{"id":30134,"date":"2023-02-22T11:56:43","date_gmt":"2023-02-22T11:56:43","guid":{"rendered":"https:\/\/cosmewax.camsec.es\/mocra-el-mayor-cambio-de-regulacion-cosmetica-en-us\/"},"modified":"2023-02-22T12:12:32","modified_gmt":"2023-02-22T12:12:32","slug":"mocra-el-mayor-cambio-de-regulacion-cosmetica-en-us","status":"publish","type":"post","link":"https:\/\/cosmewax.camsec.es\/es?p=30134","title":{"rendered":"MoCRA – EL mayor cambio en la regulaci\u00f3n cosm\u00e9tica de US"},"content":{"rendered":"\t\t
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El 29 de diciembre de 2022, el presidente Biden promulg\u00f3 la Ley de Asignaciones Consolidadas de 2023.<\/span><\/span>\n\n<\/span><\/span>La modernizaci\u00f3n de la Regulaci\u00f3n Cosm\u00e9tica.<\/span><\/span> Act, \u201cMoCRA\u201d, es la primera actualizaci\u00f3n importante de las autoridades de cosm\u00e9ticos de la FDA desde 1938 e introduce cambios significativos.<\/span><\/span><\/span><\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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MoCRA - Disposiciones clave<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Sec. 605 Efecto adverso <\/b><\/p>

Los efectos adversos causados por el uso del producto deben ser informados a la FDA en 15 d\u00edas.<\/span><\/span> Adem\u00e1s, los registros deben conservarse durante 6 a\u00f1os.<\/span><\/span><\/span><\/p>

Sec. 606 Good <\/b>Manufacturing<\/b> Practice<\/b><\/p>

La FDA finalizar\u00e1 sus est\u00e1ndares GMP para alinearlos con los internacionales.<\/span><\/span> Se espera que est\u00e9 terminado en 2025.<\/span><\/span><\/span><\/p>

Sec. 607\u00a0<\/b>Registro obligatorio de instalaciones y listado de productos<\/span><\/span><\/span><\/strong><\/p>

Las instalaciones deben registrarse dentro de un a\u00f1o de la promulgaci\u00f3n de MoCRA y deben renovarse cada 2 a\u00f1os.<\/span><\/span> Los responsables deben registrar los productos que colocan en el mercado incluyendo el lugar de fabricaci\u00f3n, contacto, etc. Este registro puede incluir m\u00faltiples productos cosm\u00e9ticos con formulaciones id\u00e9nticas, o formulaciones que se diferencien \u00fanicamente en cuanto a colores, fragancias o contenido.<\/span><\/span> Este registro debe realizarse antes de diciembre de 2023 para los que ya est\u00e9n en el mercado, o 120 d\u00edas para nuevos lanzamientos.<\/span><\/span><\/span><\/p>

\u00a0<\/p>

Sec. 608: Justificaci\u00f3n de seguridad<\/span><\/span><\/span>
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Una persona responsable debe garantizar y mantener registros que respalden que existe una justificaci\u00f3n adecuada de la seguridad del producto cosm\u00e9tico.<\/span><\/span> Las empresas deber\u00e1n mantener registros para garantizar la seguridad de los productos.
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Sec.<\/b> 609 <\/b>Etiquetado<\/b><\/p>

MoCRA required the FDA to determine by regulation which fragrance allergens must be disclosed in cosmetic label. Cosmetic lable will be required to identify every fragrance allergen in a product. The labeling requirement will take effect at the end of 2024.<\/p>

Sec. 3505 <\/b>Talc<\/b><\/p>

MoCRA requiri\u00f3 que la FDA determinara por regulaci\u00f3n qu\u00e9 al\u00e9rgenos de fragancias deben divulgarse en la etiqueta del cosm\u00e9tico.<\/span><\/span> Se requerir\u00e1 una etiqueta cosm\u00e9tica para identificar cada al\u00e9rgeno de fragancia en los productos.<\/span><\/span> Este requisito en eletiquetado entrar\u00e1 en vigor a finales de 2024.<\/span><\/span><\/span><\/p>

Sec. 3506 <\/b>PFAs<\/b><\/p>

MoCRA requiere que la FDA emita un informe p\u00fablico, a m\u00e1s tardar tres a\u00f1os despu\u00e9s de la promulgaci\u00f3n de MoCRA, para evaluar el uso de sustancias de perfluoroalquilo y polifluoroalquilo (PFAS) en productos cosm\u00e9ticos.<\/span><\/span><\/span><\/p>

Sec. 3209 y 3507 <\/b>Pruebas en animales<\/span><\/span><\/span><\/strong><\/p>

La necesidad de la experimentaci\u00f3n con animales para garantizar la seguridad de los cosm\u00e9ticos debe eliminarse gradualmente, con la excepci\u00f3n de las asignaciones adecuadas.<\/span><\/span> Por el momento, no existe una prohibici\u00f3n oficial de la experimentaci\u00f3n con animales.<\/span><\/span><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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CALENDARIO<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Link, page 1389: https:\/\/www.congress.gov\/117\/bills\/hr2617\/BILLS-117hr2617enr.pdf<\/u><\/a><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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En Cosmewax somos expertos en regulaci\u00f3n cosm\u00e9tica<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Cosmewax asesora a sus clientes para aplicar la legislaci\u00f3n cosm\u00e9tica de sus mercados, desarrollar la documentaci\u00f3n requerida e implementar las pruebas de calidad necesarias.<\/span><\/span><\/span><\/span><\/span><\/span><\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

ASESORAMIENTO SOBRE LA NORMATIVA APLICABLE<\/h6><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

Nuestros expertos en regulaci\u00f3n<\/a> cumplen con los requisitos de packaging y las regulaciones internacionales con respecto a los ingredientes aplicables a su territorio de ventas.<\/span><\/span> Adem\u00e1s, nuestros expertos monitorean constantemente los cambios en las regulaciones y adaptan sus recomendaciones en consecuencia, informando a nuestros clientes de inmediato para que est\u00e9n actualizados.<\/span><\/span><\/span>
<\/span><\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

El 29 de diciembre de 2022, el presidente Biden promulg\u00f3 la Ley de Asignaciones Consolidadas de 2023. La modernizaci\u00f3n de la Regulaci\u00f3n Cosm\u00e9tica. Act, \u201cMoCRA\u201d, es la primera actualizaci\u00f3n importante de las autoridades de cosm\u00e9ticos de la FDA desde 1938 e introduce cambios significativos. MoCRA – Disposiciones clave Sec. 605 Efecto adverso Los efectos adversos causados por el uso del…<\/p>\n","protected":false},"author":11,"featured_media":30123,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_eb_attr":"","_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[788,113],"tags":[789,551,790],"class_list":["post-30134","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulacion-cosmetica-es","category-sobre-el-sector","tag-fda-es","tag-legislacion-cosmetica","tag-regulacion-cosmetica-es"],"yoast_head":"\nMoCRA - EL mayor cambio en la regulaci\u00f3n cosm\u00e9tica de US<\/title>\n<meta name=\"description\" content=\"La modernizaci\u00f3n de Regulaci\u00f3n Cosm\u00e9tica Act, Mocra, es la mayor actualizaci\u00f3n de las autoridades cosm\u00e9ticas de la FDA desde 1938.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"MoCRA - 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