{"id":6024,"date":"2025-06-27T16:50:46","date_gmt":"2025-06-27T14:50:46","guid":{"rendered":"https:\/\/www.alden.ua\/chemical-registration-a-complete-guide-to-the-new-regulations\/"},"modified":"2026-02-04T23:14:57","modified_gmt":"2026-02-04T21:14:57","slug":"chemical-registration-a-complete-guide-to-the-new-regulations","status":"publish","type":"post","link":"https:\/\/www.alden.ua\/en\/chemical-registration-a-complete-guide-to-the-new-regulations\/","title":{"rendered":"Chemical registration: a complete guide to the new regulations"},"content":{"rendered":"\n<p>Since 2024, a new chemical safety system has been in force in Ukraine, requiring businesses to adapt to European standards. <strong>The pre-registration of chemical substances<\/strong>, the implementation of a Unique Formula Identifier (UFI) for hazardous mixtures, and updated labelling are no longer a future requirement, but an immediate necessity. This guide will help you understand the new rules, prepare in a timely manner, and avoid hefty fines.<\/p>\n\n<h2 class=\"wp-block-heading\"><strong>What Do the New Technical Regulations Change?<\/strong><\/h2>\n\n<p>The foundation of the new system is Law No. 2718-IX, adopted to implement key documents that harmonise Ukrainian legislation with the European REACH and CLP frameworks.<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>\u0422Technical Regulation No. <a href=\"https:\/\/zakon.rada.gov.ua\/laws\/show\/847-2024-%D0%BF?lang=en#Text\">847-2024<\/a>:<\/strong> concerns the safety of chemical products and establishes the obligation for pre-registration and full registration of each chemical substance that is manufactured or imported in quantities above 1 tonne per year. The competent authority is the <strong>Ministry of Economy, Environment and Agriculture of Ukraine<\/strong> (Ministry of Economy).<\/li>\n\n\n\n<li><strong>Technical Regulation No. <a href=\"https:\/\/zakon.rada.gov.ua\/laws\/show\/539-2024-%D0%BF?lang=en#Text\">539-2024<\/a>:<\/strong> regulates the classification, labelling, and packaging of chemical products. It introduces the concept of a <strong>Unique Formula Identifier (UFI)<\/strong> for hazardous mixtures and requires the submission of notifications to the <strong>Ministry of Health<\/strong> (MoH).<\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading\"><strong>Substances and Mixtures: Key Differences in Registration<\/strong><\/h2>\n\n<p>It is essential to recognise that distinct compliance procedures apply to individual substances and to mixtures.<\/p>\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td>Parameter<\/td><td>Chemical Substance<\/td><td>Chemical Mixture<\/td><\/tr><tr><td><strong>Pre-registration (Ministry of Economyt)<\/strong><\/td><td>\u2705<strong>Yes<\/strong> (mandatory)<\/td><td>\u274c No<\/td><\/tr><tr><td><strong>Full registration (Ministry of Economy)<\/strong><\/td><td>\u2705 <strong>Yes <\/strong> (phased)<\/td><td>\u274c No<\/td><\/tr><tr><td><strong>Classification and labelling (TR 539)<\/strong><\/td><td>\u2705 <strong>Yes<\/strong><\/td><td>\u2705 <strong>Yes<\/strong><\/td><\/tr><tr><td><strong>UFI (for hazardous mixtures)<\/strong><\/td><td>\u274c No<\/td><td>\u2705 <strong>Yes<\/strong> <\/td><\/tr><tr><td><strong>Notification (MoH)<\/strong><\/td><td>\u274c No<\/td><td>\u2705 <strong>Yes<\/strong> <\/td><\/tr><\/tbody><\/table><\/figure>\n\n<h2 class=\"wp-block-heading\"><strong>Key Deadlines: How Not to Miss Critical Dates<\/strong><\/h2>\n\n<p>Time for preparation is limited. Here are the key dates you should put in your calendar:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>By 06.12.2026 (inclusive)<\/strong> \u2014 transition period to <strong>bring products into compliance<\/strong> with TR No. 539 (classification, labelling and packaging), except for the exemptions below\n<ul class=\"wp-block-list\">\n<li><strong>By 15.11.2027 (for substances)<\/strong> \u2014 <strong>postponed <\/strong> application of classification criteria in Sections <strong>3.11.2.1\u20133.11.2.3, 4.2.2.1\u20134.2.2.3, 4.3.2.1\u20134.3.2.4, 4.4.2.1\u20134.4.2.4<\/strong> of Annex I and the corresponding hazard communication elements <strong>3.11.4.1, 4.2.4.1, 4.3.4.1, 4.4.4.1<\/strong> of Annex I.