{"id":57,"date":"2026-03-16T18:52:50","date_gmt":"2026-03-16T17:52:50","guid":{"rendered":"http:\/\/www.7virides.com\/cs\/podnikani\/cpsr-pif-cpnp\/"},"modified":"2026-03-25T11:19:30","modified_gmt":"2026-03-25T10:19:30","slug":"cpsr-pif-cpnp","status":"publish","type":"page","link":"https:\/\/www.7virides.com\/en\/podnikani\/cpsr-pif-cpnp\/","title":{"rendered":"CPSR, PIF and CPNP: the three pillars of legal soap sales in the EU"},"content":{"rendered":"<blockquote>\n<p><strong>TL;DR:<\/strong> CPSR is a professional safety report (5 000-15 000 CZK, 2-6 weeks), PIF is your dossier (CPSR + GMP records), CPNP is a free EU online registration. Order: finished prescription \u2192 CPSR from assessor \u2192 PIF \u2192 CPNP \u2192 sales. Without these three documents, the sale is illegal.<\/p>\n<\/blockquote>\n<p>If you want to sell soap as a cosmetic product in the EU - whether on farmers' markets, Etsy or your own e-shop - you need three documents: a CPSR (safety report), a PIF (information file) and a CPNP notification. This trinity is the basis of EU regulation for cosmetics under Regulation (EC) No 1223\/2009.<\/p>\n<p>This page explains what each document contains, who prepares it, how much it costs and the order in which to proceed.<\/p>\n<h2 id=\"prehled-jak-se-na-sebe-dokumenty-navazuji\">Overview: how documents relate to each other<\/h2>\n<pre><code>Recipe finalised \u2192 CPSR (assessor's safety report)\n                   \u2192 PIF (your dossier, CPSR included)\n                   \u2192 CPNP notification (online registration in the EU system)\n                   \u2192 Sales\n<\/code><\/pre>\n<h2 id=\"1-co-je-cpsr-a-jak-ji-objednat\">1. What is CPSR and how to order it?<\/h2>\n<h3 id=\"definice-a-povinnosti\">Definitions and obligations<\/h3>\n<p>A CPSR is a technical report on the safety of a specific cosmetic product. It must be prepared by a qualified <strong>Safety Assessor<\/strong> - a person with an appropriate degree in toxicology, pharmacy, dermatology or another relevant field (at least a master's degree).<\/p>\n<p>You cannot write it yourself - the law explicitly requires a competent person (Regulation (EC) 1223\/2009, Annex I).<\/p>\n<h4 id=\"co-cpsr-obsahuje\">What the CPSR contains<\/h4>\n<p><strong>Part A: Product safety information<\/strong><\/p>\n<ul>\n<li>Quantitative and qualitative composition<\/li>\n<li>Physical and chemical properties<\/li>\n<li>Microbiological quality<\/li>\n<li>Impurities<\/li>\n<li>Packaging information<\/li>\n<li>Normal and predictable use<\/li>\n<li>Product exposure<\/li>\n<li>Exposure to individual components<\/li>\n<li>Constituent toxicity profiles (NOAEL, LOAEL)<\/li>\n<li>Side effects and serious side effects<\/li>\n<\/ul>\n<p><strong>Part B: Product safety assessment<\/strong><\/p>\n<ul>\n<li>Conclusion on safety<\/li>\n<li>Recommended information on the label<\/li>\n<li>Reasoning of the assessor<\/li>\n<li>Assessor's credentials (signature, date, qualifications)<\/li>\n<\/ul>\n<h4 id=\"kde-si-cpsr-objednat-v-cr\">Where to order CPSR in the Czech Republic<\/h4>\n<p>There are several accredited laboratories and consultants in the Czech Republic that process CPSRs for small producers:<\/p>\n<ul>\n<li><strong>SQS Czech Republic<\/strong> (sqs.cz) - certification and conformity assessment for cosmetics<\/li>\n<li><strong>Eurofins<\/strong> - international testing laboratory, branch in the Czech Republic<\/li>\n<li><strong>Independent Safety Assessors<\/strong> - individual consultants with appropriate qualifications<\/li>\n<\/ul>\n<p><strong>Approximate price 2026:<\/strong> 5 000-15 000 CZK per product. The price depends on the complexity of the recipe and the assessore.<\/p>\n<p><strong>Important:<\/strong> The CPSR is tied to a specific prescription (formulation). If you change the formulation, you need a new CPSR or at least an update.<\/p>\n<h2 id=\"2-co-je-pif-a-co-v-nem-mam-mit\">2. What is a PIF and what should I have in it?<\/h2>\n<h3 id=\"pif-jako-vase-dokumentacni-povinnost\">PIF as your documentation obligation<\/h3>\n<p>A PIF (product information file) is a collection of all documents about a particular cosmetic product. Article 11 of Regulation (EC) 1223\/2009 requires the responsible person to keep the PIF available for 10 years from the date of the last batch.<\/p>\n<p>The PIF is kept by the responsible person - you, as the manufacturer, if you sell under your own brand.