{"id":12045,"date":"2026-02-17T06:05:06","date_gmt":"2026-02-17T06:05:06","guid":{"rendered":"https:\/\/kmslaser.com\/how-verify-reach-compliance-sourcing-pressotherapy-machines-to\/"},"modified":"2026-02-17T06:05:06","modified_gmt":"2026-02-17T06:05:06","slug":"%d9%83%d9%8a%d9%81-%d8%a7%d9%84%d8%aa%d8%ad%d9%82%d9%82-%d9%85%d9%86-%d9%88%d8%b5%d9%88%d9%84-%d8%a2%d9%84%d8%a7%d8%aa-%d8%a7%d9%84%d8%b9%d9%84%d8%a7%d8%ac-%d8%a8%d8%a7%d9%84%d8%b6%d8%ba%d8%b7-%d8%a5","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/ar\/how-verify-reach-compliance-sourcing-pressotherapy-machines-to\/","title":{"rendered":"\u0643\u064a\u0641\u064a\u0629 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0627\u0626\u062d\u0629 REACH \u0639\u0646\u062f \u0634\u0631\u0627\u0621 \u0622\u0644\u0627\u062a \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0636\u063a\u0637\u061f"},"content":{"rendered":"<style>article img, .entry-content img, .post-content img, .wp-block-image img, figure img, p img {max-width:100% !important; height:auto !important;}figure { max-width:100%; }img.top-image-square {width:280px; height:280px; object-fit:cover;border-radius:12px; box-shadow:0 2px 12px rgba(0,0,0,0.10);}@media (max-width:600px) {img.top-image-square { width:100%; height:auto; max-height:300px; }p:has(> img.top-image-square) { float:none !important; margin:0 auto 15px auto !important; text-align:center; }}.claim { background-color:#fff4f4; border-left:4px solid #e63946; border-radius:10px; padding:20px 24px; margin:24px 0; font-family:system-ui,sans-serif; line-height:1.6; position:relative; box-shadow:0 2px 6px rgba(0,0,0,0.03); }.claim-true { background-color:#eafaf0; border-left-color:#2ecc71; }.claim-icon { display:inline-block; font-size:18px; color:#e63946; margin-right:10px; vertical-align:middle; }.claim-true .claim-icon { color:#2ecc71; }.claim-title { display:flex; align-items:center; font-weight:600; font-size:16px; color:#222; }.claim-label { margin-left:auto; font-size:12px; background-color:#e63946; color:#fff; padding:3px 10px; border-radius:12px; font-weight:bold; }.claim-true .claim-label { background-color:#2ecc71; }.claim-explanation { margin-top:8px; color:#555; font-size:15px; }.claim-pair { margin:32px 0; }<\/style>\n<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771308242981-1.jpg\" alt=\"Verifying REACH compliance for pressotherapy machines during the sourcing process (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>Every week, our quality control team encounters a familiar challenge <a href=\"https:\/\/echa.europa.eu\/chemicals-information\/echa-chem\" target=\"_blank\" rel=\"noopener noreferrer\">ECHA database<\/a> <sup id=\"ref-1\"><a href=\"#footnote-1\" class=\"footnote-ref\">1<\/a><\/sup>. An EU buyer asks for REACH documentation, but the supplier&#8217;s test report looks questionable. When our production line runs pressotherapy suits and control units, we must verify each component meets strict chemical safety rules <a href=\"https:\/\/anab.ansi.org\/accreditation\/iso-iec-17025\/\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 17025 accreditation<\/a> <sup id=\"ref-2\"><a href=\"#footnote-2\" class=\"footnote-ref\">2<\/a><\/sup>. Get this wrong, and your entire shipment faces rejection at the EU border.<\/p>\n<p><strong>To verify REACH compliance when sourcing pressotherapy machines, you must request authentic SVHC test reports from accredited labs, cross-check registration status on the ECHA database, demand full material declarations for all components, and include explicit compliance clauses in your supplier contracts. The EU importer bears ultimate responsibility.<\/strong><\/p>\n<p>Below, we break down the key verification steps. You will learn how to spot fake test reports, which materials pose the highest risk, and what documentation protects your business during OEM production.<\/p>\n<h2>How can I verify that my supplier&#39;s REACH test reports are authentic?<\/h2>\n<p>When we first started exporting pressotherapy equipment to Europe, we learned a painful lesson. One supplier&#39;s &quot;REACH compliant&quot; letter turned out to be worthless. The test report looked professional, but it failed basic verification checks. This cost us weeks of delays and damaged a customer relationship.<\/p>\n<p><strong>To verify REACH test report authenticity, cross-check the report number on the issuing lab&#39;s online verification portal, confirm the lab holds ISO 17025 accreditation, verify the sample description matches your product exactly, and ensure the test date covers the current SVHC Candidate List version.