Eu Rohs Compliance Consultant

Decide the RoHS route before requesting tests

Directive 2011/65/EU covers electrical and electronic equipment (EEE) in Annex I, including category 11, subject to the legal definition and exclusions in Article 2(4). A battery, motor or connected feature does not settle classification on its own. Document the intended electrical function, voltage, configuration and any claimed exclusion; specialist cases require fact-specific analysis.

Definition and market-date gate. First test whether the item depends on electric currents or electromagnetic fields to work properly and has a voltage rating not exceeding 1,000 V AC or 1,500 V DC (Article 3(1)). Separately identify its first placing on the EU market, rather than treating manufacture or retail-sale dates as interchangeable. For Article 2(4)(c), also establish that the specifically designed item is intended to be installed as part of the excluded or out-of-scope equipment. These facts screen applicability; they do not alone establish an exclusion.

Two exclusions, two tests. Article 2(4)(e) addresses a qualifying large-scale fixed installation; Article 2(4)(c) separately addresses equipment specifically designed for other excluded/out-of-scope equipment, which functions only as part of it and can be replaced only by equally specifically designed equipment. Mounting an ordinary standalone controller on a fixed installation is not, by itself, an exclusion.

Legacy is not a blanket waiver. Article 4(4) addresses specified cables and spare parts linked to EEE placed on the market before category-specific cut-offs. Article 4(5) addresses reused spare parts only under its own dates and auditable closed-loop business-to-business return and consumer-notification conditions. Refurbishing or reselling a complete EEE does not itself establish either exception.

Assign RoHS duties to manufacturers, importers and distributors

Articles 7–11 allocate different tasks. Under RoHS the ordinary manufacturer route is internal production control (Module A), technical documentation, EU declaration of conformity (DoC) and CE marking; RoHS itself does not generally require a notified-body certificate or universal third-party test for every product.

• Manufacturer: determine compliance, document the assessment, issue the EU DoC, affix CE marking and retain technical documentation and the DoC for 10 years after placing on the market.
• Importer: before EU placement, verify the manufacturer’s assessment, documentation and CE marking; retain a DoC copy for 10 years and ensure the technical file can be provided on request.
• Distributor: perform the Article 10 due-care checks; an importer or distributor using its own brand or making a compliance-relevant modification may assume manufacturer obligations under Article 11.

Importer hold-and-notify decision. If an importer considers or has reason to believe that EEE does not meet Article 4, it must not place that EEE on the market until conformity is achieved and must inform the manufacturer and market-surveillance authorities under Article 9(c). If, after placing, the importer considers or has reason to believe the EEE is non-conforming, it must immediately take the necessary corrective measures (or withdraw or recall it, as appropriate) and immediately inform the competent national authorities under Article 9(f). A missing third-party laboratory certificate alone is not the Article 4 failure test.

Apply limits to homogeneous materials, not the whole product

Annex II restricts lead, mercury, hexavalent chromium, PBB, PBDE and each of the four phthalates DEHP, BBP, DBP and DIBP to 0.1% by weight per homogeneous material; cadmium is limited to 0.01%. These are material-level limits, not a permissible average for the assembled device. Annex II separately provides phase-in and spare-part provisions for the four phthalates and a specific exception for DEHP, BBP and DBP in toys already covered by REACH Annex XVII entry 51. Other legacy cables/spare-part conditions are in Article 4(4)–(5); none is automatic.

Rank evidence gaps and decide what can be reused

Use EN IEC 63000:2018 as a recognised harmonised framework for technical documentation. It supports a presumption of conformity for the requirements covered, not a guarantee that a supplier statement is true. Assess each material or component for origin, substance coverage, age, revision, exemption basis and foreseeable risk.

A practical triage uses three questions for every BOM line: What substance risk exists? How credible is the current evidence? What impact would a failure have on launch or redesign? Rank unknown high-risk materials before re-testing well-documented low-risk items. This is an advisory prioritisation model, not a statutory scoring system.

Sequence supplier inquiries and targeted testing

Decide testing only after scope and evidence mapping. Laboratories can support the assessment, but a passing finished-product screening result does not by itself establish compliance of every homogeneous material. IEC 62321-3-1:2026 describes XRF screening for total chromium and total bromine, among other elements. Those totals do not by themselves identify the restricted Cr(VI), PBB or PBDE species. Select material samples and confirmatory methods to resolve the specific uncertainty.

1. Freeze the exact model, revision, bill of materials and EU placing-on-market scenario.
2. Ask suppliers for declarations or relevant reports tied to the actual materials, finishes and supply chain.
3. Reuse credible, sufficiently current evidence; record why the covered components are equivalent.
4. Commission risk-targeted screening or confirmatory analysis for unresolved materials, then close findings by substitution, valid exemption or defensible evidence.

Recheck Annex III/IV exemptions after BOM and design changes

Annex III and Annex IV exemptions are application-specific, may be category-specific and can change or expire. For an existing exemption with a duly submitted renewal request, Commission guidance explains continued validity pending its decision; an application for a new exemption does not by itself permit placing otherwise non-compliant EEE on the EU market. Check the entry, category, renewal timing, status and operative legal text.

• Pin each claimed exemption to its exact entry, application, equipment category and relevant market date.
• Check amendment, renewal and expiry status immediately before the compliance decision; save the version checked.
• Reopen the assessment after a material substitution, supplier change, design revision, exemption amendment or changed legal scope.

Four decision outputs from a RoHS advisory review

The advisory outcome should be a reasoned route decision, not a promise of instant approval. Before commissioning implementation, obtain the following four outputs:

1. A scope memo stating category, Article 2 exclusions considered, economic operator and unresolved classification facts.
2. A version-controlled BOM-to-evidence matrix with accepted records, missing homogeneous materials and disputed exemptions.
3. A risk-ranked action register separating supplier inquiry, evidence reuse, laboratory work, substitution and legal interpretation.
4. A release gate identifying who signs the EU DoC, what remains open and what changes trigger reassessment.

For implementation rather than advice, see EU RoHS compliance services, RoHS testing and analytical evidence, EU product market-access coordination, RoHS strategy for medical devices.

RoHS questions about evidence, CE marking and own branding

EU RoHS law, Commission guidance and technical sources

• Directive 2011/65/EU, consolidated 1 July 2026
• European Commission: RoHS overview
• European Commission: exemptions and renewals
• Implementing Decision (EU) 2020/659 (EN IEC 63000:2018)
• IEC: IEC 62321-3-1:2026 — scope of XRF screening