{"id":44381,"date":"2022-12-19T00:00:00","date_gmt":"2022-12-18T23:00:00","guid":{"rendered":"https:\/\/biorius.com\/2022\/12\/19\/dioxyde-de-titane-et-classification-cmr\/"},"modified":"2024-01-19T15:24:43","modified_gmt":"2024-01-19T14:24:43","slug":"dioxyde-de-titane-et-classification-cmr","status":"publish","type":"post","link":"https:\/\/biorius.com\/fr\/cosmetic-news\/dioxyde-de-titane-et-classification-cmr\/","title":{"rendered":"Dioxyde de Titane et classification CMR"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Le Dioxyde de Titane (TiO2) sous forme de certaines poudres n\u2019est plus consid\u00e9r\u00e9 comme une substance canc\u00e9rog\u00e8ne par inhalation en Union Europ\u00e9enne<\/h2>\n\n\n\n<p><strong>La Cour de justice de l\u2019Union europ\u00e9enne (CJUE) vient d\u2019annoncer l\u2019annulation du <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/FR\/TXT\/?uri=celex%3A32008R1272\">r\u00e8glement CLP<\/a> (r\u00e8glement 2020\/217) dit ATP14 \u00ab en ce qu\u2019il concerne la classification et l\u2019\u00e9tiquetage harmonis\u00e9s du dioxyde de titane en tant que substance canc\u00e9rog\u00e8ne par inhalation sous certaines formes de poudre&#8221;<\/strong>. Quel est le contexte et comment l\u2019industrie doit-elle r\u00e9agir&nbsp;?<\/p>\n\n\n\n<p>Pour rappel, le r\u00e8glement CLP ou relatif \u00e0 la classification, \u00e0 l\u2019\u00e9tiquetage et \u00e0 l\u2019emballage des substances et m\u00e9langes s\u2019applique aux <a href=\"https:\/\/biorius.com\/fr\/autres-services\/produits-generaux\/\">produits g\u00e9n\u00e9raux<\/a> ou aux <a href=\"https:\/\/biorius.com\/fr\/services-de-conformite-au-reglement-detergents\/\">d\u00e9tergents<\/a> par exemple.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/european-union-1-e1623942728668.png\" alt=\"\" class=\"wp-image-13034\"\/><\/figure>\n<\/div>\n\n\n<h3 class=\"wp-block-heading\">1) Le dioxyde de titane en cosm\u00e9tiques, produits g\u00e9n\u00e9raux et d\u00e9tergents<\/h3>\n\n\n\n<p>Aussi appel\u00e9 TiO2, le dioxyde de titane est un compos\u00e9 min\u00e9ral existant \u00e0 l\u2019\u00e9tat naturel ou fabriqu\u00e9 industriellement. Il peut \u00eatre utilis\u00e9 en peinture, en tant que pigment blanc et opacifiant.<\/p>\n\n\n\n<p>Son nom cosm\u00e9tique INCI europ\u00e9en est titanium dioxyde ou CI77891. Sa forme de poudre blanche le place en ingr\u00e9dient de choix en formulation de cosm\u00e9tiques, principalement en protection solaire, maquillage et produits de couleur blanche. En effet, sa couleur blanche in\u00e9gal\u00e9e est utile en tant que pigment, opacifiant et filtre UV min\u00e9ral gr\u00e2ce \u00e0 ses propri\u00e9t\u00e9s de r\u00e9flexion des UVB (moindre mesure UVA).<\/p>\n\n\n\n<p>Le dioxyde de titane est autoris\u00e9 en cosm\u00e9tiques et est rependu dans la branche <a href=\"https:\/\/biorius.com\/fr\/non-categorizzato\/pourquoi-biorius-pour-vos-certifications\/\">naturelle ou biologique<\/a>. \u00c0 cet effet, la forme nano des particules de dioxyde de titane est inscrite \u00e0 l\u2019annexe VI du R\u00e8glement europ\u00e9en relatif aux cosm\u00e9tiques depuis 2016 et sa forme microm\u00e9trique et nanom\u00e9trique sont autoris\u00e9es en formulation cosm\u00e9tique (avec cependant des limites \u00e0 respecter). &nbsp; Une exception&nbsp;: son usage en sprays ou formes pouvant donner lieu \u00e0 une exposition des poumons par inhalation.