{"id":49663,"date":"2024-04-17T11:19:41","date_gmt":"2024-04-17T09:19:41","guid":{"rendered":"https:\/\/biorius.com\/cosmetic-news\/nuovo-regolamento-cosmetico-su-vitamina-a-alfa-arbutina-arbutina-e-potenziali-interferenti-endocrini\/"},"modified":"2024-05-10T09:50:22","modified_gmt":"2024-05-10T07:50:22","slug":"nuovo-regolamento-cosmetico-su-vitamina-a-alfa-arbutina-arbutina-e-potenziali-interferenti-endocrini","status":"publish","type":"post","link":"https:\/\/biorius.com\/it\/cosmetic-news\/nuovo-regolamento-cosmetico-su-vitamina-a-alfa-arbutina-arbutina-e-potenziali-interferenti-endocrini\/","title":{"rendered":"Nuovo regolamento cosmetico su Vitamina A, Alfa-Arbutina, Arbutina e potenziali interferenti endocrini"},"content":{"rendered":"\n<h4 class=\"wp-block-heading\"><strong>Lettera informativa 127 di BIORIUS<a href=\"https:\/\/biorius.com\/it\/cosmetic-news\/alfa-arbutina-retinolo-vitamina-a-acido-kojico-nuova-bozza-di-regolamento\/\" target=\"_blank\" rel=\"noreferrer noopener\">(seguito della Lettera 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\">Regolamento (UE) 2024\/996 della Commissione<\/a>, relativo all&#8217;uso di vitamina A, alfa-arbutina, arbutina e alcune sostanze con potenziali propriet\u00e0 di interferenza endocrina.<\/h4>\n\n<p>Il Regolamento (UE) 2024\/996 della Commissione, che modifica il Regolamento UE sui cosmetici 1223\/2009, \u00e8 stato pubblicato sulla Gazzetta Ufficiale dell&#8217;UE il<sup>4<\/sup> aprile.<\/p>\n\n<p>Questo regolamento modifica gli allegati del Regolamento cosmetico UE 1223\/2009, per allinearli ai pareri del Comitato scientifico per la sicurezza dei consumatori (CSSC), per le seguenti sostanze:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>4-Metilbenzilidene Canfora<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> Vietato<\/li>\n\n\n\n<li>Genisteina, daidzeina<a href=\"https:\/\/health.ec.europa.eu\/publications\/genistein-and-daidzein_en\" target=\"_blank\" rel=\"noreferrer noopener\">(SCCS\/1641\/22<\/a>), acido kojico<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>), retinolo, acetato di retinile e 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> Nuove restrizioni<\/li>\n\n\n\n<li>Triclosan e Triclocarban<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> Restrizioni aggiornate\/aggiuntive<\/li>\n<\/ul>\n\n<p class=\"is-style-info\">Rispetto alla nostra Lettera Informativa 117, i termini di attuazione sono stati spostati a causa del ritardo nella pubblicazione del regolamento, e l&#8217;avvertenza sul Retinolo, l&#8217;Acetato di Retinolo e il Palmitato \u00e8 stata leggermente riformulata in <em>&#8220;<strong>Contiene Vitamina A. Considerare l&#8217;assunzione giornaliera prima dell&#8217;uso<\/strong>&#8220;<\/em>.<\/p>\n\n<p>Le nuove restrizioni previste da questo regolamento (UE) 2024\/996 sono dettagliate e confrontate con la situazione precedente nei seguenti allegati:<\/p>\n\n<h4 class=\"wp-block-heading\">Aggiunta all&#8217;Allegato II &#8211; Sostanze vietate:<\/h4>\n\n<figure class=\"wp-block-table alignwide\"><table><tbody><tr><td><strong><em>Nome INCI<\/em><\/strong><\/td><td><strong><em>Numero CAS<\/em><\/strong><\/td><td><strong><em>Restrizione futura<\/em><\/strong><\/td><td><strong><em>Situazione attuale<\/em><\/strong><\/td><\/tr><tr><td><strong>4-METILBENZILIDENE CANFORA<\/strong><\/td><td>36861-47-9 \/ 38102-62-4<\/td><td><strong>Vietato<\/strong><\/td><td>Ammesso come filtro UV al 4% (Allegato 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\">Aggiunta all&#8217;Allegato III &#8211; Sostanze consentite in determinate condizioni:<\/h4>\n\n<figure class=\"wp-block-table alignwide\"><table><tbody><tr><td><em>\n  <strong>I<\/strong>\n<\/em><strong>\n  <em>Nome NCI<\/em>\n<\/strong><\/td><td><strong><em>Numero