{"id":15934,"date":"2020-03-17T16:22:00","date_gmt":"2020-03-17T16:22:00","guid":{"rendered":"https:\/\/www.cosmed.fr\/newsletter\/newsletter-129\/"},"modified":"2021-04-09T07:22:38","modified_gmt":"2021-04-09T07:22:38","slug":"newsletter-129","status":"publish","type":"newsletter","link":"http:\/\/www.cosmed.fr\/en\/newsletter\/newsletter-129\/","title":{"rendered":"Newsletter 129"},"content":{"rendered":"<div class=\"container\">\n<h2>Conseils Cosmed pour la mise en place rapide d&#8217;un gel hydro-alcoolique conforme au r\u00e8glement biocide<\/h2>\n<h3><strong>Etat r\u00e9glementaire<\/strong><\/h3>\n<p>Un produit hydro-alcoolique (PHA) contenant<span style=\"text-decoration: underline;\"> \u00e0 minima 60% d\u2019alcool<\/span> dont le but est de d\u00e9sinfecter\/nettoyer les mains est <strong>par d\u00e9finition un biocide quelle que soit sa pr\u00e9sentation<\/strong>, y compris un gel nettoyant pour les mains sans utilisation des termes <em>\u00abhydro-alcoolique\u00bb, \u00abd\u00e9sinfectant\u00bb, \u00abantibact\u00e9rien\u00bb, \u00abassainissant<\/em>\u00bb, etc..( r\u00e8glement (UE) n\u00b0528\/2012 ,cat\u00e9gorie TP01 &#8220;produits biocides destin\u00e9s \u00e0 l&#8217;hygi\u00e8ne humaine&#8221; ).<\/p>\n<h3><strong>Options pour la mise sur le march\u00e9 &#8211; Quelles formules ?<\/strong><\/h3>\n<p><span style=\"text-decoration: underline;\">OPTION 1<\/span> : Formuler un PHA selon les formules de <a href=\"https:\/\/www.cosmed.fr\/app\/uploads\/2020\/03\/arrtdu13mars2020.pdf\">l\u2019arr\u00eat\u00e9 du 13 mars 2020<\/a> autorisant, par d\u00e9rogation, la mise \u00e0 disposition sur le march\u00e9 et l\u2019utilisation temporaire de certains produits hydro-alcooliques utilis\u00e9s en tant que biocides d\u00e9sinfectants pour l\u2019hygi\u00e8ne humaine.<br \/>\nDans ce cas, il convient de respecter scrupuleusement <strong>la formulation, les mentions d\u2019\u00e9tiquetage ainsi que les conditions de conservation et de lib\u00e9ration des lots d\u00e9taill\u00e9es dans cet arr\u00eat\u00e9<\/strong>. Concernant les qualit\u00e9s d\u2019alcool \u00e0 utiliser, ou la qualit\u00e9 des autres mati\u00e8res premi\u00e8res biocides <em>(isopropanol et peroxyde d\u2019hydrog\u00e8ne<\/em>), il convient de respecter les exigences de l\u2019arr\u00eat\u00e9 c\u2019est-\u00e0-dire : une qualit\u00e9 conforme aux exigences de la pharmacop\u00e9e europ\u00e9enne, et\/ou provenant d\u2019un fournisseur list\u00e9 selon l\u2019article 95.<br \/>\nTout fabricant de produits cosm\u00e9tiques (<span style=\"text-decoration: underline;\">ayant une d\u00e9claration d\u2019\u00e9tablissement de fabrication<\/span>) est autoris\u00e9 \u00e0 produire ces formules sous r\u00e9serve du respect des conditions pr\u00e9cit\u00e9es et ce jusqu\u2019au 31 mai 2020.<br \/>\nDans ce cas, aucune d\u00e9claration suppl\u00e9mentaire n&#8217;est \u00e0 effectuer.