{"id":656,"date":"2023-02-24T14:49:43","date_gmt":"2023-02-24T17:49:43","guid":{"rendered":"https:\/\/sfsafetyconsulting.com.br\/?p=656"},"modified":"2024-03-20T17:10:13","modified_gmt":"2024-03-20T20:10:13","slug":"anvisa-proibe-pomadas-para-trancar-e-modelar-cabelos","status":"publish","type":"post","link":"https:\/\/sfsafetyconsulting.com.br\/en\/news\/anvisa-prohibits-ointments-for-braiding-and-styling-hair\/","title":{"rendered":"ANVISA temporarily prohibits the sale of ointments for braiding and styling hair"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-662\" src=\"https:\/\/sfsafetyconsulting.com.br\/wp-content\/uploads\/2023\/02\/ANVISA-proibe-temporariamente-a-comercialiacao-de-pomadas-para-trancar-e-modelar-cabelos.jpg\" alt=\"\" width=\"768\" height=\"580\" srcset=\"https:\/\/sfsafetyconsulting.com.br\/wp-content\/uploads\/2023\/02\/ANVISA-proibe-temporariamente-a-comercialiacao-de-pomadas-para-trancar-e-modelar-cabelos.jpg 768w, https:\/\/sfsafetyconsulting.com.br\/wp-content\/uploads\/2023\/02\/ANVISA-proibe-temporariamente-a-comercialiacao-de-pomadas-para-trancar-e-modelar-cabelos-300x227.jpg 300w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/><\/p>\n<p>The National Health Surveillance Agency (ANVISA) temporarily banned the sale of cosmetic products OINTMENTS FOR BRAIDING AND STYLING HAIR. The decision was published on 02\/10\/2023, through Resolution-RE No. 475, of 02\/09\/2023. The measure is preventive and is valid until eye irritation investigations are completed. These products MUST NOT BE USED even if the consumer already has the product purchased at home before the publication of this resolution. On 02\/17\/2023, ANVISA held a webinar. SIMONE FANAN participated and brings us the latest news on this serious problem.<\/p>\n<p>OINTMENTS FOR BRAIDING AND STYLING HAIR <u>are exempt from registration (classified as Grade 1)<\/u> and are subject to the prior communication procedure to ANVISA through <strong><u>notification<\/u><\/strong>.<\/p>\n<h3><strong>PROBLEM STATUS<\/strong><\/h3>\n<p>\u201cUntil 02\/13\/2023, ANVISA recorded 764 reported cases of exogenous poisoning related to cosmetics for braiding, styling or fixing hair.\u201d<\/p>\n<p>\u201cOf these cases, 97.8% sought medical attention due to adverse events resulting from the use of the product.\u201d<\/p>\n<p>\u201cAmong the most reported signs and symptoms are keratitis, eye pain, corneal abrasion, burning eyes, hyperemia, ocular foreign body sensation and loss of visual acuity.\u201d<\/p>\n<p>\u201cThere are more than 35 brands of cosmetic products for braiding, styling or fixing hair referred to in notifications sent to ANVISA from various companies.\u201d<\/p>\n<p>\u201cINVESTIGATION UNDERWAY TO IDENTIFY THE CAUSE OF THE PROBLEM.\u201d<\/p>\n<p>These are reported cases, but it is known that there may be a much larger number of UNreported cases, which is considered a PUBLIC HEALTH PROBLEM.<\/p>\n<h3><strong>CAUTIONARY INTERDICTION<\/strong><\/h3>\n<p>\u201cResolution-RE No. 475, of February 9, 2023: all ointments for braiding, styling or fixing hair are prohibited from being sold by ANVISA.\u201d<\/p>\n<p>\u201cMotivation: Considering the reports of serious adverse events related to ocular poisoning and in view of the provisions of articles 6, 7 of Law 6360, of September 23, 1976.\u201d<\/p>\n<p>\u201cThe ANVISA Collegiate Board of Directors (DICOL) determined that the suspensive effect of any administrative appeals filed in light of Resolution-RE No. 475, of February 9, 2023, will be removed.\u201d<\/p>\n<p>\u201cDICOL also decided to suspend new notifications to ANVISA for the regularization of products such as ointments for braiding, styling or fixing hair, during the period in which the precautionary ban determined by Resolution-RE No. 475, of February 9, is in force. 2023.\u201d<\/p>\n<h3><strong>SOME POSSIBLE CAUSES OF ADVERSE EVENTS<\/strong><\/h3>\n<p>\u201cFormula developed by responsible companies is not safe:<\/p>\n<ul>\n<li><em>Ceteareth-20<\/em> in high concentration (without explicit use restrictions in standards).<\/li>\n<li><em>Cetearyl alcohol<\/em> in high concentration (without explicit use restrictions in standards).<\/li>\n<li><em>Methylchloroisothiazolinone<\/em> It is <em>Methylisothiazolinone<\/em> (RDC 528\/2021).<\/li>\n<\/ul>\n<p>How to Use now favors greater contact of the products with the eyes:<\/p>\n<ul>\n<li>Greater amount of product throughout the hair.<\/li>\n<li>Greater amount of product applied to hair located in the frontal part.<\/li>\n<\/ul>\n<p>Use of ointments combined with other products.