{"id":786241,"date":"2025-08-03T23:23:13","date_gmt":"2025-08-03T20:23:13","guid":{"rendered":""},"modified":"2025-08-25T23:29:29","modified_gmt":"2025-08-25T20:29:29","slug":"ukraine-s-1-year-old-cosmetic-products-regulation-seeks-to-bring-ukraine-in-line-with-eu-standards","status":"publish","type":"post","link":"https:\/\/new.eba.com.ua\/en\/ukraine-s-1-year-old-cosmetic-products-regulation-seeks-to-bring-ukraine-in-line-with-eu-standards\/","title":{"rendered":"Ukraine\u2019s 1-year-old cosmetic products regulation seeks to bring Ukraine in line with EU standards"},"content":{"rendered":"<p style=\"font-weight: 400;\">The Technical Regulation on Cosmetic Products, also known as Resolution No. 65 of 20 January 2021, has been in force since 3 August 2024. Developed to align Ukrainian law with EU Regulation 1223\/2009, the Regulation ensures consumer health protection and brings Ukrainian law in line with EU standards.<\/p>\n<p style=\"font-weight: 400;\">According to the Regulation, until 3 August 2026 cosmetic products may be placed on the Ukrainian market under either:<\/p>\n<ul>\n<li>The Law of Ukraine \u201cOn General Safety of Non-Food Products\u201d, or<\/li>\n<li>The new Technical Regulation on Cosmetic Products.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">From 4 August 2026, only products compliant with the new Regulation may remain on the market.<\/p>\n<p style=\"font-weight: 400;\"><strong>Responsible person in Ukraine<\/strong><\/p>\n<p style=\"font-weight: 400;\">Every cosmetic product must have a designated Responsible Person in Ukraine. This person ensures the product complies with the Regulation in terms of:<\/p>\n<ul>\n<li>Composition;<\/li>\n<li>Labelling;<\/li>\n<li>GMP-compliant manufacturing;<\/li>\n<li>Safety documentation;<\/li>\n<li>Notification via the electronic system.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">The Responsible Person can be:<\/p>\n<ul>\n<li>A Ukrainian manufacturer;<\/li>\n<li>An importer (for foreign-made products);<\/li>\n<li>An authorised third party (based in Ukraine) (e.g. regulatory service provider).<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">From 4 August 2026, placing products on the market without an appointed Responsible Person is prohibited.<\/p>\n<p style=\"font-weight: 400;\"><strong>Product Safety Assessment and documentation<\/strong><\/p>\n<p style=\"font-weight: 400;\">The Regulation mandates a two-tier safety assessment:<\/p>\n<ol>\n<li>Ingredient-level safety;<\/li>\n<li>Finished product safety assessment by a qualified expert (e.g. medical or pharmaceutical master\u2019s degree).<\/li>\n<\/ol>\n<p style=\"font-weight: 400;\"><strong>Cosmetic Product Safety Report<\/strong><\/p>\n<p style=\"font-weight: 400;\">According to the Regulation, the Cosmetic Product Safety Report (<strong>CPSR<\/strong>):<\/p>\n<ul>\n<li>Must be compiled and signed by the safety assessor;<\/li>\n<li>Retained for ten years by the Responsible Person;<\/li>\n<li>Includes data on formulation, manufacturing methods, labelling, and product testing.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><strong>Manufacturing Practices<\/strong><\/p>\n<p style=\"font-weight: 400;\">Manufacturers must produce in accordance with Good Manufacturing Practice (<strong>GMP<\/strong>).<\/p>\n<ul>\n<li>GMP certification is optional;<\/li>\n<li>Declaration of GMP compliance required;<\/li>\n<li>Compliance with DSTU ISO EN 22716 presumes GMP compliance.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">Certification supports ongoing quality and hygiene monitoring.<\/p>\n<p style=\"font-weight: 400;\"><strong>Composition and ingredient controls<\/strong><\/p>\n<p style=\"font-weight: 400;\">The Regulation introduces EU-style ingredient restrictions via:<\/p>\n<ul>\n<li>Annex II: Prohibited substances;<\/li>\n<li>Annex III: Restricted substances;<\/li>\n<li>Annexes IV-VI: Permitted colourants, preservatives, UV filters.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">Other restrictions:<\/p>\n<ul>\n<li>No CMR substances (e.g. carcinogenic, mutagenic, reproductive toxicity);<\/li>\n<li>Nanomaterials must be notified six months before market entry.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><strong>Notification system<\/strong><\/p>\n<p style=\"font-weight: 400;\">The online notification system is administered by the Ministry of Health and operated by State Enterprise &#8220;Electronic Health&#8221;.<\/p>\n<p style=\"font-weight: 400;\">Responsible Persons must report products before placing them on the market. Required data includes:<\/p>\n<ul>\n<li>Product details;<\/li>\n<li>Graphic files of labelling;<\/li>\n<li>Photos of packaging (at least one per group).<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">Permits are not required, but notification is mandatory.