Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (known as RoHS2) became European Law on 21 July 2011 and took effect in EU Member States from 2 January 2013. RoHS2 brings a much wider range of equipment into scope but does not introduce any new substance restrictions yet. Another very important difference is that RoHS2 is a CE Marking Directive - this is discussed in detail in the BOMcheck Guide to Using BOMcheck and EN 50581 to Comply with RoHS2 Technical Documentation Requirements.
RoHS2 requires Manufacturers to produce technical documentation which demonstrates that their products are RoHS compliant, in line with Module A of Decision 768/2008/EC. This is a significant difference compared to the RoHS1 Directive which does not prescribe any requirements for Manufacturers to maintain compliance documentation. RoHS2 also includes obligations for all EU Member States to perform systematic market surveillance including "appropriate checks on product compliance on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples". In contrast, RoHS1 did not prescribe any enforcement procedures that Member States were required to implement.
There are many different approaches that companies can use to draw up the required technical documentation to demonstrate that their products are RoHS compliant. Many companies already have established compliance processes and quality management systems for RoHS1 compliance and for other product regulatory requirements. Each company has to decide the best approach for drawing up the RoHS2 technical documentation which makes best use of their existing compliance processes and quality management systems.
European Standard EN 50581:2012 "Technical documentation for the evaluation of electrical and electronic products with respect to restriction of hazardous substances" was published in September 2012 and officially endorsed by the European Commission as an approved method for compliance with RoHS2 Technical Documentation requirements. Under Article 16 (2) of the RoHS2 Directive, a Manufacturer who demonstrates compliance with EN 50581:2012 shall be deemed to be compliant to the RoHS2 technical documentation requirements. The EU RoHS regulatory authorities expect companies to adopt the EN 50581 standard or provide evidence that their compliance approach provides equivalent quality levels.
The BOMcheck Guide to Using BOMcheck and EN 50581 to Comply with RoHS2 Technical Documentation Requirements provides a step-by-step practical approach that Manufacturers can choose to adapt and implement in their supply chains to generate the required RoHS2 technical documentation for a product model and provide an EU Declaration of Conformity. This practical approach explains how Manufacturers can choose to use the EN 50581:2012 European Standard and the BOMcheck system to comply with the RoHS2 technical documentation requirements. This practical approach explains how Manufacturers can choose to use the EN 50581:2012 European Standard and the BOMcheck system to comply with the RoHS2 technical documentation requirements. One example is Carestream Health which is successfully using this approach to achieve RoHS2 compliance for Medical Devices by using EN 50581 and BOMcheck.
How BOMcheck supports the process specified in EN 50581 for Manufacturers to comply with RoHS2 Technical Documentation requirements
The above diagram summarises the process specified in EN 50581 and highlights how using BOMcheck to collect the documents from suppliers (Clause 4.3.3) enables the Manufacturer to save time and effort to comply with the Clause 4.3.4 document evaluation requirements. ENVIRON held a webinar on 19 July 2012 which demonstrates how the standardised process that suppliers follow to create materials declarations in BOMcheck ensures that these declarations already meet the Clause 4.3.4 quality and trustworthiness requirements (i.e. the Manufacturer does not need to carry out any additional document evaluation). If the Manufacturer’s assessment in Clause 4.3.2 determines that the supplier is also required to provide test reports to support their materials declarations, then the standardised process that suppliers follow to attach a test report to a declaration in BOMcheck requires the supplier to evaluate that the test report meets the Clause 4.3.4 quality and trustworthiness requirements (i.e. this reduces the time and effort for the Manufacturer to evaluate test reports). For further details please see recorded webinar on using BOMcheck and EN 50581 to comply with RoHS2 Technical Documentation Requirements and the slides from the webinar.