WorkflowEU

EU RoHS Directive BOM evidence intake workflow

RoHS evidence intake starts with the bill of materials (BOM), but the legal restriction is applied to homogeneous materials, not just purchasable part numbers.

This workflow helps decide what supplier evidence, material declarations, exemption records, or test reports are needed before the RoHS technical file and EU declaration are trusted.

Author
Sorena AI
Published
May 9, 2026
Updated
Oct 15, 2026
Overview

Use this workflow to connect supplier records to each RoHS material decision. Start with the finished and economic-operator role, then break relevant purchased parts down to each . Apply the Annex II substance limits, check any Annex III or IV exemption, select evidence that resolves the material risk, and record the owner, decision, limitation, and reassessment trigger.

Section 1

Start with scope, role, and homogeneous-material risk

Open a BOM intake record when a new is planned for the EU market, when a supplier or material changes, or when the technical file cannot show why a RoHS conclusion was accepted. Record whether the company is acting as manufacturer, importer, distributor, or authorised representative because RoHS assigns different checks and document-retention duties to those roles.

For each BOM item, break the compliance question down to homogeneous materials where practical. Directive 2011/65/EU defines a as one uniform material, or a material combination that cannot be separated into different materials by mechanical action. Supplier declarations that only say a finished assembly is compliant are weaker when they do not identify the materials, substances, exemptions, and supporting basis behind that statement.

Confirm scope before material intake. must depend on electric currents or electromagnetic fields for at least one intended function and stay within the 1,000 V AC or 1,500 V DC design limits. Record the Annex I category, including category 11 where relevant, and any exact Article 2 exclusion. Military or space equipment, qualifying means of transport, large-scale tools or fixed installations, certain non-road mobile machinery, active implantable medical devices, qualifying photovoltaic panels, and custom-built business-to-business research equipment are examples of exclusions, not generic labels to apply without the facts.

  • Identify the finished , product family, model, intended EU market, and whether any RoHS scope exclusion is being relied on.
  • Map each critical BOM line to supplier, manufacturer part number, revision, material family, contact surface, coating, solder, cable, plastic, or other homogeneous-material concern.
  • Flag high-risk gaps: missing declarations, obsolete part revisions, unknown plating or solder composition, recycled or alternate materials, separate cables or accessories, and components sold both as spare parts and as production parts.
  • Record the economic-operator role and the owner responsible for resolving missing evidence before release or shipment.
  • Set an intake disposition for every relevant BOM line: accepted, accepted with limits, supplier clarification required, exemption review required, targeted testing required, substitute part required, quarantined, or blocked.
  • For an operational intake decision, state what any acceptance limit covers: the approved part revision, supplied variant, product use, and review date. Keep a line blocked if a missing fact prevents a substance or exemption conclusion; record who must resolve it before release.
Section 2

Collect evidence that matches the material decision

BOM intake should not accept every supplier document at the same value. Match the evidence type to the risk and decision being made: low-risk catalog parts may be supported by current supplier declarations, while uncertain alloys, solders, coatings, plastics, phthalate-sensitive materials, or exemption claims may require deeper material declarations, targeted test reports, or engineering review.

The intake record should make the restricted-substance check explicit. RoHS Annex II sets maximum concentration values by weight in homogeneous materials for lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP) at 0.1%, and cadmium at 0.01%. If the evidence does not reach the homogeneous-material level, state the limitation instead of treating the BOM line as closed.

Do not average a compliant material against a non-compliant material in the same component. Apply the concentration limit to each , then check whether a specific Annex III or Annex IV exemption covers the substance, application, category, and relevant validity conditions. An exemption for one solder, coating, or application does not clear the rest of the component.

Treat the four phthalates as part of current Annex II coverage. Their restriction applied from 22 July 2019 for most and from 22 July 2021 for medical devices and monitoring and control instruments, subject to the Directive's cable, spare-part, and toy carve-outs. A declaration covering only the original six substance groups does not establish current ten-substance coverage.

