{"id":2490,"date":"2025-01-07T20:12:27","date_gmt":"2025-01-07T19:12:27","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2490"},"modified":"2025-02-26T11:01:49","modified_gmt":"2025-02-26T10:01:49","slug":"case-study-regulation-and-effectiveness-of-anti-lice-sprays","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/case-study-regulation-and-effectiveness-of-anti-lice-sprays\/","title":{"rendered":"Case study: regulation and effectiveness of anti-lice sprays"},"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><strong>Case study: regulation and effectiveness of biocidal anti-lice sprays<\/strong><\/strong><\/h1>\n\n\n\n<p style=\"font-size:18px\">Anti-lice sprays are biocidal products that can be classified as either PT18 (Insecticide) or PT19 (Repellent). Their mode of action and composition determine their regulatory classification.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:20px\"><strong>Active substances<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">The most common active substances in these sprays are:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\">Hydrated\/cyclized eucalyptus citriodora essential oil (CAS No. 1245629-80-4)<\/li>\n\n\n\n<li style=\"font-size:18px\">Geraniol (CAS No. 106-24-1)<\/li>\n<\/ul>\n\n\n\n<p style=\"font-size:18px\">These substances can be used individually or in combination.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:20px\"><strong>Regulatory framework<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">Anti-lice sprays currently fall under a transitional framework if they contain the above-mentioned active substances. This means that the national laws of each country apply while awaiting an official evaluation of these substances by the EU.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:20px\"><strong>Effectiveness<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">The assessment of effectiveness depends on the product type:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>PT19 (Repellent):<\/strong>\u00a0The duration of protection must be specified and demonstrated.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>PT18 (Insecticide):<\/strong>\u00a0The biocidal effect must be demonstrated through testing that specifies the minimum required action time.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:20px\"><strong>Risk of reclassification<\/strong><\/h2>\n\n\n\n<p>Anti-lice sprays can be reclassified as&nbsp;medical devices&nbsp;depending on their composition and mode of action. For example, a product that acts mechanically (by suffocating lice or preventing their attachment to hair) could be classified as a medical device.<\/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\">Anti-lice sprays must be appropriately positioned in the market based on their regulatory classification. Their effectiveness, composition, and mode of action require close attention to avoid potential reclassification as medical devices. Furthermore, these products remain under a transitional framework due to their active substances, meaning their regulatory status could evolve depending 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_83a4c57fbee27fff75d5b8a66fd29ae4\" 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\\\">What is the current regulation for anti-lice sprays in Europe?<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><span class=\\\"fourth-title\\\">They fall under a transitional framework if they contain one or both of the active substances mentioned above. Each country applies its own regulations while awaiting European-level approval of these substances.<\\\/span><\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"<h3><span class=\\\"third-title\\\">What is the difference between a PT18 and a PT19 anti-lice spray?<\\\/span><br \\\/>\\n<span class=\\\"third-title\\\">\\u00a0<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><span class=\\\"fourth-title\\\">A PT18 (Insecticide) eliminates lice by killing them, whereas a PT19 (Repellent) prevents their attachment without lethal action.<\\\/span><\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"<h3><span class=\\\"third-title\\\">Why can some anti-lice sprays be reclassified as medical devices?<\\\/span><br \\\/>\\n<span class=\\\"third-title\\\">\\u00a0<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><span class=\\\"fourth-title\\\">If the product acts mechanically, for example by suffocating lice without using a biocidal active substance, it can be classified as a medical device instead of a biocide.<\\\/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\">What is the current regulation for anti-lice sprays 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 if they contain one or both of the active substances mentioned above. Each country applies its own regulations while awaiting European-level approval of these substances.<\/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 difference between a PT18 and a PT19 anti-lice spray?<\/span><br \/>\n<span class=\"third-title\">\u00a0<\/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\">A PT18 (Insecticide) eliminates lice by killing them, whereas a PT19 (Repellent) prevents their attachment without lethal action.<\/span><\/p>\n                            <\/div>\n                        <\/div>\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3><span class=\"third-title\">Why can some anti-lice sprays be reclassified as medical devices?<\/span><br \/>\n<span class=\"third-title\">\u00a0<\/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\">If the product acts mechanically, for example by suffocating lice without using a biocidal active substance, it can be classified as a medical device instead of a biocide.<\/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>Case study: regulation and effectiveness of biocidal anti-lice sprays Anti-lice sprays are biocidal products that can be classified as either PT18 (Insecticide) or PT19 (Repellent). Their mode of action and composition determine their regulatory classification. Active substances The most common active substances in these sprays are: These substances can be used individually or in combination. [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1479,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[269,75,1],"tags":[],"class_list":["post-2490","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 anti-lice sprays - Pharmanager Development<\/title>\n<meta name=\"description\" content=\"Anti-lice sprays can be classified as PT18 (Insecticide) or PT19 (Repellent). 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