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771308244251-2.jpg\" alt=\"Authenticating supplier REACH test reports through lab verification portals and ISO accreditation checks (ID#2)\" title=\"Verifying REACH Test Reports\"><\/p>\n<h3>Use Official Lab Verification Portals<\/h3>\n<p>Most accredited testing labs offer online report verification systems. SGS provides a cloud-based service to verify authenticity and validity of test reports for RoHS, SVHCs, and REACH, requiring the report number, date, and security code. This takes just minutes but prevents major problems.<\/p>\n<p>You can use SGS&#39;s contact form or its online document check service to verify the authenticity of a test report. Other major labs like T\u00dcV, Intertek, and Bureau Veritas offer similar verification services.<\/p>\n<h3>Check for Critical Report Elements<\/h3>\n<p>A legitimate REACH test report should include several key elements. Review this checklist before accepting any supplier documentation:<\/p>\n<table>\n<thead>\n<tr>\n<th>Element<\/th>\n<th>What to Check<\/th>\n<th>Red Flag<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Lab Accreditation<\/td>\n<td>ISO 17025 certification<\/td>\n<td>Missing or expired accreditation number<\/td>\n<\/tr>\n<tr>\n<td>Test Date<\/td>\n<td>Within 12 months<\/td>\n<td>Outdated testing against old SVHC list<\/td>\n<\/tr>\n<tr>\n<td>Sample Description<\/td>\n<td>Exact match to your product BOM<\/td>\n<td>Generic or vague descriptions<\/td>\n<\/tr>\n<tr>\n<td>SVHC List Version<\/td>\n<td>Current version (253 substances as of Feb 2026)<\/td>\n<td>Older list versions<\/td>\n<\/tr>\n<tr>\n<td>Test Methods<\/td>\n<td>ICP-MS, GC-MS specified<\/td>\n<td>No methodology mentioned<\/td>\n<\/tr>\n<tr>\n<td>Pass\/Fail Determination<\/td>\n<td>Clear concentration levels<\/td>\n<td>Vague &quot;compliant&quot; statements<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>In <a href=\"https:\/\/environment.ec.europa.eu\/topics\/chemicals\/reach-regulation_en\" target=\"_blank\" rel=\"noopener noreferrer\">REACH compliance<\/a> <sup id=\"ref-3\"><a href=\"#footnote-3\" class=\"footnote-ref\">3<\/a><\/sup> tests, labs perform full SVHC tests and deliver detailed reports that include the REACH-compliant testing methodology used, test results, and pictures of specimens. The report will deliver a PASS\/FAIL determination and concentration levels for SVHC tests.<\/p>\n<h3>Understand the Difference Between Declarations and Test Reports<\/h3>\n<p>Many suppliers offer signed declarations instead of actual test reports. This creates risk for importers.<\/p>\n<p>Suppliers sign statements declaring they will not use any substances restricted under Annex XVII or listed as SVHCs. However, a REACH declaration does not provide actual verification of compliance and cannot be compared to an actual test report.<\/p>\n<p>When our customers send us supplier declarations, we always recommend requesting independent lab testing. Failing to provide a REACH test report upon request can result in a sales ban, fines, and recalls.<\/p>\n<h3>Contact the Lab Directly<\/h3>\n<p>If you have any doubts, call the testing lab directly. Provide the report number and ask them to confirm:<\/p>\n<ul>\n<li>The report was issued by their lab<\/li>\n<li>The sample details match your product<\/li>\n<li>The report has not been altered<\/li>\n<li>The test scope covered full SVHC screening<\/li>\n<\/ul>\n<p>Third-party lab testing is often the only way to verify if a certain product or material is compliant.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> Accredited labs offer online verification systems for their test reports <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">Major testing organizations like SGS, T\u00dcV, and Bureau Veritas provide web-based portals where you can verify report authenticity using the report number and security code.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> A signed supplier declaration provides the same protection as a third-party test report <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">Supplier declarations are self-certifications that provide no actual verification of chemical content. Only independent lab testing can confirm REACH compliance.<\/div>\n<\/div>\n<\/div>\n<h2>Which materials in my pressotherapy suits are most likely to fail REACH compliance?