{"id":110610,"date":"2025-10-09T10:29:21","date_gmt":"2025-10-09T10:29:21","guid":{"rendered":"https:\/\/insights.greyb.com\/?post_type=ht_kb&#038;p=110610"},"modified":"2025-10-09T10:30:10","modified_gmt":"2025-10-09T10:30:10","slug":"diazolidinyl-urea-replacement","status":"publish","type":"ht_kb","link":"https:\/\/insights.greyb.com\/diazolidinyl-urea-replacement\/","title":{"rendered":"Diazolidinyl Urea Replacement: Regulations, Alternatives, and Suppliers"},"content":{"rendered":"\n<p><strong>Diazolidinyl Urea<\/strong> (INCI: <em>Diazolidinyl Urea<\/em>, CAS 78491-02-8) is a widely used antimicrobial preservative across cosmetics, personal care, topical pharmaceuticals, and select household formulations.<\/p>\n\n\n\n<p>Functionally, it acts as a formaldehyde-releasing agent, slowly liberating trace formaldehyde to inhibit bacteria, yeast, and mold. While historically valued for its broad-spectrum efficacy and cost efficiency, its reliance on formaldehyde release has triggered increasing regulatory scrutiny and phase-out efforts worldwide.<\/p>\n\n\n\n<p>In the European Union, formaldehyde donors including Diazolidinyl Urea are tightly restricted under Regulation (EC) 1223\/2009 Annex V and subject to labeling when the released formaldehyde concentration exceeds 0.001 % (10 ppm).<\/p>\n\n\n\n<p>Several U.S. states-led by California and Washington-have enacted or proposed bans on intentionally added formaldehyde and formaldehyde-releasing ingredients in cosmetics by 2027, aligning with growing international trends toward \u201cformaldehyde-free\u201d preservation.<\/p>\n\n\n\n<p>This review summarizes the regulatory drivers behind replacement, examines viable non-formaldehyde preservation systems, and profiles verified global suppliers to support R&amp;D reformulation across industries.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Why Replace Diazolidinyl Urea<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Health &amp; Regulatory Concerns<\/strong><\/h3>\n\n\n\n<p><strong>1. Formaldehyde Release:&nbsp;<\/strong><\/p>\n\n\n\n<p>Diazolidinyl Urea hydrolyzes to form formaldehyde under typical formulation and storage conditions. Formaldehyde is classified in the EU as a Category 1B carcinogen and skin sensitizer (1) under CLP Regulation 1272\/2008.<\/p>\n\n\n\n<p><strong>2. EU Cosmetic Restriction:<\/strong><\/p>\n\n\n\n<p>Permitted only under Annex V entry 55 with concentration limits ensuring \u22640.2 % free formaldehyde in finished products. From 2022 onward, labeling is required at \u2265 0.001 % free formaldehyde (Reg. (EU) 2022\/1181).<br><\/p>\n\n\n\n<p><strong>3. U.S. Regulatory Trend:<\/strong><\/p>\n\n\n\n<p>The Modernization of Cosmetics Regulation Act (MoCRA, 2022) and state-level bills in Washington and California prohibit sale of products containing formaldehyde donors from Jan 2027 onward<\/p>\n\n\n\n<p><strong>4. Allergenicity:<\/strong><\/p>\n\n\n\n<p>Dermatological studies associate Diazolidinyl Urea with allergic contact dermatitis, particularly at &gt; 0.5 % use level or in leave-on formulations.<br><\/p>\n\n\n\n<p><strong>5. Consumer Perception:<\/strong><\/p>\n\n\n\n<p>\u201cFormaldehyde-free\u201d labeling has become a market expectation, especially for skin-contact products marketed as clean, vegan, or hypoallergenic.<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Functional Rationale<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Performance Limitations:<\/strong> Antimicrobial activity declines in alkaline media (> pH 7.5) and at elevated storage temperatures, where decomposition accelerates.<br><\/li>\n\n\n\n<li><strong>Compatibility Issues:<\/strong> Released formaldehyde can react with amines, proteins, or natural extracts, altering actives or colorants.<br><\/li>\n\n\n\n<li><strong>Replacement Imperative:<\/strong> Manufacturers seek safer systems offering comparable microbial protection without donor liabilities, supporting global compliance and consumer acceptance.<br><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Regulatory Landscape for Diazolidinyl Urea<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Region \/ Authority<\/strong><\/td><td><strong>Current Status<\/strong><\/td><td><strong>Key Restrictions<\/strong><\/td><td><strong>Implications for R&amp;D<\/strong><\/td><\/tr><tr><td><strong>European Union (EC\/EFSA\/SCCS)<\/strong><\/td><td>Allowed under Annex V entry 55<\/td><td>Max 1 % in finished product; label \u201creleases formaldehyde\u201d \u2265 0.001 %<\/td><td>Reformulation recommended; phase-out under discussion.<\/td><\/tr><tr><td><strong>United States (FDA \/ State Regulations)<\/strong><\/td><td>Permitted federally; proposed state bans by 2027<\/td><td>MoCRA + state bans (CA, WA)<\/td><td>Prepare formaldehyde-free replacements by 2026.