Applicability TestEU

EU RoHS Directive Applicability test

This test helps decide whether a product is electrical and electronic equipment in scope of Directive 2011/65/EU, or whether a specific exclusion, spare-part rule, cable rule, or exemption changes the RoHS answer.

The useful output is a documented scope conclusion tied to the product, EU role, restricted substances, technical documentation, declaration of conformity, and review triggers.

Author
Sorena AI
Published
May 9, 2026
Updated
Jul 25, 2026
Sections
5

Structured answer sets in this page tree.

Primary sources
6

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 25, 2026
Overview

A RoHS applicability test starts with the exact article being supplied in the EU. Identify whether it is finished , a separately placed cable, a spare part, or a component; determine the Annex I category and any Article 2 exclusion; then separate the Article 4 substance-restriction assessment from the Article 7 duties that apply to the manufacturer of finished EEE.

Section 1

Step 1: decide whether the item is EEE

Directive 2011/65/EU applies to in the Annex I categories. EEE is equipment dependent on electric currents or electromagnetic fields to work properly, or equipment for generating, transferring, or measuring those currents or fields, within the Directive's voltage limits.

Make the decision for the item and configuration that will be placed or made available on the EU market. Record its intended functions, voltage rating, whether electricity or electromagnetic fields are needed for at least one intended function, and the Annex I category. Since the open-scope expansion, EEE that meets the definition belongs in one of the 11 categories unless an Article 2 exclusion applies.

The Commission FAQ gives practical, non-binding examples. A gas cooker with an electrical clock, a singing teddy bear, lighted sports shoes, and petrol equipment with electric ignition can be EEE because an intended function depends on electricity. By contrast, if lighting and a wardrobe are separable and each remains fully functional, the lighting can be EEE while the furniture is not. Use those examples as reasoning aids, then apply the Directive to the actual marketed configuration.

  • Classify the item against Annex I: household appliances, IT and telecom equipment, consumer equipment, lighting, tools, toys and sports equipment, medical devices, monitoring and control instruments, automatic dispensers, or other EEE.
  • For multi-use equipment, do not rely on an excluded use if the same EEE is also intended for an in-scope use.
  • For professional or industrial equipment, check the express exclusions rather than assuming professional use is outside RoHS.
  • Write one of three scope outcomes: in scope, outside the EEE definition, or excluded under a cited Article 2(4) point. For an in-scope result, also record the Annex I category and responsible economic operator. A component for integration may still need material evidence even when the finished-EEE CE duties fall on another manufacturer.
Section 2

Step 2: screen exclusions, cables, and spare parts

Article 2(4) excludes specific equipment types, including military/security equipment, space equipment, certain equipment specifically designed for excluded equipment, large-scale stationary industrial tools, large-scale fixed installations, means of transport other than non-type-approved electric two-wheel vehicles, professional non-road mobile machinery, active implantable medical devices, certain photovoltaic panels, business-to-business R&D equipment, and pipe organs.

Cables and spare parts need a separate check. Article 4 covers EEE placed on the market, including cables and spare parts for repair, reuse, updating functionality, or upgrading capacity, but it also contains dated carve-outs tied to the original equipment. Record the original EEE type and placing-on-market date before applying one.

  • For large-scale tool or fixed-installation claims, keep evidence for permanent installation, professional installation and de-installation, dedicated location, scale, and the specific application.
  • For equipment designed to be installed in excluded equipment, show that the item can fulfil its function only as part of the excluded equipment and can be replaced only by the same specifically designed equipment.
  • For external cables supplied separately, determine whether they are finished EEE requiring their own RoHS conformity route; for cables supplied with EEE, document how the finished-product file and DoC cover them.
  • For an Article 2(4)(c) claim, show both conditions: the equipment is specifically designed and installed as part of excluded or out-of-scope equipment, and it can fulfil its function only as part of that equipment and be replaced only by the same specifically designed equipment.
  • Treat reused-spare-part relief as its own branch. Article 4(5) requires an auditable closed-loop business-to-business return system and notice to the consumer. As of July 2026, the reuse cutoffs for medical devices and ordinary monitoring equipment and for in vitro diagnostic devices have passed; the remaining listed cutoffs include 22 July 2027 for qualifying industrial monitoring and control instruments and 22 July 2029 for qualifying EEE that entered open scope in 2019.
Section 3

Step 3: map substance restrictions and exemptions

If the item is in scope, Article 4 points to Annex II maximum concentration values by weight in homogeneous materials. The current consolidated Annex II lists lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP at 0.1%, and cadmium at 0.01%. A homogeneous material is assessed at material level, not at finished-product average level.

