{"id":2835,"date":"2026-10-19T15:20:48","date_gmt":"2026-10-19T13:20:48","guid":{"rendered":"https:\/\/clearorg.eu\/?p=2835"},"modified":"2026-10-19T15:20:48","modified_gmt":"2026-10-19T13:20:48","slug":"nanomaterials-cosmetics-regulations","status":"publish","type":"post","link":"https:\/\/clearorg.eu\/en\/nanomaterials-cosmetics-regulations\/","title":{"rendered":"Nanomaterials in Cosmetics: Where Do We Stand?"},"content":{"rendered":"<p>Nanomaterials have been under increased scrutiny by regulatory authorities for several years and continue to raise questions for stakeholders in the cosmetics industry. Which <strong>definition<\/strong> should be used? How should they be <strong>characterised<\/strong>? <a href=\"https:\/\/clearorg.eu\/en\/\">CLEAR<\/a> <strong>takes stock of the current situation<\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<h3>IN EUROPE<\/h3>\n<p>&nbsp;<\/p>\n<h4>The key issue: the definition<\/h4>\n<p>&nbsp;<\/p>\n<p>To determine whether an ingredient is classified as a nanomaterial, it is essential to establish which <strong>definition<\/strong> applies.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Definition under the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/FR\/ALL\/?uri=celex%3A32009R1223\">European Cosmetics Regulation (EC) No 1223\/2009<\/a>:<\/strong><\/p>\n<p>Article 2<\/p>\n<ul>\n<li>(k) \u201cnanomaterial\u201d means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm;<\/li>\n<\/ul>\n<p>Accordingly, any ingredient whose particle size distribution includes values below 100 nm should be considered a potential nanomaterial, subject to information regarding its solubility, biopersistence and intentional manufacture.<\/p>\n<p>This definition has remained unchanged since the Regulation was published and remains the <strong>legally binding definition <\/strong>for regulatory purposes.<\/p>\n<p>However, the definition in the Regulation has certain <strong>practical limitations<\/strong>, particularly because it does not specify the proportion of particles that must fall within this size range (i.e. there is no defined threshold). In practice, materials generally exhibit a particle size distribution rather than a single particle size. The concept of \u201cintentional manufacture\u201d can also be difficult to establish on the basis of analytical data alone. To promote a more harmonised approach across different chemical sectors and take account of scientific and technical developments, the European Commission published an initial recommendation on a common definition of nanomaterials in 2011, which was revised in 2022.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Definition under <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=oj:JOC_2022_229_R_0001\">Commission Recommendation No 2022\/C 229\/01<\/a> :<\/strong><\/p>\n<p>\u201c1. \u2018Nanomaterial\u2019 means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles, in the number-based size distribution, fulfil at least one of the following conditions:<\/p>\n<p>(a) one or more external dimensions of the particle are in the size range 1 nm to 100 nm;<\/p>\n<p>(b) the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;<\/p>\n<p>(c) the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.\u201d<\/p>\n<p>This definition does not explicitly specify criteria relating to the solubility, bioavailability or intentional manufacture of nanomaterials. It is primarily based on the nanoscale dimensions of particles and provides further clarification on:<\/p>\n<ul>\n<li>particle size distribution, with a threshold of 50 % by number;<\/li>\n<li>the consideration of particles, agglomerates and aggregates;<\/li>\n<li>natural, incidental or manufactured materials;<\/li>\n<\/ul>\n<p>This definition provides a <strong>more pragmatic approach<\/strong> to the criteria used to determine nanomaterial status. It is<strong> not legally binding<\/strong> and does not supersede the definition laid down in the Cosmetics Regulation. However, <strong>competent authorities may take it into account during inspections<\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h4>Characterising nanomaterials: which analytical methods should be used?<\/h4>\n<p>&nbsp;<\/p>\n<p>There is <strong>no officially prescribed analytical method<\/strong>. However, following the Commission Recommendation, the Joint Research Centre (JRC) published <a href=\"https:\/\/publications.jrc.ec.europa.eu\/repository\/handle\/JRC132102\">guidance<\/a> outlining, among other things, recommended measurement methods. The test protocols used to determine whether a material meets the nanoscale criterion, as well as sample preparation procedures, can significantly influence the results in some cases. The first priority is therefore to select an appropriate method. To improve the reliability of the results, combining different analytical techniques is also recommended.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u201cScreening\u201d methods:<\/strong><\/p>\n<p>Dynamic Light Scattering (DLS) and laser diffraction, for example, can provide an initial assessment and rapidly generate information on particle size distribution. These methods generally need to be combined with a confirmatory technique, as they cannot reliably distinguish aggregates and agglomerates from primary particles. They may also produce false-negative results by overestimating particle sizes.