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ePT--the Electronic Newsletter of Pharmaceutical Technology
The European Chemical Industry Council and five national chemical associations representing France, Germany, Italy, Spain, and the United Kingdom, have launched ReachLink. ReachLink is a company founded to help companies participate in the Substance Information Exchange Forum (SIEF), which is designed as an information-sharing vehicle to facilitate companies in meeting requirements under REACH
Brussels (Aug. 28)-The European Chemical Industry Council (CEFIC) and five national chemical associations representing France, Germany, Italy, Spain, and the United Kingdom, have launched ReachLink. ReachLink is a company founded to help companies participate in the Substance Information Exchange Forum (SIEF), which is designed as an information-sharing vehicle to facilitate companies in meeting requirements under REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals), a new European Union regulation regarding registration of chemicals and their safe use.
REACH came into force in the EU on June 1, 2007, with the goal of establishing a uniform system for assessing the risk posed by new and existing chemicals. Under REACH, approximately 30,000 substances have to be registered by 2018 with the European Chemicals Agency. All companies importing or manufacturing chemical substances in quantities greater than 1 metric ton must submit registration dossiers. Preregistration is from June 1, 2008, to Dec.1, 2008.
Under SIEF, companies will be able to exchange test and other data on their identical chemical substances as a means to reduce costs and time by allowing communication through a structured channel. ReachLink makes available a European SIEF management information technology (IT) system to all European chemical and related companies that are affected by REACH. SIEFreach, as the system is called, is a web-based and industry-wide shared IT platform that went into effect Aug. 21, 2008.
SIEFreach is designed to allow companies to organize the exchange of information in a user-friendly format. It consists of the SIEFreach application and portal. It was designed and developed and is maintained by IBM. The IT platform is based on IBM WebSphere and Lotus collaboration software and is hosted by IBM. In addition to the hosting, IBM will also provide application helpdesk for the end user.
CEFIC also has published several guidances to assist companies in REACH compliance. These include Preparation for Preregistration, published in April 2008, and the Guidance on SIEF Formation, published in June 2008. A third guidance document on working together in SIEF and data and cost sharing is planned for mid-October 2008.
Information on REACH implementation may be found at the websites of CEFICand the European Chemicals Agency.