---
title: "What do the 0.1% and 0.01% substance limits mean under EU RoHS?"
canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive/faq/0-1-and-0-01-limits"
source_url: "https://www.sorena.io/artifacts/eu/rohs-directive/faq/0-1-and-0-01-limits"
author: "Sorena AI"
description: "RoHS FAQ explaining why most Annex II substances use a 0.1% homogeneous-material limit while cadmium uses 0.01%."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU RoHS Directive"
  - "RoHS 0.1%"
  - "RoHS 0.01%"
  - "RoHS homogeneous material"
  - "RoHS Annex II"
  - "RoHS"
  - "RoHS FAQ"
---
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# What do the 0.1% and 0.01% substance limits mean under EU RoHS?

RoHS FAQ explaining why most Annex II substances use a 0.1% homogeneous-material limit while cadmium uses 0.01%.

*FAQ* *EU*

## RoHS FAQ EU RoHS 0.1% and 0.01% Substance Limits

EU RoHS Annex II sets maximum concentration values by weight in homogeneous materials, not as an average across the finished electrical or electronic product.

Use this FAQ to separate the 0.1% limits from cadmium's 0.01% limit and record the material-level evidence behind the conclusion.

Under EU RoHS, the 0.1% and 0.01% values are maximum concentration values by weight in each homogeneous material. Lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP are listed at 0.1%; cadmium is listed at 0.01%. A product-level average is not enough unless every relevant homogeneous material is within the applicable limit or a valid exemption applies.

## What do the 0.1% and 0.01% substance limits mean under EU RoHS?

Article 4 of Directive 2011/65/EU points to Annex II for the maximum concentration values tolerated by weight in homogeneous materials. That means the threshold is checked against each separable material, coating, solder, plastic, alloy, wire, or other homogeneous material, not against the finished product as a whole.

The practical split is simple but easy to misapply: cadmium has the tighter 0.01% limit; the other Annex II substances are listed at 0.1%. The four phthalates added by Delegated Directive (EU) 2015/863, DEHP, BBP, DBP, and DIBP, also sit at 0.1% in Annex II.

- Use 0.1% by weight for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP.
- Use 0.01% by weight for cadmium.
- Apply the value to each homogeneous material separately; do not dilute a restricted substance by averaging it across an assembly, component, or finished EEE.
- If an Annex III or Annex IV exemption is used, record the exact exemption entry, product category, substance, material, and validity condition that makes the higher concentration acceptable.

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 and Annex II maximum concentration values by weight in homogeneous materials.
- [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 amendment that added DEHP, BBP, DBP, and DIBP to the RoHS Annex II restriction list.
- [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 for technical documentation used to assess RoHS-restricted substances.
- [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 explaining that RoHS exemptions are time-limited and subject to application or renewal.

## What evidence should be kept for RoHS 0.1% and 0.01% limits?

Evidence should let a reviewer trace the conclusion from the finished EEE down to the homogeneous materials that matter for Annex II. A supplier statement that only says "RoHS compliant" is weak if it does not identify covered parts, materials, substances, exemptions, or the basis for the declaration.

The technical file should connect the BOM, homogeneous-material list, material declarations, substance risk assessment, selected test reports, exemption register, EU declaration of conformity, and change-control history. Manufacturers must keep the technical documentation and EU declaration of conformity for 10 years after the EEE has been placed on the market.

- Map each relevant homogeneous material to the applicable Annex II substance and limit: 0.01% for cadmium or 0.1% for the other listed substances.
- Keep supplier declarations specific to the part, material, revision, and restricted substances they cover.
- When testing is used, retain the sample description, preparation logic, test method, lab report, and the material-level result being compared with the Annex II threshold.
- For exemptions, retain the Annex III or Annex IV entry, applicability category, expiry or renewal status, and the product/material facts that support use of the exemption.
- Recheck the record after material changes, supplier changes, product redesign, exemption changes, or a change to the harmonised standard used for the technical 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 Annex II limits and manufacturer obligations to keep technical documentation and the EU declaration of conformity.
- [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 amendment that added the four phthalates now checked at the 0.1% homogeneous-material limit.
- [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 as the harmonised technical-documentation standard for RoHS assessment.
- [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 request and renewal process context.

