{"id":49651,"date":"2024-04-17T11:19:41","date_gmt":"2024-04-17T09:19:41","guid":{"rendered":"https:\/\/biorius.com\/cosmetic-news\/nueva-normativa-cosmetica-sobre-la-vitamina-a-la-alfa-arbutina-la-arbutina-y-los-posibles-disruptores-endocrinos\/"},"modified":"2024-05-10T09:50:21","modified_gmt":"2024-05-10T07:50:21","slug":"nueva-normativa-cosmetica-sobre-la-vitamina-a-la-alfa-arbutina-la-arbutina-y-los-posibles-disruptores-endocrinos","status":"publish","type":"post","link":"https:\/\/biorius.com\/es\/cosmetic-news\/nueva-normativa-cosmetica-sobre-la-vitamina-a-la-alfa-arbutina-la-arbutina-y-los-posibles-disruptores-endocrinos\/","title":{"rendered":"Nueva normativa cosm\u00e9tica sobre la vitamina A, la alfa-arbutina, la arbutina y los posibles disruptores endocrinos"},"content":{"rendered":"\n<h4 class=\"wp-block-heading\"><strong>Carta<a href=\"https:\/\/biorius.com\/es\/cosmetic-news\/alfa-arbutina-retinol-vitamina-a-acido-kojico-nuevo-proyecto-de-reglamento\/\" target=\"_blank\" rel=\"noreferrer noopener\">Informativa<\/a> BIORIUS 127<a href=\"https:\/\/biorius.com\/es\/cosmetic-news\/alfa-arbutina-retinol-vitamina-a-acido-kojico-nuevo-proyecto-de-reglamento\/\" target=\"_blank\" rel=\"noreferrer noopener\">(continuaci\u00f3n de la Carta Informativa 117<\/a>):<\/strong><\/h4>\n\n<h4 class=\"wp-block-heading mb-0 pb-0 mt-0 pt-0\"><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2024\/996\/oj\" target=\"_blank\" rel=\"noreferrer noopener\">Reglamento (UE) 2024\/996<\/a> de la Comisi\u00f3n, relativo al uso de vitamina A, alfa-arbutina, arbutina y determinadas sustancias con posibles propiedades de alteraci\u00f3n endocrina.<\/h4>\n\n<p>El<sup>4 de<\/sup> abril se public\u00f3 en el Diario Oficial de la UE el Reglamento (UE) 2024\/996 de la Comisi\u00f3n, por el que se modifica el Reglamento 1223\/2009 de la UE sobre cosm\u00e9ticos.<\/p>\n\n<p>Este Reglamento modifica los anexos del Reglamento 1223\/2009 de la UE sobre cosm\u00e9ticos, para alinearlos con los dict\u00e1menes del Comit\u00e9 Cient\u00edfico de Seguridad de los Consumidores (CCSC), para las siguientes sustancias:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>4-Metilbencilideno Alcanfor<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/bc7fc1c9-9a5e-4f7c-a67f-a03b4dea312b_en?filename=sccs_o_262.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">(SCCS\/1640\/21<\/a>) <em>\u21e8<\/em> Prohibido<\/li>\n\n\n\n<li>Geniste\u00edna, Daidze\u00edna (<a href=\"https:\/\/health.ec.europa.eu\/publications\/genistein-and-daidzein_en\" target=\"_blank\" rel=\"noreferrer noopener\">SCCS\/1641\/22<\/a>), \u00c1cido k\u00f3jico<a href=\"https:\/\/health.ec.europa.eu\/publications\/kojic-acid_en\" target=\"_blank\" rel=\"noreferrer noopener\">(SCCS\/1637\/21<\/a>), Arbutina, Alfa-arbutina<a href=\"https:\/\/health.ec.europa.eu\/publications\/safety-alpha-arbutin-and-beta-arbutin-cosmetic-products_en\" target=\"_blank\" rel=\"noreferrer noopener\">(SCCS\/1642\/22<\/a>), Retinol, Acetato de retinilo y Palmitato<a href=\"https:\/\/health.ec.europa.eu\/publications\/revision-scientific-opinion-sccs157616-vitamin-retinol-retinyl-acetate-retinyl-palmitate_en\" target=\"_blank\" rel=\"noreferrer noopener\">(SCCS\/1639\/21)<\/a> <em>\u21e8<\/em> Nuevas restricciones<\/li>\n\n\n\n<li>Triclos\u00e1n y Triclocarb\u00e1n<a href=\"https:\/\/health.ec.europa.eu\/publications\/safety-triclocarban-and-triclosan-substances-potential-endocrine-disrupting-properties-cosmetic_en\" target=\"_blank\" rel=\"noreferrer noopener\">(SCCS\/1643\/22<\/a>) <em>\u21e8<\/em> Restricciones actualizadas\/adicionales<\/li>\n<\/ul>\n\n<p class=\"is-style-info\">En comparaci\u00f3n con nuestra Carta informativa 117, los plazos de aplicaci\u00f3n se han desplazado debido al retraso en la publicaci\u00f3n del reglamento, y la advertencia sobre el retinol, el acetato de retinol y el palmitato se ha reformulado ligeramente en <em>&#8220;<strong>Contiene vitamina A. Considera tu ingesta diaria antes de usar<\/strong>&#8220;.