---
title: "EU RoHS Directive (2011/65/EU)"
canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive"
source_url: "https://www.sorena.io/artifacts/eu/rohs-directive"
author: "Sorena AI"
description: "A practical EU RoHS hub for Directive 2011/65/EU (including amendments such as (EU) 2015/863 phthalates): confirm EEE scope."
published_at: "2026-02-21"
updated_at: "2026-02-21"
keywords:
  - "RoHS Directive 2011/65/EU"
  - "EU RoHS compliance"
  - "RoHS restricted substances"
  - "RoHS homogeneous material threshold 0.1%"
  - "RoHS cadmium 0.01%"
  - "RoHS phthalates 2015/863 2019"
  - "RoHS exemptions Annex III Annex IV"
  - "RoHS exemption tracking"
  - "EN IEC 63000 technical documentation"
  - "CE marking RoHS"
  - "RoHS supplier declaration template"
  - "RoHS vs REACH"
  - "RoHS"
  - "Directive 2011/65/EU"
  - "Restricted substances"
  - "Exemptions"
  - "EN IEC 63000"
---
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# EU RoHS Directive (2011/65/EU)

A practical EU RoHS hub for Directive 2011/65/EU (including amendments such as (EU) 2015/863 phthalates): confirm EEE scope.

![EU RoHS artifact preview](https://cdn.sorena.io/cdn-cgi/image/format=auto/cheatsheets/prod/sorena-ai-eu-rohs-timeline-small.jpg?v=cheatsheets%2Fprod)

*RoHS* *Free Resource*

## EU Restriction of Hazardous Substances (RoHS) Timeline and Exemptions Decision Flow

Use this hub to confirm RoHS scope for electrical and electronic equipment (EEE), apply the restricted substances thresholds in homogeneous materials, and run an exemption and evidence workflow that holds up in audits and market surveillance requests.

This is practical guidance, not legal advice. Always validate scope and exemptions against the consolidated Directive 2011/65/EU and the latest official exemption updates.

[Run the RoHS applicability test](/artifacts/eu/rohs-directive/applicability-test.md)

## What you can decide faster

- **In scope**: EEE categories, exclusions, and borderline cases.
- **Restricted substances**: Homogeneous material thresholds + where substances hide in a BOM.
- **Exemptions**: Annex III/IV eligibility, evidence, expiry risk, and change control.
- **Operator duties**: Manufacturer, importer, and distributor checks plus 10 year document retention.

By Sorena AI | Updated Feb 2026 | No signup required

### Quick scan

*RoHS*

- **Substances**: 10 restricted substances and two key thresholds (0.1% / 0.01%).
- **Exemptions**: Expiry is a product risk; treat exemptions like expiring certificates.
- **Evidence**: Supplier declarations, risk-based testing, and EN IEC 63000 technical documentation.

Use the decision flow to align engineering, quality, and suppliers on what is allowed and what needs proof.

| Value | Metric |
| --- | --- |
| 2011/65/EU | Directive |
| 10 | Substances |
| EN IEC 63000 | Tech docs |
| 18 months | Renewal deadline |

**Key highlights:** Homogeneous material | Exemption tracking | Supplier evidence

## 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 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.

## Key dates for materials compliance

*RoHS Timeline*

Track RoHS milestones across amendments, staged category dates, phthalates cutovers, and exemption renewal timing that impact engineering and procurement.

## Does RoHS apply to your equipment

*RoHS Decision Flow*

Use the decision flow to confirm scope, identify restricted substances exposure, decide whether an exemption is relevant, and build the evidence needed for Article 7, 9, and 10 duties.

*Next step*

## Turn EU Restriction of Hazardous Substances (RoHS) Timeline and Exemptions Decision Flow into an operational assessment workflow

EU Restriction of Hazardous Substances (RoHS) Timeline and Exemptions Decision Flow should be the shared entry point for your team. Route execution into Assessment Autopilot for live work and into SSOT when the artifact needs deeper research, evidence governance, or supporting analysis.

- Start from EU Restriction of Hazardous Substances (RoHS) Timeline and Exemptions Decision Flow and route the work by entity, product, team, or control owner.
- Use Assessment Autopilot to turn the guidance into owned tasks, evidence requests, and review checkpoints.
- Use SSOT to keep documents, evidence, and control records in one governed system.
- Move from artifact reading to accountable execution without rebuilding the guidance in separate files.

- [Open Assessment Autopilot](/solutions/assessment.md): Turn the guidance into owned tasks, evidence requests, and review checkpoints for EU Restriction of Hazardous Substances (RoHS) Timeline and Exemptions Decision Flow.
- [Open SSOT](/solutions/ssot.md): Keep documents, evidence, and control records in one governed system from the same artifact.
- **Download decision flow**: Share restriction + exemption logic internally.
- **Download timeline**: Coordinate milestones across teams.
- [Talk through EU Restriction of Hazardous Substances (RoHS) Timeline and Exemptions Decision Flow](/contact.md): Review your current process, evidence model, and next steps for EU Restriction of Hazardous Substances (RoHS) Timeline and Exemptions Decision Flow.

