RoHS
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.
BOMcheck supports EN 50581 for compliance 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.
BOMcheck manages compliance with RoHS in China, Korea and Japan
Other RoHS legislation around the world focuses on the same list of RoHS substances, but has different requirements. BOMcheck analyses the substance declarations provided by suppliers to identify any restrictions on using these parts in other parts of the world.
China RoHS
China RoHS2 - the final Administrative Measures for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products - came into force in July 2016 and requires a broad scope of products to comply with product labelling and substance disclosure requirements. All electrical and electronic products in scope must be labelled with an environmental protection symbol. This is exactly the same labelling requirements as China RoHS1 but now applied to a much wider scope of products in China RoHS2 from 1 July 2016.
In addition to a label on the product, if any part in the product exceeds the RoHS maximum concentration values in any homogenous material the product instructions must include a table in Chinese which identifies the part names which contain the RoHS substances. This is the same substance disclosure requirements as China RoHS1 but now applied to a much larger scope of products. The China RoHS2 table follows same format as China RoHS1 but has updated references to the updated standards for product marking (SJ/T 11364) and the RoHS maximum concentration values (GB/T 26572).
On 15 March 2018 China issued the first "Compliance Management Catalogue" detailing 12 types of electrical and electronic products which also need to comply with hazardous substance restriction limits set out in national standard GB/T 26572 2011 from 15 March 2019. Similar to EU RoHS2, some applications are exempt from the substance restrictions, including 39 uses of lead, cadmium, mercury and hexavalent chromium which are detailed in a list of China RoHS2 exemptions. The numbering of the exemptions in the China RoHS2 product catalogue is different compared to numbering of the exemptions listed in Annex III of EU RoHS2. However, the re-numbered list of China RoHS2 exemptions includes all the exemptions listed in EU RoHS2 Annex III as at July 2016, as direct translations without any expiry dates.
Korea RoHS
The Act for Resource Recycling of Electrical/Electric Products and Automobiles was published on 2 April 2007 and came into force on 1 January 2008. The Act applies the same EC RoHS materials restrictions and maximum concentration values to 10 categories of electrical and electronic equipment which are listed in Article 6, Enforcement Ordinance of the Act.
Japan RoHS
Under an amendment to the Law for the Promotion of the Effective Utilisation of Resources, Japan introduced a mandatory labelling standard for certain types of household electrical equipment and IT equipment from 1 July 2006. If any single homogenous material in these types of equipment contains > 0.01% by weight of cadmium or > 0.1% by weight of lead, mercury, hexavalent chromium, PBB or PBDE, the J-MOSS labeling standard requires that the equipment is marked with an orange “R” mark. If the equipment does not contain these materials it should be marked with a green “G” mark.
How does BOMcheck manage changes in RoHS exemptions?
If a supplier claims that the use of certain substances in their parts is exempted under the RoHS Directive, then BOMcheck requires the supplier to select which particular exemption the supplier is claiming. If a particular exemption is removed from the RoHS Directive, BOMcheck will require all supplier members that relied on the exemption to update their substance declarations to indicate whether their parts still comply.
The recent removal of the Deca BDE exemption is a good example. Many manufacturers had not gathered sufficient information from their suppliers and so had to re-contact their suppliers to confirm whether they had relied on this exemption.