--- title: "RoHS Requirements" canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive/requirements" source_url: "https://www.sorena.io/artifacts/eu/rohs-directive/requirements" author: "Sorena AI" description: "A practical RoHS requirements breakdown for Directive 2011/65/EU: restricted substances thresholds in homogeneous materials (Annex II)." published_at: "2026-02-21" updated_at: "2026-02-21" keywords: - "RoHS requirements" - "Directive 2011/65/EU requirements" - "RoHS Annex II restricted substances" - "RoHS Annex III exemptions" - "RoHS Annex IV exemptions" - "EN IEC 63000 technical documentation" - "CE marking RoHS" - "RoHS" - "Requirements" - "Annex II" - "Exemptions" - "EN IEC 63000" --- **[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) --- # RoHS Requirements A practical RoHS requirements breakdown for Directive 2011/65/EU: restricted substances thresholds in homogeneous materials (Annex II). *RoHS* *Requirements* ## EU RoHS Directive (2011/65/EU) Requirements RoHS requirements are simple to state and hard to prove without a system. Output: a requirements-to-evidence map you can operationalise across suppliers and SKUs. The core RoHS requirement is a materials requirement: EEE placed on the market must not exceed restricted substance thresholds in homogeneous materials unless a valid exemption applies. The operational requirement is evidence: you must be able to demonstrate compliance with a technical documentation pack and supplier-backed proof. ## 1) Substances restriction requirement (Annex II) EEE must not contain restricted substances above the maximum tolerated values in homogeneous materials. Implementation reality: your unit of control is the homogeneous material, not the part number. - Build a homogeneous-material model in your BOM and link evidence at that level - Maintain a restricted-substances risk map (hotspots like solders, cables, soft plastics) - Use supplier declarations and verification triggers; do not rely on compliant labels *Recommended next step* *Placement: after the requirement breakdown* ## Turn EU RoHS Directive (2011/65/EU) Requirements into an operational assessment Assessment Autopilot can take EU RoHS Directive (2011/65/EU) Requirements from turning the requirements into assigned actions to a reusable workflow inside Sorena. Teams working on EU RoHS Directive (2011/65/EU) can keep owners, evidence, and next steps aligned without copying this guide into separate documents. - [Open Assessment Autopilot for EU RoHS Directive (2011/65/EU) Requirements](/solutions/assessment.md): Start from EU RoHS Directive (2011/65/EU) Requirements and turn the guidance into owned tasks, evidence requests, and review checkpoints. - [Talk through EU RoHS Directive (2011/65/EU)](/contact.md): Review your current process, evidence gaps, and next steps for EU RoHS Directive (2011/65/EU) Requirements. ## 2) Exemptions logic (Annex III/IV) and expiry risk Exemptions are narrow allowances for specific applications and conditions, often time-limited and revised. The requirement is not to have an exemption, but to prove that the exact application in your product matches the exemption scope and is still valid. - Traceability: exemption -> application -> part/material -> supplier - Expiry monitoring: plan redesign or renewal work 18 - 24 months ahead - Evidence pack: technical justification, supplier confirmations, and release/change control ## 3) Supplier evidence and verification (your control layer) RoHS is enforced through the supply chain: if suppliers can't back their claims, you can't back yours. Implement supplier requirements as contractual and process controls. - Supplier declarations covering Annex II substances and homogeneous material scope - Change notification duties (material, process, formulation, plating, cable insulation changes) - Verification plan: when you test, how you sample, what you do with failures - Traceability: link supplier artifacts to specific SKUs/variants ## 4) Technical documentation and CE evidence (EN IEC 63000) A defensible RoHS program produces a technical documentation pack that is retrievable and consistent. EN IEC 63000 is the harmonised standard referenced for RoHS technical documentation; use it to structure your evidence. Article 13 also allows a single technical documentation set where another applicable Union conformity-assessment procedure is at least as stringent. - Technical file structure aligned to EN IEC 63000: evidence sources, evaluation logic, and conclusions - Evidence artifacts: declarations, test reports, exemption register, change history - Release governance: ensure the technical file matches the shipped configuration and suppliers - Retention: keep the technical documentation and DoC for 10 years and make sure importer copies remain available ## A simple requirements-to-evidence map (what 'done' means) Use this mapping to assign owners and define acceptance criteria. If you can't retrieve these artifacts quickly, your program is not operational. - Scope memo (owner: compliance/engineering): product category, variants, exclusions logic - Substances map (owner: engineering): homogeneous materials + hotspots + acceptance criteria - Supplier evidence pack (owner: procurement/quality): declarations + change controls + traceability - Exemption register (owner: compliance): applicability + expiry + redesign/renewal plan - Technical documentation pack (owner: compliance/QA): EN IEC 63000-aligned file + evidence links ## Primary sources - [Directive 2011/65/EU (RoHS 2) consolidated (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011L0065-20250101&ref=sorena.io) - Primary source for substance restrictions, exemptions framework, and documentation responsibilities. - [Commission Implementing Decision (EU) 2020/659 - EN IEC 63000 reference (EUR-Lex)](https://eur-lex.