Appliance Design - November 2008 - (Page 36)

QUALITY & STANDARDS Fig. 1. Timeline for REACH regulation. safety handling guidelines. If, however, a producer or importer can prove that humans or the environment are not exposed to the SVHC through normal or foreseeable use including disposal of the article, they are not required to notify the ECHA of the SVHCs in the article. Substance registration The REACH Regulation has two categories of substances that require registration: Non-phase in substances: These substances Non-phase have not been manufactured or placed on the EU market prior to the REACH Regulation being put into force. Phase in substances: These are substances Phase that are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) or chemicals that have been produced in the EU but have not been placed on the market in the EU since 1992. A non-phase in substance must be registered with the ECHA before it can be placed on the market in the EU. As the registration requirements are rather stringent and comprehensive, the registration process can be costly to companies – estimated to cost between € 2.8 billion and € 5.2 billion total, and some have even argued that the REACH Regulation is actually a barrier to trade. The EU has rebutted those accusations with the allowance of consortia or Substances Information Exchange Fora (SIEF) for data sharing (for those importers/producers who have taken advantage of pre-registration), Only-Representative agreements for foreign producers and other potential cost-saving tools. The verdict is still out as to how much money the provided tools from the EU will actually save the downstream users. 36 applianceDESIGN November 2008 Phase-in substances have a more lenient timeframe for registration as compared to the non-phase in substances. These substances have three different registration periods based on the annual sales tonnage. A. Pre-registration – June 1, 2008 to December 1, 2008. 1. Phase-in substances can be pre-registered which allows the importer/producer to take advantage of the extended registration periods (detailed below). B. 3 1/2 years after REACH entered into force (Dec. 1, 2010). 1. Substances that exceed 1,000 ton per year per importer or producer. 2. Substances that exceed 1 ton per year that are deemed to be a CMR (both for category 1 and 2). a. Category 1 CMRs: substances and preparations that are known to be CMR for humans. b. Category 2 CMRs: substances and preparations for which human exposure to such substances and preparations is strongly suspected to cause or increase the frequency of appearance of CMR effects. C. 6 years after REACH entered into force (June 1, 2013). 1. Substances that exceed 100 tonnes per year per importer or producer. D. 11 years after REACH entered into force (June 1, 2018). 1. Substances that exceed 1 tonne per year per importer or producer. Communication of the presence of each substance is not required until six months after the substance has been identified on an SVHC candidate list. The first notification will not be required until December 2011. This should allow producers or importers sufficient time to gather the required information in order to make the proper notification. Implications The reality of the REACH Regulation is that article manufacturers worldwide will receive requests from their downstream users to identify potential SVHCs that are present in their articles or products. Suppliers will be expected to provide information pertaining to all substances used in the production of their products/articles, including the disclosure of proprietary information. The producers/ importers of articles placed on the market in the EU will need to obtain this information in order to comply with REACH registration and notification obligations. Currently, industry leaders are taking a proactive approach to complying with the REACH Regulation, simply because of the complexity of the regulation. Due to the detailed information that is to be supplied to the ECHA, communication throughout the entire supply chain will be required to provide the proper registration and notification information. Where suppliers and downstream users were able to maintain business relationships with minimal communication and exchange of information on supplied materials, the REACH Regulation will simply not support the existence of those types of relationships. It is expected that the first requests from producer/importers to their supply chain will be rather muddy. The majority of the companies outside the EU community are unprepared or unable to provide this type www.applianceDESIGN.com http://www.appliancedesign.com

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Appliance Design - November 2008

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