{"id":5132,"date":"2018-10-04T10:59:27","date_gmt":"2018-10-04T08:59:27","guid":{"rendered":"https:\/\/cosmeservice.com\/1107-2\/"},"modified":"2025-11-04T14:15:45","modified_gmt":"2025-11-04T12:15:45","slug":"parabenos-en-cosmetica-2025","status":"publish","type":"post","link":"https:\/\/cosmeservice.com\/es\/noticias\/parabenos-en-cosmetica-2025\/","title":{"rendered":"Parabenos en cosm\u00e9ticos: seguridad y regulaci\u00f3n vigente"},"content":{"rendered":"<h2>\u00bfQu\u00e9 son los parabenos y por qu\u00e9 se utilizan?<\/h2>\n\n\n<p class=\"wp-block-paragraph\">Los parabenos son \u00e9steres del \u00e1cido 4-hidroxibenzoico que se emplean como conservantes para mantener los cosm\u00e9ticos seguros a nivel microbiol\u00f3gico. Son eficaces en un amplio rango de pH, tienen un coste reducido y suelen combinarse entre s\u00ed para lograr una protecci\u00f3n antimicrobiana m\u00e1s amplia.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00bfQu\u00e9 parabenos est\u00e1n prohibidos en la Uni\u00f3n Europea?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La Uni\u00f3n Europea proh\u00edbe el uso de cinco parabenos debido a la falta de datos de seguridad suficientes. Estos son <strong>isopropylparaben<\/strong>, <strong>isobutylparaben<\/strong>, <strong>phenylparaben<\/strong>, <strong>benzylparaben<\/strong> y <strong>pentylparaben<\/strong>, incluidos en el Anexo II del Reglamento 1223\/2009.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Concentraciones m\u00e1ximas permitidas en la UE y el Reino Unido<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Seg\u00fan el Anexo V del <strong><a href=\"https:\/\/cosmeservice.com\/es\/servicios\/regulacion-europea\/\">Reglamento de Cosm\u00e9ticos de la UE<\/a><\/strong> y la normativa equivalente del Reino Unido (Great Britain Cosmetic Products Enforcement Regulations), se aplican los siguientes l\u00edmites. Estos valores se mantienen vigentes en 2025.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 <strong>Methylparaben<\/strong> y <strong>Ethylparaben<\/strong>: hasta un 0,4 por ciento cada uno, con un total combinado m\u00e1ximo del 0,8 por ciento cuando se usan juntos.<br>\u2022 <strong>Propylparaben<\/strong> y <strong>Butylparaben<\/strong>: hasta un 0,14 por ciento.<br>\u2022 La mezcla total de todos los parabenos permitidos no puede superar el 0,8 por ciento.<br>\u2022 <strong>Propylparaben<\/strong> y <strong>Butylparaben<\/strong> no est\u00e1n permitidos en productos de aplicaci\u00f3n sin aclarado destinados a la zona del pa\u00f1al en ni\u00f1os menores de tres a\u00f1os.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><sub>Nota: El l\u00edmite global del 0,8 por ciento sigue aplic\u00e1ndose a cualquier combinaci\u00f3n de parabenos autorizados.<\/sub><\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Opiniones cient\u00edficas a considerar en la UE y el Reino Unido<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Las autoridades reguladoras revisan peri\u00f3dicamente la seguridad de los conservantes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Para <strong>Propylparaben<\/strong>, el SCCS confirma su seguridad en el l\u00edmite actual del 0,14 por ciento.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Para <strong>Butylparaben<\/strong>, el SCCS mantiene un enfoque prudente y eval\u00faa la exposici\u00f3n agregada. Cualquier modificaci\u00f3n futura del Anexo V requerir\u00eda un nuevo reglamento antes de ser jur\u00eddicamente vinculante.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Estados Unidos: posici\u00f3n de la FDA y del CIR<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">En Estados Unidos, los parabenos no est\u00e1n sujetos a l\u00edmites legales espec\u00edficos. La FDA permite su uso siempre que el producto sea seguro en condiciones normales. El Cosmetic Ingredient Review Expert Panel ha concluido repetidamente que los parabenos son seguros en los usos cosm\u00e9ticos actuales. Bajo MoCRA, las marcas deben garantizar la seguridad fundamentada y mantener la documentaci\u00f3n correspondiente, pero no existen restricciones espec\u00edficas para parabenos.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Canad\u00e1: \u00bfCu\u00e1l es la situaci\u00f3n de los parabenos?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">En Canad\u00e1, los parabenos est\u00e1n permitidos en cosm\u00e9ticos. No existe ninguna entrada espec\u00edfica sobre parabenos en la <strong>Cosmetic Ingredient Hotlist<\/strong> seg\u00fan las actualizaciones de 2025. Los fabricantes deben garantizar la seguridad general del producto conforme al <strong>Food and Drugs Act<\/strong> y a las <strong><a href=\"https:\/\/cosmeservice.com\/es\/servicios\/regulacion-cosmetica-de-canada\/\">Cosmetic Regulations<\/a><\/strong>. Conviene seguir monitorizando, ya que Canad\u00e1 actualiza la Hotlist de forma peri\u00f3dica.