## Decision Steps

### STEP 1: Is your product Electrical and Electronic Equipment (EEE)?

*Reference: Art. 3(1)*

- EEE = equipment dependent on electric currents or electromagnetic fields to work properly, designed for voltage rating not exceeding 1000V AC or 1500V DC.
- 'Dependent' means needing electric currents or electromagnetic fields to fulfil at least one intended function.
- Includes equipment for generation, transfer and measurement of such currents and fields.

- **NO** Out of RoHS Scope
- **YES** Does an Article 2(4) exclusion apply to your EEE?

### STEP 2: Does an Article 2(4) exclusion apply to your EEE?

*Reference: Art. 2(4)*

- If yes: RoHS does not apply.
- If no: continue to substance restrictions and compliance requirements.

- **YES** Out of RoHS Scope
- **NO** Your EEE is within RoHS scope

### IN SCOPE: Your EEE is within RoHS scope

*Reference: Art. 2(1)*

- Your EEE must comply with substance restrictions (Art. 4) and conformity assessment requirements (Arts. 7-15).
- Check when substance restrictions apply based on your EEE category (see timeline).

- -> Do any Annex II substances exceed the maximum concentration values in any homogeneous material?

### STEP 3: Do any Annex II substances exceed the maximum concentration values in any homogeneous material?

*Reference: Art. 4(1)-(2) and Annex II*

- RoHS prohibits placing EEE on the market if it contains restricted substances above the Annex II limits in any homogeneous material.
- If no: proceed with conformity assessment, declaration of conformity, and CE marking.
- If yes: continue to exemptions and transitional provisions.

- **YES** Does your application benefit from an exemption in Annex III or IV?
- **NO** Manufacturer: Have you completed the conformity assessment?

### STEP 4: Does your application benefit from an exemption in Annex III or IV?

*Reference: Art. 4(6) & Art. 5*

- Annex III lists exemptions for all EEE categories.
- Annex IV lists exemptions specific to medical devices (category 8) and monitoring/control instruments (category 9).
- Exemptions have validity periods and may expire.
- If your application is exempt: you may use the restricted substance for that specific application (and proceed with conformity assessment).
- If not exempt: check transitional provisions for cables and spare parts (Art. 4(4)) and reused spare parts (Art. 4(5)), or consider substitution or applying for an exemption under Article 5.

- **YES** Manufacturer: Have you completed the conformity assessment?
- **NO** Are you placing on the market cables or spare parts for existing EEE?

### STEP 5: Are you placing on the market cables or spare parts for existing EEE?

*Reference: Art. 4(4)*

- Article 4(4) provides transitional provisions for cables and spare parts for repair, reuse, updating or upgrading of EEE placed on the market before the substance restrictions applied to that EEE category.
- If yes: check the Art. 4(4) dates for your EEE category and proceed with conformity assessment steps.
- If no: check whether you qualify for the reused spare parts conditions in Art. 4(5).

- **YES** Manufacturer: Have you completed the conformity assessment?
- **NO** Are you using reused spare parts in an auditable closed-loop B2B return system and notifying the consumer?

### STEP 6: Are you using reused spare parts in an auditable closed-loop B2B return system and notifying the consumer?

*Reference: Art. 4(5)*

- Article 4(5) allows reuse of spare parts containing restricted substances if reuse takes place in auditable closed-loop business-to-business return systems and reuse is notified to the consumer.
- If yes: check the Art. 4(5) time limits and proceed with conformity assessment steps.
- If no: substitution or an exemption under Article 5 may be needed before the EEE can be placed on the market.

- **YES** Manufacturer: Have you completed the conformity assessment?
- **NO** Application Uses Restricted Substance - Check Exemptions

### STEP 7: Manufacturer: Have you completed the conformity assessment?

*Reference: Art. 7(b)-(c)*

- Draw up required technical documentation and carry out internal production control (Module A of Annex II to Decision 768/2008/EC).
- Draw up EU Declaration of Conformity (DoC) and affix CE marking on the finished product.
- Keep technical documentation and DoC for 10 years after placing EEE on market.

- **YES** RoHS Compliant - Ready for EU Market
- **NO** Non-Compliant - Cannot Be Placed on EU Market

## Reference Information

### What is EEE?

- Electrical and Electronic Equipment (EEE) depends on electric currents or electromagnetic fields to work properly.
- EEE also includes equipment for generation, transfer and measurement of such currents and fields.
- Voltage rating: not exceeding 1000V AC or 1500V DC.
- Equipment without electrical or electronic parts (for example compact discs and optical cables) is outside the scope of RoHS 2.

