Europe’s Reduction of Hazardous Substances (RoHS) directive identifies six hazardous substances and their maximum permissible levels within electrical and electronic equipment. RoHS imposes upon producers of such goods responsibility for knowing whether their finished products contain these substances and whether the contents are within the regulatory limits.

Once the threats of criminal and financial consequences for noncompliance were introduced into the equation a “better safe than sorry” response became prevalent up and down the supply chain. We trust, but we must verify. The inevitable outcome was a tremendous increase in product testing.

Some companies felt they had the expertise and capability to perform the necessary testing. Many of these companies soon learned that was not true. Upon close scrutiny, they found there are many scientific challenges and nuances in testing to meet the specific language of the RoHS directive.

Independent testing labs with greater expertise and more specialized equipment soon expanded or were launched to meet the rush of demand for RoHS-related testing by offering a third-party solution to meet the testing demands.

One of the U.S.-based laboratories with the needed expertise is AmeriSci Group, a network of analytical testing companies specializing in environmental toxicology, asbestos, food and microbial testing. AmeriSci has a worldwide client base with affiliate companies in Europe and Asia, and U.S. offices in Los Angeles, New York City, Boston and Richmond, Virginia.

To help you know more about RoHS testing and how testing fits with QC 080000 IECQ HSPM, SBGi interviewed Clifton Kiser, laboratory director at AmeriSci Los Angeles.

SBGi: What percentage of the companies that bring product to you for testing are doing so to provide evidence in support of their self-declaration of RoHS compliance?

Kiser: One hundred percent.

SBGi: What percentage are customer companies testing the RoHS compliance of products supplied to them? Of those, what percentage is to question the validity of a Supplier’s self-declaration of compliance?

Kiser: About 70 percent and 10 percent.

SBGi: What percentage are companies that depend on AmeriSci as part of their production process for objective determination of what their finished product actually contains?

Kiser: About 25 percent.

SBGi: Since AmeriSci first started testing because of RoHS requirements, what percentage of those products that had been self-declared as compliant actually are not compliant?

Kiser: About 15 percent.

SBGi: Much money has been spent in response to the RoHS-imposed accountabilities. Where do you see the greatest waste of resources occurring?

Kiser: Among the greatest challenges manufacturers will face once the regulations are more strictly enforced will be the re-analysis of products that were initially ‘self-declared compliant’ that are later determined to be noncompliant during the upper-tier distributor quality control (QC) validation processes.

SBGi: How have the EU’s RoHS and WEEE and similar governmental regulations affected the testing industry?

Kiser: The commercial laboratory testing industry hasn’t experienced a significant effect as yet. Major manufacturers are still relying on self-declarations from sub-suppliers, or they utilize in-house and affiliate (e.g., UL Corp.) testing laboratories for QC purposes. Third-party testing typically only comes into play when serious QC compliance issues arise, which will inevitably happen more and more frequently.

SBGi: What scientific and other challenges for laboratories have emerged relative to these regulations?

Kiser: Among the testing laboratories’ challenges is the development of efficient and applicable homogenization techniques for small components to meet milling/grinding requirements for the testing methods. The wide variety of material types and matrices presents numerous unique sampling and preparation/digestion challenges. The lack of international standardization of testing methods has resulted in the laboratories having to develop suitable and applicable in-house preparative and analytical methods.

SBGi: What should companies know when selecting their testing partners in preparing for RoHS compliance?

Kiser: They should always ensure that their laboratory of choice is ISO 17025-compliant in their operations, and that the laboratory maintains accreditation by an ISO 17025-oriented agency in the applicable related testing genres (e.g., elemental analysis by ICP). The laboratory must also have appropriate preparation and analytical equipment to ensure reliable and reproducible data sets, which are critical for quality control comparisons and long-term batch quality tracking.

SBGi: How does adoption of QC 080000 IECQ HSPM affect RoHS compliance testing routines?

Kiser: This will help to bring about greater standardization in the way the manufacturers’ quality control programs are established and maintained, and will help to provide greater assurance of the comparability of quality control data sets.

SBGi: What are the advantages of utilizing an outside, third-party lab partner in today’s legal environment?

Kiser: By having a third-party laboratory routinely involved in the QC processes, the manufacturers eliminate conflict-of-interest issues. The data from a certified laboratory provide an added measure of both integrity and defensibility.

SBGi: RoHS address six hazardous substances. What will be the challenges to the testing industry as additional substances come under regulation?

Kiser: Very few new challenges are anticipated by our laboratories. Most certified labs already routinely perform analyses for hundreds of different inorganic and organic compounds. It is likely that any new compounds added to the RoHS or other similar legislations will already be among those routinely analyzed for other regulatory testing genres, or at the very least well within the instrumental capabilities of our certified testing laboratories. The major adjustment will be standardizing and streamlining the sample disassembly and preparation process to address the wide variety of matrices.

Next month’s “SBGi on HSF” will give more detail on the six hazardous substances identified in RoHS, why they are a hazard, where they are found and how they are used in many products.