The recast of the EU RoHS Directive opens the scope of EU RoHS and introduces mandatory requirements for conformity assessment and marking. Many additional products will need to comply and the RoHS Directive becomes a CE mark directive with specific obligations for manufacturers, importers, and distributors.
Manufacturers will need to carry out conformity assessments based on internal production control procedures that are compliant with EU Decisions and harmonized standards. 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. The documentation must be made available to EU members state authorities upon request.
CENELEC published the standard EN 50581 that sets requirements for RoHS 2 technical documentation.
Key obligations for manufacturers to implement/document Compliance Assurance System
- draw up the required technical documentation and carry out the internal production control procedure;
- ensure that their products have been designed and manufactured in accordance with the requirements for substance restrictions;
- ensure that procedures are in place for series production to remain in conformity;
- take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation and with the requirements of the RoHS Directive;
- EU declaration of conformity
- register of non-conforming EEE and product recalls, and keep distributors informed;
- ensure that their EEE bears a type, batch or serial number or other element allowing its identification;
- materials, components and EEE which have been tested or measured in accordance with harmonised standards demonstrating compliance, shall be presumed to comply with the requirements of the RoHS Directive;
ECD Compliance (ECD Technology Ltd.) has helped organizations with their RoHS compliance programs since 2003. We have directly contributed to the development of several of the International standards are applicable to RoHS-2 and have 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.
