RoHS 3 (2011/65/EU)
Restriction of Hazardous Substances in Electrical and Electronic Equipment
Standard Introduction
The Restriction of Hazardous Substances Directive (RoHS 3), formally EU Directive 2011/65/EU as amended by 2015/863/EU, restricts the use of ten hazardous substances in electrical and electronic equipment (EEE) sold in the European Union. Originally introduced in 2006 with six restricted substances, RoHS was updated in 2019 to add four phthalates, bringing the total to ten. The directive covers products across eleven categories including consumer electronics, IT equipment, lighting, household appliances, medical devices, and monitoring instruments.
RoHS compliance requires manufacturers to prepare technical documentation, issue a Declaration of Conformity, and affix CE marking. The restricted substances include lead (0.1%), mercury (0.1%), cadmium (0.01%), hexavalent chromium (0.1%), PBB (0.1%), PBDE (0.1%), and four phthalates — DEHP, BBP, DBP, and DIBP (each 0.1%). Specific exemptions exist for applications where technically viable alternatives are not yet available, but these have expiry dates. RoHS works alongside the REACH regulation and WEEE directive as part of the EU's broader approach to managing hazardous substances in products.
10 Restricted Substances
Restricts lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, and four phthalates (DEHP, BBP, DBP, DIBP) in electrical and electronic equipment.
Maximum Concentration Values
Each restricted substance has a maximum concentration value (MCV) by weight in homogeneous materials — typically 0.1% (1000 ppm) except cadmium at 0.01% (100 ppm).
Broad Product Scope
Covers 11 categories of EEE including household appliances, IT equipment, lighting, toys, medical devices, and monitoring/control instruments.
list_alt Restricted Substances
- Lead (Pb) — max 0.1%
- Mercury (Hg) — max 0.1%
- Cadmium (Cd) — max 0.01%
- Hexavalent chromium (Cr VI) — max 0.1%
- Polybrominated biphenyls (PBB) — max 0.1%
- Polybrominated diphenyl ethers (PBDE) — max 0.1%
- Bis(2-ethylhexyl) phthalate (DEHP) — max 0.1%
- Butyl benzyl phthalate (BBP) — max 0.1%
Who Needs to Comply?
Manufacturers, importers, and distributors placing electrical and electronic equipment (EEE) on the EU market. Applies to all 11 EEE categories including large/small household appliances, IT equipment, lighting, and toys.
Key Requirements
Substance Testing & Compliance
Test products and components to verify restricted substance concentrations are below MCVs. Use XRF screening and confirmatory wet chemistry analysis per IEC 62321 test methods.
Technical Documentation
Maintain technical documentation demonstrating RoHS compliance for at least 10 years after the product is placed on the market. Include test reports, material declarations, and supply chain evidence.
EU Declaration of Conformity
Prepare and sign an EU Declaration of Conformity specifically referencing Directive 2011/65/EU. Affix the CE mark to the product indicating RoHS compliance alongside other applicable directives.
Supply Chain Due Diligence
Obtain material declarations and compliance certificates from component suppliers. Establish procedures to manage substance restrictions throughout the supply chain.
Penalties & Enforcement
Enforcement varies by EU member state. Penalties include product recalls, customs seizure, market withdrawal, and fines. In Germany, violations can result in fines up to EUR 100,000. Products may be listed on the EU RAPEX safety alert system.