--- title: "EU RoHS CE Marking and Declaration of Conformity" canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive/ce-and-doc" source_url: "https://www.sorena.io/artifacts/eu/rohs-directive/ce-and-doc" author: "Sorena AI" description: "source-linked guide to RoHS CE marking, EU Declaration of Conformity, technical documentation, EN IEC 63000, and importer or distributor checks." published_at: "2026-05-09" updated_at: "2026-05-27" keywords: - "EU RoHS CE marking" - "RoHS Declaration of Conformity" - "EN IEC 63000" - "Directive 2011/65/EU" - "RoHS technical documentation" - "EU RoHS Directive" - "RoHS CE marking" - "EU Declaration of Conformity" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # EU RoHS CE Marking and Declaration of Conformity source-linked guide to RoHS CE marking, EU Declaration of Conformity, technical documentation, EN IEC 63000, and importer or distributor checks. *Artifact Guide* *EU* ## EU RoHS Directive CE marking and DoC For RoHS-covered electrical and electronic equipment, CE marking is tied to technical documentation, internal production control, and an EU Declaration of Conformity before the finished product is placed on the EU market. Use this guide to decide what the manufacturer, importer, distributor, and technical-file owner need to verify before a RoHS DoC is signed or accepted. RoHS CE marking is not a standalone label exercise. Directive 2011/65/EU requires the manufacturer to demonstrate conformity with the hazardous-substance restrictions, draw up technical documentation, use the internal production control procedure, issue an EU Declaration of Conformity, and affix the CE mark on the finished EEE when conformity has been demonstrated. ## What RoHS adds to the CE and DoC file Directive 2011/65/EU applies CE marking and EU Declaration of Conformity duties to electrical and electronic equipment that is within RoHS scope. The practical question is whether the finished EEE has evidence showing that Article 4 restrictions have been met at the homogeneous-material level, including any valid exemption relied on. The manufacturer is the party that draws up the required technical documentation, carries out or has carried out the internal production control procedure under Module A, issues the EU Declaration of Conformity, and affixes the CE marking once conformity has been demonstrated. The same directive allows a single technical documentation set when another applicable EU law uses a conformity-assessment procedure that is at least as stringent. - Confirm the product is EEE in scope before treating RoHS as part of the CE pack. - Tie the DoC statement to Article 4 compliance, not only to a supplier certificate or a generic RoHS-compliant label. - Keep the RoHS evidence with the same release record used for the finished product, because the CE marking is affixed to the finished EEE or, where allowed, to packaging and accompanying documents. Sources for this answer: - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding consolidated RoHS source for manufacturer duties, EU Declaration of Conformity, CE marking, presumption of conformity, and Annex II substance limits. - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - General EU product-law guidance for what CE marking and the EU Declaration of Conformity communicate. ## Minimum checks before signing or accepting a RoHS DoC A RoHS DoC should not be signed from a marketing claim alone. The file needs enough traceable evidence to show that the finished EEE was assessed against the restricted substances, threshold structure, and any applicable exemption position. RoHS Annex II lists maximum concentration values by weight in homogeneous materials, so BOM evidence has to resolve below product level where necessary. EN IEC 63000:2018 is the harmonised standard identified by Commission Implementing Decision (EU) 2020/659 for technical documentation used to assess materials, components, and electrical and electronic equipment against RoHS hazardous-substance restrictions. Using harmonised standards whose references are published in the Official Journal can support the directive's presumption-of-conformity framework. - Identify the exact finished EEE, model, type, batch, serial number, or equivalent identifier covered by the DoC. - Map materials, components, supplier declarations, exemption claims, and test evidence to the restricted substances relevant to the product. - Record whether EN IEC 63000:2018 is used for the technical-documentation approach and keep the standard reference with the technical file. - Keep assumptions separate from conclusions, especially where supplier evidence is incomplete, component substitutions are pending, or an exemption expiry has to be monitored. Sources for this answer: - [Commission Implementing Decision (EU) 2020/659 on EN IEC 63000](https://data.