{"id":49377,"date":"2022-03-03T00:00:00","date_gmt":"2022-03-02T23:00:00","guid":{"rendered":"https:\/\/biorius.com\/cosmetic-news\/reglamento-omnibus-v-y-recordatorio-omnibus-iv\/"},"modified":"2024-05-08T11:39:05","modified_gmt":"2024-05-08T09:39:05","slug":"reglamento-omnibus-v-y-recordatorio-omnibus-iv","status":"publish","type":"post","link":"https:\/\/biorius.com\/es\/cosmetic-news\/reglamento-omnibus-v-y-recordatorio-omnibus-iv\/","title":{"rendered":"Reglamento Omnibus V y Recordatorio Omnibus IV"},"content":{"rendered":"\n<p>Siguiendo con el <a href=\"https:\/\/mcusercontent.com\/d3d80b99002742cef41679506\/files\/d96bed97-856f-49fd-be7c-19ca69224f2d\/Biorius_IL_085_Omnibus_IV_Regulation_.pdf\">art\u00edculo Omnibus IV<\/a>, te recordamos que <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32021R1902&amp;from=EN\">el Reglamento (UE) 2021\/1902 de la Comisi\u00f3n<\/a>, el llamado Reglamento Omnibus IV, entra en vigor el<sup>1<\/sup> de marzo de 2022. As\u00ed pues, a partir de ahora, s\u00f3lo podr\u00e1n comercializarse y estar disponibles en el mercado los productos conformes.<\/p>\n\n<p>Debe organizarse una retirada del mercado de los productos no conformes, si no se ha hecho ya.<\/p>\n\n<p>Sin embargo, hay una excepci\u00f3n: El HIDROXIMETILGLICINATO DE SODIO (CAS 70161-44-3) no estar\u00e1 prohibido seg\u00fan lo previsto en este reglamento. De hecho, se ha a\u00f1adido err\u00f3neamente en el anexo II, la lista de ingredientes prohibidos. Su clasificaci\u00f3n como carcin\u00f3geno de categor\u00eda 1B s\u00f3lo es aplicable si no puede demostrarse que la concentraci\u00f3n te\u00f3rica m\u00e1xima de formaldeh\u00eddo liberable, independientemente de la fuente, en la mezcla tal como se comercializa es inferior al 0,1%. Por lo tanto, el HIDROXIMETILGLICINATO S\u00d3DICO se mantendr\u00e1 en la entrada 51 del anexo V como conservante permitido en las condiciones que se indican a continuaci\u00f3n:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Concentraci\u00f3n m\u00e1xima del 0,5%.<\/li>\n\n\n\n<li>No debe utilizarse si no puede demostrarse que la concentraci\u00f3n te\u00f3rica m\u00e1xima de formaldeh\u00eddo liberable, independientemente de la fuente, en la mezcla tal como se comercializa es \u22640,1% en peso.<\/li>\n<\/ul>\n\n<p>Esta correcci\u00f3n se establece en el pr\u00f3ximo Reglamento \u00d3mnibus V.<\/p>\n\n<p>El proyecto de Reglamento \u00d3mnibus V ha sido notificado a la Organizaci\u00f3n Mundial del Comercio (OMC), con una fecha prevista de adopci\u00f3n durante el<sup>3er<\/sup> trimestre de 2022 y una fecha de aplicaci\u00f3n el 17 de diciembre de 2022.<\/p>\n\n<p>Adem\u00e1s de la correcci\u00f3n relativa al HIDROXIMETILGLICINATO DE SODIO, este Reglamento \u00d3mnibus V tambi\u00e9n incluye la prohibici\u00f3n de 14 sustancias clasificadas como CMR por el ATP 17 del CLP (en anexo), y la restricci\u00f3n del SALICILATO DE METILO. De hecho, el CCSC concluy\u00f3 en su dictamen de octubre de 2021<a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2021-11\/sccs_o_255_0.pdf\">(SCCS\/1633\/21<\/a>) que el SALICILATO DE METILO puede considerarse seguro en los productos cosm\u00e9ticos hasta las concentraciones m\u00e1ximas evaluadas. As\u00ed, en el anexo III se a\u00f1adir\u00e1 SALICILATO DE METILO, que podr\u00eda utilizarse en las condiciones que se indican a continuaci\u00f3n:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Productos sin aclarado para la piel (excepto maquillaje facial, loci\u00f3n corporal en spray\/aerosol, desodorante en spray\/aerosol y fragancias de base hidroalcoh\u00f3lica) y productos sin aclarado para el cabello (excepto productos en spray\/aerosol): M\u00e1ximo 0,06%.<\/li>\n\n\n\n<li>Maquillaje facial (excepto productos labiales, maquillaje de ojos y desmaquillante): M\u00e1ximo 0,05%.<\/li>\n\n\n\n<li>Desmaquillante de ojos y desmaquillante: M\u00e1ximo 0,002%.<\/li>\n\n\n\n<li>Producto capilar sin aclarado (spray\/aerosol): M\u00e1ximo 0,009%.<\/li>\n\n\n\n<li>Desodorante en spray\/aerosol: M\u00e1ximo 0,003<\/li>\n\n\n\n<li>Loci\u00f3n corporal en spray\/aerosol: M\u00e1ximo 0,04%.<\/li>\n\n\n\n<li>Productos para la piel que se aclaran (excepto jab\u00f3n de manos y productos capilares que se aclaran): M\u00e1ximo 0,06%.<\/li>\n\n\n\n<li>Lavado a mano: 0,6%.<\/li>\n\n\n\n<li>Fragancias de base hidroalcoh\u00f3lica: M\u00e1ximo 0,6%.<\/li>\n\n\n\n<li>Productos labiales: M\u00e1ximo 0,03%.<\/li>\n\n\n\n<li>Pasta dent\u00edfrica: M\u00e1ximo 2,52<\/li>\n\n\n\n<li>Enjuague bucal destinado a ni\u00f1os de 6 a 10 a\u00f1os: M\u00e1ximo 0,1%<\/li>\n\n\n\n<li>Enjuague bucal destinado a ni\u00f1os mayores de 10 a\u00f1os y adultos: M\u00e1ximo 0,6%.<\/li>\n\n\n\n<li>Pulverizador bucal: M\u00e1ximo 0,65%.<\/li>\n<\/ul>\n\n<p>Adem\u00e1s, no puede utilizarse en preparados para ni\u00f1os menores de 6 a\u00f1os.<\/p>\n\n<p>Si BIORIUS es tu<a href=\"https:\/\/biorius.com\/cosmetics-compliance\/emea\/europe\/european-union\/responsible-person\/\"> Responsable<\/a>, no dudes en <a href=\"https:\/\/biorius.com\/contact\/\">ponerte en contacto con<\/a> tu CRM<strong>(<\/strong> <strong>Gestor de<\/strong> <strong>Relaciones con<\/strong><strong>el Cliente<\/strong>) dedicado para obtener m\u00e1s explicaciones.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Siguiendo con el art\u00edculo Omnibus IV, te recordamos que el Reglamento (UE) 2021\/1902 de la Comisi\u00f3n, el llamado Reglamento Omnibus IV, entra en vigor el1&#8230;<\/p>\n","protected":false},"author":2,"featured_media":46706,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"categories":[2292],"tags":[],"ppma_author":[2340],"class_list":["post-49377","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-reglamento-cosmeticos","author-nicolas-lenaersbiorius-com"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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