New challenges

Since 2006, the European Union has regulated hazardous substances in electrical and electronic equipment, starting with directive 2002/95/EC (RoHS I). In May 2011 lawmakers revisited this mandate, producing an updated version, directive 2011/65/EU (RoHS II). The changes outlined in this document took effect January 3, 2013. While the new directive does not seem at first glance substantially different from its predecessor, modifications have been made which make complying with RoHS II no simple and straightforward task. The superficial similarity between the two versions stems from the fact that the restricted substances list remains unaltered. However, the new directive carries with it changes in scope, additional documentation requirements, CE marking requirements and legal responsibilities that will impact a greater number of manufacturers, suppliers, importers and distributors than ever before.

Before companies can define their strategy for complying with RoHS II, they need to fully understand the key changes associated with the new directive. Firstly, the definition of Electrical and Electronic Equipment (EEE) has been broadened to include all products requiring electric currents or electromagnetic fields to “fulfill at least one intended function.” Secondly, the new, eleventh category includes all EEE “not covered by any of the categories above (categories 1–10).” While categories one through seven, including products such as household appliances, IT equipment, entertainment electronics, lighting, power tools and toys, among others, are already affected by the legislation, categories eight and nine include articles slated to be incorporated on a rolling basis over the next four years. Thus, starting in July 2014 the RoHS II regulations apply to medical devices and monitoring and control instruments; in July 2016 to in vitro medical devices; and in July 2017 to industrial monitoring and industrial control instruments.

New product categories: In practical terms, this means that some products previously beyond the range of hazardous substance regulation will soon be brought under its umbrella. Medical devices are especially affected, for example magnetic resonance imaging (MRI) equipment and computerized tomography (CT) machines. However, even some everyday household devices, such as smoke detectors and hand-held thermometers must soon comply with the directive. As of July 22, 2019, all EEE not included in categories 1 thru 10 will be in scope of RoHS II.

CE Marking: Requirements for CE Marking have also been expanded. Since 1993, the CE mark (Conformité Européenne) has been a mandatory symbol affixed to products to show compliance with an array of EU health, safety and environmental requirements. The symbol will now indicate compliance with RoHS II and all supporting CE documentation as well, including conformity assessments. Declarations and technical files must also include proof of restricted substance compliance as demonstrated by EN 50581:2012 and supporting analytical data per IEC 62321 Standard.

Homogenous material: In the original directive, the limits on restricted substances were based on their concentration in “homogeneous material.” However, the term itself was not clearly defined, creating confusion for manufacturers. The new directive corrects this oversight by introducing the following definition of “homogeneous material”:

“One material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be mechanically disjointed into different materials, meaning that the materials cannot be separated by mechanical actions such as unscrewing, cutting, crushing, grinding or abrasive processes.”

Taken together, these changes present challenges both for businesses already operating according to RoHS legislation and for those newly affected.

The biggest challenges under RoHS II will be faced by companies that were not in the scope of the original directive. These companies have two primary options. The first requires gathering declarations of conformity and/or full material composition data, from every material, component, sub-assemble supplier, outsourced design and manufacturer, and contract manufacturer along the supply chain for every material contained in the finished product. A declaration of conformity is a self-generated document stating that the requirements of RoHS II have been met. When best practices are followed, this document is supported by technical data kept on file at the company’s offices.

Not only is this approach extremely labor intensive, it also places the legal responsibility squarely on the manufacturer’s shoulders. The company can be held accountable if a supplier’s technical data are out of date or inaccurate. And contamination does not need to result from deliberate action: a simple spill when mixing paint could increase the concentration of a hazardous substance. However, for some manufacturers this approach can be a sensible –– even cost-effective –– option. It is best suited for companies making small pieces of equipment with few components and those who manufacture their products in very limited quantities.

The alternative is to have complete RoHS chemical testing performed per IEC 62321 standard. This is recommended when supplier information is lacking or when there are lapses in the quality or integrity of the data. Companies like SGS Consumer Testing Services, with extensive experience in hazardous substance compliance issues, could provide the support needed in this case.

This option involves the manufacturer commissioning a certified laboratory or testing facility to test the supplied material or finished product for the presence of hazardous substances. Sometimes complete testing is necessary, by which the product is broken down into its smallest “homogeneous” components. In some cases the process can be strategically expedited. For instance, testing could be limited to only those components that would logically contain a restricted substance. Similarly, testing could focus only on those substances that would likely be found in such a product. For example, it typically isn’t necessary to test for PBDE, a flame retardant used in circuit boards, in a product that does not contain a known PBDE application.. Of course, this approach also has its challenges. Manufacturers must find an accredited facility that can handle the necessary tests, and incur the related expenses.

Manufacturers already adhering to RoHS have work ahead of them, as well. One of their main tasks will be ensuring that compliance documentation is up to date. Of particular concern is the new application of the CE marking. Manufacturers need to ensure that the necessary data on restricted substances is included in all technical files –– their own and their suppliers’. In addition, further testing and documentation may be necessary. Most industry experts agree that compliance is not a one-time challenge. Conformity to directives like RoHS II must be constantly updated to reflect changes in material composition, expiration of exemptions, and each time a new supplier or component is added to the product Bill of Material. Once collected, compliance data must be saved for 10 years beginning with the product’s introduction on the EU market.

Implementation of Restriction of Hazardous Materials legislation has been adopted or is being considered across the globe. China, India, and Korea are examples of countries which have put in place legislation similar to EU RoHS. In the USA, the states of California and New Jersey have implemented state legislation banning the sale of EEE which would not be allowed to be placed on the EU market per RoHS. The number of countries and the list of restricted materials will continue to expand as the global community places greater emphasis upon manufacturers to control or eliminate the use of “hazardous materials” designed into their products. What we see today is classically stated as only the “Tip on the Iceberg”.

Companies need to stay abreast of new developments in order to confidently manufacture and distribute their products in the EU and elsewhere.