<\/p>\n<p>Addition of ingredients not reported to ANVISA to products:<\/p>\n<ul>\n<li>Manufacturer<\/li>\n<li>Consumers or professionals who use the product.<\/li>\n<\/ul>\n<p>Impurities of raw materials.\u201d<\/p>\n<h4><strong>INVESTIGATION \u2013 FORMULA DEVELOPED BY RESPONSIBLE COMPANIES IS NOT SAFE<\/strong><\/h4>\n<p>\u201cEvaluation of regularization processes for products with adverse reactions:<\/p>\n<ul>\n<li>Ingredients with the potential to cause adverse ocular reactions identified.<\/li>\n<li>No common ingredient was identified among all products with adverse reactions.<\/li>\n<li>Research to identify whether products with <em>Methylchloroisothiaxolinone<\/em> It is <em>Methylisothiazolinone<\/em> at concentrations permitted before 08\/11\/2021 could cause the adverse reactions observed.<\/li>\n<li>Research to identify the safe concentration of <em>Ceteareth-20<\/em> It is <em>Cetearyl<\/em> <em>Alcohol<\/em> for products with the possibility of contact with eyes.<\/li>\n<li>Eye safety assessment requested for products and data supporting safety <em>Ceteareth-20<\/em> and\/or <em>Cetearyl Alcohol<\/em> in the concentration used.\u201d<\/li>\n<li>\u201cProcesses canceled with <em>Methylchloroisothiazolinone<\/em> It is <em>Methylisothiazolinone<\/em> notified as of 08\/11\/2021 (RDC 528\/2021).<\/li>\n<li>Processes that did not present the documentation required by RDC 752, of 2023, were cancelled.<\/li>\n<li>Processes that did not respond to ANVISA\u2019s request within the specified period have been cancelled.\u201d<\/li>\n<\/ul>\n<p>\u201cLaboratory assessments:<\/p>\n<ul>\n<li>pH analysis and eye corrosion\/irritation test <em>in vitro<\/em> following the OECD TG 437 (BCOP) method at different concentrations of <em>Ceteareth-20<\/em> It is <em>Cetearyl Alcohol<\/em> to check the maximum safe concentration in products that can come into contact with the eyes.<\/li>\n<li>NMR or HPLC analysis of finished products to investigate the presence of potential impurities.\u201d<\/li>\n<\/ul>\n<h4><strong>RDC 528\/2021 \u2013 LIST OF PRESERVATIVE SUBSTANCES ALLOWED FOR PERSONAL HYGIENE PRODUCTS, COSMETICS AND PERFUMES<\/strong><\/h4>\n<p>\u201cItem 35 (<em>Methylchloroisothiazolinone<\/em> It is <em>Methylisothiazolinone<\/em>) and item 57 (<em>Methylisothiazolinone<\/em>):<\/p>\n<ul>\n<li>Prohibited in products that cannot be rinsed (including wet wipes).<\/li>\n<li>Of the 594 canceled regularization processes, the reason for the majority of cancellations is non-compliance with RDC 528\/2021.\u201d<\/li>\n<\/ul>\n<h3><strong>OBJECTIVES OF THE RESEARCH<\/strong><\/h3>\n<p>\u201cIdentify the cause of adverse reactions.<\/p>\n<p>Adopt regulatory measures restricted to the products that are causing adverse reactions.<\/p>\n<p>Avoid the need to analyze the regularization processes of all products:<\/p>\n<ul>\n<li>It demands a lot of ANVISA&#039;s time.<\/li>\n<li>It can result in costs for companies.<\/li>\n<li>It may not solve the cause.\u201d<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>The National Health Surveillance Agency (ANVISA) temporarily banned the sale of cosmetic products OINTMENTS FOR BRAIDING AND STYLING HAIR. The decision was published on 02\/10\/2023, through Resolution-RE No. 475, of 02\/09\/2023. The measure is preventive and is valid until eye irritation investigations are completed. These products SHOULD NOT BE USED even if the consumer has already purchased the product in\u2026 <\/p>","protected":false},"author":1,"featured_media":662,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[20],"tags":[26,30],"class_list":["post-656","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-avaliacao-seguranca-cosmeticos","tag-cosmeticos","tag-seguranca","clearfix"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ANVISA pro\u00edbe temporariamente a comercialia\u00e7\u00e3o de pomadas para tran\u00e7ar e modelar cabelos - SF Safety, Consulting &amp; Innovation<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sfsafetyconsulting.com.br\/en\/news\/anvisa-prohibits-ointments-for-braiding-and-styling-hair\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANVISA pro\u00edbe temporariamente a comercialia\u00e7\u00e3o de pomadas para tran\u00e7ar e modelar cabelos - SF Safety, Consulting &amp; Innovation\" \/>\n<meta property=\"og:description\" content=\"A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (ANVISA) proibiu temporariamente a comercializa\u00e7\u00e3o de produtos cosm\u00e9ticos POMADAS PARA TRAN\u00c7AR E MODELAR CABELOS. 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