### EEE Categories (Annex I)

- 1. Large household appliances
- 2. Small household appliances
- 3. IT and telecommunications equipment
- 4. Consumer equipment
- 5. Lighting equipment
- 6. Electrical and electronic tools (except large-scale stationary industrial tools)
- 7. Toys, leisure and sports equipment
- 8. Medical devices (including in vitro diagnostic medical devices)
- 9. Monitoring and control instruments (including industrial monitoring and control instruments)
- 10. Automatic dispensers
- 11. Other EEE not covered by categories 1-10 (open scope from 22 July 2019)

### Article 2(4) Exclusions

- (a) Equipment necessary for protection of essential security interests of Member States, including arms, munitions and war material for military purposes.
- (b) Equipment designed to be sent into space.
- (c) Equipment specifically designed and to be installed as part of another type of equipment excluded or outside RoHS scope, which can only function as part of that equipment, and can only be replaced by the same specifically designed equipment.
- (d) Large-scale stationary industrial tools.
- (e) Large-scale fixed installations.
- (f) Means of transport for persons or goods (excluding electric two-wheel vehicles which are not type-approved).
- (g) Non-road mobile machinery made available exclusively for professional use.
- (h) Active implantable medical devices.
- (i) Photovoltaic panels in systems designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light.
- (j) Equipment specifically designed solely for research and development only made available on a business-to-business basis.
- (k) Pipe organs.

### Restricted Substances (Annex II)

- 1. Lead (Pb) - max 0.1% by weight in homogeneous materials
- 2. Mercury (Hg) - max 0.1% by weight in homogeneous materials
- 3. Cadmium (Cd) - max 0.01% by weight in homogeneous materials
- 4. Hexavalent chromium (Cr(VI)) - max 0.1% by weight in homogeneous materials
- 5. Polybrominated biphenyls (PBB) - max 0.1% by weight in homogeneous materials
- 6. Polybrominated diphenyl ethers (PBDE) - max 0.1% by weight in homogeneous materials
- 7. Bis(2-ethylhexyl) phthalate (DEHP) - max 0.1% by weight in homogeneous materials (from 22 July 2019; medical/monitoring devices from 22 July 2021)
- 8. Butyl benzyl phthalate (BBP) - max 0.1% by weight in homogeneous materials (from 22 July 2019; medical/monitoring devices from 22 July 2021)
- 9. Dibutyl phthalate (DBP) - max 0.1% by weight in homogeneous materials (from 22 July 2019; medical/monitoring devices from 22 July 2021)
- 10. Diisobutyl phthalate (DIBP) - max 0.1% by weight in homogeneous materials (from 22 July 2019; medical/monitoring devices from 22 July 2021)

### Homogeneous Material

- Homogeneous material = one material of uniform composition throughout, or a material consisting of a combination of materials that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes (Art. 3(20)).
- Maximum concentration values apply by weight in homogeneous materials (Art. 4(2)).

### Exemptions (Annex III & IV)

- Exemptions allow specific applications to use restricted substances where elimination or substitution is scientifically/technically impracticable, reliability of substitutes is not ensured, or substitution would cause greater harm (Art. 5(1)).
- Annex III: exemptions for categories 1-7, 10, 11 (validity up to 5 years, renewable).
- Annex IV: exemptions for categories 8 and 9 (medical devices and monitoring/control instruments; validity up to 7 years, renewable).
- Exemptions are specific to the application and may include scope and expiry dates.
- Exemption applications must be submitted 18 months before expiry (Art. 5(5)).
- Existing exemptions remain valid until Commission decision on renewal (Art. 5(5)).

### Spare Parts & Cables (Art. 4(4))

- Article 4(1) does not apply to cables or spare parts for repair, reuse, updating or upgrading of:
- (a) EEE placed on the market before 1 July 2006 (RoHS 1 start).
- (b) Medical devices placed on the market before 22 July 2014.
- (c) In vitro diagnostic medical devices placed on the market before 22 July 2016.
- (d) Monitoring and control instruments placed on the market before 22 July 2014.
- (e) Industrial monitoring and control instruments placed on the market before 22 July 2017.
- (ea) All other EEE that was outside RoHS 1 scope and placed on the market before 22 July 2019.
- (f) EEE which benefited from an exemption and was placed on the market before that exemption expired (for that specific exemption).

### Reused Spare Parts (Art. 4(5))

- Provided that reuse takes place in auditable closed-loop business-to-business return systems, and that reuse is notified to the consumer, Art. 4(1) does not apply to reused spare parts:
- (a) Recovered from EEE placed on market before 1 July 2006 and used in EEE placed on market before 1 July 2016.
- (b) Recovered from medical/monitoring devices placed on market before 22 July 2014 and used in EEE placed on market before 22 July 2024.
- (c) Recovered from in vitro diagnostic medical devices placed on market before 22 July 2016 and used in EEE placed on market before 22 July 2026.
- (d) Recovered from industrial monitoring/control instruments placed on market before 22 July 2017 and used in EEE placed on market before 22 July 2027.
- (e) Recovered from all other EEE outside RoHS 1 scope placed on market before 22 July 2019 and used in EEE placed on market before 22 July 2029.

