{"id":8021,"date":"2026-06-16T14:59:00","date_gmt":"2026-06-16T12:59:00","guid":{"rendered":"https:\/\/www.chemicalsconsulting.eu\/permanent-and-temporary-tattoos-and-european-regulations\/"},"modified":"2026-06-16T14:59:00","modified_gmt":"2026-06-16T12:59:00","slug":"permanent-and-temporary-tattoos-and-european-regulations","status":"publish","type":"post","link":"https:\/\/www.chemicalsconsulting.eu\/en\/permanent-and-temporary-tattoos-and-european-regulations\/","title":{"rendered":"Permanent and temporary tattoos and European regulations."},"content":{"rendered":"<h2><strong>Tattoos and safety: what European regulations say  <\/strong><\/h2>\n<p>Tattoos are no longer just a passing fad. From their origins as a form of tribal expression, they have evolved into a global cultural phenomenon, with millions of people choosing each year to have permanent symbols, text, or images inked onto their skin. However, few people realize that behind every tattoo lies a complex issue: the regulation of the inks used.  <\/p>\n<p>In 2015, the European Commission asked ECHA to assess the health risks posed by chemicals found in tattoo inks and permanent makeup and to evaluate the need for an EU-wide restriction on their use.<\/p>\n<p>A study has shown that over 12% of the European population has at least one tattoo, and that certain chemicals found in tattoo inks could pose significant risks to human health, including allergic reactions, skin irritation, and potential carcinogenic effects. This evidence prompted authorities to take action, leading to the adoption of new REACH restrictions to improve the safety of the products used. <\/p>\n<p>In this article, we examine the European regulatory framework governing tattoo inks, explaining why they do not fall under the definition of cosmetics within the meaning of  <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/en\/ALL\/?uri=celex%3A32009R1223\">Regulation (EC) No. 1223\/2009<\/a>, what are the obligations under the <strong>REACH Regulation <\/strong> <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/en\/TXT\/?uri=CELEX%3A32006R1907\">Regulation (EC) No. 1907\/2006<\/a>, and how temporary tattoos are regulated, including those intended for children, which in some cases fall under toy regulations. Finally, we take a look at <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/988\/oj?locale=en\">Regulation (EU) 2023\/988 (GPSR<\/a>), which helps address certain gaps regarding borderline products. <\/p>\n<h2><strong>The scope of the definition of a cosmetic product under Regulation (EC) No. 1223\/2009<\/strong><\/h2>\n<p>Regulation (EC) No. 1223\/2009 defines a cosmetic product as: <\/p>\n<p><em>\u201cAny substance or mixture intended to be placed in contact with the external parts of the human body [&#8230;] for the sole or main purpose of cleaning, perfuming, altering the appearance, protecting, maintaining in good condition, or correcting body odors\u201d<\/em>(Article 2).<\/p>\n<p>This definition clarifies a fundamental point: cosmetics must act on the surface of the human body. Tattoo inks, on the other hand, are injected into the dermis using needles and therefore cannot be considered cosmetics. <\/p>\n<p>This position was also reiterated by <a href=\"https:\/\/health.ec.europa.eu\/scientific-committees\/scientific-committee-consumer-safety-sccs_en\">the Scientific Committee on Consumer Safety (SCCS)<\/a>, which pointed out that tattoo inks:<\/p>\n<ul>\n<li>involve an invasive route of administration;<\/li>\n<li>can enter the bloodstream;<\/li>\n<li>expose the body to potential systemic risks over the long term.<\/li>\n<\/ul>\n<p>Consequently, the use of color pigments authorized in cosmetics does not automatically mean that they are safe or approved for tattoos. In this case, safety assessment requires a different and more rigorous approach. <\/p>\n<h2>The REACH Regulation: the actual governing legislation (Regulation (EC) No. 1907\/2006)<\/h2>\n<p>In the absence of specific regulations governing cosmetics, the REACH Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals) provides the regulatory framework for tattoo inks.<\/p>\n<p>The <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/en\/ALL\/?uri=CELEX:32020R2081\"><strong>Regulation (EU) 2020\/2081<\/strong><\/a> amended Annex XVII of the REACH Regulation, introducing a restriction covering <strong>4,000 hazardous substances<\/strong> in tattoo and permanent makeup products.<\/p>\n<p>The restriction applies to substances that:<\/p>\n<ol>\n<li>are classified at the EU level as:<\/li>\n<\/ol>\n<ul>\n<li>carcinogenic, mutagenic, or toxic to reproduction;<\/li>\n<li>skin sensitizers;<\/li>\n<li>corrosive to the skin;<\/li>\n<li>skin irritants;<\/li>\n<li>eye irritants; or<\/li>\n<li>harmful to the eyes.