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - Official source identifying EN IEC 63000:2018 as the harmonised standard for RoHS technical documentation. - [European Commission - harmonised standards for RoHS](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/restriction-use-certain-hazardous-substances-rohs_en?ref=sorena.io) - Commission page for RoHS harmonised standards and Official Journal publication context. - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for homogeneous-material thresholds and the presumption-of-conformity rule. ## Importer and distributor review points Importers and distributors do not get to ignore the RoHS CE and DoC file. Before placing EEE on the EU market, importers must ensure the manufacturer has carried out the appropriate conformity-assessment procedure, drawn up technical documentation, applied CE marking, supplied required documents, and met identification and contact-information duties. Distributors must act with due care when making EEE available on the market. For RoHS, that includes checking that the EEE bears CE marking, is accompanied by required documents in a language understandable to consumers and other end-users in the relevant Member State, and that manufacturer and importer identification duties have been met. An importer or distributor that places EEE on the market under its own name or trademark, or modifies EEE in a way that may affect compliance, is treated as the manufacturer for RoHS purposes. - Ask for the RoHS DoC and enough technical-file access assurance to respond to national authority requests. - Check that the product identity on the DoC matches the units being imported, stocked, relabelled, bundled, or shipped. - Escalate before private labelling, major component substitution, refurbishment, or market-specific repackaging if the change may affect RoHS compliance. Sources for this answer: - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for importer, distributor, and manufacturer-equivalent obligations under Articles 9, 10, and 11. - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - General guidance explaining importer and distributor responsibilities around CE marking, DoCs, and technical documentation. ## Retention, updates, and market-surveillance readiness The RoHS file has to remain useful after launch. Manufacturers must keep the technical documentation and EU Declaration of Conformity for 10 years after the EEE has been placed on the market. Authorised representatives may be mandated to keep those documents available to national surveillance authorities for the same 10-year period. RoHS also requires procedures for series production to remain in conformity, taking account of changes in product design or characteristics and changes in harmonised standards or technical specifications used for the declaration. That makes the DoC a controlled release artifact: it should be reopened when the product, supplier evidence, restricted-substance assessment, exemption position, or cited standard changes. - Keep signed DoCs, technical documentation, supplier evidence, test reports where used, exemption analysis, and product-identification records together. - Record non-conforming EEE and product recalls where they occur, and keep distributors informed as the directive requires. - Prepare authority-response language in advance; manufacturers, importers, and distributors must provide information and documentation after a reasoned request from a competent national authority. Sources for this answer: - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for 10-year retention, series-production conformity, non-conformity records, and authority-response duties. - [European Commission - harmonised standards for RoHS](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/restriction-use-certain-hazardous-substances-rohs_en?ref=sorena.io) - Commission page noting Official Journal publication and withdrawal of RoHS harmonised-standard references. *Recommended next step* *Placement: after implementation section* ## Review your RoHS CE and DoC evidence Use this page to check whether the RoHS part of your CE file has product identity, Article 4 evidence, EN IEC 63000 