Directive 2011/65/EU, the recast RoHS Directive, lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE) to protect human health and the environment, including the environmentally sound recovery and disposal of waste EEE (Article 1). It applies to EEE in the eleven categories of Annex I, from large and small household appliances, IT and consumer equipment, lighting and tools to toys, medical devices, monitoring instruments, automatic dispensers and, since the open scope took full effect, any other EEE not covered elsewhere, subject to the exclusions in Article 2.
Article 4 contains the core rule: EEE placed on the market, including cables and spare parts, must not contain the substances listed in Annex II above the maximum concentration values by weight in homogeneous materials, which are 0.1 % for lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE) and the phthalates DEHP, BBP, DBP and DIBP, and 0.01 % for cadmium. Annexes III and IV list time-limited exemptions for specific applications, such as mercury in certain lamps or lead in certain alloys and solders, which the Commission renews or withdraws by delegated act.
RoHS follows the New Legislative Framework. Under Article 7 manufacturers must design and manufacture in accordance with Article 4, draw up technical documentation and carry out internal production control (module A of Decision 768/2008), draw up an EU declaration of conformity and affix the CE marking; importers and distributors have the usual verification duties. The declaration of conformity therefore has to cover RoHS as well as the Low Voltage or Radio Equipment Directive, and the technical file must show how compliance with Annex II was established, typically through supplier declarations and material testing.