{"id":2523,"date":"2025-01-28T17:16:30","date_gmt":"2025-01-28T16:16:30","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2523"},"modified":"2025-02-26T11:01:32","modified_gmt":"2025-02-26T10:01:32","slug":"case-studies-biocides-2","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/case-studies-biocides-2\/","title":{"rendered":"Biocides: Comparative analysis of regulation, effectiveness, and reclassification risks"},"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>Case study: Regulation and effectiveness of biocides<\/strong><\/h1>\n\n\n\n<p style=\"font-size:18px\">Biocides play a crucial role in disinfection, pest control, and hygiene, both human and veterinary. However, their market authorization is subject to specific regulatory requirements that vary depending on their type, composition, and expected effectiveness. In this case study, we analyze three commonly used biocides:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Hydroalcoholic gel (PT1 \u2013 Human hygiene)<\/strong><\/li>\n\n\n\n<li style=\"font-size:18px\"><strong>Anti-lice spray (PT18 \u2013 Insecticide or PT19 \u2013 Repellent)<\/strong><\/li>\n\n\n\n<li style=\"font-size:18px\"><strong>Teat disinfectant for cows (PT3 \u2013 Veterinary hygiene)<\/strong><\/li>\n<\/ul>\n\n\n\n<p style=\"font-size:18px\">We will examine the specificities of each based on key criteria: active substance, applicable regulatory framework, effectiveness, and risks of reclassification.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\"><strong>Product type (PT) and active substances<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">Each biocide falls under a specific regulatory category, defined by its\u00a0product type (PT)\u00a0and\u00a0main active substance:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Hydroalcoholic gel (PT1):<\/strong>\u00a0Ethanol is the most common active substance.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Anti-lice spray (PT18 or PT19):<\/strong>\u00a0The most frequently used active substances are hydrated\/cyclized eucalyptus citriodora essential oil and geraniol.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Teat disinfectant for cows (PT3):<\/strong>\u00a0Lactic acid is the primary active substance used.<\/li>\n<\/ul>\n\n\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\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\">The regulatory status primarily depends on the active substance used:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Hydroalcoholic gel and anti-lice spray:<\/strong>\u00a0These products still fall under the transitional framework, meaning they are subject to national regulations in each country until their active substance(s) receive official approval from the European Union.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Teat disinfectant for cows:<\/strong>\u00a0It falls under the established framework, requiring a marketing authorization (MA) since its active substance (lactic acid) has been approved in the EU since 2017.<\/li>\n<\/ul>\n\n\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\"><strong>Effectiveness and regulatory requirements<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">The effectiveness of a biocide must be demonstrated through standardized tests (when available):<\/p>\n\n\n\n<ul style=\"font-size:18px\" class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Hydroalcoholic gel:<\/strong>\u00a0It must be proven as\u00a0<strong>bactericidal, fungicidal, and often virucidal<\/strong>\u00a0using phase 2 tests.<\/li>\n<\/ul>\n\n\n\n<ul style=\"font-size:18px\" class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Anti-lice spray:<\/strong>\u00a0Less standardized, but there are recommendations.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Teat disinfectant for cows:<\/strong>\u00a0Labeling must comply with the MA, which has validated the efficacy claims.<\/li>\n<\/ul>\n\n\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\"><strong>Risks of reclassification<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">Certain products may be reclassified depending on their composition or mode of action:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Hydroalcoholic gel:<\/strong>\u00a0Its biocidal status is well-defined, with no regulatory ambiguity.<\/li>\n\n\n\n<li style=\"font-size:18px\"><strong>Anti-lice spray:<\/strong>\u00a0It can be reclassified as a\u00a0<strong>medical device<\/strong>\u00a0if its mode of action is mechanical (e.g., suffocating lice by coating them).<\/li>\n\n\n\n<li style=\"font-size:18px\"><strong>Teat disinfectant:<\/strong>\u00a0It can be reclassified as a\u00a0<strong>veterinary medicine<\/strong>\u00a0if it is used to treat a condition such as mastitis.<\/li>\n<\/ul>\n\n\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\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\">Biocides are subject to strict requirements regarding\u00a0regulation, effectiveness, and classification. The\u00a0transitional framework\u00a0still in effect for some products (due to the active substance used) requires\u00a0close monitoring of regulatory developments. Additionally, the\u00a0boundary between biocide, medical device, and veterinary medicine\u00a0must be carefully assessed to prevent unexpected reclassification.<\/p>\n\n\n\n<p style=\"font-size:18px\">All these factors must be taken into account to ensure compliance and the successful commercialization of these products in the\u00a0European market.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<section id=\"block_83304e7a84f0c04a6b4a79b59d605ccc\" 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\\\">Can I use any substance I want to achieve the desired effect in my biocidal product?