Conformity Magazine - July 2008 - (Page 32)

of those substances may occur in a concentration over 0.1% (of whatever it ends up being – or if unresolved, pick the worst case) and go after that. And while you’re at it, use a standard material disclosure format like IPC-1752, class 5 or 6 until it too is revised for REACH. This will make your task and, importantly, your supply network’s task, easier. The other issue to keep in mind is that the SVHC candidate list (or Annex XIV in the REACH regulation) is not static; it can and will be updated. Under these conditions, it’s important to put in place a mechanism to keep substance information flowing quickly and easily through your supply network. Trying to obtain full material disclosure and contractually obligating suppliers to notify you when substances change is one approach. The Article 7 issue is narrower but potentially more onerous. Producers or importers of articles which intentionally release a substance, regardless of what the substance is, during normal and reasonably foreseeable conditions of use in quantities totaling over one metric ton per producer or importer per year, must register the substance. If the substance is a candidate SVHC, you also must notify the European Chemicals Agency. There are few obvious situations in electronics where this is the case; one example is electronic air fresheners. But then the definition of “intended release” is perhaps not as explicit or concise as we engineers would like it to be. The draft guidance does provide a reasonable set of examples, and indicates for instance that normal wear and tear (such as for automobile tires, brake linings, bearings, and lubricants) is not considered “intended release.” Business and Supply Network Risks of REACH Since most article manufacturers at the OEM level tend not to directly use individual substances or import them in to the EU, the legal obligations most article companies will face under REACH are not so extensive, but the regulatory obligation back upstream in the supply network could in fact be quite significant. Your supplier’s failure or desire not to register a substance used in your product could potentially result in your being locked out of the EU market or, worse yet, having no product to ship. So an important non-regulatory obligation is to determine where the risk of disruption lies in your supply network if you are an article manufacturer, and that’s really an obligation to your key stakeholders like employees, investors, and customers. Make sure that your supply network understands REACH and companies upstream that need to pre-register will do so or, if not, what their plans are. We expect this to be an important source of supply network disruptions. ASTM’s F40 committee has developed guidance on supply chain communications, which is now available and can help with this task. 32 Conformity JULy 2008 We have been hearing from some of our component manufacturing clients that they are being told that some of their suppliers will no longer produce certain substances, formulations, or products, or that they’ll change the recipe. While you may find out about these issues by passively waiting for Product Change Notices, you will do yourselves and your company a favor by taking a proactive approach, and asking your suppliers whether they have reviewed their supply networks, what if anything is going to change, and when and how is it is expected to change. What to Do If You Must Register If your company exports articles to the EU, and you determine that you have notification or registration requirements, then compliance on your behalf must be ensured by your EUbased division(s) if you have any, your EU-based importer, or a third party operating on your behalf (called an “only representative”). If you have no EU-based divisions then you may choose your importer or “only representative.” The FAQ on the European Chemicals Agency website (see links, below) points out that it is possible that the information required may be considered confidential and you may not want to disclose it to your importer. In that case, you should consider an “only representative” in combination with a third-party representative. The only representative does all the legal interaction on your behalf, and also bears all legal responsibility and liability, while the third party effectively shields your company’s identity from public (but not ECHA) view. If you have a registration obligation, it is imperative that you pre-register the required substance(s) with the obligation. Pre-registration takes places between June 1 and December 1, 2008 only. If you do not pre-register, you will be unable to take advantage of the extended timeframes for registration (between 2010 and 2018, based on annual volume of the substance placed on the EU market) and will have to register immediately upon your next shipment, or your product will be barred from the EU market. You can learn more about the pre-registration process at the European Chemicals Agency website, www.echa.eu. Guidance Documents While several industry organizations have produced guidance documents for their membership that are well-worth reviewing (particularly if you are a member or sell in to those industries – these are listed below), the set of official European Union guidance documents, called “RIP”s (for “REACH Implementation Projects”), are of primary importance to read. Specifically, RIP 3.8, the “technical guidance document on requirements for substances in articles” should be read and understood by everyone selling articles, and those who think that they may be selling articles, in to the European Union. http://www.echa.eu

Table of Contents Feed for the Digital Edition of Conformity Magazine - July 2008

Conformity Magazine - July 2008 Contents Editor's Note FCC Adopts 6 Million Dollars in DTV Enforcement Orders Commission Enforcement Bureau Adopts V-Chip Consent Decree FDA Seeks 2 Million Dollars from Medical Device Manufacturer FDA Answers Questions About CFLs and UV Radiation EPA Issues Energy Star Specs for TV, Video Boxes Canada Unveils Sweeping Product Safety Legislation How the Evolution of CISPR Standards Continues to Shape the Requirements for Anechoic Chambers ESD Open Forum Reach Compliance for Non-EU Article Manufacturers The iNARTE Informer Preamplifier Considerations for Emission Measurement Systems Effective Shielding in Medical Electronics Applications Product News Focus On...Power Components Buyer's Guide Updated Standards List for the EU's ATEX Directive EOS/ESD Symposium Set for September CPSC Actions in the News Researchers Work to Develop Non-Flammable Batteries Safety Link Launches Redesigned, Enhanced Web Site IEC Standards Update UL Standards Update Product Reviews Telcordia Standards Update From Our "You Can't Make This Stuff Up" Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - July 2008

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