Intertek’s regulatory and technical experts help electrical and electronic equipment (EEE) product manufacturers in creating a product Technical File to comply with the EU Restriction of Hazardous Substances (RoHS) Directive (2011/65/EU) conformity assessment requirements.
According to the European Standard IEC 63000, a Technical File is a comprehensive collection of information and documents detailing everything about a manufacturer's product or device. An incomplete or improperly completed Technical File may result in unexpected delays, prevent market entry, or lead authorities to take enforcement actions.
European Union (EU) Restriction of Hazardous Substances (RoHS) Directive Compliance Requirements
With the revision of the RoHS Directive and the adoption of RoHS as a CE marking directive in 2013, preparing a technical documentation file which demonstrates that products are RoHS-compliant has become an integral step in companies' product compliance management systems.
To harmonise the compliance processes, the EU published the European Standard EN 50581:2012 “Technical documentation for the evaluation of electrical and electronic products with respect to restriction of hazardous substances” in 2013 (now referred to as EN IEC 63000:2018). Under Article 16 (2) of the RoHS II Directive, a manufacturer who demonstrates compliance with EN 50581:2012 will automatically be deemed to be compliant to the RoHS II technical documentation requirements.
Compliance with IEC 63000:2018 and the submission of a CE Technical File has also been established as a requirement to place electrical and electronic equipment (EEE) on the market in the United Arab Emirates (UAE) using the Emirates Quality Mark (EQM).
Manufacturers are required to keep records to prove compliance, and they must hold onto these records for a minimum of 10 years.
What is Needed to Support your CE Technical File?
- Quality management systems that mitigate risk by supporting design, supplier qualification, and manufacturing to mitigate risk
- Due diligence that supports compliance documentation for all components and materials in the finished product
- Conformity assessment to identify remaining risks and risk-mitigation strategies for high-risk suppliers and materials/components
- Appropriately managing and reporting risk when not all of the compliance documentation can be collected.
The Intertek Advantage
Our experts help EEE product manufacturers comply with the conformity assessment requirements established under the RoHS Directive. By reviewing companies’ Restricted Substance Compliance Assurance Systems (CAS), we assess the effectiveness of the policies and procedures they have in place for controlling the use of restricted materials throughout the product realization cycle.
The company’s documentation, policies, procedures, and practices all factor into the assessment. We review existing compliance documentation, the results of risk assessments, to ensure the documentation meets the requirements laid out by IEC 63000 even when not all of the documentation can be collected from the supplier base. We also advise on proper use of information and processes. If there is a gap in the information or processes, Intertek will identify it and may support the development of required processes and documentation.
Technical File Services Workflow: 
Intertek provides the following services to help companies achieve compliance with RoHS and IEC 63000:
- Education & Training
- IEC 63000 Review & Gap Assessment
- Technical File Creation Support
- Material and Supplier Risk Assessment
- Bill of Material Conformity Assessment
- Supply Chain Data Collection
- RoHS Analytical Testing
- Development of Compliance Management Road Map
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