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u201cConfirmatory\u201d methods:<\/strong><\/p>\n<p>Scanning Electron Microscopy (SEM) is a reference technique for nanoscale characterisation. It enables the presence of nanomaterials to be investigated through direct measurement of primary particle sizes. It also allows the number-based criterion to be assessed, which indirect techniques do not provide reliably or may misrepresent.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h4>Could the definition in the Cosmetics Regulation change?<\/h4>\n<p>&nbsp;<\/p>\n<p>In 2023, the French authorities indicated that the <strong>revision of the definition of nanomaterials<\/strong> in light of the European Commission Recommendation was planned as part of the forthcoming revision of the Cosmetics Regulation. Pending this revision, the <strong>Commission Recommendation is taken into account when determining the follow-up to non-compliance<\/strong>, reflecting the transitional situation in which cosmetic product regulation currently finds itself.<\/p>\n<p>As of the date of writing, publication of the revised Regulation is expected in 2029. The revision is expected to include an <strong>update to the definition of nanomaterials<\/strong>, although it has not been specified whether the Commission\u2019s definition will be adopted in its entirety. The Commission has established a dedicated working group to address this topic.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h4>At national level<\/h4>\n<p>&nbsp;<\/p>\n<p>Certain Member States, including France and Belgium, also have their own definitions of nanomaterials, together with specific <strong>national notification requirements<\/strong> (French Decrees <a href=\"https:\/\/www.legifrance.gouv.fr\/loda\/id\/JORFTEXT000025377246\">No. 2012-232<\/a> and <a href=\"https:\/\/www.legifrance.gouv.fr\/loda\/id\/JORFTEXT000025377246\">No. 2012-233<\/a>; <a href=\"https:\/\/www.health.belgium.be\/fr\/organisation-politique\/reglementation-documents-politique\/arrete-royal-27-mai-2014\">Belgian Royal Decree of 27 May 2014<\/a>).<\/p>\n<p>It is therefore important to distinguish between the European requirements applicable to cosmetic products and any additional national obligations.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3>WHAT ABOUT GREAT BRITAIN?<\/h3>\n<p><strong>\u00a0<\/strong><\/p>\n<p>In <strong>Great Britain<\/strong>, the definition of nanomaterials is d<strong>erived from European Cosmetics Regulation (EC) No 1223\/2009<\/strong>.<\/p>\n<p>Depending on how the definition evolves in the European Union, differences in the classification of nanomaterials could emerge between the regulatory frameworks of the two jurisdictions.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>This remains a complex and evolving topic. Contact <a href=\"https:\/\/clearorg.eu\/en\/contact\/\">CLEAR<\/a> to benefit from our expertise and stay up to date!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><em><u>Sources<\/u><\/em><\/p>\n<p><em>2026-07-03_NanoMesureFrance_Guide_methodologique_Identification_Nanomat\u00e9riaux<\/em><\/p>\n<p><em>COMMISSION RECOMMENDATION of 10 June 2022 on the definition of nanomaterial (2022\/C 229\/01)<\/em><\/p>\n<p><a href=\"https:\/\/publications.jrc.ec.europa.eu\/repository\/handle\/JRC132102\"><em>https:\/\/publications.jrc.ec.europa.eu\/repository\/handle\/JRC132102<\/em><\/a><\/p>\n<p><em>DGCCRF \/ ANSM \u2013 Information note on the application of the definition of nanomaterials under Regulation (EC) No 1223\/2009 on cosmetic products \u2013 February 2023<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nanomaterials have been under increased scrutiny by regulatory authorities for several years and<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":114,"featured_media":2839,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[204,252,99,261,290,289,101],"class_list":["post-2835","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-expert-insights","tag-compliance","tag-cosmetic-regulation","tag-cosmetics","tag-cosmetics-compliance","tag-nano","tag-nanomaterials","tag-regulation"],"_links":{"self":[{"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/posts\/2835","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/users\/114"}],"replies":[{"embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/comments?post=2835"}],"version-history":[{"count":4,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/posts\/2835\/revisions"}],"predecessor-version":[{"id":2850,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/posts\/2835\/revisions\/2850"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/media\/2839"}],"wp:attachment":[{"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/media?parent=2835"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/categories?post=2835"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/tags?post=2835"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}