{"id":21474,"date":"2023-08-02T06:55:17","date_gmt":"2023-08-02T04:55:17","guid":{"rendered":"https:\/\/kaeltia.com\/what-is-the-reach-regulation\/"},"modified":"2025-02-06T15:18:55","modified_gmt":"2025-02-06T13:18:55","slug":"what-is-the-reach-regulation","status":"publish","type":"post","link":"https:\/\/kaeltia.com\/en\/what-is-the-reach-regulation\/","title":{"rendered":"What is the REACH regulation?"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_77 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a03561f8355d\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"ez-toc-cssicon\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a03561f8355d\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/kaeltia.com\/en\/what-is-the-reach-regulation\/#What_is_the_meaning_of_REACH\" >What is the meaning of REACH?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/kaeltia.com\/en\/what-is-the-reach-regulation\/#What_stipulates_the_EU_REACH_legislation\" >What stipulates the EU REACH legislation?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/kaeltia.com\/en\/what-is-the-reach-regulation\/#Who_is_REACH_mandatory_for\" >Who is REACH mandatory for?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/kaeltia.com\/en\/what-is-the-reach-regulation\/#How_does_REACH_work\" >How does REACH work?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/kaeltia.com\/en\/what-is-the-reach-regulation\/#What_chemicals_are_included_in_the_REACH_regulation\" >What chemicals are included in the REACH regulation?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/kaeltia.com\/en\/what-is-the-reach-regulation\/#What_is_the_CLP_regulation\" >What is the CLP regulation?<\/a><\/li><\/ul><\/nav><\/div>\n<p>The <em><b>REACH regulation<\/b><\/em>\u00a0is an EU legislation that aims <strong>to protect human health and the environment<\/strong> against the risks arising from chemical substances, while promoting new testing and research methods for these substances in order to minimise animal testing. Let\u2019s not forget that during their manufacture and use, chemicals can seriously affect human health and ecosystems, so the <strong>REACH regulation<\/strong> seeks precisely to establish all the necessary measures and controls to avoid these risks.<\/p>\n<p><strong>Companies<\/strong> that market chemical substances &#8211; or modified natural substances &#8211; within the EU <strong>must comply with the REACH regulation<\/strong>, identifying the hazards of these substances and all their chemical properties, as well as establishing the safest way to use them. In order to be able to sell chemicals within the EU, these companies must therefore obtain a <strong>REACH certificate<\/strong>: that&#8217;s the reason why many of them contact us to get the expert assessment and advice provided by <a href=\"https:\/\/kaeltia.com\/en\/regulatory\/\">Kaeltia&#8217;s regulatory service<\/a>. But, let&#8217;s take a closer look at what REACH regulation is, and why it is so important.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_the_meaning_of_REACH\"><\/span>What is the meaning of REACH?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><em>REACH<\/em> stands for <strong>Registration, Evaluation, Authorisation and restriction of CHemicals<\/strong>. When we talk about <a href=\"https:\/\/www.miteco.gob.es\/es\/calidad-y-evaluacion-ambiental\/temas\/productos-quimicos\/reglamento-reach.html\" target=\"_blank\" rel=\"noopener nofollow\">REACH Regulation<\/a>, we are referring to the EC <strong>Regulation No 1907\/2006<\/strong>, which entered into force on 1 June 2007, and aims to protect human health and the environment from the risks of chemicals.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_stipulates_the_EU_REACH_legislation\"><\/span>What stipulates the EU REACH legislation?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The REACH regulation specifies that companies must identify the properties and risks associated with the chemical substances that they manufacture and sell on EU territory, providing information on how to use them safely. To this end, the REACH regulation sets out a series of obligations for these companies, such as the need to obtain a REACH registration number, or to notify the chemical substances in the products that are sold in the European market.<\/p>\n<p>However, the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/ES\/TXT\/?uri=CELEX%3A32006R1907&amp;qid=1604582377617\" target=\"_blank\" rel=\"noopener nofollow\">text of the REACH regulation states<\/a> that <strong>not all companies are subjected to the same regulatory obligations<\/strong>, but that this will depend on the role of that company in placing the chemical on the market.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Who_is_REACH_mandatory_for\"><\/span>Who is REACH mandatory for?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>REACH is a cross-cutting regulation that, with several degrees of involvement, implies <strong>obligations for most companies<\/strong> &#8211; even those that may at first sight appear to be outside the chemical industry. <strong>Depending on the type of activity<\/strong> carried out by each company within the production and\/or distribution process of chemical substances, the REACH regulation establishes the following <strong>types of enterprises<\/strong>:<\/p>\n<ul>\n<li><strong>Manufacturers<\/strong>: companies based in the EU that manufacture chemicals, either for their own use or for sale or export. These are probably the companies with the most obligations according to REACH.