{"id":10730,"date":"2026-09-29T12:21:28","date_gmt":"2026-09-29T11:21:28","guid":{"rendered":"https:\/\/mcamps.com\/?p=10730"},"modified":"2026-09-29T12:48:23","modified_gmt":"2026-09-29T11:48:23","slug":"como-lanzar-un-cosmetico-en-espana-guia-legal-y-pasos","status":"publish","type":"post","link":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/como-lanzar-un-cosmetico-en-espana-guia-legal-y-pasos\/","title":{"rendered":"I want to launch a cosmetic product in Spain: where do I start?"},"content":{"rendered":"<p class=\"wp-block-paragraph\">If you\u2019re wondering how <strong>launch a cosmetic product in Spain<\/strong>, you should be aware that launching a new product onto the market may seem straightforward: developing the formula, choosing the container, designing the packaging and starting to sell\u2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">However, before marketing a cosmetic product in Spain and the European Union, it is necessary to ensure that the product complies with a number of legal and safety requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The regulatory aspect should be part of the project from the outset, rather than being left until the end.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In this article, we explain the key steps you need to bear in mind.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>1. Define the product correctly<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The first step is to determine whether the product can actually be regarded as a <strong>cosmetic product<\/strong> in accordance with the applicable legislation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This is particularly important when the product is intended for use in relation to health, hygiene or the treatment of certain conditions, as it may fall into a different regulatory category, such as a medicinal product or a medical device.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Correct classification will determine all subsequent steps.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>2. Check the formula and ingredients<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Once the product category has been defined, it is necessary to check its composition.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The ingredients used in a cosmetic product must comply with the requirements laid down by European legislation, and there are certain substances whose use is prohibited, restricted or subject to specific conditions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It is also important to check aspects such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The correct names of the ingredients.<\/li>\n\n\n\n<li>The applicable restrictions.<\/li>\n\n\n\n<li>The concentrations used.<\/li>\n\n\n\n<li>The specific requirements for certain ingredients.<\/li>\n\n\n\n<li>The information required to demonstrate the safety of the product.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Reviewing the formula at an early stage can prevent subsequent changes that would entail costs and delays to the launch.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>3. Carry out the safety assessment<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Before a cosmetic product is placed on the market, a <strong>cosmetic product safety assessment<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The result is set out in the relevant <strong>Cosmetic Product Safety Report (CPSR)<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This assessment must be carried out by a person who meets the qualifications required by law.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Product safety is, therefore, one of the key issues that must be addressed before a product is placed on the market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>4. Prepare the Product Information File (PIF)<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The manufacturer or the person responsible must have a <strong>Product Information File (PIF)<\/strong> or product information file.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This dossier contains the documentation required to demonstrate that the product complies with the established requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Among other information, you may include documentation relating to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Product description.<\/li>\n\n\n\n<li>The Security Report.<\/li>\n\n\n\n<li>The qualitative and quantitative approach.<\/li>\n\n\n\n<li>The manufacturing process.<\/li>\n\n\n\n<li>The claims made about the product.<\/li>\n\n\n\n<li>Data relating to trials and tests.<\/li>\n\n\n\n<li>The information required to demonstrate compliance with the applicable requirements.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The PIF must be kept up to date and made available to the competent authorities when required.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>5. Check the labelling and packaging<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">This is one of the areas that can cause the most problems if left until the last minute.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Before printing large quantities of packaging, it is advisable to check that all the mandatory information appears correctly on the labelling.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Among other things, the following must be checked:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The identity and address of the person responsible.<\/li>\n\n\n\n<li>The nominal content.<\/li>\n\n\n\n<li>The minimum shelf life or PAO, where applicable.<\/li>\n\n\n\n<li>Precautions for use.<\/li>\n\n\n\n<li>The batch number.<\/li>\n\n\n\n<li>The product\u2019s function, where applicable.<\/li>\n\n\n\n<li>The list of ingredients.<\/li>\n\n\n\n<li>The applicable language requirements.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Furthermore, the text used on the packaging and in advertising must be consistent with the nature and characteristics of the product.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>6. Check the claims<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">What can we say about our cosmetic product?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This question is far more important than it might seem.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Expressions such as <strong>\u201cmoisturises\u201d<\/strong>, <strong>\u201crepair\u201d<\/strong>, <strong>\u201canti-wrinkle\u201d<\/strong>, <strong>\u201cfirmer skin\u201d<\/strong>, <strong>\u201cnatural\u201d<\/strong> o <strong>\u201cdermatologically tested\u201d<\/strong> may be subject to specific requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Claims must be properly substantiated and must not attribute to the product characteristics or functions that are not appropriate for a cosmetic product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It is therefore advisable to review the claims <strong>before designing the packaging and launching the marketing campaign<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>7. Issue the relevant notification<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">One of the essential steps for <strong>launch a cosmetic product in Spain<\/strong> and the European Union, it is necessary to carry out the relevant <strong>notification on the Cosmetic Products Notification Portal (CPNP)<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This step forms part of the market authorisation process and must be carried out correctly before marketing begins.