{"id":56599,"date":"2023-01-19T10:44:22","date_gmt":"2023-01-19T15:44:22","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-cosmetics\/usfda-cosmetics-registration\/"},"modified":"2023-03-16T12:35:15","modified_gmt":"2023-03-16T16:35:15","slug":"usfda-cosmetics-registration","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/fr\/fda-cosmetics\/usfda-cosmetics-registration\/","title":{"rendered":"US FDA Cosmetics Requirements"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row el_id=&#8221;deadlineBar&#8221; el_class=&#8221;hidden&#8221;][vc_column]<div id=\"section-49837\" class=\"el-202564304363c9607c23f9e ss-element gusta-section-vc-element \"><div class=\"section-container\">[vc_section css=\".vc_custom_1625576502073{background-color: #f18805 !important;}\"][vc_row][vc_column][vc_row_inner][vc_column_inner][vc_raw_html]JTNDaDMlM0UlM0NzdHJvbmclM0VPZmZyZSUyMGxpbWl0JUMzJUE5ZSUzQSUzQyUyRnN0cm9uZyUzRSVDMiVBME9idGVuZXolQzIlQTAlM0NzdHJvbmclMjBjbGFzcyUzRCUyMm1vbnRoRGlmZmVyZW5jZSUyMiUzRTE4JTIwbW9pcyUzQyUyRnN0cm9uZyUzRSVDMiVBMGRlJTIwc2VydmljZSUyMGQlRTIlODAlOTllbnJlZ2lzdHJlbWVudCUyMGV0JTIwZCVFMiU4MCU5OWFnZW50JTIwVS5TLiUyMCUzQ3N0cm9uZyUzRWF1JTIwdGFyaWYlMjBkZSUyMDEyJTNDJTJGc3Ryb25nJTNFJTIwc2klMjB2b3VzJTIwdm91cyUyMGVucmVnaXN0cmV6JTIwYXVqb3VyZCVFMiU4MCU5OWh1aS4lM0MlMkZoMyUzRQ==[\/vc_raw_html][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][\/vc_section][vc_row][vc_column][vc_raw_js]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[\/vc_raw_js][\/vc_column][\/vc_row][vc_row][vc_column][vc_raw_html]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[\/vc_raw_html][\/vc_column][\/vc_row]\r\n<\/div><\/div>[\/vc_column][\/vc_row][vc_section el_id=&#8221;section-app&#8221;][vc_row css=&#8221;.vc_custom_1674515691852{background-color: rgba(255,255,255,0.9) !important;*background-color: rgb(255,255,255) !important;}&#8221;][vc_column width=&#8221;1\/4&#8243;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text]\n<h2>Pr\u00e9parez-vous d\u00e8s maintenant \u00e0 vous conformer aux nouvelles exigences de l\u2019US FDA pour les entreprises cosm\u00e9tiques<\/h2>\n<p>Les Etats-Unis ont r\u00e9cemment adopt\u00e9 la loi de <a href=\"https:\/\/regstaging.wpengine.com\/10-ways-mocra-will-transform-cosmetics-regulations\/\">Modernisation des Cosm\u00e9tiques MoCRA de 2022 (Modernization of Cosmetics Regulation Act of 2022)<\/a>, \u00e9largissant le pouvoir de r\u00e9glementation de la FDA (Food and Drug Administration) des \u00c9tats-Unis sur l\u2019industrie cosm\u00e9tique. La loi MoCRA demande \u00e0 la FDA d\u2019\u00e9tablir de nouvelles r\u00e8glementations pour les entreprises qui fabriquent et distribuent des cosm\u00e9tiques aux \u00c9tats-Unis.<\/p>\n<p>De nombreuses r\u00e9glementations entrent en vigueur d\u00e8s 2023.[\/vc_column_text][vc_row_inner css=&#8221;.vc_custom_1676296349619{padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #eaeaea !important;border-radius: 15px !important;}&#8221; el_class=&#8221;box1&#8243;][vc_column_inner][vc_column_text]\n<h2>Comment Registrar Corp peut vous aider\u00a0?