technical-documentation support, signed DoC ownership, retention controls, and importer or distributor review points. - [Open Research Copilot](/solutions/research-copilot.md): Answer RoHS scope, CE marking, DoC, and evidence questions with cited outputs. - [Talk through implementation](/contact.md): Review your technical file, supplier evidence, conformity controls, and next actions. ## Primary sources - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding consolidated RoHS source for manufacturer, importer, distributor, EU Declaration of Conformity, CE marking, retention, authority-response, presumption-of-conformity, and Annex II threshold duties. - Quote: "manufacturers draw up an EU declaration of conformity and affix the CE marking" - [Commission Implementing Decision (EU) 2020/659 on EN IEC 63000](https://data.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - Official source identifying EN IEC 63000:2018 as the harmonised standard for RoHS technical documentation. - Quote: "Technical documentation for the assessment of electrical and electronic products" - [European Commission - harmonised standards for RoHS](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/restriction-use-certain-hazardous-substances-rohs_en?ref=sorena.io) - Commission page for RoHS harmonised-standard references and Official Journal publication context. - Quote: "references of harmonised standards are published" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - General EU product-law guidance for CE marking, EU Declaration of Conformity, and economic-operator responsibilities. - Quote: "the manufacturer declares on his sole responsibility" ## Related Topic Guides - [Are cables in scope of EU RoHS? Cable evidence, CE marking, and DoC FAQ](/artifacts/eu/rohs-directive/faq/cables.md): EU RoHS cable FAQ covering when cables are EEE, how internal and external cables are treated, when separate CE marking and a DoC are needed, and what evidence to keep. - [Do Components Need EU RoHS Compliance? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/components.md): RoHS FAQ for components in electrical and electronic equipment: substance restrictions, homogeneous materials, CE marking, technical files, exemptions, and supplier evidence. - [EN IEC 63000 RoHS Technical Documentation](/artifacts/eu/rohs-directive/en-iec-63000-technical-documentation.md): source-linked guide to EN IEC 63000:2018 technical documentation for EU RoHS, including manufacturer duties, evidence records, harmonised-standard status, and file maintenance. - [EU RoHS Annex III and IV exemptions guide](/artifacts/eu/rohs-directive/annex-iii-and-iv-exemptions.md): How to use, renew, or challenge EU RoHS Annex III and Annex IV exemptions, with Article 5 criteria, timing rules, and evidence requirements. - [EU RoHS Applicability Test for EEE Scope](/artifacts/eu/rohs-directive/applicability-test.md): Decide whether EU RoHS applies to electrical and electronic equipment, cables, spare parts, exclusions, exemptions, CE marking, and evidence records. - [EU RoHS compliance checklist for EEE](/artifacts/eu/rohs-directive/checklist.md): Checklist for EU RoHS scope, restricted substances, homogeneous materials, exemptions, CE marking, technical documentation, and supplier evidence. - [EU RoHS Compliance Guide for EEE](/artifacts/eu/rohs-directive/compliance.md): Practical EU RoHS compliance guide for electrical and electronic equipment: scope, restricted substances, exemptions, CE marking, technical documentation, and supplier evidence. - [EU RoHS Deadlines and Compliance Calendar](/artifacts/eu/rohs-directive/deadlines-and-compliance-calendar.md): source-linked RoHS calendar for scope phase-ins, phthalate dates, exemption renewals, spare-parts cutoffs, EN IEC 63000, CE files, and review triggers. - [EU RoHS Declarations vs Lab Tests FAQ](/artifacts/eu/rohs-directive/faq/declarations-vs-lab-tests.md): When supplier declarations can support EU RoHS technical documentation, when IEC 62321 lab testing is stronger evidence, and how to document the decision. - [EU RoHS Directive FAQ: scope, substances, CE marking](/artifacts/eu/rohs-directive/faq.md): Practical EU RoHS Directive FAQ covering EEE scope, Annex II substance limits, cables, spare parts, technical documentation, CE marking, and exemptions. - [EU RoHS EEE Categories and Open Scope](/artifacts/eu/rohs-directive/eee-categories-and-open-scope.md): Map products to EU RoHS EEE categories, category 11 open scope, Article 2 exclusions, cables, spare parts, and evidence