### Technical Documentation (Art. 7(b))

- Manufacturers must draw up the required technical documentation and carry out internal production control (Art. 7(b)).
- Harmonised standard EN IEC 63000:2018 is referenced for the technical documentation required for assessing materials, components and EEE under RoHS (Implementing Decision (EU) 2020/659).
- Keep documentation for 10 years after placing EEE on market (Art. 7(d)).
- Provide documentation to competent authorities upon request (Art. 7(j)).

### CE Marking & Declaration of Conformity

- After demonstrating compliance, manufacturer must draw up EU Declaration of Conformity (DoC) and affix CE marking (Art. 7(c)).
- The EU Declaration of Conformity must state that it has been demonstrated that the requirements specified in Article 4 have been met, and follow the model structure and contain the elements specified in Annex VI (Art. 13).
- The EU Declaration of Conformity must be translated into the language or languages required by the Member State on the market of which the product is placed or made available (Art. 13(2)).
- CE marking must be visible, legible and indelible on the finished EEE or its data plate (Art. 15(1)).
- If size or nature of EEE does not allow, CE marking may be on packaging and accompanying documents (Art. 15(1)).
- The CE marking must be affixed before the EEE is placed on the market (Art. 15(2)).
- A single technical documentation may be drawn up where other applicable Union legislation requires a conformity assessment procedure that is at least as stringent (Art. 7(c) and Art. 13(2)).

### Authorised Representative (Art. 8)

- A manufacturer may appoint an authorised representative by written mandate.
- The obligations in Article 7(a) and the drawing up of technical documentation shall not form part of the authorised representative's mandate.
- The mandate must allow the authorised representative at least to keep the EU declaration of conformity and technical documentation available for market surveillance authorities for 10 years, provide information and documentation upon request, and cooperate with competent national authorities.

### Traceability (Art. 12)

- Economic operators must, on request, identify to market surveillance authorities for 10 years following placing on the market: (a) any economic operator who supplied them with an EEE, and (b) any economic operator to whom they supplied an EEE.

### Manufacturer Obligations (Art. 7)

- (a) Ensure EEE placed on market is designed and manufactured in accordance with Art. 4.
- (b) Draw up technical documentation and carry out internal production control (Module A).
- (c) Draw up EU Declaration of Conformity and affix CE marking.
- (d) Keep technical documentation and DoC for 10 years.
- (e) Ensure procedures are in place for series production to remain in conformity; take account of changes.
- (f) Keep a register of non-conforming EEE and product recalls; inform distributors.
- (g) Ensure EEE bears type, batch or serial number or other identification.
- (h) Indicate name, registered trade name/mark and contact address on EEE or packaging/documents.
- (i) Take corrective measures (withdraw, recall) and inform authorities if EEE is non-compliant.
- (j) Provide information and documentation to authorities upon request; cooperate on compliance actions.

### Importer Obligations (Art. 9)

- (a) Place only compliant EEE on the Union market.
- (b) Before placing EEE on market, ensure manufacturer has carried out conformity assessment, drawn up technical documentation, affixed CE marking, provided required documents, and complied with identification/labelling.
- (c) If the importer considers or has reason to believe the EEE is not in conformity with Article 4, do not place it on the market until it has been brought into conformity, and inform the manufacturer and market surveillance authorities.
- (d) Indicate importer name, registered trade name/mark, and a single contact address on the EEE (or packaging/accompanying document where not possible).
- (e) Keep a register of non-compliant EEE and EEE recalls, and keep distributors informed thereof.
- (f) If the importer considers or has reason to believe EEE placed on the market is not in conformity, take corrective measures (bring into conformity, withdraw or recall) and inform competent national authorities.
- (g) Keep a copy of the EU Declaration of Conformity at the disposal of market surveillance authorities for 10 years and ensure the technical documentation can be made available upon request.
- (h) Provide information and documentation to competent authorities upon request and cooperate on actions to ensure compliance.

### Distributor Obligations (Art. 10)

- (a) Act with due care when making EEE available on market; verify CE marking, required documents, manufacturer/importer identification, and language requirements.
- (b) Do not make non-compliant EEE available on market; inform manufacturer/importer and authorities if EEE presents a risk.
- (c) If the distributor considers or has reason to believe EEE is not in conformity with Article 4, do not make it available on the market until it has been brought into conformity, and inform the manufacturer or the importer and the market surveillance authorities.
- (d) If the distributor considers or has reason to believe EEE made available is not in conformity, ensure corrective measures are taken (bring into conformity, withdraw or recall) and inform competent national authorities.
- (e) Provide information and documentation to competent authorities upon request and cooperate on actions to ensure compliance.
- An importer or distributor is considered a manufacturer (and subject to Article 7 obligations) if it places EEE on the market under its name or trademark, or modifies EEE so that compliance may be affected (Art. 11).

### Market Surveillance and Controls (Art. 18)

- Member States carry out market surveillance and controls of EEE entering the Union market in accordance with Regulation (EC) No 765/2008 (Art. 18).
- Regulation (EU) 2019/1020 provides a framework for market surveillance and compliance of products, including cooperation and enforcement tools for market surveillance authorities.
- Market surveillance authorities may request the EU Declaration of Conformity and technical documentation and take action where EEE is non-compliant.

