Descripci\u00f3n del <strong>envase primario y secundario.<\/strong> <\/span><b>primary and secondary packaging<\/b><span style=\"font-weight: 400;\">.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Permiso para presentar la documentaci\u00f3n en su idioma original, salvo disposici\u00f3n contraria de la autoridad nacional competente.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Este nuevo enfoque estandariza la calidad de la informaci\u00f3n presentada por los titulares de productos cosm\u00e9ticos, elevando el nivel t\u00e9cnico de las evaluaciones sanitarias.<\/span><\/p>\n<p><b>Eliminaci\u00f3n de la obligatoriedad de traducci\u00f3n al espa\u00f1ol<\/b><\/p>\n<p><span style=\"font-weight: 400;\">La Decisi\u00f3n 944 elimina expresamente la obligaci\u00f3n de traducir al espa\u00f1ol la informaci\u00f3n t\u00e9cnica y general del producto, a menos que la autoridad nacional as\u00ed lo requiera. Esta medida permite reducir costos operativos y acortar los tiempos de procesamiento, lo que facilita el comercio intracomunitario sin menoscabar la evaluaci\u00f3n t\u00e9cnica.<\/span><\/p>\n<p><b>Vigencia Inmediata<\/b><\/p>\n<p class=\"translation-block\">La norma <strong>entr\u00f3 en vigor el mismo d\u00eda de su publicaci\u00f3n,<\/strong> es decir, el 24 de junio de 2025. A partir de esa fecha, toda solicitud de NSO y cualquier tr\u00e1mite relacionado con productos cosm\u00e9ticos en el \u00e1mbito de la Comunidad Andina deben cumplir con las disposiciones establecidas en la Decisi\u00f3n 944.<\/p>\n<p><b>Consideraciones finales<\/b><\/p>\n<p><span style=\"font-weight: 400;\">La publicaci\u00f3n de la Decisi\u00f3n 944 representa una evoluci\u00f3n significativa en la regulaci\u00f3n comunitaria de productos cosm\u00e9ticos. Al modernizar y simplificar los requisitos, esta modificatoria promueve un entorno regulatorio m\u00e1s eficiente, predecible y alineado con est\u00e1ndares internacionales. Para los titulares de productos cosm\u00e9ticos y sus representantes, resulta fundamental revisar y adecuar sus estrategias de registro sanitario conforme a este nuevo marco legal.<\/span><\/p>\n<p class=\"translation-block\"><strong>Elaborado por:<\/strong><br>\n<\/span><i><span style=\"font-weight: 400\">\nCarolina N\u00fa\u00f1ez \u2013 Consultora Asociada de Aseguramiento de la Calidad e Inteligencia Regulatoria<\/span><\/i><\/p>","protected":false},"excerpt":{"rendered":"<p>On June 24, 2025, the Commission of the Andean Community (CAN) approved Decision No. 944, a key amendment to Decision 833, aimed at updating and optimizing the regional regulatory framework for cosmetic products. This decision strengthens legislative harmonization among CAN member countries (Bolivia, Colombia, Ecuador, and Peru) by incorporating technological advances, modern regulatory practices, and [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":5483,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,81],"tags":[],"class_list":["post-5475","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-cosmetics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Decision 944: Andean Community Cosmetic Products Regulation<\/title>\n<meta name=\"description\" content=\"Decision 944 updates the Andean Community framework for cosmetic products, strengthening harmonization across Bolivia, Colombia, Ecuador and Peru while reducing administrative burdens.\" 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