--- title: "EU RoHS Directive FAQ: scope, substances, CE marking" canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive/faq" source_url: "https://www.sorena.io/artifacts/eu/rohs-directive/faq" author: "Sorena AI" description: "Practical EU RoHS Directive FAQ covering EEE scope, Annex II substance limits, cables, spare parts, technical documentation, CE marking, and exemptions." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU RoHS Directive" - "RoHS FAQ" - "Directive 2011/65/EU" - "EEE scope" - "RoHS substance limits" - "RoHS CE marking" - "EN IEC 63000" - "RoHS" - "RoHS technical documentation" --- **[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 Directive FAQ: scope, substances, CE marking Practical EU RoHS Directive FAQ covering EEE scope, Annex II substance limits, cables, spare parts, technical documentation, CE marking, and exemptions. *Artifact Guide* *EU* ## EU RoHS Directive FAQ RoHS restricts listed hazardous substances in electrical and electronic equipment at homogeneous-material level and ties compliance to technical documentation, EU declarations of conformity, and CE marking for finished EEE. This FAQ helps answer the recurring RoHS questions that affect product scope, supplier evidence, cables, spare parts, exemptions, testing, and release decisions. This EU RoHS Directive FAQ focuses on the questions product, quality, procurement, legal, and regulatory teams usually need to settle before placing electrical and electronic equipment on the EU market: whether the product is EEE, which homogeneous materials must meet Annex II limits, what evidence belongs in the technical file, and when exemptions or transition rules need separate review. ## Browse sub-FAQ modules ### [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. - 4 items ### [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. - 4 items ### [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. - 4 items ### [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. - 5 items ### [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. - 5 items ### [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. - 4 items ### [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%. - 4 items ### [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. - 4 items ### [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. - 4 items ### [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. - 4 items Browse all indexed questions: [/artifacts/eu/rohs-directive/faq/items](/artifacts/eu/rohs-directive/faq/items.md) ## What products are in scope of the EU RoHS Directive? RoHS applies to electrical and electronic equipment that falls within the categories in Annex I unless a specific Article 2 exclusion applies. The Directive defines EEE as equipment dependent on electric currents or electromagnetic fields to work properly, including equipment for generating, transferring, or measuring those currents or fields, within the stated voltage ratings. A scope answer should not stop at a product label. Record the intended function, electrical dependency, Annex I category, whether the product is finished EEE or a component, and whether any exclusion such as large-scale stationary industrial tools or large-scale fixed installations is being relied on. - Classify the item against Annex I categories, including category 11 for other EEE not covered by categories 1 to 10. - Check the Article 2 exclusions before treating professional, industrial, installation, military, transport, or medical-related products as out of scope. - For mixed products, assess whether the electrical function is integrated into the product or separable as its own EEE. - Keep the scope memo with drawings, product description, intended-use evidence, role assessment, and any exclusion rationale. 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 scope, EEE definitions, Article 2 exclusions, and Annex I categories. - [European Commission RoHS 2 FAQ guidance](https://environment.ec.europa.eu/system/files/2021-01/FAQ%20key%20guidance%20document%20-%20RoHS.pdf?ref=sorena.io) - Commission guidance for interpreting RoHS scope questions, mixed-use EEE, cables, components, and CE marking. ## Which substances and concentration limits does RoHS restrict? Annex II sets maximum concentration values by weight in homogeneous materials. Lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP are listed at 0.1%; cadmium is listed at 0.01%. These limits apply at homogeneous-material level, not as an average across the finished product. The consolidated Directive defines a homogeneous material as a material of uniform composition or a material combination that cannot be separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, or abrasive processes. - Build the evidence matrix around homogeneous materials such as plastics, solders, coatings, wires, alloys, and other separable materials. - Do not dilute a risky material by testing a mixed sample that combines separable homogeneous materials. - Treat the four phthalates added by Delegated Directive (EU) 2015/863 as Annex II restrictions, with the specific medical, monitoring, cable, spare-part, and toy rules stated in Annex II. - Use exemptions only for the specific substance, material or component, application, product category, and date range covered by Annex III or Annex IV. 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 Annex II substance limits, homogeneous-material definition, and exemption annexes. - [Commission Delegated Directive (EU) 2015/863 adding phthalates to RoHS Annex II](https://data.europa.eu/eli/dir_del/2015/863/oj?ref=sorena.io) - Binding source for adding DEHP, BBP, DBP, and DIBP to Annex II and related transition provisions. - [European Commission RoHS 2 FAQ guidance](https://environment.ec.europa.eu/system/files/2021-01/FAQ%20key%20guidance%20document%20-%20RoHS.pdf?ref=sorena.io) - Commission guidance explaining homogeneous materials, maximum concentration values, and compliance sampling concerns. ## Do cables, spare parts, and components need their own RoHS evidence? Cables, spare parts, and components are frequent sources of RoHS mistakes because the substance restrictions and CE-marking duties are not always identical. Article 4 covers EEE placed on the market, including cables and spare parts for repair, reuse, updating, or capacity upgrading, but the FAQ guidance distinguishes finished EEE from internal wiring, external cables, and components supplied for integration. Internal wires and components used in finished EEE need substance evidence because the finished EEE can comply only if its parts meet the relevant material restrictions. They generally do not need their own RoHS CE marking or EU declaration of conformity unless they are themselves finished EEE placed on the market. - External cables sold separately as EEE need their own RoHS conformity evidence, EU declaration of conformity, and CE marking from the relevant application date. - External cables sold with, marketed for, or shipped for use with a finished EEE can be covered by the finished EEE declaration when the EEE is CE marked. - Spare parts that are not finished EEE must meet substance restrictions for the covered EEE, but the Commission FAQ says they do not need a separate RoHS CE mark or declaration. - Supplier declarations should identify the exact part, material, date, exemption if any, and the product or assembly they support. 