<\/h2>\n<p>Registrar Corp rend la conformit\u00e9 avec les exigences MoCRA facile et rapide. D\u00e9signez Registrar Corp comme votre agent US de communication avec la FDA, et nous enregistrerons votre \u00e9tablissement cosm\u00e9tique d\u00e8s que possible. Nous vous tiendrons \u00e9galement inform\u00e9s \u00e0 mesure que la FDA mettra en \u0153uvre des directives suppl\u00e9mentaires de MoCRA pour vous aider \u00e0 rester en conformit\u00e9.<\/p>\n<p><center><br \/>\n<a class=\"form-button form-next\" style=\"background: red; color: #fff; border: red; padding: 10px 15px; font-weight: bold;\" href=\"https:\/\/regstaging.wpengine.com\/fda-cosmetics\/usfda-cosmetics-registration\/registration\/\" type=\"button\">D\u00e9marrer maintenant<\/a><\/center>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner css=&#8221;.vc_custom_1676307641790{margin-top: 30px !important;margin-bottom: 30px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #eaeaea !important;border-radius: 15px !important;}&#8221; el_class=&#8221;box1&#8243;][vc_column_inner][vc_column_text]\n<h2>Que siginifie MoCRA pour les entreprises cosm\u00e9tiques\u00a0?<\/h2>\n<p>Selon la loi MoCRA, la FDA va \u00e9tablir des r\u00e8glementations qui affectent le cycle de vie complet de vos produits cosm\u00e9tiques, de la fabrication \u00e0 la commercialisation. Les nouvelles exigences comprennent\u00a0:<\/p>\n<ul>\n<li>L\u2019enregistrement FDA obligatoire des \u00e9tablissements cosm\u00e9tiques<\/li>\n<li>Les Listings de produit obligatoires pour chaque produit cosm\u00e9tique commercialis\u00e9 aux Etats-Unis<\/li>\n<li>Le Reporting des effets ind\u00e9sirables<\/li>\n<li>Le respect des Bonnes Pratiques de Fabrication \u00e9mises par la FDA (GMPs)<\/li>\n<li>Le maintien des enregistrements, y compris des \u00e9v\u00e9nements ind\u00e9sirables et des dossiers de s\u00e9curit\u00e9 produit<\/li>\n<li>Le rappel de produits obligatoire<\/li>\n<li>La d\u00e9claration des allerg\u00e8nes de parfum<\/li>\n<\/ul>\n<p>Bien que la FDA n\u2019ait pas encore \u00e9tabli de r\u00e9glementations pour ces exigences, la loi fournit des informations g\u00e9n\u00e9rales, de sorte que les entreprises cosm\u00e9tiques peuvent commencer \u00e0 se pr\u00e9parer \u00e0 ces nouvelles exigences de la FDA.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_tta_accordion active_section=&#8221;1&#8243; title=&#8221;FAQ&#8221;][vc_tta_section title=&#8221;Qu\u2019est-ce que MoCRA ? &#8221; tab_id=&#8221;1677758902503-63490b56-6927&#8243;][vc_column_text]MoCRA est la loi de modernisation des cosm\u00e9tiques (Modernization of Cosmetics Regulation Act) qui a \u00e9t\u00e9 promulgu\u00e9e le 29 d\u00e9cembre 2022. MoCRA est la plus grande r\u00e9forme de la r\u00e9glementation cosm\u00e9tique existante aux \u00c9tats-Unis en 84 ans et \u00e9tablit de nombreuses nouvelles exigences, telles que :<\/p>\n<ul>\n<li>L\u2019enregistrement de l\u2019\u00e9tablissement<\/li>\n<li>Les Listings de produits<\/li>\n<li>Les Bonnes pratiques de fabrication (GMPs)<\/li>\n<li>La s\u00e9curit\u00e9 produit<\/li>\n<li>Les nouvelles exigences en mati\u00e8re d\u2019\u00e9tiquetage<\/li>\n<li>La d\u00e9claration des \u00e9v\u00e9nements ind\u00e9sirables<\/li>\n<li>Le maintien des donn\u00e9es d\u2019enregistrement<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Comment seront affect\u00e9s les \u00e9tablissements cosm\u00e9tiques par MoCRA ? &#8221; tab_id=&#8221;1677758902524-a3bd06a9-5f11&#8243;][vc_column_text]Selon la loi MoCRA, le terme \u00ab \u00e9tablissement \u00bb comprend toute installation physique o\u00f9 sont fabriqu\u00e9s ou transform\u00e9s des produits cosm\u00e9tiques distribu\u00e9s aux \u00c9tats-Unis. Les installations devront s\u2019enregistrer et se conformer aux GMPs indiqu\u00e9es par la FDA.