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Evaluaciones de riesgo y posibles medidas futuras en Canad\u00e1<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Health Canada <strong>complet\u00f3 una evaluaci\u00f3n preliminar<\/strong> del Grupo de Parabenos en 2020 y public\u00f3 un <strong>documento de alcance de gesti\u00f3n<\/strong> de riesgos que contemplaba posibles acciones si se confirmaban preocupaciones, como considerar la inclusi\u00f3n de ciertos parabenos en el <strong>CEPA Schedule 1<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Una actualizaci\u00f3n informativa del gobierno en 2023 reiter\u00f3 estas conclusiones preliminares y la posibilidad de controles futuros. <strong>No son restricciones aplicadas en la Hotlist<\/strong>, pero indican vigilancia activa.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Implicaciones pr\u00e1cticas para el etiquetado y los claims en Canad\u00e1<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Los parabenos permitidos pueden utilizarse sin aparecer en la Hotlist, siempre que el producto sea seguro y est\u00e9 debidamente notificado.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se recomienda evitar denigrar ingredientes legales en los claims \u201cfree from\u201d. Deben alinearse con las gu\u00edas canadienses sobre publicidad cosm\u00e9tica.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00bfLos parabenos son disruptores endocrinos o est\u00e1n relacionados con el c\u00e1ncer?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Las preocupaciones se originaron en un estudio de 2004 que detect\u00f3 parabenos en tejido mamario, aunque dicho estudio no estableci\u00f3 ninguna relaci\u00f3n causal. Desde entonces, diversas evaluaciones del SCCS, la FDA y el CIR no han confirmado riesgos de c\u00e1ncer ni de disrupci\u00f3n endocrina dentro de los l\u00edmites autorizados. Las autoridades siguen revisando nuevos datos para garantizar la protecci\u00f3n del consumidor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Claims \u201cparaben free\u201d: consideraciones regulatorias<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Los \u201cfree from\u201d claims est\u00e1n permitidos cuando son veraces, no inducen a error y no denigran ingredientes permitidos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Recomendaciones para su uso:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 Asegurar que la f\u00f3rmula est\u00e1 realmente libre de los parabenos mencionados.<br>\u2022 Evitar implicar que los ingredientes permitidos son inseguros.<br>\u2022 Sustentar el claim con evidencia clara y alinearlo con los principios de los Criterios Comunes de la UE y con las gu\u00edas nacionales del mercado objetivo.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00bfNecesitas ayuda para revisar tu f\u00f3rmula o actualizar tu CPSR, PIF o claims?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Nuestro equipo regulatorio puede evaluar tu sistema conservante y garantizar la conformidad en la UE, Reino Unido, Estados Unidos y Canad\u00e1. Contacta con <strong><a>info@cosmeservice.com<\/a><\/strong> para recibir asesoramiento experto.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Referencias<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/ALL\/?uri=celex%3A32009R1223\">EU Regulation 1223 2009 and Annex V updates.<br><\/a><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32014R1004\">Commission Regulations 358 2014 and 1004 2014 on parabens.<\/a><br><a href=\"https:\/\/ec.europa.eu\/health\/scientific_committees\/consumer_safety\/docs\/sccs_o_132.pdf\">SCCS opinions on propylparaben and butylparaben.<\/a><br><a href=\"https:\/\/www.cir-safety.org\/sites\/default\/files\/paraben_web.pdf\">FDA information on parabens and CIR safety assessments.<\/a><br><a href=\"https:\/\/www.canada.ca\/en\/environment-climate-change\/services\/evaluating-existing-substances\/draft-screening-assessment-parabens-group.html\">Health Canada Cosmetic Ingredient Hotlist and Parabens Group draft assessment<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00bfQu\u00e9 son los parabenos y por qu\u00e9 se utilizan? Los parabenos son \u00e9steres del \u00e1cido 4-hidroxibenzoico que se emplean como conservantes para mantener los cosm\u00e9ticos seguros a nivel microbiol\u00f3gico. Son eficaces en un amplio rango de pH, tienen un coste reducido y suelen combinarse entre s\u00ed para lograr una protecci\u00f3n antimicrobiana m\u00e1s amplia. \u00bfQu\u00e9 parabenos [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":36451,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAowjay7DA:productID":"","_joinchat":[],"footnotes":""},"categories":[364],"tags":[439,476,482,481,428,441,381,433,477],"class_list":["post-5132","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias","tag-cosmetica-es","tag-cosmetrade-es-2","tag-parabenos-es","tag-parabens-es","tag-product-safety-es","tag-regulacion-es","tag-regulatory-ko-es","tag-seguridad-cosmetica-es","tag-skin-care-es"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Parabenos en cosm\u00e9tica: regulaci\u00f3n en 2025 | Cosmeservice<\/title>\n<meta name=\"description\" content=\"\u00bfSon seguros los parabenos en cosm\u00e9tica? 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