<\/li>\n<li><strong>Importers<\/strong>: European companies that bring chemicals acquired outside the EU or EEA into their territory; this includes not only chemicals or mixtures, but also finished products such as clothing, devices, plastic products&#8230;<\/li>\n<li><strong>Middle users<\/strong>: this refers to EU companies that use or handle chemicals.<\/li>\n<li><strong>Distributors<\/strong>: these are European companies that do not use chemicals, but are responsible for their storage, distribution and\/or sale to third parties.<\/li>\n<li><strong>Producers<\/strong>: refers to European companies that produce or manufacture within the EU products that may contain chemicals.<\/li>\n<\/ul>\n<p>Representatives: this refers to EU companies that are commissioned &#8211; through an exclusivity deal &#8211; by companies outside the European Union to make the necessary arrangements to meet the REACH requirements for importers.<br \/>\nRegarding <strong>companies based outside the EU<\/strong>, they are not obliged to comply with REACH, even if they export their products to EU territory; in this case, however, the obligations under REACH legislation fall on the <strong>EU-based companies importing those products<\/strong>, or on the exclusive representatives arranged by these non-EU companies.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_does_REACH_work\"><\/span>How does REACH work?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The<strong> ECHA<\/strong> (European Chemicals Agency), created in 2007 and based in Helsinki, is the organisation in charge of applying the <strong>REACH legislation<\/strong>, whose task is to help companies to comply with the REACH regulations; this is carried out by providing them with all kinds of <strong>information on chemical substances<\/strong>, and handling the reports on these substances that ECHA receives from companies. However, ECHA does not have the capacity to <strong>enforce the REACH regulation<\/strong>, but this role is assumed by the competent authorities of each EU-member country.<\/p>\n<p>The REACH regulation requires companies to carry out and submit several <strong>laboratory tests<\/strong>; in practice, this means that <strong>companies must identify the risks of the chemical substances<\/strong> they manufacture and\/or market on European territory, demonstrate to ECHA that they can be used safely, and inform users about how to deal with these risks and avoid them.<\/p>\n<p><strong>This is where Kaeltia comes in, helping companies<\/strong> to understand which parts of the REACH regulation they are obliged to comply with, what information they need to collect, what reports they must issue, and &#8211; finally &#8211; how to submit all these documents to the competent authorities, monitoring all the process until they obtain the certificate, if needed.<\/p>\n<p>Then, an <strong>ECHA scientific committee<\/strong> will consider the company request; if ECHA considers that the risks associated with the chemical cannot be managed properly, it may apply restrictions on its use, or even completely ban it. In any case, the spirit of the REACH regulation also involves the progressive substitution of those more hazardous substances with less dangerous alternatives.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_chemicals_are_included_in_the_REACH_regulation\"><\/span>What chemicals are included in the REACH regulation?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>REACH applies not only to chemicals used in <strong>industrial processes<\/strong>, but also to chemicals commonly used in <strong>people&#8217;s homes<\/strong>: from cleaning products or paints, to clothing or electronic devices. That\u2019s why, in the end, <strong>this regulation affects almost every company<\/strong> operating in the European Union.<\/p>\n<p>By principle, <strong>REACH concerns any chemical substance<\/strong> that is imported or manufactured in the EU, whether it is mixed or contained in any form in products and devices, except for the exceptions set out in the Art. 2 of the REACH Regulation (radioactive substances, transported substances, waste&#8230;). The full list of substances subjected to the authorisation process is included in <strong>REACH Annex XIV<\/strong>, also called <strong>REACH authorization list<\/strong>; this list can also be extended when necessary to <strong>include new chemical substances<\/strong>: this is what happened with the last update of the REACH regulation in 2022.<\/p>\n<p>Up to 17 January 2023, REACH Annex IV includes about 59 chemical <strong>Substances of Very High Concern (SVHC)<\/strong>, such as CMRs (Carcinogenic, Mutagenic and Reprotoxic chemicals, that may cause<strong> cancer<\/strong>, genetic mutations, and reproductive or birth defects) or phthalates, which are one of the world&#8217;s most common plasticisers but also a powerful endocrine disruptor.