By Sorena AIPublished Updated

RoHS

EU Restriction of Hazardous Substances (RoHS)

EU RoHS: check equipment scope, substance limits by , exemptions, technical documentation and CE marking.

Directive
2011/65/EU
Substances
10
Tech docs
Renewal lead
18 months

Understand EU Restriction of Hazardous Substances (RoHS)

Use this hub to decide whether an item is electrical and electronic equipment under Directive 2011/65/EU, apply the limits to each , and prepare the evidence needed before EU market placement. includes equipment that needs electric current or electromagnetic fields for at least one intended function and stays within the Directive's voltage limits.

Start with the marketed product and your manufacturer, importer, or distributor role. Then document any Article 2 exclusion, the category, each relied-on Annex III or IV entry, and the current conformity evidence. A is one uniform material, or a material combination that cannot be separated mechanically; the limits apply to each such material, not to the product average.

Review this hub before design freeze, supplier onboarding, exemption renewal review, product release, importer checks, distributor review, or market-surveillance response.

Quick scan

Substances

lists 10 restricted substances. Cadmium is limited to 0.01% by weight in homogeneous materials; the other nine listed substance groups use 0.1%.

Exemptions

Article 5 exemptions are time-limited and reassessed; renewal applications are due no later than 18 months before expiry.

Evidence

is the cited harmonised technical-documentation standard. Its voluntary use can support presumption of conformity for the documentation requirement; it does not replace the underlying Article 4 substance assessment.

What this RoHS hub helps you decide

  1. 1

    Scope and category

    Check whether the marketed item needs electricity or electromagnetic fields for an intended function, is designed for no more than 1,000 V AC or 1,500 V DC, and fits one of the 11 categories. Then test every condition of any Article 2 exclusion or dated cable or spare-part rule.

  2. 2

    Restricted substances

    Map lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP against the maximum concentration values in each , such as a plastic housing, copper wire, coating, alloy, or solder joint.

  3. 3

    Exemptions

    Match the exact Annex III or Annex IV wording to the substance, material, use, category, and date. A pending request for a new exemption does not permit market placement; a timely renewal request can keep an existing exemption valid until the Commission decides.

  4. 4

    Release evidence

    Manufacturers plan supplier declarations, material-risk review, method-appropriate IEC 62321 testing where needed, EN IEC 63000 technical documentation, internal production control, the , CE marking, change control, and 10-year retention. Importers and distributors perform their separate pre-market checks.

Key dates for RoHS product-release planning

Separate historical scope and phthalate phase-ins from live controls. Other brought into open scope and the first general phthalate application date reached 22 July 2019; the phthalate restrictions reached medical devices and monitoring and control instruments on 22 July 2021. For a current release, use the latest consolidated Directive and delegated acts to verify Annex III and IV wording, category coverage, expiry, and renewal status.

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Start with the RoHS evidence decision

Confirm scope under the EU Restriction of Hazardous Substances Directive (RoHS) and apply its material-level limits. Then build technical documentation from supplier evidence, targeted checks, exemptions, and controlled product records.

Review supplier declarations

A states what the supplier claims about a named part or material. Match it to the part number, material, supplier, restricted substances, claimed exemption, and document revision. For example, a declaration for a cable jacket does not prove that the connector, solder, and finished device comply.

Build EN IEC 63000 technical documentation

EN IEC 63000 is the European standard for preparing RoHS technical documentation. Structure the file around product identity, materials and components, supplier information, test decisions, exemptions, the EU declaration of conformity, and change triggers. The standard explains how to build the evidence file; it does not certify every material as compliant.

Apply limits by homogeneous material

means electrical and electronic equipment. Apply the RoHS limits to each , meaning one material that cannot be mechanically separated into different materials. Test solder, a plastic housing, and a cable coating separately; do not average them across the finished product. lists the restricted substances and maximum concentrations.

Check EEE scope and category

means electrical and electronic equipment that depends on electric current or electromagnetic fields to work, or equipment that generates, transfers, or measures them. An can remove a product from scope, such as certain military equipment or a large-scale fixed installation. groups covered products into ten named categories; is the catch-all for other EEE, such as a covered electronic product that fits none of Categories 1 to 10.

