{"id":10429,"date":"2026-01-15T11:10:48","date_gmt":"2026-01-15T10:10:48","guid":{"rendered":"https:\/\/regulatory.cosmeticsinmind.com\/blog\/how-to-develop-a-cosmetic-product-from-scratch-under-european-regulation\/"},"modified":"2026-01-15T11:10:48","modified_gmt":"2026-01-15T10:10:48","slug":"how-to-develop-a-cosmetic-product-from-scratch-under-european-regulation","status":"publish","type":"blog","link":"https:\/\/regulatory.cosmeticsinmind.com\/en\/blog\/how-to-develop-a-cosmetic-product-from-scratch-under-european-regulation\/","title":{"rendered":"How to develop a cosmetic product from scratch under European regulation"},"content":{"rendered":"<p data-start=\"253\" data-end=\"671\"><strong data-start=\"253\" data-end=\"286\">Developing a cosmetic product<\/strong> involves far more than creating an attractive formula. When consumers apply a cream or a shampoo, they rarely think about what lies behind it: <strong data-start=\"430\" data-end=\"557\">toxicological assessments, legal ingredient limits, technical documentation, official notifications and regulatory controls<\/strong>. A cosmetic is not just a beauty product \u2013 it is a <strong data-start=\"609\" data-end=\"670\">legally regulated product from the moment it is conceived<\/strong>.<\/p>\n<p data-start=\"673\" data-end=\"968\">In the European Union, developing a cosmetic means complying with one of the most demanding regulatory frameworks in the world: <strong data-start=\"801\" data-end=\"833\">Regulation (EC) No 1223\/2009<\/strong> and the legislation that supports it. Regulation does not start at the end of the process \u2013 it starts at the <strong data-start=\"943\" data-end=\"967\">product design stage<\/strong>.<\/p>\n<p data-start=\"975\" data-end=\"1032\"><strong data-start=\"978\" data-end=\"1032\">1. The product concept is already a legal decision<\/strong><\/p>\n<p data-start=\"1034\" data-end=\"1202\">Before a formula exists, the cosmetic must exist as a regulatory concept. At this stage, key elements are defined that directly determine the product\u2019s legal viability:<\/p>\n<ul data-start=\"1204\" data-end=\"1350\">\n<li data-start=\"1204\" data-end=\"1269\">\n<p data-start=\"1206\" data-end=\"1269\">Product type (leave-on, rinse-off, sunscreen, haircare, etc.)<\/p>\n<\/li>\n<li data-start=\"1270\" data-end=\"1291\">\n<p data-start=\"1272\" data-end=\"1291\">Cosmetic function<\/p>\n<\/li>\n<li data-start=\"1292\" data-end=\"1311\">\n<p data-start=\"1294\" data-end=\"1311\">Intended claims<\/p>\n<\/li>\n<li data-start=\"1312\" data-end=\"1330\">\n<p data-start=\"1314\" data-end=\"1330\">Market of sale<\/p>\n<\/li>\n<li data-start=\"1331\" data-end=\"1350\">\n<p data-start=\"1333\" data-end=\"1350\">Target consumer<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1352\" data-end=\"1572\">Each of these factors determines which ingredients can be used, which tests are required and what type of documentation will be needed. A mistake at this stage can make a product <strong data-start=\"1531\" data-end=\"1571\">illegal before it is even formulated<\/strong>.<\/p>\n<p data-start=\"1579\" data-end=\"1638\"><strong data-start=\"1582\" data-end=\"1638\">2. Cosmetic formulation under the EU legal framework<\/strong><\/p>\n<p data-start=\"1640\" data-end=\"1772\">Every ingredient in a cosmetic formula is regulated under European cosmetic law. During formulation, the following must be verified:<\/p>\n<ul data-start=\"1774\" data-end=\"1961\">\n<li data-start=\"1774\" data-end=\"1810\">\n<p data-start=\"1776\" data-end=\"1810\">Prohibited substances (Annex II)<\/p>\n<\/li>\n<li data-start=\"1811\" data-end=\"1848\">\n<p data-start=\"1813\" data-end=\"1848\">Restricted substances (Annex III)<\/p>\n<\/li>\n<li data-start=\"1849\" data-end=\"1926\">\n<p data-start=\"1851\" data-end=\"1926\">Permitted colourants, preservatives and UV filters (Annexes IV, V and VI)<\/p>\n<\/li>\n<li data-start=\"1927\" data-end=\"1961\">\n<p data-start=\"1929\" data-end=\"1961\">SCCS restrictions and opinions<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1963\" data-end=\"2122\">Formulation is not just a chemical exercise, it is a regulatory process. A formula can be technically excellent and still be impossible to place on the market.