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EU REACH Update for Article Manufacturers

04.25.2012 // Mike Kirschner // Supply Chain

As noted in last year’s MarketEye article on REACH, it is nothing if not dynamic. Last year at this time there were:

  • 46 (SVHC) substances, today there are 73, with 13 more proposed
  • 6 SVHCs that had, just a few days earlier, been added to the authorization annex (Annex XIV) and sent down the path toward restriction – today there are 14 and 13 more on the way
  • Zero Article 7-related notifications by December were 203
  • Zero dossier evaluations (the “E” in REACH); in February European Chemicals Agency (ECHA) published that they had evaluated 146 registration dossiers for completeness
  • Zero substance Evaluations (still more “E”) under the CoRAP process; plans were recently put in place to evaluate 90 substances to determine whether their risk rises to SVHC status

What do these changes mean? How should you, as a component manufacturer or systems manufacturer, deal with this? We’ll review each one at a time:

The Growing SVHC List

Twice a year ECHA adds to the candidate list of substances of very high concern. In the last year 27 substances were added, none of which appear to be particularly interesting to the electronics industry, however in February a new proposal to add 13 substances to the list of SVHCs was floated.

Of critical importance to TTI’s suppliers and customers is the fact that among these substances is diboron trioxide (a.k.a. boron oxide) which is widely used in surface mount resistors and capacitors. Its presence on this list may indicate a future where passives manufacturers must reformulate and their customers msut re-qualify replacement parts. This implies the potential need for time, money and resources across a vast stretch of the electronics industry.

This is a lesson that the SVHC list can hit any category of component; if you’re only worrying today about plastics due to the various phthalates on the list, you’ll likely need to start worrying about passive components. Can metals be far behind?

Note that you can get a look ahead by viewing the SVHC “Registry of Intentions.” This contains a list of substances that EHCA and the member states intend to submit dossiers on to propose their inclusion in the SVHC list. As I write, an interesting one is perfluorooctanic acid (PFOA), used in semiconductor photoresist – while PFOA usually doesn’t end up in electronic products, this should raise a flag for those using it in European fabs. Two additional phthalates are on the list as well.

Authorization

Even though authorization doesn’t directly impact non-EU producers of articles which are imported in to the EU it’s only a concern if the authorized substance is used in the supply chain within the EU), it still points to the fact that:

  • You need to have a solid understanding of your supply chain to ensure that, in fact, it does NOT run through the EU.
  • More commonly used substances are on their way to the restriction chopping block. Don’t forget that ECHA’s goal is that restriction is the ultimate fate of any SVHC!

Today you (or, if your company is not in the EU or European Economic Area, your importer or only representative) can begin the application process if you want to try to get your use of a substance authorized in the EU for 14 SVHC substances. If you buy a substance, such as DEHP, in the EU from a supplier that has registered it then they must apply. Note that applications are for a specific use and a specific supply chain.

Notification

According to Article 7 of REACH, if you sell articles in the EU/EEA, and in aggregate over the period of one year they contain over one metric ton of an SVHC substance, you must notify ECHA within 6 months of that SVHC appearing on the candidate list. Note that you only have to do this if your use is not covered by the existing registration. This is an ongoing responsibility since new substances are added to the candidate list of SVHCs biannually.

In early March, ECHA published information about the 203 notifications made between June 1, 2011 (when the requirement began) and December 31, 2011. The greatest number of notifications was for the four phthalates. DEHP led the pack with 88 notifications and flame retardant HBCDD had the second highest quantity.

An analysis of the uses related to the DEHP notifications, however, indicates that many were for common uses. While the ECHA registration database, IUCLID 5, has use categories, it is insufficient in and of itself to determine whether your use is already covered by a registration. Section 6.4.1 of the Guidance on Substances in Articles confirms that, in fact, you need to contact the registrants to understand more precisely the uses they cover in their registrations. A quick search of the web led to the DEHP consortium that had registered the substance. On their website is a file that describes the uses covered by their registration and, sure enough, they cover common uses of DEHP such as:

  • Cables and wires
  • Gaskets
  • Packaging (such as PVC)

All of which, and more, are uses companies notified to ECHA per Article 7. Bottom line: do you homework before you decide you need to notify ECHA of the presence of SVHCs in articles you sell in the EU!

Evaluation

Evaluation (the “E” in REACH) focuses on three different areas:

  1. Examination of testing proposals submitted by registrants
  2. Compliance check of the dossiers submitted by registrants
  3. Substance evaluation, in the form of the Community Rolling Action Plan (CoRAP)

The first area relates to the use of animals when testing is required to fulfill reporting requirements. The EU wants to avoid as much animal testing as is possible so reviews all these proposals in advance.

The second area evaluates dossiers on a sample basis (the requirement is to evaluate 5% of all registrations received for each tonnage band) for completeness and correctness more qualitatively than the registration process does. In this case, of the 146 dossiers evaluated so far they found 105 – 72% required additional information.

ECHA’s annual report on these two areas is available here.

Finally, the third area selects specific substances for which the data provided, and their own analysis, leads to a desire to assess more deeply the potential for risk. The potential is for these substances to be placed on a track for consideration as SVHCs. The CoRAP process (they had to put that “o” in there…) spreads this analysis out across EU Member State resources and over three years for 90 substances. Some of the substances are extremely important to the electronics industry, including:

  • Silicon Dioxide
  • Gallium Arsenide
  • Toluene
  • Titanium Dioxide

All manufacturers should be aware of this process and understand its implications. You can learn more at ECHA’s Community Rolling Action Plan web page.

There is much more to REACH than we are able to cover here. Contact DCA for more information and if you have questions about REACH.

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

Featured Contributor:
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. ( More... )

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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