Choose the next RoHS decision

If you are new to RoHS, start with product scope and economic-operator duties. Once those decisions are documented, go to the substance, exemption, evidence, deadline, enforcement, or comparison question that is blocking release.

Start here: scope, roles, and core duties

Decide whether the item is , identify its category or exclusion, record the manufacturer, authorised representative, importer, or distributor role, and map the resulting RoHS duties.

Substances, thresholds, and special product cases

Apply at homogeneous-material level, then check phthalate timing, medical and monitoring equipment, cables, and spare-part rules against the exact product history.

Exemption decisions and lifecycle tracking

Match Annex III or IV wording to the product, material, use, category, and date, then govern renewal status and substitution planning without treating an exemption as a blanket waiver.

Dates, transitions, and enforcement

Separate historical phase-ins from live product controls, track exemption and reused-spare-part cutoffs, and assess national penalty exposure and market-surveillance response duties.

Compare adjacent regimes or answer a focused question

Keep RoHS evidence distinct from REACH, POPs, Batteries, WEEE, LVD, and EMC work, or use the FAQ when a narrow scope, cable, component, threshold, declaration, exemption, or spare-part question is already known.

Sources

data.europa.eu
Referenced sections
  • Legal source for adding DEHP, BBP, DBP, and DIBP to Annex II and for the 22 July 2019 and 22 July 2021 phthalate application dates and related cable, spare-part, medical-device, and monitoring-instrument provisions.
eur-lex.europa.eu
Referenced sections
  • Current consolidated text as of 1 July 2026 for RoHS scope, EEE definitions, homogeneous-material concentration limits, Annex I categories, Annex II restricted substances, current Annex III and IV entries, economic-operator duties, the EU declaration of conformity, CE marking, and 10-year retention.
environment.ec.europa.eu
Referenced sections
  • Non-binding Commission guidance supporting practical interpretation of intended electrical functions, separable equipment, homogeneous-material examples, cables, spare parts, and large-scale exclusions.
environment.ec.europa.eu
Referenced sections
  • Official Commission source for the exemption procedure, renewal timing, reassessment factors, the current 18- to 24-month decision timeframe, transition periods, and the rule that a new request does not authorize non-compliant market placement.
environment.ec.europa.eu
Referenced sections
  • Official Commission overview supporting the RoHS purpose, the ten restricted substances, product scope, and implementation resources.
webstore.iec.ch
Referenced sections
  • IEC publisher source describing IEC 63000 technical documentation for assessing electrical and electronic products with respect to restricted substances.

Next steps

Prepare RoHS substance, exemption, and release evidence

This hub is the shared entry point for RoHS product classification, substance checks, exemption reliance, supplier evidence, test planning, technical documentation, , CE marking, and importer or distributor review.

  • Start with the product boundary, category, intended market placement, economic-operator role, substance-risk materials, and any claimed Annex III or IV exemption.
  • Use Assessment Autopilot to request supplier declarations, material declarations, BOM risk review, targeted IEC 62321 testing, exemption rationale, expiry monitoring, technical documentation, , and CE marking checks.
  • Use SSOT to keep product facts, supplier records, substance evidence, test reports, exemption decisions, standards references, release approvals, and market-surveillance responses connected to one governed product file.
  • Keep exemption renewal timing visible so procurement and engineering are not relying on an expired or narrowed exemption during a product release.
  • Open Assessment Autopilot

    Convert RoHS scope, substance checks, exemption decisions, supplier evidence, test needs, and release approvals into owned tasks and review checkpoints.

  • Open SSOT

    Keep product facts, supplier declarations, material evidence, test reports, exemption rationale, records, and approval history in one governed system.

  • Align engineering, procurement, quality, regulatory, importer, distributor, and release teams on RoHS milestones.

  • Talk through RoHS readiness

    Review product scope, substance risk, exemption reliance, supplier evidence, testing strategy, technical documentation, and release gaps.