<\/h2>\n<p>In our factory, we have tested hundreds of compression suit samples from different material suppliers. Some materials consistently raise concerns during REACH testing. Knowing which components carry the highest risk helps you focus verification efforts where they matter most.<\/p>\n<p><strong>The materials most likely to fail REACH compliance in pressotherapy suits are PVC-based fabrics containing phthalate plasticizers (especially DEHP), wiring with heavy metal stabilizers, printed graphics with azo dyes, and adhesives containing SVHCs. PVC compression boots are the highest-risk component.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771308245738-3.jpg\" alt=\"High-risk materials in pressotherapy suits like PVC and phthalates failing REACH compliance standards (ID#3)\" title=\"High-Risk Pressotherapy Suit Materials\"><\/p>\n<h3>PVC and Phthalate Plasticizers<\/h3>\n<p>Pressotherapy compression garments often use PVC or PVC-coated fabrics for durability and flexibility. These materials frequently contain <a href=\"https:\/\/echa.europa.eu\/hot-topics\/phthalates\" target=\"_blank\" rel=\"noopener noreferrer\">phthalate plasticizers<\/a> <sup id=\"ref-4\"><a href=\"#footnote-4\" class=\"footnote-ref\">4<\/a><\/sup> that are heavily restricted under REACH.<\/p>\n<p>Entry 51 of <a href=\"https:\/\/echa.europa.eu\/regulations\/reach\/legislation\/annex-xvii-to-reach\" target=\"_blank\" rel=\"noopener noreferrer\">Annex XVII to REACH<\/a> <sup id=\"ref-5\"><a href=\"#footnote-5\" class=\"footnote-ref\">5<\/a><\/sup> restricts the use of specific phthalates, including DEHP, BBP, DBP, and DiBP. These four phthalates are prohibited from being used, individually or in combination, at concentrations equal to or greater than 0.1% by weight of the plasticized material, including PVC.<\/p>\n<p>The total quantity and composition of added plasticizers determines the degree of flexibility in the final product. The total plasticizer content of flexible PVC tubing could be as high as 50 percent by weight of the final material.<\/p>\n<h3>High-Risk Components Table<\/h3>\n<table>\n<thead>\n<tr>\n<th>Component<\/th>\n<th>Common Material<\/th>\n<th>SVHC Risk<\/th>\n<th>Typical Substances of Concern<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Compression boots\/sleeves<\/td>\n<td>Flexible PVC<\/td>\n<td>Very High<\/td>\n<td>DEHP, BBP, DBP, DIBP<\/td>\n<\/tr>\n<tr>\n<td>Air bladders<\/td>\n<td>Polyurethane, PVC<\/td>\n<td>High<\/td>\n<td>Phthalates, flame retardants<\/td>\n<\/tr>\n<tr>\n<td>Outer fabric<\/td>\n<td>Nylon, polyester<\/td>\n<td>Medium<\/td>\n<td>Azo dyes, fluorinated compounds<\/td>\n<\/tr>\n<tr>\n<td>Zippers\/hardware<\/td>\n<td>Nickel-plated metal<\/td>\n<td>Medium<\/td>\n<td>Nickel, cadmium<\/td>\n<\/tr>\n<tr>\n<td>Air tubing<\/td>\n<td>Flexible PVC<\/td>\n<td>High<\/td>\n<td>Phthalates, lead stabilizers<\/td>\n<\/tr>\n<tr>\n<td>Control unit casing<\/td>\n<td>ABS plastic<\/td>\n<td>Medium<\/td>\n<td>Brominated flame retardants<\/td>\n<\/tr>\n<tr>\n<td>Printed labels<\/td>\n<td>Inks<\/td>\n<td>Medium<\/td>\n<td>Heavy metals, phthalates<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Phthalate-Free Alternatives<\/h3>\n<p>Phthalate-free PVC has been formulated under regulations such as REACH, FDA, and EN 71. This guarantees its safety for applications in contact with humans, such as toys, medical devices, or food packaging.<\/p>\n<p>When sourcing pressotherapy suits, we now specify phthalate-free materials from the beginning. Instead of phthalates, approved alternative plasticizers such as DOTP or DINCH are added along with health-safe stabilizers and lubricants.<\/p>\n<h3>Electronics and Wiring<\/h3>\n<p>The control unit and wiring in pressotherapy machines present additional REACH concerns. DBDPE is a brominated flame retardant widely used in the manufacturing of plastics, cables, electronic device housings, and construction materials. This substance was recently added to the <a href=\"https:\/\/echa.europa.eu\/candidate-list-of-substances-of-very-high-concern-for-authorisation\" target=\"_blank\" rel=\"noopener noreferrer\">SVHC Candidate List<\/a> <sup id=\"ref-6\"><a href=\"#footnote-6\" class=\"footnote-ref\">6<\/a><\/sup> for being very persistent and very bioaccumulative.<\/p>\n<p>Electronics manufacturers need to be aware of substances added to the SVHC Candidate List as they may be used in components in their bills of materials.