needed for RoHS scope decisions. - [EU RoHS for medical devices and monitoring equipment](/artifacts/eu/rohs-directive/medical-devices-and-monitoring-equipment.md): RoHS category 8 and 9 guide covering application dates, Annex IV exemptions, phthalates, spare parts, CE marking, declarations, and technical documentation. - [EU RoHS penalties and fines: Member State sanctions](/artifacts/eu/rohs-directive/penalties-and-fines.md): source-linked guide to EU RoHS penalty exposure: national sanctions, no EU-wide fine table, CE marking misuse, corrective actions, recalls, and evidence records. - [EU RoHS Phthalates: DEHP, BBP, DBP, DIBP](/artifacts/eu/rohs-directive/phthalates.md): source-linked RoHS guide to DEHP, BBP, DBP, and DIBP: 0.1% homogeneous-material limits, 2019 and 2021 application dates, exemptions, evidence, and testing standards. - [EU RoHS requirements for EEE, substances, and CE evidence](/artifacts/eu/rohs-directive/requirements.md): Practical EU RoHS requirements guide covering EEE scope, Annex II substance limits, exemptions, technical documentation, EU declaration of conformity, CE marking, and operator evidence. - [EU RoHS Restricted Substances and Thresholds | Annex II Limits](/artifacts/eu/rohs-directive/restricted-substances-and-thresholds.md): EU RoHS Annex II restricted substances and maximum concentration values by weight in homogeneous materials, including cadmium's 0.01% limit and the 0.1% limits for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP. - [EU RoHS Spare Parts: Repair and Reuse](/artifacts/eu/rohs-directive/spare-parts.md): source-linked RoHS spare-parts guide covering Article 4 repair parts, reused recovered parts, closed-loop conditions, phthalate carve-outs, CE evidence, and cutoff dates. - [EU RoHS test plan selection workflow](/artifacts/eu/rohs-directive/test-plan-selection-workflow.md): Choose RoHS supplier evidence, EN IEC 63000 technical documentation, and IEC 62321 testing without over-testing or under-documenting restricted substances. - [How should RoHS lead, mercury, and cadmium exemptions be documented? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/lead-mercury-and-cadmium-exemptions.md): RoHS FAQ on documenting lead, mercury, and cadmium exemptions with Annex III or IV entries, material-level limits, expiry status, supplier evidence, and technical documentation. - [RoHS BOM evidence intake workflow](/artifacts/eu/rohs-directive/bom-evidence-intake-workflow.md): Build a RoHS BOM evidence intake process for EEE: map parts to homogeneous materials, collect supplier declarations, handle exemptions, and feed EN IEC 63000 technical documentation. - [RoHS exemption register workflow: expiry, renewal, evidence](/artifacts/eu/rohs-directive/exemption-register-workflow.md): Build a RoHS exemption register that tracks Annex III and IV entries, product scope, expiry dates, renewal status, evidence owners, and Commission source links. - [RoHS exemptions tracker guide: fields, evidence, gates](/artifacts/eu/rohs-directive/rohs-exemptions-tracker-guide.md): Build a RoHS exemptions tracker for Annex III and IV claims, renewal timing, supplier evidence, EN IEC 63000 documentation, and release decisions. - [RoHS Exemptions Tracking Register](/artifacts/eu/rohs-directive/exemptions-tracking.md): Track EU RoHS Annex III and IV exemptions by material, component, category, expiry date, renewal status, Article 5 rationale, and evidence record. - [RoHS Homogeneous Material Definition and Limits](/artifacts/eu/rohs-directive/faq/homogeneous-material.md): Plain-English EU RoHS FAQ on homogeneous materials, Annex II thresholds, coatings, cables, assemblies, and evidence needed for material-level RoHS decisions. - [RoHS Homogeneous Material Thresholds](/artifacts/eu/rohs-directive/homogeneous-material-thresholds.md): EU RoHS guide to homogeneous material thresholds: 0.1% limits, the 0.01% cadmium limit, material splitting, coatings, samples, exemptions, and technical evidence. - [RoHS importer checks for imported EEE before EU market placement](/artifacts/eu/rohs-directive/faq/imported-eee.md): Importer-focused RoHS FAQ covering CE marking, EU declaration of conformity, technical documentation availability, importer identity, nonconformity handling, and 10-year DoC retention. - [RoHS Risk-Based Testing Guide](/artifacts/eu/rohs-directive/risk-based-testing.md): source-linked EU RoHS guide to risk-based testing, EN IEC 63000 documentation, IEC 62321 methods, supplier evidence, and technical-file decisions. - [RoHS Supplier