<\/li>\n\n\n\n<li><strong>By 01.05.2028 (for mixtures)<\/strong> \u2014 <strong>postponed <\/strong> application of the same Annex I criteria (<strong>3.11.2.1\u20133.11.2.3, 4.2.2.1\u20134.2.2.3, 4.3.2.1\u20134.3.2.4, 4.4.2.1\u20134.4.2.4<\/strong>) and the same hazard communication elements (<strong>3.11.4.1, 4.2.4.1, 4.3.4.1, 4.4.4.1<\/strong>).<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>By 01.07.2028<\/strong> \u2014 chemical products placed on the market before 01.01.2027 and still labelled\/packaged under the \u201cold\u201d rules may not be prohibited or restricted solely due to non-compliance with TR No. 539 labelling\/packaging requirements<\/li>\n\n\n\n<li><strong>After 06.12.2026: Within<\/strong> <strong>30 days after the first placing on the market<\/strong> \u2014 for each new hazardous substance, a classification notification must be submitted to the Ministry of Economy, Environment and Agriculture (paras. 125\u2013129 of TR No. 539).<\/li>\n\n\n\n<li><strong>26.01.2025 \u2013 26.01.2027<\/strong> \u2014 <strong>the pre-registration submission \u201cwindow\u201d<\/strong> for chemical substances (UA-REACH). Substances without pre-registration cannot be legally placed\/kept on the market. Products without pre-registration will not be permitted to remain on the market legally. After 26.01.2027, placing substances on the market is possible only after full registration.<\/li>\n\n\n\n<li><strong>2029 \/ 2031 \/ 2033<\/strong> \u2014 deadlines for full registration of substances depending on annual tonnage and hazard profile, provided that pre-registration was submitted.<\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading\"><strong>When Documents Must Be Submitted: Key Criteria<\/strong><\/h2>\n\n<p><strong>1) Classification Notification (UA-CLP)<\/strong><\/p>\n\n<p>Submission is mandatory if both of the following conditions are <strong>met simultaneously:<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li>The substance is classified as <strong>hazardous<\/strong>;<\/li>\n\n\n\n<li><strong>and<\/strong> the annual volume placed on the market is <strong>\u2265 1 tonne per year<\/strong>.<\/li>\n<\/ul>\n\n<p><strong>What if the conditions are not met?<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>If the volume is &lt; 1 tonne per year:<\/strong> no notification is required, but you must still prepare an internal classification, ensure proper labelling, and have a safety data sheet (SDS).<\/li>\n\n\n\n<li><strong>If the substance is not hazardous:<\/strong> no notification is required (even if the volume is &gt; 1 tonne per year). In this case, an internal classification report and a label (without GHS symbols) are prepared. <\/li>\n<\/ul>\n\n<p><strong>2) Preliminary State Registration (UA-REACH)<\/strong><\/p>\n\n<p>Here, the only decisive factor is volume; the hazard classification does not matter.<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Mandatory if:<\/strong> the annual volume of the substance (including in mixtures) is <strong>\u2265 1 tonne per year<\/strong>.<\/li>\n\n\n\n<li><strong>Not required if:<\/strong> the annual volume is <strong>&lt; 1 tonne per year<\/strong>. In this case, it is sufficient to have internal classification, proper labelling, and an SDS. <\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading\"><strong>Your Step-by-Step Compliance Plan<\/strong><\/h2>\n\n<p>To adapt your business to the new requirements, act sequentially:<\/p>\n\n<ol class=\"wp-block-list\">\n<li><strong>Inventory:<\/strong> Conduct a full audit of all chemical substances and mixtures that you manufacture or import. Determine their volumes and composition.<\/li>\n\n\n\n<li><strong>Classification and labelling:<\/strong> Determine the hazard classes for your products and update <strong>safety data sheets<\/strong> and labels in line with TR No. 539.<\/li>\n\n\n\n<li><strong>Appointment of a representative:<\/strong> If the manufacturer is a non-resident of Ukraine, an authorised representative responsible for compliance with the regulations must be appointed.