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>8. Also review the manufacturing and quality assurance systems<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory requirements do not end with the formula and labelling.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It is also important to ensure that manufacturing is carried out in accordance with the relevant requirements and that appropriate procedures are in place to guarantee the quality and safety of the product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In this context, the <strong>Good Manufacturing Practice (GMP)<\/strong> They are a key component of the cosmetics industry.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In addition to ensuring that manufacturing complies with the applicable requirements, in certain cases it will be necessary to submit a Declaration of Responsibility regarding manufacturing and\/or import activities to the AEMPS.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>9. Submit the Affidavit regarding manufacturing and\/or import activities<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">If your company <strong>carries out, in Spain, the actual manufacture, preparation, packaging and\/or labelling of cosmetic products<\/strong>, you must submit a <strong>Declaration of Responsibility for the manufacture and\/or import of cosmetic products to the Spanish Agency for Medicines and Health Products (AEMPS)<\/strong> before commencing the activity. It must also be submitted by companies that <strong>import cosmetic products from countries outside the European Union<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">On the other hand, if you are a trademark owner and <strong>you fully outsource the manufacturing, preparation, packaging and labelling<\/strong> of your product, you could be the <strong>person in charge<\/strong> of the cosmetic product and be listed as such on the labelling, without this requiring you to submit a Declaration of Responsibility for the activities carried out by the manufacturer \u2013 although the manufacturer must, of course, have already done so.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Furthermore, the name or business name and address of the responsible person must appear on the labelling of the cosmetic product.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>10. What if the product is manufactured outside the European Union?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Where the product originates from a country outside the EU, the project requires a further review of the responsibilities of the various operators and the requirements applicable to import and marketing.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">One must<em> to assume that a product already legally marketed in another country can be sold directly in Spain.<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The requirements may vary and must be checked before the product is placed on the European market.<strong><br><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Checklist for <strong>launch a cosmetic product in Spain<\/strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Before launching a new cosmetic product on the market, it is advisable to check:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Is the product correctly classified as a cosmetic?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Does the formula comply with the relevant legislation?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Has the safety assessment been carried out?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Is the CPNP ready?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Is the PIF complete?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Does the labelling comply with the relevant requirements?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Are the claims properly substantiated?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Has the relevant notification been issued?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Does the manufacturing process comply with the relevant requirements?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/docs.google.com\/document\/d\/1ZRLlloY1n2OFtGshAnUu5TPenASXRKzKKM0nQ33J1w8\/copy\" target=\"_blank\" rel=\"noopener\">CHE<\/a><a href=\"https:\/\/docs.google.com\/document\/d\/1ZRLlloY1n2OFtGshAnUu5TPenASXRKzKKM0nQ33J1w8\/export?format=pdf\" target=\"_blank\" rel=\"noopener\">CKLIST IN PDF<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Are you getting everything ready for <strong>launch a cosmetic product in Spain<\/strong>? The regulatory aspect should be taken into account from the earliest stages of the project.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The regulatory aspect should be taken into account from the earliest stages of the project.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A preliminary review can help you identify issues with the formulation, labelling, claims or documentation before they lead to delays or additional costs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full\"><a href=\"https:\/\/mcamps.com\/wp-content\/uploads\/2021\/06\/logo_mcamps-1.png\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" width=\"446\" height=\"148\" src=\"https:\/\/mcamps.com\/wp-content\/uploads\/2021\/06\/logo_mcamps-1.png\" alt=\"\" class=\"wp-image-7771\" title=\"\" srcset=\"https:\/\/mcamps.com\/wp-content\/uploads\/2021\/06\/logo_mcamps-1.png 446w, https:\/\/mcamps.com\/wp-content\/uploads\/2021\/06\/logo_mcamps-1-300x100.png 300w\" sizes=\"(max-width: 446px) 100vw, 446px\" \/><\/a><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>At <strong>Gabinete T\u00e9cnico Farmac\u00e9utico M. Camps, S.L.<\/strong> We\u2019ll guide you every step of the way to <strong>launch a cosmetic product in Spain<\/strong> With complete peace of mind and in full compliance with the law, we will answer your questions and support you throughout the process to ensure your products are brought to market with every guarantee.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Tell us about your situation; you can contact us via our website or by email<\/strong> <a href=\"mailto:gtf@mcamps.com\"><strong>gtf@mcamps.com<\/strong><\/a> <strong>or by telephone on 93 414 67 06<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Si te preguntas c\u00f3mo lanzar un cosm\u00e9tico en Espa\u00f1a, debes saber que poner un nuevo producto al mercado puede parecer sencillo: desarrollar la f\u00f3rmula, elegir el envase, dise\u00f1ar el packaging y empezar a vender&#8230;. Sin embargo, antes de comercializar un cosm\u00e9tico en Espa\u00f1a y en la Uni\u00f3n Europea, es necesario asegurarse de que el producto [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":10731,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[99,3998,50],"tags":[103],"class_list":["post-10730","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cosmeticos","category-facs-preguntas-frecuentes","category-noticias","tag-cosmeticos"],"_links":{"self":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts\/10730","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/comments?post=10730"}],"version-history":[{"count":0,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts\/10730\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/media\/10731"}],"wp:attachment":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/media?parent=10730"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/categories?post=10730"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/tags?post=10730"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}