{"id":18319,"date":"2025-08-10T18:55:46","date_gmt":"2025-08-10T17:55:46","guid":{"rendered":"https:\/\/www.cosmacon.de\/?post_type=encyclopedia&#038;p=18319"},"modified":"2025-08-10T18:55:46","modified_gmt":"2025-08-10T17:55:46","slug":"cosmetic-safety-assessment","status":"publish","type":"encyclopedia","link":"https:\/\/www.cosmacon.de\/en\/glossary\/cosmetic-safety-assessment\/","title":{"rendered":"Cosmetic safety assessment"},"content":{"rendered":"<p style=\"font-weight: 400;\">\n<h3 style=\"font-weight: 400;\">Introduction<\/h3>\n<p style=\"font-weight: 400;\">Cosmetic safety assessment\u00a0is the crucial step in ensuring that cosmetic products are safe for consumers. It is enshrined in law in the EU Cosmetics Regulation (EC) No. 1223\/2009 and requires that every product be assessed by a competent person before it is placed on the market. This assessment covers not only the ingredients, but the entire product \u2013 from its composition and packaging to possible side effects.<\/p>\n<p style=\"font-weight: 400;\">\n<h3 style=\"font-weight: 400;\">What data must a safety assessor use?<\/h3>\n<p style=\"font-weight: 400;\">A well-founded\u00a0safety assessment for cosmetics\u00a0is based on a wide range of data that the safety assessor carefully reviews and documents. <strong>This includes:<\/strong><\/p>\n<ul style=\"font-weight: 400;\">\n<li>Product composition: All ingredients with their exact concentration and function.<\/li>\n<li>Physical and chemical properties: Stability, pH value, viscosity, colour, odour.<\/li>\n<li>Toxicological profiles: Risks of individual ingredients, possible allergic reactions or irritations.<\/li>\n<li>Exposure assessment: How much of the product comes into contact with the skin or mucous membranes during normal use?<\/li>\n<li>Side effect data: Information on known undesirable effects, especially serious cases.<\/li>\n<li>Stability and preservation tests: Testing of shelf life and microbiological safety.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><strong>These points form the core of every\u00a0cosmetic safety assessment.<\/strong><\/p>\n<p style=\"font-weight: 400;\">\n<h3 style=\"font-weight: 400;\">What documentation is required for each raw material?<\/h3>\n<p style=\"font-weight: 400;\">For a complete\u00a0cosmetic safety assessment, the following documentation must be available for each raw material used:<\/p>\n<ol style=\"font-weight: 400;\">\n<li>INCI name\u00a0and CAS and EINECS\/ELINCS number.<\/li>\n<li>Detailed composition\u00a0including possible trace substances or impurities.<\/li>\n<li>Function in the product\u00a0(e.g. preservative, moisturiser, colourant).<\/li>\n<li>Toxicological data\u00a0from studies or recognised databases.<\/li>\n<li>Purity criteria\u00a0and limit values for impurities.<\/li>\n<li>Safety data sheets\u00a0(SDS).<\/li>\n<\/ol>\n<p style=\"font-weight: 400;\">Without these documents, a legally compliant\u00a0safety assessment for cosmetics\u00a0is not possible.<\/p>\n<p style=\"font-weight: 400;\">\n<h3 style=\"font-weight: 400;\">Training and qualifications of a safety assessor<\/h3>\n<p style=\"font-weight: 400;\">The\u00a0safety assessment of cosmetics\u00a0may only be carried out by persons who have undergone appropriate training in accordance with the EU Cosmetics Regulation. As a rule, a university degree in one of the following subjects is required:<\/p>\n<ul style=\"font-weight: 400;\">\n<li>Pharmacy<\/li>\n<li>Toxicology<\/li>\n<li>Medicine<\/li>\n<li>or a comparable scientific discipline.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">In addition, the safety assessor must be able to carry out a\u00a0risk analysis\u00a0and prepare the safety report with comprehensible reasoning. This requires both scientific expertise and practical experience in the evaluation of cosmetic ingredients.<\/p>\n<p style=\"font-weight: 400;\">\n<h3 style=\"font-weight: 400;\">Procedure for a safety assessment<\/h3>\n<p style=\"font-weight: 400;\">A typical\u00a0safety assessment for cosmetics\u00a0follows this pattern:<\/p>\n<ol style=\"font-weight: 400;\">\n<li>Collection of all raw material and product data.<\/li>\n<li>Analyse the toxicological properties\u00a0of each ingredient.<\/li>\n<li>Evaluate the product formulation\u00a0in terms of exposure and potential risks.<\/li>\n<li>Prepare the safety report\u00a0with conclusions, warnings and recommendations for use.<\/li>\n<li>Archive in the product information file (PIF).<\/li>\n<\/ol>\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\"><strong>Here you will find a checklist for a safety assessment of cosmetics, including a download<\/strong><\/p>\n<p style=\"font-weight: 400;\">\n<table id=\"tablepress-445\" class=\"tablepress tablepress-id-445\">\n<thead>\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><th class=\"column-2\"><strong>Checklist \u2013 Safety assessment for cosmetics<\/strong><\/th><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><em>\u00a9 Cosmacon GmbH \u2013 Development and consulting for innovative cosmetics<\/em><\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\"><strong>Status<\/strong><\/td><td class=\"column-2\"><strong>Checkpoints<\/strong><\/td><td class=\"column-3\"><strong>Comments<\/strong><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\"><strong>General product information<\/strong><\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Product name &amp; category<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Intended use<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Packaging description<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\"><strong>Full composition<\/strong><\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-10\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">INCI list of all ingredients<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-11\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Quantity in %<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-12\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\"><strong>Raw material documentation<\/strong><\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-13\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">INCI name<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-14\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Safety