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2) Le Dioxyde de Titane et classification CMR jusqu&#8217; \u00e0 aujourd&#8217;hui<\/h3>\n\n\n\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile\" style=\"grid-template-columns:32% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/ramiro-pianarosa-eepeujrm1z4-unsplash-e1657444746166-838x1024-1.jpg\" alt=\"\" class=\"wp-image-20923 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p>En effet, malgr\u00e9 ses nombreux avantages, le dioxyde de titane est une substance qui a fait d\u00e9bat notamment lorsqu\u2019elle se pr\u00e9sente sous forme de nanoparticules (int\u00e9r\u00eat pour les filtres UV). En 2006, le Centre International de Recherche sur le Cancer (CIRC) l\u2019a d\u00e9sign\u00e9 canc\u00e9rog\u00e8ne par inhalation chez l\u2019Homme et son utilisation sous forme de nanomat\u00e9riaux dans les a\u00e9rosols et produits pr\u00e9sentant un risque d\u2019inhalation \u00e9tait interdite.<\/p>\n\n\n\n<p>Puis, en 2020, il a \u00e9t\u00e9 officiellement list\u00e9 comme canc\u00e9rog\u00e8ne de cat\u00e9gorie 2 par inhalation en fonction de la quantit\u00e9 de particules inhalables par une <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32020R0217&amp;from=EN\">adaptation du r\u00e8glement CLP<\/a>.<\/p>\n\n\n\n<p>Malgr\u00e9 tout, aucune \u00e9tude scientifique n\u2019a fait consensus jusqu\u2019\u00e0 pr\u00e9sent.<\/p>\n<\/div><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">3) Le Dioxyde de Titane sous forme de certaines poudres n\u2019est plus consid\u00e9r\u00e9 comme une substance canc\u00e9rog\u00e8ne par inhalation en Union Europ\u00e9enne<\/h3>\n\n\n\n<p class=\"wp-block-coblocks-highlight\"><mark class=\"wp-block-coblocks-highlight__content\"><strong>La pr\u00e9c\u00e9dente d\u00e9cision de classer le TiO2 sous forme inhalable comme CMR a \u00e9t\u00e9 annul\u00e9e sur la base de deux \u00e9l\u00e9ments majeurs&nbsp;:<br>&#8211;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Les principales \u00e9tudes utilis\u00e9es pour justifier la classification ont \u00e9t\u00e9 jug\u00e9es peu fiables. Le point de d\u00e9saccord concernait principalement l\u2019\u00e9valuation de la densit\u00e9 des particules permettant d\u2019estimer la surcharge pulmonaire.<br>&#8211;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; La classification \u00e9tait uniquement fond\u00e9e sur la forme et la taille des particules de dioxyde de titane, celles-ci n\u2019\u00e9tant pas des propri\u00e9t\u00e9s intrins\u00e8ques du dioxyde de titane.<\/strong><br>&nbsp;<br><strong>Sur la base de ces facteurs, la CJUE a annul\u00e9 la classification harmonis\u00e9e du dioxyde de titane&nbsp;; d\u00e9cision \u00e0 application imm\u00e9diate.<\/strong><\/mark><\/p>\n\n\n\n<p>Au-del\u00e0 du cas sp\u00e9cifique du dioxyde de titane, <strong>la CJUE rejette en g\u00e9n\u00e9ral la consid\u00e9ration des particules dites peu solubles (<em>Poorly Soluble Particles<\/em> ou PSP) comme canc\u00e9rog\u00e8nes<\/strong>. Il est connu qu\u2019une exposition chronique \u00e0 ce type de particules peut mener \u00e0 un risque accru de canc\u00e9rog\u00e9nicit\u00e9. Cependant, l\u2019un des \u00e9l\u00e9ments cl\u00e9s de la toxicit\u00e9 observ\u00e9e est la quantit\u00e9 de particules inhal\u00e9es, laquelle doit \u00eatre suffisante pour provoquer une r\u00e9duction sensible des m\u00e9canismes d\u2019\u00e9limination des particules. Or, c\u2019est cette r\u00e9duction qui est indispensable \u00e0 l\u2019apparition d\u2019une inflammation chronique, laquelle \u00e0 son tour entra\u00eene les effets canc\u00e9rog\u00e8nes observ\u00e9s.