<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><span class=\\\"fourth-title\\\">No. Only specific substances listed in various regulatory frameworks can be used as biocidal active substances (AS):<\\\/span><\\\/p>\\n<ul>\\n<li>AS officially approved at the EU level (list maintained by the European Chemicals Agency &#8211; ECHA)<\\\/li>\\n<li>AS listed in Annex I of Regulation 528\\\/2012 (Biocidal Products Regulation &#8211; BPR)<\\\/li>\\n<li>AS included in Regulation 1062\\\/2014 (Review Program Regulation)<br \\\/>\\nThese substances are generally linked to one or more product types (PT), meaning they are approved for specific uses. This is known as the AS\\\/PT pair.<\\\/li>\\n<\\\/ul>\\n<p>For example, if a substance is only approved for PT1 (human hygiene), it cannot be used in a product claiming effectiveness under PT2 (surface disinfection).<\\\/p>\\n<p>Additionally, these active substances must be sourced from approved suppliers (except for AS listed in Annex I of the Biocidal Products Regulation). These suppliers are referenced on the &#8220;Article 95 list&#8221;, maintained by ECHA.<\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"<h3><span class=\\\"third-title\\\">What is the procedure for placing a biocidal product on the market?<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><span class=\\\"fourth-title\\\">There are two main regulatory frameworks for market authorization, depending on the active substances used and the claimed effectiveness:<\\\/span><\\\/p>\\n<ul>\\n<li><strong>Permanent framework:<\\\/strong> This is the standard procedure, which will eventually become the only applicable system. It requires obtaining a marketing authorization (MA) for each biocidal product before it can be placed on the market. This framework applies when all active substances in the product are officially approved for the claimed efficacy.<\\\/li>\\n<li><strong>Transitional framework:<\\\/strong> In some cases, regulations allow the placement of biocidal products on the market even if they contain active substances that have not yet been officially approved. To qualify for this framework, the product must contain an AS listed in Regulation 1062\\\/2014. Under these conditions, an MA is generally not required (except in rare cases), as national regulations of the country where the product is marketed apply to labeling and registration requirements.<\\\/li>\\n<\\\/ul>\\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\">Can I use any substance I want to achieve the desired effect in my biocidal product?<\/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\">No. Only specific substances listed in various regulatory frameworks can be used as biocidal active substances (AS):<\/span><\/p>\n<ul>\n<li>AS officially approved at the EU level (list maintained by the European Chemicals Agency &#8211; ECHA)<\/li>\n<li>AS listed in Annex I of Regulation 528\/2012 (Biocidal Products Regulation &#8211; BPR)<\/li>\n<li>AS included in Regulation 1062\/2014 (Review Program Regulation)<br \/>\nThese substances are generally linked to one or more product types (PT), meaning they are approved for specific uses. This is known as the AS\/PT pair.<\/li>\n<\/ul>\n<p>For example, if a substance is only approved for PT1 (human hygiene), it cannot be used in a product claiming effectiveness under PT2 (surface disinfection).<\/p>\n<p>Additionally, these active substances must be sourced from approved suppliers (except for AS listed in Annex I of the Biocidal Products Regulation). These suppliers are referenced on the &#8220;Article 95 list&#8221;, maintained by ECHA.<\/p>\n                            <\/div>\n                        <\/div>\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3><span class=\"third-title\">What is the procedure for placing a biocidal product on the market?<\/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\">There are two main regulatory frameworks for market authorization, depending on the active substances used and the claimed effectiveness:<\/span><\/p>\n<ul>\n<li><strong>Permanent framework:<\/strong> This is the standard procedure, which will eventually become the only applicable system. It requires obtaining a marketing authorization (MA) for each biocidal product before it can be placed on the market. This framework applies when all active substances in the product are officially approved for the claimed efficacy.<\/li>\n<li><strong>Transitional framework:<\/strong> In some cases, regulations allow the placement of biocidal products on the market even if they contain active substances that have not yet been officially approved. To qualify for this framework, the product must contain an AS listed in Regulation 1062\/2014. Under these conditions, an MA is generally not required (except in rare cases), as national regulations of the country where the product is marketed apply to labeling and registration requirements.<\/li>\n<\/ul>\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>Case study: Regulation and effectiveness of biocides Biocides play a crucial role in disinfection, pest control, and hygiene, both human and veterinary. However, their market authorization is subject to specific regulatory requirements that vary depending on their type, composition, and expected effectiveness. In this case study, we analyze three commonly used biocides: We will examine [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1703,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[269,75,1],"tags":[],"class_list":["post-2523","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>Regulatory case studies on biocides<\/title>\n<meta name=\"description\" content=\"Regulatory case studies on biocides: hydroalcoholic gels, anti-lice sprays, and veterinary disinfectants.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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