### Penalties (Art. 23)

- Member States must lay down rules on penalties applicable to infringements of national provisions adopted pursuant to the Directive and ensure they are implemented.
- Penalties must be effective, proportionate and dissuasive.
- Member States must notify the penalty rules to the Commission by 2 January 2013 and notify subsequent amendments without delay.

### RoHS Evolution: RoHS 1 -> RoHS 2 -> RoHS 3

- RoHS 1 (Directive 2002/95/EC): original RoHS directive restricting the use of hazardous substances in EEE (substance restrictions apply from 1 July 2006).
- RoHS 2 (Directive 2011/65/EU): recast directive with updated scope and definitions and alignment with the CE marking and EU declaration of conformity framework.
- RoHS 3 (Delegated Directive (EU) 2015/863): adds four phthalates (DEHP, BBP, DBP, DIBP) to Annex II (applies from 22 July 2019 for most EEE and from 22 July 2021 for medical devices and monitoring/control instruments).
- Directive (EU) 2017/2102: further amendments to RoHS 2 scope and exemptions.
- Consolidated RoHS 2 (as of 1 January 2025) incorporates all amendments.

### Open Scope (Category 11)

- From 22 July 2019, RoHS applies to all EEE not covered by categories 1-10 and not excluded by Art. 2(4) (open scope).
- This means any new EEE types are automatically in RoHS scope unless specifically excluded.
- Article 2(2) transitional provision: non-compliant EEE that were outside the scope of RoHS 1 but inside the scope of RoHS 2 had full market access until 22 July 2019 (subject to specific application dates in Articles 4(3) and 4(4)).

### Cables (Art. 3(5))

- Cables = all cables with a rated voltage of less than 250 volts that serve as a connection or extension to connect EEE to the electrical outlet or to connect two or more EEE to each other (Art. 3(5)).
- Cables are within RoHS scope from 3 January 2013 (with transitional provisions for cables outside RoHS 1 scope until 22 July 2019).
- Internal wires and internal cables (inside EEE) are part of the EEE and follow the EEE's scope and compliance dates.
- External cables (separate accessories) have separate compliance requirements.
- Optical cables (no electrical current) are not EEE and not in RoHS scope.

### Components & Consumables

- Finished EEE can only meet the substance restriction requirements if its components and parts meet the substance restrictions according to Article 4.
- Components used in finished EEE (or for repair/upgrade of EEE in scope) must meet the substance restrictions, but do not need CE marking as stand-alone components (FAQ Q7.3).
- Consumables are in scope only if they meet the definition of EEE (for example, printer cartridges); consumables without an equipment constituent are not in scope (FAQ Q7.4).
- Manufacturers placing finished EEE on the market must ensure it is designed and manufactured in accordance with Article 4 (Art. 7(a)).

### Professional vs Consumer Use

- RoHS applies to both professional and consumer EEE (unless specifically excluded, e.g., large-scale stationary industrial tools, non-road mobile machinery for professional use).
- Professional use does not automatically exempt EEE from RoHS scope.
- Industrial monitoring and control instruments (category 9) are in scope from 22 July 2017.
- Large-scale stationary industrial tools and large-scale fixed installations are excluded (Art. 2(4)(d)-(e)).

### RoHS & REACH

- RoHS and REACH are complementary but distinct EU legislation on chemicals.
- REACH (Regulation (EC) 1907/2006) is horizontal legislation covering all products; RoHS is sector-specific for EEE.
- RoHS review and amendment of Annex II must be coherent with REACH, particularly Annexes XIV (authorisation) and XVII (restrictions) (Art. 6(1)).
- Some substances are restricted under both RoHS and REACH (for example, DEHP, BBP and DBP in toys under REACH Annex XVII entry 51; Annex II notes that RoHS restrictions for those substances do not apply to toys already subject to that REACH restriction).
- RoHS applies without prejudice to REACH and other chemicals legislation (Art. 2(3)).

## Possible Outcomes

### [COMPLIANT] RoHS Compliant - Ready for EU Market

CE marking affixed; DoC and technical documentation complete

- Your EEE complies with RoHS substance restrictions (Annex II) or benefits from a valid exemption (Annex III/IV).
- You have completed conformity assessment, drawn up technical documentation (EN IEC 63000:2018), issued DoC and affixed CE marking.
- Ensure ongoing compliance during series production and keep documentation for 10 years.
- Monitor exemption expiry dates and apply for renewals 18 months before expiry if needed.
- Stay informed of Annex II reviews and any new substance additions (Art. 6).

### [ACTION REQUIRED] Application Uses Restricted Substance - Check Exemptions

Exemption may be required

- Your application uses a restricted substance above the maximum concentration value.
- Check if an exemption in Annex III or IV covers your application.
- Until the restriction does not apply or a valid exemption covers the application, the EEE cannot be placed on the EU market.
- If no exemption exists or exemption has expired: consider substitution or apply for new/renewed exemption under Art. 5.
- Exemption applications must demonstrate scientific/technical impracticability of substitution, unreliability of substitutes, or that substitution would cause greater harm.
- Apply for exemption renewal at least 18 months before expiry; existing exemption remains valid until decision (Art. 5(5)).