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Qui est consid\u00e9r\u00e9 comme la personne responsable dans MoCRA? &#8221; tab_id=&#8221;1677759041239-cced8334-7c96&#8243;][vc_column_text]Le terme \u00ab personne responsable \u00bb d\u00e9signe le fabricant, le conditionneur ou le distributeur d\u2019un produit cosm\u00e9tique dont le nom appara\u00eet sur l\u2019\u00e9tiquette du produit, conform\u00e9ment \u00e0 l\u2019article 609(a) du FD&amp;C Act ou \u00e0 l\u2019article 4(a) du Fair Packaging and Labeling Act.<\/p>\n<p>La \u00ab personne responsable \u00bb aura pour responsabilit\u00e9 :<\/p>\n<ul>\n<li>Le listing des produits cosm\u00e9tiques<\/li>\n<li>Les effets ind\u00e9sirables<\/li>\n<li>La s\u00e9curit\u00e9 produit<\/li>\n<li>L\u2019\u00e9tiquetage<\/li>\n<li>La divulgation et l\u2019enregistrement des donn\u00e9es d\u2019allerg\u00e8nes dans les parfums<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Existe-t-il des exemptions pour l\u2019enregistrement des \u00e9tablissements ?&#8221; tab_id=&#8221;1677759120478-76bbe6d4-257b&#8221;][vc_column_text]Oui, les petites entreprises auront des exigences plus souples et simplifi\u00e9es. La FDA d\u00e9finit une petite entreprise comme une entreprise dont les ventes annuelles brutes moyennes aux \u00c9tats-Unis pour la p\u00e9riode pr\u00e9c\u00e9dente de 3 ans sont inf\u00e9rieures \u00e0 1 000 000 $, ajust\u00e9es en fonction de l\u2019inflation. Cela ne s\u2019applique pas aux personnes responsables ou \u00e9tablissements engag\u00e9s dans la fabrication de produits cosm\u00e9tiques qui :<\/p>\n<ul>\n<li>Entrent en contact avec les yeux<\/li>\n<li>Sont inject\u00e9s<\/li>\n<li>Sont destin\u00e9s \u00e0 un usage interne<\/li>\n<li>Modifient l\u2019apparence pendant plus de 24 heures dans des conditions d\u2019utilisation normales<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quand les enregistrements d\u2019\u00e9tablissement et les listings de produits sont-ils requis ? &#8221; tab_id=&#8221;1677759224118-2cadfdcc-aaf9&#8243;][vc_column_text]Pour les installations existantes, l\u2019enregistrement des \u00e9tablissements et les listings de produits doivent \u00eatre obtenus au plus tard le 29 d\u00e9cembre 2023. Les nouveaux \u00e9tablissements qui fabriquent ou transforment des produits cosm\u00e9tiques destin\u00e9s \u00e0 la distribution aux \u00c9tats-Unis doivent s\u2019enregistrer dans les 60 jours suivants la commercialisation du produit ou dans les 60 jours suivants la date limite pour les \u00e9tablissements existants (selon la plus tardive).[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Que se passe-t-il si j\u2019ai plusieurs produits cosm\u00e9tiques ? Comment dois-je les lister ? &#8221; tab_id=&#8221;1677759259005-aa153caf-516d&#8221;][vc_column_text]MoCRA permet des \u00ab listings flexibles \u00bb. Pour les listings flexibles, les entreprises peuvent soumettre un seul listing pour les produits cosm\u00e9tiques qui ont des formulations identiques, ou des formulations qui ne diff\u00e8rent que par les couleurs, les parfums ou les ar\u00f4mes, ou la quantit\u00e9 de contenu.