data sheet (SDS)<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-15\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Technical data sheet<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-16\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Specifications<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-17\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Toxicological data<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-18\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Information on impurities (e.g. heavy metal content in pigments)<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-19\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\"><strong>Stability report<\/strong><\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-20\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">pH value<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-21\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Viscosity<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-22\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Colour, odour<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-23\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Stability<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-24\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Compatibility with packaging<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-25\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\"><strong>Microbiological safety<\/strong><\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-26\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Challenge test \/ preservation stress test<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-27\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\"><strong>Archiving<\/strong><\/td><td class=\"column-3\">Can be provided by Cosmacon<\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-28\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Complete storage in the PIF<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-29\">\n\t<td class=\"column-1\">\u2610<\/td><td class=\"column-2\">Accessibility for authorities<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-445 from cache --><\/p>\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\"><a href=\"https:\/\/www.cosmacon.de\/wp-content\/uploads\/2025\/08\/Checkliste-Sicherheitsbewertung_englisch.pdf\">checklist for a safety assessment of cosmetics<\/a><\/p>\n<p style=\"font-weight: 400;\">\n<h3 style=\"font-weight: 400;\">Conclusion<\/h3>\n<p style=\"font-weight: 400;\">The\u00a0safety assessment of cosmetics\u00a0is much more than a formal step \u2013 it is a guarantee of consumer safety. Only through comprehensive data collection, professional analysis and the work of a qualified safety assessor can it be ensured that a cosmetic product complies with legal requirements and can be safely placed on the market.<\/p>\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\"><a href=\"https:\/\/www.cosmacon.de\/en\/contact\/enquiry\/\" target=\"_blank\" rel=\"noopener\">We can help you carry out these assessments professionally and efficiently, thereby strengthening your brand in the long term. Because products must be safe so that your brand is in a good position right from the start. And we offer all this for a fixed price of Euro 750 per product.<\/a><\/p>\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\"><strong>Literature:<\/strong><\/p>\n<p style=\"font-weight: 400;\">\n<ul>\n<li style=\"font-weight: 400;\">EU Regulation (EC) No. 1223\/2009 on cosmetic products<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/?uri=CELEX:32009R1223\">https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/?uri=CELEX:32009R1223<\/a><\/p>\n<ul>\n<li style=\"font-weight: 400;\">European Commission \u2013 Guidelines on the safety information file for cosmetic products<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/cosmetic_prod_safety_report_de_0.pdf\">https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/cosmetic_prod_safety_report_de_0.pdf<\/a><\/p>\n<ul>\n<li style=\"font-weight: 400;\">Sicherheitsbewerter.info \u2013 Technical information and checklists<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><a href=\"https:\/\/sicherheitsbewerter.info\/\">https:\/\/sicherheitsbewerter.info<\/a><\/p>\n<ul>\n<li style=\"font-weight: 400;\">Tentamus Group \u2013 Safety assessment for cosmetics<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><a href=\"https:\/\/www.tentamus.de\/laboranalysen\/kosmetikanalyse\/sicherheitsbewertung-kosmetik\">https:\/\/www.tentamus.de\/laboranalysen\/kosmetikanalyse\/sicherheitsbewertung-kosmetik<\/a><\/p>\n<ul>\n<li style=\"font-weight: 400;\">Certified Cosmetics \u2013 Safety testing and PIF documentation<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><a href=\"https:\/\/www.certifiedcosmetics.com\/de\/product\/kosmetische-sicherheitsprufung\/komplettes-paket-zur-sicherheitsbewertung-kosmetischer-produkte\/\">https:\/\/www.certifiedcosmetics.com\/de\/product\/kosmetische-sicherheitsprufung\/komplettes-paket-zur-sicherheitsbewertung-kosmetischer-produkte\/<\/a><\/p>\n<p style=\"font-weight: 400;\">\n","protected":false},"excerpt":{"rendered":"<p>Introduction Cosmetic safety assessment\u00a0is the crucial step in ensuring that cosmetic products are safe for consumers. It is enshrined in law in the EU Cosmetics Regulation (EC) No. 1223\/2009 and requires that every product be assessed by a competent person before it is placed on the market. This assessment covers not only the ingredients, but&hellip;<\/p>\n","protected":false},"author":2,"featured_media":18322,"template":"","class_list":["post-18319","encyclopedia","type-encyclopedia","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cosmetic safety assessment - Cosmacon<\/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:\/\/www.cosmacon.de\/en\/glossary\/cosmetic-safety-assessment\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cosmetic safety assessment - Cosmacon\" \/>\n<meta property=\"og:description\" content=\"Introduction Cosmetic safety assessment\u00a0is the crucial step in ensuring that cosmetic products are safe for consumers. 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