### [NON-COMPLIANT] Non-Compliant - Cannot Be Placed on EU Market

Conformity assessment not completed

- You have not completed the required conformity assessment steps for RoHS.
- Before placing EEE on the EU market, complete internal production control, draw up the EU Declaration of Conformity, and affix CE marking (Art. 7).
- Member States must lay down penalties for infringements and ensure they are implemented (Art. 23).
- Member States carry out market surveillance and controls in accordance with Article 18.

### [OUT OF SCOPE] Out of RoHS Scope

RoHS does not apply

- Your product is not EEE, or an Article 2(4) exclusion applies.
- RoHS substance restrictions and conformity assessment do not apply.
- Other EU legislation may still apply (e.g., REACH, Machinery Directive, Low Voltage Directive, EMC Directive, product-specific directives).

## RoHS Timeline

| Date | Event | Reference |
| --- | --- | --- |
| 2003-02-13 | RoHS 1 published in the Official Journal | Dir. 2002/95/EC |
| 2006-07-01 | RoHS 1 substance restrictions apply to new EEE | Dir. 2002/95/EC |
| 2011-06-08 | RoHS 2 (Directive 2011/65/EU) adopted (recast) | Dir. 2011/65/EU |
| 2011-07-21 | RoHS 2 entered into force | Dir. 2011/65/EU |
| 2013-01-02 | Member States transpose RoHS 2 / CE marking begins | Dir. 2011/65/EU |
| 2015-03-31 | 4 phthalates added to Annex II (DEHP, BBP, DBP, DIBP) | Del. Dir. (EU) 2015/863 |
| 2019-07-22 | Open scope applies (category 11) and RoHS 3 phthalates apply for most EEE | Art. 2(2) and Del. Dir. (EU) 2015/863 |
| 2020-05-15 | Implementing Decision (EU) 2020/659 adopted (EN IEC 63000:2018) | Impl. Dec. (EU) 2020/659 |
| 2021-07-22 | 4 phthalates apply to medical devices and monitoring/control instruments | Annex II (as amended) |
| 2021-11-18 | EN 50581:2012 reference withdrawn | Impl. Dec. (EU) 2020/659 |

## Compliance Timeline

| Date | Event | Category | Reference |
| --- | --- | --- | --- |
| 2003-01-27 | RoHS 1 Directive Adopted | Legislation |  |
| 2003-02-13 | RoHS 1 Published in Official Journal | Legislation |  |
| 2004-08-13 | RoHS 1 Transposition Deadline | Implementation |  |
| 2005-02-13 | RoHS 1 First Review Deadline | Implementation |  |
| 2006-07-01 | RoHS 1 Substance Restrictions Effective | Substances |  |
| 2011-06-08 | RoHS 2 Directive Adopted (Recast) | Legislation |  |
| 2011-07-01 | RoHS 2 Published in Official Journal | Legislation |  |
| 2011-07-21 | RoHS 2 Entry into Force | Implementation |  |
| 2012-01-01 | EN 50581:2012 referenced as RoHS technical documentation standard | Standards |  |
| 2012-12-12 | RoHS 2 Official FAQ Published | Guidance |  |
| 2013-01-02 | RoHS 2 transposition deadline; CE marking presumption begins | Implementation |  |
| 2013-01-03 | RoHS 1 Exemptions Expire | Implementation |  |
| 2014-07-22 | Medical Devices and Monitoring Instruments in Scope | Implementation |  |
| 2015-03-31 | RoHS 3 Phthalates Amendment Adopted | Substances |  |
| 2015-06-04 | RoHS 3 Published in Official Journal | Substances |  |
| 2016-07-01 | Reuse cutoff for recovered spare parts (Article 4(5) exemption) | Implementation |  |
| 2016-07-22 | In Vitro Diagnostic Medical Devices in Scope | Implementation |  |
| 2016-12-31 | RoHS 3 Transposition Deadline | Implementation |  |
| 2017-07-22 | Industrial Monitoring Instruments in Scope | Implementation |  |
| 2017-11-15 | Directive 2017/2102 Adopted (Scope Amendment) | Legislation |  |
| 2017-11-21 | Directive 2017/2102 Published | Legislation |  |
| 2018-01-01 | EN IEC 63000:2018 Adopted | Standards |  |
| 2018-07-17 | Commission receives exemption application (phthalates spare parts) | Implementation |  |
| 2018-11-01 | Technical/scientific assessment study starts (exemption request) | Implementation |  |
| 2019-03-18 | Stakeholder consultation opens (RoHS exemption assessment) | Implementation |  |
| 2019-05-17 | Stakeholder consultation closes (RoHS exemption assessment) | Implementation |  |
| 2019-06-12 | Directive 2017/2102 Transposition Deadline | Implementation |  |
| 2019-07-22 | Four Phthalates Restriction Effective (General EEE) | Substances |  |
| 2019-07-22 | Open Scope Fully Effective (Category 11) | Implementation |  |
| 2020-05-15 | Commission Decision 2020/659 on EN IEC 63000:2018 | Standards |  |
| 2021-02-23 | Member State expert group consultation (delegated acts) | Implementation |  |
| 2021-07-22 | Four Phthalates Restriction Effective (Medical Devices) | Substances |  |
| 2021-08-11 | Delegated directive signed on recovered spare parts exemption (phthalates) | Legislation |  |
| 2021-11-18 | EN 50581:2012 Reference Withdrawn | Standards |  |
| 2021-12-13 | Commission adopts mercury-in-lamps exemptions updates | Substances |  |
| 2022-02-24 | Delegated acts published ending mercury use in lamps | Substances |  |
| 2022-03-10 | Public consultation on RoHS review opens | Implementation |  |
| 2022-06-02 | Public consultation on RoHS review closes | Implementation |  |
| 2022-06-29 | Commission Notice 2022/C 262/04 Published | Guidance |  |
| 2023-12-07 | RoHS review finalised; targeted amendment proposed | Implementation |  |
| 2024-07-22 | Reuse Exemption Expires (Medical Devices Cat 8/9) | Implementation |  |
| 2026-07-22 | Reuse Exemption Expires (In Vitro Devices) | Implementation |  |
| 2027-07-22 | Reuse Exemption Expires (Industrial Instruments) | Implementation |  |
| 2029-07-22 | Reuse Exemption Expires (Category 11) | Implementation |  |

