As the EC reviews RoHS, where’s the scientific data to support updates?

The European Commission is set to review the RoHS Directive before the end of the year. One of the changes on the table is the addition of part or all of WEEE’s Categories 8 and 9, which include the medical electronics sector as well as monitoring devices.

Circuits Assembly recently spoke to Ken Stanvick, an expert on RoHS – now having been in effect for more than two years – and one of three cofounders of Design Chain Associates (www.designchainassociates.com).

When asked when and if medical electronics would be affected by the regulation, he laughed. “If I had the answers, I’d give you the lottery numbers,” he said.

But then he proceeded to give some solid answers – and raised a few questions of his own. A number of options are under review, Stanvick said. “I suspect the time frame for which way they are leaning will be the latter part of this year or the beginning of next year.” For Category 8 (medical) and Category 9 (monitoring), “the intention is to include them. It’s more a matter of when than if.” One possibility, according to Stanvick, is the continued exclusion of the categories, an option he deems unlikely. Second, the EC may exclude them, but encourage ecodesign. That, however, doesn’t seem feasible. “No one trusts the industry to do it on their own,” he noted. Third, and most likely, is to include parts of the categories. At the earliest, medical and monitoring electronics could be included in RoHS by 2012, according to Stanvick. “My concern is that they don’t have any real good/bad examples of reliability issues with the use of Pb-free solders out there, so it’s hard to convince people who are reviewing the exemptions. Where are the scientific data to prove this is any more or less reliable than what is currently included?” he asked. “The counterargument to [rapid inclusion of Categories 8 and 9] will be that companies should have, in fact, looked at it in 1993 when the whole discussion started to take place.” He believes the EC thinks firms have already had time to prepare. 2012 will provide time for state laws to catch up, but is a conservative estimate. “2014 is one of the options recommended, but the manufacturers look at 2012 as a reasonable deadline.”

For the medical segment, Stanvick is confident “what may be excluded in the category of medical will be implanted devices because they are encased” and already controlled by the FDA. But, for example, for heart monitors – and other non-implantable products – insufficient reliability information exists, so they could be included. We’d be “hard pressed to continue Category 8 as a blanket statement.” They will “include some or exclude some; they may continue material exemptions associated as products.”

He knows many medical electronics companies looking at and even doing Pb-free designs. “They are hedging their bets. There is really no fear because there is good information out there.”

The addition of these categories is only one part of the overall RoHS review. The commission is looking at additional materials separately. They are reviewing existing exemptions (required to be reviewed by 2010).

But again, he added, “based on state holder feedback, there is a lack of scientific evidence. There are Pb-free solders in millions of products and billions of solder joints, and bad news in this country travels fast. If there were a secret liability problem that a company ran into, we would have heard about it.”

Asked about reinforcement for compliance, Stanvick said, “In the US, the attitude is to catch someone not in compliance and make it a headline. In Europe, they want to test products coming in and work with the manufacturers of the products. As long as you are cooperative, they’re not going to put you up as a poster child for RoHS enforcement.”

Europe’s approach has its positives and negatives. It’s a “nice way to do business. However, the downside is it makes people more bold who aren’t making the investment.”

As RoHS stands, product categories are not well defined and there is no consistent interpretation beyond the specific items in the categories, according to Stanvick. One member state may include a product, but another state may say it’s outside the scope. “RoHS is meant to be indicative,” he said. (China, on the other hand, has a specific list of products.) “Interpretation of RoHS leads to frustration with manufacturers,” he concluded.

But this is just another learning curve, he added, just as it was with the transition from SnPb to SAC. And that transition “didn’t sink the industry.”

What is his advice for the medical electronics industry? Right now, they should have a plan for legacy products and how to support them. And with new designs, they should design in a Pb-free system where it makes sense.

Indeed, even with Pb-free components more readily available than leaded today, Stanvick sees the glass as half-full. “I think we are losing tribal knowledge about making leaded joints; if you’re using leaded, you’re the exception.” The lack of higher volume processes using SnPb hastens the knowledge loss.

As an aside, Stanvick mentioned China’s version of RoHS. He said indigenous Chinese companies have somewhat put the regulation on hold, with a don’t-worry-about-it attitude, while the US continues to struggle to be compliant with China’s labeling rules. “I see no rush for their catalog,” he said.

Furthermore, get ready for the next big industry buzz: carbon footprints, or greenhouse gas emissions. “Big questions are coming from significant players,” he emphasized, and “work is being done on this right now.” Companies need to know, “What is the carbon footprint of my product?” This includes harvesting materials from the ground all the way through to recovery and disposable. “This is the next hazardous material, and it’s coming faster than most people think. It’s the next RoHS,” he concluded.