Artifact GuideEU

EU RoHS Directive Checklist

This checklist helps decide whether electrical or electronic equipment is in RoHS scope, confirm restricted-substance evidence at homogeneous-material level, and keep the CE and technical-file records tied to the right legal source.

The checkpoints below focus on Directive 2011/65/EU, the phthalate amendment, EN IEC 63000 technical documentation, and Commission guidance on exemptions.

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Author

Sorena AI

Published

May 9, 2026

Updated

Jul 25, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published May 9, 2026

Updated Jul 25, 2026

Overview

An EU RoHS checklist should start by identifying the finished , the EU economic-operator role, the Annex I category, and any Article 2 exclusion. It should then apply Annex II limits to homogeneous materials, verify Annex III or IV exemptions, assign evidence and release owners, and connect the result to technical documentation, the EU declaration of conformity, CE marking, retention, and reassessment triggers.

Section 1

1. Decide whether the product is EEE in RoHS scope

Directive 2011/65/EU applies to in the categories listed in Annex I, subject to the Directive's exclusions. The definition covers equipment dependent on electric currents or electromagnetic fields for at least one intended function and designed for voltage ratings not exceeding 1,000 volts AC or 1,500 volts DC.

Do not treat every assembly, cable, spare part, component, or building installation the same way. The checklist should record whether the item is finished EEE, a separately placed cable, a spare part, a component for integration, or equipment claimed to be outside scope under a specific exclusion.

Article 2 excludes equipment necessary for security or military purposes, equipment designed to be sent into space, qualifying means of transport, large-scale stationary industrial tools, large-scale fixed installations, certain non-road mobile machinery, active implantable medical devices, qualifying photovoltaic panels, and custom-built business-to-business research equipment. The large-scale exclusions require the full installation or tool definition; ordinary large products, stand-alone machines, or equipment merely used in a building do not qualify on size or location alone.

Scope owner: record the product name, model or family, intended use, voltage, marketed configuration, EU role, first placing-on-market facts, Annex I category, and the approved in-scope, out-of-definition, or Article 2 exclusion conclusion.
Check the Annex I EEE category, including category 11 for other EEE not covered by earlier categories, unless a specific Article 2 exclusion applies.
For cables, distinguish external cables sold separately from cables supplied with finished EEE; separately placed external cables need their own RoHS conformity route from the relevant applicability date.
For spare parts and sub-assemblies, document whether they are finished EEE or parts used for repair, reuse, updating, or upgrading of specific EEE.
For legacy repair, identify the original EEE placing-on-market date and the exact Article 4 spare-part rule. Do not assume that any old stock, reused part, or replacement part inherits a blanket exclusion.
For components, confirm that the finished EEE can meet RoHS only if its components and parts meet the substance restrictions, even where the component itself does not carry CE marking.
Expected evidence: signed scope memo, product specification, intended-use statement, voltage data, category rationale, exclusion evidence where claimed, and a review trigger for design or market changes.

Sources for this answer

Directive 2011/65/EU on restriction of hazardous substances (RoHS)

Current consolidated RoHS text as of 1 July 2026 for scope, EEE definitions, categories, exclusions, cables, spare parts, and economic-operator duties.

European Commission RoHS FAQ key guidance document

Non-binding Commission guidance used for practical scope distinctions on cables, components, spare parts, finished EEE, and exclusions.

Section 2

2. Check restricted substances at homogeneous-material level

RoHS substance limits are assessed by weight in each homogeneous material, not by the weight of the complete product. A homogeneous material is a material of uniform composition throughout, or a material combination that cannot be separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, or abrasive processes.

The current Annex II list includes lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP. Cadmium has a maximum concentration value of 0.01 % by weight in homogeneous materials; the other listed substances have 0.1 % values unless an applicable exemption changes the conclusion for the specific use.

Engineering or compliance owner: map each material, coating, solder, plastic, cable insulation, fastener, and supplied component to a homogeneous-material record where the substance risk is material to the product.
Use declarations, material data, supplier evidence, and testing so the file can show why each restricted substance is below the applicable concentration value or covered by a valid exemption.
Treat DEHP, BBP, DBP, and DIBP as part of the RoHS substance review, while preserving the Directive's specific timing and carve-outs for certain cables, spare parts, toys, medical devices, and monitoring and control instruments.
Avoid testing shortcuts that mix materials in a way that could dilute a restricted substance above the limit in one homogeneous material.
When a material or supplier changes, reopen the substance matrix instead of relying on an older declaration for a different bill of materials.
Expected evidence: controlled BOM, material or supplier declarations tied to part and revision, risk rationale, method-specific test reports where used, exception record, and approval of unresolved data gaps.

Sources for this answer

Directive 2011/65/EU on restriction of hazardous substances (RoHS)

Current consolidated RoHS text for homogeneous-material limits, Annex II substances, and current Annex III and IV entries.