<\/p>\n<p style=\"font-weight: 400;\"><strong>Labelling requirements<\/strong><\/p>\n<p style=\"font-weight: 400;\">All mandatory information must be in Ukrainian (other languages may be added) and must include:<\/p>\n<ul>\n<li>Product name and manufacturer details;<\/li>\n<li>INCI ingredient list;<\/li>\n<li>Date of manufacture, shelf life or PAO, batch number;<\/li>\n<li>Volume\/weight and storage conditions;<\/li>\n<li>Warnings, precautions, and usage instructions.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><strong>Market surveillance and enforcement<\/strong><\/p>\n<p style=\"font-weight: 400;\">The State Service of Ukraine on Medicines and Drugs Control supervises compliance.<\/p>\n<p style=\"font-weight: 400;\">Inspections may occur:<\/p>\n<ul>\n<li>At customs;<\/li>\n<li>In retail and storage locations;<\/li>\n<li>At fairs and exhibitions.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">Authorities may impose corrective measures for unsafe or non-compliant products.<\/p>\n<p style=\"font-weight: 400;\"><strong>Looking Ahead<\/strong><\/p>\n<p style=\"font-weight: 400;\">A new regulatory authority for cosmetic products is expected from 1 January 2027, replacing the State Service and bringing Ukraine closer to the EU&#8217;s institutional model.<\/p>\n<p style=\"font-weight: 400;\"><strong>Proposed amendments<\/strong><\/p>\n<p style=\"font-weight: 400;\">On 3 July 2025, the Ministry of Health published for public consultation a Draft Resolution proposing amendments to the Technical Regulation on Cosmetic Products. The Draft Resolution proposes the following:<\/p>\n<ul>\n<li>Revising and reissuing Annexes II\u2013VI (see section 5 above) to reflect updated lists of prohibited, restricted, and permitted substances (i.e. colourants, preservatives, UV filters).<\/li>\n<li>Introducing phased transition periods for products containing certain substances. Specifically:\n<ul>\n<li>Placement on the market would be allowed until 3 August 2026-2028 (depending on the substance).<\/li>\n<li>Commercial distribution must cease between 2027 and 2030.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">These changes are not yet adopted but are intended to align the Ukrainian framework with ongoing EU updates while giving industry operators time to adapt.<\/p>\n<p><span style=\"font-weight: 400;\">For more information on investment opportunities in Ukraine, contact your CMS client partner or these CMS experts:<\/span><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-665271 size-large\" src=\"https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/08\/CMS_3_25082025-1024x139.png\" alt=\"\" width=\"1024\" height=\"139\" srcset=\"https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/08\/CMS_3_25082025-1024x139.png 1024w, https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/08\/CMS_3_25082025-300x41.png 300w, https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/08\/CMS_3_25082025-768x104.png 768w, https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/08\/CMS_3_25082025-1536x208.png 1536w, https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/08\/CMS_3_25082025-650x88.png 650w, https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/08\/CMS_3_25082025-800x108.png 800w, https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/08\/CMS_3_25082025-100x14.png 100w, https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/08\/CMS_3_25082025.png 1604w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Technical Regulation on Cosmetic Products, also known as Resolution No. 65 of 20 January 2021, has been in force since 3 August 2024. Developed to align Ukrainian law with EU Regulation 1223\/2009, the Regulation ensures consumer health protection and brings Ukrainian law in line with EU standards. According to the Regulation, until 3 August [&hellip;]<\/p>\n","protected":false},"author":4489,"featured_media":665273,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[15576,15575],"tags":[],"class_list":["post-786241","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-and-articles-en","category-news-and-articles-from-companies-en","company-16421"],"_links":{"self":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/786241","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/users\/4489"}],"replies":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/comments?post=786241"}],"version-history":[{"count":0,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/786241\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media\/665273"}],"wp:attachment":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media?parent=786241"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/categories?post=786241"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/tags?post=786241"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}