<\/li>\n\n\n\n<li><strong>Pre-registration:<\/strong> Prepare and submit dossiers for the pre-registration of substances to the Ministry of Economy within the established timelines.<\/li>\n\n\n\n<li><strong>Preparation for UFI:<\/strong> For hazardous mixtures, generate a Unique Formula Identifier (UFI) and prepare the data required for notification.<\/li>\n<\/ol>\n\n<h2 class=\"wp-block-heading\"><strong>Consequences of Inaction: From Fines to Customs Blocks<\/strong><\/h2>\n\n<p>Ignoring the new rules may lead to serious financial and operational losses:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Fines:<\/strong> from UAH 17,000 to 340,000 for violations of chemical safety legislation (Article 244-8 of the Code of Administrative Offences).<\/li>\n\n\n\n<li><strong>Criminal liability:<\/strong> for the manufacture or sale of hazardous products that violate sanitary or environmental safety (Article 325-2 of the Criminal Code of Ukraine).<\/li>\n\n\n\n<li><strong>Customs issues:<\/strong> Blocking the import and export of products that do not comply with the regulations.<\/li>\n\n\n\n<li><strong>Market surveillance:<\/strong> Orders to withdraw products from the market and bans on their sale.<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\"><strong>Do Not Risk Your Business: Get Professional Support<\/strong><\/h3>\n\n<p>The adaptation process is complex and requires deep expertise. To ensure that you pass all stages correctly and on time, seek professional assistance.<\/p>\n\n<p><strong>Order an audit of your products, and we will help you:<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li>Carry out inventory and <a href=\"https:\/\/www.alden.ua\/services\/klasyfikacziya-himichnyh-rechovyn-ta-sumishej-ghs-clp\/\">classification<\/a>.<\/li>\n\n\n\n<li>Prepare files for <strong>the registration of chemical substances <\/strong> and UFI.<\/li>\n\n\n\n<li>Complete the preliminary state <a href=\"https:\/\/www.alden.ua\/en\/services\/reyestracziya-tovariv-u-profilnyh-vidomstvah\/preliminary-state-registration-of-chemicals\/\">registration<\/a>.<\/li>\n\n\n\n<li>Develop compliant <a href=\"https:\/\/www.alden.ua\/en\/services\/markuvannya-clp-ufi-ta-pakuvannya-himichnoyi-produkcziyi\/\">labelling <\/a> and <a href=\"https:\/\/www.alden.ua\/en\/services\/tehnichna-dokumentacziya\/rozrobka-pasportiv-bezpeky-msds\/\">safety data sheets<\/a>.<\/li>\n\n\n\n<li>Find an authorised representative in Ukraine.<\/li>\n<\/ul>\n\n<p><\/p>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.alden.ua\/en\/services\/tehnichna-dokumentacziya\/rozrobka-pasportiv-bezpeky-msds\/\">MSDS Authoring<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-text-align-center wp-element-button\" href=\"https:\/\/www.alden.ua\/en\/services\/markuvannya-clp-ufi-ta-pakuvannya-himichnoyi-produkcziyi\/\">CLP-UFI Labeling<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.alden.ua\/services\/klasyfikacziya-himichnyh-rechovyn-ta-sumishej-ghs-clp\/\">Classification (GHS \/ CLP)<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.alden.ua\/en\/services\/reyestracziya-tovariv-u-profilnyh-vidomstvah\/preliminary-state-registration-of-chemicals\/\">Pre-registration<\/a><\/div>\n<\/div>\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Since 2024, a new chemical safety system has been in force in Ukraine, requiring businesses to adapt to European standards. The pre-registration of chemical substances, the implementation of a Unique Formula Identifier (UFI) for hazardous mixtures, and updated labelling are no longer a future requirement, but an immediate necessity. This guide will help you understand [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":5636,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[38],"tags":[],"class_list":["post-6024","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legal-services"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Chemical registration: how to avoid fines in 2025 - ALDEN<\/title>\n<meta name=\"description\" content=\"New regulations for 2024! 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