EU RoHS Directive Requirements

Directive 2011/65/EU applies to electrical and electronic equipment falling within Annex I categories, subject to Article 2 exclusions. The definition of EEE covers equipment dependent on electric currents or electromagnetic fields to fulfil at least one intended function, within the voltage ratings stated in Article 3.

The central duty is in Article 4: EEE placed on the EU market, including covered cables and spare parts, must not contain the Annex II restricted substances above the maximum concentration values tolerated by weight in homogeneous materials. A homogeneous material is one material of uniform composition throughout, or a combination that cannot be mechanically separated into different materials by actions such as unscrewing, cutting, crushing, grinding, or abrasion. Assess that material rather than averaging across a multi-material product.

A supplier certificate alone does not establish the finished product's conformity. The manufacturer needs a scoped product record, material-level substance evidence selected according to risk, an exact exemption check where a restricted substance exceeds a limit, and a release decision that supports the technical documentation, EU declaration of conformity, and CE marking.

Manufacturers must draw up the required technical documentation, carry out internal production control, draw up the EU declaration of conformity after compliance is demonstrated, affix the CE marking, and keep the technical documentation and EU declaration of conformity for 10 years after the EEE has been placed on the market.

The technical file should make the material-level conclusion traceable. For most products that means a controlled bill of materials (BOM), supplier declarations or material declarations, substance-risk assessment, test reports where risk justifies testing, exemption register, EU declaration of conformity, label and marking evidence, and change-control records.

Commission Implementing Decision (EU) 2020/659 publishes EN IEC 63000:2018 as the harmonised standard for technical documentation required to assess materials, components, and EEE under RoHS. Applying a cited harmonised standard is voluntary and can support presumption of conformity for the covered documentation requirement; the manufacturer still owns the product-specific Article 4 conclusion.

Annex III and Annex IV exemptions are not blanket permissions to ignore RoHS. Article 5 ties exemptions to listed applications, technical or scientific impracticability of substitution, reliability and safety considerations, substitute availability, socioeconomic impacts, and lifecycle impacts where relevant.

Exemptions are limited in time and are reassessed. The Commission implementation page states that renewal applications must be made no later than 18 months before expiry, current exemption decisions can take 18 to 24 months from application, and timely renewal requests keep existing exemptions valid until the Commission decision.

Role matters too. Importers must place only compliant EEE on the market and check that the manufacturer has drawn up technical documentation, the EEE bears CE marking, and required documents are present. Distributors must act with due care, verify CE marking and required documents, and avoid making EEE available when they know or have reason to believe it is not RoHS-conforming. An authorised representative may keep documents and cooperate with authorities under a written mandate, but Article 8 does not allow the manufacturer's duty to ensure compliant design or draw up technical documentation to be transferred into that mandate.

A product-level conclusion fails when it cannot be traced to homogeneous materials, component evidence, and the exact legal duty. A supplier statement, test report, or exemption citation is useful only when it matches the product version, material, category, market placement date, and applicable Annex wording.

Another frequent problem is stale standards and exemptions. Commission Decision 2020/659 published EN IEC 63000:2018 for RoHS technical documentation and withdrew EN 50581:2012 from the Official Journal as of the date set out in that decision. Annex III and IV entries also change through delegated acts, so verify the current consolidated text and any pending-renewal status instead of treating an old annex extract as permanent.