This month, the European Commission’s updated RoHS2 directive kicks in for medical devices, and it also affects numerous other types of electrical equipment. We asked Katina Kravik, CEO of custom technical wire and cable OEM and contract manufacturing firm Northwire, to get us up to speed on the new regulations.
What is RoHS2?
The Restriction of Hazardous Substances Directive, or RoHS for short, was enacted in 2006 and governed the use of certain hazardous substances in electrical and electronic equipment. The Recast RoHS Directive (RoHS2) is an updated version of the original regulation that took effect last year. It addresses additional types of equipment and clarifies issues like conformity assessment and CE marking of products.
What substances are regulated?
The RoHS2 Directive outlines the six hazardous substances and restricts their use in regulated components and products. For five of the materials — lead, hexavalent chromium, mercury, polybrominated biphenyls, and polybrominated diphenyl ethers — maximum allowable concentration is 0.1% by weight. For cadmium, it’s 0.01%.
What types of equipment are affected?
The original directive covered eight product categories, including large and small household appliances; IT, communications, lighting, and consumer equipment; electrical and electronic tools; toys, leisure, and sports equipment; and automatic dispensers.
Now, a number of formerly excluded categories fall under RoHS2, including medical devices starting on July 22. Others include monitoring and control instruments in 2015, in-vitro diagnostic medical devices in 2016, and industrial monitoring and control instruments in 2017. RoHS2 will affect all other electrical and electronic equipment (EEE) not previously covered on July 22, 2019, and active implantable medical devices will be reviewed for inclusion in 2020.
Who’s responsible for meeting the directive?
According to RoHS2, “economic operators” are responsible for ensuring CE-mark compliance. That includes a product’s manufacturer, authorized representative, importer, and distributor.
Is compliance optional?
For those wondering, “Does this apply to me?,” let’s be crystal clear — every manufacturer and supplier of electrical and electronic equipment conducting business in the European Union (E. U.) must comply with the RoHS2 directive and cannot CE mark their products without doing so. RoHS2 validation, verification, and technical documentation are the manufacturer’s responsibility.
To enforce the rules, every E. U. country is obligated to conduct “market surveillance” of applicable products and ensure compliance with RoHS2. These requirements are legally enforceable. Some consequences of noncompliant products include documentation checks, physical inspection and laboratory testing of samples, financial penalties, product recalls, and even restricting or prohibiting goods from the E. U.
Any advice on complying with RoHS2?
While the RoHS2 Directive outlines the specific responsibilities of each party in the supply chain, we advise our customers to seek the assistance of well-qualified suppliers with comprehensive product-testing capabilities, the engineering expertise to handle technical documentation, and internal production-control procedures that result in an expedient and cost-effective compliance program.
Northwire, for example, has more than 43 years of experience navigating the complexities of international and domestic regulatory compliance. We back that up with cutting-edge testing capabilities and a rigorous quality-management system that helps our customers meet RoHS2 quickly and economically. For instance, our field-proven X-ray fluorescence material analyzer detects restricted substances instantly and provides both an electronic and hard copy record. This nondestructive test capability relies on the same technology used by regulatory agencies.
In the event a product does not meet the RoHS2 Directive, we can recommend alternative, approved, strategic suppliers. And Northwire’s comprehensive database of validated materials and range of contract engineering services lets us quickly respond to regulators’ requests for the required documentation. Less-sophisticated suppliers can take months to produce the same data, which could delay or prohibit a CE mark.
Partnering with an effective and experienced supplier can help OEMs meet RoHS2 faster and more economically than with outside testing labs and, of course, avoid the delays and penalties of noncompliance.