  • Ask suppliers for the exact part number, revision, declaration date, substance coverage, exemption number if used, and whether the declaration covers all supplied variants.
  • Separate supplier declarations, full material declarations, test reports, exemption justifications, and engineering assumptions so reviewers can see the evidence basis.
  • Reject stale or ambiguous evidence when it does not cover the part revision, the supplied configuration, the relevant substance list, or the claimed exemption.
  • Escalate to testing or supplier corrective action when a material is unknown, evidence conflicts, or a restricted substance is plausible in a .
Recommended next step

Review the BOM evidence before release

Convert supplier declarations, material records, exemption claims, and test decisions into a RoHS evidence pack that supports technical documentation, release reviews, and authority responses.

Section 3

Close the loop into the RoHS technical file

The workflow is finished only when the BOM evidence can be traced into the RoHS technical documentation and the EU declaration decision. Manufacturers must draw up technical documentation, carry out the internal production control procedure, draw up the EU declaration of conformity when conformity is demonstrated, affix CE marking, and keep the technical documentation and EU declaration for 10 years after the has been placed on the market.

Use EN IEC 63000:2018 as the technical-documentation anchor where applicable. Commission Implementing Decision (EU) 2020/659 lists EN IEC 63000:2018 for technical documentation used to assess materials, components, and with respect to hazardous-substance restrictions, and the Commission harmonised-standards page explains that RoHS harmonised-standard references are published through Commission implementing decisions.

EN IEC 63000 is a voluntary documentation standard, not a rule that every material must be laboratory-tested. Close a line when the combined supplier information, material knowledge, exemption evidence, prior testing, and risk assessment resolve the question. Escalate when the evidence is missing, stale, contradictory, outside the supplied revision, or unable to distinguish a screened element from the regulated substance form.

  • Store a scope and role memo, BOM evidence matrix, supplier evidence files, restricted-substance decisions, exemption register, test-plan rationale, test reports where used, and unresolved assumptions.
  • Link each accepted evidence item to the exact BOM line, material concern, supplier revision, source date, reviewer, and release decision.
  • Trigger review after part changes, supplier changes, exemption expiry or renewal activity, standard-reference changes, non-conforming product findings, recalls, complaints, or authority requests.
  • For importers and distributors, record the checks performed on CE marking, required documents, manufacturer and importer details, and access to conformity documentation.
Primary sources

References and citations

eur-lex.europa.eu4 citations
Referenced sections
  • Binding consolidated RoHS source for definitions, scope, restricted-substance thresholds, exemptions, technical documentation, EU declaration, CE marking, and economic-operator obligations.
  • Binding consolidated RoHS source for definitions, economic-operator roles, scope, restricted substances, technical documentation, EU declarations, and CE marking.
  • Binding consolidated RoHS source for Annex II restricted substances, maximum concentration values, exemptions, and conformity obligations.
Show 1 more
  • Binding consolidated RoHS source for technical documentation, EU declaration, CE marking, manufacturer, importer, and distributor obligations.
"maximum concentration values tolerated by weight in homogeneous materials"
More quoted passages
"homogeneous material means one material of uniform composition throughout"
"keep the technical documentation and the EU declaration of conformity for 10 years"
data.europa.eu2 citations
Referenced sections
  • Official source for EN IEC 63000 as RoHS technical-documentation standard.
  • Official source listing EN IEC 63000:2018 for RoHS technical documentation for materials, components, and EEE.
"technical documentation required for assessing materials"
More quoted passages
"technical documentation required for assessing materials, components and electrical and electronic equipment"
single-market-economy.ec.europa.eu2 citations
Referenced sections
  • Commission page for RoHS harmonised standards, Official Journal references, and standard-reference updates.
  • Commission page for RoHS harmonised standards and Official Journal references.
"references of harmonised standards are published"
environment.ec.europa.eu2 citations
Referenced sections
  • Commission implementation page covering RoHS exemption procedures, assessment studies, and decision timing context.
  • Commission implementation page covering RoHS exemptions, applications, assessment studies, and the exemption decision process.
"The RoHS Directive allows for exemptions from its restrictions"
eur-lex.europa.eu
Referenced sections
  • General EU product-law guidance for economic-operator responsibilities, CE marking, EU declarations, conformity assessment, and market surveillance concepts.
"The manufacturer is responsible for the conformity assessment"
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