EU RoHS Directive Compliance

Start with the product as it will be placed or made available on the EU market. Directive 2011/65/EU applies to EEE in the Annex I categories, including household appliances, IT and telecommunications equipment, consumer equipment, lighting equipment, electrical and electronic tools, toys and sports equipment, medical devices, monitoring and control instruments, automatic dispensers, and other EEE not covered by earlier categories.

Then document any exclusion separately. The Directive lists exclusions such as equipment designed to be sent into space, large-scale stationary industrial tools, large-scale fixed installations, certain means of transport, non-road mobile machinery made available exclusively for professional use, active implantable medical devices, qualifying photovoltaic panels, certain business-to-business research and development equipment, and pipe organs.

RoHS concentration limits are not applied to the finished product as a whole. Article 4 and Annex II work at homogeneous-material level, so the evidence package needs to trace restricted substances through materials, components, subassemblies, coatings, cables, and spare parts.

The current Annex II list covers lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP). Cadmium has a 0.01 percent maximum concentration value by weight in homogeneous materials; the other listed substances have 0.1 percent values. The four phthalates were added through Commission Delegated Directive (EU) 2015/863, with specific application and carve-out language for medical devices, monitoring and control instruments, cables, spare parts, and toys already covered by REACH Annex XVII entry 51.

Manufacturers must design and manufacture covered EEE in accordance with Article 4, draw up required technical documentation, carry out internal production control, issue an EU declaration of conformity when compliance is demonstrated, and affix CE marking on the finished product. Manufacturers must keep the technical documentation and EU declaration of conformity for 10 years after the EEE has been placed on the market.

Importers and distributors also need role-specific checks. Importers must place only compliant EEE on the Union market and verify, before placing EEE on the market, that the manufacturer has completed the conformity assessment, drawn up technical documentation, applied CE marking, and supplied required documents. Distributors must act with due care, including checking CE marking and required documents before making EEE available.

RoHS exemptions are narrow and time-sensitive. Article 4 does not apply to applications listed in Annexes III and IV, but those entries carry scopes, categories, and dates that must be checked against the exact use case and current consolidated text. A timely renewal request can keep an existing exemption valid until the Commission decides; an application for a new exemption does not permit non-compliant EEE to be placed on the market before the exemption is granted.

Treat every engineering change, supplier change, material substitution, standard change, complaint, non-conformity, recall, or authority request as a trigger to reopen the RoHS file. Article 7 requires manufacturers to account for changes in product design or characteristics and changes in harmonised standards or technical specifications by reference to which conformity is declared.