<\/p>\n<p>Among the most <strong>recent updates of the EU REACH regulation<\/strong> is the new legislation applicable to fertilisers; the new <strong>Regulation on Fertilising Products (FPR)<\/strong> &#8211; (EU) 2019\/1009 &#8211; regulates the marketing of EU fertiliser products, and after it came into force it has modified the <strong>requirements of the REACH regulation<\/strong> that were mandatory in the European Union. From now on, only if the fertilising product is placed on the market under the new FPR Regulation, will the new REACH requirements &#8211; known as <strong>REACH+<\/strong> (REACHplus) &#8211; apply to it.<\/p>\n<p>The FPR stipulates that <strong>all substances that make up an EU fertiliser<\/strong> product must be registered under REACH by means of a dossier containing, as a minimum:<\/p>\n<p>a) the <strong>information requirements<\/strong> described in REACH for the &gt;10 T\/year tonnage band (mandatory minimum tonnage, more restrictive requirements than lower tonnage)<\/p>\n<p>b) a <strong>chemical safety report<\/strong>, analysing the use of the substance as a fertiliser; if the fertiliser product is placed on the market without <strong>CE marking<\/strong> it will not be considered as an EU fertiliser product, and then the usual REACH requirements apply: that is, the REACH dossier corresponding to the tonnage range being manufactured or imported, shall be submitted for registration as usual.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_the_CLP_regulation\"><\/span>What is the CLP regulation?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>While REACH is responsible for evaluating, authorising and &#8211; if needed &#8211; restricting chemicals used in the EU, the <strong>CLP regulation is responsible for the classification<\/strong>, <strong>labelling and packaging of chemicals and their mixtures<\/strong>. In short, CLP seeks to identify through labelling all the <strong>properties and potential hazards<\/strong> of each chemical substance or mixture, also establishing rules for their packaging.<\/p>\n<p>Like REACH, CLP also imposes a number of <strong>obligations on companies<\/strong> depending on their role in the product supply chain. Both REACH and CLP regulations are, therefore, key to the EU&#8217;s legislation for assessing and <strong>managing chemicals and their risks<\/strong>.<\/p>\n<p>In summary, all the REACH regulation is of key importance to <strong>ensure the protection of human health and the environment in the European Union<\/strong>, against the potentially high risks posed by the chemical substances produced and marketed by companies; therefore, it is vital that all those involved in the production and distribution of products using these chemicals are aware of their risks and <strong>respect REACH norms<\/strong>.<\/p>\n<p>Precisely, in order to ensure a proper compliance with regulations, <strong>Kaeltia Consulting advises and provides technical support<\/strong> to manufacturers, distributors and importers of all types of chemical and natural substances; our services include the following:<\/p>\n<ul>\n<li>review and making of <strong>Safety Data Sheets<\/strong> (SDS)<\/li>\n<li>review of <strong>product labelling<\/strong>, and its adaptation to the destiny country<\/li>\n<li>review and elaboration of <strong>CLP<\/strong> on chemical substances<\/li>\n<li>elaboration, submission and follow-up of <strong>REACH certification<\/strong> dossiers<\/li>\n<\/ul>\n<p><strong>At Kaeltia, we are committed to quality and best customer experience<\/strong>, offering a professional and flexible service that adapts to every client&#8217;s needs. If you have to apply the REACH regulation; if you are not sure if your company must comply with this regulation; if you don&#8217;t know how to apply or deal with REACH obligations&#8230; <strong>We can help you<\/strong>!! Do not hesitate to <a href=\"https:\/\/kaeltia.com\/en\/contact\/\"><strong>contact us<\/strong><\/a>: let the best professional team deal with it!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The REACH regulation\u00a0is an EU legislation that aims to protect human health and the environment against the risks arising from chemical substances, while promoting new testing and research methods for these substances in order to minimise animal testing. Let\u2019s not forget that during their manufacture and use, chemicals can seriously affect human health and ecosystems, so the REACH regulation seeks precisely to establish all the necessary measures and controls to[&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":21065,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_wpscppro_custom_social_share_image":0,"_facebook_share_type":"","_twitter_share_type":"","_linkedin_share_type":"","_pinterest_share_type":"","_linkedin_share_type_page":"","_selected_social_profile":[]},"categories":[62],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/posts\/21474"}],"collection":[{"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/comments?post=21474"}],"version-history":[{"count":4,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/posts\/21474\/revisions"}],"predecessor-version":[{"id":21478,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/posts\/21474\/revisions\/21478"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/media\/21065"}],"wp:attachment":[{"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/media?parent=21474"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/categories?post=21474"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/tags?post=21474"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}