{"id":2512,"date":"2025-01-07T20:10:36","date_gmt":"2025-01-07T19:10:36","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2512"},"modified":"2025-02-26T11:01:49","modified_gmt":"2025-02-26T10:01:49","slug":"case-study-regulation-and-effectiveness-of-hydroalcoholic-gels","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/case-study-regulation-and-effectiveness-of-hydroalcoholic-gels\/","title":{"rendered":"Case study: regulation and effectiveness of hydroalcoholic gels"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h1 class=\"wp-block-heading\" style=\"font-size:25px\"><strong>Regulation of hydroalcoholic gels and biocidal effectiveness<\/strong><\/h1>\n\n\n\n<p style=\"font-size:18px\">Hydroalcoholic gels are biocidal products of type PT1, used for human hygiene. They play a key role in hand disinfection, particularly in medical environments or during epidemic periods. Their marketing and effectiveness are governed by strict regulations.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\"><strong>Active substance<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">Ethanol (CAS No. 64-17-5) is the most commonly used active substance in hydroalcoholic gels.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\"><strong>Regulatory framework<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">Hydroalcoholic gels containing ethanol as an active substance currently fall under a transitional framework. This means that national regulations in each country apply until ethanol is officially evaluated by the European Union under the Biocidal Products Regulation (BPR).<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\"><strong>Effectiveness<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">Hydroalcoholic gels must demonstrate at least bactericidal and fungicidal efficacy and are often also virucidal.<br>These efficacies must be proven through standardized phase 2 tests, and the minimum required action time must be specified and validated.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\"><strong>Risk of reclassification<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">The biocidal status of hydroalcoholic gels is clearly established, and there is no regulatory ambiguity regarding their classification.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:30px\"><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">Hydroalcoholic gel is an essential product for human hygiene. However, it remains under a transitional framework due to ethanol as an active substance, meaning its regulatory status could evolve based on decisions made by the European Union.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<section id=\"block_c96932db6607504f12f91425a931a5de\" class=\"stafe-blocks-faq sbfaq section section_faq-block section_faq-bg-color\" style=\"background-color: #f8f9fa;\">\n    <script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"<h3><span class=\\\"third-title\\\">Why are hydroalcoholic gels considered PT1 biocides?<br \\\/>\\n<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><span class=\\\"fourth-title\\\">Hydroalcoholic gels are classified as PT1 because they are intended for human hygiene and contain biocidal active substances like ethanol to eliminate microorganisms.<\\\/span><\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"<h3><span class=\\\"third-title\\\">What is the regulatory framework for hydroalcoholic gels in Europe?<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><span class=\\\"fourth-title\\\">They fall under a transitional framework due to ethanol as an active substance, meaning national regulations apply until the active substance (ethanol) is approved under the Biocidal Products Regulation (BPR).<\\\/span><\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"<h3><span class=\\\"third-title\\\">What tests must be conducted to prove the effectiveness of a hydroalcoholic gel?<\\\/span><\\\/h3>\\n<p>&nbsp;<\\\/p>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><span class=\\\"fourth-title\\\">It must demonstrate bactericidal, fungicidal, and often virucidal efficacy through standardized phase 2 tests, which assess its performance under real-world conditions.<\\\/span><\\\/p>\\n\"}}]}<\/script>\n    <div class=\"faq-block_container\">\n        <div class=\"container\">\n                            <div class=\"faq_title\">\n                    <h2 style=\"text-align: center; font-size: 30px;\">Mastering biocide regulations<\/h2>\n                <\/div>\n            \n                            <div class=\"faq_accordion\">\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3><span class=\"third-title\">Why are hydroalcoholic gels considered PT1 biocides?<br \/>\n<\/span><\/h3>\n                                <span class=\"btn btn-brown\">\n                                    <span class=\"icon icon-keyboard_arrow_down\"><\/span>\n                                <\/span>\n                            <\/span>\n                            <div class=\"accordion-content\">\n                                <p><span class=\"fourth-title\">Hydroalcoholic gels are classified as PT1 because they are intended for human hygiene and contain biocidal active substances like ethanol to eliminate microorganisms.<\/span><\/p>\n                            <\/div>\n                        <\/div>\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3><span class=\"third-title\">What is the regulatory framework for hydroalcoholic gels in Europe?<\/span><\/h3>\n                                <span class=\"btn btn-brown\">\n                                    <span class=\"icon icon-keyboard_arrow_down\"><\/span>\n                                <\/span>\n                            <\/span>\n                            <div class=\"accordion-content\">\n                                <p><span class=\"fourth-title\">They fall under a transitional framework due to ethanol as an active substance, meaning national regulations apply until the active substance (ethanol) is approved under the Biocidal Products Regulation (BPR).<\/span><\/p>\n                            <\/div>\n                        <\/div>\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3><span class=\"third-title\">What tests must be conducted to prove the effectiveness of a hydroalcoholic gel?<\/span><\/h3>\n<p>&nbsp;<\/p>\n                                <span class=\"btn btn-brown\">\n                                    <span class=\"icon icon-keyboard_arrow_down\"><\/span>\n                                <\/span>\n                            <\/span>\n                            <div class=\"accordion-content\">\n                                <p><span class=\"fourth-title\">It must demonstrate bactericidal, fungicidal, and often virucidal efficacy through standardized phase 2 tests, which assess its performance under real-world conditions.<\/span><\/p>\n                            <\/div>\n                        <\/div>\n                                    <\/div>\n                                <\/div>\n    <\/div>\n<\/section>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Regulation of hydroalcoholic gels and biocidal effectiveness Hydroalcoholic gels are biocidal products of type PT1, used for human hygiene. They play a key role in hand disinfection, particularly in medical environments or during epidemic periods. Their marketing and effectiveness are governed by strict regulations. Active substance Ethanol (CAS No. 64-17-5) is the most commonly used [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1488,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[269,75,1],"tags":[],"class_list":["post-2512","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biocides-en","category-news","category-non-classifiee"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Case study: regulation and effectiveness of hydroalcoholic gels - Pharmanager Development<\/title>\n<meta name=\"description\" content=\"Learn about the regulatory requirements and effectiveness of hydroalcoholic gels (PT1): active substances, legal framework, and compliance challenges.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pharmanager-development.com\/en\/case-study-regulation-and-effectiveness-of-hydroalcoholic-gels\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Case study: regulation and effectiveness of hydroalcoholic gels - 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