--- title: "Restricted Substances and Thresholds" canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive/restricted-substances-and-thresholds" source_url: "https://www.sorena.io/artifacts/eu/rohs-directive/restricted-substances-and-thresholds" author: "Sorena AI" description: "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." published_at: "2026-02-21" updated_at: "2026-02-21" keywords: - "RoHS restricted substances list" - "RoHS thresholds 0.1% homogeneous material" - "RoHS cadmium 0.01%" - "RoHS phthalates 2015/863 DEHP BBP DBP DIBP" - "EN IEC 63000 RoHS documentation" - "IEC 62321 RoHS testing" - "RoHS" - "Restricted substances" - "Homogeneous material" - "Phthalates" - "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) --- # Restricted Substances and Thresholds 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. *Annex II* *Thresholds* ## EU RoHS Directive (2011/65/EU) Restricted Substances and Thresholds 10 substances, 2 key thresholds, and the BOM reality behind them. Output: a restricted-substances risk map + evidence rules you can enforce on suppliers. RoHS compliance is measured at the homogeneous material level. That means a product-level compliant claim is never enough; you need a repeatable way to prove that each high-risk homogeneous material in your BOM meets the thresholds or is covered by a valid exemption. ## The RoHS thresholds (homogeneous material is the unit of control) Directive 2011/65/EU restricts substances in EEE when the concentration exceeds the maximum tolerated value in homogeneous materials. In practice, you need a design rule: define homogeneous materials in your BOM model (not just part numbers) and attach evidence at that level. - General threshold: 0.1% by weight in homogeneous material - Cadmium threshold: 0.01% by weight in homogeneous material - Homogeneous material means one material of uniform composition or a material that cannot be separated into different materials by mechanical actions - Evidence approach: supplier declarations + risk-based testing + technical documentation aligned to EN IEC 63000 *Recommended next step* *Placement: after the scope or definition section* ## Use EU RoHS Directive (2011/65/EU) Restricted Substances and Thresholds as a cited research workflow Research Copilot can take EU RoHS Directive (2011/65/EU) Restricted Substances and Thresholds from clarifying scope and applicability with cited answers 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 Research Copilot for EU RoHS Directive (2011/65/EU) Restricted Substances and Thresholds](/solutions/research-copilot.md): Start from EU RoHS Directive (2011/65/EU) Restricted Substances and Thresholds and answer scope, timing, and interpretation questions with cited outputs. - [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) Restricted Substances and Thresholds. ## The 10 restricted substances (Annex II) RoHS currently restricts six classic substances and four phthalates added by (EU) 2015/863. Treat this list as a procurement control: every supplier should be able to answer where these substances can appear in their materials. - Lead (Pb) - 0.1% - Mercury (Hg) - 0.1% - Cadmium (Cd) - 0.01% - Hexavalent chromium (Cr(VI)) - 0.1% - PBB - 0.1% - PBDE - 0.1% - DEHP - 0.1% - BBP - 0.1% - DBP - 0.1% - DIBP - 0.1% ## Where these substances hide in real BOMs (high-risk hotspots) Most RoHS failures come from predictable hotspots: solders, platings, cables, pigments, soft plastics, and legacy components. Use this list to prioritise evidence depth and decide where testing is worth the cost. - Solders and terminations: lead in solders; legacy components and rework - Platings and coatings: hexavalent chromium processes and surface treatments - Cables and wire insulation: plasticisers (phthalates) and pigments - Plastics and elastomers: phthalates as plasticisers; brominated flame retardants in legacy polymers - Displays and lamps: mercury historically (validate supplier controls for any relevant components) ## Phthalates: the implementation reality (EU) 2015/863 The phthalates restriction applies from 22 July 2019 for most EEE and from 22 July 2021 for medical devices and monitoring/control instruments (including industrial). Your program should separate: (1) phthalate exposure mapping and (2) spare parts/cables carve-outs for repair/reuse of older equipment. - Applies from 22 Jul 2019 (most EEE): DEHP, BBP, DBP, DIBP - Applies from 22 Jul 2021 (medical devices and monitoring/control): same four phthalates - Carve-out: cables/spare parts for repair/reuse/updating of equipment placed on the market before the applicable dates ## Evidence strategy: declarations, testing, and EN IEC 63000 documentation Declarations alone can be sufficient for low-risk materials and stable suppliers, but you need verification triggers for high-risk cases. EN IEC 63000 is the harmonised standard for RoHS technical documentation; use it to structure your file and avoid ad-hoc evidence formats. - Supplier declarations: substances list + homogeneous material coverage + change-notification duty - Risk-based testing: trigger tests for high-risk materials, supplier changes, or inconsistent declarations (use IEC 62321 methods as appropriate) - Technical documentation: maintain an EN IEC 63000-aligned evidence pack per product family and variant ## 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 Annex II restricted substances, threshold logic, and scope/exemptions framework. - [Delegated Directive (EU) 2015/863 (phthalates) (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015L0863&ref=sorena.io) - Adds four phthalates to Annex II and defines the application dates (22 Jul 2019; 22 Jul 2021 for specific categories). - [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) - Publishes the reference of EN IEC 63000:2018 for RoHS technical documentation. - [DG Environment - RoHS Directive overview](https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive_en?ref=sorena.io) - Official overview and links to implementation resources. ## 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). - [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 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). 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