Exemptions are not general waivers. Article 4(6) points to Annex III and Annex IV applications, and Article 5 sets time-limited exemption procedures. An applicability record should identify the exact exemption entry, product category, substance, application wording, expiry status, and any renewal dependency rather than saying only that the product is RoHS exempt.

  • Build the substance matrix at homogeneous-material level for the product, cable, spare part, coating, solder, polymer, glass, metal, and component materials that drive risk.
  • Use Annex III or Annex IV only for the exact material, component, application, category, and date conditions stated in the current RoHS text.
  • For phthalates, include DEHP, BBP, DBP, and DIBP in the screen, and check the special rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
Section 4

Step 4: decide the evidence file for the EU role

For in-scope EEE, the manufacturer must draw up technical documentation, carry out or have carried out the internal production control procedure, draw up an EU declaration of conformity when compliance is demonstrated, affix the CE marking, and keep the technical documentation and declaration for 10 years after placing the EEE on the market.

Importers and distributors also have RoHS checks. Importers must place only compliant EEE on the Union market and verify that the manufacturer has carried out conformity assessment, drawn up technical documentation, provided CE marking, and supplied required documents. Distributors must act with due care, including checking CE marking and required documents before making EEE available.

  • Manufacturer file: product identification, scope memo, BOM, material declarations, supplier evidence, test or assessment rationale, exemption register, technical documentation, EU declaration of conformity, CE marking check, and change-control record.
  • Importer file: manufacturer documentation access, EU declaration copy retention, CE and traceability checks, non-compliance register, and authority-response process.
  • Distributor file: due-care checks for CE marking, required documents, language requirements, manufacturer/importer identification, and escalation if there is reason to believe the EEE is not compliant.
  • Outside-scope or excluded file: the product facts, legal branch, cited exclusion if any, reviewer, approval date, and a trigger to reassess if the intended use, configuration, voltage, market channel, host equipment, or applicable law changes.
Recommended next step

Check a RoHS scope conclusion before release

Use the applicability result to decide whether the next artifact is a RoHS technical file, an exemption register, a supplier evidence request, or an out-of-scope rationale tied to Article 2.

Section 5

Common mistakes in RoHS applicability records

Weak RoHS records usually fail because they stop at a broad label such as electronic product, spare part, supplier declared, or CE marked. The applicability decision has to show why the specific article is in scope, excluded, exempted, or covered by a dated transition or spare-part rule.

The record should also keep RoHS separate from adjacent regimes. RoHS substance restrictions can overlap with REACH, POPs, batteries, WEEE, Low Voltage, EMC, and sector legislation, but each regime has its own trigger and evidence. A RoHS conclusion should not imply that those other duties are resolved.

  • Do not average restricted substances across the finished product when the legal threshold is set at homogeneous-material level.
  • Do not cite an Annex III or IV exemption without recording the exact entry, application wording, category, date condition, and whether a renewal issue exists.
  • Do not treat an old supplier declaration as sufficient after a material, component, coating, supplier, exemption, standard, or product-design change.
  • Re-run the applicability test when the intended function, voltage rating, marketed configuration, standalone-versus-integrated status, Annex I category, Article 2 exclusion facts, first market-placement date, economic-operator role, or destination market changes.
Primary sources

References and citations

environment.ec.europa.eu
Referenced sections
  • Commission guidance warning that scope, exclusions, cables, components, and category decisions require case-specific analysis.
"case-by-case basis"
environment.ec.europa.eu
Referenced sections
  • Commission implementation page explaining exemption procedure, renewal timing, assessment studies, and validity while renewal decisions are pending.
"Exemptions are limited in time"
webstore.iec.ch
Referenced sections
  • IEC source describing the technical documentation standard used to assess electrical and electronic products against hazardous-substance restrictions.
"specifies the technical documentation"
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