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The useful record is not a generic RoHS certificate. It is a material-level trail that shows how the product was split, which Annex II threshold was applied, what declaration or test evidence supports the conclusion, and which exemptions or carve-outs were considered where relevant.

EN IEC 63000:2018 is the harmonised technical-documentation standard referenced for assessing materials, components, and electrical and electronic equipment under Directive 2011/65/EU. Use it as the organizing frame for supplier declarations, test reports, risk assessment, and conformity records.

The most common mistake is treating a supplier's broad product declaration as proof for every material in the part. That declaration may be useful, but it should still map to the homogeneous materials and Annex II thresholds that RoHS actually uses.

Another mistake is testing a mixed sample and treating the result as decisive when one high-risk separable material could be diluted by lower-risk material mass. If the legal question is material-level, the evidence should stay material-level.

Article 9 of Directive 2011/65/EU makes the importer a gatekeeper for imported EEE. The importer must place only EEE that complies with RoHS on the Union market, and must check the manufacturer's conformity work before the first EU market placement.

The practical pre-placement check is not just a supplier questionnaire. It should verify the manufacturer's conformity assessment, technical documentation, CE marking, required documents, manufacturer identification and address details, importer identification and contact address, and any facts that could show the EEE is not in conformity with Article 4 substance restrictions.

The importer must keep a copy of the EU declaration of conformity for 10 years after placing the EEE on the market and must ensure the technical documentation can be made available to market surveillance authorities on request. That makes the import file an evidence index as much as a purchasing record.

A useful importer file links the exact product identity to the EU declaration, technical documentation access route, CE marking check, manufacturer and importer traceability markings, supplier material evidence, and any exemption or change-control assumptions used to support the RoHS conclusion.

Article 9 is explicit: if an importer considers or has reason to believe that EEE is not in conformity with Article 4, the importer must not place it on the market until it has been brought into conformity. The importer must also inform the manufacturer and market surveillance authorities.

Use that rule as an escalation trigger. A missing or mismatched EU declaration, missing CE marking, inaccessible technical documentation, unexplained supplier evidence gap, unsupported exemption claim, product change, or credible restricted-substance concern should pause placement until the evidence is corrected.

Treat imported EEE review as a release gate tied to the exact product being placed on the EU market. The decision should be readable by procurement, logistics, quality, legal, and product teams without relying on undocumented supplier conversations.

The strongest record is short but specific: what product was imported, who the manufacturer and importer are, what DoC and technical-file evidence was checked, what supplier evidence supports substance compliance, what issues were found, and who approved release or blocked placement.

Article 4 of Directive 2011/65/EU points to Annex II for the maximum concentration values tolerated by weight in homogeneous materials. That means the threshold is checked against each separable material, coating, solder, plastic, alloy, wire, or other homogeneous material, not against the finished product as a whole.

The practical split is simple but easy to misapply: cadmium has the tighter 0.01% limit; the other Annex II substances are listed at 0.1%. The four phthalates added by Delegated Directive (EU) 2015/863, DEHP, BBP, DBP, and DIBP, also sit at 0.1% in Annex II.

Evidence should let a reviewer trace the conclusion from the finished EEE down to the homogeneous materials that matter for Annex II. A supplier statement that only says "RoHS compliant" is weak if it does not identify covered parts, materials, substances, exemptions, or the basis for the declaration.

The technical file should connect the BOM, homogeneous-material list, material declarations, substance risk assessment, selected test reports, exemption register, EU declaration of conformity, and change-control history. Manufacturers must keep the technical documentation and EU declaration of conformity for 10 years after the EEE has been placed on the market.

Use the limits as a material-level screening question before release, supplier approval, design change, or exemption review. The output should be a clear pass, exemption-supported, or nonconforming-material decision for each material-substance pair.

Most mistakes come from using the right percentage at the wrong level of detail. Annex II limits are material-level values, so a finished-product calculation can hide a nonconforming coating, solder, plastic, or cable material.

Start with the legal entry, not with a supplier statement. RoHS exemptions are tied to a listed application in Annex III or Annex IV, and the Directive allows those lists to be adapted to scientific and technical progress.

For each product that depends on an exemption, record the Annex entry number, exact wording, EEE category, restricted substance, homogeneous material or component use, expiry date, renewal status, and technical-file evidence. If the application no longer matches the exemption wording, treat the product as needing a new compliance path.

Do not build a current-status table unless it is sourced from the current consolidated Directive, the official Commission exemptions list, or the delegated directive that changed the relevant entry.

Article 5 sets the renewal clock. A renewal application must be submitted no later than 18 months before the exemption expires, and the existing exemption remains valid until the Commission takes a decision on that renewal application.

The Commission implementation page states that RoHS exemption decisions currently take 18 to 24 months from the application date. It also describes the evaluation sequence: technical and scientific assessment with stakeholder consultation, draft delegated act feedback, WTO Technical Barriers to Trade notification, and European Parliament and Council scrutiny.

The maximum validity period depends on the Annex and category. For Annex III exemptions listed as at 21 July 2011, unless a shorter period is specified, RoHS sets 5 years for categories 1 to 7 and 10, 7 years for categories 8 and 9 from the relevant Article 4(3) dates, and 5 years for category 11 from 22 July 2019. Annex IV exemptions listed as at 21 July 2011 have a renewable maximum validity period of 7 years from the relevant Article 4(3) dates unless a shorter period is specified.

