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REACH Update: Pre-registration—A Case Report
Posted: September 8, 2008
At the start of REACH implementation, there was a list of raw materials mainly used as ingredients in cosmetic products that were sorted by trade names. In REACH terms, most of these products were preparations, mixtures or solutions composed of two or more substances. So, at first, the components had to be identified qualitatively and quantitatively. The REACH substance inventory was created using a spreadsheet, and its consistent and precise transfer quickly made it an important management tool for REACH compliance processes.
50 substances were identified exceeding the import volume threshold of 1 ton/year. All substances could be described with EINECS numbers, which were carefully checked in the European Chemical Substances Information System (ESIS), http://ecb.jrc.it/esis. The availability of EINECS numbers made all substances phase-in substances. Consequently, they were admissible for pre-registration, and the registration can be executed at the respective extended deadlines of the REACH schedule.
The pre-registration procedures were started by logging on to REACH-IT on the ECHA Web site at https://reach-it.echa.europa.eu/reach/public/welcome.faces. Upon initial login, the terms and conditions of use must be accepted. The company account with user-ID, password and billing information then was created and a company Universal Unique Identifier (UUID) was obtained. No problem or difficulty arose, and the URL of the REACH-IT login page was saved as a favorite on the Web browser. After starting this login and entering the user ID and password, the personal REACH-IT access opens, which is used anytime a pre-registration or other information is submitted to the ECHA. Also, any email response from the ECHA on the processing status and any ECHA information related to SIEFs and pre-SIEFs is accessed from here.
The next hurdle was the pre-registration software format. Having 50 substances to pre-register and knowing that bulk pre-registration was advised and now available on REACH-IT at http://echa.europa.eu/doc/reachit/bulk_submission_manual.pdf, after start-up difficulties had been solved, either a IUCLID 5 or a XML submission was to be decided on. As recommended in cases where IUCLID 5 had not been used before, the XML format was chosen. All information on software was available on the IUCLID 5 page of the ECHA Web site; however, a pre-registration template and bulk pre-registration tool for XML created by Cefic and Concawe was used. This can be downloaded for free at http://www.cefic.be/Templates/shwNewsFull.asp?HID=1&NSID=698 or http://www.concawe.be/Content/Default.asp?PageID=469 and was found helpful and time saving as it also came with a well structured online tutorial allowing its users to understand each step easily.
Substances in the substance inventory were sorted in order of EINECS numbers. This information was copied and pasted in the template and bulk pre-registration tool. Also the company UUID, the contact and information on similar substances had to be provided. Just by pressing a button, the XML file, according to REACH-IT requirements, was created and saved on the personal computer. The final step was to download this XML file via the personal access into REACH-IT. The successful submission was immediately confirmed. A submission report with substance reference numbers (pre-registration numbers) was obtained from the ECHA several hours later. As it had been indicated, the bulk file is stored in a staging area for 6 hours, to ensure that the virus scanner is updated and the file can be processed safely.