**Event details:**

- **2003-01-27 - RoHS 1 Directive Adopted**: Directive 2002/95/EC adopted by European Parliament and Council, restricting use of hazardous substances in electrical and electronic equipment.
- **2003-02-13 - RoHS 1 Published in Official Journal**: Directive 2002/95/EC published in Official Journal L 37/19, entering into force on day of publication.
- **2004-08-13 - RoHS 1 Transposition Deadline**: Member States required to bring into force laws, regulations and administrative provisions to comply with Directive 2002/95/EC.
- **2005-02-13 - RoHS 1 First Review Deadline**: Commission required to review measures and present proposals for additional equipment and substance restrictions.
- **2006-07-01 - RoHS 1 Substance Restrictions Effective**: Prohibition effective for lead, mercury, cadmium, hexavalent chromium, PBB, and PBDE in new EEE placed on market.
- **2011-06-08 - RoHS 2 Directive Adopted (Recast)**: Directive 2011/65/EU adopted as recast of RoHS 1, expanding scope to all EEE and improving legal clarity.
- **2011-07-01 - RoHS 2 Published in Official Journal**: Directive 2011/65/EU published in Official Journal L 174, entering into force 20 days after publication.
- **2011-07-21 - RoHS 2 Entry into Force**: Directive 2011/65/EU enters into force, establishing open scope for all EEE with specific exclusions.
- **2012-01-01 - EN 50581:2012 referenced as RoHS technical documentation standard**: The Commission FAQ references harmonised European Standard EN 50581:2012 for RoHS technical documentation (year reference).
- **2012-12-12 - RoHS 2 Official FAQ Published**: Commission publishes comprehensive FAQ on scope, exclusions, CE marking, and substance restrictions.
- **2013-01-02 - RoHS 2 transposition deadline; CE marking presumption begins**: Deadline for Member States to transpose RoHS 2. From 2 January 2013, CE-marked EEE in scope is presumed to conform with RoHS 2 requirements and CE marking is the only marking attesting conformity.
- **2013-01-03 - RoHS 1 Exemptions Expire**: Exemptions granted under RoHS 1 expire; new exemption framework under RoHS 2 fully operative.
- **2014-07-22 - Medical Devices and Monitoring Instruments in Scope**: RoHS 2 restrictions apply to medical devices and monitoring/control instruments placed on market.
- **2015-03-31 - RoHS 3 Phthalates Amendment Adopted**: Commission Delegated Directive (EU) 2015/863 adds four phthalates (DEHP, BBP, DBP, DIBP) to restricted substances list.
- **2015-06-04 - RoHS 3 Published in Official Journal**: Delegated Directive (EU) 2015/863 published in Official Journal L 137, entering into force 20 days after publication.
- **2016-07-01 - Reuse cutoff for recovered spare parts (Article 4(5) exemption)**: Recovered spare parts from EEE placed on the market before 1 July 2006 can be reused in new EEE placed on the market before 1 July 2016 under the Article 4(5) closed-loop B2B exemption.
- **2016-07-22 - In Vitro Diagnostic Medical Devices in Scope**: RoHS 2 restrictions apply to in vitro diagnostic medical devices placed on market.
- **2016-12-31 - RoHS 3 Transposition Deadline**: Member States required to adopt national laws implementing four phthalates restriction by December 31, 2016.
- **2017-07-22 - Industrial Monitoring Instruments in Scope**: RoHS 2 restrictions apply to industrial monitoring and control instruments placed on market.
- **2017-11-15 - Directive 2017/2102 Adopted (Scope Amendment)**: Directive (EU) 2017/2102 adopted, excluding pipe organs and clarifying secondary market operations and exemptions.
- **2017-11-21 - Directive 2017/2102 Published**: Directive (EU) 2017/2102 published in Official Journal L 305, entering into force 20 days after publication.
- **2018-01-01 - EN IEC 63000:2018 Adopted**: EN IEC 63000:2018 is referenced as the (year) harmonised standard that replaces EN 50581:2012 for RoHS technical documentation.
- **2018-07-17 - Commission receives exemption application (phthalates spare parts)**: Commission receives an application for an exemption to allow DEHP, BBP, DBP and DIBP in recovered spare parts from medical devices (referenced as received 17 July 2018).
