Making Sure Supplier REACH Declarations are Full and Complete

My last column focused on how to improve component- and material-level RoHS compliance declarations or “certificates of compliance” (CofCs). Most OEMs also request compliance declarations for the EU REACH Regulation, (EC) 1907/2006.

REACH has three relevant aspects with which to declare compliance; two of these are important to all OEMs that place products on the EU market. These two important aspects are Annex XVII restricted substances and the Article 33-related disclosure of the presence of candidate list substances of very high concern (SVHCs).

The third aspect is the use of SVHCs listed in Annex XIV. These are SVHCs that require authorization by ECHA to be used by manufacturers within the EU; thus this is only relevant if the supplier has a manufacturing facility in the EU.

I continue to see plenty of REACH CofCs that make no statement regarding the restricted substances listed in Annex XVII. If you are going to state compliance with a regulation, then be sure your statement covers all relevant requirements.

I also often see REACH SVHC declarations that spend pages and pages re-stating every single SVHC substance. This, to me, is a waste of electrons and file storage space: we all know where the list is and the declaration can simply point to the list, if necessary. By the way, very soon suppliers will have to provide more detailed information regarding SVHCs so that data can be entered into ECHA’s SCIP database.

I rarely see references to Annex XIV. This is a generally acceptable omission: these days, most suppliers are not based in the EU and do not have manufacturing facilities located there. However, if a supplier is located in or has a manufacturing location in the EU, a customer’s inquiry to them should also include a request for a statement about whether they are authorized to use any Annex XIV substances. (This is a circumstance OEM customers should be aware of: understanding where supplier facilities are located is an important aspect of the supplier approval process because it informs political, geographic, geopolitical and regulatory risk assessments.)

These questions from customers may drive further discussion about the nature of Annex XIV substances used, and any plans suppliers may have for replacement or other alternatives.

Proposed Changes to Model Toxics in Packaging Legislatiom

As stated on the TPCH website:

The Toxics in Packaging Clearinghouse (TPCH) maintains the Model Toxics in Packaging Legislation and coordinates implementation of state legislation, based on the Model, on behalf of its member states, with the goal of promoting consistency across states. TPCH is a resource and single point of contact for companies seeking information on toxics in packaging requirements or an exemption.

Nine states in the USA are TPCH members, and ten more have legislation based on the TPCH model.

Fundamentally, the Model Toxics in Packaging Legislation restricts the presence of four heavy metals – lead (Pb), mercury (Hg), cadmium (Cd), and hexavalent chromium (Cr6+) – to under 100ppm by weight of each piece of packaging. These four heavy metals are the same ones defined in the EU Packaging Directive, 94/62/EC (current consolidated version is here), and are restricted to the same limits defined in that directive.

TPCH has an open call for comments on updates to the Model Toxics in Packaging Legislation for Toxics in Packaging” that will be of interest if you produce packaging materials or use them for shipment of product within or to the USA. The proposal would amend the Model to restrict, in addition to the four heavy metals already restricted, the presence of the following substances in all packaging materials:

  • Perfluoroalkyl and polyfluoroalkyl substances (PFAS): “PFAS shall not be present above the detection limit”
  • Ortho-phthalates: up to 100ppm (same limit as the four heavy metals already restricted)

The proposal is that the restrictions are effective two years after enactment. Note that the Model does not, by itself, have any regulatory power. Each state will have to implement these changes, should they be approved, separately through its own legislative processes.

By the way, note that the Model (and most implementations) require that packaging manufacturers provide a “Certificate of Compliance stating that a package or packaging component is in compliance with the requirements of this Act … Certificates of Compliance, or copies thereof, shall be furnished to the [state administrative agency] upon its request.” So be sure to collect and keep those packaging CofCs, too.

The comment period closes on August 24.

Endangered Elements: A Warning and a Future Challenge

The American Chemical Society continues to raise the alarm:

Of the 118 elements that make up everything from the compounds in a chemist’s arsenal to consumer products on the shelf – 44 will face supply limitations in the coming years. These critical elements include rare earth elements, precious metals, and even some that are essential to life, like phosphorus.

The vast majority of these are essential to electronics, too – life probably takes precedence, I suppose.

Zinc, gallium, arsenic, germanium, silver, indium, tellurium, helium and hafnium face what ACS is calling a “serious threat in the next 100 years.” This is a call to action for manufacturers in the electronics supply chain. Manufacturers must expand their focus on sustainability to identify the presence, location and purpose of these substances in their products.

The process for determining what these next steps should be goes way beyond the scope of this column, but should include assessing necessity, source of supply and (most importantly) recyclability and reuse. It is becoming increasingly important to find ways to reuse components and materials containing these endangered elements, and (perhaps more challenging for the electronics industry) to find ways to safely and cost-effectively extricate these substances from end-of-life finished goods at a purity level comparable to virgin material.

Visit DCA at www.DesignChainAssociates.com or email the author with any questions or comments on this post.

Statements of fact and opinions expressed in posts by contributors are the responsibility of the authors alone and do not imply an opinion of the officers or the representatives of TTI, Inc. or the TTI Family of Companies.


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
Product regulation, and performance standards such as 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 and in 2014 to the American Chemical Society Green Chemistry Institute
Advisory Board. 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.

View other posts from Mike Kirschner. View other posts from Mike Kirschner.

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