<\/li>\n<\/ul>\n<ol start=\"2\">\n<li>are included in the Cosmetics Regulation (CPR (EC) No. 1223\/2009) as: <\/li>\n<\/ol>\n<ul>\n<li>substances prohibited in cosmetic products, as listed in Annex II of the CPR.<\/li>\n<li>substances\/colorants listed in Annex IV of the CPR with the following conditions of use:<\/li>\n<li>not to be used in products applied to mucous membranes;<\/li>\n<li>Do not use in eye care products;<\/li>\n<li>permitted only in rinse-off products; and<\/li>\n<li>other requirements, such as those relating to purity, listed in Annex IV.<\/li>\n<\/ul>\n<p>While some Member States already had national legislation in place to restrict hazardous chemicals in tattoo inks, new EU-wide rules have been adopted to ensure equal protection for people across the EU, regardless of the country where they get a tattoo or whether the ink is produced in the EU.<\/p>\n<p>This restriction has been in effect since January 4, 2022, and for Pigment Blue 15:3 and Pigment Green 7\u2014for which the Commission and EU Member States have agreed on a 24-month transition period\u2014it will take effect on January 4, 2023.<\/p>\n<p>Although the restriction applies to tattooing practices, it also covers \u201cpermanent makeup,\u201d \u201ccosmetic tattooing,\u201d \u201cmicroblading,\u201d and \u201cmicropigmentation.\u201d<\/p>\n<p>Manufacturers must provide:<\/p>\n<ul>\n<li><strong>Safety Data Sheets (SDS)<\/strong> for each ink (Article 31 of REACH),<\/li>\n<li><strong>Labeling that complies with<\/strong> the warnings, composition, and hazard information specified in the restriction.<\/li>\n<\/ul>\n<h2><strong>Temporary tattoos and long-lasting makeup: when are they considered cosmetics?<\/strong><\/h2>\n<p>In addition to permanent tattoos, there is a wide range of products that simulate the appearance of a tattoo without penetrating the dermis. Some examples include: <\/p>\n<ul>\n<li>Temporary decals (also known as \u201ctransfer tattoos\u201d),<\/li>\n<li>Long-lasting eyeliner or lipstick with a &#8220;tattoo&#8221; effect,<\/li>\n<li>Semi-permanent surface pigments for eyebrows and lips.<\/li>\n<\/ul>\n<p>When these products are applied to the skin and serve a purely cosmetic purpose, they fall under the definition of a cosmetic product, as defined in Regulation (EC) No. 1223\/2009. In that case, they must comply with all applicable regulatory requirements, including:<\/p>\n<ul>\n<li>the CPNP (Cosmetic Products Notification Portal) notification,<\/li>\n<li>the preparation of the Product Information File (PIF),<\/li>\n<li>labeling in accordance with Article 19 of the Regulation,<\/li>\n<li>a safety assessment conducted by a qualified assessor, in accordance with Article 10.<\/li>\n<\/ul>\n<p>But be careful: some long-lasting cosmetics may contain the same pigments used in tattoo inks. In such cases, it is essential to verify that the colorants used are authorized for cosmetic use, in accordance with Annexes II (prohibited substances) and IV (authorized colorants) of Regulation 1223\/2009. The use of non-compliant pigments poses a risk both to consumer safety and to the product\u2019s legal compliance.  <\/p>\n<h2>Tattoos for Children: Cosmetics, Toys, and Product Safety<\/h2>\n<p>One particularly interesting area is that of temporary tattoos for children, which are often sold as promotional items, stickers, or as inserts in magazines, candy, etc.<\/p>\n<p>In that case, one must take into account <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/en\/LSU\/?uri=oj:JOL_2009_170_R_0001_01\"><strong>Directive 2009\/48\/EC,<\/strong><\/a> on toys.<\/p>\n<h2>Regulation (EU) 2023\/988 (GPSR): A Response to Gray Areas<\/h2>\n<p>As we have seen, the regulation of tattoo-related products depends heavily on their intended use and route of administration. While permanent inks are primarily regulated under REACH and cosmetics fall under Regulation 1223\/2009, there is a wide range of products that may fall outside the scope of clear and unambiguous regulations. <\/p>\n<p>To address these ambiguities, the new Regulation (EU) 2023\/988 on general product safety, known as the GPSR, was introduced in 2023. This regulation aims to strengthen consumer protection for all products placed on the market that are not covered by specific sectoral regulations. <\/p>\n<p>Among the key changes introduced are the requirement for economic operators to conduct a risk assessment based on the target group (e.g., children, people with allergies, vulnerable individuals), and extended liability throughout the supply chain, which covers manufacturers, importers, distributors, and even online marketplaces.