Eu Rohs Compliance Services
EU RoHS compliance services should deliver a traceable route from product intake to a defensible EU declaration of conformity—not just a laboratory report. The manufacturer retains legal responsibility even when a coordinator gathers evidence, manages testing and drafts the file.
Fix the product, scope and owner before ordering tests
First record the model, version, intended function, EU first-placement date, manufacturer, importing entity, target Member States, BOM and current suppliers. Check whether the item is electrical/electronic equipment under Articles 2–3 and Annex I; document any exclusion rather than assuming that an industrial or custom-made item is outside scope. Check cable and spare-part rules and any claimed Annex III/IV exemption by exact application, product category and status. Medical-device questions may require a separate product-specific review.
- Classify every marketed model and its accessories; distinguish components from finished EEE.
- Identify the legal manufacturer; a private-label importer can acquire manufacturer obligations under Article 11.
- Freeze a dated BOM and supplier/material map; mark missing declarations and substitutions.
Six execution gates: input, evidence, tests, file, declaration, release
An accountable coordinator can operate the following project gates; they are a service process, not a statutory six-step filing procedure.
| Stage | Execution decision | Deliverable |
|---|---|---|
| 1 · Intake | Confirm EEE scope, actors, model variants and exemptions. | Signed scope and role register. |
| 2 · Collect | Request BOM, part numbers, supplier declarations and underlying composition/test evidence. | Traceability matrix with gaps. |
| 3 · Decide | Rank homogeneous-material risks and choose supplier remediation, screening or targeted analysis. | Approved evidence/test plan. |
| 4 · Verify | Commission suitable laboratory work where needed; link each report to material, lot, revision and limit. | Resolved exceptions and test decisions. |
| 5 · Compile | Build technical documentation, internal production-control record and Annex VI EU declaration draft. | Versioned dossier and review log. |
| 6 · Release | Manufacturer signs declaration and authorises CE marking after all applicable EU regimes pass. | Documented release and change-control owner. |
Choose evidence and testing by material risk
Annex II currently lists ten restricted substances: lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP at 0.1% by weight in each homogeneous material; cadmium at 0.01%. A whole-product average is not the legal test. Annex II also contains targeted transitional rules, including for certain earlier products, cables, spare parts and toys. Evidence is assessed for the actual application and date. EN IEC 63000:2018 is the cited harmonised documentation standard; it is a means of demonstrating compliance, not a separate law demanding universal third-party tests.
| Evidence signal | Action | Release condition |
|---|---|---|
| Complete, current supplier material evidence | Check scope, substance coverage, material identity and supplier-change controls; record why it is credible. | Use if sufficient for the specific risk. |
| Unknown solder, plating, cable jacket or recycled polymer | Request composition, targeted laboratory analysis and/or replacement; XRF is screening, not a universal phthalate test. | Hold affected materials until resolved. |
| Report from another model or older revision | Reconcile BOM, homogeneous material and lot differences; retest if equivalence cannot be justified. | Do not extrapolate automatically. |
| Claimed RoHS exemption | Match exact Annex III/IV wording, category, conditions and current expiry/renewal status. | No reliance on a generic exemption claim. |
Trace each RoHS material decision through the technical file
Arrange evidence so a market-surveillance officer can follow product → BOM revision → homogeneous material → supplier statement / analysis → exemption, if any → conclusion. Keep dated records of risk assessment, sample selection, lab methods/limits, unresolved issues, supplier actions, responsible review and production controls. For a mixed-regime product, a common technical file is possible but RoHS evidence must remain identifiable.
- Controlled product description, drawings, variant list and BOM; evidence coverage per component/material.
- Substance matrix and qualified exemption register with dates, legal references and scope.
- Supplier declarations, laboratory reports, material-risk rationale and corrective actions.
- Internal production-control checks, EU declaration of conformity and traceability/marking records.
What is—and is not—filed under RoHS
For the ordinary RoHS conformity route there is no general EU-level pre-market RoHS registration, authority submission or compulsory notified-body RoHS certificate. “Filing” here means internally compiling, approving, retaining and making the dossier available to competent national authorities on reasoned request. Do not confuse this with separate filing duties under another product regime. Article 7 requires the manufacturer to retain the technical documentation and EU declaration for 10 years after placing the EEE on the market. A separate application to add, renew or revoke an Annex III/IV exemption under Article 5(3) is a Commission procedure, not routine product filing.
- Complete internal production control under Module A of Decision 768/2008/EC.
- Manufacturer issues an up-to-date EU declaration following Annex VI; translate it as required by destination Member State.
