REACH Update: A Status Report Nearly One Year Before the First Registration Deadline

Oct 20, 2009 | Contact Author | By: Annelie Struessmann, PhD, CONUSBAT
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Title: REACH Update: A Status Report Nearly One Year Before the First Registration Deadline
  • Article

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.

On Sept. 30, 2009, the number of SIEFs with active LRs totaled 1,766, as published on the ECHA Web site. In addition, the number of submitted registration dossiers in August 2009 reached 578, with only 109 registrations completed.

As the first deadline will be reached in December 2010, all these steps will have been performed in less than two years, as the ECHA performs checks on completeness of the dossiers. Checking that all requirements are met will take several weeks, especially if a registration dossier is found to be incomplete and/or the payment of the registration fee is missing.

If this is the case, the registrant will be granted a period of time for re-submission; however, if the registrant fails to complete the submission within the given deadline for a second time, the ECHA will reject it. It should also be noted that after a rejection, the registration fee will not be reimbursed and the company will not be allowed to manufacture or import this substance within the EU. And if the registration is made by a lead registrant, the consequences will apply to all joint registrants.

Key Summary
• The challenges of REACH are based in a large quantity of legal texts and require comprehensive technical skills
• All the steps to compliance must be taken in a yet-unknown environment
• For the dissemination of REACH contents, ECHA provides guidance documentation and videos as well as stakeholder events
• The formation and management of SIEFs still involves difficulties
• ECHA will provide further guidance tools to support SIEFs, specifically in support of LRs
• LRs bear the main responsibility for registration
• Failed completion of a registration leads to rejection, a non-reimbursable registration fee, and ceased manufacture or importation in the EU
• The consequences of a rejection apply to all registrants in a joint submission

To read or submit additional questions regarding REACH, visit C&T magazine online's REACH Round Table.

*Readers are reminded that this free service provides basic answers to questions about REACH, but in-depth, consultative services are provided by CONUSBAT for a fee. CONUSBAT reserves the right to determine what information can be provided at no cost, and to refer readers to its services when detailed information is requested.