<\/p>\n<p>The regulation also introduces modern digital traceability tools, such as QR codes and smart labels, to facilitate access to safety information. Finally, the European rapid alert system, now called Safety Gate (formerly RAPEX), has been enhanced to report dangerous products and facilitate their withdrawal from the market. <\/p>\n<p>The GPSR represents an important step toward greater harmonization and protection for products that, while not clearly falling into a category such as cosmetics or toys, may pose health risks and must therefore be subject to equivalent safety standards.<\/p>\n<h2>Inspections and Oversight: What Happens in Case of Noncompliance?<\/h2>\n<p>Non-compliant products can be reported by national authorities (e.g., the Ministry of Health in Italy) through the <strong>Safety Gate system<\/strong>. The most common reports concern: <\/p>\n<ul>\n<li>the presence of prohibited or undeclared pigments,<\/li>\n<li>lack of labeling in Italian,<\/li>\n<li>packaging without the manufacturer&#8217;s or importer&#8217;s information.<\/li>\n<\/ul>\n<p>In Italy, for example, the <a href=\"https:\/\/www.indicenormativa.it\/sites\/default\/files\/Circolare_Ministero_salute_Tatuaggio-piercing.pdf\"><strong>Ministerial Circular of February 5, 1998<\/strong><\/a> (still partially used as a national reference in the absence of harmonized standards) established that all tattoo shops must use traceable products, complete with safety data sheets and indications of origin. Logically, this practice should in any case be extended to any tattoo studio located within the European Union. <\/p>\n<p>For cosmetics, failure to submit a CPNP or PIF notification may result in a market withdrawal and administrative penalties.<\/p>\n<h2>Conclusions<\/h2>\n<p>Tattoo inks are not cosmetics, either legally or technically. The European Union has chosen to regulate them under the REACH Regulation, treating them as potentially hazardous chemicals rather than products intended for superficial cosmetic use. <\/p>\n<p>Conversely, temporary tattoos may fall under the category of cosmetics or toys, depending on their intended use and target audience. The growing prevalence of hybrid or borderline products requires economic operators\u2014from manufacturers to distributors to beauty professionals\u2014to have a solid and up-to-date understanding of applicable regulations to avoid classification errors and the risk of penalties. <\/p>\n<p>With the entry into force of the new Regulation (EU) 2023\/988 (GPSR), the European Union aims to address these very gray areas, ensuring greater protection for consumers, especially the most vulnerable.<\/p>\n<p>For those working in the cosmetics, distribution, or manufacturing sectors, it is now more important than ever to correctly identify the regulatory category of their product and implement best practices for notification, traceability, and safety.<\/p>\n<p>? Do you have questions about a product&#8217;s classification or the compliance of your cosmetics line? <\/p>\n<p>? <strong>Trust <a href=\"https:\/\/www.chemicalsconsulting.eu\/contatti-form\/\">Chemicals Consulting<\/a><\/strong>:<\/p>\n<ul>\n<li>If you&#8217;re looking <strong>for operational support<\/strong>, contact us for a <strong>personalized consultation<\/strong> and find out how to ensure your products are fully compliant with European regulations.<\/li>\n<li>If you want <strong>to stay up to date, learn more, and exchange ideas with other professionals<\/strong>, join our <strong><a href=\"https:\/\/www.chemicalsconsulting.eu\/community-c-e-chimica-tra-noi\/\">&#8220;There\u2019s Chemistry Between Us&#8221;community<\/a><\/strong>: every month, we offer educational content, live Q&#038;As, and technical insights on key topics like this one.<\/li>\n<\/ul>\n<p>? Contact us or join the community: safety starts with knowledge. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tattoos and safety: what European regulations say Tattoos are no longer just a passing fad. From their origins as a form of tribal expression, they have evolved into a global cultural phenomenon, with millions of people choosing each year to have permanent symbols, text, or images inked onto their skin. However, few people realize that [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[30,33],"tags":[],"class_list":["post-8021","post","type-post","status-publish","format-standard","hentry","category-cosmetici-en","category-reach-en"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.8 - aioseo.com -->\n\t<meta name=\"description\" content=\"Tattoo inks are not cosmetics: find out what European regulations\u2014including REACH, cosmetics, temporary tattoos, and the GPSR Regulation\u2014have to say.\" \/>\n\t<meta name=\"robots\" content=\"max-image-preview:large\" \/>\n\t<meta name=\"author\" content=\"Chemicals Consulting\"\/>\n\t<link rel=\"canonical\" href=\"https:\/\/www.chemicalsconsulting.eu\/en\/permanent-and-temporary-tattoos-and-european-regulations\/\" \/>\n\t<meta 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