- Place CE marking in accordance with Article 15 before marketing; verify any additional applicable legislation separately.
Responsibility and supplier-to-importer handoffs
The manufacturer owns design compliance, technical documentation, declaration and production consistency (Article 7). A coordinator or laboratory may prepare evidence but cannot replace that responsibility. The importer checks conformity assessment, file, CE marking and required documents before EU placement (Article 9); a distributor checks applicable documents and marking (Article 10). An authorised representative acts within a written mandate but cannot be delegated product design compliance or preparation of technical documentation under Article 8. Record who requests supplier data, who approves deviations, who signs, and who holds records.
Operational handoffs (not a transfer of legal responsibility):
| Party | Execution handoff | Approval or retained evidence |
|---|---|---|
| Material supplier | Provide part/revision-linked material declarations and supporting analytical data. | Identifiable material, supplier, revision and covered substances. |
| Service coordinator | Log missing items, commission appropriate tests, link results to the BOM and prepare a versioned dossier. | Open-issue register, tested-material map and review trail; no substitution for manufacturer sign-off. |
| Legal manufacturer | Approve the assessment and Module A controls, issue the EU declaration, authorise CE release. | Signed declaration, released model/BOM revision and 10-year dossier custody. |
| EU importer | Before placing on the market, verify the manufacturer’s assessment/file, CE marking, required documents and identification. | Dated verification and escalation of any identified nonconformity. |
Importer recordkeeping is separate: under Article 9(g), the importer retains a copy of the EU declaration of conformity for 10 years after placing the EEE on the market and ensures that the technical documentation can be provided to market-surveillance authorities on request. The importer must also provide its name and contact address as required by Article 9(d).
Go, hold or stop an EEE model based on RoHS evidence
No product moves to market merely because an XRF screen passed. Apply an explicit release gate to each model and relevant variant.
| Status | Minimum evidence | Decision |
|---|---|---|
| GO | Applicable scope and exemptions checked; evidence supports each material; Module A completed; signed declaration and CE/traceability requirements met. | Manufacturer releases the documented configuration. |
| HOLD | Missing suppliers, uncertain exception, incomplete phthalate coverage, mismatched revisions or outstanding lab analysis. | Obtain evidence or amend design; no RoHS release. |
| STOP / REMEDIATE | Confirmed excess over applicable homogeneous-material limit without valid exemption, or a known mismatch in legal responsibility. | Correct or replace; reassess and repeat affected checks before release. |
Revalidate RoHS evidence after BOM and supplier changes
Changes to a solder alloy, coating, polymer, cable vendor, assembly site or regulated substance/exemption can invalidate prior evidence. Tie purchase-order substitutions and engineering changes to a RoHS impact check: map affected material, seek new supplier evidence, retest proportionately, update the dossier and declaration where relevant, and record release approval. If non-compliance is detected after placement, assess corrective action, withdrawal/recall and authority notification under the relevant operator duties.
Hand off RoHS strategy, analytical methods and other EU regimes
This page owns execution and handoffs. For strategic classification engage the RoHS advisory workstream; for sample design and analytical methods use the RoHS testing workstream; for parallel CE/REACH/other product obligations use the EU market-access workstream. A standalone RoHS dossier does not demonstrate compliance with every EU requirement.
RoHS evidence, filing, exemptions and revisions: five questions
Does every SKU need a separate ten-substance laboratory test?
No blanket third-party test obligation follows from the RoHS Module A route. Group truly equivalent materials only with documented justification; target missing or risky evidence and never infer phthalate compliance from XRF alone.
Can a supplier RoHS declaration be the whole technical file?
Not by itself for a complex product. Link it to an identified part/material, current revision, the covered substances, credibility review and any required additional evidence.
Where do we submit the RoHS certificate?
There is no general EU RoHS certificate submission or pre-market RoHS filing. The manufacturer retains the file and declaration and provides them to a competent authority when properly requested.
Can an exemption rescue a failed solder result?
Only if the exact current Annex III/IV entry covers that use, category and relevant date. Record the evidence and expiry or pending renewal position before release. For a renewal, verify that the application was made at least 18 months before expiry: Article 5(5) preserves the existing exemption until the Commission decides. An application for a new exemption does not itself authorise use.
What if a non-EU supplier changes a cable material after approval?
Block automatic reuse of the old evidence, identify affected lots/models, request revised material information, test if necessary and re-authorise the configuration before further placements.
Verify the RoHS legal route, Module A and exemptions
Official texts: