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REACH Update: A Status Report Nearly One Year Before the First Registration Deadline
By: Annelie Struessmann, PhD, CONUSBAT
Posted: October 20, 2009
The challenge that REACH imposes on registrants becomes evident while performing the steps necessary for compliance and while facing the magnitude of regulatory knowledge and cutting-edge science skills required. More than 20 guidance documents and other publications have been published by the European Chemicals Agency (ECHA) to complement the legal framework and help in understanding the provisions. However, these documents and publications are challenging in and of themselves, as they comprise thousands of pages of legal and scientific elaborations.
Further EU rules and regulations, specifically the community's competition rules, apply to the provisions of REACH regulations and have been considered for the compliance procedures. Knowledge of the aforementioned elements is required when performing the steps for compliance—steps that have never been taken before; for example, SIEF formation, exchange of data and joint dossier submissions. Beyond these steps, comprehensive work in the areas of chemistry, toxicology, chemical processing, data processing, etc., is required in order to complete the technical dossier and the chemical safety report.
The additional dissemination of REACH contents provided by ECHA includes stakeholder events such as round tables and workshops, many of which can be followed online. The most recent event, directed toward lead registrants (LRs), was held in Brussels on Sept. 11, 2009. Contributions to this workshop and to earlier events can be viewed as videos on the ECHA's Web site where additional information about upcoming events is also listed. However, in spite of the guidance provided, ECHA's help desk receives another 600-700 REACH-related questions each month.
In April 2009, ECHA called on companies to become involved in SIEFs in anticipation of the 2010 registration deadline. For more information regarding this request, see the REACH update from May 2009, "ECHA Urges Companies to Organize SIEFs." At that time, communication and start-up difficulties had been reported and during the LR workshop in September, these difficulties were substantiated as having been caused either by the complexity of REACH matter, unprofessional or profit-oriented SIEF formation facilitators, large numbers of SIEF participants or language difficulties stemming from multicultural backgrounds in the EU. Additionally, some consortia involved were described as being non-transparent.
The role and professional performance of an LR was found to be the most crucial for a successful registration. To support SIEFs, ECHA will begin a public relations campaign and provide further help to LRs through a series of webinars and a Web forum. Both Web features will only be accessible to LRs, who must sign up at the ECHA Web site.