EU RoHS Directive Technical Documentation and CE

The RoHS evidence file should show why the EEE meets Article 4 restricted-substance requirements, including how each homogeneous material was assessed, the supplier evidence, exemptions if used, and any testing or assessment relied on.

Decision (EU) 2020/659 identifies EN IEC 63000:2018 as the harmonised standard for technical documentation used to assess materials, components, and electrical and electronic equipment against hazardous-substance restrictions. That standard supports the technical documentation record; it is not itself the EU declaration of conformity and it is not the act of affixing CE marking.

Under Article 7 of Directive 2011/65/EU, the manufacturer draws up the required technical documentation, carries out internal production control under Module A of Decision No 768/2008/EC or has it carried out, then draws up the EU declaration of conformity and affixes CE marking when compliance has been demonstrated.

Module A is manufacturer-controlled conformity assessment; RoHS does not generally require a notified body or third-party certificate. Using EN IEC 63000 is voluntary, but a harmonised standard whose reference is published in the Official Journal can support the Article 16 presumption of conformity. The binding duties and Annex II limits still come from the Directive and national implementing law.

A useful RoHS file lets a reviewer trace the finished product back to material-level restrictions. Start with the exact product identity, category, role, market-placement date, BOM or component list, homogeneous-material assumptions, and the restricted substances in Annex II.

Then attach the evidence that supports each material or component decision. Depending on risk and supplier maturity, that may include supplier declarations, material declarations, exemption rationale, test reports, or IEC 62321-family test evidence. If a harmonised standard or technical specification changes, Article 7 requires manufacturers to take those changes into account for series production.

Do not treat CE marking as proof that the underlying RoHS file is complete or as an authority approval. The manufacturer uses the mark to indicate conformity with applicable Union harmonisation legislation that provides for CE marking; the technical documentation is the inspectable record that explains the assessment path.

Apply Annex II at homogeneous-material level: 0.01% by weight for cadmium and 0.1% for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP. If an exemption is used, record the exact Annex III or IV wording, EEE category, application, validity status, affected BOM line, and evidence showing that the product facts fit the entry.

The manufacturer owns RoHS design-and-manufacture conformity, technical documentation, internal production control, the EU declaration of conformity, CE marking, series-production controls, non-conforming product records, corrective action, and authority responses.

Importers do not simply collect a supplier certificate. Before placing EEE from a third country on the Union market, they must ensure that the manufacturer carried out the appropriate conformity assessment, drew up technical documentation, applied CE marking, supplied required documents, and met product-identification and contact-address duties. Importers must also keep a copy of the EU declaration for 10 years and ensure technical documentation can be made available on request.

Distributors act with due care when making EEE available. They verify CE marking, required documents in the relevant language, manufacturer and importer identification, and they must not make EEE available if they know or have reason to believe it is not in conformity with Article 4.

Before release, confirm that the evidence file, declaration, marking, labels, and operator records tell the same story. The product identity in the technical file should match the EU declaration, CE-marked finished product, packaging or accompanying documents, and importer/distributor records where applicable.

Article 13 requires the EU declaration to state that Article 4 requirements have been met, follow the Annex VI model structure, stay updated, and be translated into required Member State languages. Article 15 requires CE marking to be visible, legible, and indelible on the finished EEE or data plate, or on packaging and accompanying documents when product marking is not possible or warranted because of the nature of the EEE.

Use a release gate: do not ship CE-marked EEE until the RoHS technical documentation supports the declaration, the operator role is clear, and the 10-year retention and authority-response path is assigned.