Commission Delegated Directive (EU) 2015/863 adding phthalates to RoHS Annex II

Binding source adding DEHP, BBP, DBP, and DIBP to Annex II and setting related application rules.

European Commission RoHS FAQ key guidance document

Commission guidance used for homogeneous-material examples and practical testing cautions.

Section 3

3. Build the technical file, declaration, and CE evidence

Manufacturers must draw up the required technical documentation, complete the conformity assessment procedure, draw up an EU declaration of conformity, and affix CE marking when compliance has been demonstrated. Directive 2011/65/EU also requires manufacturers to keep the technical documentation and EU declaration of conformity for 10 years after the EEE has been placed on the market.

EN IEC 63000:2018 is the harmonised standard referenced for technical documentation used to assess materials, components, and EEE against RoHS substance restrictions. The checklist should identify which evidence supports the declaration rather than treating a supplier statement as a substitute for the manufacturer's file.

Manufacturer or technical-file owner: keep a product identification record, bill of materials, supplier declarations, material declarations, test reports where used, exemption rationale, and change-control history.
Confirm the EU declaration of conformity identifies the EEE, manufacturer or authorised representative, and the applicable RoHS reference.
Check that CE marking is placed visibly, legibly, and indelibly on the finished EEE. Only when that is not possible or not warranted because of the nature of the EEE may it be placed on the packaging and accompanying documents.
For importers, verify that the manufacturer completed conformity assessment, technical documentation, CE marking, and required documents before the EEE is placed on the Union market.
For distributors, check CE marking, required documents, and manufacturer/importer identification duties before making EEE available on the market.
Expected evidence: approved technical documentation, completed internal production-control record, signed and current EU DoC, CE artwork or product photograph, identification and contact markings, and 10-year retention control.

Sources for this answer

Directive 2011/65/EU on restriction of hazardous substances (RoHS)

Current binding source for manufacturer, importer, distributor, EU declaration, CE marking, record-retention, and authority-response duties.

Commission Implementing Decision (EU) 2020/659 on EN IEC 63000

Official source publishing EN IEC 63000:2018 as the harmonised RoHS technical-documentation standard.

IEC 63000:2016 technical documentation standard

IEC publisher page describing the technical documentation standard for restricted-substance compliance declarations.

European Commission RoHS harmonised standards page

Commission page for RoHS harmonised standards and Official Journal reference tracking.

Recommended next step

Turn RoHS checks into a reusable evidence file

Use the checklist to connect scope, substance evidence, exemptions, supplier declarations, technical documentation, and release decisions in one traceable RoHS workflow.

Research workflow

Open Research Copilot

Answer RoHS scope, exemption, and evidence questions with cited outputs.

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Talk through implementation

Review your RoHS scope decision, substance matrix, technical file, and release blockers.

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Section 4

4. Control exemptions, renewals, and release blockers

Annex III and Annex IV exemptions are application-specific and limited in time. A checklist should identify the exact exemption entry, product category, material or component use, expiry conditions, and evidence showing that the product fits the exemption wording.

Commission implementation guidance states that renewal applications must be made no later than 18 months before an exemption expires. Existing exemptions with timely renewal requests remain valid until the Commission decides, while a new exemption request does not itself allow non-compliant equipment to be placed on the EU market before the exemption is granted.

The Directive permits exemption validity of up to five years for Annex I categories 1 to 7, 10, and 11 and up to seven years for categories 8 and 9, but the adopted entry controls the actual period. After rejection or revocation, the legal expiry falls 12 to 18 months after the decision. Use the current consolidated Annex and adopted act, not an assessment report or supplier estimate, for the release date.

Keep an exemption register with the Annex, entry number, application wording, product category, expiry date or status, owner, and supporting evidence.
Escalate before design release if a product depends on an exemption that is expired, close to expiry, under review, or narrower than the intended use.
For renewal planning, track the 18-month application timing and the Commission decision status rather than assuming an exemption continues automatically.
For rejected or revoked exemptions, document the transition period and the engineering, supplier, or market action needed before the exemption ends.
Review the checklist after supplier changes, redesigns, new restricted-substance amendments, harmonised-standard updates, authority requests, recalls, or market-surveillance findings.
Assign each open point an owner, due date, affected SKU or BOM revision, interim control, and release outcome. An unresolved scope, substance, exemption, or identity question blocks the RoHS conclusion; a documentation-only gap still needs a recorded correction before the manufacturer signs or updates the EU declaration.

Sources for this answer

Directive 2011/65/EU on restriction of hazardous substances (RoHS)

Current consolidated RoHS text for the Annex III and IV exemption structure, validity periods, renewal rules, and economic-operator obligations.

European Commission - RoHS Directive implementation

Commission implementation source for exemption requests, renewal timing, review status, and transition-period guidance.

European Commission RoHS exemption application guidance

Guidance for exemption, renewal, amendment, and deletion applications under Article 5(8).

Primary sources