© Smith & Associates Electronics Production | October 16, 2012

RoHS 2 heightens the value of agile supply chain partners

As 2013 approaches, the industry is preparing itself for a new round of environmental guidelines imposed by the European Union (EU) Restrictions on Hazardous Substances (RoHS).

RoHS 2, as this second round is called, will increase requirements pertaining to declarations of conformity, technical documents and archiving, Conformité Européenne (CE) mandatory product marking, product identification, traceability, compliance demonstration through testing or assessment, as well as the phase out of exceptions from the initial RoHS directive. RoHS update It has been a few years since the industry learned and then mastered the requirements of the initial RoHS directive, now called RoHS 1. RoHS 1 was originally adopted in 2003 but took effect first in July 2006 and governs the use of six hazardous substances in the manufacturing of electronic and electrical equipment. From the outset, RoHS was seen as a means to improve and ensure the successful implementation of waste electrical and electronic equipment (WEEE) legislation put into place to address the concerns of mounting electronic waste and provide proper handling guidelines for recycling and disposal. RoHS 1 included provisions for industry review to ensure the ability to arrive at solutions that simultaneously protect the environment and improve safe product development. Thus, revision to the original RoHS legislation was contemplated after an initial period of operation. Another set of regulations, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), was implemented in 2006 and took effect as of 1 June 2007. REACH is a stringent law governing the use of specified chemicals in products and applies to all chemicals either manufactured or imported in the EU. For companies importing goods into the EU, REACH mandates that the manufacturer register the products and the type and amount of the various chemical substances contained in those products with the regulatory board, European Chemicals Agency (ECHA). Different chemicals have different amount allowances based on the level of toxicity as determined by REACH. The European Union is set, on January 2, 2013, to have all of the new provisions for RoHS come into effect. The RoHS recast, or RoHS 2, was approved and came into effect on July 21, 2011, but member EU states were given until this coming January to adopt national legislation to meet and carry out the new provisions. More manufacturers must comply Because RoHS 2 revises the industry exemptions offered in RoHS 1, new players will need to come in line with the RoHS requirements. The device sectors that are particularly affected include medical electronic devices which will follow a graduated requirement of compliance with RoHS from 2014 to 2019. Specifically, the following categories will lose their exemptions over the next six years:
  • 22 July 2014 Category 8 medical devices and Category 9 monitoring and control instruments;
  • 22 July 2016 in vitro diagnostic medical devices;
  • 22 July 2017 industrial monitoring and control instruments;
  • 23 July 2019 all electrical and electronic equipment (EEE) except ones otherwise explicitly excluded.
While these phased-in loss of exemptions present challenges and concerns for the medical electronics sector, it is the CE (Conformité Européenne) marking directive that is seen by industry experts to likely be the most discussed new requirement. The reason is that the CE marking, is mandatory for all electrical and electronic equipment (EEE) under RoHS 2, signifies that the product meets all of the CE requirements, including RoHS 2 and the declaration of conformity for the product and its sub-components. It is the responsibility of the manufacturer, importer, distributor, and authorized representative to ensure that all EEE is in conformity with RoHS 2 and in the event that it is not, the proper reporting must be made.
Kirk Wehby - Vice President, Global Operations - joined Smith in 2008 to head worldwide operations and quality. He was formerly Director of Operations and Supply Chain for Cardone Industries (1997-2008), where he managed start-up and integration of operations in Belgium and Mexico. Kirk received a B.S. from Oral Roberts University and M.B.A. from Westchester University.© Smith & Associates
Material content testing & verification Once we can appreciate the impact of the latest RoHS directives, the next step is to understand what changes in processes and requirements need to be made. Along the semiconductor and electronics supply chain, verification of compliance with RoHS 2, as well as with WEEE and REACH are a critical requirement. Penalties for not ensuring compliance are heavy. Responsible value chain partners with the sophisticated, high-tech, testing laboratories and quality management procedures that can ensure compliance are essential. When considering suppliers or distributors for electronic components, choosing those with accredited and certified laboratories and quality management procedures should be a primary requirement. One of the highest regarded industry standards for accrediting testing laboratories is the ISO/IEC 17025 quality standard. Businesses receiving ISO/IEC 17025 and ISO 9001 accreditation have demonstrated that both operations and procedures (O&P) and the quality management processes are well-established, adopted throughout the organization, and meet rigorous requirements. It is important to note that the ISO/IEC 17025 is both a management and a technical facility quality standard and is importantly related to ISO 9001, Quality Management Systems. Testing laboratories with this accreditation certifies that the testing is performed by appropriately competent professionals and meets multiple levels of equipment, facility management, and performs standard, non-standard and laboratory-developed methods for testing and calibration of the products being handled. One of the important verification methods for RoHS and now RoHS 2 testing is a process using Hawk I X-Ray Florescence (XRF). This testing method provides RoHS analyses of electronic components by identifying substances of concern and verifying material content. Importantly, for compliance and proper documentation for declarations of conformity, having a value chain partner with the ability to verify material content in an accredited testing laboratory with specifically trained and qualified engineers is vital to RoHS 2 compliance. Compliance necessitates responsible value chain partners According to the European Commission (EC), RoHS 2 also has as a goal of "aligning and harmonizing RoHS with other EU legislation, such as the New Legislative Framework – 'Marketing of Products Package', REACH (regulation (EC) No 1907/2006), the ErP Directive (Directive 2009/125/EC) and legislation related to management of waste from EEE […]." (RoHS 2 FAQ, 15 June 2012, pp. 5, 22ff) In line with the inclusion of all EEE to meet and have CE marking, spare parts and sub-assemblies that are EEE or are "separately made available as functional units such as computer network interface cards and graphics […] are considered equipment and must meet all relevant requirements." (RoHS 2 FAQ, 15 June 2012, p. 23) Therefore these items must have the required documentation of conformity and conform to RoHS 2, REACH, and WEEE directives. Ensuring this compliance is a detailed and complex process, and so having accredited testing facilities in-house at distributors' facilities is obviously an important and valuable service. The set of products and components that must meet RoHS 2, REACH, and WEEE continues to expand and the importation of these items from the global supply chain requires just in time (JiT) delivery but without compromising verification of compliance. In turn, it is essential that companies conducting business in countries requiring various global RoHS directives (e.g., China, Japan, and the US) partner with those distributors and service providers that have the experience, knowledge and best in class products and services. The stakes are high and the requirements can be complex in today's global supply chain, so knowledge and service alone are no longer enough. Distributors and partners working to ensure that you meet RoHS 2 directives and the related legislation in the EU and globally, should also have accredited ISO/IEC 17025 laboratories, industry certified and accredited quality management systems and engineers, counterfeit mitigation procedures, corporate sustainability management, and the programs that can be customized to meet your specific requirements, regardless of the complexity or challenges. The obligations under RoHS 2 are significantly more stringent and having the best value chain partners will help ensure compliance with the various new requirements across the many product and component categories.
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