The chemical regulatory train keeps accelerating, with more and more chemicals being added to the REACH SVHC list every six months, new proposals for substance restrictions in many markets and product categories worldwide, and an increasing number of “copycat” regulations coming into existence worldwide. As mentioned previously, there are over a dozen versions of the European Union’s RoHS Directive in various markets around the world, but harmonization between them is hardly complete.

From this perspective alone, you operate in an increasingly complex and confounding marketplace. So what is a manufacturer to do? I’ll present an approach to taking a more proactive and defensive approach to this challenge in this, and coming, installments of my TTI MarketEYE contribution.

The basic precept of chemical regulation targeted at manufactured goods (articles) is that the agency regulating the substance(s) wants the manufacturers of those goods to not use that substance any more. This presupposes that you actually know whether your products incorporate the substance and that you can (easily) replace it with something else. While this presupposition may occasionally be baseless and reflect an inadequate understanding of how articles are actually designed and manufactured, manufacturing industries (not just the electronics industry) have generally done a poor job of both understanding how and why regulators regulate and helping them devise a more effective way to achieve their ends. I won’t address those issues here (they are big, meta-issues), but rather use them as a starting point.

There are three basic steps to chemical-related environmental compliance:

First, identify and understand the substances in the products you are placing on markets around the world.

Second, understand the regulatory (and market/customer) requirements regarding the substances in the products you placing on those markets.

Third, make sure that the products placed into and sold in those markets meet or exceed the requirements.

The first and second items can be swapped, in fact, in a linear implementation (and they often are) but I will argue that doing so can incent a narrower, and thereby more reactive, approach. So let’s get started.

1. Identify and Understand Substances

Clearly, if you know the identity of every single substance that is contained in the product(s) you are selling, where it is located in your product, and what it is used for when a new requirement comes along you can immediately know whether your product is impacted by the requirement.

So how do you do this?

Ask your suppliers, of course! Well that’s easier said than done:

  • There will be situations where you, regardless of your place in the supply chain, specify one or more of the chemical substances. Sometimes you’ll specify a metal to a specific standard, and that standard defines the chemical composition of the metal…but is that adequate?
  • There will be situations where your suppliers either will give you less information than you are asking for, won’t give you any information, or simply won’t have it available.
  • Sometimes they will happily and quickly give you what you’re asking for, or it will even be publicly available on their website.

You will need to determine when and how you ask your suppliers for, or otherwise obtain, this information.

2. Understand the regulatory and customer requirements for your products in your markets

There are an increasing number of regulatory requirements in markets around the world. As noted above, lots of them are similar but there are often significant (and not so significant) differences. For instance, Vietnam RoHS requires a compliance statement on your website but the scope isn’t exactly the same as EU RoHS; China’s “RoHS” does not restrict substances but requires product labels and substance disclosure; and so on. Battery material restrictions and labeling requirements broadly lack harmonization around the world, though usually targeting the same metals and types of batteries. Thankfully, packaging material-related restrictions are generally reasonably in-common with EU Packaging Directive requirements; however labeling requirements are, like battery labeling, poorly harmonized. Then there is EU REACH, which crosses so many domains and has both restriction and disclosure (and registration) requirements. Keeping up with regulatory requirements that restrict or require labeling or disclosure regarding substances (not to mention energy efficiency and producer responsibility requirements) is a significant challenge.

Many industries have created standards that track restriction or disclosure requirements across markets like IEC 62474, but they are necessarily reactive and incomplete since updating the substance list in the standard after a new regulatory requirement comes into place can take months, and the scope of the standard can exclude your products or even certain markets.

Ensuring you have a mechanism to monitor ever-dynamic regulatory and customer requirements is critical to putting a successful compliance program into place.

3. Make sure your products comply with market requirements.

Once you have the data and the market information, you theoretically have the input information necessary to produce a compliant product. How you assess, review, and incorporate that information into your product development and lifecycle process is key to tying it all together to produce compliant product on a consistent basis.

This is actually the most difficult step of all, and in fact it is the first step you should take. Putting in place a system that identifies what information is needed, ensures its availability, and produces compliant products takes development and implementation of some business processes and modification of many existing ones, acquisition and implementation of a software data management system, and internal enforcement of the process through a solid phase gate-based product lifecycle management process.

From the product concept phase, where you define the product’s features and markets, you must consider what substances are available – and allowable - for use in producing it and have checkpoints along the line to make sure you identify substance-related challenges and issues. We have all seen what happens when a product comes to market only to be either pulled back or be unsellable due to a material-, component-, or supplier selection issue that should have been identified prior to first shipment. It’s almost always easier and less costly in many ways to make a change to the product design before it’s in volume production than after.

In the next installment I’ll cover some approaches for, and challenges to, weaving environmental compliance into product lifecycle processes.

Mike Kirschner


Mike Kirschner

Mike Kirschner is a product environmental compliance and performance expert who provides advice and expertise to manufacturers in a variety of industries. His primary areas of focus include EU RoHS, the impact of EU's REACH regulation on article manufacturers, California’s Safer Consumer Products regulation, and performance standards like IEEE-1680.x for electronics. Mike helps manufacturers define, implement and troubleshoot internal management systems that result in compliant products, and assesses and monitors environmental regulations around the world on their behalf.

He contributed two chapters to the Governance, Risk, and Compliance Handbook, published by Wiley in 2008, and is featured in the critically acclaimed book, Exposed: The Toxic Chemistry of Everyday Products and What's at Stake for American Power. In 2009 he was appointed to the California EPA Department of Toxic Substance Control's Green Ribbon Science Panel. Prior to joining ENVIRON, Mike founded product lifecycle and environmental consultancy Design Chain Associates, LLC (DCA), where he served as president and managing partner. Before founding DCA in 2001, Mike spent 20 years in engineering and engineering management roles within the electronics industry with manufacturers including Intel and Compaq. He holds a BS in electrical engineering from Worcester Polytechnic Institute.

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