<\/p>\n<h4 id=\"co-pif-obsahuje\">What PIF contains<\/h4>\n<ol>\n<li><strong>CPSR<\/strong> (safety report) - see above<\/li>\n<li><strong>Product description<\/strong> - function, intended use, target group<\/li>\n<li><strong>Description of the production method<\/strong> - how you make soap, GMP compliance<\/li>\n<li><strong>GMP Declaration of Conformity<\/strong> - See ISO 22716 or simplified GMP for small manufacturers<\/li>\n<li><strong>Evidence of the claimed effect<\/strong> - if you claim \"heals eczema&#8220; or any other health claim, you need proof. Recommendations: avoid health claims, use cosmetic claims (cleanses, moisturizes, soothes)<\/li>\n<li><strong>Adverse reaction data<\/strong> - records of any complaints or adverse reactions<\/li>\n<li><strong>Batch records<\/strong> - batch numbers, date of manufacture, raw materials used<\/li>\n<\/ol>\n<h4 id=\"kdo-pif-pripravuje\">Who prepares the PIF<\/h4>\n<p>You as the manufacturer - the PIF is your documentation. The Safety Assessor will supply the CPSR as part of the PIF. The rest of the documentation you compile yourself.<\/p>\n<p><strong>PIF template:<\/strong> Sample PIF templates are available from some consultants or small producer associations.<\/p>\n<h2 id=\"3-co-je-cpnp-a-jak-se-registruji\">3. What is CPNP and how do I register?<\/h2>\n<h3 id=\"bezplatna-eu-databaze-kosmetiky\">Free EU cosmetics database<\/h3>\n<p>The CPNP is the EU's online database where cosmetic products are registered before they are placed on the market. It is managed by the European Commission at ec.europa.eu\/growth\/tools-databases\/cpnp.<\/p>\n<h4 id=\"jak-cpnp-funguje\">How CPNP works<\/h4>\n<p>Registration is <strong>Retrieved from<\/strong> and is carried out by you as the responsible person.<\/p>\n<p><strong>What you enter when you register:<\/strong><\/p>\n<ul>\n<li>Product name<\/li>\n<li>Category (soap = \"soap&#8220;)<\/li>\n<li>Ingredients (INCI list)<\/li>\n<li>Product features<\/li>\n<li>Contact details of the responsible person<\/li>\n<li>Attach Part A of the CPSR or a link to the assessor<\/li>\n<li>Photograph of label\/packaging<\/li>\n<\/ul>\n<p><strong>After registration:<\/strong> You will receive a confirmation. The product can be placed on the market.<\/p>\n<p><strong>Timing:<\/strong> CPNP notification must be done <strong>Before<\/strong> first time on the EU market. Not retrospective.<\/p>\n<p><strong>Each variant = new notification:<\/strong> If you produce lavender and chamomile soap - each must be notified separately (different composition).<\/p>\n<h2 id=\"postup-krok-za-krokem\">Step-by-step procedure<\/h2>\n<h3 id=\"krok-1-je-recept-finalizovany\">Step 1: Is the recipe finalised?<\/h3>\n<p>Before you invest in CPSR, the recipe must be ready and tested. Changing the recipe after CPSR = new CPSR.<\/p>\n<h3 id=\"krok-2-jake-podklady-potrebuje-safety-assessor\">Step 2: What documentation does the Safety Assessor need?<\/h3>\n<p>Assessor needs:<\/p>\n<ul>\n<li>Exact recipe (grammages, percentages, INCI for each ingredient)<\/li>\n<li>SDS (Safety Data Sheet) for each ingredient<\/li>\n<li>IFRA certificates for EO and FO<\/li>\n<li>Description of production (how and where you produce)<\/li>\n<li>Packaging description<\/li>\n<\/ul>\n<h3 id=\"krok-3-kdo-zpracuje-cpsr\">Step 3: Who will prepare the CPSR?<\/h3>\n<p>The Safety Assessor will prepare the CPSR. Time: usually 2-6 weeks. Depends on assessor workload and prescription complexity.<\/p>\n<h3 id=\"krok-4-jak-se-sestroj-pif\">Step 4: How to build a PIF?<\/h3>\n<p>Put in the folder\/shade: CPSR + product description + production description + batch records + label.<\/p>\n<h3 id=\"krok-5-jak-se-zaregistruji-v-cpnp\">Step 5: How do I register with CPNP?<\/h3>\n<p>Online at ec.europa.eu\/growth\/tools-databases\/cpnp. Free, after registration, immediately.<\/p>\n<h3 id=\"krok-6-jsem-pripraveny-prodavat\">Step 6: I'm ready to sell!<\/h3>\n<p>With complete documentation (CPSR + PIF + CPNP) you are legally entitled to sell.<\/p>\n<h2 id=\"co-se-stane-kdyz-prodavam-bez-dokumentace\">What happens if I sell without documentation?<\/h2>\n<h3 id=\"pravni-a-prakticke-dusledky\">Legal and practical implications<\/h3>\n<p>The sale of cosmetics without CPSR and CPNP notification in the EU is a violation of Regulation (EC) 1223\/2009. Controls are carried out by the KHS (regional health stations) and customs authorities. Penalties: administrative fine, withdrawal of the product from the market, marketing ban.