<\/p>\n<h3>Current SVHC List Status<\/h3>\n<p>On February 4, 2026, ECHA released the new Candidate List of SVHCs with the addition of two new substances. The current list now contains 253 substances.<\/p>\n<p>This constantly expanding list means your verification processes must be ongoing. The EU REACH SVHC List is typically updated twice per year, resulting in affected companies needing to re-evaluate their product compliance and possibly re-collect substance data from suppliers.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> Flexible PVC materials in pressotherapy suits commonly contain phthalate plasticizers that require REACH verification <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">PVC flexibility comes from added plasticizers, and many traditional options like DEHP are now restricted SVHCs. Testing is essential to confirm compliance.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> If a material passed REACH testing two years ago, it remains compliant today <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">The SVHC Candidate List expands approximately twice per year. A material that was compliant in 2024 may contain substances added to the list in 2025 or 2026.<\/div>\n<\/div>\n<\/div>\n<h2>How do I ensure my private-label machines meet REACH standards during the OEM process?<\/h2>\n<p>Our engineering team works with private-label customers across Europe and North America. We have learned that REACH compliance must be built into the OEM process from day one. Waiting until production is complete creates expensive problems.<\/p>\n<p><strong>To ensure private-label pressotherapy machines meet REACH during OEM production, incorporate compliance requirements into your supplier agreement, demand full material declarations before production starts, specify REACH-compliant materials in design specifications, and schedule testing at multiple production stages.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771308246578-4.jpg\" alt=\"Ensuring private-label pressotherapy machines meet REACH standards during the OEM manufacturing process (ID#4)\" title=\"OEM REACH Compliance Process\"><\/p>\n<h3>The Private Labeler&#39;s Legal Position<\/h3>\n<p>Under EU regulations, the company that places a product on the market bears full responsibility for compliance. The private labeler brings the product onto the market under their own trade name, making them legally the manufacturer. This means the private labeler is equal to the manufacturer and has the same obligations in accordance with applicable legislation.<\/p>\n<p>Non-EU manufacturers have no direct compliance responsibilities, therefore the job of ensuring REACH compliance of imported products falls onto the EU importer. However, many EU importers may insist that non-EU manufacturers comply with REACH Regulations.<\/p>\n<h3>Building REACH into OEM Contracts<\/h3>\n<p>Your supplier agreement should include explicit REACH provisions:<\/p>\n<table>\n<thead>\n<tr>\n<th>Contract Element<\/th>\n<th>Purpose<\/th>\n<th>Enforcement Mechanism<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Full Material Disclosure<\/td>\n<td>Know all chemicals in product<\/td>\n<td>Production holds until received<\/td>\n<\/tr>\n<tr>\n<td>SVHC Declaration per component<\/td>\n<td>Identify high-risk parts<\/td>\n<td>Reject non-compliant materials<\/td>\n<\/tr>\n<tr>\n<td>Third-party testing rights<\/td>\n<td>Verify supplier claims<\/td>\n<td>Random sample testing<\/td>\n<\/tr>\n<tr>\n<td>Non-compliance penalties<\/td>\n<td>Motivate compliance<\/td>\n<td>Financial liability clauses<\/td>\n<\/tr>\n<tr>\n<td>Update notification<\/td>\n<td>Track regulatory changes<\/td>\n<td>Mandatory communication<\/td>\n<\/tr>\n<tr>\n<td>Documentation retention<\/td>\n<td>Audit readiness<\/td>\n<td>10-year retention requirement<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>When engaging subcontractors and OEM manufacturers, the manufacturer is obliged to exercise overall control over the medical devices and ensure they receive all information necessary to fulfill their obligations. The manufacturer cannot exempt themselves from their obligations and transfer them to the OEM manufacturer or distributor.