<\/p>\n\n\n\n<p>Dans leur d\u00e9cision, les autorit\u00e9s avaient pr\u00e9c\u00e9demment jug\u00e9 ce m\u00e9canisme suffisant pour consid\u00e9rer le dioxyde de titane, et par extension toutes les PSP, comme canc\u00e9rog\u00e8nes. A l\u2019inverse, <strong>la CJUE a statu\u00e9 que ce m\u00e9canisme n\u2019\u00e9tait pas une toxicit\u00e9 \u00ab&nbsp;intrins\u00e8que&nbsp;\u00bb au dioxyde de titane et ne justifiait donc pas une classification en tant que canc\u00e9rog\u00e8ne.<\/strong><\/p>\n\n\n\n<p class=\"is-style-info coblocks-alert-paragraph\">Cette d\u00e9cision est extr\u00eamement importante en termes de jurisprudence, car en appliquant le m\u00eame raisonnement de nombreuses autres substances du m\u00eame type auraient \u00e9galement pu \u00eatre class\u00e9es comme canc\u00e9rog\u00e8nes, comme le noir de carbone ainsi que la plupart des pigments d\u2019origine min\u00e9rale par exemple.<br>\u00c0 la suite de cette d\u00e9cision, il a \u00e9t\u00e9 clarifi\u00e9 que l\u2019ensemble des PSP ne peuvent pas \u00eatre class\u00e9s en tant que canc\u00e9rog\u00e8nes sur la base de leurs propri\u00e9t\u00e9s physicochimiques seulement. Il faut par cons\u00e9quent prouver l\u2019existence d\u2019une canc\u00e9rog\u00e9nicit\u00e9 intrins\u00e8que et non pas secondaire \u00e0 une surcharge pulmonaire.<\/p>\n\n\n\n<p>En revanche, des mesures de protection de la population, et particuli\u00e8rement des travailleurs qui sont les plus expos\u00e9s, doivent \u00eatre mises en place. <strong>La strat\u00e9gie des autorit\u00e9s europ\u00e9ennes est attendue et pourrait prendre la forme d\u2019une classification harmonis\u00e9e pour la toxicit\u00e9 par exposition r\u00e9p\u00e9t\u00e9e ou la mise en place d\u2019une limite d\u2019exposition europ\u00e9enne <\/strong>(qui \u00e9tait la strat\u00e9gie propos\u00e9e par l\u2019industrie au d\u00e9part), pr\u00e9venant ainsi l\u2019apparition d\u2019une inflammation chronique menant \u00e0 une potentielle canc\u00e9rog\u00e9nicit\u00e9.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/books-1845614_1920-edited-1024x1024-1.jpg\" alt=\"\" class=\"wp-image-9743\" style=\"width:158px;height:158px\"\/><\/figure>\n<\/div>\n\n\n<p>Les cons\u00e9quences sur le long terme de cette d\u00e9cision sont encore incertaines et des clarifications doivent \u00eatre apport\u00e9es. Afin de vous tenir au courant des derniers d\u00e9veloppements et apports d\u2019information attendus sur le Dioxyde de Titane et classification CMR, <strong>n\u2019h\u00e9sitez pas \u00e0 vous rapprocher de BIORIUS afin de b\u00e9n\u00e9ficier de notre expertise r\u00e9glementaire \u00e0 l\u2019\u00e9coute des changements les plus r\u00e9cents<\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Le Dioxyde de Titane (TiO2) sous forme de certaines poudres n\u2019est plus consid\u00e9r\u00e9 comme une substance canc\u00e9rog\u00e8ne par inhalation en Union Europ\u00e9enne La Cour de&#8230;<\/p>\n","protected":false},"author":2,"featured_media":40610,"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":[2290,2290],"tags":[],"ppma_author":[],"class_list":["post-44381","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-reglementations-cosmetique"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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