--- title: "RoHS Compliance Program" canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive/compliance" source_url: "https://www.sorena.io/artifacts/eu/rohs-directive/compliance" author: "Sorena AI" description: "A practical RoHS compliance program playbook for Directive 2011/65/EU: set up governance, map homogeneous material risks across your BOM." published_at: "2026-02-21" updated_at: "2026-02-21" keywords: - "RoHS compliance program" - "RoHS implementation playbook" - "RoHS supplier controls" - "RoHS exemption tracking program" - "EN IEC 63000 compliance documentation" - "RoHS audit readiness" - "RoHS" - "Compliance program" - "Supplier evidence" - "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 Compliance Program A practical RoHS compliance program playbook for Directive 2011/65/EU: set up governance, map homogeneous material risks across your BOM. *RoHS* *Program* ## EU RoHS Directive (2011/65/EU) Compliance A scalable RoHS system beats one-off material scrambles. Build a repeatable program for restricted substances, exemptions, supplier evidence, and technical documentation. RoHS compliance is portfolio compliance. If you ship multiple SKUs or update suppliers, the only sustainable approach is a program: define the unit of control (homogeneous materials), enforce supplier evidence and change control, track exemptions with expiry risk, and maintain technical documentation you can retrieve on request. ## Program architecture (workstreams that map to reality) RoHS work breaks into a small number of durable workstreams. Assign owners and define evidence deliverables per stream. Treat each workstream as part of release gating, not a separate compliance project. - Scope + category mapping: what is EEE, which variants, and any exclusions - Restricted substances control: thresholds and hotspots across homogeneous materials - Supplier evidence + verification: declarations, test triggers, change control - Exemptions management: register, evidence pack, expiry monitoring, redesign/renewal decisions - Technical documentation + CE evidence: EN IEC 63000-aligned technical file + DoC discipline - Operator duties: manufacturer, importer, and distributor checks under Articles 7, 9, and 10 ## Release gating (minimal gates that prevent rework) The easiest way to keep RoHS defensible is strict gating: no shipment without matching evidence. Treat supplier changes and polymer formulation changes as compliance-impacting changes. - Gate 1: scope memo updated for the shipped variant - Gate 2: restricted substances risk map complete for new/changed materials - Gate 3: supplier declarations collected (and verified when triggers apply) - Gate 4: exemption register updated (if used) and expiry risk reviewed - Gate 5: technical documentation pack updated (EN IEC 63000-aligned) and exportable ## Cadence (what to review and how often) Compliance breaks when it has no cadence. Put RoHS on a schedule. Your cadence should reflect risk: high-risk materials and exemptions need more frequent review. - Monthly: exemptions expiring within 24 months; redesign/renewal decisions - Quarterly: high-risk suppliers/materials (cables, soft plastics, solders, coatings) evidence refresh and sampling - Per release: BOM changes, supplier changes, and any exemption scope checks - Annually: program audit and evidence retrieval drill (can you export packs quickly?) ## What 'audit-ready' looks like Audit-ready means you can answer questions fast and consistently. Build a retrieval-first evidence vault and test it periodically. - Evidence vault index: product -> part -> homogeneous material -> evidence - Consistent artifacts: declarations, test reports, exemption evidence packs, and technical file - Clear ownership: who responds to authority requests and how information is validated - Version control: technical file and DoC aligned to shipped configurations - Retention control: manufacturer and importer copies of the technical documentation and DoC kept for 10 years *Recommended next step* *Placement: after the compliance steps* ## Turn EU RoHS Directive (2011/65/EU) Compliance into an operational assessment Assessment Autopilot can take EU RoHS Directive (2011/65/EU) Compliance from operationalizing the guidance into a tracked program 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) Compliance](/solutions/assessment.md): Start from EU RoHS Directive (2011/65/EU) Compliance 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) Compliance. ## 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 RoHS compliance obligations and exemption framework. - [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. - [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 implementing RoHS across scope, evidence, 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 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 Requirements | EU RoHS Directive 2011/65/EU | Substance Restrictions (Annex II), Exemptions (Annex III/IV), CE Evidence](/artifacts/eu/rohs-directive/requirements.md): A practical RoHS requirements breakdown for Directive 2011/65/EU: restricted substances thresholds in homogeneous materials (Annex II). - [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). All rights reserved. Source: https://www.sorena.io/artifacts/eu/rohs-directive/compliance