Artifact GuideEU

EU RoHS Directive EEE Categories and Open Scope

Use RoHS scope rules to decide whether a product is electrical and electronic equipment, whether an Article 2 exclusion applies, and which Annex I category should be recorded.

This guide focuses on category 11 open scope, cables, spare parts, and the evidence a team should keep when classifying equipment under Directive 2011/65/EU.

Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Sections
5

Structured answer sets in this page tree.

Primary sources
3

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

An EU RoHS scope decision should answer three questions in order: is the item EEE, is it excluded by Article 2(4), and which Annex I category applies. Category 11 captures other EEE not covered by categories 1 to 10, so an open-scope review needs a documented category rationale instead of a generic 'electrical product' label.

Section 1

Start with the RoHS definition of EEE

Directive 2011/65/EU defines EEE as equipment that depends on electric currents or electromagnetic fields to work properly, or equipment for generating, transferring, or measuring those currents and fields, within the Directive's voltage limits. The Directive also defines dependent as needing electricity or electromagnetic fields to fulfil at least one intended function.

The Commission FAQ explains the practical effect: an electric function can bring the whole product into scope even when electricity is not the main energy source, if that function is intended and integrated. If the electric part is separable and fully functional on its own, document whether only that electric equipment is in scope.

  • Record the intended electric or electromagnetic function, not just the presence of a battery, wire, sensor, lamp, or control board.
  • Check whether the product is designed for use within 1,000 V AC or 1,500 V DC, because that voltage boundary is part of the EEE definition.
  • For mixed products, separate integral EEE from detachable equipment that can be used independently, then record the classification basis.
Section 2

Map the product to an Annex I category

Annex I lists 11 RoHS EEE categories: large household appliances; small household appliances; IT and telecommunications equipment; consumer equipment; lighting equipment; electrical and electronic tools; toys, leisure and sports equipment; medical devices; monitoring and control instruments including industrial monitoring and control instruments; automatic dispensers; and other EEE not covered above.

Category 11 is the open-scope category. The Commission FAQ states that all equipment placed on the market and meeting the EEE definition is within one of the 11 Annex I categories unless an Article 2(4) exclusion applies. That makes category 11 a residual category, not a shortcut for avoiding the category analysis.

  • Try categories 1 to 10 first and document why the closest categories do or do not fit.
  • Use category 11 only when the product is EEE but is not covered by categories 1 to 10.
  • Keep the category decision with the technical file because category can affect exemption validity periods and application dates.
Section 3

Check open-scope timing and Article 2 exclusions

RoHS 2 expanded scope over time. Article 4(3) states that substance restrictions applied from 22 July 2014 for medical devices and monitoring and control instruments, 22 July 2016 for in vitro diagnostic medical devices, 22 July 2017 for industrial monitoring and control instruments, and 22 July 2019 for other EEE that was outside RoHS 1 scope.

Article 2(4) exclusions remain part of the decision. Examples include equipment designed to be sent into space, specifically designed equipment installed as part of another excluded or out-of-scope equipment type, large-scale stationary industrial tools, large-scale fixed installations, certain means of transport, professional non-road mobile machinery, active implantable medical devices, certain photovoltaic panels, R&D-only equipment made available business-to-business, and pipe organs.

  • For newly scoped or category 11 products, record the first EU placing-on-market date and whether any transition rule was relevant.
  • Do not treat category 11 as automatically compliant or non-compliant; it only answers category placement.
  • If relying on an Article 2(4) exclusion, cite the exact exclusion and retain design, intended-use, installation, and market-channel evidence.
Section 4

Classify cables, spare parts, and sub-assemblies carefully

The Directive defines cables as cables under 250 V that connect EEE to an electrical outlet or connect EEE to each other. The Commission FAQ says cables are generally in scope from 3 January 2013 unless they belong to EEE or a combination of EEE outside RoHS scope; optical cables are treated as outside the EEE definition because they do not have electrical or electronic parts.

External cables sold separately need their own RoHS compliance route from the relevant date. External cables sold together or marketed for use with a specific EEE must meet material restrictions but can be covered by that EEE's DoC and CE marking. Internal wiring follows the EEE it belongs to and does not need separate CE marking or a separate DoC.

  • For cables, capture whether they are internal wiring, a permanently attached cable, an external cable supplied with the EEE, or a separately placed-on-market product.
  • For spare parts, distinguish parts marketed for repair, reuse, updating, or upgrading of specific EEE from finished EEE sold in their own right.
  • Do not issue standalone CE/DoC conclusions for sub-assemblies unless the record explains whether they are finished EEE or supplied only for integration.
Section 5

Evidence to keep in a RoHS scope memo

A useful RoHS category memo is short but specific. It should let a reviewer reconstruct the classification without asking the product team to remember design history, market channels, or old transition assumptions.

Keep the memo linked to the technical documentation set. Article 7 requires manufacturers to draw up required technical documentation and carry out internal production control; a category and open-scope memo helps explain why the product was treated as in scope, excluded, or category 11.

  • Product description, model/version, intended functions, voltage rating, power source, and first EU placing-on-market date.
  • Annex I category analysis, including rejected categories and the reason for any category 11 conclusion.
  • Article 2(4) exclusion analysis, if relevant, with evidence for design purpose, installation context, professional-only channel, or excluded host equipment.
  • Cable, spare-part, accessory, and sub-assembly treatment, especially where items are sold separately or supplied only for integration.
  • Owner, approval date, source citations, and review triggers for design changes, supplier changes, market changes, or legal amendments.
Recommended next step

Turn the RoHS scope decision into reusable evidence

Use a structured RoHS category memo to connect product facts, Article 2 exclusions, Annex I category reasoning, cable and spare-part treatment, citations, owners, and review triggers.

Primary sources

References and citations

environment.ec.europa.eu
Referenced sections
  • Commission FAQ used for cable classification, internal wiring, external cables, spare parts, sub-assemblies, and CE/DoC handling.
"External cables placed on the market separately"
Related guides

Explore more topics

Are cables in scope of EU RoHS? Cable evidence, CE marking, and DoC FAQ
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
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
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
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
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
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
Checklist for EU RoHS scope, restricted substances, homogeneous materials, exemptions, CE marking, technical documentation, and supplier evidence.
EU RoHS Compliance Guide for EEE
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
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
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
Practical EU RoHS Directive FAQ covering EEE scope, Annex II substance limits, cables, spare parts, technical documentation, CE marking, and exemptions.
EU RoHS for medical devices and monitoring equipment
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
source-linked RoHS comparison guide for separating EEE hazardous-substance restrictions from REACH, POPs, battery, waste, and technical-file workstreams.
What do the 0.1% and 0.01% substance limits mean under EU RoHS? | RoHS FAQ
RoHS FAQ explaining why most Annex II substances use a 0.1% homogeneous-material limit while cadmium uses 0.01%.
What should teams do before a RoHS exemption expires? | RoHS FAQ
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
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
EU RoHS scope FAQ explaining when a product is electrical and electronic equipment, which Article 2 exclusions to check, and what evidence to keep.