<\/p>\n<p><span style=\"text-decoration: underline;\">OPTION 2 : Formuler un PHA selon toute autre formule<\/span><br \/>\nL\u2019alcool doit \u00eatre fourni par un fournisseur r\u00e9pondant aux dispositions de l\u2019article 95 dont vous trouverez <a href=\"https:\/\/www.cosmed.fr\/app\/uploads\/2020\/03\/ethanolsupplierart95.pdf\">la liste ci-jointe<\/a>.<\/p>\n<p><span style=\"color: #ff6600;\">Quelles d\u00e9clarations pour l&#8217;option 2 ?<\/span><br \/>\n&#8211; Vous devez effectuer une d\u00e9claration d\u2019\u00e9tablissement \u00ab<a href=\"https:\/\/www.simmbad.fr\/servlet\/loginSav.html\">D\u00e9claration d&#8217;activit\u00e9 d&#8217;utilisateur ou de distributeur<\/a>\u00bb\u00a0 ainsi qu\u2019une d\u00e9claration de formule \u00ab<a href=\"https:\/\/www.simmbad.fr\/servlet\/loginUtilisateur.html\">D\u00e9claration inventaire<\/a>\u00bb sur le <a href=\"https:\/\/www.simmbad.fr\/servlet\/accueilMinistere.html\">portail SIMMBAD<\/a> ;<br \/>\n&#8211; Vous devez respecter les mentions d\u2019\u00e9tiquetage telles que d\u00e9finies dans le r\u00e8glement biocide : <a href=\"https:\/\/www.cosmed.fr\/app\/uploads\/2020\/03\/syntheseetiquetagebiocides.pdf\">Cf synth\u00e8se ci-jointe<\/a> ;<br \/>\n&#8211; Vous devez effectuer une d\u00e9claration de la formule aupr\u00e8s des CAP qui se fait normalement sur<a href=\"https:\/\/www.declaration-synapse.fr\/synapse\/jsp\/index.jsp\"> le portail SYNAPSE<\/a>.<\/p>\n<p><span style=\"color: #ff6600;\">IMPORTANT : en cas d\u2019urgence, si vous n\u2019avez pas de compte, il est possible de faire vos d\u00e9clarations par courrier (R + AR si possible) aupr\u00e8s de l\u2019INRS, ou par mail \u00e0 cpinrs@inrs.fr, reprenant les informations ci-dessous :<\/span><br \/>\nEn t\u00eate : \u00ab D\u00e9claration de produits biocides \u00bb<br \/>\nAdresse postale :<br \/>\nINRS, D\u00e9partement Expertise et conseil technique<br \/>\nP\u00f4le risques chimiques<br \/>\n65 boulevard Richard Lenoir<br \/>\n75011 Paris<br \/>\nContenu : joindre une lettre \u00e0 ent\u00eate de la soci\u00e9t\u00e9 d\u00e9clarante +\u00a0 la FDS + copie de l\u2019\u00e9tiquetage.<\/p>\n<p><span style=\"color: #ff6600;\">Ces d\u00e9clarations peuvent \u00eatre effectu\u00e9es relativement rapidement et sont \u00e0 la port\u00e9e de toute entreprise cosm\u00e9tique.<\/span><\/p>\n<h2>Base l\u00e9gale des dispositions en mati\u00e8re de d\u00e9placement<\/h2>\n<p><a href=\"https:\/\/www.cosmed.fr\/app\/uploads\/2020\/03\/decret16mars2020.pdf\">De\u0301cret no 2020-260 du 16 mars 2020<\/a> portant re\u0301glementation des de\u0301placements dans le cadre de la lutte contre la propagation du virus covid-19.<\/p>\n<p><a class=\"btn\" href=\"https:\/\/www.cosmed.fr\/app\/uploads\/2020\/03\/news129.pdf\">\u00a0T\u00e9l\u00e9chargez la newsletter<\/a><\/div>\n","protected":false},"featured_media":0,"template":"","class_list":["post-15934","newsletter","type-newsletter","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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