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2011/65/EU

In force

Restriction of Hazardous Substances Directive

Restricts ten hazardous substances — including lead, mercury, cadmium and four phthalates — in electrical and electronic equipment. Compliance is self-assessed, documented through material declarations, and forms part of the CE marking.

Read the official text

Applies to

Electrical and electronic equipment (EEE) in the 11 categories of Annex I — household appliances, IT and telecoms equipment, lighting, tools, toys with electrical functions, medical devices, monitoring instruments and, since the 'open scope' date, essentially all other EEE. Exclusions include military and space equipment, large-scale stationary industrial tools and means of transport.

Key obligations

  1. 01Ensure homogeneous materials do not exceed the Annex II maximum concentrations: 0.1% by weight for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP; 0.01% for cadmium.source
  2. 02The four phthalates (DEHP, BBP, DBP, DIBP) were added by Delegated Directive (EU) 2015/863 and apply to most EEE from 22 July 2019 (medical devices and monitoring/control instruments from 22 July 2021).source
  3. 03Carry out the internal production control procedure in line with Module A of Decision 768/2008/EC, draw up technical documentation, and keep it (with the EU Declaration of Conformity) for 10 years (Article 7).source
  4. 04Draw up an EU Declaration of Conformity and affix the CE marking to the finished product (Article 7).source
  5. 05Maintain traceability (registers of non-conforming products, product identification) and use the Annex III/IV exemptions only while they remain valid — exemptions expire after 5 years (categories 1-7, 10-11) or 7 years (categories 8-9) unless renewed.source

Conformity routes

  • Self-assessment — internal production control (Module A)Always. RoHS uses Module A of Decision 768/2008/EC only; no notified body is involved. Manufacturers typically rely on supplier material declarations and, where needed, analytical testing.source

Documentation

  • EU Declaration of ConformityRoHS is declared alongside other CE legislation; kept for 10 years.source
  • Technical documentation per EN IEC 63000Material declarations, analytical test reports and supplier certificates organised per the harmonised documentation standard.source

Marking requirements

  • Affix the CE marking to the finished EEE — RoHS conformity is one of the requirements the CE marking attests for electronics. No separate RoHS mark is required by the directive.source

Testing standards

Harmonised and designated standards lists change over time: confirm the currently cited version before testing.

EN IEC 63000IEC 62321 (unverified)

Key dates

  • 2013-01-02Transposition deadline for RoHS 2 (Directive 2011/65/EU), which recast RoHS 1 (2002/95/EC).source
  • 2019-07-22Open scope: EEE previously outside RoHS 1 must comply from this date; the four phthalate restrictions also apply to most EEE from this date.source
  • 2021-07-22Phthalate restrictions apply to medical devices (including in vitro) and monitoring and control instruments.source

Penalties

Member States set their own penalties for RoHS infringements (Article 23); they must be effective, proportionate and dissuasive.source

Further guidance

Applies to these product types

Frequently asked

Which substances does RoHS restrict?+

Ten: lead, mercury, cadmium, hexavalent chromium, the flame retardants PBB and PBDE, and the phthalates DEHP, BBP, DBP and DIBP. The limit is 0.1% by weight in each homogeneous material, except cadmium at 0.01%.

What does 'homogeneous material' mean in practice?+

Each material that cannot be mechanically disjointed into different materials — e.g. the solder joint, the wire insulation, the plating layer — is assessed separately against the limits, not the product as a whole. That is why supplier-level material declarations matter.

Do I need lab testing to prove RoHS compliance?+

Not necessarily. The legal route is internal production control with technical documentation per EN IEC 63000 — usually supplier declarations and certificates, with analytical testing (IEC 62321 methods) used where risk or uncertainty justifies it.

Is RoHS part of CE marking?+

Yes. Since RoHS 2, conformity is declared on the EU Declaration of Conformity and covered by the CE marking on the product — there is no separate RoHS label.

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