<\/p>\n<h3>Pre-Production Material Verification<\/h3>\n<p>Before production begins, request:<\/p>\n<ol>\n<li>Full <a href=\"https:\/\/en.wikipedia.org\/wiki\/Bill_of_materials\" target=\"_blank\" rel=\"noopener noreferrer\">Bill of Materials (BOM)<\/a> <sup id=\"ref-7\"><a href=\"#footnote-7\" class=\"footnote-ref\">7<\/a><\/sup> with chemical composition data<\/li>\n<li>Safety Data Sheets (SDS) for all chemical-containing components<\/li>\n<li>Existing test reports from material suppliers<\/li>\n<li>Declaration of SVHC content for each component<\/li>\n<\/ol>\n<p>Since REACH is applicable not only to chemical substances and mixtures but also includes certain provisions applicable to articles, it is important for consumer product manufacturers and importers to understand their roles and responsibilities within the REACH framework. Substance restriction, authorization, and notification are important factors for articles placed on the European market.<\/p>\n<h3>In-Production Quality Control<\/h3>\n<p>Our production process includes REACH checkpoints:<\/p>\n<ol>\n<li><strong>Incoming Material Inspection<\/strong>: Verify supplier certificates match actual materials<\/li>\n<li><strong>First Article Testing<\/strong>: Send initial production samples to accredited lab<\/li>\n<li><strong>Batch Sampling<\/strong>: Test representative samples from each production batch<\/li>\n<li><strong>Pre-Shipment Verification<\/strong>: Final documentation review and random testing<\/li>\n<\/ol>\n<h3>Working with Your OEM Partner<\/h3>\n<p>Strict requirements are applied to ensure quality, and OEM manufacturers must adhere to complex documentation requirements to guarantee compliance with regulatory standards for the final product. When choosing an OEM manufacturer, clear criteria should be established and everything should be thoroughly checked, including capacities, pricing, quality, resources, standards, and compliance with norms.<\/p>\n<p>At our facility, we maintain a compliance database tracking SVHC status for every component we use. When the ECHA updates the Candidate List, we automatically flag affected products and notify customers.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> Private labelers bear the same legal obligations as manufacturers for REACH compliance <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">Under EU regulations, the entity placing a product on the market under their tradename assumes full manufacturer responsibility, including chemical safety compliance.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> OEM suppliers in China are responsible for EU REACH compliance <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">Non-EU manufacturers have no direct REACH obligations. The EU importer or private labeler must verify compliance and cannot transfer this legal responsibility to suppliers.<\/div>\n<\/div>\n<\/div>\n<h2>What documentation should I demand from my manufacturer to prove my machines are REACH compliant?<\/h2>\n<p>When our customers request REACH documentation, we provide a comprehensive package. Years of experience have taught us exactly what EU customs authorities and regulatory bodies expect to see. Missing documentation creates delays, fines, and market access problems.<\/p>\n<p><strong>Essential REACH documentation includes full material declarations for all components, SVHC test reports from accredited labs dated within 12 months, supplier compliance letters with tonnage coverage confirmation, SCIP database notification proof, and Only Representative certificates if applicable.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771308247452-5.jpg\" alt=\"Essential REACH documentation including SVHC test reports and material declarations for pressotherapy machines (ID#5)\" title=\"Required REACH Compliance Documentation\"><\/p>\n<h3>Core Documentation Requirements<\/h3>\n<p>EU or EEA suppliers of an article containing a Candidate List SVHC in a concentration of more than 0.1% are required to provide information to the recipient of the article to allow safe use. The equivalent information should be supplied to consumers within 45 days when requested.<\/p>\n<p>Your documentation package should include:<\/p>\n<table>\n<thead>\n<tr>\n<th>Document Type<\/th>\n<th>Purpose<\/th>\n<th>Update Frequency<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Full Material Declaration (FMD)<\/td>\n<td>Complete chemical composition<\/td>\n<td>Each design change<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/www.hqts.com\/top-5-substances-on-the-eu-reach-svhc-list-compliance-and-testing-guide\/\" target=\"_blank\" rel=\"noopener noreferrer\">SVHC Test Reports<\/a> <sup id=\"ref-8\"><a href=\"#footnote-8\" class=\"footnote-ref\">8<\/a><\/sup><\/td>\n<td>Prove compliance to current list<\/td>\n<td>Every 6-12 months<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/en.wikipedia.org\/wiki\/Safety_data_sheet\" target=\"_blank\" rel=\"noopener noreferrer\">Safety Data Sheets (SDS)<\/a> <sup id=\"ref-9\"><a href=\"#footnote-9\" class=\"footnote-ref\">9<\/a><\/sup><\/td>\n<td>Chemical hazard information<\/td>\n<td>When formulation changes<\/td>\n<\/tr>\n<tr>\n<td>Supplier Compliance Letters<\/td>\n<td>Written commitment<\/td>\n<td>Annual renewal<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/echa.europa.eu\/scip\" target=\"_blank\" rel=\"noopener noreferrer\">SCIP Database Notification<\/a> <sup id=\"ref-10\"><a href=\"#footnote-10\" class=\"footnote-ref\">10<\/a><\/sup><\/td>\n<td>EU waste framework compliance<\/td>\n<td>When SVHC detected<\/td>\n<\/tr>\n<tr>\n<td>Only Representative Certificate<\/td>\n<td>Non-EU supplier representation<\/td>\n<td>Annual verification<\/td>\n<\/tr>\n<tr>\n<td>Bill of Materials<\/td>\n<td>Component traceability<\/td>\n<td>Each production lot<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>SVHC Notification Requirements<\/h3>\n<p>Importers and producers must notify ECHA if their article contains SVHC substances above a concentration of 0.1% weight by weight and the substance is present in quantities totalling over 1 tonne per producer or importer per year. The notifications must be submitted within six months from the date the substance is included in the list.<\/p>\n<p>Since January 2021, EU suppliers of articles containing more than 0.1% of an SVHC on the Candidate List are obliged to notify ECHA. This notification is published on ECHA&#39;s SCIP database.<\/p>\n<h3>Only Representative Requirements<\/h3>\n<p>Only persons or companies established in the EU may submit a REACH registration. A non-EU company with no EU presence may do so by appointing an Only Representative to act on its behalf.<\/p>\n<p>If your pressotherapy machine manufacturer is based in China (like us), they need an Only Representative for substances exceeding one tonne per year. Request documentation showing:<\/p>\n<ul>\n<li>OR appointment letter<\/li>\n<li>Tonnage coverage certificate<\/li>\n<li>Registration confirmation from ECHA<\/li>\n<\/ul>\n<h3>Documentation Verification Checklist<\/h3>\n<p>Before accepting any compliance documentation, verify:<\/p>\n<ol>\n<li>\n<p><strong>Test Report Authenticity<\/strong><\/p>\n<ul>\n<li>Lab accreditation valid<\/li>\n<li>Report number verifiable online<\/li>\n<li>Sample matches your product<\/li>\n<\/ul>\n<\/li>\n<li>\n<p><strong>SVHC Coverage<\/strong><\/p>\n<ul>\n<li>Tests cover current Candidate List<\/li>\n<li>All product components included<\/li>\n<li>Concentration levels clearly stated<\/li>\n<\/ul>\n<\/li>\n<li>\n<p><strong>Supplier Commitments<\/strong><\/p>\n<ul>\n<li>Written on company letterhead<\/li>\n<li>Signed by authorized person<\/li>\n<li>Specific to your products<\/li>\n<\/ul>\n<\/li>\n<li>\n<p><strong>Regulatory Currency<\/strong><\/p>\n<ul>\n<li>Documents dated within 12 months<\/li>\n<li>References current regulations<\/li>\n<li>Includes latest SVHC additions<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p>Importers and producers of articles must notify ECHA if their article contains a Candidate List substance within six months from the date it has been included in the list. EU and EEA suppliers must update the safety data sheet they provide to customers.<\/p>\n<h3>Ongoing Monitoring<\/h3>\n<p>The REACH framework may affect consumer products with regard to substance authorization according to Annex XIV or restriction according to Annex XVII, as well as SVHC notification according to Article 7 or declaration according to Article 33. Manufacturers and importers must be aware that REACH standards are subject to constant change and must closely follow the latest requirements.<\/p>\n<p>We recommend establishing a document management system that:<\/p>\n<ul>\n<li>Tracks expiration dates for all certificates<\/li>\n<li>Alerts you when ECHA updates the SVHC list<\/li>\n<li>Maintains version control for all compliance documents<\/li>\n<li>Provides audit-ready access to historical records<\/li>\n<\/ul>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> SVHC notifications must be submitted to ECHA within six months of a substance being added to the Candidate List <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">REACH regulations require notification within six months when an article contains an SVHC above 0.1% concentration and exceeds one tonne annually.