<\/p>\n<p data-start=\"2129\" data-end=\"2182\"><strong data-start=\"2132\" data-end=\"2182\">3. Testing, stability and safety justification<\/strong><\/p>\n<p data-start=\"2184\" data-end=\"2290\">Before a cosmetic can be sold, it must demonstrate that it is stable and safe. This is documented through:<\/p>\n<ul data-start=\"2292\" data-end=\"2397\">\n<li data-start=\"2292\" data-end=\"2313\">\n<p data-start=\"2294\" data-end=\"2313\">Stability studies<\/p>\n<\/li>\n<li data-start=\"2314\" data-end=\"2341\">\n<p data-start=\"2316\" data-end=\"2341\">Microbiological testing<\/p>\n<\/li>\n<li data-start=\"2342\" data-end=\"2361\">\n<p data-start=\"2344\" data-end=\"2361\">Challenge tests<\/p>\n<\/li>\n<li data-start=\"2362\" data-end=\"2397\">\n<p data-start=\"2364\" data-end=\"2397\">Packaging\u2013formula compatibility<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2399\" data-end=\"2523\">These data feed into the <strong data-start=\"2424\" data-end=\"2458\">Product Information File (PIF)<\/strong>, which is the central document required by Regulation 1223\/2009.<\/p>\n<p data-start=\"2530\" data-end=\"2569\"><strong data-start=\"2533\" data-end=\"2569\">4. Safety assessment and the PIF<\/strong><\/p>\n<p data-start=\"2571\" data-end=\"2689\">Every cosmetic must have a <strong data-start=\"2598\" data-end=\"2619\">Safety Assessment<\/strong> carried out by a qualified professional.<br data-start=\"2660\" data-end=\"2663\" \/>This assessment evaluates:<\/p>\n<ul data-start=\"2691\" data-end=\"2777\">\n<li data-start=\"2691\" data-end=\"2739\">\n<p data-start=\"2693\" data-end=\"2739\">The toxicological profile of each ingredient<\/p>\n<\/li>\n<li data-start=\"2740\" data-end=\"2777\">\n<p data-start=\"2742\" data-end=\"2777\">The real exposure of the consumer<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2779\" data-end=\"2833\">All of this is recorded in the <strong data-start=\"2810\" data-end=\"2817\">PIF<\/strong>, together with:<\/p>\n<ul data-start=\"2835\" data-end=\"2965\">\n<li data-start=\"2835\" data-end=\"2875\">\n<p data-start=\"2837\" data-end=\"2875\">Qualitative and quantitative formula<\/p>\n<\/li>\n<li data-start=\"2876\" data-end=\"2926\">\n<p data-start=\"2878\" data-end=\"2926\">Description of the manufacturing process (GMP)<\/p>\n<\/li>\n<li data-start=\"2927\" data-end=\"2951\">\n<p data-start=\"2929\" data-end=\"2951\">Claim substantiation<\/p>\n<\/li>\n<li data-start=\"2952\" data-end=\"2965\">\n<p data-start=\"2954\" data-end=\"2965\">Labelling<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2967\" data-end=\"3022\">This file must be available to authorities at any time.<\/p>\n<p data-start=\"3029\" data-end=\"3076\"><strong data-start=\"3032\" data-end=\"3076\">5. GMP, ISO 22716 and compliance control<\/strong><\/p>\n<p data-start=\"3078\" data-end=\"3196\">The manufacturer must operate under <strong data-start=\"3114\" data-end=\"3152\">Good Manufacturing Practices (GMP)<\/strong> in accordance with <strong data-start=\"3172\" data-end=\"3185\">ISO 22716<\/strong>, ensuring:<\/p>\n<ul data-start=\"3198\" data-end=\"3315\">\n<li data-start=\"3198\" data-end=\"3227\">\n<p data-start=\"3200\" data-end=\"3227\">Raw material traceability<\/p>\n<\/li>\n<li data-start=\"3228\" data-end=\"3247\">\n<p data-start=\"3230\" data-end=\"3247\">Process control<\/p>\n<\/li>\n<li data-start=\"3248\" data-end=\"3270\">\n<p data-start=\"3250\" data-end=\"3270\">Production records<\/p>\n<\/li>\n<li data-start=\"3271\" data-end=\"3295\">\n<p data-start=\"3273\" data-end=\"3295\">Deviation management<\/p>\n<\/li>\n<li data-start=\"3296\" data-end=\"3315\">\n<p data-start=\"3298\" data-end=\"3315\">Quality control<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"3317\" data-end=\"3382\">Without GMP, a cosmetic product cannot legally be sold in the EU.