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 Article 4 coverage of EEE, cables, spare parts, and substance restrictions. - [European Commission RoHS 2 FAQ guidance](https://environment.ec.europa.eu/system/files/2021-01/FAQ%20key%20guidance%20document%20-%20RoHS.pdf?ref=sorena.io) - Commission guidance on cables, internal wiring, external cables, components, spare parts, CE marking, and declarations. *Recommended next step* *Placement: after implementation section* ## This RoHS FAQ is a cited release checklist Turn scope, substance-limit, supplier-evidence, exemption, technical-file, and CE-marking answers into a repeatable RoHS review for product, quality, procurement, legal, and regulatory teams. - [Open RoHS Research Copilot](/solutions/research-copilot.md): Answer RoHS scope, timing, and interpretation questions with cited outputs. - [Talk through RoHS implementation](/contact.md): Review your scope, evidence model, controls, and next actions. ## What technical documentation, declaration, and CE marking does RoHS require? Manufacturers must draw up the required technical documentation, carry out or have carried out the applicable internal production control procedure, draw up an EU declaration of conformity when compliance has been demonstrated, affix the CE marking, and keep the technical documentation and declaration for 10 years after the EEE has been placed on the market. EN IEC 63000:2018 is the harmonised standard reference published for technical documentation used to assess materials, components, and EEE under RoHS. Using the harmonised standard supports presumption of conformity for the requirements covered by that standard, but it does not remove the need for product-specific evidence or corrective action when non-conformity is found. - Keep the technical file tied to the specific model, BOM, supplier evidence, material risk assessment, test reports where needed, exemptions, and change history. - Make sure the EU declaration of conformity identifies the EEE and states that the Article 4 requirements have been demonstrated. - Affix CE marking visibly, legibly, and indelibly to finished EEE or, where the nature of the EEE does not allow it, to packaging and accompanying documents. - Check importer and distributor records because RoHS also requires downstream operators to verify CE marking, required documents, and authority-response documentation. 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 manufacturer, importer, distributor, EU declaration, CE marking, retention, and presumption-of-conformity duties. - [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 publishing EN IEC 63000:2018 as the harmonised standard for RoHS technical documentation. - [European Commission RoHS harmonised standards page](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 overview of RoHS harmonised standards references published in the Official Journal. - [IEC 63000:2016 publication page](https://webstore.iec.ch/en/publication/25985?ref=sorena.io) - IEC publisher page for the international standard underlying EN IEC 63000 technical documentation. ## How should RoHS exemptions be handled in FAQ answers? RoHS exemptions are not blanket product approvals. The Commission guidance and Directive framework treat exemptions as time-limited, application-specific entries that must be read against the exact substance, material or component, EEE category, application wording, and expiry or review status. An exemption answer should state whether the exemption is already listed in Annex III or IV, whether it applies to the relevant EEE category, whether the application wording fits the actual use, and what review trigger will reopen the decision before expiry, supplier change, redesign, or authority challenge. - For exemption renewals, the Commission implementation page states that renewal applications must be made no later than 18 months before expiry. - The Commission implementation page states that exemption decisions currently take 18 to 24 months from application date. - Existing exemptions with timely renewal requests remain valid until the Commission decides on the renewal application. - If a renewal is rejected or an exemption is revoked, the Directive provides that the exemption expires at the earliest 12 months and at the latest 18 months after the decision. 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 Article 5 exemption conditions, renewal timing, continuing validity, and Annex III and IV exemption entries. - [European Commission - RoHS Directive implementation](https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/rohs-directive-implementation_en?ref=sorena.io) - Commission implementation source for exemption requests, renewals, evaluation timing, and reassessment criteria. - [European Commission exemption application guidance](https://environment.ec.europa.eu/document/download/f1f65e3d-1b90-4dd1-a0d4-797bd6cabe98_en?filename=Guidance_Document.pdf&ref=sorena.io) - Commission guidance document for preparing RoHS exemption applications under Article 5. ## 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 scope, substance thresholds, exemptions, technical documentation, CE marking, and categories. - Quote: "restriction of the use of certain hazardous substances" - [Commission Delegated Directive (EU) 2015/863 adding phthalates to RoHS Annex II](https://data.europa.eu/eli/dir_del/2015/863/oj?ref=sorena.io) - Binding source for adding DEHP, BBP, DBP, and DIBP to RoHS Annex II. - Quote: "amending Annex II" - [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 for EN IEC 63000:2018 as the RoHS harmonised technical-documentation standard. - Quote: "EN IEC 63000:2018" - [European Commission RoHS 2 FAQ guidance](https://environment.ec.europa.eu/system/files/2021-01/FAQ%20key%20guidance%20document%20-%20RoHS.pdf?ref=sorena.io) - Commission guidance for interpreting RoHS scope, cables, components, CE marking, declarations, and substance limits. - Quote: "not legally binding" - [European Commission - RoHS Directive implementation](https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/rohs-directive-implementation_en?ref=sorena.io) - Commission implementation source for exemption requests, renewals, evaluation timing, and reassessment criteria. - Quote: "Exemptions are limited in time" - [European Commission RoHS harmonised standards page](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/restriction-use-certain-hazardous-substances-rohs_en?ref=sorena.io) - Official Commission overview of RoHS harmonised standards references published in the Official Journal. - Quote: "presumption of conformity" - [IEC 63000:2016 publication page](https://webstore.iec.ch/en/publication/25985?ref=sorena.io) - IEC publisher page for the international standard underlying EN IEC 63000 technical documentation. - Quote: "technical documentation" --- [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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