A useful record should let a reviewer see why the product can still be placed on the EU market, or why it needs redesign before the exemption lapses. Keep the decision tied to the exact exemption wording and product configuration.

For technical documentation, EN IEC 63000 is the harmonised standard cited for assessing electrical and electronic products with respect to restricted substances. Use it as the structure for supplier evidence, material declarations, test reports where needed, and the rationale for relying on an exemption.

The main risk is treating an old exemption reference as a standing permission. RoHS exemptions can be renewed, amended, or deleted, and the Commission reassesses them against substitution, health, environmental, consumer-safety, socioeconomic, and innovation considerations.

A supplier declaration is not enough if it only says the part is RoHS compliant. The declaration must connect the part, material, substance, and exemption wording that the finished product relies on.

Start with the exact role of the part. RoHS defines a spare part as a separate part of EEE that can replace a part of EEE, where the EEE cannot function as intended without it and functionality is restored or upgraded when the part is replaced.

Article 4(4) keeps the restriction from applying to cables or spare parts used to repair, reuse, update functionality, or upgrade capacity of specified legacy EEE. The relevant legacy dates are: EEE placed on the market before 1 July 2006; medical devices before 22 July 2014; in vitro diagnostic medical devices before 22 July 2016; monitoring and control instruments before 22 July 2014; industrial monitoring and control instruments before 22 July 2017; and other EEE newly brought into RoHS scope before 22 July 2019.

There is also a narrow exemption for EEE that benefited from an exemption and was placed on the market before that exemption expired, but only as far as that specific exemption is concerned. That makes the exemption entry, expiry date, product placement date, and spare-part use case essential facts.

Article 4(5) is narrower than the general spare-part transition rule. It applies only where reuse happens in auditable closed-loop business-to-business return systems and the reuse of spare parts is notified to the consumer.

For reused spare parts, the recovered-from and used-in dates must both fit the Directive. Reused parts recovered from EEE placed on the market before 1 July 2006 may be used in EEE placed on the market before 1 July 2016. Reused parts recovered from medical devices or monitoring and control instruments placed before 22 July 2014 may be used in EEE placed before 22 July 2024. Reused parts recovered from in vitro diagnostic medical devices placed before 22 July 2016 may be used in EEE placed before 22 July 2026. Reused parts recovered from industrial monitoring and control instruments placed before 22 July 2017 may be used in EEE placed before 22 July 2027. Reused parts recovered from other EEE that was outside RoHS 1 scope and placed before 22 July 2019 may be used in EEE placed before 22 July 2029.

Article 4(6) excludes applications listed in Annex III and Annex IV from the Article 4(1) restriction. Those exemptions are application-specific and time-limited; they should not be treated as product-wide approval.

Some Annex IV entries expressly mention spare parts. For example, Annex IV includes an entry for lead, cadmium, hexavalent chromium, and PBDE in recovered spare parts used for repair or refurbishment of certain medical devices, in vitro diagnostic medical devices, or electron microscopes, with auditable closed-loop B2B reuse and customer notification. That entry expired on 21 July 2021 for medical devices other than in vitro diagnostic medical devices, 21 July 2023 for in vitro diagnostic medical devices, and 21 July 2024 for electron microscopes and their accessories.

Annex IV also includes a later entry for DEHP, BBP, DBP, and DIBP in spare parts recovered from and used for repair or refurbishment of medical devices, in vitro diagnostic medical devices, and their accessories, under the same closed-loop and notification conditions. The consolidated Directive lists that entry as expiring on 21 July 2028.

A useful spare-parts decision file should let a reviewer re-run the RoHS logic without interviewing the service team. The key facts are the spare part identity, supported EEE identity, product category, placement dates, whether the part is new or recovered, and the exact legal route used.

For ordinary compliant spare parts, keep supplier declarations, material declarations, restricted-substance assessment, and any test evidence used to assess homogeneous materials. For transition or reused-part cases, add placement-date evidence, return-system controls, customer notification proof, and the Annex exemption register if an exemption is being relied on.

A product is in RoHS scope when it meets the Directive's definition of electrical and electronic equipment, falls within one of the Annex I categories, is placed or made available on the EU market, and is not covered by an Article 2(4) exclusion.

The definition is broader than products whose main purpose is electrical. The Commission FAQ explains that a product can be EEE where an electric function is only a minor but intended and integral function, such as a gas cooker with an electrical clock or petrol-powered equipment with an electric spark for ignition.

Do not stop at a broad product label. A finished product, a separately marketed cable, a component sold as a finished EEE product, or a consumable with an EEE constituent can each need its own RoHS scope analysis.

RoHS scope often turns on how the product is placed on the market, not only on what it contains. The same physical item may be assessed differently if it is sold as a finished EEE product, built into another EEE, sold only as a component for integration, or designed solely for an excluded application.

The Commission FAQ also draws a distinction between electrical parts that are integrated into the product's intended function and detachable EEE that can be separated and used as a fully functional product. That distinction matters for furniture with lighting, cards and boards, consumables, RFID tags, and similar mixed products.