Change Control Workflow](/artifacts/eu/rohs-directive/supplier-change-control-workflow.md): source-linked EU RoHS supplier change control workflow for part substitutions, material changes, supplier declarations, testing decisions, and technical-file updates. - [RoHS Supplier Declaration Template](/artifacts/eu/rohs-directive/rohs-supplier-declaration-template.md): source-linked EU RoHS supplier declaration template guidance for collecting material evidence, exemption claims, test records, and EN IEC 63000 technical-file inputs. - [RoHS Supplier Declarations and Verification Guide](/artifacts/eu/rohs-directive/supplier-declarations-and-verification.md): Build a RoHS supplier evidence file without confusing supplier declarations with manufacturer EU DoC, CE marking, technical documentation, or importer checks. - [RoHS Supplier Declarations Guide](/artifacts/eu/rohs-directive/supplier-declarations.md): Use RoHS supplier declarations as supporting evidence for BOM, material, exemption, and technical-file reviews without replacing manufacturer EU DoC or CE duties. - [RoHS technical documentation, EU DoC and CE marking](/artifacts/eu/rohs-directive/technical-documentation-and-ce.md): source-linked guide to RoHS technical documentation, EN IEC 63000 evidence, EU declarations of conformity, CE marking, and manufacturer, importer and distributor duties. - [RoHS Timeline: practical guide](/artifacts/eu/rohs-directive/timeline.md): EU RoHS Directive guide to Timeline with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps. - [RoHS vs Batteries Regulation scope comparison](/artifacts/eu/rohs-directive/rohs-vs-batteries-regulation.md): RoHS-focused comparison explaining when RoHS applies to EEE, why batteries sit outside RoHS, and what evidence should not be reused without separate battery-law support. - [RoHS vs LVD/EMC CE evidence: what belongs in the RoHS file](/artifacts/eu/rohs-directive/rohs-vs-lvd-emc-ce-evidence.md): Compare RoHS substance evidence with separate LVD and EMC CE evidence streams, using RoHS-grounded scope, technical file, DoC, CE marking, exemption, and supplier records. - [RoHS vs POPs for EEE substance compliance](/artifacts/eu/rohs-directive/rohs-vs-pops.md): Compare EU RoHS and POPs obligations for electrical and electronic equipment: scope, substances, evidence, CE files, exemptions, waste overlap, and source-linked decision rules. - [RoHS vs REACH for electronics: scope, evidence, overlap](/artifacts/eu/rohs-directive/rohs-vs-reach.md): Compare EU RoHS and REACH for electrical and electronic equipment: scope, restricted substances, evidence, CE marking, exemptions, and overlap decisions. - [RoHS vs WEEE: EU electronics compliance comparison](/artifacts/eu/rohs-directive/rohs-vs-weee.md): Compare EU RoHS restricted-substance duties with WEEE end-of-life recycling obligations, with RoHS scope, evidence, CE marking, exemptions, and source-linked decision points. - [RoHS, REACH, POPs, and batteries overlap](/artifacts/eu/rohs-directive/reach-pop-and-batteries-overlap.md): source-linked RoHS comparison guide for separating EEE hazardous-substance restrictions from REACH, POPs, battery, waste, and technical-file workstreams. - [What do the 0.1% and 0.01% substance limits mean under EU RoHS? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/0-1-and-0-01-limits.md): RoHS FAQ explaining why most Annex II substances use a 0.1% homogeneous-material limit while cadmium uses 0.01%. - [What should teams do before a RoHS exemption expires? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/exemption-expiry.md): How to handle EU RoHS exemption expiry: confirm the Annex entry, renewal deadline, pending-decision status, fallback plan, and technical-file evidence. - [When can RoHS spare parts use transition rules? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/spare-parts.md): EU RoHS FAQ on spare parts, repair parts, reused parts, closed-loop B2B reuse, legacy EEE cutoffs, Annex III and IV exemptions, and evidence to keep. - [Which EEE is in scope under EU RoHS? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/eee-scope.md): EU RoHS scope FAQ explaining when a product is electrical and electronic equipment, which Article 2 exclusions to check, and what evidence to keep. --- [Privacy Policy](https://www.sorena.io/privacy) | [Terms of Use](https://www.sorena.io/terms-of-use) | [DMCA](https://www.sorena.io/dmca) | [About Us](https://www.sorena.io/about-us) (c) 2026 Sorena AB (559573-7338). 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