Beverage manufacturing plant with employee working

My October MarketEYE column originally stated that lead in glass or ceramic is reportable as an SVHC. A few weeks after it was published, Walter Jager of ECD Compliance sent me an email that said, “Are you sure about that, Mike?”

We went back and forth discussing it; Walter, the very knowledgeable consultant that he is, made some good points. So I pulled the column, reached out to some Ph.D. chemists and got back in touch with ECHA on the subject to ask for clarification.

While my chemist buddies couldn’t help because they are not glass, or REACH, experts, ECHA continued to provide guidance that was unclear to me. Meanwhile, I eventually replaced that segment because I was increasingly unsure that I was interpreting this correctly.

I also reached out to another very knowledgeable colleague, Randy Flinders of GreenSoft Technology, Inc., when I saw his blog that contradicted my interpretation. Randy and his communication from a different person at ECHA made the point, clearly, that glass ultimately has its own chemical composition and, by definition, is a different substance from lead. And the light bulb went on. (Walter had also made this point to me! Apparently, I needed to be virtually kicked in the head several times for it to sink in…)

The SVHC entry for lead (Pb) is the metal, not a different substance where the lead is bound to other elements. This is why lead monoxide (PbO), for instance, continues to have its own entry in the candidate list. While there are several other lead compounds in the list as well, not all lead compounds that exist are included. Lead glass is one (or, actually, many) of them.

Lead is disclosable, therefore, as an SVHC due to its presence in metal alloys like brass or high-lead-content solder that would be found in electronics due to EU RoHS exemptions, including the 6-series, 7(a) or 15/15(a). However, lead may also be used in certain RoHS-exempt applications where it is part of a different substance, such as in glass or ceramic (e.g. EU RoHS exemptions 7(c)-I or 13(a)) because these exemptions state that it must be in glass or ceramic to be able to take the exemption.

Metallic lead used in these applications may be disclosable as an SVHC under REACH; if it is bound to the ceramic or glass matrix and is part of the ceramic or glass substance, then it is not disclosable as an SVHC.

Saudi Arabia RoHS

In 2018, the GCC Standardization Organization (GSO), which is a Regional Standardization Organization for the Arab State members of the Gulf Cooperation Council (GCC), issued a draft RoHS-like regulation. We have not heard from them since.

Last month, Saudi Arabia issued a draft RoHS-like regulation to the World Trade Organization Technical Barriers to Trade (WTO TBT) Committee. They then cancelled the draft and replaced it on December 1, but without the text of the proposed regulation. On December 4, they finally reissued an updated text. While an English translation is not yet available, Google Translate comes to the rescue (sort of).

Prior to the initial WTO TBT release, another version had been posted on the Saudi Standards, Metrology and Quality Organization (SASO) website that was similar, but included an appendix listing exemptions. That exemption listing is not included in the WTO TBT draft.

Generally, while far from harmonized, the draft is based on the structure and content of the EU RoHS Directive, 2011/65/EU. For instance:

  • Eight product categories are listed, but not all correlate to EU RoHS, so there are scope differences. The WTO TBT notification does list HS codes for products covered, so that may help assess the scope. But those HS codes are not listed in the regulation itself.
  • The list of ten restricted substances is consistent with the current list restricted by EU RoHS.
  • The obligation to create a technical document file appears to be the same, as do a number of other typical manufacturer/importer obligations.

What is not consistent is the requirement for conformity assessment. The manufacturer (or the manufacturer’s Saudi importer/distributor) must submit a Declaration of Conformity (defined in Appendix 4), a “risk assessment document” and safe use instructions. The draft mentions obtaining test reports, but also references IEC 63000 which requires a risk-based approach to assessing compliance that may (or may not) include test.

Appendix 3 describes two approval approaches: one is the “examination” (i.e. test) of a sample of the product, while the other is a review of the technical documents and product manuals along with a product sample “of one or more of the risky parts of the product.” This sounds reminiscent of UAE RoHS, where one of the options is to submit test reports on three “risky” components. What makes a component or material “risky” is not defined.

As far as the “examination” of a product sample, test is not conclusive regarding compliance unless it is done on the homogeneous substances that comprise a product and its component parts. Nor is test conclusive under any circumstance since it only reflects the specific lot tested. Process control, design specs and full material disclosures result in a far better and more defensible conclusion of RoHS compliance. But test absolutely has its place when these are not available or are suspect; so does finding a more trustworthy supplier.

In addition, the draft seems to make mandatory certain voluntary standards like ISO 9001 and IEC 62476. If so, this is a far more radical requirement than they may imagine it to be.

January 19, 2021 is the final date for comments to your WTO TBT enquiry point (in the U.S., this is handled by NIST – sign up if you’re not already receiving notices). Curiously, Saudi Arabia says the proposed date of adoption is January 7. The proposed date of entry into force is June 7, 2021.

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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