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.
Implementation Roadmap
Prepare scope, obligations and evidence model
Define the hazardous-substance restriction compliance program scope across electrical and electronic equipment, components, materials, suppliers, substance declarations, exemptions, technical documentation, CE marking links, and product change controls. Identify applicable legal, product, customer, certification, or market-access obligations and agree how evidence will be owned, updated, and retained.
Gap analysis and risk classification
Assess current practices against EU RoHS requirements and risk context. Review restricted substance thresholds, homogeneous material assessment, supplier declarations, material testing, exemption tracking, technical documentation, EU declaration of conformity, and change control for components and suppliers, then prioritize gaps by market-access impact, safety or environmental risk, customer exposure, and documentation readiness.
Implement controls, testing and documentation
Deploy required controls, supplier workflows, testing or assessment activities, labeling or communication steps, and technical documentation. Build traceable evidence around bill of materials, material declarations, supplier certificates, test reports, exemption justifications, technical files, declarations of conformity, change notices, and substance risk assessments.
Review, maintain and respond to changes
Complete readiness reviews and corrective actions before the technical documentation review or market surveillance review. Keep the program current after product, supplier, substance, design, regulatory, market, or incident changes.
Compliance Checklist
checklist Scope and obligations
checklist Controls and evidence
checklist Monitoring and maintenance
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.
Frequently Asked Questions
Who needs EU RoHS?
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EU RoHS is relevant for organizations whose products, services, or activities fall within electrical and electronic equipment, components, materials, suppliers, substance declarations, exemptions, technical documentation, CE marking links, and product change controls. It is commonly driven by market access, safety, environmental, customer, or regulatory obligations.
What is the main purpose of EU RoHS?
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The practical purpose is to create a repeatable program for restricted substance thresholds, homogeneous material assessment, supplier declarations, material testing, exemption tracking, technical documentation, EU declaration of conformity, and change control for components and suppliers. The program should make obligations visible, define accountable owners, and maintain evidence that remains current as products and rules change.
What should be done first?
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Start with scope. Identify which products, components, sites, suppliers, markets, and activities are covered before writing procedures or commissioning tests.
How long does implementation take?
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Implementation can take weeks for a narrow product family or many months for complex multi-market portfolios. Timing depends on testing, supplier evidence, technical documentation quality, and whether third-party assessment is needed.
What evidence is most important?
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Important evidence includes bill of materials, material declarations, supplier certificates, test reports, exemption justifications, technical files, declarations of conformity, change notices, and substance risk assessments. Authorities, auditors, customers, and test labs usually expect traceable records that connect requirements to decisions, tests, labels, and declarations.
How should suppliers be managed?
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Suppliers should provide declarations, test reports, change notifications, and traceable material or component data. High-risk suppliers need periodic review and contractual flow-down of compliance requirements.
When should the file be updated?
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Update the file after regulatory changes, design changes, supplier changes, material changes, incidents, complaints, or new market launches. Static files quickly become unreliable in product compliance.
Can this be integrated with other programs?
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Yes. EU RoHS can share supplier management, document control, risk management, test planning, labeling review, and corrective-action workflows with related quality, safety, environmental, or product-compliance programs.
Official Documentation
RoHS Directive 2011/65/EU
EUR-Lex • Full Directive Text • All EU Languages
European Commission RoHS Portal
External Link • ec.europa.eu • Official Guidance & Updates
RoHS Compliance Resources
External Link • Exemption Lists & FAQ