<\/p>\n<p>KHS has the right to request access to the PIF at any time - it must be available within 10 days.<\/p>\n<h2 id=\"vyjimky-a-specialni-situace\">Exceptions and special situations<\/h2>\n<h3 id=\"kdy-se-cpsr-nevyzaduje\">When is a CPSR not required?<\/h3>\n<p>If you make soap for your own consumption only (not for sale, not as a gift in the course of business), CPSR, PIF and CPNP are not mandatory. The obligations come into play when you sell or offer to sell.<\/p>\n<h3 id=\"lze-sdilet-cpsr-mezi-vice-vyrobci\">Can CPSR be shared between multiple manufacturers?<\/h3>\n<p>If you use the same recipe with another manufacturer (co-op, soapmaking group), one CPSR can technically be shared - but the responsible person is always one (the one whose name is on the label). Each responsible person needs their own CPSR or their own assessor.<\/p>\n<h2 id=\"caste-otazky\">Frequently asked questions<\/h2>\n<p><strong>How long does it take to receive a CPSR?<\/strong> Usually 2-6 weeks after sending all documents to the Safety Assessor. The time depends on the expert's workload and the complexity of the prescription. Order the CPSR well in advance.<\/p>\n<p><strong>What happens if I change my prescription after CPSR?<\/strong> Changing a prescription requires a new or updated CPSR. Some minor changes (e.g. colour change) can be addressed by additional analysis. Check with your Safety Assessor.<\/p>\n<p><strong>Can I order a CPSR before I open my business?<\/strong> Yes. CPSR is ordered without a trade certificate. Then you open the trade certificate in parallel so that everything is ready for sale.<\/p>\n<p><strong>Who is the Responsible Person?<\/strong> For a small Czech manufacturer, you are the Responsible Person (if you are a self-employed person or s.r.o. established in the Czech Republic and selling in the EU). The Responsible Person is the one whose name and address is on the label.<\/p>\n<p><strong>How long do I have to keep the PIF?<\/strong> At least 10 years from the last production of the batch. After the end of the sale of the product, you will keep the PIF for archival and legal protection.<\/p>\n<p><strong>What if I sell soap abroad, not just in the Czech Republic?<\/strong> CPNP notification covers all EU countries. Once the soap is notified, you can sell it throughout the EU. The label must be in the language of the selling country (not Czech for Poland, but English for Poland).<\/p>\n<p><strong>See also:<\/strong><\/p>\n<ul>\n<li><a href=\"\/en\/selling-handmade-soap\/eu-regulations-soap-making\/\">EU regulation for manufacturers<\/a> - an overview of all regulatory obligations<\/li>\n<li><a href=\"\/en\/selling-handmade-soap\/inci-labeling-soap\/\">INCI labelling<\/a> - how to make a label with the correct INCI<\/li>\n<li><a href=\"\/en\/selling-handmade-soap\/soap-making-costs\/\">Cost of legal production<\/a> - financial planning regulation<\/li>\n<li><a href=\"\/en\/selling-handmade-soap\/soap-pricing\/\">Soap pricing<\/a> - how to reflect regulatory costs in the price<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>TL;DR: CPSR je odborn\u00e1 zpr\u00e1va o bezpe\u010dnosti (5 000\u201315 000 K\u010d, 2\u20136 t\u00fddn\u016f), PIF je va\u0161e dokumenta\u010dn\u00ed spis (CPSR + [&hellip;]<\/p>\n","protected":false},"author":0,"featured_media":0,"parent":19,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-57","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.7virides.com\/en\/wp-json\/wp\/v2\/pages\/57","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.7virides.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.7virides.com\/en\/wp-json\/wp\/v2\/types\/page"}],"replies":[{"embeddable":true,"href":"https:\/\/www.7virides.com\/en\/wp-json\/wp\/v2\/comments?post=57"}],"version-history":[{"count":1,"href":"https:\/\/www.7virides.com\/en\/wp-json\/wp\/v2\/pages\/57\/revisions"}],"predecessor-version":[{"id":160,"href":"https:\/\/www.7virides.com\/en\/wp-json\/wp\/v2\/pages\/57\/revisions\/160"}],"up":[{"embeddable":true,"href":"https:\/\/www.7virides.com\/en\/wp-json\/wp\/v2\/pages\/19"}],"wp:attachment":[{"href":"https:\/\/www.7virides.com\/en\/wp-json\/wp\/v2\/media?parent=57"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}