CAS<\/em><\/strong><\/td><td><strong><em>Restrizione futura<\/em><\/strong><\/td><td><strong><em>Situazione attuale<\/em><\/strong><\/td><\/tr><tr><td><strong>GENISTEIN<\/strong><\/td><td>446-72-0<\/td><td><strong>Max. 0.007%<\/strong><\/td><td>Non regolamentato<\/td><\/tr><tr><td><strong>DAIDZEIN<\/strong><\/td><td>486-66-8<\/td><td><strong>Max. 0.02%<\/strong><\/td><td>Non regolamentato<\/td><\/tr><tr><td><strong>ACIDO KOJICO<\/strong><\/td><td>501-30-4<\/td><td><strong>Max. 1% solo nei prodotti per il viso e le mani<\/strong><\/td><td>Non regolamentato<\/td><\/tr><tr><td><strong>ALFA-ARBUTINA<\/strong> *<\/td><td>84380-01-8<\/td><td><strong>Crema viso max. 2%<br\/>Lozione per il corpo max. 0.5%<\/strong><\/td><td>Non regolamentato<\/td><\/tr><tr><td><strong>ARBUTINO <\/strong>*<\/td><td>497-76-7<\/td><td><strong>Max. 7% solo nella crema viso<\/strong><\/td><td>Non regolamentato<\/td><\/tr><tr><td><strong>RETINOLO ACETATO DI RETINILE PALMITATO DI RETINILE<\/strong><\/td><td>11103-57-4 \/ 68-26-8 127-47-9 79-81-2   <\/td><td>&#8211;  <strong>Lozione per il corpo: max. 0,05% Retinolo Equivalente (RE)<\/strong><br\/>&#8211;  <strong>Altri prodotti leave-on e a risciacquo: max. 0,3% RE<br\/>Etichettatura obbligatoria per qualsiasi prodotto cosmetico contenente uno di questi ingredienti: <em>&#8216;Contiene vitamina A. Considerare l&#8217;assunzione giornaliera prima dell&#8217;uso&#8217;.<\/em><\/strong><\/td><td>Non regolamentato<\/td><\/tr><\/tbody><\/table><\/figure>\n\n<p>*I livelli di idrochinone devono rimanere il pi\u00f9 bassi possibile nelle formulazioni contenenti questo ingrediente e non devono essere superiori al livello di traccia inevitabile.<\/p>\n\n<div style=\"height:29px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h4 class=\"wp-block-heading\">Modifica dell&#8217;Allegato V &#8211; Conservanti consentiti:<\/h4>\n\n<figure class=\"wp-block-table alignwide\"><table><tbody><tr><td><strong><em>Nome INCI<\/em><\/strong><\/td><td><strong><em>Numero CAS<\/em><\/strong><\/td><td><strong><em>Restrizione futura<\/em><\/strong><\/td><td><strong><em>Situazione attuale<\/em><\/strong><\/td><\/tr><tr><td><strong>TRICLOCARBANO<\/strong><\/td><td>101-20-2<\/td><td><strong>Max. 0,2% in tutti i prodotti cosmetici ad eccezione dei collutori.<\/strong>  Criteri di purezza:<br\/>3,3\u2032,4,4\u2032-<br\/>Tetracloroazobenzene \u2264 1 ppm 3,3\u2032,4,4\u2032-<br\/>Tetracloroazoxybenzene \u2264 1 ppm<br\/><strong>Non deve essere utilizzato nei dentifrici destinati ai bambini di et\u00e0 inferiore ai 6 anni.<\/strong> <strong>Etichettatura obbligatoria per i dentifrici contenenti Triclocarban: <em>&#8220;Da non utilizzare per i bambini di et\u00e0 inferiore ai 6 anni&#8221;.<\/em><\/strong><br\/>Per gli usi diversi da quello di conservante, vedi l&#8217;Allegato III\/100.<\/td><td>Max. 1,5% nei prodotti a risciacquo. Criteri di purezza:<br\/>3,3\u2032,4,4\u2032-Tetracloroazobenzene \u2264 1 ppm<br\/>3,3\u2032,4,4\u2032-Tetracloroazoxybenzene \u2264 1 ppm. Per scopi diversi dall&#8217;inibizione dello sviluppo di microrganismi nel prodotto. Questo scopo deve essere evidente fin dalla presentazione del prodotto. Per gli usi diversi da quello di conservante, vedi Allegato III\/100 (Allegato V\/23)<\/td><\/tr><tr><td><strong>TRICLOSAN<\/strong><\/td><td>3380-34-5<\/td><td><strong>Max. 0,3% in dentifrici; saponi per le mani; saponi per il corpo\/gel doccia; deodoranti (non spray); polveri per il viso e correttori di imperfezioni; prodotti per le unghie per la pulizia delle unghie di mani e piedi prima dell&#8217;applicazione di sistemi di unghie artificiali.<\/strong><br\/><strong>Non deve essere utilizzato nei dentifrici destinati ai bambini di et\u00e0 inferiore ai 3 anni.  <\/strong><br\/><strong>Etichetta obbligatoria per i dentifrici contenenti Triclosan: <em>&#8220;Da non utilizzare per i bambini di et\u00e0 inferiore ai 3 anni&#8221;.<\/em><\/strong><\/td><td>Max. 0,3% in dentifrici; saponi per le mani; saponi per il corpo\/gel doccia; deodoranti (non spray); polveri per il viso e correttori di imperfezioni; prodotti per le unghie per la pulizia delle unghie di mani e piedi prima dell&#8217;applicazione di sistemi di unghie artificiali.<br\/>Max. 0,2% in collutori (Allegato 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\">Periodi di transizione<\/h3>\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Interdizione della canfora di 4-metilbenzilidene:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>I prodotti immessi sul mercato dell&#8217;UE dovranno essere conformi a questo regolamento a partire dal<sup>1\u00b0<\/sup> maggio 2025.<\/li>\n\n\n\n<li>I prodotti non conformi a questo regolamento dovranno essere ritirati dal mercato dell&#8217;UE entro il<sup>1\u00b0<\/sup> maggio 2026.<\/li>\n<\/ul>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Limitazioni di Genisteina, Daidzeina, Acido Kojico, Alfa-Arbutina e Arbutina:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>I prodotti immessi sul mercato dell&#8217;UE dovranno essere conformi a questo regolamento a partire dal<sup>1\u00b0<\/sup> febbraio 2025.<\/li>\n\n\n\n<li>I prodotti non conformi a questo regolamento dovranno essere ritirati dal mercato dell&#8217;UE entro il<sup>1\u00b0<\/sup> novembre 2025.<\/li>\n<\/ul>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Restrizioni di Retinolo, Retinil Acetato e Retinil Palmitato:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>I prodotti immessi sul mercato dell&#8217;UE dovranno essere conformi a questo regolamento a partire dal<sup>1\u00b0<\/sup> novembre 2025.<\/li>\n\n\n\n<li>I prodotti non conformi a questo regolamento dovranno essere ritirati dal mercato dell&#8217;UE entro il<sup>1\u00b0<\/sup> maggio 2027.<\/li>\n<\/ul>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Nuove restrizioni per il Triclosan e il Triclocarban utilizzati come conservanti:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>I prodotti conformi alle precedenti restrizioni sul Triclosan\/Triclocarban possono essere immessi sul mercato dell&#8217;UE fino al<sup>31<\/sup> dicembre 2024.<\/li>\n\n\n\n<li>I prodotti conformi alle precedenti restrizioni sul Triclosan\/Triclocarban possono essere messi a disposizione dei consumatori fino al<sup>31<\/sup> ottobre 2025, a condizione che siano stati immessi sul mercato prima del<sup>31<\/sup> dicembre 2024. Dopo il<sup>31<\/sup> ottobre 2025, i prodotti non conformi a questa nuova restrizione dovranno essere ritirati dal mercato dell&#8217;UE.<\/li>\n<\/ul>\n\n<div style=\"height:33px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Ci auguriamo che questo possa essere d&#8217;aiuto e restiamo a tua disposizione per qualsiasi domanda relativa a questo argomento. Per qualsiasi domanda, non esitare a contattare il tuo Customer Relationship Manager dedicato.<\/p>\n<script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\nvar gform;gform||(document.addEventListener(\"gform_main_scripts_loaded\",function(){gform.scriptsLoaded=!0}),document.addEventListener(\"gform\/theme\/scripts_loaded\",function(){gform.themeScriptsLoaded=!0}),window.addEventListener(\"DOMContentLoaded\",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,themeScriptsLoaded:!1,isFormEditor:()=>\"function\"==typeof InitializeEditor,callIfLoaded:function(o){return!(!gform.domLoaded||!gform.scriptsLoaded||!gform.themeScriptsLoaded&&!gform.isFormEditor()||(gform.isFormEditor()&&console.warn(\"The use of gform.initializeOnLoaded() is deprecated in the form editor context and will be removed in Gravity Forms 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