<\/td><\/tr><tr><td><strong>Canada (Health Canada Hotlist)<\/strong><\/td><td>Under review<\/td><td>May be restricted to rinse-off only<\/td><td>Monitor updates; avoid in leave-on.<\/td><\/tr><tr><td><strong>ASEAN \/ India<\/strong><\/td><td>Allowed with Annex V alignment<\/td><td>Labeling if donor present<\/td><td>Shift toward non-donor blends.<\/td><\/tr><tr><td><strong>Japan (MHLW)<\/strong><\/td><td>Permitted under preservative list<\/td><td>Formaldehyde \u2264 0.2 % free<\/td><td>Verify in-use free formaldehyde.<\/td><\/tr><tr><td><strong>Codex \/ WHO \/ JECFA<\/strong><\/td><td>Not applicable (cosmetic additive)<\/td><td>JECFA withdrawn formaldehyde specifications for ingestion<\/td><td>Supports precautionary removal in global trade.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Manufacturers of Non-Formaldehyde Preservative Alternatives<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Sch\u00fclke &amp; Mayr GmbH (Germany; Global)<\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/www.schuelke.com\/intl-en\/index.php\">Sch\u00fclke<\/a> markets <strong>Euxyl PE 9010<\/strong> (Phenoxyethanol 90 % + Ethylhexylglycerin 10 %) as a broad-spectrum, paraben- and formaldehyde-free preservative effective at 0.5\u20131.0 %.<br><\/p>\n\n\n\n<p>Stable across pH 3\u201310 and heat-resistant up to 80 \u00b0C, PE 9010 meets EU Annex V and FDA GRAS criteria. The company provides preservative efficacy data (ISO 11930) and formulation support for cosmetics, pharmaceuticals, and industrial cleaners.<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Ashland Global Holdings Inc. (USA; Global)<\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/www.ashland.com\/\">Ashland\u2019s<\/a> Optiphen series (Optiphen, Optiphen ND, Optiphen Plus) combines Phenoxyethanol, Caprylyl Glycol, and Sorbic Acid derivatives.They offer broad-spectrum protection at 0.5\u20131.2 % with high solubility and minimal odor.&nbsp;<\/p>\n\n\n\n<p>Optiphen ND is optimized for natural emulsions (pH \u2264 6.5) and Ecocert\/COSMOS-approved.<br>Ashland supports preservative stress testing and claims substantiation.<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3. Lonza (Specialty Ingredients, Switzerland; Global)<\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/arxada.com\/en\">Lonza<\/a> (now Arxada) supplies Geogard\u00ae Ultra (Gluconolactone + Sodium Benzoate) and Geogard\u00ae ET (Phenoxyethanol + Ethylhexylglycerin).<br><\/p>\n\n\n\n<p>Both are globally accepted, broad-spectrum, and listed in Annex V &amp; EPA Safer Choice programs.Geogard Ultra functions optimally at pH 3\u20136 and is suitable for natural and clean-label systems.<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>4. Clariant AG (Switzerland; Global)<\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/www.clariant.com\/en\/Solutions\/Industries\">Clariant\u2019s<\/a> Nipaguard SCE is a synergistic preservative blend (Sodium Benzoate, Potassium Sorbate, and Gluconolactone) tailored for \u201cpreservative-free claim\u201d formulations.<\/p>\n\n\n\n<p>Effective at 0.75\u20131.5 % in aqueous and emulsion systems, it is readily biodegradable, COSMOS-approved, and REACH-registered.Clariant provides formulation guidelines for leave-on and rinse-off products with pH \u2264 6.<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>5. Evonik Industries AG (Germany; Global)<\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/personal-care.evonik.com\/en\">Evonik<\/a> offers Verstatil BL and Verstatil TBG as next-generation non-donor preservation systems. Verstatil\u00ae TBG (Phenylpropanol + Caprylyl Glycol + Glycerin) is effective 0.8\u20131.2 %, heat-stable \u2264 85 \u00b0C, pH 3\u20139, and suitable for both emulsions and aqueous gels.Compliant with REACH and COSMOS, these blends enable \u201cformaldehyde-free\u201d claims and high sensory acceptance.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>6. Symrise AG (Germany; Global)<\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/www.symrise.com\/\">Symrise\u2019s<\/a> SymOcide BHO (Benzyl Alcohol + Caprylyl Glycol + Glyceryl Caprylate) provides balanced antibacterial and antifungal coverage at 0.8\u20131.0 %.<\/p>\n\n\n\n<p>Its blend avoids parabens and formaldehyde donors, maintaining broad pH (4\u20138) stability and positive sensory profiles.Symrise supplies microbiological challenge data and regulatory dossiers per EU and ASEAN requirements.<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>7. INOLEX Inc. (USA; Global)<\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/inolex.com\/\">INOLEX\u2019s<\/a> Lexgard Natural MB (Caprylyl Glycol + Glyceryl Caprylate) and Aminat CG (Phenoxyethanol + Caprylyl Glycol) serve as multifunctional antimicrobials compatible with emulsions, surfactant systems, and wipes.They are biobased, vegan, and COSMOS-approved, supporting clean-label and natural formulations.