<\/em><\/p>\n\n<p>Las nuevas restricciones de este reglamento (UE) 2024\/996 se detallan y comparan con la situaci\u00f3n anterior, en los siguientes anexos:<\/p>\n\n<h4 class=\"wp-block-heading\">Adici\u00f3n al Anexo II &#8211; Sustancias prohibidas:<\/h4>\n\n<figure class=\"wp-block-table alignwide\"><table><tbody><tr><td><strong><em>Denominaci\u00f3n INCI<\/em><\/strong><\/td><td><strong><em>N\u00famero CAS<\/em><\/strong><\/td><td><strong><em>Restricci\u00f3n futura<\/em><\/strong><\/td><td><strong><em>Situaci\u00f3n actual<\/em><\/strong><\/td><\/tr><tr><td><strong>4-METILBENCILIDENO ALCANFOR<\/strong><\/td><td>36861-47-9 \/ 38102-62-4<\/td><td><strong>Prohibido<\/strong><\/td><td>Permitido como filtro UV al 4% (Anexo VI\/18)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h4 class=\"wp-block-heading\">Adici\u00f3n al Anexo III &#8211; Sustancias permitidas en determinadas condiciones:<\/h4>\n\n<figure class=\"wp-block-table alignwide\"><table><tbody><tr><td><em>\n  <strong>I<\/strong>\n<\/em><strong>\n  <em>Nombre NCI<\/em>\n<\/strong><\/td><td><strong><em>N\u00famero CAS<\/em><\/strong><\/td><td><strong><em>Restricci\u00f3n futura<\/em><\/strong><\/td><td><strong><em>Situaci\u00f3n actual<\/em><\/strong><\/td><\/tr><tr><td><strong>GENISTEIN<\/strong><\/td><td>446-72-0<\/td><td><strong>M\u00e1x. 0.007%<\/strong><\/td><td>No regulado<\/td><\/tr><tr><td><strong>DAIDZEIN<\/strong><\/td><td>486-66-8<\/td><td><strong>M\u00e1x. 0.02%<\/strong><\/td><td>No regulado<\/td><\/tr><tr><td><strong>\u00c1CIDO KOJICO<\/strong><\/td><td>501-30-4<\/td><td><strong>M\u00e1x. 1% s\u00f3lo en productos para la cara y las manos<\/strong><\/td><td>No regulado<\/td><\/tr><tr><td><strong>ALFA-ARBUTINA<\/strong> *<\/td><td>84380-01-8<\/td><td><strong>Crema facial m\u00e1x. 2%<br\/>Loci\u00f3n corporal m\u00e1x. 0.5%<\/strong><\/td><td>No regulado<\/td><\/tr><tr><td><strong>ARBUTINA <\/strong>*<\/td><td>497-76-7<\/td><td><strong>M\u00e1x. 7% s\u00f3lo en crema facial<\/strong><\/td><td>No regulado<\/td><\/tr><tr><td><strong>RETINOL RETINIL ACETATO RETINIL PALMITATO<\/strong><\/td><td>11103-57-4 \/ 68-26-8 127-47-9 79-81-2   <\/td><td>&#8211;  <strong>Loci\u00f3n corporal: m\u00e1x. 0,05% Equivalente de Retinol (RE)<\/strong><br\/>&#8211;  <strong>Otros productos sin aclarado ni enjuague: m\u00e1x. 0,3% RE<br\/>Etiquetado obligatorio para cualquier producto cosm\u00e9tico que contenga uno de estos ingredientes: <em>Contiene vitamina A. Considera tu ingesta diaria antes de utilizarlo&#8221;.<\/em><\/strong><\/td><td>No regulado<\/td><\/tr><\/tbody><\/table><\/figure>\n\n<p>*Los niveles de hidroquinona se mantendr\u00e1n lo m\u00e1s bajos posible en las f\u00f3rmulas que contengan este ingrediente y no ser\u00e1n superiores al nivel de trazas inevitable.<\/p>\n\n<div style=\"height:29px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h4 class=\"wp-block-heading\">Modificaci\u00f3n del Anexo V &#8211; Conservantes permitidos:<\/h4>\n\n<figure class=\"wp-block-table alignwide\"><table><tbody><tr><td><strong><em>Denominaci\u00f3n INCI<\/em><\/strong><\/td><td><strong><em>N\u00famero CAS<\/em><\/strong><\/td><td><strong><em>Restricci\u00f3n futura<\/em><\/strong><\/td><td><strong><em>Situaci\u00f3n actual<\/em><\/strong><\/td><\/tr><tr><td><strong>TRICLOCARBAN<\/strong><\/td><td>101-20-2<\/td><td><strong>M\u00e1x. 0,2% en todos los productos cosm\u00e9ticos, salvo el enjuague bucal.<\/strong>  Criterios de pureza:<br\/>3,3\u2032,4,4\u2032-<br\/>Tetracloroazobenceno \u2264 1 ppm 3,3\u2032,4,4\u2032-<br\/>Tetracloroazoxibenceno \u2264 1 ppm<br\/><strong>No debe utilizarse en dent\u00edfricos destinados a ni\u00f1os menores de 6 a\u00f1os.<\/strong> <strong>Etiquetado obligatorio de las pastas dent\u00edfricas que contienen Triclocarb\u00e1n: <em>&#8220;No utilizar en ni\u00f1os menores de 6 a\u00f1os&#8221;.<\/em><\/strong><br\/>Para usos distintos del de conservante, v\u00e9ase el Anexo III\/100.