- **2018-11-01 - Technical/scientific assessment study starts (exemption request)**: Commission begins a study (referenced as starting in November 2018) to prepare the technical and scientific assessment for a RoHS exemption request concerning phthalates in recovered spare parts for medical devices.
- **2019-03-18 - Stakeholder consultation opens (RoHS exemption assessment)**: Online stakeholder consultation referenced as running from 18 March 2019 in the exemption assessment process for recovered spare parts containing certain phthalates.
- **2019-05-17 - Stakeholder consultation closes (RoHS exemption assessment)**: Online stakeholder consultation referenced as ending 17 May 2019 in the exemption assessment process for recovered spare parts containing certain phthalates.
- **2019-06-12 - Directive 2017/2102 Transposition Deadline**: Member States required to transpose Directive (EU) 2017/2102 into national law.
- **2019-07-22 - Four Phthalates Restriction Effective (General EEE)**: Restriction of DEHP, BBP, DBP, and DIBP effective for all EEE placed on market (except medical devices and monitoring instruments).
- **2019-07-22 - Open Scope Fully Effective (Category 11)**: RoHS 2 open scope applies to all other EEE previously outside RoHS 1 scope (category 11).
- **2020-05-15 - Commission Decision 2020/659 on EN IEC 63000:2018**: Commission publishes reference of EN IEC 63000:2018 in Official Journal, establishing presumption of conformity.
- **2021-02-23 - Member State expert group consultation (delegated acts)**: Commission consults a Member State expert group on RoHS delegated acts on 23 February 2021 (as referenced in the delegated directive file).
- **2021-07-22 - Four Phthalates Restriction Effective (Medical Devices)**: Restriction of DEHP, BBP, DBP, and DIBP effective for medical devices, in vitro medical devices, and monitoring/control instruments.
- **2021-08-11 - Delegated directive signed on recovered spare parts exemption (phthalates)**: Delegated directive dated 11 August 2021 amends RoHS Annex IV to grant an exemption allowing DEHP, BBP, DBP and DIBP in recovered spare parts from medical devices used for repair/refurbishment (LV language version in source).
- **2021-11-18 - EN 50581:2012 Reference Withdrawn**: Reference of EN 50581:2012 withdrawn from Official Journal; EN IEC 63000:2018 becomes sole harmonised standard for technical documentation.
- **2021-12-13 - Commission adopts mercury-in-lamps exemptions updates**: Commission adopts a package of delegated directives (mostly dated 13 December 2021) updating exemptions for the use of mercury in lamps under the RoHS Directive; these were later published in OJ L 43 on 24 February 2022.
- **2022-02-24 - Delegated acts published ending mercury use in lamps**: Commission publishes delegated acts ending the use of mercury in lamps, updating RoHS exemptions to reflect mercury-free alternatives.
- **2022-03-10 - Public consultation on RoHS review opens**: Commission launches an open public consultation on the review of the RoHS Directive (10 March 2022).
- **2022-06-02 - Public consultation on RoHS review closes**: Commission closes the open public consultation on the review of the RoHS Directive (2 June 2022).
- **2022-06-29 - Commission Notice 2022/C 262/04 Published**: Commission publishes implementation guidance notice in Official Journal C 262/04 on RoHS 2 application.
- **2023-12-07 - RoHS review finalised; targeted amendment proposed**: Commission finalises the RoHS review and proposes a targeted amendment of the RoHS Directive.
- **2024-07-22 - Reuse Exemption Expires (Medical Devices Cat 8/9)**: Exemption for reused spare parts from medical devices/monitoring instruments placed before July 2014 expires.
- **2026-07-22 - Reuse Exemption Expires (In Vitro Devices)**: Exemption for reused spare parts from in vitro diagnostic medical devices placed before July 2016 expires.
- **2027-07-22 - Reuse Exemption Expires (Industrial Instruments)**: Exemption for reused spare parts from industrial monitoring/control instruments placed before July 2017 expires.
- **2029-07-22 - Reuse Exemption Expires (Category 11)**: Exemption for reused spare parts from all other EEE (category 11) placed before July 2019 expires.


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