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Formulation Considerations<\/strong><\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Target Spectrum:<\/strong><strong><br><\/strong>\n<ul class=\"wp-block-list\">\n<li>Phenoxyethanol-based systems: broad antibacterial with moderate antifungal; combine with organic acids for yeast\/mold coverage.<br><\/li>\n\n\n\n<li>Organic acid systems: effective at acidic pH (&lt; 6); less suited for alkaline cleaners.<br><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Dosage &amp; pH:<\/strong><strong><br><\/strong>\n<ul class=\"wp-block-list\">\n<li>Phenoxyethanol blends: 0.5\u20131.2 %; stable pH 3\u201310.<br><\/li>\n\n\n\n<li>Organic acid systems: 0.75\u20131.5 %; effective pH 3\u20136.<br><\/li>\n\n\n\n<li>Glycol\/glycerin blends: 0.8\u20131.2 %; pH 3\u20139.<br><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Compatibility:<\/strong><strong><br><\/strong> Test interactions with surfactants, proteins, and actives; chelating agents (EDTA, gluconates) improve efficacy. Avoid anionic conflict with sorbates\/benzoates.<br><\/li>\n\n\n\n<li><strong>Thermal Stability:<\/strong><strong><br><\/strong> Add preservatives during cool-down (&lt; 60 \u00b0C) to prevent degradation. Conduct accelerated aging (45 \u00b0C, 12 weeks) and freeze-thaw cycles.<br><\/li>\n\n\n\n<li><strong>Packaging:<\/strong><strong><br><\/strong> Use oxygen-barrier and low-headspace packaging (HDPE, PET, airless pumps). Avoid metal contact if benzoates or acids are present.<br><\/li>\n\n\n\n<li><strong>Shelf Life Validation:<\/strong><strong><br><\/strong> Conduct preservative efficacy (ISO 11930), microbial limits (USP &lt;61>, &lt;62>), and sensory stability testing over 6\u201312 months.<br><\/li>\n\n\n\n<li><strong>Labeling &amp; Claims:<\/strong><strong><br><\/strong> For global compliance, declare preservatives per INCI; apply allergen labeling if benzyl alcohol \u2265 0.001 % in leave-on products.<br><\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p>Diazolidinyl Urea has served as a cost-effective preservative for decades, yet its formaldehyde-releasing mechanism is no longer aligned with modern regulatory or market expectations.Pending U.S. state bans, EU tightening of formaldehyde-labeling thresholds, and global consumer aversion collectively render the ingredient commercially obsolete for new developments.<\/p>\n\n\n\n<p>Modern non-formaldehyde preservation systems-notably phenoxyethanol\/glycol blends, organic acid systems, and multifunctional biobased boosters-offer equivalent antimicrobial efficacy, global regulatory acceptance, and superior sensory performance.<br>Cross-industry R&amp;D teams should prioritize these alternatives, supported by robust efficacy validation and supplier documentation.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Looking to replace Diazolidinyl Urea with safer, compliant preservatives? Use the form below to connect with our experts for specifications, supplier references, and technical support.<\/strong><\/h4>\n\n\n\n<!-- [if lte IE 8]>\r\n<script charset=\"utf-8\" type=\"text\/javascript\" src=\"\/\/js.hsforms.net\/forms\/v2-legacy.js\"><\/script>\r\n<![endif]-->\r\n<p><script charset=\"utf-8\" type=\"text\/javascript\" src=\"\/\/js.hsforms.net\/forms\/v2.js\"><\/script> <script>\r\n  hbspt.forms.create({\r\n              region: \"na1\",\r\n              portalId: \"1791848\",\r\n              formId: \"80423420-ed8c-4752-9c8b-6930b6dc7c52\"\r\n});\r\n<\/script><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Diazolidinyl Urea (INCI: Diazolidinyl Urea, CAS 78491-02-8) is a widely used antimicrobial preservative across cosmetics, personal care, topical pharmaceuticals, and select household formulations. Functionally, it acts as a formaldehyde-releasing agent,&#8230;<\/p>\n","protected":false},"author":10,"comment_status":"open","ping_status":"closed","template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"ht-kb-category":[13609],"ht-kb-tag":[13610],"class_list":["post-110610","ht_kb","type-ht_kb","status-publish","format-standard","hentry","ht_kb_category-ban-ingredients","ht_kb_tag-ban-ingredients"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Diazolidinyl Urea Replacement: Regulations, Alternatives, and Suppliers<\/title>\n<meta name=\"description\" content=\"Explore global regulations, safe non-formaldehyde preservatives, and top suppliers replacing Diazolidinyl Urea in cosmetics, pharma, and personal care.\" \/>\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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