Conformity Magazine - July 2008 - (Page 29)

As I write this in early April 2008, about half the substances that could ultimately be on the SVHC candidate list are already known, and various industry groups and environmental advocacy groups are trying to guess the rest; a draft listing is expected to be available by the time this article is published. The SVHC candidates consist of substances that are known or suspected to be: • Carcinogenic, mutagenic, or toxic for reproduction (CMR) category 1 or 22; • Substances which are: ° ° base metal alloy stock the wire is made from can come in any of several shapes and the particular composition of it in that state is more important than the shape, so it is not an article. With a description this vague there are, of course, borderline situations, and the Commission Working Group (CWG) has already proposed resolutions to some of those. For example, the electronics industry argued that full ink and toner cartridges sold in the EU should be considered articles (that intentionally release a substance or preparation/mixture). However, the determination was made by the CWG that the empty ink and toner cartridges are indeed considered articles, while the ink or toner filling them is considered a “preparation in a container” and is subject to registration according to article 6 of REACH (which is beyond the scope of this article). There continue to be unclear cases and a methodology has been proposed for determining whether a product is or is not an article. This has been published in Appendix 2 of the revised final draft guidance (dated December 2007) on substances in Articles (RIP3.8), which will hopefully be finalized and available for reference by the time this article is published. The requirements for article manufacturers revolve primarily around the SVHC class of substances, as well as intentionally Persistent, bioaccumulative and toxic (PBT); or Very persistent and very bioaccumulative (vPvB); • Endocrine disruptors, or have any other property giving rise to an equivalent level of concern. The European Union (EU) wants to make sure that the applications of these substances are known, and the substances are either not hazardous (i.e., do not have properties as described above), or are controlled throughout their lifecycle so that exposure, and therefore risk (defined as a function of hazard and exposure), is minimized. “Article” Defined Before we go any further, let’s describe in a practical sense what “article” really refers to. The REACH regulation, in article 3 paragraph (3), defines an article as: “…an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.” “Articles” include wires, lamps, diodes, computers, automobiles, screws, chairs, shirts, etc. Deconstructing a wire into insulation and bare wire still results in articles. However, the bar stock(s) that the wire is produced from and the raw polymeric material the insulation is produced from are not articles. Insulation can be made from many materials, but it must surround the wire; therefore, its shape is more important than its “chemical composition.” Likewise, a wire must be a certain shape; it can be made of many different substances that can help determine its shape or diameter based on desired current carrying capacity or other parameters. The JULy 2008 Conformity 29 http://www.spira-emi.com http://www.spira-emi.com

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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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