<\/p>\n<p data-start=\"3389\" data-end=\"3437\"><strong data-start=\"3392\" data-end=\"3437\">6. CPNP notification and market placement<\/strong><\/p>\n<p data-start=\"3439\" data-end=\"3596\">Before a cosmetic is placed on the European market, it must be notified in the <strong data-start=\"3518\" data-end=\"3566\">CPNP (Cosmetic Products Notification Portal)<\/strong>.<br data-start=\"3567\" data-end=\"3570\" \/>The notification includes:<\/p>\n<ul data-start=\"3598\" data-end=\"3668\">\n<li data-start=\"3598\" data-end=\"3620\">\n<p data-start=\"3600\" data-end=\"3620\">Responsible person<\/p>\n<\/li>\n<li data-start=\"3621\" data-end=\"3632\">\n<p data-start=\"3623\" data-end=\"3632\">Formula<\/p>\n<\/li>\n<li data-start=\"3633\" data-end=\"3646\">\n<p data-start=\"3635\" data-end=\"3646\">Labelling<\/p>\n<\/li>\n<li data-start=\"3647\" data-end=\"3668\">\n<p data-start=\"3649\" data-end=\"3668\">Countries of sale<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"3670\" data-end=\"3749\">Without CPNP, the product is illegal, even if it has already been manufactured.<\/p>\n<p data-start=\"3756\" data-end=\"3820\"><strong data-start=\"3759\" data-end=\"3820\">Regulation is not a formality \u2013 it is part of development<\/strong><\/p>\n<p data-start=\"3822\" data-end=\"3982\">Cosmetic regulation is not a final administrative step. It is a layer that runs through the entire product lifecycle, from the first idea to the last unit sold.<\/p>\n<p data-start=\"3984\" data-end=\"4127\">That is why more and more brands, manufacturers and legal teams rely on <strong data-start=\"4056\" data-end=\"4086\">regulatory.cosmeticsinMind<\/strong> as their central regulatory platform to:<\/p>\n<ul data-start=\"4129\" data-end=\"4283\">\n<li data-start=\"4129\" data-end=\"4162\">\n<p data-start=\"4131\" data-end=\"4162\">Access up-to-date legislation<\/p>\n<\/li>\n<li data-start=\"4163\" data-end=\"4196\">\n<p data-start=\"4165\" data-end=\"4196\">Check ingredient restrictions<\/p>\n<\/li>\n<li data-start=\"4197\" data-end=\"4251\">\n<p data-start=\"4199\" data-end=\"4251\">Monitor SCCS, European Commission and ECHA updates<\/p>\n<\/li>\n<li data-start=\"4252\" data-end=\"4283\">\n<p data-start=\"4254\" data-end=\"4283\">Anticipate regulatory risks<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"4290\" data-end=\"4351\"><strong data-start=\"4294\" data-end=\"4349\">Access the legal platform with a 1-month <a href=\"https:\/\/regulatory.cosmeticsinmind.com\/landing-trial\/\">free trial<\/a>:\u00a0<\/strong>Keep your products, formulas and claims fully aligned with European cosmetic law without relying on multiple sources or external consultants.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Developing a cosmetic product involves far more than creating an attractive formula. When consumers apply a cream or a shampoo, they rarely think about what lies behind it: toxicological assessments, legal ingredient limits, technical documentation, official notifications and regulatory controls. A cosmetic is not just a beauty product \u2013 it is a legally regulated product [&hellip;]<\/p>\n","protected":false},"author":111,"featured_media":10428,"comment_status":"closed","ping_status":"closed","template":"","categories":[399],"class_list":["post-10429","blog","type-blog","status-publish","has-post-thumbnail","hentry","category-blog-en"],"_links":{"self":[{"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/blog\/10429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/blog"}],"about":[{"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/types\/blog"}],"author":[{"embeddable":true,"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/users\/111"}],"replies":[{"embeddable":true,"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/comments?post=10429"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/media\/10428"}],"wp:attachment":[{"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/media?parent=10429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/categories?post=10429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}