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Que puis-je faire d\u00e8s maintenant pour me pr\u00e9parer au MoCRA ?&#8221; tab_id=&#8221;1677759287044-0ef4249f-200e&#8221;][vc_column_text]Contactez Registrar Corp pour d\u00e9terminer les responsabilit\u00e9s que votre entreprise devra assumer pour \u00eatre conforme.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quelles sont les nouvelles exigences en mati\u00e8re d\u2019\u00e9tiquetage ? &#8221; tab_id=&#8221;1677759315065-59bd9656-91ae&#8221;][vc_column_text]Les \u00e9tiquettes des produits doivent \u00eatre mises \u00e0 jour pour inclure :<\/p>\n<ul>\n<li>Une adresse aux \u00c9tats-Unis<\/li>\n<li>Un num\u00e9ro de t\u00e9l\u00e9phone aux \u00c9tats-Unis, ou<\/li>\n<li>Les coordonn\u00e9es \u00e9lectroniques d\u2019une personne responsable qui peut recevoir les d\u00e9clarations d\u2019\u00e9v\u00e9nements ind\u00e9sirables<\/li>\n<\/ul>\n<p>Les produits cosm\u00e9tiques qui contiennent des parfums comprenant des allerg\u00e8nes doivent mettre \u00e0 jour leur \u00e9tiquette pour \u00e9num\u00e9rer ces allerg\u00e8nes. Pour les produits cosm\u00e9tiques professionnels, les \u00e9tiquettes doivent indiquer clairement et de mani\u00e8re bien visible que le produit est administr\u00e9 ou utilis\u00e9 uniquement par des professionnels agr\u00e9\u00e9s et qu\u2019il est conforme aux exigences existantes en mati\u00e8re d\u2019\u00e9tiquetage des cosm\u00e9tiques.<br \/>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quand les nouvelles exigences en mati\u00e8re d\u2019\u00e9tiquetage entreront-elles en vigueur? &#8221; tab_id=&#8221;1677759412299-a76f8648-86fc&#8221;][vc_column_text]Dans un d\u00e9lai de <strong>1<\/strong><strong> an<\/strong> : les \u00e9tiquettes des produits cosm\u00e9tiques professionnels doivent inclure toutes les informations requises et indiquer que seuls les professionnels agr\u00e9\u00e9s peuvent utiliser le produit.<\/p>\n<p>Dans les <strong>2<\/strong><strong> ans<\/strong> : les \u00e9tiquettes doivent inclure les coordonn\u00e9es de la personne responsable des effets ind\u00e9sirables et doivent identifier les allerg\u00e8nes de parfum d\u00e9termin\u00e9s par la FDA.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][vc_column_text css=&#8221;.vc_custom_1677767535188{border-bottom-width: 30px !important;padding-bottom: 50px !important;}&#8221;]\n<h3>Pour designer Registrar Corp comme votre agent US de communication FDA, compl\u00e9tez simplement le formulaire suivant\u00a0:<\/h3>\n<p><center><br \/>\n<a class=\"form-button form-next\" style=\"background: red; color: #fff; border: red; padding: 10px 15px; font-weight: bold;\" href=\"https:\/\/regstaging.wpengine.com\/fda-cosmetics\/usfda-cosmetics-registration\/registration\/\" type=\"button\">D\u00e9marrer maintenant<\/a><\/center>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/4&#8243;][\/vc_column][\/vc_row][vc_row][vc_column][\/vc_column][\/vc_row][vc_row disable_element=&#8221;yes&#8221; el_class=&#8221;tile-box&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_row_inner 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