CE RoHS Certification

RoHS Directive 2011/65/EU

Directive 2011/65/EU (RoHS) regulates the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE), with the objective of contributing to the protection of human health and the environment.

It also promotes safer and more sustainable waste recovery and disposal.

The currently applicable directive is 2011/65/EU, subsequently amended by Delegated Directive (EU) 2015/863, which updated the list of restricted substances.

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Evolution of the RoHS Regulation

Compared to the previous RoHS 1 (Directive 2002/95/EC), RoHS 2011/65/EU introduces an autonomous regulatory framework, with:

  • defined scope of application
  • specific obligations
  • structured conformity procedures

Over time, the scope of application has been extended to include, except for exclusions, all EEE listed in Annex I.

Category 11 (open scope) has also been introduced, relating to equipment not covered by the previous categories.

EEE Categories Regulated by RoHS

  • Large household appliances
  • Small household appliances
  • IT and telecommunications equipment
  • Consumer equipment
  • Lighting equipment
  • Electrical and electronic tools
  • Toys and leisure and sports equipment
  • Medical devices
  • Monitoring and control instruments (including industrial)
  • Automatic dispensers
  • Other EEE not covered by the previous categories

Restricted Substances

  • Lead (Pb): 0.1%
  • Mercury (Hg): 0.1%
  • Cadmium (Cd): 0.01%
  • Hexavalent chromium (Cr VI): 0.1%
  • Polybrominated biphenyls (PBB): 0.1%
  • Polybrominated diphenyl ethers (PBDE): 0.1%
  • Bis(2-ethylhexyl) phthalate (DEHP): 0.1%
  • Butyl benzyl phthalate (BBP): 0.1%
  • Dibutyl phthalate (DBP): 0.1%
  • Diisobutyl phthalate (DIBP): 0.1%

Update of Substances (Directive 2015/863)

The substances DEHP, BBP, DBP and DIBP were introduced by Delegated Directive (EU) 2015/863.

The restrictions apply:

  • from 22 July 2019 for EEE in general
  • from 22 July 2021 for medical devices and monitoring and control instruments (including industrial)

Regulatory exclusions and exemptions may apply.

Technical Documentation

For RoHS conformity, the main reference is standard EN IEC 63000 – Technical documentation for the assessment of electrical and electronic products.

This standard has replaced the previous EN 50581.

Final Note

RoHS conformity must be assessed on a case-by-case basis, considering the type of product, the category to which it belongs, any exclusions from the scope of application and possible exemptions provided for in Annexes III and IV.