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - References EN IEC 63000:2018 for RoHS technical documentation. - [DG GROW - 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) - Official entry point for harmonised standards supporting RoHS compliance evidence. - [RoHS FAQ and key guidance (DG Environment)](https://environment.ec.europa.eu/system/files/2021-01/FAQ%20key%20guidance%20document%20-%20RoHS.pdf?ref=sorena.io) - Practical Q&A on scope, exclusions, cables, spare parts, and CE expectations. ## Related Topic Guides - [EU RoHS FAQ (Scope, Exemptions, Phthalates, Technical File, CE) | RoHS Directive 2011/65/EU](/artifacts/eu/rohs-directive/faq.md): High-signal EU RoHS FAQ grounded in official sources: what counts as EEE, staged applicability (22 July 2014/2017/2019). - [EU RoHS Timeline: RoHS 1 (2002) -> RoHS 2 (2011/2013) -> Open Scope (2019) -> Phthalates (2019/2021)](/artifacts/eu/rohs-directive/timeline.md): A date-by-date EU RoHS timeline for implementers: RoHS 1 (2002), RoHS 2 recast and transposition (2011 - 2013). - [Restricted Substances and Thresholds | EU RoHS Directive 2011/65/EU | Homogeneous Material Limits (0.1% / 0.01%) + Phthalates (2015/863)](/artifacts/eu/rohs-directive/restricted-substances-and-thresholds.md): A practical RoHS restricted substances guide for Directive 2011/65/EU: the 10 substances in Annex II, homogeneous material threshold logic (0.1% for most. - [RoHS Applicability Test | Is My Product In Scope of EU RoHS Directive 2011/65/EU? | EEE, Cables, Spare Parts, Open Scope](/artifacts/eu/rohs-directive/applicability-test.md): A structured EU RoHS applicability test for Directive 2011/65/EU: determine if your product is electrical and electronic equipment (EEE). - [RoHS Compliance Checklist | EU RoHS Directive 2011/65/EU | Supplier Evidence, Exemptions, EN IEC 63000 Technical File](/artifacts/eu/rohs-directive/checklist.md): An audit-ready RoHS compliance checklist for Directive 2011/65/EU: scope and EEE category mapping. - [RoHS Compliance Program | EU RoHS Directive 2011/65/EU Implementation Playbook | Supplier Controls, Exemptions, Evidence](/artifacts/eu/rohs-directive/compliance.md): A practical RoHS compliance program playbook for Directive 2011/65/EU: set up governance, map homogeneous material risks across your BOM. - [RoHS Deadlines and Compliance Calendar (2013, 2014, 2017, 2019, 2021) | EU RoHS Directive 2011/65/EU](/artifacts/eu/rohs-directive/deadlines-and-compliance-calendar.md): A RoHS compliance calendar you can actually operationalize: staged applicability dates (22 July 2014/2017/2019). - [RoHS Enforcement, Penalties, and Fines | EU RoHS Directive 2011/65/EU (Member State rules)](/artifacts/eu/rohs-directive/penalties-and-fines.md): What EU RoHS enforcement looks like in practice: market surveillance checks, documentation requests, CE marking scrutiny. - [RoHS Exemptions Tracker Guide | How to Build an Exemption Register (Annex III/IV), Link to BOM, Monitor Expiry](/artifacts/eu/rohs-directive/rohs-exemptions-tracker-guide.md): A practical guide to building a RoHS exemptions tracker: recommended tracker fields (exemption reference, exact wording, scope conditions. - [RoHS Exemptions Tracking | Directive 2011/65/EU Annex III and Annex IV | Expiry Risk, Evidence, Renewal Strategy](/artifacts/eu/rohs-directive/exemptions-tracking.md): A practical RoHS exemptions tracking guide for Directive 2011/65/EU: how Annex III and Annex IV exemptions work. - [RoHS Supplier Declaration Template | Annex II Substances, Homogeneous Material Coverage, Exemptions Disclosure](/artifacts/eu/rohs-directive/rohs-supplier-declaration-template.md): A practical RoHS supplier declaration template for Directive 2011/65/EU. - [RoHS vs REACH | What's the Difference? | EU RoHS Directive 2011/65/EU vs REACH Regulation (EC) 1907/2006](/artifacts/eu/rohs-directive/rohs-vs-reach.md): A practical RoHS vs REACH guide: RoHS (Directive 2011/65/EU) restricts specific substances in EEE above thresholds in homogeneous materials and is tied to CE. - [Supplier Declarations and Verification | RoHS Compliance Program | Supplier Questionnaires, Change Control, Risk-Based Testing](/artifacts/eu/rohs-directive/supplier-declarations-and-verification.md): A practical supplier evidence playbook for EU RoHS Directive 2011/65/EU. - [Technical Documentation and CE | RoHS Directive 2011/65/EU | EN IEC 63000, EU Declaration of Conformity, Evidence Vault](/artifacts/eu/rohs-directive/technical-documentation-and-ce.md): A practical RoHS technical documentation guide for Directive 2011/65/EU. --- [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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