RoHS 2 Technical Documentation

The technical documentation for compliance to RoHS 2 is the greatest challenge for manufacturers of products that were already RoHS compliant. We can provide a template for technical documentation and assist you to compile conformity documentation that aligns with the RoHS-2 harmonized standard.

For RoHS 2 compliance, manufacturers must carry out conformity assessment based on internal production control procedures that are in conformance with EU Decision 768/2008/EC and EU Regulation 765/2008/EC. The RoHS 2 Directive Article 7(b) specifies:

b) manufacturers draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC or have it carried out;

Products may not be sold on the EU market unless the manufacturer has drawn up the technical documentation.
The RoHS 2 Technical documentation File (TDF) must meet specific requirements

  • makes it possible to assess the products’ conformity and includes an adequate analysis and assessment of the risk(s).
  • Shall specify the applicable requirements for design and manufacture of the product.

Harmonized and referenced Standards for Technical Documentation

  • EN 50581: Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
  • IEC/TR62476: Guidance for evaluation of product with respect to substance-use restrictions in electrical and electronic products
  • IEC 62321: Analytical Test Methods
  • IEC 62474: Materials Declaration

EN 50581 specifies that technical documentation shall include at least:

  • a general description of the product (product category and exemptions)
  • documents for materials, parts, and/or sub-assemblies
  • information showing the relationship between the technical documents identified and the corresponding materials, parts and/or sub-assemblies in the product;
  • list of harmonized standards and/or other technical specifications that have been used to establish the technical documents or to which such documents refer.