<\/td><td>M\u00e1x. 1,5% en productos que se aclaran. Criterios de pureza:<br\/>3,3\u2032,4,4\u2032-Tetracloroazobenceno \u2264 1 ppm<br\/>3,3\u2032,4,4\u2032-Tetracloroazoxibenceno \u2264 1 ppm. Para fines distintos de la inhibici\u00f3n del desarrollo de microorganismos en el producto. Esta finalidad tiene que quedar patente en la presentaci\u00f3n del producto. Para usos distintos del de conservante, v\u00e9ase el Anexo III\/100 (Anexo V\/23)<\/td><\/tr><tr><td><strong>TRICLOSAN<\/strong><\/td><td>3380-34-5<\/td><td><strong>M\u00e1x. 0,3% en dent\u00edfricos; jabones de manos; jabones corporales\/geles de ducha; desodorantes (sin aerosol); polvos faciales y correctores de manchas; producto de u\u00f1as para limpiar las u\u00f1as de manos y pies antes de la aplicaci\u00f3n de sistemas de u\u00f1as artificiales.<\/strong><br\/><strong>No utilizar en dent\u00edfricos destinados a ni\u00f1os menores de 3 a\u00f1os.  <\/strong><br\/><strong>Etiquetado obligatorio de los dent\u00edfricos que contienen Triclos\u00e1n: <em>&#8220;No utilizar en ni\u00f1os menores de 3 a\u00f1os&#8221;.<\/em><\/strong><\/td><td>M\u00e1x. 0,3% en dent\u00edfricos; jabones de manos; jabones corporales\/geles de ducha; desodorantes (sin aerosol); polvos faciales y correctores de manchas; producto de u\u00f1as para limpiar las u\u00f1as de manos y pies antes de la aplicaci\u00f3n de sistemas de u\u00f1as artificiales.<br\/>M\u00e1x. 0,2% en colutorios (Anexo V\/23)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n<div style=\"height:24px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading\">Periodos transitorios<\/h3>\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Prohibici\u00f3n del alcanfor 4-metilbencilideno:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Los productos comercializados en la UE deber\u00e1n cumplir esta normativa a partir<sup>del 1 de<\/sup> mayo de 2025.<\/li>\n\n\n\n<li>Los productos que no cumplan esta normativa deber\u00e1n haber sido retirados del mercado de la UE a m\u00e1s tardar el<sup>1 de<\/sup> mayo de 2026.<\/li>\n<\/ul>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Restricciones de geniste\u00edna, daidze\u00edna, \u00e1cido k\u00f3jico, alfa-arbutina y arbutina:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Los productos comercializados en la UE deber\u00e1n cumplir esta normativa a partir<sup>del 1 de<\/sup> febrero de 2025.<\/li>\n\n\n\n<li>Los productos que no cumplan esta normativa deber\u00e1n haber sido retirados del mercado de la UE a m\u00e1s tardar el<sup>1 de<\/sup> noviembre de 2025.<\/li>\n<\/ul>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Restricciones de Retinol, Acetato de Retinilo y Palmitato de Retinilo:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Los productos comercializados en la UE deber\u00e1n cumplir esta normativa a partir<sup>del 1 de<\/sup> noviembre de 2025.<\/li>\n\n\n\n<li>Los productos que no cumplan esta normativa deber\u00e1n haber sido retirados del mercado de la UE a m\u00e1s tardar el<sup>1 de<\/sup> mayo de 2027.<\/li>\n<\/ul>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Nuevas restricciones del Triclos\u00e1n y el Triclocarb\u00e1n utilizados como conservantes:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Los productos que cumplan la antigua restricci\u00f3n sobre el Triclos\u00e1n\/Triclocarb\u00e1n pueden comercializarse en la UE hasta<sup>el 31 de<\/sup> diciembre de 2024.<\/li>\n\n\n\n<li>Los productos que cumplan la antigua restricci\u00f3n sobre el Triclos\u00e1n\/Triclocarb\u00e1n pueden ponerse a disposici\u00f3n del consumidor hasta<sup>el 31 de<\/sup> octubre de 2025, siempre que se hayan comercializado antes del<sup>31<\/sup> de diciembre de 2024. Despu\u00e9s del<sup>31 de<\/sup> octubre de 2025, los productos que no cumplan esta nueva restricci\u00f3n deber\u00e1n haber sido retirados del mercado de la UE.<\/li>\n<\/ul>\n\n<div style=\"height:33px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Esperamos que te sea de ayuda y quedamos a tu disposici\u00f3n para cualquier duda relacionada con este tema. 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