The recast of the EU RoHS Directive was approved by the European Parliament on November 24, 2010 and by the EU Council of Ministers on May 27, 2011. The recast introduces many significant changes and new obligations with many additional products added to the scope of the Directive and new obligations for all economic actors. The RoHS Directive becomes a CE mark directive with specific obligations for manufacturers, importers, and distributors.

The key changes include:

• Open Scope
• Mechanism to add restricted substances
• CE Mark Directive / EU Declaration of Conformity
• Conformity assessment and Harmonized Standards
• Clearer requirements for manufacturers, importers, and distributors
• Formalized process for requesting/renewing exemptions

Open Scope

Electrical/Electronic products are included unless explicitly excluded. The directive now includes three additional product categories:

• category 8 - medical devices
  • Medical devices: July 22, 2014
  • In vitro diagnostic medical devices: July 22, 2016
• category 9 - control and monitoring instruments
  • Monitoring and control instruments: July 22, 2014
  • Industrial monitoring and control instruments: July 22, 2017
• category 11 - Other Electrical and Electronic Equipment not covered by any of the existing categories

The Definition of EEE is expanded to include products which use electricity for any intended function. The original RoHS Directive defined EEE as equipment that was dependent on electricity for its primary function. The new definition brings products such as many toys with secondary electronic functions within the scope of the substance restrictions.

Transition periods are provided for the new products added to the scope of the directive

Mechanism to add restricted substances:

The EU Commission is granted the ability to add additional substance restrictions with delegated acts. A broad range of justification considerations have been included including health, safety, environment, recycling and disposal. The EU Council of Ministers has warned the industry (in a press release) to expect additional substance restrictions.

CE Mark Directive / EU Declaration of Conformity:

The RoHS Directive becomes a CE mark, whereby the CE mark attests conformity of the product to the RoHS substance restrictions.

By drawing up the EC declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EEE

Conformity assessment and Harmonized Standards:

Manufacturers will need to carry out conformity assessments based on internal production control procedures that are compliant with EU Decisions and harmonized standards. The recast directive provides for presumption of conformity. EEE that has been assessed by tests and measurements according to harmonized standards (and shown to conform), will be presumed to comply with the requirements of this Directive.
Manufacturers will be required to draw up 'Technical Documentation' that demonstrates conformity prior to placing products on the EU market. This documentation must be made available to EU members state authorities upon request.

Additional information on Manufacturer obligations is available here.

ECD Compliance (ECD Technology Ltd.) has the skills and expertise to help your organization become compliant to RoHS 2 and other environmental requirements.For additional information on RoHS 2 compliance services click here or contact us to discuss a compliance support.