## How to apply the RoHS 0.1% and 0.01% limits

Use the limits as a material-level screening question before release, supplier approval, design change, or exemption review. The output should be a clear pass, exemption-supported, or nonconforming-material decision for each material-substance pair.

- Identify the EEE, category, part number, supplier, revision, and date of placing on the market.
- Break the relevant assemblies into homogeneous materials, including plastics, metals, coatings, solder, insulation, cables, and phthalate-relevant polymer parts.
- For each homogeneous material, mark whether cadmium, lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, or DIBP is relevant.
- Compare cadmium results or declarations to 0.01% by weight and all other Annex II substance results or declarations to 0.1% by weight.
- If a value exceeds the Annex II limit, stop treating the material as compliant unless an exact Annex III or Annex IV exemption covers that use.
- Store the conclusion in the RoHS technical documentation package used to support the CE marking and EU declaration of conformity.

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 restrictions, Annex II limits, CE marking, and EU declaration of conformity obligations.
- [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 the four phthalate restrictions that must be included in Annex II material checks.
- [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 as the RoHS technical-documentation standard.
- [European Commission - RoHS Directive implementation](https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/rohs-directive-implementation_en?ref=sorena.io) - Commission source for checking whether an exemption request or renewal affects the material decision.

## Common mistakes to avoid when documenting EU RoHS 0.1% and 0.01% substance limits

Most mistakes come from using the right percentage at the wrong level of detail. Annex II limits are material-level values, so a finished-product calculation can hide a nonconforming coating, solder, plastic, or cable material.

- Do not apply 0.1% to cadmium; Annex II lists cadmium at 0.01%.
- Do not average a restricted substance across a component or finished EEE when separable homogeneous materials should be checked individually.
- Do not forget DEHP, BBP, DBP, and DIBP when reviewing phthalate-relevant polymers; they are listed in Annex II at 0.1%.
- Do not rely on an exemption unless the exact material use, product category, and exemption timing still match Annex III or Annex IV.
- Do not reuse supplier declarations after a material, coating, cable, adhesive, solder, or supplier revision changes unless the declaration still covers the changed material.

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 the homogeneous-material threshold structure and Annex II substance list.
- [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 confirming that DEHP, BBP, DBP, and DIBP are part of the Annex II limit checks.
- [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 technical-documentation expectations when assessing restricted substances.
- [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 timing and review context.

## 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 Article 4, Annex II threshold values, homogeneous materials, exemptions, technical documentation, CE marking, and EU declaration of conformity.
  - Quote: "maximum concentration values tolerated by weight in homogeneous materials"
- [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 to Directive 2011/65/EU"
- [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 as the harmonised technical-documentation standard for assessing RoHS-restricted substances.
  - Quote: "technical documentation required for assessing materials"
- [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 RoHS exemption requests, renewals, and time-limited exemption context.
  - Quote: "Exemptions are limited in time"
- [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Official Commission overview for how harmonised standards and OJEU references support EU product-law conformity assessments.
  - Quote: "Harmonised standards are European standards adopted on the basis of a request."

## 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 CE Marking and Declaration of Conformity](/artifacts/eu/rohs-directive/ce-and-doc.md): source-linked guide to RoHS CE marking, EU Declaration of Conformity, technical documentation, EN IEC 63000, and importer or distributor checks.
- [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 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.

*Recommended next step*

*Placement: after implementation section*

## Check RoHS limits at material level

Use the 0.1% and 0.01% split to review BOM materials, supplier declarations, test reports, exemptions, and the technical documentation behind CE marking.

- [Open Research Copilot](/solutions/research-copilot.md): Answer RoHS threshold, exemption, and evidence questions with cited outputs.
- [Talk through implementation](/contact.md): Review material declarations, test evidence, exemption use, and technical-file gaps.


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