Best Practices for RoHS Compliance in Support of CE Marking
In 2012,The European Directive on Reduction of Hazardous Substances was recast. The new version of the directive now requires products to be adequately validated as RoHS compliant in order to be eligible for CE marking and access to the EU market. Additionally,the recast also increased due diligence requirements for companies validating their products as compliant,including elevated documentation,data validation,risk analysis,and record keeping requirements. Methods used to address RoHS compliance before this change,such as simply collecting RoHS compliance statements from suppliers,may no longer be adequate. This paper starts by reviewing the evolution of the RoHS directive and how it has evolved. It then moves on to cover the requirements and scope of the directive,as well as which standards are used to demonstrate compliance,and how those standards must be referenced in internal company quality processes. Suggestions on best practices for building a comprehensive,efficient,and effective product environmental compliance process with a focus on risk mitigation and cost containment are provided,including real world examples. New specific requirements for classifying parts and materials according to risk will be addressed,as well as new requirements to rank all part and material suppliers by evaluating the trustworthiness of the data they provide. Marking requirements,declaration of conformity formatting and examples,and technical compliance files,will be covered with examples provided. The EU REACH law is also addressed briefly. Although the REACH law is not tied to the RoHS directive or CE-Marking,REACH validation is required for access to the EU market,and compliance validation techniques can be similar to RoHS compliance validation. References to standards and industry resources are provided.