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> REACH documentation only needs to be obtained once at product launch <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">The SVHC list expands twice yearly, and regulations evolve continuously. Documentation must be updated regularly to reflect current requirements and maintain compliance.<\/div>\n<\/div>\n<\/div>\n<h2>Conclusion<\/h2>\n<p>REACH compliance for pressotherapy machines requires systematic verification at every sourcing stage. Authenticate test reports through official lab portals. Focus testing on high-risk PVC components. Build compliance into your OEM contracts from day one. Maintain complete documentation that covers the current SVHC list.<\/p>\n<h2>Footnotes<\/h2>\n<p><span id=\"footnote-1\"><br \/>\n1. Provides information on the official European Chemicals Agency&#8217;s public chemical database. <a href=\"#ref-1\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-2\"><br \/>\n2. Replaced with an authoritative accreditation body&#8217;s page on ISO\/IEC 17025 accreditation. <a href=\"#ref-2\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-3\"><br \/>\n3. Explains the core EU regulation for chemical safety and environmental protection. <a href=\"#ref-3\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-4\"><br \/>\n4. Describes a common group of chemicals restricted under REACH due to health concerns. <a href=\"#ref-4\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-5\"><br \/>\n5. Explains the restrictions on manufacturing, placing on the market, and use of certain dangerous substances. <a href=\"#ref-5\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-6\"><br \/>\n6. Provides details on the official list of Substances of Very High Concern under REACH. <a href=\"#ref-6\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-7\"><br \/>\n7. Replaced with a neutral and comprehensive Wikipedia article on Bill of Materials. <a href=\"#ref-7\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-8\"><br \/>\n8. Details the critical documentation for verifying chemical safety against SVHCs. <a href=\"#ref-8\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-9\"><br \/>\n9. Explains documents providing information on hazardous chemicals and safe handling procedures. <a href=\"#ref-9\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-10\"><br \/>\n10. Details the requirement to submit information on articles containing SVHCs to ECHA&#8217;s SCIP database. <a href=\"#ref-10\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How to Verify REACH Compliance When Sourcing Pressotherapy Machines?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"To verify REACH compliance when sourcing pressotherapy machines, you must request authentic SVHC test reports from accredited labs, cross-check registration status on the ECHA database, demand full material declarations for all components, and include explicit compliance clauses in your supplier contracts. The EU importer bears ultimate responsibility.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How can I verify that my supplier's REACH test reports are authentic?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"To verify REACH test report authenticity, cross-check the report number on the issuing lab's online verification portal, confirm the lab holds ISO 17025 accreditation, verify the sample description matches your product exactly, and ensure the test date covers the current SVHC Candidate List version.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Which materials in my pressotherapy suits are most likely to fail REACH compliance?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The materials most likely to fail REACH compliance in pressotherapy suits are PVC-based fabrics containing phthalate plasticizers (especially DEHP), wiring with heavy metal stabilizers, printed graphics with azo dyes, and adhesives containing SVHCs. 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\u0627\u0644\u062a\u0633\u062c\u064a\u0644\u2026<\/p>","protected":false},"author":3,"featured_media":12040,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[169],"tags":[],"class_list":["post-12045","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pressotherapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>How to Verify REACH Compliance When Sourcing Pressotherapy Machines? - KMSLaser<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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